POISONS
STANDARD 2014
I, ANTHONY GILL, a delegate of
the Secretary to the Department of Health for the purposes of paragraph
52D(2)(b) of the Therapeutic Goods Act 1989 (the Act) and acting in
accordance with the Secretary’s power under that paragraph of the Act, prepare
this new Poisons Standard, in substitution for the current Poisons Standard.
(Signed by)
ANTHONY GILL
Delegate of the Secretary to the
Department of Health
Dated this 8th of October
2014
1.
Citation
This instrument is the Poisons
Standard 2014.
2.
The New Poisons Standard
The Poisons Standard 2014 consists
of the Standard for the Uniform Scheduling of Medicines and Poisons No. 5 (the
SUSMP5) as set out in Schedule 1.
3.
Commencement
The Poisons Standard 2014 commences
on the day after registration.
Schedule
1-Standard for the Uniform Scheduling of Medicines and Poisons No. 5
STANDARD FOR THE UNIFORM SCHEDULING OF
MEDICINES AND POISONS
No. 5
October
2014
The amendments listed in
this document are a result of decisions made by the Secretary of the Department
of Health or the Secretary’s Delegate in July 2014. The basis of these
amendments can be found in the ‘Reasons for scheduling delegate’s final
decisions’, which can be accessed from the TGA website at http://www.tga.gov.au/industry/scheduling-decisions-final.htm.
Further
inquiries should be directed to:
Media
Liaison Unit
Australian
Government Department of Health
Contents
INTRODUCTION.. iii
CLASSIFICATION.. iv
PRINCIPLES OF SCHEDULING.. iv
READING THE SCHEDULES. v
Availability
of poisons. vi
Preparations
containing poisons listed in two or more Schedules. vi
PART
1 - INTERPRETATION.. 2
PART
2 - LABELS AND CONTAINERS. 11
LABELS. 11
General requirements. 11
Immediate wrapper 11
Primary packs and immediate
containers. 11
Statements of
quantity, proportion or strength. 17
Exemptions. 18
Selected containers and measure packs. 18
Ampoules, pre-filled syringes and injection vials. 18
Transport containers and wrappings. 19
Dispensary, industrial, laboratory and manufacturing poisons. 19
Exemptions from label requirements in certain circumstances. 19
Dispensed medicines. 20
Gas cylinders. 20
Paints. 20
Camphor and naphthalene. 21
Prohibitions. 21
CONTAINERS. 21
Containers for poisons other than
Schedule 5 poisons. 21
Containers for
Schedule 5 poisons. 22
Approved containers. 22
Child-resistant
closures. 23
Schedule 8 poisons. 25
Exemptions. 25
Camphor and
naphthalene. 25
Prohibitions. 26
PART
3 - MISCELLANEOUS REGULATIONS. 27
ADVERTISING.. 27
SALE OR SUPPLY.. 27
Schedule 2 poisons. 27
Schedule 3 poisons. 27
Schedule 4 poisons. 28
Schedule 7 poisons. 28
PROHIBITIONS ON SALE,
PRESCRIBING AND POSSESSION.. 28
STORAGE.. 29
PART 4 - THE SCHEDULES. 31
SCHEDULE 1. 32
SCHEDULE 2. 33
SCHEDULE 3. 49
SCHEDULE 4. 55
SCHEDULE 5. 136
SCHEDULE 6. 165
SCHEDULE 7. 204
SCHEDULE 8. 215
SCHEDULE 9. 218
PART 5 - THE APPENDICES. 224
APPENDIX A - General exemptions. 225
APPENDIX B - Substances considered not to require control by scheduling 228
APPENDIX C - Substances, other than
those included in Schedule 9, of such danger to health as to warrant prohibition of sale, supply and
use. 237
APPENDIX D - Additional controls on possession or supply of poisons included in Schedule
4 or 8. 241
APPENDIX E - First aid instructions for
poisons. 243
APPENDIX F - Warning statements and general safety directions for poisons. 259
APPENDIX G - Dilute preparations. 283
APPENDIX H - Schedule 3 poisons permitted to be advertised. 284
APPENDIX I - Uniform Paint Standard. 285
APPENDIX J - Conditions for availability and use of Schedule 7 poisons. 287
APPENDIX K - Drugs required to be labelled with a sedation warning. 290
APPENDIX L - Requirements for dispensing labels for human and veterinary medicines. 293
The Poisons Standard 2014, which, under
section 2 above consists of the Standard for the
Uniform Scheduling of Medicines and Poisons (the Standard, or
the SUSMP), is made under paragraph 52D(2)(b) of the Therapeutic Goods Act
1989, and is a compilation of the decisions made under section 52D of the
same Act. The SUSMP should be read in conjunction with the Scheduling
Policy Framework (SPF) of the National Coordinating Committee on
Therapeutic Goods. Further information on the scheduling amendments and the
SPF can be accessed at www.tga.gov.au. Refer to Part 1, Interpretation,
on page 2 below for definitions of specific terms used in this document
including “medicine” and “poison” (noting that the definition of poison
includes medicine).
The SUSMP serves two key purposes.
Firstly, the SUSMP contains the decisions
of the Secretary of the Department of Health or the Secretary's delegates
regarding the classification of poisons into Schedules, as recommendations to
Australian States and Territories. The scheduling classification sets the
level of control on the availability of poisons. The scheduling of poisons is
implemented through relevant State and Territory legislation. Certain
advertising, labelling and packaging requirements may also be a consequence of
scheduling, but are the subject of other Commonwealth registration schemes.
Secondly, the SUSMP includes model
provisions for labelling, containers, storage and possession of poisons in
general, which are intended to be adopted for use in each jurisdiction of
Australia, according to local requirements and local law. Appropriate
labelling and container requirements for products, other than therapeutic goods
and agricultural and veterinary chemicals, are imposed through adoption of
Parts 1, 2 and 3 of the SUSMP into State or Territory legislation. Other
government agencies may also impose controls on certain products, for example
cosmetics.
The requirements for labelling and
containers in the SUSMP are intended to integrate with existing legislative
instruments for labelling and containers. Advertising, labelling and packaging
of therapeutic goods and agricultural and veterinary chemicals are also dealt
with through the respective product registration schemes provided for in
Commonwealth legislation.
Poisons which are packed and sold solely
for industrial, manufacturing, laboratory or dispensary use are exempt from all
labelling requirements included in the SUSMP as they are covered by Safe Work Australia's National Code
of Practice for the Labelling of Workplace Substances [NOHSC: 2012(1994)]. Note, however that this exemption does not extend to
controls on supply of these poisons.
The SUSMP is presented with a view to
promoting uniform:
- scheduling of poisons
throughout Australia;
- signal headings on labels
for poisons throughout Australia;
- labelling and packaging
requirements for poisons throughout Australia;
- additional controls on
the availability and use of poisons in Australia.
The various Commonwealth Acts, legislative
instruments and other documents which integrate with the SUSMP include:
- the Agricultural and
Veterinary Chemicals Code Act 1994
- the Agricultural and
Veterinary Chemicals Code Regulations 1995
- the Therapeutic Goods
Act 1989
- Therapeutic Goods Order 69 – General
requirements for labels for medicines
- Therapeutic
Goods Order 80
– Child-Resistant Packaging Requirements for Medicines
- the Required Advisory
Statements for Medicine Labels (RASML).
Poisons are classified according to the
Schedules in which they are included. The following is a general description
of the Schedules. For the legal definitions, however, it is necessary to check
with each relevant State or Territory authority.
Schedule
1. This
Schedule is intentionally blank.
Schedule
2. Pharmacy Medicine – Substances, the safe use of which may require
advice from a pharmacist and which should be available from a pharmacy or,
where a pharmacy service is not available, from a licensed person.
Schedule
3. Pharmacist Only Medicine – Substances, the safe use of which
requires professional advice but which should be available to the public from a
pharmacist without a prescription.
Schedule
4. Prescription Only Medicine, or Prescription Animal Remedy –
Substances, the use or supply of which should be by or on the order of persons
permitted by State or Territory legislation to prescribe and should be
available from a pharmacist on prescription.
Schedule
5. Caution – Substances with a low potential for causing harm, the extent of
which can be reduced through the use of appropriate packaging with simple
warnings and safety directions on the label.
Schedule
6. Poison – Substances with a moderate potential for causing harm, the
extent of which can be reduced through the use of distinctive packaging with
strong warnings and safety directions on the label.
Schedule
7. Dangerous Poison – Substances with a high potential for causing harm at low exposure and
which require special precautions during manufacture, handling or use. These
poisons should be available only to specialised or authorised users who have
the skills necessary to handle them safely. Special regulations restricting
their availability, possession, storage or use may apply.
Schedule
8. Controlled Drug – Substances which should be available for use but
require restriction of manufacture, supply, distribution, possession and use to
reduce abuse, misuse and physical or psychological dependence.
Schedule
9. Prohibited Substance – Substances which may be abused or misused, the manufacture,
possession, sale or use of which should be prohibited by law except when
required for medical or scientific research, or for analytical, teaching or
training purposes with approval of Commonwealth and/or State or Territory
Health Authorities.
Poisons are not scheduled on the basis of
a universal scale of toxicity. Although toxicity is one of the factors
considered, and is itself a complex of factors, the decision to include a
substance in a particular Schedule also takes into account many other criteria
such as the purpose of use, potential for abuse, safety in use and the need for
the substance.
This Standard lists poisons in nine
Schedules according to the degree of control recommended to be exercised over
their availability to the public.
Poisons for therapeutic use (medicines)
are mostly included in Schedules 2, 3, 4 and 8 with progression through these Schedules
signifying increasingly restrictive regulatory controls.
For some medicines and agricultural,
domestic and industrial poisons, Schedules 5, 6 and 7 represent increasingly
stricter container and labelling requirements with special regulatory controls
over the availability of the poisons listed in Schedule 7. Products for
domestic use must not include poisons listed in Schedule 7.
Schedule 9 contains substances that should
be available only for teaching, training, medical or scientific research
including clinical trials conducted with the approval of Commonwealth and/or
State and Territory health authorities. Although appearing as a Schedule in
this Standard, the method by which it is implemented in the States and
Territories may vary.
Substances in products which have been
considered for scheduling, but have been exempted from this Standard, may be
listed in either Appendix A (general exemptions) or Appendix B (substances
considered not to require control by scheduling).
Appendix C contains a list of substances
or preparations, the sale, supply or use of which should be prohibited because
of their known dangerous properties. It is recommended that the provisions of
this Appendix be put into effect through inclusion of the substances in
appropriate State and Territory legislation.
Schedule entries have been designed to be
as simple as possible while retaining readability, legal integrity and as much
freedom from ambiguity and contradiction as possible. As a result, they are
expressed in a number of ways, though this number has been kept to a minimum.
It is necessary to keep this variety of expression in mind when searching or
interpreting Schedule entries.
Firstly, poisons are scheduled
individually using their approved names wherever practicable although
exceptions are necessary in some cases. Some of those are mentioned overleaf.
Older group entries are revised and replaced by individual entries as time
permits, although in some of these cases a group term has also been retained to
deal with any members of the group or class that may have escaped attention but
should be scheduled.
Secondly, Schedule entries have been
expressed in either positive or negative terms and care must be taken to
distinguish between the two different forms of expression. Thus, selenium is in
Schedule 6 only when one of the clauses in this Schedule entry applies, while
fluorides are in Schedule 6 unless one of the exempting clauses applies.
Where exceptions are included in an entry,
these have been emphasised by printing the word “except” in bold type.
Where the Schedule entries for a poison
make a specific exclusion or exemption, the requirements of this Standard do
not apply to that poison within the constraints of that exclusion or exemption
although controls under other legislation, such as pesticide registration, may
apply.
Where a Schedule entry for a poison
requires a specific statement to be included on a label as a condition for a
product to qualify for an exemption (‘reverse scheduling’), then in cases where
it is impracticable for a supplier to use the exact wording of such a
statement, its wording may be varied provided that the full intent and meaning
of the statement is not changed.
Where a poison has been included in more
than one Schedule, the principal entry, where practicable, has been included in
the most restrictive Schedule with references to the other Schedule(s)
involved.
It is important to remember that a
Schedule entry includes preparations containing the poison in any concentration
and all salts and derivatives of the poison unless it specifically states
otherwise. (See Part 1, Interpretation, subparagraph 1(2).
It is important to note that a substance
is not classed as a derivative on the basis of a single, prescriptive set of
criteria. Classification of a substance as a derivative of a scheduled poison
relies on a balanced consideration of factors to decide if a substance has a
similar nature (e.g. structurally, pharmacologically, toxicologically) to a scheduled
poison or is readily converted (either physically or chemically) to a scheduled
poison. However, a substance is only considered a derivative of a scheduled poison
if it is not individually listed elsewhere in the Schedules, or captured by a
more restrictive group or class entry. Additionally, some entries specifically
exclude derivatives. Once a substance is determined to be a derivative of a scheduled
poison, the same scheduling requirements as the scheduled poison, including
limits on access, supply and availability, will apply.
Finally, when using this Standard to
determine the scheduling status of a poison, it may be necessary to search each
relevant Schedule as well as Appendices A, B and C and the Index. In this
process, if the poison is not found under its “approved name” it may be shown
under a group term such as:
Group Example
the parent acid of
salts “oxalic acid” to find sodium oxalate
the radical of a
salt “chromates” to find potassium
chromate
the element “arsenic”
to find arsenic trioxide
a chemical group
with similar “hydrocarbons, liquid” to find
toxicological or
pharmacological kerosene
activity
a pharmacological
group “anabolic steroidal agents” to find
“androsterone”
The purpose of classification is to group
substances into Schedules that require similar regulatory controls over their
availability.
These Schedules have been developed over a
long period and contain poisons that may be obsolete for various reasons. Also,
as part of the move to harmonise the Australian and New Zealand classifications,
many substances have been added to the Schedules for that purpose, irrespective
of their availability in either country.
Inclusion of a poison in a Schedule
indicates the degree of control required if it is marketed. It does not
indicate:
- that the poison is
available; nor
- that is has been approved
or is efficacious for any use that may be specified in a Schedule; nor
- does it negate any
obligation for registration of a therapeutic good, or agricultural or
veterinary chemical product containing that poison.
If a preparation contains two or more
poisons, the provisions relating to each of the Schedules in which those
poisons are included apply.
Where it is not possible to comply both
with a provision relating to one of those Schedules and with a provision
relating to another of those Schedules, the provision of the more restrictive
Schedule applies, unless a contrary intention is indicated in the Schedules or
relevant legislation.
The Schedules listed in order of greatest
to least restriction on access and availability are 9, 8, 4, 7, 3, 2, 6, 5.
Schedule 1 is not currently in use.
Some substances in certain circumstances
are also subject to exemptions or additional restrictions as described in the
Appendices of this Standard. The table below summarises the purpose of each of
the Appendices and the controls imposed on substances included in them.
|
Appendix
|
Title
|
Purpose/ controls imposed
|
|
Appendix A
|
General exemptions
|
List of classes of products or uses exempted from this Standard.
|
|
Appendix B
|
Substances considered not to require control by scheduling
|
List of poisons exempted from scheduling.
|
|
Appendix C
|
Substances, other than those included in Schedule 9, of such
danger to health as to warrant prohibition of sale, supply and use
|
List of poisons prohibited from sale, supply or use because of
their known potential for harm to human and/or animal health.
|
|
Appendix D
|
Additional controls on possession or supply of poisons included
in Schedule 4 or 8
|
List of poisons included in Schedule 4 or 8 where additional specified
controls apply on possession or supply.
|
|
Appendix E
|
First aid instructions for poisons
|
First aid instructions for poisons (other than agricultural and
veterinary chemicals and chemicals packed and sold solely for industrial,
dispensary, manufacturing or laboratory use).
|
|
Appendix F
|
Warning statements and general safety directions for poisons
|
Warning statements and general safety directions for poisons
(other than human medicines, agricultural and veterinary chemicals and
chemicals packed and sold solely for industrial, dispensary, manufacturing or
laboratory use).
|
|
Appendix G
|
Dilute preparations
|
Concentration cut-offs for specified poisons, below which the
requirements of the Standard do not apply
|
|
Appendix H
|
Schedule 3 medicines permitted to be advertised
|
List of medicines included in Schedule 3 that are permitted to
be advertised to the public.
|
|
Appendix I
|
Uniform Paint Standard
|
Requirements applying to poisons included in paints or tinters.
|
|
Appendix J
|
Conditions for availability and use of Schedule 7 poisons
|
List of poisons included in Schedule 7 where additional
specified conditions apply to their availability and use.
|
|
Appendix K
|
Human medicines required to be labelled with a sedation warning
|
List of human medicines required to be labelled with a warning
regarding their sedation potential.
|
|
Appendix L
|
Requirements for dispensing labels for medicines
|
Requirements applying to labels attached to medicines at the
time of dispensing.
|
1. (1) In this
Standard, unless the contrary intention appears —
“Agricultural
chemical” means a substance that is represented, imported, manufactured,
supplied or used as a means of directly or indirectly:
(a) destroying,
stupefying, repelling, inhibiting the feeding of, or preventing infestation by
or attacks of, any pest in relation to a plant, a place or a thing;
(b) destroying
a plant;
(c) modifying
the physiology of a plant or pest so as to alter its natural development,
productivity, quality or reproductive capacity;
(d) modifying
an effect of another agricultural chemical;
(e) attracting
a pest for the purpose of destroying it; or
(f) any
active ingredient included in a product declared by regulation under the Agricultural
and Veterinary Chemicals Code Act 1994 to be an agricultural chemical
product;
but
does not include:
(g) a
veterinary chemical.
“Agricultural
chemical product” has the meaning defined in the Agricultural and
Veterinary Chemicals Code Act 1994.
“Animal”
means any animal (other than a human being), whether vertebrate or not, and
whether a food producing species or not, and includes mammals, birds, bees,
reptiles, amphibians, fish, crustaceans and molluscs.
“Animal
feed premix”
means a concentrated preparation, containing one or more poisons, for mixing
with food ingredients to produce a bulk feed for a group of animals (including
fish or birds), but does not include a preparation for mixing with an
individual animal’s food.
“Appropriate
authority” means:
(a) in
the Australian Capital Territory, ACT Government Health Directorate;
(b) for
the purpose of providing an exemption from all or part of paragraphs 2 to 12 in
Part 2 of this Standard by the Australian Pesticides and Veterinary Medicines
Authority, the Chief Executive Officer or their delegate;
(c) in
New South Wales, the Director-General of the NSW Ministry of Health;
(d) in
the Northern Territory, the Chief Health Officer of the Department of Health;
(e) in
Queensland, the Chief Executive of Queensland Health;
(f) in
South Australia, the Chief Executive of the Department for Health and Ageing;
(g) in
Tasmania, the Secretary of the Department of Health and Human Services;
(h) for
the purpose of providing an exemption from all or part of paragraphs 2 to 12 of
this Standard
by
the Therapeutic Goods Administration, the National Manager or their delegate;
(i) in
Victoria, the Secretary to the Department of Health;
(j) in
Western Australia, the Chief Executive Officer of the Department of Health.
“Approved
name”
means:
(a) in
relation to a poison that is for human therapeutic use, the name approved for
use by the Therapeutic Goods Administration;
(b) in
relation to a poison that is for animal or agricultural use, the name approved
for use by the Australian Pesticides and Veterinary Medicines Authority;
(c) in
relation to all other poisons:
(i) the
name used in an entry in these Schedules; or, if no such name is given,
(ii) the
English name recommended by Standards Australia as the common name for the
poison; or, if no such name is given,
(iii) the
English name given to the poison by the International Organization for
Standardization; or, if no such name is given,
(iv) the
English name given to the poison by the British Standards Institution; or, if
no such name is given,
(v) the
name that would comply with the requirements of part (a) or (b) of this
definition, or, if no such name is given,
(vi) the
English name given to the poison by the European Committee for Standardization (CEN);
or, if no such name is given,
(vii) the
international non-proprietary name recommended for the poison by the World
Health Organization; or, if no such name is given,
(viii) the
International Nomenclature Cosmetic Ingredient name for the poison listed in
the International Cosmetic Ingredient Dictionary & Handbook published
by the Personal Care Products Council of America; or, if no such name is given,
(ix) the
accepted scientific name or the name descriptive of the true nature and origin
of the poison.
“Australian
Code
for the Transport of Dangerous Goods by Road and Rail” means the seventh
edition of the document of that name.
“Authorised
prescriber” means a registered medical, dental or veterinary practitioner
or such other person authorised by the appropriate authority.
“Blood”
means whole blood extracted from human donors.
“Blood
components” means therapeutic components that have been manufactured from
blood (including red cells, white cells, stem cells, platelets and plasma),
except for products derived through fractionation of plasma.
“Child-resistant
closure” means:
(a) a
closure that complies with the requirements for a child-resistant closure in the Australian Standard AS 1928-2007
entitled Child-resistant packaging – Requirements and testing
procedures for reclosable packages (ISO 8317:2003, MOD);
(b) a
closure approved by an order made under subsection 10(3) of the Commonwealth Therapeutic
Goods Act 1989; or
(c) in
the case of a can fitted with a press-on lid, a lid of the design known as
“double tight” or “triple tight”.
See
also "Non-access packaging”.
“Child-resistant packaging” means packaging that:
(a) complies with the requirements of the Australian
Standard AS 1928-2007 entitled
Child
resistant packaging – Requirements and testing procedures for reclosable
packages (ISO 8317:2003, MOD);
(b) is
reclosable and complies with the requirements of at least one of the following
Standards:
(i) the
International Organization for Standardization Standard ISO 8317:2003 entitled Child-resistant
packaging – Requirements and testing procedures for reclosable packages;
(ii) the
British Standards Institution Standard BS EN ISO 8317:2004 entitled
Child-resistant
packaging. Requirements and testing procedures for reclosable packages;
(iii) the
Canadian Standards Association Standard CSA Z76.1-06 entitled Reclosable
Child-Resistant Packages;
(iv) the United States Code of Federal Regulations,
Title 16, Section 1700.15, entitled Poison prevention packaging standards
and Section 1700.20, entitled Testing procedure for special packaging;
(c) is
approved as child-resistant by any order made under subsection 10(3) of the
Commonwealth Therapeutic Goods Act 1989; or
(d) is
in the form of blister or strip packaging in which a unit of use is
individually protected until the time of release and that complies with Section
3 (Requirements for non-reclosable packages) of Australian Standard AS
1928-2001 entitled Child-resistant packages.
See also
"Non-access packaging".
“Compounded” in
relation to a substance means combined with one or more other therapeutically
active substances in such a way that it cannot be separated from them by simple
dissolution or other simple physical means.
“Cosmetic”
means:
(a) a substance or preparation intended for
placement in contact with any external part of the human body, including:
(i) the
mucous membranes of the oral cavity; and
(ii) the
teeth;
with a view to:
(iii) altering
the odours of the body; or
(iv) changing
its appearance; or
(v) cleansing it; or
(vi) maintaining it in good condition;
or
(vii) perfuming it; or
(viii) protecting it.
“Debitterised
neem seed oil” means highly purified oil from the neem seed containing only
fatty acids and glycerides of fatty acids.
“Dermal
use”
means application to the skin primarily for localised effect.
“Designated
solvent”
means the following:
acetone
dimethylformamide
N-(N-dodecyl)-2-pyrrolidone
hydrocarbons,
liquid
methanol
when included in Schedule 5
methyl ethyl ketone
methyl
isoamyl ketone
methyl isobutyl ketone
N-methyl-2-pyrrolidone
N-(N-octyl)-2-
pyrrolidone
phenyl
methyl ketone
styrene
tetrachloroethylene
1,1,1-trichloroethane
“Dispensing
label” means
the label attached to the immediate container of a substance for therapeutic
use at the time of dispensing.
“Distributor”
means a person who imports, sells or otherwise supplies a poison.
“Divided
preparation”
means a preparation manufactured and packed as discrete pre-measured dosage
units prior to sale or supply, and includes tablets, capsules, cachets, single
dose powders or single dose sachets of powders or granules.
“Dosage
unit”
means an individual dose of a poison for therapeutic use and includes a tablet,
capsule, cachet, single dose powder or single dose sachet of powders or
granules.
“Drug” means a poison
intended for human or animal therapeutic use.
“Essential
oils”
means products obtained from natural raw materials either by distillation with
water or steam or from the epicarp of citrus fruits by a mechanical process, or
by dry distillation. For scheduling purposes it also means:
(a) oils
of equivalent composition derived through synthetic means; or
(b) prepared
mixtures of oils of equivalent composition comprising a mixture of synthetic
and natural components.
“External” in relation to the
use of a poison means application in the ears, eyes or nose or to a body
surface other than in the mouth, rectum, vagina, urethra or other body orifice.
“First
Schedule Paint” means a paint containing the specified proportion of any
substance in the First Schedule to Appendix I of this Standard.
“Free
formaldehyde” includes all hydrated and non-hydrated formaldehyde present
in aqueous solution, including methylene glycol.
“Graphic
material”
means the material which is to be deposited on another material by a graphic
instrument during writing, drawing or marking and includes cores of pencils,
school pastels or crayons, blackboard chalks, finger or showcard colours,
poster paints and watercolour blocks.
“Height” in relation to
letters used for words, expressions or statements on labels means the height of
capital letters or lower case letters having an ascender or a descender.
“Hemp
seed oil”
means the oil obtained by cold expression from the ripened fruits (seeds) of
Cannabis sativa.
“Immediate
container”
includes all forms of containers in which a poison is directly packed but does
not include any such container intended for consumption or any immediate
wrapper.
“Immediate
wrapper”
means metal foil, plastic foil, waxed paper, or any other such material not
intended for consumption, when used as the first wrapper for a dosage unit or
dressing.
“Internal
use” means administration:
(a) orally,
except for topical effect in the mouth; or
(b) for
absorption and the production of a systemic effect;
(i) by
way of a body orifice other than the mouth; or
(ii)
parenterally, other than by application to unbroken skin.
“Label” means:
(a) a
written statement on a container of a poison; and
(b) in
relation to a therapeutic good, includes a display of printed information about
the product:
(i)
on, or attached to, the good;
(ii) on,
or attached to, a container or primary pack in which the good is supplied; or
(iii) supplied
with such a container or pack.
“Main
label”
means, where there are two or more labels on a container or a label is divided
into two or more portions:
(a) the part of a label
that is most likely to be displayed, presented, shown, or examined under
ordinary or customary conditions of display; and
(b) where there are two
or more labels or two or more portions of a single label – that label or
portion of the label where the product name is more or most conspicuously
shown; or
(c) where the product
name is equally conspicuous on two or more labels or portions of a label – each
such label or portion.
“Manufacturer”
means a person who manufactures, produces, or packs a poison.
“Measure
pack”
means a sealed container which contains a measured quantity of poison for use
on one occasion as a pesticide or domestic product and one or more of which is
enclosed in a primary pack.
“Medicine”
means
any poison for therapeutic use.
Note:
To be preceded by “human” or “veterinary” where restriction of the “medicine”
to human or animal use is intended.
“Name
and address”
means the name and address, in Australia, of the manufacturer or distributor of
a poison but does not include a post office, cable, telegraphic or code
address. Where such manufacturer or distributor is a company incorporated in
accordance with the appropriate law of any State or Territory of the
Commonwealth of Australia or a firm registered under the Business Names Act of
any State or Territory, the inclusion in the label of the registered name of
the corporation or firm or its branch or its division and the city or town in
which a registered office is situated shall be deemed to comply with the
requirements.
“Non-access
packaging”
is packaging that complies with the requirements of Australian Standard
AS4710-2001 entitled Packages for chemicals not intended for access or
contact with their contents by humans, in relation to products that are not
intended for human therapeutic use.
See
also "Child-resistant closure" and "Child-resistant packaging”.”.
“Non-volatile
content”
in relation to a paint or tinter means that portion of a paint or tinter
determined to be the non-volatile content by Method 301.1 of Australian Standard AS 1580-301.1-2005 entitled
Paints and related materials – Methods of test – Non-volatile content by
mass.
“Oromucosal
use” means administration to the oral mucosa, specifically the oral cavity
and/or the pharynx.
“Paint”, without limiting the
ordinary meaning, includes any substance used or intended to be used for
application as a colouring or protective coating to any surface but does not
include graphic material or paints for therapeutic use.
“Pesticide” means any substance
or mixture of substances used or intended to be used:
(a) for
preventing, destroying, repelling, attracting, inhibiting or controlling any
insects, rodents, birds, nematodes, bacteria, fungi, weeds or other forms of
plant or animal life or viruses, which are pests; or
(b) as
a plant regulator, promoter, defoliant or desiccant for food storage,
household, industrial, commercial, agricultural and non-agricultural
application, but does not include veterinary drugs, stock medicines, stock
feeds, stock feed additives, drugs for human use, food additives or
fertilisers.
“Poison” means any substance
or preparation included in a Schedule to this Standard.
“Primary
pack”
means the pack in which a poison and its immediate container or immediate
wrapper or measure pack are presented for sale or supply.
“Required Advisory
Statements for Medicine Labels” means the document made under subsection 3(5A) of
the Therapeutic Goods Act 1989 by the Therapeutic Goods Administration.
“Restricted
flow insert”
means a restriction fitted, or moulded, in the neck of a container which:
(a) cannot
readily be removed from the container by manual force; and
(b) limits
the delivery of the contents to drops each of which is not more than 200 microlitres.
“Second
Schedule Paint”
means a paint containing the specified proportion of any substance in the
Second Schedule to Appendix I of this Standard.
“Selected
container”
means:
(a) an
injection vial having a nominal capacity of ten millilitres or less;
(b) a
single use syringe; or
(c) any
other container for substances for therapeutic use having a nominal capacity of
ten millilitres or less.
“Solid”
is considered to include “powder” for the purposes of scheduling.
“Therapeutic
good” has
the meaning defined in the Commonwealth Therapeutic Goods Act
1989.
“Therapeutic
use”
means use in or in connection with:
(a) preventing,
diagnosing, curing or alleviating a disease, ailment, defect or injury in human
beings or animals;
(b) influencing,
inhibiting or modifying a physiological process in human beings or animals;
(c) testing
the susceptibility of human beings or animals to a disease or ailment;
(d) influencing,
controlling or preventing conception in persons or animals;
(e) testing
for pregnancy in persons or animals; or
(f) the
replacement or modification of parts of the anatomy in persons or animals.
“Third
Schedule Paint”
means a paint containing the specified proportion of any substance in the Third
Schedule to Appendix I of this Standard.
“Tinter” means any pigment or
admixture of pigment with other substances, in powder, semi-solid or liquid
form, sold or supplied for the purpose of adding to paint in order to change
the colour of the paint.
“Topical
use”
means application of a poison for the purpose of producing a localised effect
on the surface of the organ or within the tissue to which it is applied.
“Toy” means an object or
number of objects manufactured, designed, labelled or marketed as a plaything
for a child or children up to the age of fourteen years.
“Transdermal
use”
means application to the skin primarily for systemic effect.
“Veterinary
chemical” means
a substance that is represented as being suitable for, or is manufactured,
supplied or used for, administration or application to an animal by any means,
or consumption by an animal, as a way of directly or indirectly:
(a) preventing, diagnosing, curing or alleviating
a disease or condition in the animal or an infestation of the animal by a pest;
(b) curing
or alleviating an injury suffered by the animal;
(c) modifying
the physiology of the animal:
(i) so as to alter its natural development,
productivity, quality or reproductive capacity; or
(ii) so
as to make it more manageable;
(d) modifying
the effect of another veterinary chemical
(e) any vitamin, mineral substance, or additive,
if, and only if, the vitamin, substance or additive is used for a purpose
mentioned in paragraph (a), (b), (c) or (d); or
(f) any active ingredient included in a product
declared by regulation under the Agricultural and Veterinary Chemicals Code
Act 1994 to be an veterinary chemical product;
but
does not include:
(g) an
agricultural chemical.
“Veterinary
chemical product” has
the meaning defined in the Agricultural and Veterinary Chemicals Code Act
1994.
“Writing” includes the visible
representation or reproduction of words or figures in any form, and “to write”
and “written” have corresponding meanings.
(2) Unless
the contrary intention appears a reference to a substance in a Schedule or an Appendix
to this Standard includes:
(a) that
substance prepared from natural sources or artificially; and
(b) where
the substance is a plant (other than a plant included in Schedule 8 or 9), that
plant or any part of that plant when packed or prepared for therapeutic use;
and
(c) every
salt, active principle or derivative of the substance, including esters and
ethers, and every salt of such an active principle or derivative; and
(d) every
alkaloid of the substance and every salt of such an alkaloid; and
(e) every
stereoisomer of the substance and every salt of such a stereoisomer; and
(f) every
recombinant form of the substance; and
(g) a
preparation or admixture containing any proportion of the substance,
but
does not include:
(h) a
preparation or product included in Appendix A, or a substance and the reason
for its entry in Appendix B; or
(i) a
substance included in Appendix G at a concentration not exceeding the
concentration specified in column 2 of that Appendix in respect of that
substance; or
(j) any
other substance included in Schedules 1 to 6, at a concentration not exceeding
10 mg per litre or 10 mg per kilogram, unless that substance is also included
in Schedule 7 or 8; or
(k) any
substance present as an impurity in a pesticide, at a concentration at or below
the maximum content for that substance, specified for the pesticide in the Standards
for Active Constituents, as published by the Australian Pesticides and
Veterinary Medicines Authority.
(3) Unless
the contrary intention appears where a concentration, strength or quantity is
specified in a Schedule or an Appendix to this Standard in respect of a
substance:
(a) if
the substance is present as a salt, active principle or derivative (including
an ester or ether), the concentration, strength or quantity is calculated as
the equivalent amount of the substance that is listed in the Schedule or
Appendix; and
(b) the
expression “one per cent” means:
(i) in
the case of a liquid preparation, 1 gram of the substance per 100 millilitres
of the preparation; or
(ii) in
the case of a solid, semi-solid or pressurised spray aerosol preparation, 1
gram of the substance per 100 grams of the preparation; and
(iii) any
expression of greater or lesser percentages shall have a corresponding meaning;
and
(c) in
the case of codeine, such concentration, strength or quantity is calculated as
anhydrous codeine.
(4) A
reference to a boiling or distillation temperature in the Schedules means that
temperature at an atmospheric pressure of 101.325 kPa (760 millimetres of
mercury).
2. A person must
not sell or supply a poison unless it is labelled in accordance with paragraphs
3 to 19 of this Standard.
3. Any word,
expression or statement required by this Standard to be written on a label or
container must be written:
(1) on
the outside face of the label or container; and
(2) in
the English language; and
(3) in
durable characters; and
(4) in a
colour or colours to provide a distinct contrast to the background colour; and
(5) in
letters at least 1.5 millimetres in height.
4. Subparagraph
3(5) does not apply to a word, expression or statement on a container which has
a capacity of 20 millilitres or less, or on the label of such a container if:
(1) an
appropriate authority approves the use of smaller letters; and
(2) the
letters are at least 1 millimetre in height.
5. The label must
be printed on, or securely attached to:
(1) the
outside of the immediate container; and
(2) if
the immediate container is enclosed in a primary pack, the outside of that
primary pack.
6. (1) A poison
enclosed in an immediate wrapper must be contained in a primary pack labelled
in accordance with paragraph 7 of this Standard; and
(2) the
immediate wrapper must be conspicuously labelled with:
(a) the
name of the manufacturer or distributor or the brand name or trade name used
exclusively by the manufacturer or distributor for that poison; and
(b) the
approved name of the poison; and
(c) a
statement of the quantity or strength of the poison in accordance with
paragraph 8 of this Standard.
7. (1) The
primary pack and immediate container of a poison must be labelled as follows:
(a) with
the signal word or words relating to the Schedule in which the poison is
included and the purpose for which it is to be
used, as shown in the following table:
Schedule Purpose Signal
words required
2 for
any purpose PHARMACY MEDICINE
3 for
any purpose PHARMACIST ONLY MEDICINE
4 for
human use PRESCRIPTION ONLY MEDICINE
4 for
animal use PRESCRIPTION ANIMAL REMEDY
5 for
any purpose CAUTION
6 for
any purpose POISON
7 for
any purpose DANGEROUS POISON
8 for
any purpose CONTROLLED DRUG
written:
(i) on
the first line or lines of the main label; and
(ii) in
bold-face sans serif capital letters of uniform thickness; and
(iii) in
letters at least half the height of the largest letter or numeral on the label
but need not be larger than:
(A) 6
millimetres on labels for packages having a nominal capacity of
2 litres or less; or
(B) 15
millimetres on labels for packages having a nominal capacity of more than 2
litres; and
(iv) if
the poison:
(A) is
a Schedule 5 poison, with nothing, other than a Class label as specified in the
Australian Code for the Transport of Dangerous Goods by Road and Rail or
a statement of the principal hazard of the poison, written on that line; or
(B) is
not a Schedule 5 poison, with nothing, other than a Class label as specified in
the Australian Code for the Transport of Dangerous Goods by Road and Rail,
written on that line;
(b) if
the poison is a Schedule 8 poison, with the cautionary statement –
POSSESSION WITHOUT
AUTHORITY ILLEGAL
written:
(i) on
a separate line or lines immediately below the signal words required by
subparagraph 7(1)(a); and
(ii) in
bold-face sans serif capital letters of uniform thickness; and
(iii) in
letters at least four-tenths the height of the letters used for the signal
words; and
(iv) with
no other statement written on the same line;
(c) with
the cautionary statement –
KEEP OUT OF REACH OF
CHILDREN
written:
(i) on
a separate line or lines:
(A) immediately
below the signal word or words required by subparagraph 7(1)(a); or
(B) where
the cautionary statement “POSSESSION WITHOUT AUTHORITY ILLEGAL” is required by
subparagraph 7(1)(b), on the line immediately below that statement; and
(ii) in
bold-face sans serif capital letters of uniform thickness; and
(iii) in
letters at least four-tenths the height of the letters used for the signal word
or words; and
(iv) with
nothing, other than a Class label as specified in the Australian Code for
the Transport of Dangerous Goods by Road and Rail, written on the same
line;
(d) if
the poison is a dry chlorinating compound containing more than 10 per cent of
available chlorine, except for preparations certified by a relevant
State or Territory authority as not being a Dangerous Good of Class 5, Division
5.1: Oxidising substances, as specified in the Australian Code for the
Transport of Dangerous Goods by Road and Rail, with the cautionary statement –
FIRE AND EXPLOSION
HAZARD
written:
(i) on
a separate line or lines immediately below the cautionary statement “KEEP OUT
OF REACH OF CHILDREN” as required by subparagraph 7(1)(c); and
(ii) in
bold-face sans serif capital letters of uniform thickness; and
(iii) in
letters at least four-tenths the height of the letters used for the signal word
or words; and
(iv) with
nothing, other than a Class label as specified in the Australian Code for
the Transport of Dangerous Goods by Road and Rail, written on the same
line;
(e) if
the poison is an alkaline salt in a dishwashing machine product, with the
cautionary statement –
BURNS SKIN AND THROAT
written:
(i) on
a separate line or lines immediately below the cautionary statement “KEEP OUT
OF REACH OF CHILDREN” as required by subparagraph 7(1)(c); and
(ii) in
bold-face sans serif capital letters of uniform thickness; and
(iii) in
letters at least four-tenths the height of the letters used for the signal
word; and
(iv) with
nothing, other than a Class label as specified in the Australian Code for
the Transport of Dangerous Goods by Road and Rail, written on the same line
of the main label;
(f) if
the poison is an aqueous solution of paraquat, with the cautionary statements –
CAN KILL IF SWALLOWED
DO NOT PUT IN DRINK
BOTTLES
KEEP LOCKED UP
written:
(i) on
separate lines immediately below the cautionary statement “KEEP OUT OF REACH OF
CHILDREN” as required by subparagraph 7(1)(c); and
(ii) in
bold-face sans serif capital letters of uniform thickness; and
(iii) in
letters at least four-tenths the height of the letters used for the signal
words; and
(iv) with
nothing, other than a Class label as specified in the Australian Code for
the Transport of Dangerous Goods by Road and Rail, written on the same
lines of the main label;
(g) for
any poison other than a poison for human therapeutic use labelled in accordance
with the Required Advisory Statements for Medicine Labels, if safety
directions are required on the label by subparagraph 7(1)(n), with the
cautionary statement –
READ SAFETY DIRECTIONS
BEFORE OPENING
OR USING
or
with the cautionary statement –
READ SAFETY DIRECTIONS
written:
(i) on
a separate line or lines;
(A) immediately
below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by
subparagraph 7(1)(c); or
(B) if
one or more other cautionary statements is required to be on the line
immediately below “KEEP OUT OF REACH OF CHILDREN”, immediately below that
statement or those statements; and
(ii) in
bold-face sans serif capital letters of uniform thickness; and
(iii) in
letters at least four-tenths the height of the letters used for the signal word
or words; and
(iv) with
nothing, other than a Class label as specified in the Australian Code for
the Transport of Dangerous Goods by Road and Rail, written on the same
line;
(h) if
the poison meets the criteria for a ‘flammable liquid’ in the Australian
Code for the Transport of Dangerous Goods by Road and Rail, with the cautionary
statement –
FLAMMABLE
written
on the main label in bold-face sans serif capital letters of uniform thickness,
unless already present in accordance with the requirements of the Australian
Code for the Transport of Dangerous Goods by Road and Rail;
(i) if the poison is for the treatment of animals,
with the cautionary statement –
FOR ANIMAL TREATMENT
ONLY
written
on the main label in bold-face sans serif capital letters of uniform thickness;
(j) if
the poison is a Schedule 5 poison intended for any purpose other than internal
or pesticidal use, with the cautionary statement –
DO NOT SWALLOW
written
in sans serif capital letters on the main label or as part of the directions
for use;
(k) with
the approved name of the poison and a statement of the quantity, proportion or
strength of the poison in accordance with paragraph 8:
(i) if
the poison is for human therapeutic use, written in accordance with orders made
under subsection 10(3) of the Commonwealth Therapeutic Goods Act, 1989;
or
(ii) if
the poison is not for human therapeutic use, written in bold-face sans serif
capital letters on the main label, unless:
(A) a
list of approved names is required; and
(B) it
is impractical to include the list on the main label; and
(C) an
appropriate authority has authorised its inclusion on another part of the
label; or
(iii) if
the poison is a Schedule 5 poison referred to in column 1 of the following
table the appropriate name opposite thereto in column 2 may be used as the
approved name:
TABLE
Column
1 Column 2
Alkaline
salts Alkaline
salts
Amines
for use as curing Aliphatic amines
or
agents
for epoxy resins aromatic amines
(unless
separately specified
in
the Schedules)
Epoxy
resins, liquid Liquid epoxy resins
Hydrocarbons,
liquid Liquid hydrocarbons
Quaternary
ammonium Quaternary ammonium
compounds compound(s)
(iv) if
a poison contains a mixture of designated solvents in excess of 25 per cent of
the total volume of the poison but the proportion of one or more individual
designated solvents in the mixture is equal to or less than 25 per cent, the
approved names of those solvents may be expressed as follows:
(A) where
the designated solvent is a liquid hydrocarbon as “liquid hydrocarbons”; or
(B) where
the designated solvent is a ketone as “ketones”; or
(C) in
any other case as “solvents” or “other solvents”;
(l) if the poison is
an organophosphorus compound or carbamate for pesticidal use or for the
treatment of animals, with the following expression written immediately below
the approved name or the list of declared contents –
AN ANTICHOLINESTERASE
COMPOUND
(i) the
requirements of subparagraph 7(1)(l) do not apply to:
(A) dazomet,
mancozeb, metiram, propineb, thiram, tri-allate, zineb or ziram; or
(B) an
organophosphorus compound or carbamate contained in impregnated plastic resin
strips, medallions or granules; or
(C) an
organophosphorus compound or carbamate contained in a
pressurised
spray pack for household use;
(m) for
any poison other than a poison for human therapeutic use labelled in accordance
with Therapeutic Goods Order 69 General requirements for labels for
medicines or in an agricultural or veterinary chemical product labelled in
compliance with the Agricultural and Veterinary Chemicals Code Act 1994,
if the poison is prepared, packed or sold for a specific purpose, with clear
and adequate directions for use unless:
(i) the
poison is included in Schedule 4 or Schedule 8; or
(ii) it
is impractical to include such directions on the label and:
(A) the
primary pack and the immediate container are labelled with the statement “DIRECTIONS
FOR USE: See package insert”; and
(B) an
appropriate authority has authorised the directions for use to be written on a
package insert instead of the label; and
(C) the
insert is enclosed in the primary pack;
(n) for
any poison other than a poison for human therapeutic use labelled in accordance
with the Required Advisory Statements for Medicine Labels, if use of the
poison may be harmful to the user, with appropriate safety directions (see
Appendix F), grouped together as a distinct section of the label and prefaced
by the words –
SAFETY DIRECTIONS
written
in bold-face capital letters;
(o) for
any poison other than a poison for human therapeutic use labelled in accordance
with the Required Advisory Statements for Medicine Labels, if any
warning statement or statements are required for the poison (see Appendix F),
with that warning statement or those statements grouped together:
(i) if
safety directions are included on the label, immediately after the words
“SAFETY DIRECTIONS”; or
(ii) if
there are no safety directions, immediately preceding the directions for use;
(p) if the poison is not for human internal use and is
not a Schedule 3, Schedule 4 or Schedule 8 poison, with appropriate first aid
instructions (see Appendix E):
(i) grouped
together and prefaced by the words –
FIRST AID
written
in bold-face capital letters; or
(ii) if
a primary pack contains two or more immediate containers of poisons each requiring
different first aid instructions:
(A) written
on each immediate container as specified in subparagraph 7(1)(p)(i); and
(B) replaced
on the primary pack with the statement –
FIRST AID: See inner
packs;
(q) with
the name and address of the manufacturer or distributor.
(2) For
the purposes of subparagraph 7(1)(a)(iii) the term “largest letter or numeral”
does not include:
(a) a
single letter or numeral which is larger than other lettering on the label; or
(b) an
affix forming part of the trade name; or
(c) in
the case of a poison for therapeutic use, numerals used to distinguish the
strength of a preparation from the strengths of other preparations of the same
poison.
8. The statement
of the quantity, proportion or strength of a poison must be expressed in the
most appropriate of the following forms:
(1) if
the poison is for human therapeutic use, in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic
Goods Act 1989;
(2) if the poison
is for a purpose or purposes other than human therapeutic use and:
(a) if
the poison is in a pressurised spray aerosol preparation, as the mass of the
poison per stated mass of the preparation;
(b) if
the poison is a liquid in a liquid preparation, as the mass or volume of the
poison per stated volume of the preparation;
(c) if
the poison is a liquid in a solid or semi-solid preparation, as the mass or
volume of the poison per stated mass of the preparation;
(d) if
the poison is a solid or semi-solid in a liquid preparation, as the mass of the
poison per stated volume of the preparation;
(e) if
the poison is a solid or semi-solid in a solid or semi-solid preparation, as
the mass of the poison per stated mass of the preparation;
(f) if
the poison is a gas in a liquid preparation, as the mass of the poison per
stated volume of the preparation;
(g) if
the poison is a gas in a solid or semi-solid preparation, as the mass of the
poison per stated mass of the preparation;
(h) if
the poison is a gas in a gaseous preparation, as the mass of the poison per
stated mass of the preparation;
(3) if
the poison is a solution of a mineral acid, the proportion of the acid
(un-neutralised by any bases present in the preparation) in a preparation may
be expressed as the un-neutralised mass of the acid per stated mass of the
preparation;
(4) if
the poison is an inorganic pigment, the proportion may be expressed as a
percentage of the metal present using one of the following expressions as
appropriate:
contains
not more than 10 per cent of (insert name of the metal); or
contains
not more than 30 per cent of (insert name of the metal); or
contains
more than 30 per cent of (insert name of the metal);
(5) if
the poison is included in a paint, other than a paint for therapeutic or
cosmetic use, the proportion may be expressed as a range provided that the
limits of the range do not differ by more than 5 per cent of the product;
(6) if
the poison is a lead-based pigment included in automotive paint, the proportion
may be expressed as the maximum content of the lead that may be present in the
non-volatile content of the paint;
(7) if a
preparation contains more than one derivative of a poison, the quantity or
proportion of the poison may be expressed as the equivalent quantity or
proportion of one of the derivatives present which it would contain if all of
the derivatives were that derivative.
(8) For
the purposes of subparagraph 8(7) “derivative” includes alkaloid.
9. The
requirements of paragraph 7 do not apply to an immediate container that is a
measure pack or a selected container (other than an ampoule, a pre-filled
syringe or an injection vial to which paragraph 10 or 11 apply) when:
(1) the
immediate container is for a therapeutic good and is labelled in the manner
prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic
Goods Act 1989; or
(2) the immediate
container is:
(a) packed
in a primary pack labelled in accordance with paragraph 7; and
(b) labelled
with:
(i) the
signal word or words relating to the Schedule in which the poison is included
and the purpose for which it is to be used, as shown in the table to
subparagraph 7(1)(a); and
(ii) the
approved name of the poison and the quantity, proportion or strength of the
poison in accordance with paragraph 8; and
(iii) the
name of the manufacturer or distributor or the brand name or trade name used
exclusively by the manufacturer or distributor for the poison; and
(iv) if the poison is for the treatment of animals,
with the cautionary statement –
FOR ANIMAL TREATMENT
ONLY
written
in sans serif capital letters.
10. The requirements
of paragraph 7 do not apply to a selected container, or an ampoule (other than
an ampoule to which paragraph 11 applies) when:
(1) the
selected container or ampoule is for a therapeutic good and is labelled in the
manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic
Goods Act 1989; or
(2) the
selected container or ampoule is:
(a) packed
in a primary pack labelled in accordance with paragraph 7; and
(b) labelled
with:
(i) the approved name
of the poison and the quantity, proportion or strength of the poison in
accordance with paragraph 8; and
(ii) with the name of
the manufacturer or distributor or the brand name or trade name used
exclusively by the manufacturer or distributor for the poison; and
(iii) if the poison is
for the treatment of animals, with the cautionary statement –
FOR ANIMAL TREATMENT
ONLY
written
in sans serif capital letters.
11. The requirements
of paragraph 7 do not apply to a selected container that is a plastic ampoule
that is continuous with a strip of the same material and opens as it is
detached from the strip when:
(1) the
selected container is a plastic ampoule that is continuous with a strip of the
same material and opens as it is detached from the strip, is for a therapeutic
good and is labelled in the manner prescribed by orders made under subsection
10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(2) the
selected container is a plastic ampoule that is continuous with a strip of the
same material and opens as it is detached from the strip, is:
(a) packed
in a primary pack labelled in accordance with paragraph 7; and
(b) the
strip is labelled in accordance with paragraph 10; and
(c) the
ampoule is labelled with:
(i) the approved name
of the poison or the trade name of the product; and
(ii) the quantity,
proportion or strength of the poison in accordance with paragraph 8.
12. The labelling
requirements of this Standard do not apply to a transparent cover, or to any
wrapper, hamper, packing case, crate or other cover used solely for the
purposes of transport or delivery.
13. The labelling
requirements of this Standard do not apply to a poison that:
(1) is
packed and sold solely for dispensary, industrial, laboratory or manufacturing
purposes; and
(2) is
labelled in accordance with Safe Work Australia's National Code of Practice
for the Labelling of Workplace Substances [NOHSC: 2012(1994)].
13A. (1) The labelling requirements
of paragraphs 7 to 12 do not apply to a poison where an appropriate authority
has granted a labelling exemption in whole or in part for these sections for a
specified product; and
(2) the labelling exemption from
an appropriate authority referred to in subparagraph (1) is limited to no more
than 12 months from the effective date of the decision for retail supply of the
product; and
(3) for the avoidance of doubt
this paragraph does not apply to exemptions issued under subparagraph
7(1)(m)(ii)(B) of this Standard.
14. Unless otherwise
specified by regulation:
(1) The
labelling requirements of this Standard do not apply to a medicine that:
(a) is supplied by an authorised
prescriber or other person authorised to supply and is labelled in accordance
with the requirements of Appendix L Part 1 of this Standard; or
(b) is supplied on and in
accordance with a prescription written by an authorised prescriber and is
labelled in accordance with the requirements of Appendix L Part 1 of this
Standard; or
(c) is prepared and supplied by
a pharmacist for an individual patient and is labelled in accordance with the
requirements of Appendix L Part 1 of this Standard.
(2) A
person must not supply a dispensed medicine for human use containing:
(a) a poison listed in column 1
of the table at Appendix L Part 2 of this Standard unless it is clearly
labelled with the warning statement(s) specified in column 2 of that table; or
(b) a poison listed in Appendix
K unless it is clearly labelled with a sedation warning (being statement 39, 40
or 90 as specified in Appendix F Part 1 of this Standard).
15. The requirements
of subparagraphs 7(1)(a)(iv), 7(1)(c)(iv), and 7(1)(g)(iv) do not apply to a
cylinder containing a poison that is a compressed gas.
16. The requirements
of paragraph 7 do not apply to:
(1) paint
(other than a paint for therapeutic or cosmetic use) which:
(a) contains
only Schedule 5 poisons; or
(b) is
a First Schedule or Second Schedule paint that is labelled with:
(i) the
word “WARNING”, written in bold-face sans serif capital letters, the height of
which is not less than 5 mm, on the first line of the main label with no other
words written on that line; and
(ii) the
expression “KEEP OUT OF REACH OF CHILDREN”, written in bold-face sans serif
capital letters, the height of which is not less than 2.5 mm, on a separate
line immediately below the word “WARNING”; and
(iii) the
appropriate warnings specified for the paint in Appendix F, written immediately
below the expression “KEEP OUT OF REACH OF CHILDREN”; and
(iv) the
name and proportion of the First Schedule or Second Schedule poisons it
contains, provided that where the substance is a metal or metal salt the
proportion is expressed as the metallic element present “calculated on the
non-volatile content” or “in the dried film” of the paint; or
(2) a
tinter which contains:
(a) only
Schedule 5 poisons; or
(b) a
poison included in the First Schedule or Second Schedule to Appendix I,
provided that it is labelled with the name and proportion of that poison, and
where the poison is a metal or metal salt, the proportion is expressed as the
metallic element present as “calculated on the non-volatile content” or “in the
dried film”.
17. The labelling
requirements of subparagraph 3(4) and paragraph 7 do not apply to a device that
contains camphor or naphthalene in block, ball, disc, pellet or flake form if
the device:
(1) complies
with paragraph 28; and
(2) is
sold or supplied in a primary pack labelled in accordance with paragraphs 3 and
7.
18. A label used in
connection with any poison must not include:
(1) any
reference to this Standard, or any comment on, reference to, or explanation of
any expression required by this Standard that directly or by implication
contradicts, qualifies or modifies such expression; or
(2) any
expression or device suggesting or implying that the poison is safe, harmless,
non-toxic, non-poisonous, or is recommended or approved by the Government or
any government authority unless required by legislation; or
(3) any
expression or device which is false or misleading in any particular concerning
the safety of the poison or any of its ingredients; or
(4) any
trade name or description that:
(a) represents
any single constituent of a compound preparation; or
(b) misrepresents
the composition or any property or quality of the poison; or
(c) gives
any false or misleading indication of origin or place of manufacture of the
poison.
19. A label must not
be attached to the immediate container or primary pack used in connection with
any poison in such a manner as to obscure:
(1) any
expression required by this Standard to be written or embossed on the container
or pack; or
(2) any
of the ribs or embossed or printed words required by paragraph 21, 22 or 23 as
appropriate.
20. A person must not
sell or supply a poison unless the immediate container complies with the
requirements of paragraphs 21 to 28 of this Standard.
21. If a poison, other
than a Schedule 5 poison, is sold or supplied in a container with a nominal
capacity of 2 litres or less, the container must comply with Australian Standard AS 2216-1997, entitled
Packaging for poisonous substances.
21a. Notwithstanding
subparagraph 21, a poison which is in Schedule 6 and is an essential oil may be
packed in an amber glass container which does not comply with the tactile identification
requirements of Australian
Standard AS 2216-1997, entitled Packaging for poisonous substances, if:
(1) the
other safety factors are not diminished; and
(2) the
container has a restricted flow insert and a child-resistant closure.
22. If a poison,
other than a Schedule 5 poison, is sold or supplied in a container with a
nominal capacity of more than 2 litres, the container must:
(1) comply with subsection
1.4 (General Requirements) of Australian Standard AS 2216-1997 entitled Packaging
for poisonous substances;
and
(2) have
the word “POISON”:
(a) in
sans serif capital letters the height of which is at least one thirty second
part of the length, height or width of the container, whichever is the
greatest:
(i) embossed;
or
(ii) indelibly
written in a colour in distinct contrast to the background colour;
(b) on
the side or shoulder of the container.
23. (1) The
container in which any Schedule 5 poison is sold or supplied must:
(a) comply
with the container requirements of paragraph 21 or paragraph 22; or
(b) be
readily distinguishable from a container in which food, wine or other beverage
is sold; and
(i) comply with subsection
1.4 (General Requirements) of Australian Standard AS 2216-1997 entitled Packaging
for poisonous substances,
excluding paragraph 1.4.3;
(ii) be
securely closed and, except when containing a preparation for use on one
occasion only, be capable of being re-closed to prevent spillage of its
contents; and
(iii) have
the expression “POISON”, “NOT TO BE TAKEN” or “NOT TO BE USED AS A FOOD
CONTAINER” embossed or indelibly written thereon, or printed on a permanent
adhesive label designed to adhere to a substrate without lifting and which
cannot be removed without damaging either the label or the substrate.
(2) Notwithstanding subparagraph 23(1), the following
Schedule 5 poisons namely:
(a) methylated
spirit(s);
(b) liquid hydrocarbons when
packed as kerosene, lamp oil, mineral turpentine, thinners, reducers, white
petroleum spirit or dry cleaning fluid;
(c) petrol;
(d) toluene; or
(e) xylene,
must
not be sold or supplied in a bottle or jar having a nominal capacity of 2
litres or less, unless the immediate container complies with the container
requirements specified in paragraph 21.
24. Notwithstanding
subparagraphs 21, 22 and 23 a poison may be packed in a container that does not
comply with the tactile identification requirements of Australian Standard
AS2216-1997
entitled Packaging for poisonous substances or the requirements of subparagraphs
22(2) or 23(1)(iii) if:
(1) the
other safety factors are not diminished;
(2) the
container is for a specific purpose; and
(3) an
appropriate authority has approved the use of the container for that purpose.
25. (1) If a
poison, other than a poison included in a therapeutic good packaged in a manner
compliant with orders made under subsection 10(3) of the Commonwealth Therapeutic
Goods Act 1989, listed in column 1 of the following table is sold or
supplied in a container having a nominal capacity specified for that poison in
column 2, it must be closed with a child-resistant closure.
TABLE
______________________________________________________________________
Column 1 Column
2
Name of the poison Nominal
capacity
______________________________________________________________________
Alkaline salts included in
Schedule 5, All sizes
when packed and labelled as dishwashing
machine tablets.
Alkaline salts included in
Schedule 5, 5 litres /kilograms or
less
when packed and labelled as dishwashing
machine liquids, solids or gels.
Alkaline
salts included in Schedule 5, when 2.5 litres or
less
packed
and labelled as a food additive.
Anise
oil when included in Schedule 5. 200
millilitres or less
Basil
oil when included in Schedule 5. 200
millilitres or less
Bay
oil when included in Schedule 6. 200
millilitres or less
Cajuput
oil when included in Schedule 6. 200
millilitres or less
Cassia
oil when included in Schedule 5. 200
millilitres or less
Cineole
when included in Schedule 6. 2 litres
or less
Cinnamon
bark oil when included 200
millilitres or less
in
Schedule 5.
Cinnamon
leaf oil when included in Schedule 6. 200 millilitres or
less
Clove
oil when included in Schedule 6. 200
millilitres or less
Essential
oils when included in Schedule 6 200
millilitres or less
because
of their natural camphor component.
Ethylene
glycol when included in Schedule 6. 5 litres or less
Ethylene
glycol when included in 5
litres or less
Schedule
5 in preparations containing
more
than 50 per cent of ethylene glycol.
Eucalyptus
oil when included in Schedule 6. 2 litres or less
Eugenol
when included in Schedule 6. 200
millilitres or less
Hydrocarbons,
liquid, when packed 5 litres or
less
as kerosene, lamp oil, mineral
turpentine,
thinners, reducers, white
petroleum spirit
or dry cleaning fluid.
Hydrochloric acid when included
in Schedule 6. 5 litres or less
Leptospermum scoparium oil
(manuka oil) 200 millilitres or less
when included in Schedule 6
Marjoram oil when included in
Schedule 5. 200 millilitres or less
Melaleuca oil (tea-tree oil) when
included 200 millilitres or less
in Schedule 6.
Methylated spirit excluding
preparations or 5 litres or less
admixtures.
Methyl
salicylate and preparations containing 200
millilitres or less
more
than 50 per cent of methyl salicylate.
Nutmeg
oil when included in Schedule 5. 200
millilitres or less
Oil
of turpentine. 5
litres or less
Pennyroyal
oil when included in Schedule 6. 200 millilitres
or less
Potassium
hydroxide as such. 2.5
litres or less
Potassium
hydroxide in oven, hot plate or 5 litres or
less
drain
cleaners when included in Schedule 6
except
when in pressurised spray packs.
d-Pulegone
when included in Schedule 6. 200 millilitres
or less
Sage
oil (Dalmatian) when included 200
millilitres or less
in
Schedule 6.
Sodium
hydroxide as such. 2.5
litres or less
Sodium
hydroxide in oven, hot plate or 5 litres or
less
drain
cleaners when included in Schedule 6
except
when in pressurised spray packs.
Thujone
when included in Schedule 6. 200
millilitres or less
Thyme
oil when included in Schedule 5. 200
millilitres or less
(2) The
manufacturer or packer of a poison must ensure that the child-resistant closure
is appropriate for the container and the poison and that it retains its
child-resistant properties for the expected life of the poison.
25A. (1) A person who
supplies any Schedule 8 poison must ensure that the Schedule 8 poison is
packaged in such a way that its primary pack is so sealed that, when the seal
is broken, it is readily distinguishable from other sealed primary packs.
(2) This paragraph
does not apply to the supply of a Schedule 8 poison by an:
(a) authorised
prescriber or other authorised supplier;
(b) pharmacist
on the prescription of an authorised prescriber;
(c) pharmacist
employed at a hospital, on the written requisition of a medical practitioner, a
dentist or the nurse or midwife in charge of the ward in which the Schedule 8
poison is to be used or stored; or
(d) nurse
or midwife on the direction in writing of an authorised prescriber.
26. (1) Paragraphs
21, 22 and 23 do not apply to the immediate container of a poison prepared,
packed and sold:
(a) for
human internal or animal internal use; or
(b) as
a solid or semi-solid preparation for human external or animal external use; or
(c) as
a paint, other than a paint for therapeutic or cosmetic use; or
(d) in
containers having a nominal capacity of 15 millilitres or less; or
(e) for
use in automatic photographic or photocopy processing machines if the container
is specifically designed to fit into the machines; or
(f) solely
for dispensary, industrial, laboratory or manufacturing purposes.
(2) Paragraph
25 does not apply to a poison prepared, packed and sold solely for dispensary,
industrial, laboratory or manufacturing purposes.
27. The tactile
identification or embossing required by paragraphs 21, 22 or 23 of this
Standard or Australian Standard AS 2216-1997 entitled Packaging for
poisonous substances
do not apply to a container that is an aerosol container, a collapsible tube,
or a measure pack which is a flexible sachet.
28. The container
requirements of paragraph 21 do not apply to a device that contains only
camphor or naphthalene in block, ball, disc, pellet or flake form for domestic
use, if the device:
(1) in
normal use, prevents removal or ingestion of its contents; and
(2) is
incapable of reacting with the poison; and
(3) is
sufficiently strong to withstand the ordinary risks of handling, storage or
transport; and
(4) has
the word “POISON” and the approved name of the poison embossed or indelibly
printed on it.
29. A person must not
sell or supply camphor or naphthalene in ball, block, disc, pellet or flake form
for domestic use unless the balls, blocks, discs, pellets or flakes are
enclosed in a device which prevents removal or ingestion of its contents.
30. A person must not
sell or supply a poison in a container which has the name of another poison
embossed or indelibly marked thereon.
31. A person must not
sell any poison which is for internal use or any food, drink or condiment in a
container prescribed by paragraph 21, 22 or 23 of this Standard.
31A. A person must not
sell any poison in a container used expressly for any food, drink or condiment.
(It
is recommended that the States and Territories implement regulations which
provide controls similar to those included in this Part of the Standard.)
32. A person must not
include any reference to a poison included in:
(a) Schedule
3 unless included in Appendix H; or
(b) Schedule
4 or Schedule 8,
of this
Standard in any advertisement except in genuine professional or trade journals
or other publications intended for circulation only within the medical,
nursing, veterinary, dental or pharmaceutical professions or the wholesale drug
industry.
33. A person must not
include any reference to a poison included in Schedule 9 or Appendix C of this
Standard in any advertisement.
34. A person, other
than a pharmacist (or an assistant under the direction of a pharmacist) or a
medical, dental or veterinary practitioner in the lawful practice of their
professions, must not sell or supply a Schedule 2 poison unless licensed to do
so.
35. A person is not eligible
to be granted a licence to sell a Schedule 2 poison by way of retail sale
unless:
(1) he or
she is carrying on the business of selling goods by retail; and
(2) the
premises from which the poison will be sold is more than 25 kilometres by the shortest
practical route from the nearest pharmacy; and
(3) he or
she produces such evidence, as may be required, that he or she is a fit and
proper person to be so licensed.
36. A person, other
than a pharmacist, or a medical, dental or veterinary practitioner, in the
lawful practice of his or her profession, must not sell or supply a Schedule 3
poison.
37. The person who
sells or supplies a Schedule 3 poison must:
(1) provide
adequate instructions for use, either written or verbal, at the time of supply
or sale; and
(2) label
the container with his or her name or the name of the pharmacy and the address
from which it was sold or supplied; and
(3) if
required by regulation, make a record of the transaction in a prescription book
or other approved recording system.
Schedule 4 poisons
38. A person, other
than a medical, dental or veterinary practitioner in the ordinary course of
their professions or a pharmacist dispensing a legal prescription must not sell
or supply a Schedule 4 poison.
39. Paragraph 38 does
not apply to a pharmacist who sells or supplies a Schedule 4 poison, other than
a poison excepted by regulation from this provision, without a prescription if:
(1) the
patient is under medical treatment with the poison and continuation of
medication is essential; and
(2) the
quantity sold or supplied does not exceed 3 days' medication; and
(3) the
pharmacist is satisfied that an emergency exists.
40. Paragraphs 34, 36,
37 and 38 do not apply to sale by way of wholesale dealing to a pharmacist,
medical practitioner, veterinary practitioner, dentist or a person licensed or
otherwise authorised to possess, sell or supply such poisons.
41. (1) A person
must not possess or use a Schedule 7 poison for domestic or domestic garden
purposes.
(2) A
person must not sell or supply:
(a) a
Schedule 7 poison for domestic or domestic garden purposes; or
(b) a
Schedule 7 poison being a liquid preparation containing paraquat unless it is
coloured blue or green and contains sufficient stenching agent to produce an
offensive smell; or
(c) a
Schedule 7 poison for which an authorisation to possess or use is required by
subparagraph (3) unless the purchaser produces his or her authorisation.
(3) A
person must not possess or use any of the following Schedule 7 poisons unless
he or she is authorised to do so by the appropriate authority:
Arsenic
Cyanides
Fluoroacetic
acid
Fluoroacetamide
Hydrocyanic
acid
Strychnine
Thallium.
(4) The appropriate
authority may exempt a person or a class of persons from the requirement to
hold an authorisation under subparagraph (3) and may vary or revoke the
exemption by notice in writing.
42. A person must not:
(1) knowingly
have in his or her possession or sell, supply or use a poison listed in
Appendix C of this Standard for the purpose or purposes indicated in relation
to that poison in Appendix C; or
(2) sell
or supply, other than by way of wholesale dealing, or prescribe a poison listed
in Appendix D paragraphs 1, 2, 3 or 4 except in accordance with the provisions
indicated for that poison in Appendix D; or
(3) knowingly
have in his or her possession a poison listed in Appendix D paragraph 5 without
authority.
43. A person who sells
or supplies Schedule 2 poisons must keep those poisons in such a way that
public access to advice from a pharmacist is available if required.
44. A person who
sells or supplies Schedule 3, Schedule 4 or Schedule 7 poisons must keep those
poisons in a part of the premises to which the public does not have access.
This page is
intentionally blank.
PART 4
This Schedule is
intentionally blank.
(Substances marked †
are listed in Appendix C)
ACETIC ACID (excluding its salts
and derivatives) and preparations containing more than 80 per cent of acetic
acid (CH3COOH) for therapeutic use.
ACETYLCYSTEINE in preparations
for oral use except when labelled with a recommended daily dose of 1 g
or less of acetylcysteine.
ACONITUM spp. for therapeutic use
in adults:
(a) in
preparations for oral use in packs each containing 0.2 mg or less of total
alkaloids except in packs containing 0.02 mg or less of total alkaloids;
or
(b) in
preparations for dermal use containing 0.02 per cent or less of total
alkaloids, in packs each containing 0.2 mg or less of total alkaloids except
in packs containing 0.02 mg or less of total alkaloids.
ALOXIPRIN.
AMETHOCAINE in preparations for
topical use other than eye drops, containing 10 per cent or less of total local
anaesthetic substances except in dermal preparations containing 2 per
cent or less of total local anaesthetic substances.
AMOROLFINE in preparations for
topical use except in preparations for the treatment of tinea pedis.
ANTAZOLINE in eye drops.
ASPIRIN except:
(a) when
included in Schedule 4, 5 or 6;
(b) in
individually wrapped powders or sachets of granules each containing 650 mg or
less of aspirin as the only therapeutically active constituent other than an
effervescent agent when:
(i) enclosed
in a primary pack that contains 12 or less such powders or sachets of granules;
and
(ii) compliant
with the requirements of the Required Advisory Statements for Medicine
Labels;
(c) in
tablets or capsules each containing no other therapeutically active constituent
other than an effervescent agent when:
(i) packed
in blister or strip packaging or in a container with a child-resistant closure;
(ii) in
a primary pack of not more than 25 tablets or capsules, each containing 325
mg or less of aspirin, or in a primary pack of not more than 16 tablets or
capsules, each containing 500 mg or less of aspirin; and
(iii) compliant
with the requirements of the Required Advisory Statements for Medicine
Labels;
(d) in tablets
or capsules each containing no other therapeutically active constituent other
than an effervescent agent when:
(i)
packed in blister or strip packaging or in a container with a
child-resistant
closure;
(ii) in
a primary pack containing 100 or less tablets or capsules, each containing 100
mg or less of aspirin when packed and labelled for the prevention of
cardiovascular disease or for the inhibition of platelet aggregation; and
(iii) compliant
with the requirements of the Required Advisory Statements for Medicine
Labels.
ATROPA BELLADONNA (belladonna):
(a) for
external use in preparations containing 0.03 per cent or less of total
solanaceous alkaloids; or
(b) for oral
use:
(i) in
undivided preparations containing 0.03 per cent or less of total solanaceous
alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous
alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous
alkaloids; or
(ii) in
divided preparations containing 0.3 mg or less of total solanaceous alkaloids
per dosage unit, when labelled with a recommended daily dose of 1.2 mg or less
of total solanaceous alkaloids.
ATROPINE (excluding atropine methonitrate)
for oral use:
(a) in
undivided preparations containing 0.03 per cent or less of total solanaceous
alkaloids
when
labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a
recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
(b) in divided
preparations containing 0.3 mg or less of total solanaceous alkaloids per
dosage unit when labelled with a recommended daily dose of 1.2 mg or less of
total solanaceous alkaloids.
AZELAIC ACID in dermal
preparations.
AZELASTINE:
(a) in
preparations for nasal use; or
(b) in topical
eye preparations containing 0.05 per cent or less of azelastine.
BECLOMETHASONE in aqueous nasal
sprays delivering 50 micrograms or less of beclomethasone per actuation when
the maximum recommended daily dose is no greater than 400 micrograms and when
packed in a primary pack containing 200 actuations or less, for the prophylaxis
or treatment of allergic rhinitis for up to 6 months in adults and children 12
years of age and over.
BENZOCAINE in preparations for
topical use other than eye drops:
(a) containing
10 per cent or less of total local anaesthetic substances, except in
dermal preparations containing 2 per cent or less of total local anaesthetic
substances; or
(b) in divided
preparations containing 200 mg or less of total local anaesthetic substances
per dosage unit, except in lozenges containing 30 mg or less of total
local anaesthetic substances per dosage unit.
BENZOYL PEROXIDE in preparations
for human external therapeutic use containing 10 per cent or less of benzoyl
peroxide except in preparations containing 5 per cent or less of benzoyl
peroxide.
BENZYDAMINE in preparations for
topical use, except in preparations for dermal use.
BEPHENIUM SALTS.
BIFONAZOLE in preparations for
dermal use except:
(a) in
preparations containing 1 per cent or less of bifonazole for the treatment of
the scalp; or
(b) in
preparations for the treatment of tinea pedis.
BROMHEXINE.
BROMPHENIRAMINE when combined
with one or more other therapeutically active substances in oral preparations
when:
(a) at least
one of the other therapeutically active substances is a sympathomimetic
decongestant; or
(b) in a
day-night pack containing brompheniramine in the bed-time dose where the day
and night doses are in the same immediate container or immediate wrapper,
except in
preparations for the treatment of children under 2 years of age.
BUDESONIDE in aqueous nasal
sprays delivering 50 micrograms or less of budesonide per actuation when the
maximum recommended daily dose is no greater than 400 micrograms and when
packed in a primary pack containing 200 actuations or less, for the prophylaxis
or treatment of allergic rhinitis for up to 6 months in adults and children 12
years of age and over.
CARBETAPENTANE except in
preparations containing 0.5 per cent or less of carbetapentane.
CARBOCISTEINE.
CETIRIZINE in preparations for oral use except in divided
preparations for the treatment of seasonal allergic rhinitis in adults and
children 12 years of age and over when:
(a)
in a primary pack containing not
more than 5 days’ supply; and
(b)
labelled with a
recommended daily dose not exceeding 10 mg of cetirizine.
CHLOPHEDIANOL.
CHLORBUTOL for human use in
topical preparations containing 5 per cent or less of chlorbutol except
in preparations containing 0.5 per cent or less of chlorbutol.
CHLOROFORM in preparations for
therapeutic use except:
(a) when
included in Schedule 4; or
(b) in
preparations containing 0.5 per cent or less of chloroform.
CHLORPHENIRAMINE when combined
with one or more other therapeutically active substances in oral preparations
when:
(a) at least
one of the other therapeutically active substances is a sympathomimetic
decongestant; or
(b) in a
day-night pack containing chlorpheniramine in the bed-time dose where the day
and night doses are in the same immediate container or immediate wrapper,
except
in preparations for the treatment of children under 2 years of age.
CICLOPIROX:
(a)
in preparations for dermal use
containing 2 per cent or less of ciclopirox except in preparations for
the treatment of tinea pedis; or
(b)
in preparations for application to the
nails containing 8 per cent or less of ciclopirox.
CINCHOCAINE in preparations for topical use other than
eye drops, containing 0.5 per cent or less of
total local anaesthetic substances.
CINNAMEDRINE.
CLOTRIMAZOLE for human use in
dermal preparations and for application to the nails except in
preparations for the treatment of tinea pedis.
CODEINE in
preparations for the treatment of coughs and colds when:
(a)
not
combined with any other opiate substance;
(b)
compounded
with one or more other therapeutically active substances, of which at least one
is phenylephrine and not more than one is an analgesic substance:
(i)
in
divided preparations containing 10 mg or less of codeine per dosage unit; or
(ii) in
undivided preparations containing 0.25 per cent or less of codeine;
(c)
labelled
with a recommended daily dose not exceeding 60 mg of codeine; and
(d) in packs
containing not more than 6 days' supply at the maximum dose recommended on the
label.
CREOSOTE derived from wood other
than beechwood for human therapeutic use, except in preparations
containing 10 per cent or less of creosote derived from wood other than
beechwood.
DATURA spp. for oral use:
(a) in
undivided preparations containing 0.03 per cent or less of total solanaceous
alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous
alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous
alkaloids, or
(b) in divided
preparations containing 0.3 mg or less of total solanaceous alkaloids per
dosage unit when labelled with a recommended daily dose of 1.2 mg or less of
total solanaceous alkaloids,
except when separately
specified in these Schedules.
DATURA STRAMONIUM (stramonium)
for oral use when:
(a) in
undivided preparations containing 0.03 per cent or less of total solanaceous
alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous
alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous
alkaloids; or
(b) in divided
preparations containing 0.3 mg or less of total solanaceous alkaloids per
dosage unit when labelled with a recommended daily dose of 1.2 mg or less of
total solanaceous alkaloids,
except for smoking or
burning.
DATURA TATULA (stramonium) for
oral use:
(a) in
undivided preparations containing 0.03 per cent or less of total solanaceous
alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous
alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous
alkaloids; or
(b) in divided
preparations containing 0.3 mg or less of total solanaceous alkaloids per
dosage unit when labelled with a recommended daily dose of 1.2 mg or less of
total solanaceous alkaloids,
except for smoking or
burning.
DELPHINIUM STAPHISAGRIA except
in preparations containing 0.2 per cent or less of Delphinium staphisagria.
DESLORATADINE in preparations for
oral use.
DEXCHLORPHENIRAMINE when combined
with one or more other therapeutically active substances in oral preparations
when:
(a) at least
one of the other therapeutically active substances is a sympathomimetic
decongestant; or
(b) in a
day-night pack containing dexchlorpheniramine in the bed-time dose where the
day and night doses are in the same immediate container or immediate wrapper,
except in
preparations for the treatment of children under 2 years of age.
DEXTROMETHORPHAN (excluding its
stereoisomers) when supplied in a pack containing 600 mg or less of
dextromethorphan and with a recommended daily dose of 120 mg or less of
dextromethorphan.
DIBROMOPROPAMIDINE for ophthalmic
use.
DICLOFENAC when:
(a)
in divided preparations for oral
use containing 12.5 mg or less of diclofenac per dosage unit in a pack
containing 20 or less dosage units and labelled with a recommended daily dose
of 75 mg or less of diclofenac;
(b)
in preparations for dermal use
containing 4 per cent or less of diclofenac except in preparations for
dermal use containing 1 per cent or less of diclofenac or for the treatment of
solar keratosis; or
(c)
in transdermal preparations for
topical use containing 140 mg or less of diclofenac.
DIHYDROCODEINE when compounded
with aspirin and no other therapeutically active substance in divided
preparations:
(a) containing
5 mg or less of dihydrocodeine per dosage unit;
(b) packed in
blister or strip packaging or in a container with a child-resistant closure;
(c) enclosed
in primary packs containing 25 or less dosage units; and
(d) labelled with a recommended dose not exceeding 10
mg of dihydrocodeine.
DIMENHYDRINATE in primary packs
of 10 doses or less for the prevention or treatment of motion sickness, except
in preparations for the treatment of children under 2 years of age.
DIPHENHYDRAMINE in oral
preparations:
(a) in a
primary pack containing 10 dosage units or less for the prevention or treatment
of motion sickness; or
(b) when
combined with one or more other therapeutically active substances when:
(i) at
least one of the other therapeutically active substances is a sympathomimetic
decongestant; or
(ii) in
a day-night pack containing diphenhydramine in the bed-time dose where the day
and night doses are in the same immediate container or immediate wrapper,
except in
preparations for the treatment of children under 2 years of age.
DOXYLAMINE when combined with one
or more other therapeutically active substances in oral preparations when:
(a) at least
one of the other therapeutically active substances is a sympathomimetic
decongestant; or
(b) in
a day-night pack containing doxylamine in the bed-time dose where the day and
night doses are in the same immediate container or immediate wrapper,
except in preparations for
the treatment of children under 2 years of age.
DUBOISIA LEICHHARDTII for oral
use:
(a) in
undivided preparations containing 0.03 per cent or less of total solanaceous
alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous
alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous
alkaloids; or
(b) in divided
preparations containing 0.3 mg or less of total solanaceous alkaloids per
dosage unit when labelled with a recommended daily dose of 1.2 mg or less of
total solanaceous alkaloids.
DUBOISIA MYOPOROIDES for oral
use:
(a) in
undivided preparations containing 0.03 per cent or less of total solanaceous
alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous
alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous
alkaloids; or
(b) in divided
preparations containing 0.3 mg or less of total solanaceous alkaloids per
dosage unit when labelled with a recommended daily dose of 1.2 mg or less of
total solanaceous alkaloids.
ECONAZOLE for human use in dermal
preparations except in preparations for the treatment of tinea pedis.
ETAFEDRINE.
ETHER for therapeutic use except:
(a) when
included in Schedule 4; or
(b) in
preparations containing 10 per cent or less of ether.
ETHYLMORPHINE when:
(a) compounded
with one or more other therapeutically active substances:
(i) in
divided preparations containing 10 mg or less of ethylmorphine per dosage unit;
or
(ii) in
undivided preparations containing 0.25 per cent or less of ethylmorphine;
(b) labelled
with a recommended dose not exceeding 15 mg of ethylmorphine.
ETOFENAMATE in preparations for
external use.
FAMOTIDINE when sold in the
manufacturer’s original pack containing not more than 14 days' supply.
FELBINAC in preparations for
external use.
FEXOFENADINE in preparations for oral use except
in divided preparations for the treatment of seasonal allergic rhinitis in
adults and children 12 years of age and over when:
(a)
in a primary pack containing 10
dosage units or less and not more than 5 days’ supply; and
(b)
labelled with a recommended daily
dose not exceeding 120 mg of fexofenadine.
FLUORIDES for human use:
(a) in
preparations for ingestion containing 0.5 mg or less of fluoride ion per dosage
unit; or
(b) in liquid
preparations for topical use containing 1000 mg/kg or less of fluoride ion, in
a container with a child-resistant closure:
(i) for
therapeutic use when compliant with the requirements of the Required
Advisory Statements for Medicine Labels except in preparations
containing 220 mg/kg or less of fluoride ion, in packs containing not more than
120 mg total fluoride when fitted with a child-resistant closure and compliant
with the requirements of Required Advisory Statements for Medicine Labels;
or
(ii) for
non-therapeutic use when labelled with warnings to the following effect:
(A) Do
not swallow; and
(B) Do
not use [this product/name of product] in children six years of age or less,
except in preparations
containing 220 mg/kg or less of fluoride ion, in packs containing not more than
120 mg total fluoride, when fitted with a child-resistant closure and labelled
with warnings to the following effect:
(A) Do
not swallow; and
(B) Do
not use [this product/name of product] in children six years of age or less,
except in preparations
containing 15 mg/kg or less of fluoride ion or preparations for supply to
registered dental professionals or by approval of an appropriate authority.
FLURBIPROFEN in preparations
for topical oral use when:
(a) in divided
preparations containing 10 mg or less of flurbiprofen per dosage unit; or
(b) in
undivided preparations containing 0.25 per cent or less, or 10 mg or less per
dose, of flurbiprofen.
FLUTICASONE in aqueous nasal
sprays delivering 50 micrograms or less of fluticasone per actuation when the
maximum recommended daily dose is no greater than 400 micrograms and when
packed in a primary pack containing 200 actuations or less, for the prophylaxis
or treatment of allergic rhinitis for up to 6 months in adults and
children 12 years of age and over.
FOLIC ACID for human therapeutic
use except:
(a) when
included in Schedule 4; or
(b) in
preparations containing 500 micrograms or less of folic acid per recommended
daily dose.
FOLINIC ACID for human
therapeutic use except:
(a) when
included in Schedule 4; or
(b) in
preparations containing 500 micrograms or less of folinic acid per recommended
daily dose.
† FORMALDEHYDE (excluding its
derivatives) for human therapeutic use except:
(a) in oral
hygiene preparations containing 0.1 per cent or less of free formaldehyde; or
(b) in other
preparations containing 0.2 per cent or less of free formaldehyde.
GUAIPHENESIN in a modified
release dosage form of 1200 mg or less of guaiphenesin with a recommended daily
dose of 2400 mg or less when not labelled for the treatment of children under
12 years of age.
GELSEMIUM SEMPERVIRENS.
GLUTARALDEHYDE for human
therapeutic use.
HEXACHLOROPHANE in preparations
for human use containing 3 per cent or less of hexachlorophane except:
(a) in
preparations containing 0.75 per cent or less of hexachlorophane; or
(b) in
preparations for use on infants, as specified in Schedule 4.
HYDROCORTISONE and HYDROCORTISONE
ACETATE, but excluding other salts and derivatives, in preparations for human
therapeutic use containing 0.5 per cent or less of hydrocortisone:
(a) for dermal
use, in packs containing 30 g or less of such preparations, containing no other
therapeutically active constituent other than an antifungal substance; or
(b) for rectal
use when combined with a local anaesthetic substance but no other
therapeutically active constituent except unscheduled astringents:
(i) in
undivided preparations in packs of 35 g or less; or
(ii) in
packs containing 12 or less suppositories.
HYDROQUINONE (excluding monobenzone and alkyl ethers of hydroquinone
included in Schedule 4) in preparations for human external
therapeutic or cosmetic use containing 2 per cent or less of hydroquinone except:
(a)
in hair preparations containing 0.3 per cent or less of hydroquinone; or
(b)
in cosmetic nail
preparations containing 0.02 per cent or
less of hydroquinone.
8-HYDROXYQUINOLINE and its
non-halogenated derivatives for human therapeutic use, except in
preparations for external use containing 1 per cent or less of such substances.
HYOSCINE (excluding hyoscine
butylbromide):
(a) for
transdermal use in preparations containing 2 mg or less of total solanaceous
alkaloids per dosage unit; or
(b) for oral
use:
(i) in
undivided preparations containing 0.03 per cent or less of total solanaceous
alkaloids, when labelled with a dose of 0.3 mg or less of total solanaceous
alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous
alkaloids; or
(ii) in
divided preparations containing 0.3 mg or less of total solanaceous alkaloids
per dosage unit when labelled with a recommended daily dose of 1.2 mg or less
of total solanaceous alkaloids.
HYOSCINE BUTYLBROMIDE as the only therapeutically
active substance, in divided preparations for oral use, containing 20 mg or
less of hyoscine butylbromide per dosage unit in a pack containing 200 mg or
less of hyoscine butylbromide.
HYOSCYAMINE:
(a) for
external use in preparations containing 0.03 per cent or less of total
solanaceous alkaloids; or
(b) for oral
use:
(i) in
undivided preparations containing 0.03 per cent or less of total solanaceous
alkaloids, when labelled with a dose of 0.3 mg or less of total solanaceous
alkaloids and
a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
(ii) in divided
preparations containing 0.3 mg or less of total solanaceous alkaloids per
dosage unit when labelled with a recommended daily dose of 1.2 mg or less
total solanaceous alkaloids.
HYOSCYAMUS NIGER for oral use:
(a) in
undivided preparations containing 0.03 per cent or less of total solanaceous
alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous
alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous
alkaloids; or
(b) in divided
preparations containing 0.3 mg of total solanaceous alkaloids or less per
dosage unit when labelled with a recommended daily dose of 1.2 mg or less of
total solanaceous alkaloids,
except in a pack containing
0.03 mg or less of total solanaceous alkaloids.
IBUPROFEN in preparations for
oral use when labelled with a recommended daily dose of 1200 mg or less of
ibuprofen:
(a) in
liquid preparations when sold in the manufacturer’s original pack containing 8
grams or less of ibuprofen; or
(b) in
divided preparations, each containing 200 mg or less of ibuprofen, in packs of
not more than 100 dosage units except when:
(i) as
the only therapeutically active constituent (other than phenylephrine or when
combined with an effervescent agent);
(ii) packed
in blister or strip packaging or in a container with a child-resistant closure;
(iii) in
a primary pack containing not more than 25 dosage units;
(iv) compliant
with the requirements of the Required Advisory Statements for Medicine
Labels;
(v) not
labelled for the treatment of children 6 years of age or less; and
(vi) not
labelled for the treatment of children under 12 years of age when combined with
phenylephrine.
INDANAZOLINE.
INDOMETHACIN in
preparations for external use containing 1 per cent or less of indomethacin.
IODINE:
(a) in
preparations for human internal therapeutic use containing 300 micrograms or
more of iodine per recommended daily dose; or
(b) in
preparations for human external therapeutic use containing more than 2.5 per
cent of available iodine (excluding salts, derivatives or iodophors),
except in oral preparations
for use in prophylaxis and treatment in the event of radioactive iodine
exposure under an emergency plan approved by an appropriate authority.
IPRATROPIUM in preparations for
nasal use.
IRON COMPOUNDS (excluding iron
oxides when present as an excipient, in divided preparations containing 10 mg
or less of total iron oxides per dosage unit or in undivided preparations
containing 1 per cent or less of total iron oxides) for human internal use except:
(a) when
included in Schedule 4; or
(b) when
labelled with a recommended daily dose of 24 mg or less of iron:
(i)
in undivided preparations supplied in packs each containing 750 mg or less
of iron; or
(ii)
in divided preparations:
(A)
containing more than 5 mg of iron per dosage unit in packs each containing
750 mg or less of iron; or
(B) containing 5 mg or less of iron
per dosage unit.
ISOCONAZOLE for human use in
dermal preparations.
ISOPROPAMIDE in preparations for
dermal use containing 2 per cent or less of isopropamide.
KETOCONAZOLE in preparations for
dermal use except:
(a) in
preparations containing 1 per cent or less of ketoconazole for the treatment of
the
scalp;
or
(b) in
preparations for the treatment of tinea pedis.
KETOTIFEN
for ophthalmic use in preparations containing 0.025 per cent or less of
ketotifen.
LEVOCABASTINE in topical eye or
nasal preparations.
LIGNOCAINE in preparations for
topical use other than eye drops:
(a) containing
10 per cent or less of total local anaesthetic substances, except in
dermal preparations containing 2 per cent or less of total local anaesthetic
substances; or
(b) in divided
preparations containing 200 mg or less of total local anaesthetic substances
per dosage unit, except in lozenges containing 30 mg or less of total
local anaesthetic substances per dosage unit.
LINDANE in
preparations for human external therapeutic use containing 2 per cent or less
of lindane.
LITHIUM in preparations for
dermal use containing 1 per cent or less of lithium except:
(a) when
present as an excipient at 0.25 per cent or less of lithium; or
(b) in
preparations containing 0.01 per cent or less of lithium.
LOBELIA INFLATA except for
smoking or burning.
LOBELINE except in
preparations for smoking or burning.
LODOXAMIDE in preparations for
ophthalmic use.
LOPERAMIDE in divided
preparations for oral use in packs of 20 dosage units or less except in
preparations containing 2 mg or less of loperamide per dosage unit, in a
primary pack containing 8 dosage units or less.
LORATADINE
in preparations for oral use except in divided preparations for the
treatment of seasonal allergic rhinitis in adults and children 12 years of age
and over when:
(a) in
a primary pack containing 5 dosage units or less; and
(b) labelled
with a recommended daily dose not exceeding 10 mg of loratadine.
MACROGOLS in
preparations for oral use as a liquid concentrate for laxative use.
MEBENDAZOLE for human therapeutic
use.
MECLOZINE in primary packs
containing 12 or less tablets or capsules of meclozine for the prevention or
treatment of motion sickness, except in preparations for the treatment
of children under 2 years of age.
MEFENAMIC ACID in divided
preparations for oral use in packs of 30 or less dosage units for the treatment
of dysmenorrhoea.
MEPYRAMINE for dermal use.
MERCUROCHROME in preparations for
external use containing 2 per cent or less of mercurochrome except when
included in Schedule 6.
MERCURY for external use in
preparations containing 0.5 per cent or less of mercury.
METHOXAMINE in preparations for
external use except in preparations containing 1 per cent or less
of methoxamine.
METHOXYPHENAMINE.
METHYLEPHEDRINE.
MICONAZOLE for human use in
dermal preparations and for application to the nails except in
preparations for the treatment of tinea pedis.
MINOXIDIL in preparations for
dermal use containing 5 per cent or less of minoxidil.
MOMETASONE in aqueous nasal
sprays delivering 50 micrograms or less of mometasone per actuation when the
maximum recommended daily dose is no greater than 200 micrograms for the
prophylaxis or treatment of allergic rhinitis for up to six months in adults
and children 12 years of age and over.
NAPHAZOLINE.
NAPROXEN in divided preparations
containing 250 mg or less of naproxen per dosage unit in packs of 30 or less
dosage units.
NICLOSAMIDE for human therapeutic
use.
NIZATIDINE when sold in the
manufacturer’s original pack containing not more than 14 days' supply.
NOSCAPINE.
NYSTATIN in dermal preparations.
OXETACAINE (oxethazaine) in
preparations for internal use.
OXICONAZOLE for dermal use except
in preparations for the treatment of tinea pedis.
OXYMETAZOLINE.
PAPAVERINE except when
included in Schedule 4.
PARACETAMOL for therapeutic use except:
(a) when
included in Schedule 4;
(b) in
individually wrapped powders or sachets of granules each containing 1000 mg or
less of paracetamol as the only therapeutically active constituent (other than
phenylephrine and/or guaiphenesinor when combined with effervescent agents)
when:
(i)
enclosed
in a primary pack that contains not more than 10 such powders or sachets of
granules;
(ii)
compliant
with the requirements of the Required Advisory Statements for Medicine
Labels;
(iii)
not
labelled for the treatment of children 6 years of age or less; and
(iv)
not
labelled for the treatment of children under 12 years of age when combined
with phenylephrine and/or guaiphenesin; or
(c) in
tablets or capsules each containing 500 mg or less of paracetamol as the only
therapeutically active constituent (other than phenylephrine and/or
guaiphenesin or when combined with effervescent agents) when:
(i)
packed
in blister or strip packaging or in a container with a child-resistant closure;
(ii)
in
a primary pack containing not more than 20 tablets or capsules;
(iii)
compliant
with the requirements of the Required Advisory Statements for Medicine
Labels;
(iv)
not
labelled for the treatment of children 6 years of age or less; and
(v)
not
labelled for the treatment of children under 12 years of age when combined with
phenylephrine and/or guaiphenesin.
†
PARAFORMALDEHYDE (excluding its derivatives) for human therapeutic use except:
(a) in oral
hygiene preparations containing 0.1 per cent or less of free formaldehyde; or
(b) in other
preparations containing 0.2 per cent or less of free formaldehyde.
PENCICLOVIR for external use for
the treatment of herpes labialis.
PHEDRAZINE.
PHENAZONE for human external use.
PHENIRAMINE:
(a) in eye
drops; or
(b) when
combined with one or more other therapeutically active substances in oral
preparations when:
(i) at
least one of the other therapeutically active substances is a sympathomimetic
decongestant; or
(ii) in
a day-night pack containing pheniramine in the bed-time dose where the day and
night doses are in the same immediate container or immediate wrapper,
except in
preparations for the treatment of children under 2 years of age.
PHENOL, or any
homologue boiling below 220°C, for human therapeutic use except:
(a) when
included in Schedule 4; or
(b) in
preparations for external use containing 3 per cent or less of such substances.
PHENYLEPHRINE except:
(a) when
included in Schedule 4;
(b) in oral
preparations containing 50 mg or less of phenylephrine per recommended daily
dose in packs containing 250 mg or less of phenylephrine; or
(c) in
topical eye or nasal preparations containing 1 per cent or less of
phenylephrine.
PHOLCODINE:
(a) in liquid
preparations containing 0.5 per cent or less of pholcodine and with a
recommended dose not exceeding 25 mg of pholcodine; or
(b) when compounded with one or more other
therapeutically active substances in divided preparations containing 10
mg or less of pholcodine per dosage unit and with a recommended
dose not exceeding 25 mg of pholcodine.
PIPERAZINE for human therapeutic
use.
PODOPHYLLOTOXIN
in preparations containing 0.5 per cent or less of podophyllotoxin for human use for the
treatment of warts other than anogenital warts.
PODOPHYLLUM EMODI (podophyllin)
in preparations containing 10 per cent or less of podophyllin for human use for the treatment of warts other than
anogenital warts.
PODOPHYLLUM PELTATUM
(podophyllin) in preparations containing 10 per cent or less of podophyllin for
human use for the treatment of warts other than anogenital warts.
POTASSIUM CHLORATE for
therapeutic use except in preparations containing 10 per cent or less of
potassium chlorate.
PRILOCAINE in preparations for
dermal use containing 10 per cent or less of total local anaesthetic
substances.
PROCYCLIDINE in preparations
containing 5 per cent or less of procyclidine for dermal use.
PROMETHAZINE in oral
preparations:
(a) in a
primary pack containing 10 dosage units or less for the prevention or treatment
of motion sickness; or
(b) when
combined with one or more other therapeutically active substances when:
(i) at
least one of the other therapeutically active substances is a sympathomimetic
decongestant; or
(ii) in
a day-night pack containing promethazine in the bed-time dose where the day and
night doses are in the same immediate container or immediate wrapper,
except in
preparations for the treatment of children under 2 years of age.
PROPAMIDINE for ophthalmic use.
PYRANTEL for human therapeutic
use.
PYRETHRINS, naturally occurring,
being pyrethrolone, cinerolone or jasmolone esters of chrysanthemic or
pyrethric acids, for human therapeutic use in preparations containing more than
10 per cent of such substances.
PYRITHIONE ZINC for human
therapeutic use, except in preparations for the treatment of the scalp
containing 2 per cent or less of pyrithione zinc when compliant with the
requirements of the Required Advisory Statements for Medicine Labels.
RANITIDINE in preparations
supplied in the manufacturer’s original pack containing not more than 14 days'
supply except in divided preparations for oral use containing 150 mg or
less of ranitidine per dosage unit in the manufacturer’s original pack containing
not more than 14 dosage units.
SALICYLAMIDE except when
included in Schedule 4.
SELENIUM in preparations for
human therapeutic use except:
(a) for topical use containing 3.5 per cent or less of
selenium sulfide;
(b) when
included in Schedule 4; or
(c) for oral
use with a recommended daily dose of 150 micrograms or less.
SILVER for therapeutic use except:
(a) in
solutions for human oral use containing 0.3 per cent or less of silver when
compliant with the requirements of the Required Advisory Statements for
Medicine Labels; or
(b) in other
preparations containing 1 per cent or less of silver.
SODIUM CROMOGLYCATE in
preparations for nasal or ophthalmic use.
SODIUM NITRITE for therapeutic
use (excluding when present as an excipient).
SQUILL except in
preparations containing 1 per cent or less of squill.
SULCONAZOLE in preparations for
dermal use.
TERBINAFINE for dermal use except
in preparations for the treatment of tinea pedis.
TETRACHLOROETHYLENE for human
therapeutic use.
TETRAHYDROZOLINE.
THIABENDAZOLE for human
therapeutic use.
TIOCONAZOLE in preparations for
dermal use except in preparations for the treatment of
tinea pedis.
TRAMAZOLINE.
TRIAMCINOLONE in aqueous nasal
sprays delivering 55 micrograms or less of triamcinolone per actuation when the
maximum recommended daily dose is no greater than 220 micrograms, for
prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and
children 12 years of age and over.
TRIMEPRAZINE when combined with
one or more other therapeutically active substances in solid oral preparations
when:
(a) at least
one of the other therapeutically active substances is a sympathomimetic
decongestant; or
(b) in a
day-night pack containing trimeprazine in the bed-time dose where the day and
night doses
are in
the same immediate container or immediate wrapper,
except in
preparations for the treatment of children under 2 years of age.
TRIPROLIDINE when combined with
one or more other therapeutically active substances in oral preparations when:
(a) at least
one of the other therapeutically active substances is a sympathomimetic
decongestant; or
(b) in a
day-night pack containing triprolidine in the bed-time dose where the day and
night
doses
are in the same immediate container or immediate wrapper,
except in
preparations for the treatment of children under 2 years of age.
TUAMINOHEPTANE.
TYMAZOLINE.
XYLOMETAZOLINE.
ZINC CHLORIDE for human dermal
use except in preparations containing 5 per cent or less of zinc
chloride.
ADRENALINE in preparations
containing 1 per cent or less of adrenaline except in preparations
containing 0.02 per cent or less of adrenaline unless packed and labelled
for injection.
ALCLOMETASONE as the only
therapeutically active substance in preparations for dermal use containing 0.05
per cent or less of alclometasone in packs containing 30 g or less of the
preparation.
AMINOPHYLLINE in liquid oral
preparations containing 2 per cent or less of aminophylline.
AZATADINE in oral preparations.
BROMPHENIRAMINE in oral preparations except:
(a) when
included in Schedule 2; or
(b) for the
treatment of children under 2 years of age.
BUCLIZINE in oral preparations.
BUTOCONAZOLE in preparations for
vaginal use.
CHLORAMPHENICOL for ophthalmic
use only.
CHLORBUTOL in preparations for
human use except:
(a) when
included in Schedule 2; or
(b) in
preparations containing 0.5 per cent or less of chlorbutol.
CHLORPHENIRAMINE in oral preparations except:
(a) when
included in Schedule 2; or
(b) for the
treatment of children under 2 years of age.
CICLOPIROX in preparations for
dermal use and for application to the nails except:
(a) when included in
Schedule 2; or
(b) in preparations
for the treatment of tinea pedis.
CIMETIDINE in a primary pack
containing not more than 14 days' supply.
CLEMASTINE in preparations for
oral use.
CLOBETASONE
(clobetasone-17-butyrate) as the only therapeutically active substance in
preparations for dermal use containing 0.05 per cent or less of clobetasone in
packs containing 30 g or less of the preparation.
CLOTRIMAZOLE in preparations for
vaginal use.
CODEINE when:
(a) not
combined with any other opiate substance;
(b) compounded
with one or more other therapeutically active substances, of which not more than
one is an analgesic substance:
(i) in
divided preparations containing 12 mg or less of codeine per dosage unit; or
(ii) in
undivided preparations containing 0.25 per cent or less of codeine;
(c) labelled
with a recommended daily dose not exceeding 100 mg of codeine; and
(d) in packs
containing not more than 5 days' of supply at the maximum dose recommended on
the label,
except when
included in Schedule 2.
CYCLIZINE in preparations for
oral use.
CYPROHEPTADINE in oral
preparations.
DEXCHLORPHENIRAMINE in oral preparations except:
(a) when
included in Schedule 2; or
(b) for the
treatment of children under 2 years of age.
DICLOFENAC in divided
preparations for oral use containing 25 mg or less of diclofenac per dosage
unit in a pack containing 30 or less dosage units except when included
in Schedule 2.
DIHYDROCODEINE when compounded
with one or more other therapeutically active substances:
(a) in divided
preparations containing 10 mg or less per dosage unit and with a recommended
dose not exceeding 15 mg of dihydrocodeine; or
(b) in
undivided preparations containing 0.25 per cent or less of dihydrocodeine with
a recommended dose not exceeding 15 mg of dihydrocodeine,
except when included in
Schedule 2.
DI-IODOHYDROXYQUINOLINE
(iodoquinol) for vaginal use.
DIMENHYDRINATE in oral
preparations except when included in Schedule 2.
DIMETHINDENE in oral
preparations.
DIPHENHYDRAMINE in oral preparations except:
(a) when
included in Schedule 2; or
(b) for the
treatment of children under 2 years of age.
DIPHENOXYLATE in packs of 8 or
less dosage units, each dosage unit containing 2.5 mg or less of diphenoxylate and
a quantity of atropine sulfate equivalent to at least 1 per cent of the dose of
diphenoxylate.
DITHRANOL for therapeutic use.
DOXYLAMINE in oral preparations except:
(a) when
included in Schedule 2; or
(b) for the
treatment of children under 2 years of age.
ECONAZOLE in preparations for
vaginal use.
ERYTHRITYL TETRANITRATE for therapeutic
use.
ESOMEPRAZOLE in oral preparations
containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of
gastro-oesophageal reflux disease, in
packs containing not more than 14 days supply.
FAMCICLOVIR for oral use, in
divided preparations containing a total dose of 1500 mg or less of famciclovir
for the treatment of herpes labialis (cold sores).
FLAVOXATE.
FLUCONAZOLE in single-dose oral
preparations containing 150 mg or less of fluconazole for the treatment of vaginal
candidiasis.
FLUORIDES for human topical use:
(a) in liquid
preparations containing 5500 mg/kg or less of fluoride ion, in a container with
a child-resistant closure except when included in or expressly excluded
from Schedule 2; or
(b) in non-liquid
preparations containing 5500 mg/kg or less of fluoride ion except:
(i) in
preparations for therapeutic use containing 1500 mg/kg or less of fluoride ion
and, when containing more than 1000 mg/kg fluoride ion, compliant with the
requirements of the Required Advisory Statements for Medicine Labels;
(ii) in
preparations for non-therapeutic use containing 1500 mg/kg or less of fluoride ion
and, when containing more than 1000 mg/kg fluoride ion, labelled with warnings
to the following effect:
(A) Do
not swallow; and
(B) Do
not use [this product/name of product] in children six years of age or less; or
(iii) in
preparations for supply to registered dental professionals or by approval of an
appropriate authority.
GLUCAGON.
GLYCERYL TRINITRATE:
(a) in
preparations for oral use; or
(b) in
preparations for rectal use.
GLYCOPYRRONIUM except
when included in Schedule 4.
HYDROCORTISONE and HYDROCORTISONE
ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic
use containing 1 per cent or less of hydrocortisone:
(a) for dermal
use, in packs containing 30 g or less of such preparations, containing no other
therapeutically active constituent other than an antifungal substance; or
(b) for rectal
use when combined with a local anaesthetic substance but no other
therapeutically active constituent except unscheduled
astringents:
(i) in
undivided preparations, in packs of 35 g or less; or
(ii) in
packs containing 12 or less suppositories,
except when included in
Schedule 2.
IBUPROFEN in divided
preparations, each containing 400 mg or less of ibuprofen in a primary pack
containing not more than 50 dosage units when labelled:
(a) with a
recommended daily dose of 1200 mg or less of ibuprofen; and
(b) not for
the treatment of children under 12 years of age,
except when
included in or expressly excluded from Schedule 2.
INOSITOL NICOTINATE.
ISOCONAZOLE in preparations for
vaginal use.
ISOSORBIDE DINITRATE in oral
preparations containing 10 mg or less of isosorbide dinitrate per dosage unit.
KETOPROFEN in divided
preparations for oral use containing 25 mg or less of ketoprofen per dosage
unit in a pack containing 30 or less dosage units.
LANSOPRAZOLE in oral preparations
containing 15 mg or less of lansoprazole per dosage unit for the relief of
heartburn and other symptoms of gastro-oesophageal reflux disease, in packs
containing not more than 14 days' supply.
LEVONORGESTREL for emergency
post-coital contraception.
MACROGOLS in preparations for
oral use for bowel cleansing prior to diagnostic, medical or surgical
procedures.
MAGNESIUM
SULFATE for
human therapeutic use in divided oral preparations except when
containing 1.5 g or less of magnesium sulfate per recommended daily dose.
Malathion in preparations for
human external use except in preparations containing 2 per cent or less
of malathion.
MANNITYL HEXANITRATE for
therapeutic use.
MEPYRAMINE in oral preparations.
METHDILAZINE in oral
preparations.
METOCLOPRAMIDE when combined with
paracetamol in divided preparations, packed and labelled only for the treatment
of nausea associated with migraine, in packs containing not more than 10 dosage
units.
MICONAZOLE for human use in
topical preparations:
(a) for the
treatment of oral candidiasis; or
(b) for
vaginal use.
NAPROXEN in a modified release
dosage form of 600 mg or less of naproxen per dosage unit in packs of 16 or
less dosage units when labelled not for the treatment of children under 12
years of age.
NICOTINIC ACID for human
therapeutic use in divided preparations containing 250 mg or less of
nicotinic acid per dosage unit except:
(a) in preparations containing 100 mg or less
of nicotinic acid per dosage unit; or
(b) nicotinamide.
NICOTINYL ALCOHOL except
in preparations containing 100 mg or less of nicotinyl alcohol per dosage unit.
NYSTATIN in preparations for
topical use except when included in Schedule 2.
OMEPRAZOLE in oral preparations
containing 20 mg or less of omeprazole per dosage unit for the relief of
heartburn and other gastro-oesophageal reflux disease, in packs containing not
more than 14 days' supply.
ORLISTAT in oral preparations for
weight-control purposes containing 120 mg or less of orlistat per dosage unit.
OXICONAZOLE in preparations for
vaginal use.
PANTOPRAZOLE in oral preparations
containing 20 mg or less of pantoprazole per dosage unit for the relief of
heartburn and other symptoms of gastro-oesophageal reflux disease, in packs
containing not more than 14 days' supply.
PARACETAMOL when combined with
ibuprofen in a primary pack containing 30 dosage units or less.
PHENIRAMINE in oral preparations except:
(a) when
included in Schedule 2; or
(b) for the
treatment of children under 2 years of age.
PODOPHYLLOTOXIN in preparations
containing 1 per cent or less of podophyllotoxin for human use for the
treatment of warts other than anogenital warts except when included in
Schedule 2.
PODOPHYLLUM EMODI (podophyllin)
in preparations containing 20 per cent or less of podophyllin for human use for
the treatment of warts other than anogenital warts except when included
in Schedule 2.
PODOPHYLLUM PELTATUM
(podophyllin) in preparations containing 20 per cent or less of podophyllin for
human use for the treatment of warts other than anogenital warts except
when included in Schedule 2.
PROCHLORPERAZINE in divided
preparations for oral use in packs containing not more than 10 dosage
units for the treatment of nausea associated with migraine.
PROMETHAZINE in oral preparations
except:
(a) when
included in Schedule 2; or
(b) in
preparations for the treatment of children under 2 years of age.
PSEUDOEPHEDRINE
(other than preparations for stimulant, appetite suppression or weight-control
purposes) when supplied in a primary pack:
(a) in liquid
preparations containing 800 mg or less of pseudoephedrine hydrochloride (or its
equivalent); or
(b) in other
preparations containing 720 mg or less of pseudoephedrine hydrochloride (or its
equivalent).
RABEPRAZOLE in oral preparations
containing 10 mg or less of rabeprazole per dosage unit for the relief of heartburn
and other symptoms of gastro-oesophageal reflux disease, in packs containing
not more than 14 days' supply.
SALBUTAMOL as the only
therapeutically active substance:
(a) in metered
aerosols delivering 100 micrograms or less of salbutamol per metered dose; or
(b) in dry
powders for inhalation delivering 200 micrograms or less of salbutamol per
dose.
SALICYLIC ACID in preparations
for dermal use except in preparations containing 40 per cent or less of
salicylic acid.
SANTONIN.
SODIUM PHOSPHATE in preparations
for oral use for bowel cleansing prior to diagnostic medical and surgical
procedures.
SODIUM PICOSULFATE in
preparations for oral use for bowel cleansing prior to diagnostic medical or
surgical procedures.
SULFACETAMIDE in preparations for
ophthalmic use containing 10 per cent or less of sulfacetamide.
TERBUTALINE as the only
therapeutically active substance:
(a) in metered
aerosols delivering 250 micrograms or less of terbutaline per metered dose; or
(b) in dry
powders for inhalation delivering 500 micrograms or less of terbutaline per
dose.
THEOPHYLLINE in liquid oral
preparations containing 2 per cent or less of theophylline.
TIOCONAZOLE in preparations for
vaginal use.
TRIAMCINOLONE for buccal use in
preparations containing 0.1 per cent or less of triamcinolone in a pack of 5 g
or less.
TRIMEPRAZINE:
(a) in solid
oral preparations except when included in Schedule 2; or
(b) in
liquid oral preparations containing 10 mg or less of trimeprazine per 5 mL,
except in
preparations for the treatment of children under 2 years of age.
TRIPROLIDINE in oral preparations except:
(a) when
included in Schedule 2; or
(b) for the
treatment of children under 2 years of age.
VITAMIN D for human internal therapeutic use in preparations
containing 175 micrograms or less of vitamin D per recommended single
weekly dose except in preparations containing 25 micrograms or less
of vitamin D per recommended daily dose.
(Substances marked †
are listed in Appendix C)
(Substances marked #
are listed in Appendix D)
ABACAVIR.
ABATACEPT.
ABIRATERONE ACETATE.
ABCIXIMAB.
ACAMPROSATE CALCIUM.
ACARBOSE.
ACEBUTOLOL.
ACEPROMAZINE.
ACETANILIDE and alkyl
acetanilides (excluding when present as an excipient) for human therapeutic
use.
ACETARSOL.
ACETAZOLAMIDE.
ACETOHEXAMIDE.
ACETYL ISOVALERYLTYLOSIN.
ACETYLCARBROMAL.
ACETYLCHOLINE.
ACETYLCYSTEINE except:
(a) when
included in Schedule 2; or
(b) in
preparations for oral use when labelled with a recommended daily dose of 1 g or
less of acetylcysteine.
ACETYLDIGITOXIN.
ACETYLMETHYLDIMETHYLOXIMIDOPHENYLHYDRAZINE.
ACETYLSTROPHANTHIDIN.
ACICLOVIR except in
preparations containing 5 per cent or less of aciclovir for the treatment of herpes
labialis in packs containing 10 g or less.
ACIPIMOX.
# ACITRETIN.
ACLIDINIUM BROMIDE.
ACOKANTHERA OUABAIO.
ACOKANTHERA SCHIMPERI.
ACONITUM spp. except:
(a) when
included in Schedule 2;
(b) in
preparations for oral use in adults in packs containing 0.02 mg or less of
total alkaloids; or
(c) in
preparations for dermal use in adults containing 0.02 per cent or less of total
alkaloids in packs containing 0.02 mg or less of total alkaloids.
ACRIVASTINE.
ADALIMUMAB.
ADAPALENE.
ADEFOVIR.
ADENOSINE for human therapeutic
use in preparations for injection.
ADIPHENINE.
ADONIS VERNALIS.
ADRAFINIL.
ADRENALINE. except:
(a) when
included in Schedule 3; or
(b) in
preparations containing 0.02 per cent or less of adrenaline unless packed and
labelled for injection.
ADRENOCORTICAL HORMONES except
when separately specified in these Schedules.
AFAMELANOTIDE.
afatinib
dimaleate.
AFLIBERCEPT.
AGALSIDASE.
AGLEPRISTONE.
AGOMELATINE.
ALATROFLOXACIN MESYLATE.
ALBENDAZOLE except:
(a) when
included in Schedule 5 or 6; or
(b) in
intraruminal implants each containing 3.85 g or less of albendazole for the
treatment of animals.
ALCLOFENAC.
ALCLOMETASONE except when
included in Schedule 3.
ALCURONIUM.
ALDESLEUKIN.
ALDOSTERONE.
# ALEFACEPT.
ALEMTUZUMAB.
ALENDRONIC ACID.
ALFACALCIDOL.
ALFUZOSIN.
ALGLUCERASE.
ALGLUCOSIDASE.
ALISKIREN.
ALLERGENS.
ALLOPURINOL.
ALLYLOESTRENOL.
ALOGLIPTIN.
ALOSETRON.
ALPHA1-PROTEINASE INHIBITOR
(HUMAN).
ALPHADOLONE.
ALPHAXALONE.
ALPRENOLOL.
ALPROSTADIL.
ALSEROXYLON.
ALTEPLASE.
ALTRENOGEST.
ALTRETAMINE (hexamethylmelamine).
AMANTADINE.
AMBENONIUM CHLORIDE.
# AMBRISENTAN.
AMBUCETAMIDE.
AMBUTONIUM BROMIDE.
AMCINONIDE.
AMETHOCAINE except:
(a) when
included in Schedule 2; or
(b) in dermal
preparations containing 2 per cent or less of total local anaesthetic
substances.
AMIFOSTINE.
AMIKACIN.
AMILORIDE.
AMINOCAPROIC ACID.
AMINOGLUTETHIMIDE.
5-AMINOLEVULINIC ACID.
AMINOMETRADINE.
† AMINOPHENAZONE (amidopyrine)
and derivatives for the treatment of animals.
AMINOPHYLLINE except when
included in Schedule 3.
AMINOPTERIN.
4-AMINOPYRIDINE for therapeutic
use.
AMINOREX.
AMINOSALICYLIC ACID.
AMIODARONE.
AMIPHENAZOLE.
AMISOMETRADINE.
AMISULPRIDE.
AMITRIPTYLINE.
AMLODIPINE.
AMMI VISNAGA.
AMMONIUM BROMIDE for therapeutic
use.
AMODIAQUINE.
AMOROLFINE except:
(a) when
included in Schedule 2; or
(b) in
preparations for the treatment of tinea pedis.
AMOXAPINE.
AMOXYCILLIN.
AMPHOMYCIN.
AMPHOTERICIN.
AMPICILLIN.
AMPRENAVIR.
AMRINONE.
AMSACRINE.
AMYL NITRITE.
AMYLOBARBITONE when packed and
labelled for injection.
AMYLOCAINE.
# ANABOLIC STEROIDAL AGENTS.
ANAGRELIDE.
ANAKINRA.
ANASTROZOLE.
ANCESTIM.
ANCROD and its immunoglobulin
antidote.
ANECORTAVE.
# ANDROGENIC STEROIDAL AGENTS.
# ANDROISOXAZOLE.
# ANDROSTANOLONE.
# ANDROSTENEDIOL.
# ANDROSTENEDIONE.
ANGIOTENSIN AMIDE.
ANIDULAFUNGIN.
ANISTREPLASE.
ANTAZOLINE except when
included in Schedule 2.
ANTIBIOTIC SUBSTANCES except:
(a) when
separately specified in these Schedules; or
(b) nisin.
ANTIGENS for human therapeutic
use except when separately specified in this Schedule.
ANTIHISTAMINES except:
(a) when
included in Schedule 2 or 3; or
(b) when
separately specified in this Schedule.
ANTIMONY
for therapeutic use except when separately specified in these Schedules.
ANTISERA (immunosera) for human
use by injection except when separately specified in these Schedules.
APIXABAN.
APOCYNUM spp.
APOMORPHINE.
APRACLONIDINE.
APRAMYCIN.
APREPITANT.
APRONAL.
APROTININ.
ARECOLINE.
ARIPIPRAZOLE.
ARSENIC for
human therapeutic use except when separately specified in these
Schedules.
ARTEMETHER.
ARTICAINE.
ASENAPINE.
ASPIRIN:
(a) when
combined with caffeine, paracetamol or salicylamide or any derivative of these
substances; or
(b) for
injection.
ASTEMIZOLE.
# ATAMESTANE.
ATAZANAVIR.
ATENOLOL.
ATIPAMEZOLE.
ATOMOXETINE.
ATORVASTATIN.
ATOSIBAN.
ATOVAQUONE.
ATRACURIUM BESYLATE.
ATROPA BELLADONNA (belladonna) except
when included in Schedule 2.
ATROPINE except when
included in Schedule 2.
ATROPINE METHONITRATE.
AURANOFIN.
AUROTHIOMALATE SODIUM.
AVILAMYCIN except:
(a) in animal
feed premixes containing 15 per cent or less of avilamycin activity; or
(b) in animal
feeds containing 50 mg/kg or less of avilamycin activity.
AVIPTADIL.
AXITINIB.
AVOPARCIN.
AZACITIDINE.
AZACYCLONOL.
AZAPERONE.
AZAPROPAZONE.
AZARIBINE.
AZATADINE except when
included in Schedule 3.
AZATHIOPRINE.
AZELAIC ACID except:
(a) when
included in Schedule 2; or
(b) in preparations
containing 1 per cent or less of azelaic acid for non-human use.
AZELASTINE except when
included in Schedule 2.
AZITHROMYCIN.
AZLOCILLIN.
AZTREONAM.
BACAMPICILLIN.
BACITRACIN.
BACLOFEN.
BALSALAZIDE.
BAMBERMYCIN (flavophospholipol) except:
(a) when
included in Schedule 6; or
(b) in animal
feeds for growth promotion containing 50 mg/kg or less of antibiotic
substances.
BAMBUTEROL.
BAMETHAN.
BAMIPINE.
BARBITURATES except when
separately specified in these Schedules.
BASILIXIMAB.
BAZEDOXIFENE.
BECAPLERMIN.
BECLAMIDE.
BECLOMETHASONE except when
included in Schedule 2.
BELATACEPT.
BELIMUMAB.
BEMEGRIDE.
BENACTYZINE.
BENAZEPRIL.
BENDROFLUAZIDE.
BENETHAMINE PENICILLIN.
BENORYLATE.
BENOXAPROFEN.
BENPERIDOL.
BENSERAZIDE.
BENZATHINE PENICILLIN.
BENZHEXOL.
BENZILONIUM.
BENZOCAINE except:
(a) when
included in Schedule 2;
(b) in dermal
preparations containing 2 per cent or less of total local anaesthetic
substances; or
(c) in
lozenges containing 30 mg or less of total local anaesthetic substances per
dosage unit.
# BENZODIAZEPINE derivatives except
when separately specified in these Schedules.
BENZOYL PEROXIDE in preparations
for human therapeutic use except:
(a) when
included in Schedule 2; or
(b) in
preparations for external use containing 5 per cent or less of benzoyl peroxide.
BENZPHETAMINE.
BENZTHIAZIDE.
BENZTROPINE (benzatropine).
BENZYDAMINE except:
(a) when
included in Schedule 2; or
(b) in
preparations for dermal use.
BENZYLPENICILLIN.
BEPRIDIL.
BERACTANT.
BESIFLOXACIN.
BETAHISTINE.
BETAMETHASONE.
BETAXOLOL.
BETHANECHOL CHLORIDE.
BETHANIDINE.
BEVACIZUMAB.
BEVANTOLOL.
# BEXAROTENE.
BEZAFIBRATE.
BICALUTAMIDE.
BIFONAZOLE except:
(a) when
included in Schedule 2;
(b) in
preparations for dermal use containing 1 per cent or less of bifonazole for the
treatment of the scalp; or
(c) in
preparations for dermal use for the treatment of tinea pedis.
BIMATOPROST.
BIPERIDEN.
BISMUTH COMPOUNDS for cosmetic
use, except:
(a) bismuth
citrate when incorporated in hair colourant preparations in concentrations of
0.5 per
or less; or
(b) bismuth
oxychloride.
BISMUTH COMPOUNDS for human
therapeutic use, except bismuth formic iodide or bismuth subiodide in
dusting powders containing 3 per cent or less of bismuth.
BISOPROLOL.
BIVALIRUDIN.
BLEOMYCIN.
BOCEPREVIR.
# BOLANDIOL.
# BOLASTERONE.
# BOLAZINE.
# BOLDENONE
(dehydrotestosterone).
# BOLENOL.
# BOLMANTALATE.
BORON, including boric acid and borax,
for human therapeutic use except:
(a) in
preparations for internal use containing 6 mg or less of boron per recommended
daily dose;
(b) in
preparations for dermal use containing 0.35 per cent or less of boron, which are
not for paediatric or antifungal use; or
(c) when
present as an excipient.
BORTEZOMIB.
# BOSENTAN.
BOTULINUM TOXINS for human use except
when separately specified in these Schedules.
BRETYLIUM TOSYLATE.
BRIMONIDINE.
BRINZOLAMIDE.
# BROMAZEPAM.
BROMIDES, inorganic, for
therapeutic use except when separately specified in
these Schedules.
BROMOCRIPTINE.
BROMOFORM for therapeutic use.
BROMPHENIRAMINE except
when included in Schedule 2 or 3.
BROMVALETONE.
BRUGMANSIA spp.
BUCLIZINE except when
included in Schedule 3.
BUDESONIDE except when
included in Schedule 2.
BUFEXAMAC except:
(a) in
preparations for dermal use containing 5 per cent or less of bufexamac; or
(b) in
suppositories.
BUMETANIDE.
BUPHENINE.
BUPIVACAINE except when included in Schedule 5.
BUPROPION.
BUSERELIN.
BUSPIRONE.
BUSULPHAN.
BUTACAINE.
BUTOCONAZOLE except when
included in Schedule 3.
BUTRACONAZOLE.
BUTYL AMINOBENZOATE except
in dermal preparations containing 2 per cent or less of total local anaesthetic
substances.
BUTYLCHLORAL HYDRATE.
BUTYL NITRITE.
CABAZITAXEL.
CABERGOLINE.
CADMIUM COMPOUNDS for human
therapeutic use.
CALCIPOTRIOL.
CALCITONIN.
CALCITRIOL.
CALCIUM CARBIMIDE for therapeutic
use.
CALCIUM POLYSTYRENE SULPHONATE.
CALOTROPIS GIGANTEA.
CALOTROPIS PROCERA.
# CALUSTERONE.
CAMPHORATED OIL for therapeutic
use.
CAMPHOTAMIDE.
CANAGLIFLOZIN.
CANAKINUMAB.
CANDESARTAN CILEXETIL.
CANDICIDIN.
CANINE TICK ANTI-SERUM.
CANTHARIDIN.
CAPECITABINE.
CAPREOMYCIN.
CAPTODIAME.
CAPTOPRIL.
CAPURIDE.
CARAMIPHEN.
CARBACHOL.
CARBAMAZEPINE.
CARBARYL for human therapeutic
use.
CARBAZOCHROME.
CARBENICILLIN.
CARBENOXOLONE for internal use.
CARBETOCIN.
CARBIDOPA.
CARBIMAZOLE.
CARBOCROMEN.
CARBOPLATIN.
CARBOPROST.
CARBROMAL.
CARBUTAMIDE.
CARBUTEROL.
CARINDACILLIN.
CARISOPRODOL.
CARMUSTINE.
CARNIDAZOLE.
CARPROFEN.
CARVEDILOL.
CASPOFUNGIN.
CATHINE.
CATUMAXOMAB.
CEFACETRILE.
CEFACLOR.
CEFADROXIL.
CEFALORIDINE.
CEFAMANDOLE.
CEFAPIRIN.
CEFAZOLIN.
CEFEPIME.
CEFETAMET.
CEFIXIME.
CEFODIZIME.
CEFONICID.
CEFOPERAZONE.
CEFOTAXIME.
CEFOTETAN.
CEFOTIAM.
CEFOVECIN for veterinary use.
CEFOXITIN.
CEFPIROME.
CEFPODOXIME.
CEFQUINOME.
CEFTAROLINE FOSAMIL.
CEFSULODIN.
CEFTAZIDIME.
CEFTIBUTEN.
CEFTIOFUR.
CEFTRIAXONE.
CEFUROXIME.
CELECOXIB.
CELIPROLOL.
CEPHAELIS ACUMINATA (ipecacuanha)
except in preparations containing 0.2 per cent or less of emetine.
CEPHAELIS IPECACUANHA except
in preparations containing 0.2 per cent or less of emetine.
CEPHALEXIN.
CEPHALONIUM.
CEPHALOTHIN.
CEPHRADINE.
CERIVASTATIN.
CERTOLIZUMAB PEGOL.
CERULETIDE.
CETIRIZINE
except
(a) when
included in Schedule 2; or
(b)
in divided preparations for oral use for the treatment of seasonal
allergic rhinitis in adults and children 12 years of age and over when:
(i) in
a primary pack containing not more than 5 days’ supply; and
(ii)
labelled with a recommended daily dose not exceeding 10 mg of
cetirizine.
CETRORELIX.
CETUXIMAB.
CHENODEOXYCHOLIC ACID.
CHLORAL FORMAMIDE.
CHLORAL HYDRATE except in
preparations for topical use containing 2 per cent or less of chloral hydrate.
CHLORALOSE except when
included in Schedule 6.
CHLORAMBUCIL.
CHLORAMPHENICOL except
when included in Schedule 3.
# CHLORANDROSTENOLONE.
CHLORAZANIL.
CHLORCYCLIZINE.
# CHLORDIAZEPOXIDE.
CHLORMERODRIN.
CHLORMETHIAZOLE.
CHLORMEZANONE.
CHLOROFORM for use in
anaesthesia.
# 4-CHLOROMETHANDIENONE.
2-(4-CHLOROPHENYL)-(1,2,4)TRIAZOLO[5,1-A]ISOQUINOLINE.
CHLOROQUINE.
CHLOROTHIAZIDE.
CHLOROTRIANISENE.
# CHLOROXYDIENONE.
CHLORPHENIRAMINE except
when included in Schedule 2 or 3.
CHLORPHENTERMINE.
CHLORPROMAZINE.
CHLORPROPAMIDE.
CHLORPROTHIXENE.
CHLORQUINALDOL for human topical
use.
CHLORTETRACYCLINE except
when included in Schedule 5.
CHLORTHALIDONE.
CHLORZOXAZONE.
CHOLERA VACCINE.
CHOLESTYRAMINE (colestyramine)
for human therapeutic use.
CHYMOPAPAIN for human therapeutic
use.
CICLACILLIN.
CICLESONIDE.
CICLOPIROX
except:
(a)
when
included in Schedule 2 or 3; or
(b)
in
preparations for the treatment of tinea pedis.
CIDOFOVIR.
CILASTATIN.
CILAZAPRIL.
CILOSTAZOL.
CIMETIDINE except when included in
Schedule 3.
CINACALCET.
CINCHOCAINE except when
included in Schedule 2.
CINOXACIN.
CIPROFLOXACIN.
CISAPRIDE.
CISATRACURIUM BESYLATE.
CISPLATIN.
CITALOPRAM.
CLADRIBINE.
CLANOBUTIN.
CLARITHROMYCIN.
CLAVULANIC ACID.
CLEMASTINE except when
included in Schedule 3.
CLEMIZOLE.
CLENBUTEROL.
CLEVIDIPINE.
CLIDINIUM BROMIDE.
CLINDAMYCIN.
† CLIOQUINOL and other
halogenated derivatives of 8-hydroxyquinoline for human topical use except
when separately specified in this Schedule.
CLOBAZAM.
CLOBETASOL.
CLOBETASONE (clobetasone-17-butyrate) except when included in
Schedule 3.
CLOCORTOLONE.
CLODRONIC ACID (includes sodium
clodronate).
CLOFARABINE.
CLOFAZIMINE.
CLOFENAMIDE.
CLOFIBRATE.
# CLOMIPHENE.
CLOMIPRAMINE.
CLOMOCYCLINE.
# CLONAZEPAM.
CLONIDINE.
CLOPAMIDE.
CLOPIDOGREL.
CLOPROSTENOL.
# CLORAZEPATE.
CLOREXOLONE.
CLORPRENALINE.
# CLOSTEBOL
(4-chlorotestosterone).
CLOTRIMAZOLE except:
(a) when
included in Schedule 2, 3 or 6; or
(b) in
preparations for dermal use for the treatment of tinea pedis.
CLOXACILLIN.
# CLOZAPINE.
COBALT for human therapeutic use except
as dicobalt edetate in preparations for the treatment of cyanide poisoning.
COBICISTAT.
CODEINE when compounded with one
or more other therapeutically active substances:
(a) in divided
preparations containing 30 mg or less of codeine per dosage unit; or
(b) in
undivided preparations containing 1 per cent or less of codeine,
except when included in
Schedule 2 or 3.
CO-DERGOCRINE.
COLASPASE.
COLCHICINE.
COLCHICUM AUTUMNALE.
COLESTIPOL.
COLFOSCERIL PALMITATE for human
therapeutic use.
COLISTIN.
COLLAGEN in preparations for
injection or implantation:
(a) for tissue
augmentation; or
(b) for
cosmetic use.
COLLAGENASE CLOSTRIDIUM
HISTOLYTICUM.
CONVALLARIA KEISKI.
CONVALLARIA MAJALIS.
COPPER COMPOUNDS for human use except:
(a) when
separately specified in these Schedules;
(b) in
preparations for human internal use containing 5 mg or less of copper per
recommended daily dose; or
(c) in other
preparations containing 5 per cent or less of copper compounds.
# CORIFOLLITROPIN ALFA.
CORONILLA spp.
CORTICOSTERONE.
CORTICOTROPHIN.
CORTISONE.
CO-TRIMOXAZOLE.
COUMARIN for therapeutic use
(excluding when present as an excipient).
CRIZOTINIB.
CROFELEMER.
CRYSTAL VIOLET for human use except
when used as a dermal marker.
CUPRIMYXIN.
CURARE.
CYCLANDELATE.
CYCLIZINE except when
included in Schedule 3.
CYCLOBENZAPRINE.
# CYCLOFENIL.
CYCLOHEXIMIDE.
CYCLOPENTHIAZIDE.
CYCLOPENTOLATE.
CYCLOPHOSPHAMIDE.
CYCLOPROPANE for therapeutic use.
CYCLOSERINE.
CYCLOSPORIN.
CYCLOTHIAZIDE.
CYCRIMINE.
CYMARIN.
CYPROHEPTADINE except when
included in Schedule 3.
CYPROTERONE.
CYSTEAMINE for human therapeutic use.
CYTARABINE.
DABRAFENIB
MESILATE.
DABIGATRAN.
DACARBAZINE.
DACLIZUMAB.
DACTINOMYCIN.
DALFOPRISTIN.
DALTEPARIN (includes dalteparin
sodium).
DANAPAROID (includes danaparoid
sodium).
# DANAZOL.
DANTHRON for human use.
DANTROLENE.
DAPAGLIFLOZIN.
DAPOXETINE.
DAPSONE.
DAPTOMYCIN.
# DARBEPOETIN.
DARIFENACIN.
DARUNAVIR.
DATURA spp. except:
(a) when included
in Schedule 2; or
(b) when
separately specified in this Schedule.
DASATINIB.
DATURA STRAMONIUM (stramonium) except:
(a) when
included in Schedule 2; or
(b) for
smoking or burning.
DATURA TATULA (stramonium) except:
(a) when
included in Schedule 2; or
(b) for
smoking or burning.
DAUNORUBICIN.
DEANOL for therapeutic use.
DEBRISOQUINE.
DECAMETHONIUM.
DEFERASIROX.
DEFERIPRONE.
DEFLAZACORT.
DEGARELIX.
#
DEHYDROCHLOROMETHYLTESTOSTERONE.
DEHYDROCORTICOSTERONE.
DELAVIRDINE (includes delavirdine
mesylate).
DEMBREXINE except when
included in Schedule 5.
DEMECARIUM.
DEMECLOCYCLINE.
DENOSUMAB.
DEOXYCORTONE.
DEOXYRIBONUCLEASE except:
(a) when
separately specified in this Schedule; or
(b) for
external use.
DERACOXIB.
DESFERRIOXAMINE.
DESFLURANE.
DESIPRAMINE.
DESIRUDIN.
DESLANOSIDE.
DESLORATADINE except when
included in Schedule 2.
DESLORELIN.
DESMOPRESSIN (D.D.A.V.P.).
DESOGESTREL.
DESONIDE.
DESOXYMETHASONE.
DESVENLAFAXINE.
DETOMIDINE.
DEXAMETHASONE.
DEXCHLORPHENIRAMINE except
when included in Schedule 2 or 3.
DEXFENFLURAMINE.
DEXMEDETOMIDINE.
DEXTROMETHORPHAN (excluding its
stereoisomers) except when included in Schedule 2.
# DEXTROPROPOXYPHENE:
(a) in divided
preparations containing 135 mg of dextropropoxyphene or less per dosage unit;
or
(b) liquid
preparations containing 2.5 per cent or less of dextropropoxyphene.
DEXTRORPHAN (excluding its
stereoisomers).
DIAMTHAZOLE.
DIAVERIDINE.
# DIAZEPAM.
DIAZOXIDE.
DIBENZEPIN.
DIBOTERMIN.
DIBROMOPROPAMIDINE for
therapeutic use except when included in Schedule 2.
DICHLORALPHENAZONE.
DICHLOROPHEN for human therapeutic
use.
DICHLORPHENAMIDE.
DICLOFENAC except:
(a) when
included in Schedule 2 or 3; or
(b) in
preparations for dermal use unless:
(i) for
the treatment of solar keratosis; or
(ii) containing
more than 4 per cent of diclofenac.
DICLOXACILLIN.
DICYCLOMINE.
DIDANOSINE.
DIENESTROL.
DIENOGEST.
DIETHAZINE.
DIETHYLCARBAMAZINE for human
therapeutic use.
DIETHYLPROPION.
DIFENOXIN in preparations
containing, per dosage unit, 0.5 mg or less of difenoxin and a quantity of
atropine sulfate equivalent to at least 5 per cent of the dose of difenoxin.
DIFLORASONE.
DIFLOXACIN.
DIFLUCORTOLONE.
DIFLUNISAL.
DIGITALIS LANATA.
DIGITALIS PURPUREA.
DIGITOXIN.
DIGOXIN.
DIGOXIN-SPECIFIC ANTIBODY
FRAGMENT F (Ab).
DIHYDRALAZINE.
DIHYDROCODEINE when compounded
with one or more other therapeutically active substances:
(a) in divided
preparations containing not more than 100 mg of dihydrocodeine per dosage unit;
or
(b) in
undivided preparations with a concentration of not more than 2.5 per cent of
dihydrocodeine,
except when included in
Schedule 2 or 3.
DIHYDROERGOTOXINE.
# DIHYDROLONE.
DIHYDROSTREPTOMYCIN.
DIHYDROTACHYSTEROL.
† DI-IODOHYDROXYQUINOLINE
(iodoquinol) except:
(a) when
included in Schedule 3; or
(b) for human
internal use.
DIISOPROPYLAMINE DICHLOROACETATE.
DILTIAZEM.
DIMENHYDRINATE except when
included in Schedule 2 or 3.
DIMERCAPROL.
# DIMETHANDROSTANOLONE.
# DIMETHAZINE.
DIMETHINDENE except when
included in Schedule 3.
DIMETHOTHIAZINE.
DIMETHOXANATE.
DIMETHYL FUMARATE.
DIMETHYL SULFOXIDE (excluding dimethyl
sulfone) for
therapeutic use except:
(a) when
included in Schedule 6; or
(b) in in
vitro test kits.
DIMETRIDAZOLE.
2,4-DINITROCHLOROBENZENE for
therapeutic use.
DINITROCRESOLS for therapeutic
use except when separately specified in these Schedules.
DINITRONAPHTHOLS for therapeutic
use except when separately specified in these Schedules.
DINITROPHENOLS for therapeutic
use.
DINITROTHYMOLS for therapeutic
use except when separately specified in these Schedules.
# DINOPROST.
# DINOPROSTONE.
DIPERODON.
DIPHEMANIL except in
preparations for dermal use.
DIPHENHYDRAMINE except
when included in Schedule 2 or 3.
DIPHENIDOL.
DIPHENOXYLATE in preparations
containing, per dosage unit, 2.5 mg or less of diphenoxylate and a quantity of
atropine sulfate equivalent to at least 1 per cent of the dose of diphenoxylate
except when included in Schedule 3.
DIPHENYLPYRALINE.
DIPHTHERIA TOXOID.
DIPIVEFRIN.
DIPYRIDAMOLE.
DIRITHROMYCIN.
DIRLOTAPIDE.
DISOPHENOL.
DISOPYRAMIDE.
DISTIGMINE.
DISULFIRAM for therapeutic use.
DISULPHAMIDE.
DITHIAZANINE except when
included in Schedule 6.
DITIOCARB.
DOBUTAMINE.
DOCETAXEL.
DOFETILIDE.
DOLASETRON.
DOLUTEGRAVIR.
DOMPERIDONE.
DONEPEZIL.
DOPAMINE.
DOPEXAMINE.
DORIPENEM.
DORNASE.
DORZOLAMIDE.
DOTHIEPIN.
DOXANTRAZOLE.
DOXAPRAM.
DOXAZOSIN.
DOXEPIN.
DOXORUBICIN.
DOXYCYCLINE.
DOXYLAMINE except when
included in Schedule 2 or 3.
DRONEDARONE.
DROPERIDOL.
DROSPIRENONE.
# DROSTANOLONE.
DROTRECOGIN.
DUBOISIA LEICHHARDTII except
when included in Schedule 2.
DUBOISIA MYOPOROIDES except
when included in Schedule 2.
DULOXETINE.
DUTASTERIDE.
DYDROGESTERONE.
ECONAZOLE except:
(a) when
included in Schedule 2, 3 or 6; or
(b) in
preparations for dermal use for the treatment of tinea pedis.
ECOTHIOPATE (includes ecothiopate
iodide).
ECTYLUREA.
ECULIZUMAB.
EDETIC ACID for human therapeutic
use except:
(a) in
preparations containing 0.25 per cent or less of edetic acid;
(b) as
dicobalt edetate in preparations for the treatment of cyanide poisoning; or
(c) in
contact lens preparations.
EDOXUDINE.
EDROPHONIUM.
EFALIZUMAB.
EFAVIRENZ.
EFLORNITHINE.
EFORMOTEROL.
ELETRIPTAN.
ELTENAC.
ELTROMBOPAG.
ELVITEGRAVIR.
EMEPRONIUM.
EMETINE except in
preparations containing 0.2 per cent or less of emetine.
EMPAGLIFLOZIN.
EMTRICITABINE.
ENALAPRIL.
# ENESTEBOL.
ENFLURANE for therapeutic use.
ENFUVIRTIDE.
# ENOBOSARM.
ENOXACIN.
ENOXAPARIN.
ENOXIMONE.
ENPROSTIL.
ENROFLOXACIN.
ENTACAPONE.
ENTECAVIR.
EPHEDRA spp. except in
preparations containing 0.001 per cent or less of ephedrine.
# EPHEDRINE.
EPICILLIN.
EPINASTINE.
EPIRUBICIN.
# EPITIOSTANOL.
EPLERENONE.
# EPOETINS.
EPOPROSTENOL.
EPROSARTAN.
EPTIFIBATIDE.
ERGOMETRINE.
ERGOT.
ERGOTAMINE.
ERGOTOXINE.
ERIBULIN MESYLATE.
ERLOTINIB.
ERTAPENEM.
ERYSIMUM spp.
ERYTHROMYCIN.
# ERYTHROPOIETIN.
# ERYTHROPOIETINS except
when separately specified in these Schedules.
ESCITALOPRAM.
ESMOLOL.
ESOMEPRAZOLE except
when included in Schedule 3.
ESTRAMUSTINE.
ESTROPIPATE (piperazine oestrone
sulfate).
ETANERCEPT.
ETHACRYNIC ACID.
ETHAMBUTOL.
ETHAMIVAN.
ETHANOLAMINE in preparations for
injection.
ETHCHLORVYNOL.
ETHER for use in anaesthesia.
ETHINAMATE.
ETHINYLOESTRADIOL.
ETHIONAMIDE.
ETHISTERONE.
ETHOGLUCID.
ETHOHEPTAZINE.
ETHOPROPAZINE.
ETHOSUXIMIDE.
ETHOTOIN.
ETHOXZOLAMIDE.
ETHYL CHLORIDE for human therapeutic
use.
# ETHYLDIENOLONE.
† ETHYLHEXANEDIOL for animal use.
ETHYLMORPHINE when compounded
with one or more other therapeutically active substances:
(a) in divided
preparations containing not more than 100 mg of ethylmorphine per dosage unit;
or
(b) in
undivided preparations with a concentration of not more than 2.5 per cent of
ethylmorphine;
except when included in
Schedule 2.
# ETHYLOESTRENOL.
ETHYNODIOL.
ETIDOCAINE.
ETIDRONIC ACID (includes disodium
etidronate):
(a) for
internal use; or
(b) in
topical preparations except in preparations containing 1 per cent or
less of etidronic acid.
ETILEFRIN.
ETIPROSTON.
ETODOLAC.
ETOFENAMATE except when
included in Schedule 2.
ETONOGESTREL.
ETOPOSIDE.
ETORICOXIB.
ETRAVIRINE.
# ETRETINATE.
EVEROLIMUS.
EXEMESTANE.
EXENATIDE.
EZETIMIBE.
FAMCICLOVIR except when included in
Schedule 3.
FAMOTIDINE except when
included in Schedule 2.
FEBUXOSTAT.
FELBINAC except when
included in Schedule 2.
FELODIPINE.
FELYPRESSIN.
FENBUFEN.
FENCAMFAMIN.
FENCLOFENAC.
FENFLURAMINE.
FENOFIBRATE.
FENOLDOPAM.
FENOPROFEN.
FENOTEROL.
FENPIPRAMIDE.
FENPIPRANE.
FENPROPOREX.
FENPROSTALENE.
FEXOFENADINE except:
(a) when included in
Schedule 2; or
(b) in divided
preparations for oral use for the treatment of seasonal allergic rhinitis in
adults and children 12 years of age and over when:
(i) in a primary pack
containing 10 dosage units or less and not more than 5 days’ supply; and
(ii) labelled with a
recommended daily dose not exceeding 120 mg of fexofenadine.
FIBRINOLYSIN except for
external use.
FIDAXOMICIN.
FILGRASTIM.
FINASTERIDE.
FINGOLIMOD.
FIROCOXIB.
FLECAINIDE.
FLEROXACIN.
FLOCTAFENINE.
FLORFENICOL.
FLUANISONE.
FLUCLOROLONE.
FLUCLOXACILLIN.
FLUCONAZOLE except when
included in Schedule 3.
FLUCYTOSINE.
FLUDARABINE.
FLUDROCORTISONE.
FLUFENAMIC ACID.
FLUMAZENIL.
FLUMETHASONE.
FLUMETHIAZIDE.
FLUNISOLIDE.
FLUNIXIN MEGLUMINE.
FLUOCINOLONE.
FLUOCINONIDE.
FLUOCORTIN.
FLUOCORTOLONE.
FLUORESCEIN in preparations for
injection.
FLUORIDES in preparations for
human use except when included in or expressly excluded from
Schedule 2 or 3.
FLUOROMETHOLONE.
FLUOROURACIL.
FLUOXETINE.
# FLUOXYMESTERONE.
FLUPENTHIXOL.
FLUPHENAZINE.
FLUPROSTENOL.
FLURANDRENOLONE.
# FLURAZEPAM.
FLURBIPROFEN except when
included in Schedule 2.
FLUROXENE for human therapeutic
use.
FLUSPIRILENE.
FLUTAMIDE.
FLUTICASONE except when
included in Schedule 2.
FLUVASTATIN.
FLUVOXAMINE.
FOLIC ACID in preparations for
human use for injection.
FOLINIC ACID in preparations for
human use for injection.
FOLLICLE-STIMULATING HORMONE
except when separately specified in this Schedule.
# FOLLISTATIN.
# FOLLITROPIN ALPHA.
# FOLLITROPIN BETA.
FOMIVIRSEN.
FONDAPARINUX.
# FORMEBOLONE.
FORMESTANE.
FOSAMPRENAVIR.
FOSAPREPITANT.
FOSCARNET.
FOSFESTROL (diethylstilboestrol
diphosphate).
FOSINOPRIL.
FOSPHENYTOIN.
FOTEMUSTINE.
FRAMYCETIN.
FULVESTRANT.
FURALTADONE.
# FURAZABOL.
FURAZOLIDONE.
FUROSEMIDE (frusemide).
FUSIDIC ACID.
GABAPENTIN.
GALANTAMINE.
GALANTHUS spp.
GALLAMINE.
GALSULFASE.
GANCICLOVIR.
GANIRELIX.
GATIFLOXACIN.
GEFITINIB.
GEMCITABINE.
GEMEPROST.
GEMFIBROZIL.
GEMIFLOXACIN.
GEMTUZUMAB OZOGAMICIN.
GENTAMICIN.
GESTODENE.
GESTONORONE.
GESTRINONE.
GHRH INJECTABLE PLASMID.
GITALIN.
GLATIRAMER ACETATE.
GLIBENCLAMIDE.
GLIBORNURIDE.
GLICLAZIDE.
GLIMEPIRIDE.
GLIPIZIDE.
GLISOXEPIDE.
GLUTATHIONE for parenteral use.
# GLUTETHIMIDE.
GLYCERYL TRINITRATE except when
included in Schedule 3.
GLYCOPYRRONIUM in preparations
for injection.
GLYMIDINE.
GnRH VACCINE.
GOLIMUMAB.
GONADORELIN.
GONADOTROPHIC HORMONES except
when separately specified in this Schedule.
GOSERELIN.
GRAMICIDIN.
GRANISETRON.
GREPAFLOXACIN.
GRISEOFULVIN.
GUAIPHENESIN for human
therapeutic use except:
(a) when
included in Schedule 2;
(b) in oral
liquid preparations containing 2 per cent or less of guaiphenesin; or
(c) in
divided preparations containing 200 mg or less of guaiphenesin per dosage unit.
GUANABENZ.
GUANACLINE.
GUANETHIDINE.
GUANIDINE for therapeutic use.
HACHIMYCIN.
HAEMATIN.
HAEMOPHILUS INFLUENZAE VACCINE.
HALCINONIDE.
HALOFANTRINE.
HALOFENATE.
HALOFUGINONE in preparations
containing 0.1 per cent or less of halofuginone for the treatment of animals.
HALOPERIDOL.
HALOTHANE for therapeutic use.
HEMEROCALLIS (Hemerocallis
flava).
HEPARINS for internal use except
when separately specified in this Schedule.
HEPATITIS A VACCINE.
HEPATITIS B VACCINE.
HETACILLIN.
HEXACHLOROPHANE:
(a) in
preparations for use on infants; or
(b) in other
preparations except:
(i) when
included in Schedule 2 or 6; or
(ii) in
preparations containing 0.75 per cent or less of hexachlorophane.
HEXAMETHONIUM.
HEXETIDINE for human internal
use.
HEXOBENDINE.
HEXOCYCLIUM.
HEXOPRENALINE.
HISTAMINE for therapeutic use except
in preparations containing 0.5 per cent or less of histamine.
HMG-CoA REDUCTASE INHIBITORS
(including "statins") except when separately specified in
these Schedules.
HOMATROPINE.
HUMAN CHORIONIC GONADATROPHIN except
in pregnancy test kits.
HUMAN
PAPILLOMAVIRUS VACCINE.
HYALURONIC
ACID AND ITS POLYMERS in preparations for injection or implantation:
(a) for tissue
augmentation;
(b) for
cosmetic use; or
(c) for the
treatment of animals.
HYDRALAZINE.
HYDRARGAPHEN.
HYDROCHLOROTHIAZIDE.
HYDROCORTISONE:
(a) for human
use except when included in Schedule 2 or 3; or
(b) for the
treatment of animals.
HYDROCYANIC ACID for therapeutic
use.
HYDROFLUMETHIAZIDE.
HYDROQUINONE (other than its
alkyl ethers separately specified in this Schedule) in preparations for human
therapeutic or cosmetic use except:
(a)
when
included in Schedule 2; or
(b)
in hair preparations containing 0.3 per cent or less of hydroquinone; or
(c)
in cosmetic nail
preparations containing 0.02 per cent or less of hydroquinone.
HYDROXYCHLOROQUINE.
HYDROXYEPHEDRINE.
HYDROXYPHENAMATE.
HYDROXYPROGESTERONE.
# HYDROXYSTENOZOL.
HYDROXYUREA.
HYDROXYZINE.
HYGROMYCIN.
HYOSCINE except when
included in Schedule 2.
HYOSCYAMINE except when
included in Schedule 2.
HYOSCYAMUS NIGER except:
(a) when
included in Schedule 2; or
(b) in a pack
containing 0.03 mg or less of total solanaceous alkaloids.
HYPOTHALAMIC RELEASING FACTORS except
when separately specified in this Schedule.
HYPROMELLOSE in preparations for
injection.
IBAFLOXACIN for veterinary use.
IBANDRONIC ACID.
IBOGAINE.
IBRITUMOMAB.
IBUFENAC.
IBUPROFEN except:
(a) when
included in or expressly excluded from Schedule 2 or 3; or
(b) in
preparations for dermal use.
IBUTEROL.
IBUTILIDE.
ICATIBANT.
IDARUBICIN.
IDOXURIDINE except in
preparations containing 0.5 per cent or less of idoxuridine for dermal use.
IDURSULFASE.
IFOSFAMIDE.
ILOPROST.
IMATINIB.
IMEPITOIN.
IMIDAPRIL.
IMIGLUCERASE.
IMIPENIM.
IMIPRAMINE.
IMIQUIMOD.
IMMUNOGLOBULINS for human
parenteral use except when separately specified in these Schedules.
INDACATEROL.
INDAPAMIDE.
INDINAVIR.
INDOMETHACIN except when
included in Schedule 2.
INDOPROFEN.
INDORAMIN.
INFLIXIMAB.
INFLUENZA AND CORYZA VACCINES:
(a) for
parenteral use; or
(b) for nasal
administration.
INGENOL MEBUTATE.
INSULIN GLARGINE.
# INSULIN-LIKE GROWTH FACTOR I.
# INSULIN-LIKE GROWTH FACTORS except
when separately specified in this Schedule.
INSULINS.
INTERFERONS.
INTERLEUKINS except when
separately specified in these Schedules.
IODOTHIOURACIL.
IPILIMUMAB.
IPRATROPIUM except when
included in Schedule 2.
IPRIFLAVONE.
IPRINDOLE.
IPRONIAZID.
IRBESARTAN.
IRINOTECAN.
IRON COMPOUNDS in injectable
preparations for human use.
ISOAMINILE.
ISOAMYL NITRITE.
ISOBUTYL NITRITE.
ISOCARBOXAZID.
ISOCONAZOLE except when
included in Schedule 2, 3 or 6.
ISOETARINE.
ISOFLURANE for therapeutic use.
ISOMETHEPTENE.
ISONIAZID.
ISOPRENALINE.
ISOPRINOSINE.
ISOPROPAMIDE except when
included in Schedule 2.
ISOSORBIDE DINITRATE except
when included in Schedule 3.
ISOSORBIDE MONONITRATE.
# ISOTRETINOIN.
ISOXICAM.
ISOXSUPRINE.
ISRADIPINE.
ITRACONAZOLE.
IVABRADINE.
IVACAFTOR.
IVERMECTIN:
(a) for human
use; or
(b) for the
treatment of mange in dogs.
IXABEPILONE.
JAPANESE ENCEPHALITIS VACCINE.
KANAMYCIN.
KETANSERIN except in
topical veterinary preparations containing 0.5 per cent or less of ketanserin.
# KETAZOLAM.
KETOCONAZOLE except:
(a) when
included in Schedule 2;
(b) in
preparations for dermal use containing 1 per cent or less of ketoconazole for
the treatment of the scalp; or
(c) in
preparations for dermal use for the treatment of tinea pedis.
KETOPROFEN except:
(a) in
preparations for dermal use; or
(b) when
included in Schedule 3.
KETOROLAC (includes ketoralac
trometamol).
KETOTIFEN except when
included in Schedule 2.
KHELLIN.
KITASAMYCIN except:
(a) when
included in Schedule 5 ; or
(b) in animal
feeds for growth promotion containing 100 mg/kg or less of antibiotic
substances.
LABETALOL.
LACIDIPINE.
LACOSAMIDE.
LAMIVUDINE.
LAMOTRIGINE.
LANATOSIDES.
LANREOTIDE.
LANSOPRAZOLE except when
included in Schedule 3.
LANTHANUM for therapeutic use.
LAPATINIB.
LARONIDASE.
LAROPIPRANT.
LATAMOXEF.
LATANOPROST.
LAUDEXIUM.
LAUROMACROGOLS in preparations
for injection except:
(a) when
present as an excipient; or
(b) when
separately specified in these Schedules.
† LEAD for human therapeutic use.
LEFETAMINE.
LEFLUNOMIDE.
# LENALIDOMIDE.
LENOGRASTIM.
LEPIRUDIN.
LEPTAZOL.
LERCANIDIPINE.
LETROZOLE.
LEUPRORELIN.
LEVALLORPHAN.
LEVAMISOLE:
(a) for human
therapeutic use; or
(b) in
preparations for the prevention or treatment of heartworm in dogs.
LEVETIRACETAM.
LEVOBUNOLOL.
LEVOBUPIVACAINE.
LEVOCABASTINE except when
included in Schedule 2.
LEVODOPA.
LEVOMEPROMAZINE.
LEVONORGESTREL except when
included in Schedule 3.
LEVOSIMENDAN.
LIDOFLAZINE.
LIGNOCAINE except:
(a) when included in Schedules 2 or 5;
(b) in dermal preparations containing 2 per
cent or less of total local anaesthetic substances per dosage unit; or
(c) in lozenges containing 30 mg or less of
total anaesthetic substances per dosage unit.
LINAGLIPTIN.
LINCOMYCIN.
LINDANE for human therapeutic use
except when included in Schedule 2.
LINEZOLID.
LIOTHYRONINE.
LIRAGLUTIDE.
LISINOPRIL.
LISURIDE.
LITHIUM for therapeutic use except:
(a) when
included in Schedule 2;
(b) when
present as an excipient in preparations for dermal use containing 0.25 per cent
or less of lithium; or
(c) in
preparations containing 0.01 per cent or less of lithium.
LIXISENATIDE.
LODOXAMIDE except when
included in Schedule 2.
LOFEXIDINE.
LOGIPARIN for internal use.
LOMEFLOXACIN.
LOMUSTINE.
LOPERAMIDE except:
(a) when included in
Schedule 2; or
(b) in
divided oral preparations containing 2 mg or less of loperamide per dosage
unit, in a primary pack containing 8 dosage units or less.
LOPINAVIR.
# LOPRAZOLAM.
LORACARBEF.
LORATADINE
except:
(a)
when
included in Schedule 2; or
(b)
in
divided preparations for oral use for the treatment of seasonal allergic
rhinitis in adults and children 12 years of age and over when:
(i)
in
a primary pack containing 5 dosage units or less; and
(ii)
labelled
with a recommended daily dose not exceeding 10 mg of loratadine.
# LORAZEPAM.
# LORMETAZEPAM.
LOSARTAN.
LOTEPREDNOL.
LOXAPINE.
LUMEFANTRINE.
LUMIRACOXIB.
LURASIDONE.
# LUTEINISING HORMONE except in
ovulation test kits.
LYMECYCLINE.
MAFENIDE except when
included in Schedule 6.
MANDRAGORA OFFICINARUM.
MANNOMUSTINE.
MAPROTILINE.
MARAVIROC.
MARBOFLOXACIN.
MAROPITANT.
MAVACOXIB.
MAZINDOL.
MEASLES VACCINE.
MEBANAZINE.
MEBEVERINE.
MEBHYDROLIN.
# MEBOLAZINE.
MEBUTAMATE.
MECAMYLAMINE.
MECASERMIN.
MECILLINAM.
MECLOCYCLINE.
MECLOFENAMATE.
MECLOFENOXATE.
MECLOZINE except when
included in Schedule 2.
# MEDAZEPAM.
MEDETOMIDINE.
MEDIGOXIN (methyldigoxin).
MEDROXYPROGESTERONE.
MEDRYSONE.
MEFENAMIC ACID except when
included in Schedule 2.
MEFENOREX.
MEFLOQUINE.
MEFRUSIDE.
MEGESTROL.
MELAGATRAN.
MELATONIN for human use.
MELENGESTROL except when
included in Schedule 6.
MELOXICAM.
MELPHALAN.
MEMANTINE.
MENINGOCOCCAL VACCINE.
MENOTROPHIN.
MEPACRINE.
MEPENZOLATE.
MEPHENESIN.
MEPHENTERMINE.
MEPINDOLOL.
# MEPITIOSTANE.
MEPIVACAINE.
MEPROBAMATE.
MEPTAZINOL.
MEPYRAMINE except when
included in Schedule 2 or 3.
MEQUITAZINE.
MERCAPTOMERIN.
MERCAPTOPURINE.
MERCUROCHROME except when
included in Schedule 2 or 6.
MERCURY for cosmetic or
therapeutic use except:
(a) when
separately specified in these Schedules; or
(b) in a
sealed device which prevents access to the mercury.
MEROPENEM.
MERSALYL.
# MESABOLONE.
MESALAZINE.
MESNA.
# MESTANOLONE (androstalone).
# MESTEROLONE.
MESTRANOL.
# METANDIENONE.
METARAMINOL.
# METENOLONE.
METERGOLINE.
METFORMIN.
METHACHOLINE.
METHACYCLINE.
METHALLENOESTRIL.
# METHANDRIOL.
METHANTHELINIUM.
METHAZOLAMIDE.
METHDILAZINE except when
included in Schedule 3.
# METHENOLONE.
METHICILLIN.
METHIMAZOLE.
METHISAZONE.
METHIXENE.
METHOCARBAMOL.
METHOHEXITONE.
METHOIN.
METHOTREXATE.
METHOXAMINE except:
(a) when
included in Schedule 2; or
(b) in
preparations for external use containing 1 per cent or less of methoxamine.
METHOXSALEN.
METHOXYFLURANE.
METHSUXIMIDE.
METHYCLOTHIAZIDE.
METHYL AMINOLEVULINATE.
#METHYLANDROSTANOLONE.
# METHYLCLOSTEBOL.
METHYLDOPA.
METHYLENE BLUE in preparations
for injection.
METHYLERGOMETRINE.
METHYL MERCURY for therapeutic
use.
METHYLNALTREXONE.
METHYLPENTYNOL.
METHYLPHENOBARBITONE.
METHYLPREDNISOLONE.
METHYL SALICYLATE in preparations
for internal therapeutic use.
# METHYLTESTOSTERONE.
METHYLTHIOURACIL.
# METHYLTRIENOLONE.
METHYPRYLONE.
METHYSERGIDE.
METOCLOPRAMIDE except when
included in Schedule 3.
METOLAZONE.
METOPROLOL.
# METRIBOLONE.
METRIFONATE (trichlorfon) for
human therapeutic use.
METRONIDAZOLE.
METYRAPONE.
MEXILETINE.
MEZLOCILLIN.
MIANSERIN.
MIBEFRADIL.
# MIBOLERONE.
MICAFUNGIN.
MICONAZOLE except:
(a) when
included in Schedule 2, 3 or 6; or
(b) in
preparations for dermal use for the treatment of tinea pedis.
# MIDAZOLAM.
MIDODRINE.
MIFEPRISTONE.
MIGLITOL.
MIGLUSTAT.
MILBEMYCIN OXIME except
when included in Schedule 5.
MILRINONE.
MINOCYCLINE.
MINOXIDIL except when
included in Schedule 2.
MIRABEGRON.
MIRTAZAPINE.
MISOPROSTOL.
MITOBRONITOL.
MITOMYCIN.
MITOTANE.
MITOXANTRONE.
MITRATAPIDE.
MIVACURIUM CHLORIDE.
MOCLOBEMIDE.
MODAFINIL.
MOLGRAMOSTIM.
MOLINDONE.
MOMETASONE except when
included in Schedule 2.
MONENSIN except:
(a) when
included in Schedule 5 or 6; or
(b) in animal
feeds containing 360 mg/kg or less of antibiotic substances.
MONOBENZONE and alkyl ethers of
hydroquinone for human therapeutic use or
cosmetic use except in cosmetic
nail preparations containing 0.02 per cent or less of monobenzone or alkyl
ethers of hydroquinone.
MONOCLONAL ANTIBODIES for
therapeutic use except:
(a) in
diagnostic test kits; or
(b) when
separately specified in these Schedules.
MONTELUKAST.
MOPERONE.
MORAZONE.
MORICIZINE.
MOTRAZEPAM.
MOTRETINIDE.
MOXIDECTIN in preparations for
injection containing 10 per cent or less of moxidectin except when
included in Schedule 5.
MOXIFLOXACIN.
MOXONIDINE.
MUMPS VACCINE.
MUPIROCIN.
MURAGLITAZAR.
MUROMONAB.
MUSTINE (nitrogen mustard).
MYCOPHENOLIC ACID (includes
mycophenolate mofetil).
NABUMETONE.
NADOLOL.
NADROPARIN.
NAFARELIN.
NAFTIDROFURYL.
NALBUPHINE.
NALIDIXIC ACID.
NALMEFENE.
NALORPHINE.
NALOXONE.
NALTREXONE.
# NANDROLONE.
NAPROXEN except when
included in Schedule 3 or in Schedule 2.
NARASIN except:
(a) when
included in Schedule 6; or
(b) in animal
feeds containing 100 mg/kg or less of antibiotic substances.
NARATRIPTAN.
NATALIZUMAB.
NATAMYCIN except for use
as a food additive.
NATEGLINIDE.
NEBACUMAB.
NEBIVOLOL.
NEDOCROMIL.
NEFAZODONE.
NEFOPAM.
NELFINAVIR (includes nelfinavir
mesylate).
NEOMYCIN.
NEOSTIGMINE.
NEPAFENAC.
NERIUM OLEANDER.
NESIRITIDE.
NETILMICIN.
NEVIRAPINE.
NIALAMIDE.
NICARDIPINE.
NICERGOLINE.
NICOFURANOSE.
NICORANDIL.
NICOTINE in preparations for
human therapeutic use except for use as an aid in
withdrawal from tobacco smoking in preparations for oromucosal or transdermal
use.
NICOTINIC ACID for
human therapeutic use except:
(a) when
separately specified in these Schedules;
(b) in
preparations containing 100 mg or less of nicotinic acid per dosage unit; or
(c) nicotinamide.
NICOUMALONE.
NIFEDIPINE.
NIFENAZONE.
NIKETHAMIDE.
NILOTINIB.
NILUTAMIDE.
NIMESULIDE.
NIMODIPINE.
NIMORAZOLE.
NIRIDAZOLE.
NISOLDIPINE.
NITISINONE.
# NITRAZEPAM.
NITRENDIPINE.
NITRIC OXIDE for human
therapeutic use.
NITROFURANTOIN.
NITROFURAZONE.
NITROUS OXIDE for therapeutic
use.
NITROXOLINE.
NIZATIDINE except when
included in Schedule 2.
NOMEGESTROL.
NOMIFENSINE.
NORADRENALINE.
# 19-NORANDROSTENEDIOL.
# 19-NORANDROSTENEDIONE.
# NORANDROSTENOLONE.
# NORBOLETHONE.
# NORCLOSTEBOL.
NORELGESTROMIN.
# NORETHANDROLONE.
NORETHISTERONE.
NORFLOXACIN.
NORGESTREL.
NORIBOGAINE.
NORMAL HUMAN
IMMUNOGLOBULIN.
# NORMETHANDRONE.
NORTRIPTYLINE.
NOVOBIOCIN.
NOXIPTYLINE.
NYSTATIN except when
included in Schedule 2 or 3.
OCRIPLASMIN.
OCTAMYLAMINE.
OCTATROPINE.
OCTREOTIDE.
OCTYL NITRITE.
OESTRADIOL except when
included in Schedule 5.
OESTRIOL.
OESTROGENS except when
separately specified in these Schedules.
OESTRONE.
OFATUMUMAB.
OFLOXACIN.
OLANZAPINE.
OLEANDOMYCIN except:
(a) when
included in Schedule 5; or
(b) in animal
feeds for growth promotion containing 50 mg/kg or less of antibiotic
substances.
OLEANDRIN.
OLMESARTAN.
OLODATEROL.
OLOPATADINE.
OLSALAZINE.
OMALIZUMAB.
OMEGA-3-ACID ETHYL ESTERS
(excluding salts and derivatives) for human therapeutic use, for the treatment
of post-myocardial infarction and/or hypertriglyceridaemia.
OMEPRAZOLE except when
included in Schedule 3.
ONDANSETRON.
OPIPRAMOL.
ORBIFLOXACIN.
ORCIPRENALINE.
ORGANOPHOSPHORUS COMPOUNDS with
anticholinesterase activity for human therapeutic use except:
(a) when
separately specified in these Schedules; or
(b) in
preparations containing 2 per cent or less of malathion for external use.
ORLISTAT except when
included in Schedule 3.
ORNIDAZOLE.
ORNIPRESSIN.
ORPHENADRINE.
ORTHOPTERIN.
OSELTAMIVIR.
OUABAIN.
# OVANDROTONE.
# OXABOLONE.
OXACILLIN.
OXALIPLATIN.
# OXANDROLONE.
OXAPROZIN.
# OXAZEPAM.
OXCARBAZEPINE.
OXEDRINE for human internal use except
in preparations labelled with a recommended daily dose of 30 mg or less of
oxedrine.
OXETACAINE (oxethazaine) except
when included in Schedule 2.
OXICONAZOLE except:
(a) when
included in Schedule 2 or 3; or
(b) in
preparations for the treatment of tinea pedis.
OXITROPIUM.
OXOLAMINE.
OXOLINIC ACID.
OXPENTIFYLLINE (pentoxifylline).
OXPRENOLOL.
OXYBUPROCAINE.
OXYBUTYNIN.
# OXYMESTERONE.
# OXYMETHOLONE.
OXYPHENBUTAZONE.
OXYPHENCYCLIMINE.
OXYPHENONIUM.
OXYTETRACYCLINE except
when included in Schedule 5.
OXYTOCIN.
PACLITAXEL.
PALIFERMIN.
PALIPERIDONE.
PALIVIZUMAB.
PALONOSETRON.
PAMAQUIN.
PAMIDRONIC ACID (includes
disodium pamidronate).
PANCREATIC ENZYMES except:
(a) in preparations
containing 20,000 BP units or less of lipase activity per dosage unit; or
(b) when
separately specified in these Schedules.
PANCURONIUM.
PANITUMUMAB.
PANTOPRAZOLE except when
included in Schedule 3.
PAPAVERINE in preparations for injection.
PARACETAMOL:
(a) when
combined with aspirin or salicylamide or any derivative of these substances
except when separately specified in these Schedules;
(b) when
combined with ibuprofen in a primary pack containing more than 30 dosage units;
(c) in slow
release tablets or capsules containing more than 665 mg of paracetamol;
(d) in
non-slow release tablets or capsules containing more than 500 mg of
paracetamol;
(e) in
individually wrapped powders or sachets of granules each containing more than
1000 mg of paracetamol; or
(f) for
injection.
PARALDEHYDE.
PARAMETHADIONE.
PARAMETHASONE.
PARECOXIB.
PARICALCITOL.
PAROMOMYCIN.
PAROXETINE.
PASIREOTIDE.
PAZOPANIB.
PECAZINE.
PEFLOXACIN.
PEGAPTANIB.
PEGFILGRASTIM.
PEGINTERFERON.
PEGVISOMANT.
PEMETREXED.
PEMOLINE.
PEMPIDINE.
PENBUTOLOL.
PENCICLOVIR except when
included in Schedule 2.
PENETHAMATE.
PENICILLAMINE.
PENTAERYTHRITYL TETRANITRATE.
PENTAGASTRIN.
PENTAMETHONIUM.
PENTAMIDINE (includes pentamidine
isethionate).
PENTHIENATE.
PENTOBARBITONE when packed and
labelled for injection.
PENTOLINIUM.
PENTOSAN POLYSULFATE SODIUM.
# PERAMPANEL.
PERGOLIDE.
PERHEXILINE.
PERICYAZINE.
PERINDOPRIL.
PERMETHRIN for human therapeutic
use except in preparations containing 5 per cent or less of permethrin.
PERPHENAZINE.
PERTUSSIS ANTIGEN.
PERTUZUMAB.
PHENACEMIDE.
PHENACETIN for therapeutic use
(excluding when present as an excipient).
PHENAGLYCODOL.
PHENAZONE except when
included in Schedule 2 or 5.
PHENAZOPYRIDINE.
PHENELZINE.
PHENETICILLIN.
PHENFORMIN.
PHENGLUTARIMIDE.
PHENINDIONE.
PHENIRAMINE except when
included in Schedule 2 or 3.
PHENISATIN.
PHENOBARBITONE.
PHENOL in preparations for
injection.
PHENOLPHTHALEIN for human
therapeutic use.
PHENOXYBENZAMINE.
PHENOXYMETHYLPENICILLIN.
PHENSUXIMIDE.
# PHENTERMINE.
PHENTHIMENTONIUM.
PHENTOLAMINE.
PHENYLBUTAZONE.
PHENYLEPHRINE:
(a) in
preparations for injection; or
(b) in
preparations for human ophthalmic use containing 5 per cent or more of
phenylephrine.
PHENYLPROPANOLAMINE.
PHENYLTOLOXAMINE.
PHENYTOIN.
PHOLCODINE:
(a) in divided
preparations containing 100 mg or less of pholcodine per dosage unit; or
(b) in
undivided preparations containing 2.5 per cent or less of pholcodine,
except when
included in Schedule 2.
PHOSPHODIESTERASE TYPE 5
INHIBITORS except:
(a) when
separately specified in these Schedules; or
(b) when
present as an unmodified, naturally occurring substance.
PHTHALYLSULFATHIAZOLE.
PHYSOSTIGMINE.
PICROTOXIN.
PILOCARPINE except in
preparations containing 0.025 per cent or less of pilocarpine.
PIMECROLIMUS.
PIMOBENDAN.
PIMOZIDE.
PINACIDIL.
PINDOLOL.
PIOGLITAZONE.
PIPECURONIUM.
PIPEMIDIC ACID.
PIPENZOLATE.
PIPER METHYSTICUM (kava) in
preparations for human use except when included on the Australian
Register of Therapeutic Goods in preparations:
(a) for oral
use when present in tablet, capsule or teabag form that is labelled with a
recommended maximum daily dose of 250 mg or less of kavalactones and:
(i) the
tablet or capsule form contains 125 mg or less of kavalactones per tablet or
capsule; or
(ii) the
amount of dried whole or peeled rhizome in the teabag does not exceed 3 g;
and,
where containing more than 25 mg of kavalactones per dose, compliant with the
requirements of the Required Advisory Statements for Medicine Labels;
(b) in topical
preparations for use on the rectum, vagina or throat containing dried whole or
peeled rhizome or containing aqueous dispersions or aqueous extracts of whole
or peeled rhizome; or
(c) in dermal
preparations.
PIPERACILLIN.
PIPERIDINE.
PIPERIDOLATE.
PIPOBROMAN.
PIPOTHIAZINE.
PIPRADROL.
PIRACETAM.
PIRBUTEROL.
PIRENOXINE (catalin).
PIRENZEPINE.
PIRETANIDE.
PIROXICAM except in
preparations for dermal use.
PIRPROFEN.
PITAVASTATIN.
PITUITARY HORMONES except
when separately specified in these Schedules.
PIVAMPICILLIN.
PIZOTIFEN.
PLICAMYCIN.
PLERIXAFOR.
PNEUMOCOCCAL VACCINE.
PODOPHYLLOTOXIN for human use:
(a) internally;
(b) in
preparations for the treatment of anogenital warts; or
(c) in
other preparations except when included in Schedule 2 or 3.
PODOPHYLLUM EMODI (podophyllin)
for human use:
(a) internally;
(b) in
preparations for the treatment of anogenital warts; or
(c) in other
preparations except when included in Schedule 2 or 3.
PODOPHYLLUM PELTATUM
(podophyllin) for human use:
(a) internally;
(b) in
preparations for the treatment of anogenital warts; or
(c) in other
preparations except when included in Schedule 2 or 3.
POLIDEXIDE.
POLIOMYELITIS VACCINE.
POLYACRYLAMIDE in preparations
for injection or implantation:
(a) for tissue
augmentation; or
(b) for
cosmetic use.
POLYESTRADIOL.
POLYLACTIC ACID in preparations
for injection or implantation:
(a) for tissue
augmentation; or
(b) for
cosmetic use.
POLYMYXIN.
POLYSULFATED GLYCOSAMINOGLYCANS
in preparations for injection, except when separately specified in these
Schedules.
POLYTHIAZIDE.
PORACTANT.
POSACONAZOLE.
POTASSIUM BROMIDE for therapeutic
use.
POTASSIUM CHLORIDE in oral
preparations for human therapeutic use except:
(a) when
containing less than 550 mg of potassium chloride per dosage unit;
(b) in
preparations for oral rehydration therapy;
(c) in
preparations for oral use for bowel cleansing prior to diagnostic medical and
surgical procedures; or
(d) in
preparations for enteral feeding.
POTASSIUM PERCHLORATE for
therapeutic use.
PRACTOLOL.
PRADOFLOXACIN.
PRALATREXATE.
PRALIDOXIME.
PRAMIPEXOLE.
PRAMOCAINE.
PRAMPINE.
# PRASTERONE
(dehydroepiandrosterone, dehydroisoandrosterone).
PRASUGREL.
PRAVASTATIN.
# PRAZEPAM.
PRAZIQUANTEL for human
therapeutic use.
PRAZOSIN.
PREDNISOLONE.
PREDNISONE.
PREGABALIN.
PREGNENOLONE.
PRENALTEROL.
PRENYLAMINE.
PRILOCAINE except when
included in Schedule 2.
PRIMAQUINE.
PRIMIDONE.
PROBENECID.
PROBUCOL.
PROCAINAMIDE.
PROCAINE.
PROCAINE PENICILLIN.
PROCARBAZINE.
PROCHLORPERAZINE except
when included in Schedule 3.
PROCYCLIDINE except when
included in Schedule 2.
PROGESTERONE except when
included in Schedule 5.
PROGESTOGENS except when
separately specified in these Schedules.
PROGLUMIDE.
PROGUANIL.
PROLINTANE.
PROMAZINE.
PROMETHAZINE except when
included in Schedule 2 or 3.
PROMOXOLANE.
PROPAFENONE.
PROPAMIDINE for therapeutic use except when included in Schedule 2.
PROPANIDID.
PROPANTHELINE.
PROPENTOFYLLINE.
# PROPETANDROL.
PROPIONIBACTERIUM ACNES for
therapeutic use.
PROPOFOL.
PROPRANOLOL.
PROPYLHEXEDRINE.
PROPYLTHIOURACIL.
PROPYPHENAZONE.
PROQUAZONE.
PROSCILLARIDIN.
PROSTAGLANDINS except when
separately specified in this Schedule.
PROSTIANOL.
PROTAMINE.
PROTHIONAMIDE.
PROTHIPENDYL.
PROTIRELIN.
PROTOVERATRINES.
PROTRIPTYLINE.
PROXYMETACAINE.
PRUCALOPRIDE.
PSEUDOEPHEDRINE except
when included in Schedule 3.
PYRAZINAMIDE.
PYRIDINOLCARBAMATE.
PYRIDOSTIGMINE.
PYRIDOXINE,
PYRIDOXAL OR PYRIDOXAMINE for human therapeutic use except:
(a) in oral
preparations containing 200 mg or less but more than 50 mg of pyridoxine,
pyridoxal or pyridoxamine per recommended daily dose when compliant with the
requirements of the Required Advisory Statements for Medicine Labels; or
(b) in oral
preparations containing 50 mg or less of pyridoxine, pyridoxal or pyridoxamine
per recommended daily dose.
PYRIMETHAMINE.
PYROVALERONE.
PYRVINIUM.
# QUAZEPAM.
QUETIAPINE.
QUINAGOLIDE.
QUINAPRIL.
# QUINBOLONE.
QUINETHAZONE.
QUINIDINE.
QUININE for human therapeutic use
except when the maximum recommended daily dose is 50 mg or less of
quinine.
QUINISOCAINE (dimethisoquin).
QUINUPRISTIN.
RABEPRAZOLE except when
included in Schedule 3.
RABIES VACCINE.
RACTOPAMINE except when
included in Schedule 5.
RALOXIFENE.
RALTEGRAVIR.
RALTITREXED.
RAMIPRIL.
RANIBIZUMAB.
RANITIDINE except:
(a) when
included in Schedule 2; or
(b) in divided
preparations for oral use containing 150mg or less of ranitidine per dosage
unit when supplied in the manufacturer’s original pack containing not more than
14 dosage units.
RAPACURONIUM.
RASAGILINE.
RASBURICASE.
RAUWOLFIA SERPENTINA.
RAUWOLFIA VOMITORIA.
RAZOXANE.
REBOXETINE.
RED YEAST RICE for human
therapeutic use.
REGORAFENIB.
REMOXIPRIDE.
REPAGLINIDE.
RESERPINE.
RETAPAMULIN.
RETEPLASE.
RETIGABINE.
RIBAVIRIN.
RIDAFOROLIMUS.
RIFABUTIN.
RIFAMPICIN.
RIFAMYCIN.
RIFAPENTINE.
RIFAXIMIN.
RILPIVIRINE.
RILUZOLE.
RIMEXOLONE.
RIMITEROL.
RIMONABANT.
RISEDRONIC ACID.
RISPERIDONE.
RITODRINE.
RITONAVIR.
RITUXIMAB.
RIVAROXABAN.
RIVASTIGMINE.
RIZATRIPTAN.
ROBENACOXIB.
ROCURONIUM.
ROFECOXIB.
ROFLUMILAST.
ROLITETRACYCLINE.
romidepsin.
ROMIFIDINE.
ROMIPLOSTIM.
RONIDAZOLE.
ROPINIROLE.
ROPIVACAINE.
ROSIGLITAZONE.
ROSOXACIN.
ROSUVASTATIN.
ROTIGOTINE.
# ROXIBOLONE.
ROXITHROMYCIN.
RUBELLA VACCINE.
RUBOXISTAURIN.
RUPATADINE.
RUXOLITINIB.
SALBUTAMOL except when
included in Schedule 3.
SALCATONIN.
SALICYLAMIDE when combined with aspirin,
caffeine or paracetamol or any derivative of these substances.
SALINOMYCIN except:
(a) when
included in Schedule 6; or
(b) in animal
feeds containing 60 mg/kg or less of antibiotic substances.
SALMETEROL.
SAPROPTERIN.
SAQUINAVIR.
SAXAGLIPTIN.
SCHOENOCAULON OFFICINALE
(sabadilla) except in preparations containing 10 mg/kg or 10 mg/L or
less of total alkaloids of Schoenocaulon officinale.
SCOPOLIA CARNIOLICA for
therapeutic use.
# SELECTIVE ANDROGEN RECEPTOR
MODULATORS (SARM).
SELEGILINE.
SELENIUM:
(a) for human
oral use with a recommended daily dose of more than 300 micrograms; or
(b) for the
treatment of animals except:
(i) when
included in Schedule 6 or 7;
(ii) in
solid, slow release bolus preparations each weighing 100 g or more and containing
300 mg or less of selenium per dosage unit;
(iii) in
other divided preparations containing 30 micrograms or less of selenium per
dosage unit;
(iv) as
elemental selenium, in pellets containing 100 g/kg or less of selenium; or
(v) in
feeds containing 1 g/tonne or less of selenium.
SERELAXIN.
SERMORELIN.
SERTINDOLE.
SERTRALINE.
SEVELAMER.
SEVOFLURANE.
SEX HORMONES and all substances
having sex hormonal activity except when separately specified in these
Schedules.
SIBUTRAMINE.
# SILANDRONE.
SILDENAFIL.
SILICONES for intra-ocular use.
SILVER SULFADIAZINE.
SIMEPREVIR.
SIMVASTATIN.
SIROLIMUS.
SISOMICIN (sisomycin).
SITAGLIPTIN.
# SITAXENTAN.
SODIUM BROMIDE for therapeutic
use.
SODIUM CELLULOSE PHOSPHATE for
human internal use.
SODIUM CROMOGLYCATE except
when included in Schedule 2.
SODIUM MORRHUATE in preparations
for injection.
SODIUM NITROPRUSSIDE for human
therapeutic use.
SODIUM PHOSPHATE in preparations
for oral laxative use.
SODIUM POLYSTYRENE SULPHONATE for
human therapeutic use.
SODIUM SALICYLATE in preparations
for injection for the treatment of animals.
SODIUM TETRADECYLSULFATE in
preparations for injection.
SOFOSBUVIR.
SOLASODINE.
SOLIFENACIN.
SOMATOSTATIN.
SOMATOTROPIN EQUINE.
# SOMATROPIN (human growth
hormone).
SONTOQUINE.
SORAFENIB.
SOTALOL.
SPARFLOXACIN.
SPARTEINE.
SPECTINOMYCIN.
SPIRAMYCIN.
SPIRAPRIL.
SPIRONOLACTONE.
# STANOLONE.
# STANOZOLOL.
STAVUDINE.
# STENBOLONE.
STEROID HORMONES except when
separately specified in these Schedules.
STILBOESTROL
(diethylstilboestrol).
STREPTODORNASE.
STREPTOKINASE.
STREPTOMYCIN.
STRONTIUM RANELATE.
STROPHANTHINS.
STROPHANTHUS spp.
STRYCHNINE in preparations
containing 1.5 per cent or less of strychnine for the treatment of animals.
STRYCHNOS spp. except in
preparations containing 1 mg or less per litre or per kilogram of strychnine.
STYRAMATE.
SUCCIMER.
SUGAMMADEX.
SULBACTAM.
SULCONAZOLE except when
included in Schedule 2.
SULFACETAMIDE except when
included in Schedule 3 or 5.
SULFADIAZINE except when
included in Schedule 5.
SULFADIMETHOXINE.
SULFADIMIDINE except when
included in Schedule 5.
SULFADOXINE.
SULFAFURAZOLE.
SULFAGUANIDINE.
SULFAMERAZINE except when
included in Schedule 5.
SULFAMETHIZOLE.
SULFAMETHOXAZOLE.
SULFAMETHOXYDIAZINE.
SULFAMETHOXYPYRIDAZINE.
SULFAMETROLE.
SULFAMONOMETHOXINE.
SULFAMOXOLE.
SULFAPHENAZOLE.
SULFAPYRIDINE.
SULFAQUINOXALINE.
SULFASALAZINE.
SULFATHIAZOLE except when
included in Schedule 5.
SULFATROXAZOLE.
SULFINPYRAZONE.
SULFOMYXIN.
SULFONAMIDES except:
(a) when
separately specified in this Schedule;
(b) when
included in Schedule 3, 5 or 6; or
(c) when
packed and labelled solely for use as a herbicide.
SULFONMETHANE (sulfonal and alkyl
sulfonals).
SULINDAC.
SULTAMICILLIN.
SULTHIAME.
SUMATRIPTAN.
SUNITINIB.
SUPROFEN.
SUTILAINS.
SUXAMETHONIUM.
SUXETHONIUM.
TACRINE.
TACROLIMUS.
TADALAFIL.
TAFLUPROST.
TALIGLUCERASE ALFA.
TAMOXIFEN.
TAMSULOSIN.
TANACETUM VULGARE except
in preparations containing 0.8 per cent or less of oil of tansy.
TASONERMIN.
TAZAROTENE.
TAZOBACTAM.
T-CELL RECEPTOR ANTIBODY.
TEGAFUR.
TEGASEROD.
TELAPREVIR.
TELITHROMYCIN.
TEICOPLANIN.
TELBIVUDINE.
TELMISARTAN.
# TEMAZEPAM.
TEMOZOLOMIDE.
TEMSIROLIMUS.
TENECTEPLASE.
TENIPOSIDE.
TENOFOVIR.
TENOXICAM.
TEPOXALIN.
TERAZOSIN.
TERBINAFINE except:
(a) when
included in Schedule 2; or
(b) in
preparations for dermal use for the treatment of tinea pedis.
TERBUTALINE except when
included in Schedule 3.
TERFENADINE.
TERIFLUNOMIDE.
# TERIPARATIDE.
TERLIPRESSIN.
TERODILINE.
TEROPTERIN.
# TESTOLACTONE.
# TESTOSTERONE except when
included in Schedule 6.
TETANUS ANTITOXIN except
when used for short-term protection or treatment of tetanus in animals.
TETANUS TOXOID for human use.
TETRABENAZINE.
TETRACOSACTRIN.
TETRACYCLINE except when
included in Schedule 5.
TETRAETHYLAMMONIUM.
TETROXOPRIM.
# THALIDOMIDE.
THENYLDIAMINE.
THEOPHYLLINE except when
included in Schedule 3.
THEVETIA PERUVIANA.
THEVETIN.
THIACETARSAMIDE in preparations
for the prevention or treatment of heartworm in dogs.
THIAMBUTOSINE.
THIAZOSULFONE.
THIETHYLPERAZINE.
THIOACETAZONE.
THIOCARLIDE.
THIOGUANINE.
# THIOMESTERONE (tiomesterone).
THIOPENTONE.
THIOPROPAZATE.
THIOPROPERAZINE.
THIORIDAZINE.
THIOSTREPTON.
THIOTEPA.
THIOTHIXENE.
THIOURACIL.
THIOUREA for therapeutic use except
in preparations containing 0.1 per cent or less of thiourea.
THYMOXAMINE (includes thymoxamine
hydrochloride).
THYROID except when
separately specified in this Schedule.
THYROTROPHIN.
THYROXINE (includes thyroxine
sodium).
TIAGABINE.
TIAMULIN.
TIAPROFENIC ACID.
TIARAMIDE.
TIBOLONE.
TICAGRELOR.
TICARCILLIN.
TICLOPIDINE.
TIEMONIUM.
TIENILIC ACID.
TIGECYCLINE.
TIGLOIDINE.
TILDIPIROSIN.
TILETAMINE.
TILMICOSIN.
TILUDRONIC ACID (includes
disodium tiludronate).
TIMOLOL.
TINIDAZOLE.
TINZAPARIN (includes tinzaparin
sodium).
TIOCONAZOLE except:
(a) when
included in Schedule 2 or 3; or
(b) in
preparations for dermal use for the treatment of tinea pedis.
TIOTROPIUM.
TIPEPIDINE.
TIPRANAVIR.
TIRILAZAD.
TIROFIBAN.
TOBRAMYCIN.
TOCAINIDE.
TOCERANIB.
TOCILIZUMAB.
TOLAZAMIDE.
TOLAZOLINE.
TOLBUTAMIDE.
TOLCAPONE.
TOLFENAMIC ACID.
TOLMETIN.
TOLONIUM.
TOLPROPAMINE.
TOLRESTAT.
TOLTERODINE.
TOLVAPTAN.
TOPIRAMATE.
TOPOTECAN.
TORASEMIDE.
TOREMIFENE.
TOXOIDS for human parenteral use except
when separately specified in these Schedules.
TRAMADOL.
TRANDOLAPRIL.
trametinib
dimethyl sulfoxide.
TRANEXAMIC ACID except in
preparations containing 3 per cent or less of cetyl tranexamate hydrochloride
for dermal cosmetic use.
TRANYLCYPROMINE.
TRASTUZUMAB.
Trastuzumab emtansine.
TRAVOPROST.
TRAZODONE.
# TRENBOLONE (trienbolone, trienolone)
except when included in Schedule 5.
TREOSULPHAN.
TREPROSTINIL.
# TRESTOLONE.
TRETAMINE.
# TRETINOIN.
TRIACETYLOLEANDOMYCIN.
TRIAMCINOLONE except when
included in Schedule 2 or 3.
TRIAMTERENE.
TRIAZIQUONE.
# TRIAZOLAM.
TRICHLORMETHIAZIDE.
TRICHLOROACETIC ACID for human
dermal use except when in preparations containing 12.5 per cent or less
of trichloroacetic acid for the treatment of warts other than anogenital warts.
TRICHLOROETHYLENE for therapeutic
use.
TRICLOFOS.
TRICYCLAMOL.
TRIDIHEXETHYL.
TRIFLUOPERAZINE.
TRIFLUPERIDOL.
TRIFLUPROMAZINE.
TRILOSTANE.
TRIMEPRAZINE except when
included in Schedule 2 or 3.
TRIMETAPHAN.
TRIMETHOPRIM.
TRIMIPRAMINE.
TRIMUSTINE.
TRINITROPHENOL
(excluding its derivatives) in preparations for human therapeutic use.
TRIOXYSALEN.
TRIPELENNAMINE.
TRIPLE ANTIGEN VACCINE.
TRIPROLIDINE except when
included in Schedule 2 or 3.
TRIPTORELIN.
TROGLITAZONE.
TROMETAMOL in preparations for
injection except in preparations containing 3 per cent or less of
trometamol.
TROPICAMIDE.
TROPISETRON.
TROVAFLOXACIN.
TROXIDONE.
TRYPTOPHAN for human therapeutic
use except in preparations labelled with a recommended daily dose of
100 mg or less of tryptophan.
TUBERCULIN.
TUBOCURARINE.
TULATHROMYCIN.
TULOBUTEROL.
TYLOSIN.
TYPHOID VACCINE.
UMECLIDINIUM.
UNOPROSTONE.
URACIL.
URAPIDIL.
URETHANE (excluding its
derivatives) for therapeutic use.
# UROFOLLITROPIN.
UROKINASE.
URSODEOXYCHOLIC ACID.
USTEKINUMAB.
VACCINES for human therapeutic
use except when separately specified in this Schedule.
VACCINES, veterinary live virus
except:
(a) poultry
vaccines;
(b) pigeon pox
vaccine; or
(c) scabby
mouth vaccine.
VACCINIA VIRUS VACCINE.
VALACICLOVIR.
VALDECOXIB.
VALGANCICLOVIR.
VALNOCTAMIDE.
VALPROIC ACID.
VALSARTAN.
VANCOMYCIN.
VANDETANIB.
VARDENAFIL.
VARENICLINE.
VARICELLA VACCINE.
VASOPRESSIN.
VECURONIUM.
VEDAPROFEN.
vEDOLIZUMAB.
VELAGLUCERASE ALFA.
VEMURAFENIB.
VENLAFAXINE.
VERAPAMIL.
VERATRUM spp. except when
separately specified in this Schedule.
VERNAKALANT.
VERTEPORFIN.
VIDARABINE.
VIGABATRIN.
VILANTEROL.
VILDAGLIPTIN.
VILOXAZINE.
VINBLASTINE.
VINCAMINE.
VINCRISTINE.
VINDESINE.
VINFLUNINE.
VINORELBINE.
VINYL ETHER for therapeutic use.
VIRGINIAMYCIN except when
included in Schedule 5.
VISMODEGIB.
VISNADINE.
VITAMIN A for human therapeutic
or cosmetic use except:
(a) in
preparations for topical use containing 1 per cent or less of Vitamin A;
(b) in
preparations for internal use containing 3000 micrograms retinol equivalents or
less of Vitamin A per daily dose; or
(c) in
preparations for parenteral nutrition replacement.
VITAMIN D for human internal therapeutic use except:
(a)
in preparations containing 25
micrograms or less of vitamin D per recommended daily dose ; or
(b)
when included in Schedule 3.
VORICONAZOLE.
VORINOSTAT.
VORTIOXETINE.
WARFARIN for therapeutic use.
XAMOTEROL.
XANTHINOL NICOTINATE.
XIMELAGATRAN.
XIPAMIDE.
XYLAZINE.
YOHIMBINE.
ZAFIRLUKAST.
ZALCITABINE.
ZALEPLON.
ZANAMIVIR.
ZERANOL except when
included in Schedule 6.
ZIDOVUDINE.
ZILPATEROL.
ZIMELDINE.
ZINC COMPOUNDS for human internal
use except:
(a) in
preparations with a recommended daily dose of 25 mg or less of zinc; or
(b) in
preparations with a recommended daily dose of more than 25 mg but not more than
50 mg of zinc when compliant with the requirements of the Required
Advisory Statements for Medicine Labels.
ZIPRASIDONE.
ZOLAZEPAM.
ZOLEDRONIC ACID.
ZOLMITRIPTAN.
ZOLPIDEM.
ZONISAMIDE.
ZOPICLONE.
ZOXAZOLAMINE.
ZUCLOPENTHIXOL.
(Substances marked †
are listed in Appendix C)
ABAMECTIN in preparations, for
internal use for the treatment of animals, containing 1 per cent or less of
abamectin.
ABSCISIC ACID.
ACETIC ACID (excluding its salts and
derivatives) in preparations containing more than 30 per cent of acetic acid
(CH3COOH) except:
(a) when
included in Schedule 2 or 6; or
(b) for
therapeutic use.
ACETONE except in
preparations containing 25 per cent or less of designated solvents.
ACRIFLAVINE in preparations for
veterinary use containing 2.5 per cent or less of acriflavine.
AFOXOLANER for the treatment and
prevention of flea infestations and control of ticks in dogs in oral divided
preparations each containing 140 mg or less of afoxolaner per dosage unit.
AKLOMIDE.
ALBENDAZOLE for the treatment of
animals, in preparations containing 12.5 per cent or less of albendazole except
in intraruminal implants each containing 3.85 g or less of albendazole.
† ALKALINE SALTS, being the carbonate,
silicate or phosphate salts of sodium or potassium alone or in any combination:
(a) in solid
orthodontic device cleaning preparations, the pH of which as an “in-use”
aqueous solution is more than 11.5;
(b) in solid
automatic dishwashing preparations, the pH of which in a 500 g/L aqueous
solution or mixture is more than 11.5 but less than or equal to 12.5;
(c) in other
solid preparations, the pH of which in a 10 g/L aqueous solution is more than
11.5; or
(d) in liquid
or semi-solid preparations, the pH of which is more than 11.5, unless:
(i) in
food additive preparations for domestic use; or
(ii) in
automatic dish washing preparations for domestic use with a pH of more than
12.5,
except when
separately specified in these Schedules.
ALKOXYLATED FATTY ALKYLAMINE
POLYMER in preparations containing 50 per cent or less of alkoxylated fatty
alkylamine polymer except in preparations
containing 20 per cent or less of alkoxylated fatty alkylamine polymer.
ALLETHRIN in preparations
containing 10 per cent or less of allethrin except:
(a) in
insecticidal mats; or
(b) in other
preparations containing 1 per cent or less of allethrin.
ALLOXYDIM.
ALPHA-CYPERMETHRIN:
(a) in aqueous
preparations containing 3 per cent or less of alpha-cypermethrin; or
(b) in other
preparations containing 1.5 per cent or less of alpha-cypermethrin.
AMETRYN.
AMINACRINE in preparations for
veterinary use containing 2.5 per cent or less of aminacrine.
AMINES for use as curing agents for
epoxy resins except when separately specified in these Schedules.
AMINOPYRALID in water soluble gel formulations
containing 0.5 per cent or less of aminopyralid.
AMITROLE.
AMINOCYCLOPYRACHLOR.
AMMONIA (excluding its salts and
derivatives other than ammonium hydroxide) in preparations containing
5 per cent or less of ammonia except:
(a) in
preparations for human internal therapeutic use;
(b) in
preparations for inhalation when absorbed in an inert solid material; or
(c) in
preparations containing 0.5 per cent or less of free ammonia.
AMMONIUM THIOCYANATE except
in preparations containing 10 per cent or less of ammonium thiocyanate.
ANHYDRIDES, ORGANIC ACID for use
as curing agents for epoxy resins except when separately specified in
these Schedules.
ANISE OIL except:
(a) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 50 mL or less fitted with a restricted flow insert and
compliant with the requirements of the Required Advisory Statements for
Medicine Labels;
(b) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 50 mL or less fitted with a restricted
flow insert, and labelled with the warning:
KEEP OUT
OF REACH OF CHILDREN; or
(c) in
preparations containing 50 per cent or less of anise oil.
ASPIRIN for the treatment of
animals, in divided preparations when packed in blister or strip packaging or
in a container with a child-resistant closure.
ATRAZINE.
† AZADIRACHTA INDICA EXTRACTS
(neem extracts), extracted from neem seed kernels using water, methanol or
ethanol, in preparations containing 5 per cent or less of total limonoids, for
agricultural use.
AZOXYSTROBIN.
BACILLUS THURINGIENSIS delta endotoxin encapsulated in killed Pseudomonas
fluorescens.
BARIUM SILICOFLUORIDE
when coated on paper in an amount not exceeding 8 mg of barium silicofluoride per
sq. cm.
BASIL OIL except:
(a) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 25 mL or less fitted with a restricted flow insert and
compliant with the requirements of the Required Advisory Statements for
Medicine Labels;
(b) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 25 mL or less fitted with a restricted
flow insert, and labelled with the warning:
KEEP OUT
OF REACH OF CHILDREN; or
(c) in
preparations containing 5 per cent or less of methyl chavicol.
BEAUVERIA BASSIANA in
preparations containing 1 x 108 Colony Forming Units (CFU)/mL or
less of Beauveria bassiana.
BENALAXYL.
BENDIOCARB in preparations
containing 2 per cent or less of bendiocarb.
BENTAZONE.
BENZALKONIUM CHLORIDE in
preparations containing 10 per cent or less of benzalkonium chloride except
in preparations containing 5 per cent or less of benzalkonium chloride.
BENZOFENAP.
BENZOYL PEROXIDE except:
(a) when
included in Schedule 2 or 4; or
(b) in
preparations containing 5 per cent or less of benzoyl peroxide.
BERGAMOT OIL except:
(a) when steam
distilled or rectified;
(b) in
preparations for internal use;
(c) in
preparations containing 0.4 per cent or less of bergamot oil;
(d) in soaps
or bath or shower gels that are washed off the skin;
(e) in
medicines for human therapeutic use when compliant with the requirements of the
Required Advisory Statements for Medicine Labels; or
(f) in other
preparations when packed in containers labelled with the statement:
Application
to the skin may increase sensitivity to sunlight.
BETACYFLUTHRIN:
(a) in aqueous
preparations containing 2.5 per cent or less of betacyfluthrin; or
(b) in solid
preparations containing 8 per cent or less of betacyfluthrin in a plastic
matrix.
BIFLUORIDES (including ammonium,
potassium and sodium salts), in preparations containing 0.3 per cent or less
of total bifluorides.
BIOALLETHRIN in preparations
containing 10 per cent or less of bioallethrin except in preparations containing 1 per cent
or less of bioallethrin.
BIORESMETHRIN except in
preparations containing 10 per cent or less of bioresmethrin.
BISPYRIBAC except in
preparations containing 10 per cent or less of bispyribac.
BORIC ACID (excluding its salts)
and BORAX except:
(a) when
included in Schedule 4;
(b) in
preparations, other than insect baits, containing 1 per cent or less of boron;
or
(c) in hand
cleaning preparations.
BORON TRIFLUORIDE in preparations
containing 0.1 per cent or less of boron trifluoride (BF3).
BROMUCONAZOLE in preparations containing
20 per cent or less of bromuconazole.
BUPIVACAINE in
aqueous gel preparations containing 0.5 per cent or less of bupivacaine, for
the dermal spray-on treatment of wounds associated with 'mulesing' of sheep.
BUPROFEZIN except
in preparations containing 40 per cent or less of buprofezin.
BUTHIDAZOLE.
BUTOXYCARBOXIM in solid
preparations containing 10 per cent or less of butoxycarboxim.
BUTRALIN.
BUTROXYDIM.
CAMPHOR as a natural component in
essential oils containing 10 per cent or less of camphor except:
(a) in
medicines for human therapeutic use, in essential oils when packed in
containers having a nominal capacity of 25 mL or less fitted with a restricted
flow insert and compliant with the requirements of the Required Advisory
Statements for Medicine Labels;
(b) in
preparations other than medicines for human therapeutic use, in essential oils
when packed in containers having a nominal capacity of 25 mL or less fitted
with a restricted flow insert, and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN;
(c) in
rosemary oil, sage oil (Spanish), or lavandin oils; or
(d) in
preparations containing 2.5 per cent or less of camphor.
† CARBAMIDE PEROXIDE in
preparations containing 18 per cent or less of carbamide peroxide except in preparations containing
9 per cent or less of carbamide peroxide.
CARBARYL:
(a) in
preparations containing 10 per cent or less of carbaryl except when
included in Schedule 4; or
(b) when
impregnated into plastic resin material containing 20 per cent or less of
carbaryl.
CASSIA OIL except:
(a) in food
additives;
(b) in
preparations for dermal use as a rubefacient containing 5 per cent or less of
cassia oil; or
(c) in other
preparations containing 2 per cent or less of cassia oil.
CHLORFENAC.
CHLORFENAPYR. in
preparations containing 0.5 per cent or less of chlorfenapyr.
CHLORFENSON.
CHLORHEXIDINE in preparations
containing 3 per cent or less of chlorhexidine except:
(a) in
preparations containing 1 per cent or less of chlorhexidine; or
(b) when in
solid preparations.
CHLORINATING COMPOUNDS containing
20 per cent or less of available chlorine, except:
(a) when
separately specified in these Schedules;
(b) sodium
hypochlorite preparations with a pH of less than 11.5;
(c) liquid
preparations containing not less than 2 per cent but not more than 4 per cent
of available chlorine when labelled with the statements:
WARNING – Ensure adequate
ventilation when using. Vapour may be harmful. May give off dangerous gas if
mixed with other products;
(d) liquid
preparations containing less than 2 per cent of available chlorine; or
(e) other
preparations containing 4 per cent or less of available chlorine.
CHLORNIDINE.
CHLOROCRESOL except in
preparations containing 3 per cent or less of chlorocresol.
CHLORPROPHAM.
CHLORPYRIFOS:
(a) in aqueous
preparations containing 20 per cent or less of microencapsulated chlorpyrifos;
(b) in
controlled release granular preparations containing 10 per cent or less of
chlorpyrifos; or
(c) in other
preparations containing 5 per cent or less of chlorpyrifos,
except in prepared potting
or soil mixes containing 100 g or less of chlorpyrifos per cubic metre.
CHLORSULFURON.
CHLORTETRACYCLINE in
preparations:
(a) for
topical application to animals for ocular use only; or
(b) containing
40 per cent or less of chlortetracycline, when packed and labelled for the
treatment of ornamental caged birds or ornamental fish only.
CHLORTHAL-DIMETHYL.
CINMETHYLIN.
CINNAMON BARK OIL except:
(a) in food
additives; or
(b) in preparations
containing 2 per cent or less of cinnamon bark oil.
CLETHODIM.
CLIMBAZOLE in preparations
containing 40 per cent or less of climbazole except in preparations
containing 2 per cent or less of climbazole.
CLOFENTEZINE.
CLOPYRALID.
CLOQUINTOCET-MEXYL.
CLORSULON.
CLOTHIANIDIN in preparations
containing 20 per cent or less of clothianidin.
CLOVE OIL for topical use in the
mouth in a pack containing 5 mL or less of clove oil except in
preparations containing 25 per cent or less of clove oil.
COPPER ACETATE in preparations
containing 20 per cent or less of copper acetate except in preparations
containing 5 per cent or less of copper acetate.
COPPER COMPOUNDS in animal feed
additives containing 5 per cent or less of copper except in preparations
containing 1 per cent or less of copper.
COPPER HYDROXIDE in preparations
containing 50 per cent or less of copper hydroxide except in
preparations containing 12.5 per cent or less of copper hydroxide.
COPPER OXIDES in preparations
containing 25 per cent or less of copper oxides except:
(a) in
preparations for internal use;
(b) in marine
paints; or
(c) in other
preparations containing 5 per cent or less of copper oxides.
COPPER OXYCHLORIDE in
preparations containing 50 per cent or less of copper oxychloride except
in preparations containing 12.5 per cent or less of copper oxychloride.
COPPER SULFATE in preparations
containing 15 per cent or less of copper sulfate except:
(a) in
preparations for internal use; or
(b) in other
preparations containing 5 per cent or less of copper sulfate.
COUMATETRALYL in rodenticides
containing 0.05 per cent or less of coumatetralyl.
4-CPA.
CYANATRYN.
CYANOACRYLATE ESTERS in contact adhesives
except:
(a) when
labelled with the warning:
KEEP OUT
OF REACH OF CHILDREN. Avoid contact with skin and eyes and avoid breathing
vapour. Bonds on contact. Should fingers stick together apply a solvent such
as acetone to contact areas then wash off with water. Do not use solvents near
eyes or open wounds. In case of eye contact immediately flush with water; or
(b) when
packed in sealed measure packs each containing 0.5 g or less of cyanoacrylate
esters:
(i) labelled
with the approved name or trade name of the poison, the quantity and the
warning:
Can
cause eye injury. Instantly bonds skin; and
(ii)
enclosed in a primary pack labelled with the warning:
KEEP
OUT OF REACH OF CHILDREN. Avoid contact with skin and eyes and avoid breathing
vapour. Bonds on contact. Should fingers stick together apply a solvent such
as acetone to contact areas then wash off with water. Do not use solvents near
eyes or open wounds. In case of eye contact immediately flush with water.
CYANURIC ACID (excluding its
salts and derivatives).
CYANTRANILIPROLE.
CYAZOFAMID.
CYCLOHEXANONE PEROXIDE.
CYCLOPROTHRIN except in
preparations containing 10 per cent or less of cycloprothrin.
CYCLOXYDIM.
CYFLUFENAMID.
CYFLUTHRIN:
(a) in
wettable powders containing 10 per cent or less of cyfluthrin;
(b) in
emulsifiable concentrates containing 2 per cent or less of cyfluthrin; or
(c) in
emulsions containing 5 per cent or less of cyfluthrin.
cyhalofop-butyl.
CYMIAZOLE.
CYPERMETHRIN in preparations
containing 10 per cent or less of cypermethrin.
CYPHENOTHRIN in preparations
containing 10 per cent or less of cyphenothrin.
CYPROCONAZOLE except in
preparations containing 10 per cent or less of cyproconazole.
CYPRODINIL.
CYSTEAMINE in cosmetic
preparations containing 6 per cent or less of cysteamine except in
preparations containing 1 per cent or less of cysteamine.
CYTHIOATE for the treatment of
animals:
(a) in divided
preparations containing 30 mg or less of cythioate per dosage unit when packed
in blister or strip packaging or in a container with a child-resistant closure;
or
(b) in
undivided preparations containing 5 per cent or less of cythioate.
2,4-D in preparations containing 20 per
cent or less of 2,4-D.
DAMINOZIDE.
2,4-DB.
DECOQUINATE:
DELTAMETHRIN:
(a)
when impregnated in plastic resin
strip material containing 4 per cent or less of deltamethrin;
(b)
in aqueous preparations containing
5 per cent or less of deltamethrin when no organic solvent other than a glycol
is present;
(c)
in wettable granular preparations
containing 25 per cent or less of deltamethrin when packed in child-resistant
packaging each containing 3 grams or less of the formulation;
(d)
in water-dispersible tablets each
containing 500 mg or less of deltamethrin in child-resistant packaging; or
(e)
in other preparations containing
0.5 per cent or less of deltamethrin,
except:
(a)
in factory prepared mosquito nets containing 1 per cent or less
deltamethrin; or
(b)
in preparations containing 0.1 per
cent or less of deltamethrin.
DEMBREXINE in oral preparations
for the treatment of animals.
2,4-DES.
DIAFENTHIURON.
N,N-DIALLYLDICHLOROACETAMIDE except
in preparations containing 10 per cent or less of N,N-diallyldichloroacetamide.
DIAZINON in dust preparations
containing 2 per cent or less of diazinon.
DICAMBA (including its salts and
derivatives) in preparations containing 20 per cent or less of dicamba.
DICHLONE.
para-DICHLOROBENZENE.
DICHLOROISOCYANURIC ACID
containing 40 per cent or less of available chlorine, except in:
(a) liquid preparations containing not less than 2 per
cent but not more than 4 per cent of available chlorine when labelled
with the statements:
WARNING
– Ensure adequate ventilation when using. Vapour may be harmful. May give off
dangerous gas if mixed with other products;
(b) liquid
preparations containing less than 2 per cent of available chlorine; or
(c) other
preparations containing 4 per cent or less of available chlorine.
DICHLOROMETHANE (methylene
chloride) except:
(a) in
preparations in pressurised spray packs labelled as degreasers, decarbonisers
or paint strippers and containing 10 per cent or less of dichloromethane;
(b) in other preparations
in pressurised spray packs; or
(c) in paints
and tinters containing 5 per cent or less of dichloromethane.
DICHLOROPHEN for the treatment of
animals.
DICHLORVOS:
(a) when
impregnated in plastic resin strip material containing 20 per cent or less of
dichlorvos;
(b) in
sustained release resin pellets containing 20 per cent or less of dichlorvos
for the treatment of animals; or
(c) in
pressurised spray packs containing 10 grams or less of dichlorvos.
DICLOBUTRAZOL.
DICLORAN.
DICOFOL.
DIETHANOLAMINE (excluding its
salts and derivatives) in preparations containing 20 per cent or less of
diethanolamine except in preparations containing 5 per cent or less of
diethanolamine.
† DIETHYLENE GLYCOL (excluding
its salts and derivatives) in preparations containing not less than
10 mg/kg of denatonium benzoate as a bittering agent except:
(a) in paints or
paint tinters;
(b) in
toothpastes or mouthwashes containing more than 0.25 per cent of diethylene
glycol; or
(c) in other
preparations containing 2.5 per cent or less of diethylene glycol.
DIETHYLENE GLYCOL MONOBUTYL ETHER
except in preparations containing 10 per cent or less of diethylene
glycol monobutyl ether.
DIETHYLTOLUAMIDE (DEET) except:
(a) in
medicines for human therapeutic use containing 20 per cent or less of
diethyltoluamide, when compliant with the requirements of the Required
Advisory Statements for Medicine Labels;
(b) in preparations for human use, other than
medicines, containing 20 per cent or less of diethyltoluamide, when
labelled with the warning statement:
WARNING:
May be dangerous, particularly to children, if you use large amounts on the
skin, clothes or bedding or on large areas of the body, especially if you keep
using it for a long time; or
(c) in
preparations other than for human use containing 20 per cent or less of
diethyltoluamide.
DIFENOCONAZOLE.
DIFLUBENZURON.
DIMETHICODIETHYLBENZALMALONATE except
when included in preparations containing 10 per cent or less of
dimethicodiethylbenzalmalonate.
DIMETHIRIMOL.
DIMETHOMORPH except in
preparations containing 10 per cent or less of dimethomorph.
DIMETHYLACETAMIDE in preparations
containing 20 per cent or less of dimethylacetamide.
DIMETHYLFORMAMIDE in preparations
containing 10 per cent or less of dimethylformamide except in silicone
rubber mastic containing 2 per cent or less of dimethylformamide.
DINICONAZOLE.
DI-N-PROPYL ISOCINCHOMERONATE except
in preparations containing 25 per cent or less of di-N-propyl
isocinchomeronate.
DIPHENAMID.
DITHIOPYR.
N-(N-DODECYL)-2-PYRROLIDONE in
preparations containing 50 per cent or less of N-(N-dodecyl)-2-pyrrolidone or
preparations containing 50 per cent or less of a mixture of any two or more of N-(N-dodecyl)-2-pyrrolidone,
N-methyl-2-pyrrolidone or N-(N-octyl)-2-pyrrolidone except in
preparations containing 25 per cent or less of designated solvents.
DORAMECTIN for internal use for
the treatment of animals, in preparations containing 2 per cent or less of
doramectin.
EMAMECTIN in preparations
containing 2 per cent or less of emamectin.
EMODEPSIDE in preparations:
(a) containing
2.5 per cent or less of emodepside for the external treatment of animals; or
(b) containing 30
mg or less of emodepside per dosage unit for the oral treatment of animals.
EPOXICONAZOLE.
EPOXY RESINS, LIQUID.
EPRINOMECTIN in preparations
containing 0.5 per cent or less of eprinomectin.
ESBIOTHRIN in preparations
containing 10 per cent or less of esbiothrin except in pressurised spray
packs containing 1 per cent or less of esbiothrin.
ESFENVALERATE in preparations
containing 0.1 per cent or less of esfenvalerate.
1,2-ETHANEDIAMINE
POLYMERWITH (CHLOROMETHYL)OXIRANE AND N-METHYLMETHANAMINE.
ETHANOLAMINE (excluding its salts
and derivatives) in preparations containing 20 per cent or less of ethanolamine
except:
(a) when
included in Schedule 4; or
(b) in
preparations containing 5 per cent or less of ethanolamine.
ETHER in preparations containing
more than 10 per cent of ether for use in internal combustion engines.
ETHOFUMESATE.
ETHOXYQUIN except in
preparations containing 10 per cent or less of ethoxyquin.
ETHOXYSULFURON.
† ETHYLENE GLYCOL (excluding its
salts and derivatives) in preparations containing not less than 10 mg/kg of
denatonium benzoate as a bittering agent except:
(a) in paints
or paint tinters;
(b) in
toothpastes or mouthwashes containing more than 0.25 per cent of ethylene
glycol; or
(c) in other
preparations containing 2.5 per cent or less of ethylene glycol.
ETHYL METHACRYLATE (excluding its
derivatives) for cosmetic use except in preparations containing 1 per
cent or less of ethyl methacrylate as residual monomer in a polymer.
ETRIDIAZOLE.
EUGENOL for topical use in the
mouth in a pack containing 5 mL or less of eugenol except in
preparations containing 25 per cent or less of eugenol.
EXTRACT OF LEMON EUCALYPTUS,
being acid modified oil of lemon eucalyptus (Corymbia citriodora) , except
in preparations containing 40 per cent or less of extract of lemon eucalyptus.
FENARIMOL.
FENBENDAZOLE for the treatment of
animals.
FENBUCONAZOLE.
FENCHLORAZOLE-ETHYL.
FENOPROP.
FENOXAPROP-ETHYL.
FENOXAPROP-P-ETHYL.
FENSON.
FENTHION:
(a) in
preparations containing 25 per cent or less of fenthion when packed in
single-use containers having a capacity of 2 mL or less; or
(b) in
preparations containing 10 per cent or less of fenthion.
FIPRONIL in preparations
containing 10 per cent or less of fipronil except in preparations
containing 0.05 per cent or less of fipronil.
FLAMPROP-METHYL.
FLAMPROP-M-METHYL.
FLAZASULFURON.
FLORASULAM.
FLUAZURON.
FLUBENDAZOLE for the treatment of
animals.
FLUBENDIAMIDE.
FLUCHLORALIN.
FLUDIOXONIL except in
preparations containing 10 per cent or less of fludioxonil.
FLUMETHRIN:
(a) when
impregnated in plastic resin strip material containing 3 per cent or less of
flumethrin; or
(b) in oil
based preparations containing 1 per cent or less of flumethrin.
flumiclorac
pentyl.
FLUORIDES in preparations
containing 3 per cent or less of fluoride ion except:
(a) in
preparations for human use; or
(b) in
preparations containing 15 mg/kg or less of fluoride ion.
FLUVALINATE in aqueous
preparations containing 25 per cent or less of fluvalinate.
FLUXAPYROXAD.
FORAMSULFURON.
FORMIC ACID (excluding its salts
and derivatives) except in preparations containing 0.5 per cent or less
of formic acid.
FOSPIRATE when impregnated in
plastic resin strip material containing 20 per cent or less of fospirate.
FURALAXYL.
FURATHIOCARB in microencapsulated
suspensions containing 50 per cent or less of furathiocarb.
GAMMA-CYHALOTHRIN in aqueous
preparations containing 15 per cent or less of microencapsulated
gamma-cyhalothrin.
GLUFOSINATE-AMMONIUM.
GLUTARALDEHYDE in preparations
containing 5 per cent or less of glutaraldehyde except:
(a) when
included in Schedule 2; or
(b) in
preparations containing 0.5 per cent or less of glutaraldehyde when labelled
with the statements:
IRRITANT;
and
Avoid
contact with eyes.
GLYPHOSATE.
HALOSULFURON-METHYL.
HEXACONAZOLE except in
preparations containing 5 per cent or less of hexaconazole.
HEXAZINONE in preparations
containing 25 per cent or less of hexazinone.
HYDRAMETHYLNON in solid baits
containing 2 per cent or less of hydramethylnon in welded plastic labyrinths.
HYDROCARBONS, LIQUID, including kerosene,
diesel (distillate), mineral turpentine, white petroleum spirit, toluene,
xylene and light mineral and paraffin oils (but excluding their derivatives), except:
(a) toluene
and xylene when included in Schedule 6;
(b) benzene
and liquid aromatic hydrocarbons when included in Schedule 7;
(c) food
grade and pharmaceutical grade white mineral oils;
(d) in solid
or semi-solid preparations;
(e) in
preparations containing 25 per cent or less of designated solvents;
(f) in
preparations packed in pressurised spray packs;
(g) in
adhesives packed in containers each containing 50 grams or less of adhesive;
(h) in writing
correction fluids and thinners for writing correction fluids packed in
containers having a capacity of 20 mL or less; or
(i) in other
preparations when packed in containers with a capacity of 2 mL or less.
HYDROCHLORIC ACID (excluding its
salts and derivatives) in preparations containing 10 per cent or less of
hydrochloric acid (HCl) except:
(a) in
preparations containing 0.5 per cent or less of hydrochloric acid (HCl); or
(b) for
therapeutic use.
HYDROFLUORIC ACID (excluding its
salts and derivatives) and admixtures that generate hydrofluoric acid, in
preparations containing 0.1 per cent or less of hydrogen fluoride.
† HYDROGEN PEROXIDE (excluding
its salts and derivatives):
(a) in hair
dye preparations containing 12 per cent or less of hydrogen peroxide except in
hair dyes containing 6 per cent or less of hydrogen peroxide; or
(b) in other
preparations containing 6 per cent (20 volume) or less of hydrogen peroxide except
in preparations containing 3 per cent (10 volume) or less of hydrogen peroxide.
HYDROSILICOFLUORIC ACID
(excluding its salts and derivatives) in preparations containing 0.1 per
cent or less of hydrosilicofluoric acid (H2SiF6).
IMAZALIL.
IMAZAMOX except in
preparations containing 25 per cent or less of imazamox.
IMAZAPIC except in
preparations containing 25 per cent or less of imazapic.
IMAZAPYR except in
preparations containing 25 per cent or less of imazapyr.
IMAZETHAPYR except in
preparations containing 25 per cent or less of imazethapyr.
IMIDACLOPRID in
preparations containing 20 per cent or less of imidacloprid except in
preparations containing 5 per cent or less of imidacloprid.
IMIPROTHRIN in preparations
containing 50 per cent or less of imiprothrin except in preparations
containing 10 per cent or less of imiprothrin.
INDOXACARB (includes the R and S
enantiomers) in preparations containing 1 per cent or less of
indoxacarb.
3-IODO-2-PROPYNYL BUTYL CARBAMATE
(Iodocarb) ) in preparations containing
10 per cent or less of 3-iodo-2-propynyl butyl carbamate except:
(a) in aqueous preparations not for
cosmetic use containing 10 per cent or less 3-iodo-2-propynyl
butyl carbamate; or
(b) in cosmetic preparations (other than
aerosolised preparations) containing 0.1 per cent or less of 3-iodo-2-propynyl
butyl carbamate.
IODOSULFURON-METHYL-SODIUM.
IPCONAZOLE in preparations
containing 2 per cent or less of ipconazole.
IRON COMPOUNDS:
(a) for the
treatment of animals (excluding up to 1 per cent of iron oxides when present as
an excipient):
(i) in
preparations for injection containing 20 per cent or less of iron except in
preparations containing 0.1 per cent or less of iron; or
(ii) in
other preparations containing 4 per cent or less of iron except:
(A) in
liquid or gel preparations containing 0.1 per cent or less of iron; or
(B) in
animal feeds or feed premixes; or
(b) in garden
preparations except in preparations containing 4 per cent or less of
iron.
ISOEUGENOL in preparations
containing 25 per cent or less of isoeugenol except in preparations
containing 10 per cent or less of isoeugenol.
ISOPHORONE.
ISOXABEN.
ISOXAFLUTOLE.
IVERMECTIN for use in animals:
(a) in
preparations for the prophylaxis of heartworm in cats and dogs;
(b) in
intraruminal implants containing 160 mg or less of ivermectin;
(c) in
preparations containing 3.5 per cent or less of ivermectin when packed in
child-resistant packaging or in packaging approved by the relevant registration
authority; or
(d) in other
preparations containing 2 per cent or less of ivermectin.
KITASAMYCIN in animal feed
premixes for growth promotion containing 2 per cent or less of antibiotic
substances.
LAMBDA-CYHALOTHRIN:
(a) in aqueous
preparations containing 1 per cent or less of lambda- cyhalothrin; or
(b) in aqueous
preparations containing 2.5 per cent or less of microencapsulated
lambda-cyhalothrin.
† LEAD COMPOUNDS in preparations for
use as hair cosmetics.
LEMON OIL except:
(a) when steam
distilled or rectified;
(b) in
preparations for internal use;
(c) in
preparations containing 0.05 per cent or less of lemon oil;
(d) in soaps
or bath or shower gels that are washed off the skin;
(e) in
medicines for human therapeutic use, when compliant with the requirements of
the Required Advisory Statements for Medicine Labels; or
(f) in other
preparations when packed in containers labelled with the statement:
Application
to the skin may increase sensitivity to sunlight.
LEVAMISOLE in preparations
containing 15 per cent or less of levamisole for the treatment of animals except:
(a) when
included in Schedule 4; or
(b) in
preparations for the treatment of ornamental birds or ornamental fish, in packs
containing 10 mg or less of levamisole.
LIGNOCAINE in aqueous gel preparations containing 4.5 per cent or less of
lignocaine, for the dermal spray-on treatment of wounds associated with
'mulesing' of sheep.
LIME OIL except:
(a) when steam
distilled or rectified;
(b) in
preparations for internal use;
(c) in
preparations containing 0.5 per cent or less of lime oil;
(d) in soaps
or bath or shower gels that are washed off the skin;
(e) in
medicines for human therapeutic use, when compliant with the requirements of
the Required Advisory Statements for Medicine Labels; or
(f) in other
preparations when packed in containers labelled with the statement:
Application
to the skin may increase sensitivity to sunlight.
LINDANE in preparations
containing 10 per cent or less of lindane except when included in
Schedule 2 or 4.
LUFENURON except:
(a) in divided
preparations each containing 500 mg or less of lufenuron for the treatment of
animals; or
(b) in single
use syringes each containing 500 mg or less of lufenuron for the treatment of
animals.
MADURAMICIN in animal feed
premixes containing 1 per cent or less of antibiotic substances.
MAGNESIUM CHLORATE except
in preparations containing 10 per cent or less of magnesium chlorate.
MALACHITE GREEN in preparations
for veterinary use containing 10 per cent or less of malachite green.
MALATHION in preparations
containing 10 per cent or less of malathion except:
(a) for human
therapeutic use; or
(b) in dust
preparations containing 2 per cent or less of malathion.
MANCOZEB.
MANDIPROPAMID.
MARJORAM OIL except:
(a) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 50 mL or less fitted with a restricted flow insert and compliant
with the requirements of the Required Advisory Statements for Medicine Labels;
(b) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 50 mL or less fitted with a restricted
flow insert, and labelled with the warning:
KEEP OUT
OF REACH OF CHILDREN; or
(c) in
preparations containing 50 per cent or less of marjoram oil.
MCPA:
(a) in
preparations containing 25 per cent or less of MCPA (acid); or
(b) in
preparations containing 50 per cent or less of the salts and esters of MCPA.
MCPB.
MEBENDAZOLE for the treatment of
animals:
(a) in divided
preparations each containing 300 mg or less of mebendazole per dosage unit; or
(b) in
undivided preparations containing 25 per cent or less of mebendazole.
MECLOFENAMIC ACID for the
treatment of animals.
MECOPROP in preparations
containing 2 per cent or less of mecoprop.
MEFENPYR-DIETHYL.
MEPIQUAT.
MESOTRIONE.
METAFLUMIZONE.
METALAXYL in preparations
containing 35 per cent or less of metalaxyl.
METALDEHYDE in preparations
containing 2 per cent or less of metaldehyde.
METHABENZTHIAZURON.
METHANOL (excluding its
derivatives) in preparations containing 10 per cent or less of methanol except
in preparations containing 2 per cent or less of methanol.
METHIOCARB in pelleted
preparations containing 2 per cent or less of methiocarb.
METHOXYCHLOR.
METHYLATED SPIRIT(S) (being
ethanol denatured with denatonium benzoate, methyl isobutyl ketone and
fluorescein) except:
(a) when
included in preparations or admixtures; or
(b) when
packed in containers having a capacity of more than 5 litres.
METHYLENE BLUE in preparations
for veterinary use containing 50 per cent or less of methylene blue.
METHYL ETHYL KETONE except
in preparations containing 25 per cent or less of designated solvents.
METHYL ETHYL KETONE PEROXIDE.
METHYL ISOAMYL KETONE except
in preparations containing 25 per cent or less of designated solvents.
METHYL ISOBUTYL KETONE except
in preparations containing 25 per cent or less of designated solvents.
N-METHYL-2-PYRROLIDONE:
(a) when packed
in single use containers having a capacity of 2 mL or less; or
(b) in
preparations containing 50 per cent or less of N-methyl-2-pyrrolidone or
preparations containing 50 per cent or less of a mixture of any two or
more of N-methyl-2-pyrrolidone, N-(N-octyl)-2-pyrrolidone or
N-(N-dodecyl)-2-pyrrolidone except in preparations containing
25 per cent or less of designated solvents.
METHYL SALICYLATE in preparations
containing 25 per cent or less of methyl salicylate except:
(a) in
preparations for therapeutic use; or
(b) in
preparations containing 5 per cent or less of methyl salicylate.
2-METHYLTHIO-4-(2-METHYLPROP-2-YL)
AMINO-6-CYCLOPROPYLAMINO-5- TRIAZINE.
METIRAM.
METOLACHLOR.
METRAFENONE in preparations
containing 50 per cent or less of metrafenone.
MILBEMECTIN in preparations
containing 1 per cent or less of milbemectin.
MILBEMYCIN OXIME for the
prophylaxis of heartworm in dogs and cats.
MONENSIN in
intraruminal implants for cattle, each containing 35 g or less of monensin.
MONEPANTEL.
MORANTEL in preparations
containing 25 per cent or less of morantel except in preparations
containing 10 per cent or less of morantel.
MOXIDECTIN:
(a) in
preparations for external use for the treatment of animals other than cats and
dogs, containing 0.5 per cent or less of moxidectin;
(b) in
preparations for external use for the treatment of cats and dogs, containing
2.5 per cent or less of moxidectin packed in single dose tubes with a volume of
1 mL or less; or
(c) for
internal use for the treatment of animals:
(i) in
divided preparations for dogs, containing 250 micrograms or less of moxidectin
per dosage unit in a pack containing six or less dosage units; or
(ii) in other preparations containing 2 per cent or
less of moxidectin.
MYCLOBUTANIL.
NAA except in preparations
containing 25 per cent or less of NAA.
NALED when impregnated in plastic
resin strip material containing 20 per cent or less of naled.
NAPTALAM.
NETOBIMIN for the treatment of
animals, in preparations containing 12.5 per cent or less of netobimin.
NITRIC ACID (excluding its salts
and derivatives) in preparations containing 10 per cent or less of nitric acid
(HNO3) except in preparations containing 0.5 per cent or less
of nitric acid.
NITROSCANATE for the treatment of
animals.
NONOXINOL 9 in preparations
containing 25 per cent or less of nonoxinol 9 except:
(a) when
labelled with the statements:
IRRITANT;
and
Avoid
contact with eyes;
(b) in
preparations containing 12.5 per cent or less of nonoxinol 9; or
(c) in
preparations for human use.
NORBORMIDE.
NUTMEG OIL except:
(a) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 25 mL or less fitted with a restricted flow insert and
compliant with the requirements of the Required Advisory Statements for
Medicine Labels;
(b) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 25 mL or less fitted with a restricted
flow insert, and labelled with the warning:
KEEP OUT
OF REACH OF CHILDREN; or
(c) in
preparations containing 50 per cent or less of nutmeg oil.
N-OCTYL BICYCLOHEPTENE
DICARBOXIMIDE except in preparations containing 10 per cent or less of
N-octyl
bicycloheptene dicarboximide.
N-(N-OCTYL)-2-PYRROLIDONE in
preparations containing 50 per cent or less of:
(a) N-(N-octyl)-2-pyrrolidone
or preparations containing 50 per cent or less of a mixture of any two or more
of N-(N-octyl)-2-pyrrolidone, N-methyl-2-pyrrolidone or
(b) N-(N-dodecyl)-2-pyrrolidone except
in preparations containing 25 per cent or less of designated solvents.
OESTRADIOL in implant
preparations for growth promotion in animals.
OLEANDOMYCIN in animal feed
premixes for growth promotion.
OMETHOATE in pressurised spray
packs containing 0.2 per cent or less of omethoate.
ORANGE OIL (BITTER) except:
(a) when steam
distilled or rectified;
(b) in
preparations for internal use;
(c) in
preparations containing 1.4 per cent or less of orange oil (bitter);
(d) in soaps
or bath or shower gels that are washed off the skin;
(e) in
medicines for human therapeutic use, when compliant with the requirements of
the Required Advisory Statements for Medicine Labels; or
(f) in other
preparations when packed in containers labelled with the statement:
Application
to the skin may increase sensitivity to sunlight.
OXADIARGYL.
OXADIXYL.
OXANTEL EMBONATE for the
treatment of animals.
OXFENDAZOLE for the treatment of
animals.
OXIBENDAZOLE for the treatment of
animals.
OXYCARBOXIN.
OXYTETRACYCLINE in preparations:
(a) for
topical application to animals for ocular use only; or
(b) containing 40 per cent or less of oxytetracycline
per dose, when packed and labelled for the treatment of ornamental caged birds
or ornamental fish only.
OXYTHIOQUINOX.
PACLOBUTRAZOL.
PENCONAZOLE.
PENDIMETHALIN.
PENFLUFEN.
PENTHIOPYRAD except in
preparations containing 20 per cent or less of penthiopyrad.
PERACETIC ACID in concentrations
of 10 per cent or less of peracetic acid.
PERMETHRIN (excluding
preparations for human therapeutic use):
(a) in
preparations containing 25 per cent or less of permethrin; or
(b) in
preparations for external use, for the treatment of dogs, containing 50 per
cent or less of permethrin when packed in single use containers having a
capacity of 4 mL or less,
except in
preparations containing 2 per cent or less of permethrin.
PETROL except preparations
containing 25 per cent or less of petrol.
PHENAZONE for the external
treatment of animals.
PHENISOPHAM.
PHENOL, including cresols and
xylenols and any other homologue of phenol boiling below 220°C, when in animal
feed additives containing 15 per cent or less of such substances, except in
preparations containing 3 per cent or less of such substances.
PHENYL METHYL KETONE except
in preparations containing 25 per cent or less of designated solvents.
ortho-PHENYLPHENOL except
in preparations containing 5 per cent or less of o-phenylphenol.
PHOSPHONIC ACID (excluding its
salts and derivatives) except in preparations containing 10 per cent or
less of phosphonic acid (H3PO3).
PHOSPHORIC ACID (excluding its
salts and derivatives) in preparations containing 35 per cent or less of
phosphoric acid (H3PO4) except:
(a) in
preparations containing 15 per cent or less of phosphoric acid (H3PO4);
(b) in solid
or semi-solid preparations; or
(c) in
professional dental kits.
ortho-PHTHALALDEHYDE in
preparations containing 1 per cent or less of ortho-phthalaldehyde.
PICARIDIN except in
preparations containing 20 per cent or less of picaridin.
PINE OILS in preparations
containing 25 per cent or less of pine oils when packed and labelled as a
herbicide.
PINOXADEN in preparations
containing 10 per cent or less of pinoxaden.
PIPERAZINE for animal use.
PIRIMICARB in preparations
containing 0.5 per cent or less of pirimicarb.
POLIHEXANIDE except in
preparations containing 5 percent or less of polihexanide.
POLIXETONIUM SALTS in
preparations containing 60 per cent or less of polixetonium salts except
in preparations containing 1 per cent or less of polixetonium salts.
POLYETHANOXY (15) TALLOW AMINE.
POLY(OXY-1,2-ETHANEDIYL), α -[2-[(2-HYDROXYETHYL)AMINO]-2-OXOETHYL]-
α -HYDROXY-,MONO-C13-15-ALKYL ETHERS.
POTASSIUM CHLORATE except:
(a) when
included in Schedule 2; or
(b) in
preparations containing 10 per cent or less of potassium chlorate.
† POTASSIUM HYDROXIDE (excluding
its salts and derivatives) in preparations containing 5 per cent or less of
potassium hydroxide being:
(a) solid
preparations, the pH of which in a 10 g/L aqueous solution is more than 11.5;
or
(b) liquid or
semi-solid preparations, the pH of which is more than 11.5 except in
food additive preparations for domestic use.
POTASSIUM METABISULPHITE when
packed for domestic use except in preparations containing
10 per cent or less of potassium metabisulphite.
POTASSIUM NITRITE in preparations
containing 1 per cent or less of potassium nitrite except:
(a) in
preparations containing 0.5 per cent or less of potassium nitrite;
(b) when
present as an excipient in preparations for therapeutic use; or
(c) in
aerosols.
POTASSIUM PEROXOMONOSULFATE
TRIPLE SALT in preparations containing 5 per cent or less of potassium
peroxomonosulfate triple salt being:
(a) solid
preparations, the pH of which in a 10 g/L aqueous solution is less than 2.5; or
(b) liquid or
semi-solid preparations, the pH of which is less than 2.5.
POTASSIUM SULFIDE in preparations
for metal treatment in containers each containing 50 g or less of potassium sulfide.
PRALLETHRIN (cis:trans=20:80) in
preparations containing 10 per cent or less of prallethrin except in
insecticidal mats containing 1 per cent or less of prallethrin.
PROFOXYDIM except in
preparations containing 20 per cent or less of profoxydim.
PROGESTERONE:
(a) in implant
preparations or controlled release pessaries for synchronisation of oestrus in
cattle, sheep or goats; or
(b) in implant
preparations for growth promotion in cattle.
PROHEXADIONE CALCIUM.
PROMETRYN.
PROPAMOCARB.
PROPANIL.
PROPAQUIZAFOP.
PROPICONAZOLE in preparations
containing 20 per cent or less of propiconazole.
PROPIONIC ACID (excluding its
salts and derivatives) in preparations containing 80 per cent or less of
propionic acid, except:
(a) in
preparations containing 30 per cent or less of propionic acid; or
(b) for
therapeutic use.
PROPOXUR:
(a) when
impregnated in plastic resin strip material containing 10 per cent or less of
propoxur;
(b) in dust
preparations containing 3 per cent or less of propoxur;
(c) in
granular sugar-based fly baits containing 1 per cent or less of propoxur, a
dark colouring agent and a separate bittering agent;
(d) in
pressurised spray packs containing 2 per cent or less of propoxur; or
(e) in
printed paper sheets for pest control containing 0.5 per cent or less of
propoxur and in any case not more than 100 mg of propoxur per sheet.
PROPYZAMIDE.
PROTHIOCONAZOLE-DESCHLORO except
in preparations containing 0.5 per cent or less of prothioconazole-deschloro.
PROTHIOCONAZOLE-TRIAZOLIDINETHIONE
except in preparations containing 0.5 per cent or less of
prothioconazole-triazolidinethione.
PYMETROZINE.
PYRACLOSTROBIN.
PYRAFLUFEN-ETHYL.
PYRASULFOTOLE.
PYRETHRINS, naturally occurring,
being pyrethrolone, cinerolone or jasmolone esters of chrysanthemic or
pyrethric acids except:
(a) in
preparations for human therapeutic use; or
(b) in
preparations containing 10 per cent or less of such substances.
PYRIDABEN in preparations
containing 25 per cent or less of pyridaben.
PYRIFENOX.
PYRITHIOBAC SODIUM.
PYRITHIONE ZINC in paints
containing 0.5 per cent or less of pyrithione zinc calculated on the
non-volatile content of the paint except in paints containing 0.1 per
cent or less of pyrithione zinc calculated on the non-volatile content of the
paint.
QUATERNARY AMMONIUM COMPOUNDS in
preparations containing 20 per cent or less of quaternary ammonium compounds except:
(a) when
separately specified in these Schedules;
(b) dialkyl or
dialkoyl quaternary ammonium compounds where the alkyl or alkoyl groups are derived from tallow or
hydrogenated tallow or similar chain length (C16/C18) sources; or
(c) in
preparations containing 5 per cent or less of such quaternary ammonium
compounds.
QUINCLORAC.
QUININE in preparations for
veterinary use containing 1 per cent or less of quinine.
QUINTOZENE.
QUIZALOFOP-P-ETHYL in aqueous
preparations containing 40 per cent or less of
quizalofop-p-ethyl.
RACTOPAMINE in animal feed
premixes containing 10 per cent or less of ractopamine.
RESMETHRIN in preparations
containing 10 per cent or less of resmethrin.
RIMSULFURON.
ROBENIDINE except in
preparations containing 20 per cent or less of robenidine.
SAFLUFENACIL in water dispersible
granule preparations.
SALICYLANILIDE.
SEDAXANE.
SELAMECTIN except in
preparations containing 12 per cent or less of selamectin.
SETHOXYDIM.
SIDURON.
SILICOFLUORIDES in preparations
containing 3 per cent or less of fluoride ion except:
(a) barium
silicofluoride when separately specified in this Schedule; or
(b) in
preparations containing 15 mg/kg or less of fluoride ion.
SINBIOALLETHRIN in preparations
containing 10 per cent or less of sinbioallethrin except in preparations
containing 1 per cent or less of sinbioallethrin.
SODIUM CHLORATE except in
preparations containing 10 per cent or less of sodium chlorate.
SODIUM DIACETATE except in
preparations containing 60 per cent or less of sodium diacetate.
SODIUM
DODECYLBENZENE SULFONATE except in preparations containing 30 per cent or less of
sodium dodecylbenzene sulfonate.
SODIUM HYDROGEN SULFATE except
in preparations containing 10 per cent or less of sodium hydrogen sulfate.
SODIUM HYDROSULFITE when packed
for domestic use except in preparations containing 10 per cent or less
of sodium hydrosulfite.
† SODIUM HYDROXIDE (excluding its
salts and derivatives) in preparations containing 5 per cent or less of sodium
hydroxide being:
(a) solid
preparations, the pH of which in a 10 g/L aqueous solution is more than 11.5;
or
(b) liquid or
semi-solid preparations, the pH of which is more than 11.5 except in
food additive preparations for domestic use.
SODIUM LAURETH-6 CARBOXYLATE except
in preparations containing 1 per cent or less of sodium laureth-6 carboxylate.
SODIUM METABISULPHITE when packed
for domestic use except in preparations containing 10 per cent or
less of sodium metabisulphite.
SODIUM NITRITE in preparations
containing 1 per cent or less of sodium nitrite except:
(a) in
preparations containing 0.5 per cent or less of sodium nitrite;
(b) when
present as an excipient in preparations for therapeutic use; or
(c) in
aerosols.
SODIUM PERCARBONATE (CAS No.
15630-89-4) in preparations containing 35 per cent or less of sodium
percarbonate except in preparations containing 15 per cent or less of
sodium percarbonate.
SODIUM POLYSTYRENE SULPHONATE in
preparations for cosmetic use except in preparations containing 10 per
cent or less of sodium polystyrene sulphonate.
SODIUM STANNATE except in
preparations for cosmetic use containing 1 per cent or less of sodium stannate.
SODIUM SULFIDE in preparations
for metal treatment in containers each containing 50 g or less of sodium
sulfide.
SPINETORAM.
SPINOSAD except in aqueous
suspensions containing 25 per cent or less of spinosad.
STAR ANISE OIL except:
(a) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 50 mL or less fitted with a restricted flow insert and
compliant with the requirements of the Required Advisory Statements for
Medicine Labels;
(b) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 50 mL or less fitted with a restricted
flow insert, and labelled with the warning:
KEEP OUT
OF REACH OF CHILDREN; or
(c) in
preparations containing 50 per cent or less of star anise oil.
STYRENE (excluding its
derivatives).
SULFACETAMIDE when packed and
labelled for the treatment of ornamental caged birds or ornamental fish only.
SULFADIAZINE when packed and
labelled for treatment of ornamental caged birds or ornamental fish only.
SULFADIMIDINE when packed and
labelled for treatment of ornamental caged birds or ornamental fish only.
SULFAMERAZINE when packed and
labelled for treatment of ornamental caged birds or ornamental fish only.
SULFAMIC ACID (excluding its
salts and derivatives) in preparations containing 10 per cent or less of
sulfamic acid (H3NO3S).
SULFATHIAZOLE when packed and
labelled for treatment of ornamental caged birds or ornamental fish only.
SULFOMETURON-METHYL.
SULFOXAFLOR in preparations containing 25 per
cent or less of sulfoxaflor.
† SYMPHYTUM spp. (Comfrey) for
dermal use.
2,3,6-TBA.
TDE
(1,1-dichloro-2,2-bis[4-chlorophenyl]ethane) in preparations containing 10 per
cent or less of TDE.
TEBUCONAZOLE.
TEBUFENOZIDE.
TEFLUTHRIN in preparations
containing 2 per cent or less of tefluthrin.
TEMEPHOS:
(a) in liquid
preparations containing 10 per cent or less of temephos;
(b) in powders
containing 2 per cent or less of temephos; or
(c) in
preparations containing 40 per cent or less of temephos when packed in single
use containers having a capacity of 2 mL or less.
TEPRALOXYDIM.
TERBUTRYN.
1,3,5,7-TETRAAZATRICYLO[3.3.1.13,7]
DECANE in cosmetic preparations, except in preparations containing 0.15
per cent or less of 1, 3, 5, 7-tetraazatricyclo [3.3.1.13,7] decane.
TETRACHLOROETHYLENE in
preparations containing 5 per cent or less of tetrachloroethylene except:
(a) when
included in Schedule 2;
(b) in
preparations for the treatment of animals; or
(c) when absorbed
into an inert solid.
TETRACHLORVINPHOS except
in animal feeds containing 0.2 per cent or less of tetrachlorvinphos.
TETRACONAZOLE in preparations
containing 20 per cent or less of tetraconazole.
TETRACYCLINE in preparations:
(a) for
topical application to animals for ocular use only; or
(b) containing
40 per cent or less of tetracycline when packed and labelled for the treatment
of ornamental caged birds or ornamental fish only.
TETRAMETHRIN [(R, cis): (R,
trans) = 20:80] except in pressurised spray packs.
THIABENDAZOLE:
(a) for the
treatment of animals; or
(b) when
packed and labelled for use as a fungicide except in preparations
containing 50 per cent or less of thiabendazole.
THIAMETHOXAM in preparations
containing 60 per cent or less of thiamethoxam.
THIAZOPYR.
THIFENSULFURON.
THIOBENCARB.
THIODICARB in pelleted
preparations containing 1.5 per cent or less of thiodicarb.
THIOPHANATE-METHYL in
preparations containing 25 per cent or less of thiophanate-methyl.
THYME OIL except:
(a) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 25 mL or less fitted with a restricted flow insert and
compliant with the requirements of the Required Advisory Statements for
Medicine Labels;
(b) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 25 mL or less fitted with a restricted
flow insert, and labelled with the warning:
KEEP OUT
OF REACH OF CHILDREN; or
(c) in preparations
containing 50 per cent or less of thyme oil.
TIOCARBAZIL.
TOLCLOFOS-METHYL.
TOLTRAZURIL.
TRALKOXYDIM.
TRENBOLONE in implant
preparations for growth promotion in animals.
TRIADIMEFON in wettable powders
containing 25 per cent or less of triadimefon.
TRIADIMENOL.
TRI-ALLATE.
TRIBENURON-METHYL.
TRICHLOROACETIC ACID, alkali
salts of.
† 1,1,1-TRICHLOROETHANE except:
(a) in
preparations packed in pressurised spray packs;
(b) in
preparations containing 25 per cent or less of designated solvents;
(c) in
preparations, other than writing correction fluids or thinners for writing
correction fluidsin containers having a capacity of 50 mL or less; or
(d) in writing
correction fluids or thinners for writing correction fluids, in containers
having a capacity of 50 mL or less labelled with:
(i) the
word “Trichloroethane” written in letters not less than 1 mm in height and in
distinct
contrast to the background; and
(ii) the
expression:
WARNING - DO NOT DELIBERATELY SNIFF THIS
PRODUCT. SNIFFING MIGHT HARM OR KILL YOU;
written
in bold face sans serif capital letters not less than 1 mm in height and in
distinct contrast to the background.
TRIDIPHANE.
TRIETAZINE.
TRIETHANOLAMINE (excluding its
salts and derivatives) except in preparations containing 5 per cent or
less of triethanolamine.
TRIFLOXYSTROBIN.
TRIFLUMIZOLE.
TRIFLUMURON.
TRIISOPROPANOLAMINE LAURYL ETHER
SULFATE except in preparations containing 30 per cent or less of
triisopropanolamine lauryl ether sulfate when labelled with the statements:
Avoid contact with
eyes and skin; and
Wash hands after
handling.
TRINEXAPAC-ETHYL except:
(a) when
packed in a sealed water-soluble measure pack; or
(b) in solid
preparations containing 25 per cent or less of trinexapac-ethyl in packs of 50
g or less.
3,6,9-TRIOXAUNDECANEDIOIC
ACID except in preparations containing 5 per cent or less of
3,6,9-trioxaundecanedioic
acid, the pH of which is 3.5 or greater.
TRITICONAZOLE.
TURPENTINE
OIL except in preparations containing 25 per cent or less of turpentine
oil.
VIRGINIAMYCIN in animal feed
additives containing 1 per cent or less of virginiamycin for the prevention of
laminitis in horses when in a pack of 5 kg or less.
VERNOLATE.
WARFARIN in rodent baits
containing 0.1 per cent or less of warfarin.
ZINEB.
(Substances marked †
are listed in Appendix C)
ABAMECTIN:
(a)
in preparations for pesticidal use
containing 4 per cent or less of abamectin except when included in
Schedule 5; or
(b)
in slow-release plastic
matrix ear tags for livestock use containing 1 g or less of abamectin.
ACEPHATE.
ACETAMIPRID except in
preparations containing 1 per cent or less of acetamiprid.
ACETIC ACID (excluding its salts
and derivatives) and preparations containing more than 80 per cent of acetic
acid (CH3COOH) except when included in Schedule 2.
ACETIC ANHYDRIDE excluding its
derivatives.
ACIFLUORFEN.
ACINITRAZOLE except in
preparations containing 20 per cent or less of acinitrazole.
ALBENDAZOLE for the treatment of
animals except:
(a) when
included in Schedule 5; or
(b) in
intraruminal implants each containing 3.85 g or less of albendazole.
ALDRIN.
† ALKALINE SALTS, being the
carbonate, silicate or phosphate salts of sodium or potassium alone or in any
combination for non-domestic use:
(a) in solid
automatic dishwashing preparations, the pH of which in a 500 g/L aqueous
solution or mixture is more than 12.5; or
(b) in liquid
or semi-solid automatic dishwashing preparations, the pH of which is more than
12.5.
ALKOXYLATED FATTY ALKYLAMINE
POLYMER except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 20 per cent or less of alkoxylated fatty alkylamine
polymer.
ALLETHRIN except:
(a) when
included in Schedule 5;
(b) in
insecticidal mats containing 20 per cent or less of allethrin; or
(c) in other
preparations containing 1 per cent or less of allethrin.
ALPHA-CYPERMETHRIN:
(a) in aqueous
preparations containing 25 per cent or less of alpha-cypermethrin; or
(b) in other
preparations containing 10 per cent or less of alpha-cypermethrin,
except when
included in Schedule 5.
AMICARBAZONE.
AMIDITHION.
AMINOCARB in preparations
containing 25 per cent or less of aminocarb.
AMINOETHOXYVINYLGLYCINE except
in preparations containing 15 per cent or less of aminoethoxyvinylglycine.
1-AMINOMETHANAMIDE DIHYDROGEN
TETRAOXOSULFATE.
AMINOPYRALID except
when included in Schedule 5.
AMITRAZ.
AMMONIA (excluding its salts and
derivatives other than ammonium hydroxide) except:
(a) when
included in Schedule 5;
(b) in
preparations for human internal therapeutic use;
(c) in
preparations for inhalation when absorbed in an inert solid material; or
(d) in
preparations containing 0.5 per cent or less of ammonia.
AMMONIUM PERSULFATE in hair
preparations.
ANILINE (excluding its salts and
derivatives) except in preparations containing 1 per cent or less of
aniline.
ANTIMONY COMPOUNDS except:
(a) when
included in Schedule 4;
(b) antimony
chloride in polishes;
(c) antimony
titanate pigments in paint; or
(d) in paints
or tinters containing 5 per cent or less of antimony calculated on the
non-volatile content of the paint or tinter.
ARSENIC:
(a) in ant
poisons containing 0.4 per cent or less of arsenic;
(b) in animal
feed premixes containing 4 per cent or less of arsenic; or
(c) in
preparations for the treatment of animals except thiacetarsamide when
included in Schedule 4,
except when separately
specified in this Schedule.
ASPIRIN for the treatment of
animals except when included in Schedule 4 or 5.
AZACONAZOLE except in
preparations containing 1 per cent or less of azaconazole.
† AZADIRACHTA INDICA (Neem)
including its extracts and derivatives except:
(a) when
included in Schedule 5;
(b) in
preparations for human internal use;
(c) debitterised
neem seed oil;
(d) in
preparations for human dermal therapeutic use containing cold pressed neem seed
oil, when in a container fitted with a child-resistant closure and compliant
with the requirements of the Required Advisory Statements for Medicine
Labels; or
(e) in preparations
for dermal use containing 1 per cent or less of cold pressed neem seed oil.
AZAMETHIPHOS.
AZOBENZENE.
BAMBERMYCIN (flavophospholipol)
in animal feed premixes for growth promotion containing 2 per cent or less of
antibiotic substances.
BARIUM SALTS except:
(a) when
included in Schedule 5;
(b) barium
sulfate; or
(c) in paints
or tinters containing 5 per cent or less of barium calculated on the
non-volatile content of the paint or tinter.
† BASIC ORANGE 31 (2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium
chloride) except:
(a) in
preparations for skin colouration and dyeing of eyelashes or eyebrows; or
(b) in hair
dye preparations containing 1 per cent or less of Basic Orange 31 when the
immediate container and primary pack are labelled with the following
statements:
KEEP OUT
OF REACH OF CHILDREN;
If in
eyes wash out immediately with water; and
WARNING - This product contains
ingredients which may cause skin irritation to certain individuals. A
preliminary test according to the accompanying directions should be made before
use. This product must not be used for dyeing eyelashes or eyebrows; to do so
may be injurious to the eye.
written
in letters not less than 1.5 mm in height.
BAY OIL except:
(a) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 15 mL or less fitted with a restricted flow insert and
compliant with the requirements of the Required Advisory Statements for
Medicine Labels;
(b) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 25 mL or less fitted with a restricted flow insert and a
child-resistant closure and compliant with the requirements of the Required
Advisory Statements for Medicine Labels;
(c) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 15 mL or less fitted with a restricted
flow insert and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN;
(d) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 25 mL or less fitted with a restricted
flow insert and a child-resistant closure and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN; or
(e) in
preparations containing 25 per cent or less of bay oil.
BEAUVERIA BASSIANA except
when included in Schedule 5.
BENDIOCARB:
(a) in
wettable powders containing 80 per cent or less of bendiocarb when packed in
containers or primary packs containing not less than 100 g of bendiocarb;
(b) in
wettable powders containing 20 per cent or less of bendiocarb and not less than
0.002 per cent of denatonium benzoate when packed in containers or primary
packs containing not less than 48 g of bendiocarb and labelled for use as a fly
control preparation;
(c) in
insoluble granular preparations containing 5 per cent or less of bendiocarb; or
(d) when
impregnated in plastic resin strip material containing 10 per cent or less of
bendiocarb,
except when included in
Schedule 5.
BENQUINOX.
BENSULIDE.
BENZALKONIUM CHLORIDE except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 5 per cent or less of benzalkonium chloride.
1,2-benzenediol.
6-BENZYLADENINE except in
preparations containing 2 per cent or less of 6-benzyladenine.
BERYLLIUM.
BETACYFLUTHRIN in preparations
containing 12.5 per cent or less of betacyfluthrin except when included
in Schedule 5.
BETA-CYPERMETHRIN.
BHC (excluding lindane).
BIFENTHRIN in preparations
containing 25 per cent or less of bifenthrin except in
preparations containing 0.5 per cent or less of bifenthrin.
BIFLUORIDES (including ammonium,
potassium and sodium salts) in preparations containing 3 per cent or less of
total bifluorides except when included in Schedule 5.
BIOALLETHRIN except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 1 per cent or less of bioallethrin.
N,N-BIS(PHENYLMETHYLENE)-BICYCLO-(2.2.1)HEPTANE-2,5-DIMETHANAMINE
except in preparations containing 1 per cent or less of
N,N-bis(phenylmethylene)-bicyclo- (2.2.1)heptane-2,5-dimethanamine,
or a combination of
N,N-bis(phenylmethylene)-bicyclo-(2.2.1)heptane-2,5-dimethanamine and
N,N-bis(phenylmethylene)-bicyclo-(2.2.1)heptane-2,6-dimethanamine,
when labelled with statements to the effect of:
IRRITANT;
REPEATED EXPOSURE
MAY CAUSE SENSITISATION;
Avoid contact with
eyes;
Avoid contact with
skin;
Wear protective
gloves when mixing or using; and
Ensure adequate
ventilation when using.
N,N-BIS(PHENYLMETHYLENE)-BICYCLO-(2.2.1)HEPTANE-2,6-DIMETHANAMINE
except in preparations containing 1 per cent or less of
N,N-bis(phenylmethylene)-bicyclo-(2.2.1)heptane-2,6-dimethanamine,
or a combination of
N,N-bis(phenylmethylene)-bicyclo-(2.2.1)heptane-2,5-dimethanamine and
N,N-bis(phenylmethylene)-bicyclo-(2.2.1)heptane-2,6-dimethanamine,
when labelled with statements to the effect of:
IRRITANT;
REPEATED EXPOSURE
MAY CAUSE SENSITISATION;
Avoid contact with
eyes;
Avoid contact with
skin;
Wear protective
gloves when mixing or using; and
Ensure adequate ventilation
when using.
† BITHIONOL for treatment of
animals.
BORON TRIFLUORIDE in preparations
containing 1 per cent or less of boron trifluoride (BF3) except
when included in Schedule 5.
BRODIFACOUM in preparations
containing 0.25 per cent or less of brodifacoum.
BROMADIOLONE in preparations
containing 0.25 per cent or less of bromadiolone.
BROMETHALIN in rodent baits
containing 0.01 per cent or less of bromethalin.
BROMOFORM except when
included in Schedule 4.
BROMOPHOS.
BROMOPHOS-ETHYL.
BROMOXYNIL.
BROMUCONAZOLE except when
included in Schedule 5.
BROTIANIDE.
BUNAMIDINE.
BUTACARB.
BUTOXYCARBOXIM except when
included in Schedule 5.
2-BUTOXYETHANOL and its ACETATES except
in preparations containing 10 per cent or less of such substances.
2-BUTOXY-2’-THIOCYANODIETHYL
ETHER.
BUTYRIC ACID in preparations for
use as insect lures.
CACODYLIC ACID:
(a) in animal
feed premixes containing 4 per cent or less of arsenic; or
(b) in
herbicide or defoliant preparations containing 10 per cent or less of cacodylic
acid.
CADMIUM COMPOUNDS except:
(a) when
included in Schedule 4; or
(b) in paints
or tinters containing 0.1 per cent or less of cadmium calculated on the
non-volatile content of the paint or tinter.
CADUSAFOS in aqueous preparations
containing 20 per cent or less of microencapsulated cadusafos.
CAJUPUT OIL except:
(a) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 15 mL or less fitted with a restricted flow insert and
compliant with the requirements of the Required Advisory Statements for
Medicine Labels;
(b) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 25 mL or less fitted with a restricted flow insert and a
child-resistant closure and compliant with the requirements of the Required
Advisory Statements for Medicine Labels;
(c) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 15 mL or less fitted with a restricted
flow insert and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN;
(d) in
preparations other than medicines for human therapeutic use, when packed in containers
having a nominal capacity of 25 mL or less fitted with a restricted flow insert
and a child-resistant closure and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN;
(e) in
preparations containing 25 per cent or less of cajuput oil; or
(f) in oils
containing 25 per cent or less of cajuput oil.
CALCIFEROL in rodent baits
containing 0.1 per cent or less of calciferol.
CAMBENDAZOLE.
CAMPHOR except:
(a) when
included in Schedule 4 or 5;
(b) when
enclosed in an inhaler device which prevents ingestion of its contents;
(c) in solid
or semi-solid preparations containing 12.5 per cent or less of camphor;
(d) in liquid
preparations containing 2.5 per cent or less of camphor;
(e) in essential oils when the camphor is present as a
natural component of the oil:
(i) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 15 mL or less fitted with a restricted flow insert and compliant
with the requirements of the Required Advisory Statements for Medicine
Labels;
(ii) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 25 mL or less fitted with a restricted flow insert and a
child-resistant closure and compliant with the requirements of the Required
Advisory Statements for Medicine Labels;
(iii) in
essential oils other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 15 mL or less fitted with a restricted
flow insert and labelled with the warnings:
KEEP
OUT OF REACH OF CHILDREN; and
NOT
TO BE TAKEN; or
(iv) in
essential oils other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 25 mL or less fitted with a restricted
flow insert and a child-resistant closure and labelled with the warnings:
KEEP
OUT OF REACH OF CHILDREN; and
NOT
TO BE TAKEN; or
(f) in
rosemary oil, sage oil (Spanish), or lavandin oil as such.
CAPTAN.
CARBARYL except when
included in Schedule 4 or 5.
CARBON DISULFIDE.
† CARBAMIDE PEROXIDE except:
(a) when
included in Schedule 5; or
(b) in other
preparations containing 9 per cent or less of carbamide peroxide.
CASTOR OIL, MONOMALEATE
(excluding its salts and derivatives) in preparations for cosmetic use except
in wash-off preparations containing 1 per cent or less of castor oil,
monomaleate.
CHLORALOSE
(alpha-CHLORALOSE) when packed and labelled for use as a pesticide.
CHLORDANE.
CHLORFENAPYR in preparations containing 36 per cent or less of chlorfenapyr except
when included in Schedule 5.
CHLORFENETHOL.
CHLORHEXIDINE in preparations
containing 7 per cent or less of chlorhexidine except:
(a) when
included in Schedule 5;
(b) in
preparations containing 1 per cent or less of chlorhexidine; or
(c) when in
solid preparations.
CHLORINATING COMPOUNDS except:
(a) when
included in Schedule 5;
(b) when
separately specified in these Schedules;
(c) sodium
hypochlorite preparations with a pH of less than 11.5;
(d) in liquid
preparations containing not less than 2 per cent but not more than 4 per cent
of available chlorine when labelled with the statements:
WARNING – Ensure adequate
ventilation when using. Vapour may be harmful. May give off dangerous gas if
mixed with other products;
(e) in liquid
preparations containing less than 2 per cent of available chlorine; or
(f) in other
preparations containing 4 per cent or less of available chlorine.
CHLORMEQUAT.
CHLOROFORM except:
(a) when
included in Schedule 2 or 4; or
(b) in
preparations containing 10 per cent or less of chloroform.
ALPHA-CHLOROHYDRIN.
CHLOROPHACINONE.
(E)-(S)-1-(4-CHLOROPHENYL)-4,4-DIMETHYL-2-(1H-1,2,4-TRIAZOL-1-YL)PENT-1-EN-3-OL
(uniconazole-p) except
in preparations containing 5 per cent or less of
(E)-(S)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pent-1-en-3-ol.
CHLOROPICRIN in preparations
containing 5 per cent or less of chloropicrin.
CHLOROTHALONIL except in
water-based paint containing 0.5 per cent or less of chlorothalonil.
2-CHLORO-6-(TRICHLOROMETHYL)-PYRIDINE.
CHLORPYRIFOS except:
(a) when
included in Schedule 5; or
(b) in
prepared potting or soil mixes containing 100 g or less of chlorpyrifos per
cubic metre.
CHLORPYRIFOS-METHYL.
CHLORTHIAMID.
CHROMATES (including dichromates) except
in paints or tinters containing 5 per cent or less of chromium as the ammonium,
barium, calcium, iron, potassium, sodium, strontium or zinc chromate calculated
on the non-volatile content of the paint or tinter.
CHROMIUM TRIOXIDE (excluding its
salts and derivatives).
CINEOLE except:
(a) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 15 mL or less fitted with a restricted flow insert and
compliant with the requirements of the Required Advisory Statements for
Medicine Labels;
(b) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 25 mL or less fitted with a restricted flow insert and a
child-resistant closure and compliant with the requirements of the Required
Advisory Statements for Medicine Labels;
(c) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 15 mL or less fitted with a restricted
flow insert and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN;
(d) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 25 mL or less fitted with a restricted
flow insert and a child-resistant closure and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN;
(e) in
preparations containing 25 per cent or less of cineole;
(f) in oils
containing 25 per cent or less of cineole; or
(g) in
rosemary oil or camphor oil (white).
CINNAMON LEAF OIL except:
(a) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 15 mL or less fitted with a restricted flow insert and
compliant with the requirements of the Required Advisory Statements for
Medicine Labels;
(b) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 25 mL or less fitted with a restricted flow insert and a
child-resistant closure and compliant with the requirements of the Required
Advisory Statements for Medicine Labels;
(c) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 15 mL or less fitted with a restricted
flow insert and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN;
(d) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 25 mL or less fitted with a restricted
flow insert and a child-resistant closure and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN; or
(e) in
preparations containing 25 per cent or less of cinnamon leaf oil.
CLIMBAZOLE except:
(a) when
included in Schedule 5; or
(b) in preparations
containing 2 per cent or less of climbazole.
CLODINAFOP-PROPARGYL.
CLOMAZONE.
CLOSANTEL.
CLOTHIANIDIN except when
included in Schedule 5.
CLOTRIMAZOLE for external
treatment of animals.
CLOVE OIL except:
(a) when
included in Schedule 5;
(b) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 15 mL or less fitted with a restricted flow insert and
compliant with the requirements of the Required Advisory Statements for
Medicine Labels;
(c) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 25 mL or less fitted with a restricted flow insert and a
child-resistant closure and compliant with the requirements of the Required
Advisory Statements for Medicine Labels;
(d) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 15 mL or less fitted with a restricted
flow insert and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN;
(e) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 25 mL or less fitted with a restricted
flow insert and a child-resistant closure and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN; or
(f) in
preparations containing 25 per cent or less of clove oil.
N-COCO-1,3-DIAMINOPROPANE.
COPPER ACETATE except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 5 per cent or less of copper acetate.
COPPER COMPOUNDS except:
(a) when
separately specified in these Schedules;
(b) in
preparations for human internal use containing 5 mg or less of copper per
recommended daily dose;
(c) pigments
where the solubility of the copper compound(s) in water is 1 gram per litre or
less;
(d) in feed
additives containing 1 per cent or less of copper; or
(e) in other
preparations containing 5 per cent or less of copper compounds.
COPPER HYDROXIDE except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 12.5 per cent or less of copper hydroxide.
COPPER NITRATE in preparations
containing copper chloride for the treatment of footrot in sheep.
COPPER OXIDES except:
(a) when
included in Schedule 5;
(b) in
preparations for internal use;
(c) in marine
paints; or
(d) in other
preparations containing 5 per cent or less of copper oxides.
COPPER OXYCHLORIDE except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 12.5 per cent of less of copper oxychloride.
COPPER SULFATE except:
(a) when
included in Schedule 5;
(b) in
preparations for internal use; or
(c) in other
preparations containing 5 per cent or less of copper sulfate.
COUMAPHOS:
(a) in
slow-release plastic matrix ear tags for livestock use containing 6 g or less
of coumaphos; or
(b) in other
preparations containing 5 per cent or less of coumaphos.
COUMATETRALYL in rodenticides
containing 1 per cent or less of coumatetralyl except when included in
Schedule 5.
CREOSOTE derived from wood other
than beechwood except:
(a) when
included in Schedule 2;
(b) in
preparations for human therapeutic use containing 10 per cent or less of
creosote derived from wood other than beechwood; or
(c) in other
preparations containing 3 per cent or less of phenols and homologues of phenol
boiling below 220°C.
CROTOXYPHOS.
CRUFOMATE.
CYANAMIDE.
CYANAZINE.
CYCLANILIDE.
N-cyclohexyldiazeniumdioxy-potassium.
CYFLUTHRIN except:
(a) when
included in Schedule 5; or
(b) in
pressurised spray packs containing 1 per cent or less of cyfluthrin.
CYOMETRINIL.
CYPERMETHRIN except when
included in Schedule 5.
CYPHENOTHRIN except when
included in Schedule 5.
CYSTEAMINE for cosmetic use except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 1 per cent or less of cysteamine.
CYTHIOATE except when
included in Schedule 5.
2,4-D except when included
in Schedule 5.
DAZOMET.
DELTAMETHRIN:
(a)
in aqueous preparations containing
25 per cent or less of deltamethrin, when no organic solvent, other than 10 per
cent or less of a glycol, is present;
(b)
in wettable granular preparations
containing 25 per cent or less of deltamethrin;
(c)
in water-dispersible tablets each
containing 500 mg or less of deltamethrin;
(d)
in emulsifiable concentrates
containing 11 per cent or less of deltamethrin in a solvent containing 40 per
cent or less of acetophenone and 45 per cent or less of liquid hydrocarbons; or
(e)
in other preparations containing 3
per cent or less of deltamethrin,
except:
(a)
when included in Schedule 5;
(b)
in factory prepared mosquito nets containing 1 per cent or less of
deltamethrin; or
(c)
in preparations containing 0.1 per
cent or less of deltamethrin.
DERQUANTEL.
DIAZINON except when
included in Schedule 5.
DICAMBA (including its salts and
derivatives) except when included in Schedule 5.
DICHLOBENIL.
DICHLOFENTHION.
DICHLOFLUANID.
ortho-DICHLOROBENZENE.
DICHLOROETHYL ETHER.
DICHLOROISOCYANURIC ACID except:
(a) when
included in Schedule 5;
(b) in liquid
preparations containing not less than 2 per cent but not more than 4 per cent
of available chlorine when labelled with the statements:
WARNING – Ensure adequate
ventilation when using. Vapour may be harmful. May give off dangerous gas if
mixed with other products;
(c) in liquid
preparations containing less than 2 per cent of available chlorine; or
(d) in other
preparations containing 4 per cent or less of available chlorine.
4,5-DICHLORO-2-N-OCTYL-3(2H)-ISOTHIAZOLONE.
DICHLOROPHEN except:
(a) when
included in Schedules 4 or 5; or
(b) in fabrics
other than when:
(i) for
human therapeutic use; or
(ii) as
part of a registered pesticidal product.
1,2-DICHLOROPROPANE.
2,4-DICHLORPROP (including the R
and S enantiomers).
DICHLORVOS in preparations
containing 50 per cent or less of dichlorvos except when included in
Schedule 5.
DICLOFOP-METHYL.
DICYCLANIL except in
preparations containing 5 per cent or less of dicyclanil.
DIDECYLDIMETHYLAMMONIUM SALTS except
in preparations containing 1 per cent or less of didecyldimethylammonium salts
labelled with the statement:
Avoid contact with
eyes.
DIELDRIN.
DIETHANOLAMINE (excluding its
salts and derivatives) except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 5 per cent or less of diethanolamine.
† DIETHYLENE GLYCOL (excluding its
salts and derivatives) except:
(a) when
included in Schedule 5;
(b) in paints
or paint tinters;
(c) in
toothpastes or mouthwashes containing more than 0.25 per cent of diethylene
glycol; or
(d) in other
preparations containing 2.5 per cent or less of diethylene glycol.
DIFENACOUM in preparations
containing 0.25 per cent or less of difenacoum.
DIFENZOQUAT.
DIFETHIALONE in rodent baits
containing 0.0025 per cent or less of difethialone.
† 5,6-DIHYDROXYINDOLINE.
DIMETHENAMID-P.
DIMETHIPIN.
DIMETHOATE.
DIMETHYLACETAMIDE except
when included in Schedule 5.
DIMETHYLFORMAMIDE except:
(a) when
included in Schedule 5; or
(b) in
silicone rubber mastic containing 2 per cent or less of dimethylformamide.
DIMETHYL SULFOXIDE (excluding
dimethyl sulfone):
(a) when not
for therapeutic use; or
(b) for the
treatment of animals:
(i) when
combined with no other therapeutic substance(s);
(ii) in
liquid preparations containing copper salicylate and 1 per cent or less of
methyl salicylate as the only other therapeutic substances; or
(iii) in
clay poultices containing 2 per cent or less of dimethyl sulfoxide.
DINITROCRESOLS and their
homologues in preparations containing 5 per cent or less of such compounds except:
(a) when
included in Schedule 4; or
(b) when separately
specified in this Schedule.
DINITROPHENOLS and their
homologues in preparations containing 5 per cent or less of such compounds except:
(a) when
included in Schedule 4; or
(b) when
separately specified in this Schedule.
DIOXACARB.
DIOXANE.
DIPHACINONE.
DIQUAT in preparations containing
20 per cent or less of diquat.
DISULFIRAM except when
included in Schedule 4.
DISULFOTON in granular
preparations containing 5 per cent or less of disulfoton.
DITHIANON.
DITHIAZANINE in preparations containing
2 per cent or less of dithiazanine for the treatment of animals.
DIUREDOSAN.
N-(N-DODECYL)-2-PYRROLIDONE except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 25 per cent or less of designated solvents.
DODINE.
DORAMECTIN for external use for
the treatment of animals, in preparations containing 2 per cent or less of
doramectin.
DSMA in herbicide or defoliant
preparations containing 10 per cent or less of DSMA.
ECONAZOLE for external treatment
of animals.
EMAMECTIN in preparations
containing 5 per cent or less of emamectin except when included in
Schedule 5.
EMODEPSIDE for the treatment of
animals except when included in Schedule 5.
ENDOSULFAN in aqueous
preparations containing 33 per cent or less of microencapsulated endosulfan.
ENDOTHAL in preparations
containing 20 per cent or less of endothal.
EPTC.
ESBIOTHRIN except:
(a) when
included in Schedule 5; or
(b) in
pressurised spray packs containing 1 per cent or less of esbiothrin.
ESFENVALERATE except when included in
Schedule 5.
ETHANOLAMINE (excluding its salts
and derivatives) except:
(a) when
included in Schedule 4 or 5; or
(b) in
preparations containing 5 per cent or less of ethanolamine.
ETHEPHON (excluding its salts and
derivatives).
ETHER except:
(a) when
included in Schedule 2, 4 or 5; or
(b) in
preparations containing 10 per cent or less of ether.
ETHIOFENCARB.
ETHOATE-METHYL.
ETHOPROPHOS in granular
formulations containing 10 per cent or less of ethoprophos and 2 per cent of
linseed oil.
ETHYL BROMIDE.
Ethyl
formate
when packed and labelled for use as a fumigant.
ETHYLENE CHLOROHYDRIN.
ETHYLENE DICHLORIDE.
† ETHYLENE GLYCOL (excluding its
salts and derivatives) except:
(a) when
included in Schedule 5;
(b) in paints
or paint tinters;
(c) in
toothpastes or mouthwashes containing more than 0.25 per cent of ethylene
glycol; or
(d) in other
preparations containing 2.5 per cent or less of ethylene glycol.
ETHYLENE GLYCOL MONOALKYL ETHERS
and their ACETATES, except:
(a) when
separately specified in these Schedules; or
(b) in
preparations containing 10 per cent or less of such substances.
ETRIMFOS.
EUCALYPTUS OIL except:
(a) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 15 mL or less fitted with a restricted flow insert and
compliant with the requirements of the Required Advisory Statements for
Medicine Labels;
(b) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 25 mL or less fitted with a restricted flow insert and a
child-resistant closure and compliant with the requirements of the Required
Advisory Statements for Medicine Labels;
(c) in
preparations other than medicines for human therapeutic use, when packed in containers
having a nominal capacity of 15 mL or less fitted with a restricted flow insert
and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN;
(d) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 25 mL or less fitted with a restricted
flow insert and a child-resistant closure and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN; or
(e) in
preparations containing 25 per cent or less of eucalyptus oil.
EUGENOL except:
(a) when
included in Schedule 5;
(b) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 15 mL or less fitted with a restricted flow insert and
compliant with the requirements of the Required Advisory Statements for
Medicine Labels;
(c) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 25 mL or less fitted with a restricted flow insert and a
child-resistant closure and compliant with the requirements of the Required
Advisory Statements for Medicine Labels;
(d) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 15 mL or less fitted with a restricted
flow insert and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN;
(e) in
preparations other than medicines for human therapeutic use, when packed in containers
having a nominal capacity of 25 mL or less fitted with a restricted flow insert
and a child-resistant closure and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN; or
(f) in
preparations containing 25 per cent or less of eugenol.
FAMPHUR in preparations
containing 20 per cent or less of famphur.
FEBANTEL except:
(a) in divided
preparations containing 1000 mg or less of febantel per dosage unit; or
(b) in
undivided preparations containing 10 per cent or less of febantel.
FENAMIPHOS in granular
preparations containing 5 per cent or less of fenamiphos.
FENAZAFLOR.
FENBUTATIN OXIDE.
FENCHLORPHOS.
FENITROTHION.
FENOXACRIM in preparations for
the treatment of carpets during manufacture.
FENPYROXIMATE.
FENTHION in preparations
containing 60 per cent or less of fenthion except when included in
Schedule 5.
FENVALERATE.
FIPRONIL except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 0.05 per cent or less of fipronil.
FLOCOUMAFEN in preparations
containing 0.005 per cent or less of flocoumafen.
FLONICAMID.
FLUAZIFOP-BUTYL.
FLUAZIFOP-P-BUTYL.
FLUAZINAM.
FLUCOFURON in preparations for
the treatment of carpets during manufacture.
fluensulfone.
FLUMETHRIN except when
included in Schedule 5.
FLUMIOXAZIN when contained in
water soluble bags individually packed in sealed sachets.
FLUORIDES except:
(a) when
included in Schedule 5;
(b) in
preparations for human use; or
(c) in
preparations containing 15 mg/kg or less of fluoride ion.
FLUPROPANATE.
FLUQUINCONAZOLE.
FLUSILAZOL.
FLUTRIAFOL except in
fertilisers containing 0.5 per cent or less of flutriafol.
FLUVALINATE except when
included in Schedule 5.
† FORMALDEHYDE (excluding its
derivatives) in preparations containing 0.05 per cent or more of free
formaldehyde except:
(a) for human
therapeutic use;
(b) in oral
hygiene preparations;
(c) in nail
hardener cosmetic preparations containing 5 per cent or more of free
formaldehyde;
(d) in
nail hardener cosmetic preparations containing 0.2 per cent or less of free
formaldehyde when labelled with the statement:
PROTECT
CUTICLES WITH GREASE OR OIL;
(e) in all
other cosmetic preparations; or
(f) in
other preparations containing 0.2 per cent or less of free formaldehyde when
labelled with the warning statement:
CONTAINS
FORMALDEHYDE.
FORMOTHION.
FOSPIRATE except when
included in Schedule 5.
FUMAGILLIN.
FURFURAL except in preparations containing 0.1
per cent or less of furfural.
GLUTARALDEHYDE except:
(a) when
included in Schedule 2 or 5; or
(b) in
preparations containing 0.5 per cent or less of glutaraldehyde when labelled
with the statements:
IRRITANT;
and
Avoid
contact with eyes.
GLYCERYL THIOGLYCOLLATE in hair
waving preparations except when labelled with directions for use that
include the statement:
Wear protective
gloves when using. Keep out of eyes.
GLYCOLIC ACID (including its
salts and esters) in cosmetic products or when packed and labelled for use as
an agricultural chemical except:
(a) in
cosmetic preparations for salon use only, when labelled in accordance with Safe
Work Australia’s National Code of Practice for the Labelling of Workplace
Substances [NOHSC:2012(1994)];
(b) in preparations
containing 5 per cent or less of glycolic acid; or
(c) in
preparations containing 20 per cent or less of glycolic acid with a pH of 3.5
or greater.
GUANIDINE except:
(a) when
included in Schedule 4; or
(b) in
preparations containing 1 per cent or less of guanidine.
GUAZATINE.
HALOXON.
HALOXYFOP.
HEPTACHLOR.
HEXACHLOROPHANE in preparations
for the treatment of animals.
HEXAZINONE except when
included in Schedule 5.
HEXYLOXYETHANOL except
in preparations
containing 10 per cent or less of hexyloxyethanol.
HYDRAMETHYLNON except when
included in Schedule 5.
HYDRAZINE.
HYDROCHLORIC ACID (excluding its
salts and derivatives) except:
(a) when
included in Schedule 5;
(b) in
preparations for therapeutic use; or
(c) in
preparations containing 0.5 per cent or less of hydrochloric acid (HCl).
HYDROFLUORIC ACID (excluding its
salts and derivatives) and admixtures that generate hydrofluoric acid, in
preparations containing 1 per cent or less of hydrogen fluoride except
when included in Schedule 5.
† HYDROGEN PEROXIDE (excluding
its salts and derivatives) except:
(a) when
included in Schedule 5;
(b) in hair
dye preparations containing 6 per cent (20 volume) or less of hydrogen
peroxide; or
(c) in
other preparations containing 3 per cent (10 volume) or less of hydrogen
peroxide.
HYDROQUINONE except:
(a) when
included in Schedule 2 or 4; or
(b) in
preparations containing 10 per cent or less of hydroquinone.
HYDROSILICOFLUORIC ACID
(excluding its salts and derivatives) in preparations containing 1 per cent or
less of hydrosilicofluoric acid (H2SiF6) except
when included in Schedule 5.
IMIDACLOPRID except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 5 per cent or less of imidacloprid.
IMIDOCARB.
iminoctadine
trialbesilate.
IMIPROTHRIN except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 10 per cent or less of imiprothrin.
INDAZIFLAM.
INDOXACARB (includes the R and S
enantiomers) except when included in Schedule 5.
IODINE (excluding its salts,
derivatives and iodophors) except:
(a) when
included in Schedule 2; or
(b) in solid
or semi-solid preparations containing 2.5 per cent or less of available iodine.
IODOPHORS except in
preparations containing 1.5 per cent or less of available iodine.
3-IODO-2-PROPYNYL BUTYL CARBAMATE
(Iodocarb) except:
(a) when
included in Schedule 5;
(b) in aqueous preparations not for cosmetic use
containing 10 per cent or less of 3-iodo-2-propynyl butyl carbamate (Iodocarb);
or
(c) in cosmetic preparations (other than
aerosolised preparations) containing 0.1 per cent or less of 3-iodo-2-propynyl
butyl carbamate.
IOXYNIL.
IPCONAZOLE except when
included in Schedule 5.
IRON COMPOUNDS (excluding up to 1
per cent of iron oxides when present as an excipient) for the treatment of
animals except:
(a) when
included in Schedule 5;
(b) in liquid
or gel preparations containing 0.1 per cent or less of iron; or
(c) in animal
feeds or feed premixes.
ISOCONAZOLE for external
treatment of animals.
ISOCYANATES, free organic,
boiling below 300° C, except in:
(a) viscous
polyurethane adhesives; or
(b) viscous
polyurethane sealants;
containing not more
than 0.7 per cent of free organic isocyanates boiling below 300°C.
ISOEUGENOL except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 10 per cent or less of isoeugenol.
LAMBDA-CYHALOTHRIN:
(a)
in aqueous preparations containing
25 per cent or less of microencapsulated lambda-cyhalothrin; or
(b) in other preparations containing 1.6 per cent
or less of lambda-cyhalothrin
except
when included in Schedule 5
LASALOCID except in animal
feeds containing 100 mg/kg or less of antibiotic substances.
LAURETH CARBOXYLIC ACIDS
(excluding its salts and derivatives) except:
(a) in
leave-on preparations containing 1.5 per cent or less of laureth carboxylic
acids;
(b) in
wash-off preparations containing 30 per cent or less of laureth carboxylic
acids and, if containing more than 5 per cent of laureth carboxylic acids, when
labelled with a warning to the following effect:
IF IN
EYES WASH OUT IMMEDIATELY WITH WATER; or
(c) in other
preparations containing 30 per cent or less of laureth carboxylic acids and, if
containing more than 5 per cent of laureth carboxylic acids, when labelled with
warnings to the following effect:
IF IN EYES
WASH OUT IMMEDIATELY WITH WATER; and
IF
SKIN OR HAIR CONTACT OCCURS, REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN AND
HAIR WITH RUNNING WATER.
LAURYL ISOQUINOLINIUM BROMIDE.
† LEAD COMPOUNDS except:
(a) when included
in Schedule 4 or 5;
(b) in paints,
tinters, inks or ink additives;
(c) in preparations
for cosmetic use containing 100 mg/kg or less of lead;
(d) in pencil
cores, finger colours, showcard colours, pastels, crayons, poster
paints/colours or coloured chalks containing 100 mg/kg or less of lead; or
(e) in
ceramic glazes when labelled with the warning statement:
CAUTION - Harmful if swallowed. Do not use
on surfaces which contact food or drink.
written
in letters not less than 1.5 mm in height.
LEPTOSPERMUM SCOPARIUM OIL
(manuka oil) except:
(a) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 15 mL or less fitted with a restricted flow insert and
compliant with the requirements of the Required Advisory Statements for
Medicine Labels;
(b) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 25 mL or less fitted with a restricted flow insert and a
child-resistant closure and compliant with the requirements of the Required
Advisory Statements for Medicine Labels;
(c) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 15 mL or less fitted with a restricted
flow insert and labelled with the warnings:
KEEP OUT OF REACH OF CHILDREN; and
NOT TO BE TAKEN;
(d) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 25 mL or less fitted with a restricted
flow insert and a child-resistant closure and labelled with the warnings;
KEEP OUT OF REACH OF CHILDREN; and
NOT TO BE TAKEN; or
(e) in
preparations containing 25 per cent or less of Leptospermum scoparium
oil.
LEVAMISOLE for the treatment of
animals except:
(a) when
included in Schedule 4 or 5; or
(b) in preparations
for the treatment of ornamental birds or ornamental fish, in packs containing
10 mg or less of levamisole.
LINDANE except when
included in Schedule 2, 4 or 5.
MAFENIDE when packed and labelled
for the treatment of ornamental fish only.
MALATHION except:
(a) when
included in Schedule 5;
(b) for human
therapeutic use; or
(c) in dust
preparations containing 2 per cent or less of malathion.
MCPA except when included
in Schedule 5.
MEBENDAZOLE for the treatment of
animals except when included in Schedule 5.
MECOPROP except when
included in Schedule 5.
MECOPROP-P.
MEFLUIDIDE.
MELALEUCA OIL (tea tree oil) except:
(a) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 15 mL or less fitted with a restricted flow insert and
compliant with the requirements of the Required Advisory Statements for
Medicine Labels;
(b) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 25 mL or less fitted with a restricted flow insert and a
child-resistant closure and compliant with the requirements of the Required
Advisory Statements for Medicine Labels;
(c) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 15 mL or less fitted with a restricted
flow insert and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN;
(d) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 25 mL or less fitted with a restricted
flow insert and a child-resistant closure and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN; or
(e) in
preparations containing 25 per cent or less of melaleuca oil.
MELENGESTROL ACETATE when used as
an animal feed additive.
MENAZON.
2-MERCAPTOETHANOL in preparations
for use as insect lures.
MERCURIC OXIDE for the treatment
of animals, in preparations for ocular use.
MERCUROCHROME for the treatment
of animals, in preparations for topical use.
METACRESOLSULPHONIC ACID AND
FORMALDEHYDE CONDENSATION PRODUCT for the treatment of animals.
METALAXYL except when
included in Schedule 5.
METALDEHYDE except when
included in Schedule 5.
METHACRIFOS in preparations
containing 60 per cent or less of methacrifos.
METHAM.
METHANOL (excluding its
derivatives) except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 2 per cent or less of methanol.
METHIOCARB in preparations
containing 20 per cent or less of methiocarb except when included in
Schedule 5.
METHOMYL in fly-baits containing 1 per
cent or less of methomyl and not less than 0.002 per cent of denatonium
benzoate as a bittering agent.
Methylcyclopentadienyl
Manganese Tricarbonyl in preparations containing 10 per cent or less of methylcyclopentadienyl
manganese tricarbonyl when fitted with a child-resistant closure.
† METHYLDIBROMO GLUTARONITRILE except
in preparations intended to be in contact with the skin, including cosmetic
use.
METHYLENE BISTHIOCYANATE except
in preparations containing 1 per cent or less of methylene bisthiocyanate.
METHYLEUGENOL except in
preparations containing 1 per cent or less of methyleugenol.
METHYL ETHYL KETONE OXIME except in
preparations containing 1 per cent or less of methyl ethyl ketone oxime.
METHYL ISOTHIOCYANATE.
† METHYL METHACRYLATE (excluding
its derivatives) except:
(a) for
cosmetic use; or
(b) in preparations
containing 1 per cent or less of methyl methacrylate as residual monomer in a
polymer.
METHYL NEODECANAMIDE except
in liquid preparations containing 2 per cent or less of methyl neodecanamide.
METHYLNORBORNYLPYRIDINE.
N-METHYL-2-PYRROLIDONE except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 25 per cent or less of designated solvents.
METHYL SALICYLATE except:
(a) when
included in Schedule 5;
(b) in
preparations for therapeutic use; or
(c) in
preparations containing 5 per cent or less of methyl salicylate.
METOFLUTHRIN.
METOSULAM.
METRAFENONE except when
included in Schedule 5.
METRIBUZIN.
MICONAZOLE for the external
treatment of animals.
MILBEMECTIN except when
included in Schedule 5.
MONENSIN:
(a) in animal
feed premixes containing 12.5 per cent or less of antibiotic substances; or
(b) in
stockfeed supplements, blocks or licks containing 0.75 per cent or less of
antibiotic substances.
MORANTEL except:
(a) when included
in Schedule 5; or
(b) in
preparations containing 10 per cent or less of morantel.
MOXIDECTIN for external use:
(a) in
preparations containing 2.5 per cent or less of moxidectin when packed in
single dose tubes for the treatment of cats and dogs; or
(b) in
preparations containing 2 per cent or less of moxidectin for the treatment of
animals,
except when included in
Schedule 5.
MSMA in herbicide or defoliant
preparations containing 10 per cent or less of MSMA.
NALED except when included
in Schedule 5.
NAPHTHALENE (excluding its
derivatives) except in liquid hydrocarbons as an impurity.
NAPHTHALOPHOS in preparations
containing 80 per cent or less of naphthalophos.
NARASIN in animal feed premixes
containing 12 per cent or less of narasin.
NETOBIMIN for the treatment of
animals except when included in Schedule 5.
NICKEL SULFATE.
NICOTINE in preparations
containing 3 per cent or less of nicotine when labelled and packed for the
treatment of animals.
NIMIDANE in preparations
containing 25 per cent or less of nimidane.
NITENPYRAM except in
divided preparations containing 100 mg or less of nitenpyram.
NITRIC ACID (excluding its salts
and derivatives) except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 0.5 per cent or less of nitric acid (HNO3).
NITROBENZENE except:
(a) in solid
or semi-solid polishes;
(b) in soaps
containing 1 per cent or less of nitrobenzene; or
(c) in other
preparations containing 0.1 per cent or less of nitrobenzene.
NITROPHENOLS, ortho, meta and
para, except when separately specified in these Schedules.
NITROPRUSSIDES in preparations
containing 2.5 per cent or less of nitroprussides except when included
in Schedule 4.
NITROXYNIL.
NONOXINOL 9 except:
(a) when
included in Schedule 5;
(b) in
preparations containing 25 per cent or less of nonoxinol 9 when labelled with
the statements:
IRRITANT;
and
Avoid
contact with eyes;
(c) in
preparations containing 12.5 per cent or less of nonoxinol 9; or
(d) in
preparations for human use.
1-Octen-3-ol
except in preparations
containing 5 per cent or less of 1-octen-3-ol.
OCTHILINONE except in paints, jointing
compounds and sealants containing 1 per cent or less of octhilinone calculated
on the non-volatile content.
N-(N-OCTYL)-2-PYRROLIDONE except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 25 per cent or less of designated solvents.
OLAQUINDOX except in
preparations containing 10 per cent or less of olaquindox.
N-OLEYL-1,3-DIAMINOPROPANE.
OMETHOATE in preparations
containing 30 per cent or less of omethoate except when included in
Schedule 5.
OXADIAZON.
OXALIC ACID except its
derivatives and insoluble salts.
OXYCLOZANIDE.
PAECILOMYCES LILACINUS Strain 251.
† PARAFORMALDEHYDE (excluding its
derivatives) in preparations containing 0.05 per cent or more of free
formaldehyde except:
(a) for human
therapeutic use;
(b) in oral
hygiene preparations;
(c) in nail
hardener cosmetic preparations containing 5 per cent or more of free
formaldehyde;
(d) in
nail hardener cosmetic preparations containing 0.2 per cent or less of free
formaldehyde when labelled with the statement:
PROTECT
CUTICLES WITH GREASE OR OIL;
(e) in all
other cosmetic preparations; or
(f) in
other preparations containing 0.2 per cent or less of free formaldehyde when
labelled with the warning statement:
CONTAINS
FORMALDEHYDE.
PARATHION-METHYL in aqueous
preparations containing 45 per cent or less of microencapsulated
parathion-methyl.
PARBENDAZOLE.
PEBULATE.
PENNYROYAL OIL except:
(a) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 15 mL or less fitted with a restricted flow insert and a
child-resistant closure and compliant with the requirements of the Required
Advisory Statements for Medicine Labels;
(b) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 15 mL or less fitted with a restricted
flow insert and a child-resistant closure and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN; or
(c) in
preparations containing 4 per cent or less of d-pulegone.
PENTACHLOROPHENOL in preparations
containing 1.5 per cent or less of pentachlorophenol.
PERACETIC ACID except when
included in Schedule 5.
PERFLUIDONE.
PERMANGANATES except potassium
permanganate in aqueous solutions containing 1 per cent or less of potassium
permanganate.
PERMETHRIN except:
(a) when
included in Schedule 4 or 5;
(b) in
preparations for human therapeutic use containing 5 per cent or less of
permethrin; or
(c) in
preparations containing 2 per cent or less of permethrin.
2-PHENOXYETHANOL except:
(a) in
cosmetic preparations containing 1 per cent or less of 2-phenoxyethanol; or
(b) in other preparations containing 15 per
cent or less of 2-phenoxyethanol.
PHENOL, including cresols and
xylenols and any other homologue of phenol boiling below 220°C, except:
(a) when
separately specified in these Schedules;
(b) when
included in Schedule 5; or
(c) in
preparations containing 3 per cent or less of such substances.
PHENOTHIAZINE (excluding its
derivatives) except in preparations containing 10 per cent or less of
phenothiazine.
† PHENYLENEDIAMINES and alkylated
phenylenediamines not elsewhere specified in these Schedules:
(a) in
preparations packed and labelled for photographic purposes;
(b) in
preparations packed and labelled for testing water except tablets
containing 10 mg or less of diethyl-para-phenylenediamine or
dimethyl-para-phenylenediamine in opaque strip packaging provided the
directions for use include the statement, “Do not discard testing solutions
into the pool”;
(c) in hair
dye preparations except when the immediate container and primary pack
are labelled with the following statements:
KEEP OUT
OF REACH OF CHILDREN, and
WARNING - This product contains
ingredients which may cause skin irritation to certain individuals. A
preliminary test according to the accompanying directions should be made before
use. This product must not be used for dyeing eyelashes or eyebrows; to do so
may be injurious to the eye.
written
in letters not less than 1.5 mm in height; or
(d) in eyelash
and eyebrow tinting products when the immediate container and primary pack are
labelled with the following statement:
WARNING - This product contains
ingredients which may cause skin irritation to certain individuals, and when
used for eyelash and eyebrow tinting may cause injury to the eye. A preliminary
test according to the accompanying directions should be made before use.
written
in letters not less than 1.5 mm in height.
PHOSALONE.
PHOSMET.
PHOSPHORIC ACID (excluding its
salts and derivatives) except:
(a) when
included in Schedule 5;
(b) in
preparations containing 15 per cent or less of phosphoric acid (H3PO4);
(c) in solid
or semi-solid preparations; or
(d) in
professional dental kits.
PHOXIM.
ortho-PHTHALALDEHYDE except
when included in Schedule 5.
PINDONE.
PINE OILs
when packed and labelled as a herbicide except when included in Schedule
5.
PINOXADEN except when
included in Schedule 5.
PIPEROPHOS.
PIRIMICARB except when
included in Schedule 5.
PIRIMIPHOS-ETHYL.
PIRIMIPHOS-METHYL.
POLIXETONIUM SALTS except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 1 per cent or less of polixetonium salts.
POTASSIUM AZELOYL DIGLYCINATE except
in preparations for cosmetic use containing 1 per cent or less of potassium
azeloyl diglycinate.
POTASSIUM BROMATE except
in preparations containing 0.5 per cent or less of potassium bromate.
POTASSIUM CYANATE.
† POTASSIUM HYDROXIDE (excluding
its salts and derivatives) except:
(a) when
included in Schedule 5;
(b) in
preparations containing 5 per cent or less of potassium hydroxide being:
(i) solid
preparations, the pH of which in a 10 g/L aqueous solution is 11.5 or less; or
(ii) liquid
or semi-solid preparations, the pH of which is 11.5 or less; or
(c) in liquid
or semi-solid food additive preparations, the pH of which is more than 11.5,
for domestic use.
POTASSIUM NITRITE in preparations
containing 40 per cent or less of potassium nitrite except:
(a) when
included in Schedule 5;
(b) in
preparations containing 0.5 per cent or less of potassium nitrite;
(c) when
present as an excipient in preparations for therapeutic use; or
(d) in
aerosols containing 2 per cent or less of potassium nitrite.
POTASSIUM PEROXOMONOSULFATE
TRIPLE SALT except:
(a) when
included in Schedule 5;
(b) in solid
orthodontic device cleaning preparations, the pH of which as an “in-use”
aqueous solution is 2.5 or more, but not more than 11.5; or
(c) in
preparations containing 5 per cent or less of potassium peroxomonosulfate
triple salt being:
(i) solid
preparations, the pH of which in a 10 g/L aqueous solution is 2.5 or more; or
(ii) liquid or semi-solid preparations, the pH of which
is 2.5 or more.
POTASSIUM PERSULFATE in hair
preparations.
PRALLETHRIN (cis:trans=20:80) except:
(a) when
included in Schedule 5; or
(b) in
insecticidal mats containing 1 per cent or less of prallethrin.
PROCHLORAZ.
PROFENOFOS.
PROMACYL.
PROPACHLOR.
PROPARGITE.
PROPETAMPHOS.
PROPICONAZOLE except when
included in Schedule 5.
PROPINEB.
PROPIONIC ACID (excluding its
salts and derivatives) except:
(a) when
included in Schedule 5;
(b) in
preparations containing 30 per cent or less of propionic acid; or
(c) for
therapeutic use.
PROPOXUR except when
included in Schedule 5.
PROQUINAZID.
PROSULFOCARB.
PROSULFURON.
PROTHIOFOS.
d-PULEGONE except in
preparations containing 4 per cent or less of d- pulegone.
PYRACLOFOS.
PYRAZOPHOS.
PYRIDABEN except when
included in Schedule 5.
Pyridalyl.
PYRIDATE.
PYRIPROLE.
pyrithione
copper.
PYRITHIONE ZINC except:
(a) when
included in Schedule 2 or 5;
(b) for human
use in preparations for the treatment of the scalp containing 2 per cent or
less of pyrithione zinc when compliant with the requirements of the Required
Advisory Statements for Medicine Labels;
(c) in
semi-solid hair preparations for animal use;
(d) in
shampoos for animal use containing 2 per cent or less of pyrithione zinc when
labelled with the statements “Keep out of eyes” and “If in eyes rinse well with
water”;
(e) when
immobilised in solid preparations containing 0.5 per cent or less of pyrithione
zinc; or
(f) in
paints, jointing materials or sealants containing 0.1 per cent or less of
pyrithione zinc calculated on the non-volatile content.
PYROXASULFONE.
PYROXSULAM.
QUATERNARY AMMONIUM COMPOUNDS except:
(a) when
separately specified in these Schedules;
(b) when
included in Schedule 5;
(c) dialkyl
or dialkoyl quaternary ammonium compounds where the alkyl or alkoyl groups are
derived from tallow or hydrogenated tallow or similar chain length (C16/C18)
sources; or
(d) in preparations
containing 5 per cent or less of such quaternary ammonium compounds.
QUIZALOFOP ETHYL.
QUIZALOFOP-P-ETHYL except
when included in Schedule 5.
QUIZALOFOP-P-TEFURYL.
RESMETHRIN except when
included in Schedule 5.
ROTENONE except in solid
or semi-solid preparations containing 2 per cent or less of rotenone.
† SAFROLE except:
(a) for
internal use; or
(b) in other
preparations containing 1 per cent or less of safrole.
SAGE OIL (Dalmatian) except:
(a) in
medicines for human therapeutic use, when packed in containers having a nominal
capacity of 15 mL or less fitted with a restricted flow insert and a
child-resistant closure and compliant with the requirements of the Required
Advisory Statements for Medicine Labels;
(b) in
preparations other than medicines for human therapeutic use, when packed in
containers having a nominal capacity of 15 mL or less fitted with a restricted
flow insert and a child-resistant closure and labelled with the warnings:
KEEP OUT
OF REACH OF CHILDREN; and
NOT TO
BE TAKEN; or
(c) in
preparations containing 4 per cent or less of thujone.
SALINOMYCIN in animal
feed premixes containing 12 per cent or less of antibiotic substances.
SASSAFRAS OIL except:
(a) for
internal use; or
(b) in other
preparations containing 1 per cent or less of safrole.
SELENIUM:
(a) in
preparations containing 2.5 per cent or less of selenium when packed and
labelled:
(i) for
the blueing of gun barrels;
(ii) for
photographic purposes; or
(iii) for
the colouring of lead or lead alloys;
(b) in coated
granules containing 1 per cent or less of selenium for application to pasture except
in fertilisers containing 200 g/tonne or less of selenium; or
(c) for the
treatment of animals:
(i) in
a drench, injection, paste, stocklick, vaccine or horse feed supplement
containing 0.5 per cent or less of selenium;
(ii) in
animal feed premixes containing 2 per cent or less of selenium for the
preparation of feeds containing 1 g/tonne or less of selenium;
(iii) in
controlled release bolus preparations containing 25 mg or less of selenium with
a release rate not greater than 0.25 mg/day; or
(iv) as
barium selenate in preparations for injection containing 5 per cent or less of
selenium.
SEMDURAMICIN in animal feed
premixes for coccidiosis prevention containing 5 per cent or less of antibiotic
substances.
SILICOFLUORIDES except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 15 mg/kg or less of fluoride ion.
SILVER NITRATE except:
(a) when
included in or expressly excluded from Schedule 2; or
(b) in
preparations containing 1 per cent or less of silver.
SINBIOALLETHRIN except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 1 per cent or less of sinbioallethrin.
SODIUM ALUMINATE (excluding its
salts and derivatives) except:
(a) in solid
preparations, the pH of which in a 10 g/L aqueous solution is 11.5 or less; or
(b) in liquid
preparations, the pH of which is 11.5 or less.
SODIUM BROMATE except in
preparations containing 0.5 per cent or less of sodium bromate.
† SODIUM HYDROXIDE (excluding its
salts and derivatives) except:
(a) when
included in Schedule 5;
(b) in
preparations containing 5 per cent or less of sodium hydroxide being:
(i) solid
preparations, the pH of which in a 10 g/L aqueous solution is 11.5 or less; or
(ii) liquid
or semi-solid preparations, the pH of which is 11.5 or less; or
(c) liquid or
semi-solid food additive preparations, the pH of which is more than 11.5, for
domestic use.
SODIUM LAURYL SULFATE (excluding
its salts and derivatives) except:
(a) in
wash-off preparations containing 30 per cent or less of sodium lauryl sulfate
and, if containing more than 5 per cent of sodium lauryl sulfate, when labelled
with a warning to the following effect:
IF IN
EYES WASH OUT IMMEDIATELY WITH WATER;
(b) in
leave-on preparations containing 1.5 per cent or less of sodium lauryl sulfate;
(c) in
toothpaste and oral hygiene preparations containing 5 per cent or less of
sodium lauryl sulfate;
(d) in other
preparations for animal use containing 2 per cent or less of sodium lauryl
sulfate; or
(e) in other
preparations containing 30 per cent or less of sodium lauryl sulfate and, if
containing more than 5 per cent of sodium lauryl sulfate, when labelled with
warnings to the following effect:
IF IN EYES
WASH OUT IMMEDIATELY WITH WATER; and
IF
SKIN OR HAIR CONTACT OCCURS, REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN AND
HAIR WITH RUNNING WATER.
SODIUM
NITRITE in preparations containing 40 per cent or less of sodium nitrite except:
(a) when
included in Schedule 2 or 5;
(b) in
preparations containing 0.5 per cent or less of sodium nitrite;
(c) when
present as an excipient in preparations for therapeutic use; or
(d) in
aerosols containing 2 per cent or less of sodium nitrite.
SODIUM PERCARBONATE (CAS No.
15630-89-4) except:
(a) when
included in Schedule 5; or
(b) in
preparations containing 15 per cent or less of sodium percarbonate.
SODIUM PERSULFATE:
(a) in hair
preparations; or
(b) in
products for the treatment of water for swimming pools and spas.
SODIUM SULFIDE in preparations
for use as insect lures.
SPIROTETRAMAT.
SPIROXAMINE.
SULCOFURON in preparations for
the treatment of carpets during manufacture.
SULFAMIC ACID (excluding its
salts and derivatives) except when included in Schedule 5.
SULFLURAMID.
SULFOXAFLOR except when included in Schedule 5.
SULFURIC ACID (excluding its
salts and derivatives) except:
(a) in fire
extinguishers; or
(b) in
preparations containing 0.5 per cent or less of sulfuric acid (H2SO4).
SULFURYL FLUORIDE.
SULPROFOS.
2,4,5-T.
N-TALLOW ALKYL-1,3-PROPANEDIAMINE
DIACETATE and TALLOW ALKYLAMINE ACETATES.
TAR ACIDS distilling within the
range 230-290°C inclusive.
TCMTB
(2-[thiocyanomethylthio]benzothiazole).
TDE (1,1-dichloro-2,2-bis[4-chlorophenyl]ethane)
except when included in Schedule 5.
TEBUFENPYRAD.
TEBUTHIURON.
TEMEPHOS except when in
Schedule 5.
TERBUTHYLAZINE except in
preparations containing 5 per cent or less of terbuthylazine.
TERPENES, CHLORINATED.
TESTOSTERONE in implant
preparations for use in animals.
TETRACHLOROETHYLENE except:
(a) when
included in Schedule 2 or 5;
(b) in
preparations containing 6 per cent or less of tetrachloroethylene when absorbed
into an inert solid; or
(c) in preparations
for the treatment of animals.
TETRACONAZOLE except when
included in Schedule 5.
TETRADIFON.
2,2’,6,6’-TETRAISOPROPYL-DIPHENYL-CARBODIIMIDE
in amitraz formulations containing 2 per cent or less of
2,2’,6,6’-tetraisopropyl-diphenyl-carbodiimide.
TETRAMISOLE in preparations for
the treatment of animals.
THIACLOPRID.
THIAMETHOXAM except when
included in Schedule 5.
THIAZAFLURON.
THIODICARB except when
included in Schedule 5.
THIOMETON.
THIOPHANATE-METHYL except
when included in Schedule 5.
THIOUREA AND ALKYL THIOUREAS except:
(a) when
separately specified in these Schedules; or
(b) for
therapeutic use.
THIRAM except in paint
containing 0.5 per cent or less of thiram.
THUJONE except in
preparations containing 4 per cent or less of thujone.
THYMOL when packed and
labelled for the control of Varroa mites in bee hives.
TOLUENE (excluding its
derivatives) except in preparations containing 50 per cent or less of
toluene or toluene and xylene.
†TOLUENEDIAMINE not elsewhere
specified in these Schedules:
(a) in hair
dye preparations except when the immediate container and primary pack
are labelled with the following statements:
KEEP OUT
OF REACH OF CHILDREN, and
WARNING - This product contains ingredients
which may cause skin irritation to certain individuals. A preliminary test
according to the accompanying directions should be made before use. This
product must not be used for dyeing eyelashes or eyebrows; to do so may be
injurious to the eye.
written
in letters not less than 1.5 mm in height; or
(b) in eyelash
and eyebrow tinting products when the immediate container and primary pack are
labelled with the following statement:
WARNING - This product contains
ingredients which may cause skin irritation to certain individuals, and when
used for eyelash and eyebrow tinting may cause injury to the eye. A preliminary
test according to the accompanying directions should be made before use.
written
in letters not less than 1.5 mm in height.
TOLYLFLUANID.
TRANSFLUTHRIN except:
(a) in
preparations containing 1 per cent or less of transfluthrin; or
(b) in a
cartridge for vaporiser use containing 600 mg or less of transfluthrin per cartridge.
TRIADIMEFON except:
(a) when
included in Schedule 5; or
(b) in
fertilisers containing 5 g/kg or less of triadimefon.
TRICHLORFON except
metrifonate included in Schedule 4.
TRICHLOROACETIC ACID except:
(a) when
included in Schedule 4 or 5; or
(b) in human
dermal preparations containing 12.5 per cent or less of trichloroacetic acid
for the treatment of warts other than anogenital warts.
TRICHLOROETHYLENE except
when included in Schedule 4.
TRICHLOROPHENOL.
TRICLABENDAZOLE except in
preparations containing 20 per cent or less of triclabendazole.
TRICLOPYR.
TRICLOSAN in cosmetic
preparations for human use containing more than 0.3 per cent of triclosan.
TRIDEMORPH.
TRIETHYL PHOSPHATE.
TRIFLUOROMETHANESULFONIC ACID.
TRINITROPHENOL (excluding its
derivatives) except:
(a) in
preparations for human therapeutic use; or
(b) in
preparations containing 5 per cent or less of trinitrophenol.
TRISODIUM NITRILOTRIACETATE except
in preparations containing 20 per cent or less of trisodium nitrilotriacetate.
VAMIDOTHION.
WARFARIN except when
included in Schedule 4 or 5.
XYLENE (excluding its
derivatives) except in preparations containing 50 per cent or less of
xylene or xylene and toluene.
ZERANOL in ear implants for use
as a growth promotant in steer cattle.
ZETA-CYPERMETHRIN in preparations
containing 10 per cent or less of zeta-cypermethrin.
ZINC BORATE (excluding its
derivatives) for use as an agricultural chemical.
ZINC CHLORIDE except:
(a) when
included in Schedule 2; or
(b) in
preparations containing 5 per cent or less of zinc chloride.
ZINC para-PHENOLSULFONATE except
in preparations containing 5 per cent or less of zinc para-phenolsulfonate.
ZINC SULFATE except:
(a) when
included in or expressly excluded from Schedule 4; or
(b) in other
preparations containing 5 per cent or less of zinc sulfate.
ZIRAM in granular preparations.
ABAMECTIN except when
included in Schedule 5 or 6.
ACIBENZOLAR-S-METHYL.
ACRIFLAVINE for veterinary use except
when in Schedule 5.
ACROLEIN.
ACRYLONITRILE.
ALACHLOR.
ALDICARB.
ALDOXYCARB.
ALLYL ALCOHOL.
ALPHA-CYPERMETHRIN except
when included in Schedule 5 or 6.
AMINACRINE for veterinary use except
when included in Schedule 5.
AMINOCARB except when
included in Schedule 6.
4-AMINOPYRIDINE except
when included in Schedule 4.
AMITON.
ARPRINOCID.
ARSENIC except:
(a) when
separately specified in this Schedule;
(b) when
included in Schedule 4 or 6;
(c) as selenium
arsenide in photocopier drums;
(d) as
10,10’-oxydiphenoxarsine in silicone rubber mastic containing 120 mg/kg or less
of arsenic;
(e) as 10,10’-oxydiphenoxarsine
contained in polyvinyl chloride and polyurethane extruded and moulded articles
containing 160 mg/kg or less of arsenic other than when included in
articles:
(i) in contact
with food stuffs, animal feeds or potable water;
(ii) of
clothing and footwear in contact with the skin;
(iii) used
as infant wear; or
(iv) intended
for use as packaging materials;
(f) in animal feeds
containing 75 g/tonne or less of arsenic; or
(g) in paints
containing 0.1 per cent or less of arsenic calculated on the non-volatile
content of
the paint.
AZAFENIDIN.
AZINPHOS-ETHYL.
AZINPHOS-METHYL.
AZOCYCLOTIN.
BENDIOCARB except when
included in Schedule 5 or 6.
BENOMYL except in paints
containing 0.5 per cent or less of benomyl.
BENZENE (excluding its
derivatives) except:
(a) preparations
containing 15 mL/L or less of benzene; or
(b) petrol
containing 50 mL/L or less of benzene.
BENZIDINE-BASED AZO DYES
being:
2,2'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[N-(4-chlorophenyl)-3-oxobutanamide]
CAS
No. 94249-03-3
Acid Red 85 (Acid Fast Red A)
1,3-Naphthalenedisulfonic
acid,
7-hydroxy-8-[[4'-[[4-[[(4-methylphenyl)sulfonyl]oxy]phenyl]azo][1,1'-biphenyl]-4-yl]azo]-,
disodium salt
CAS
No. 3567-65-5
Direct Black 38
2,7-Naphthalenedisulfonic
acid,
4-amino-3-[[4'-[(2,4-diaminophenyl)azo][1,1'-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-,
disodium salt
CAS
No. 1937-37-7
Direct Blue 2
2,7-Naphthalenedisulfonic
acid, 5-amino-3-[[4'-[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl)azo][1,1'-biphenyl]-4-yl]azo]-4-hydroxy-,
trisodium salt
CAS
No. 2429-73-4
Direct Blue 6
2,7-Naphthalenedisulfonic
acid, 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxy-,
tetrasodium salt
CAS
No. 2602-46-2
Direct Brown 2
5-[[4'-[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl)azo][1,1'-biphenyl]-4-yl]azo]-2-hydroxy-
benzoic acid disodium salt
CAS
No. 2429-82-5
Direct Brown 95
Cuprate(2-),
[5-[[4'-[[2,6-dihydroxy-3-[(2-hydroxy-5-sulfophenyl)azo]phenyl]azo][1,1'-biphenyl]-4-yl]azo]-2-hydroxybenzoato(4-)]-,
disodium salt
CAS
No. 16071-86-6
Direct Green 1
2,7-Naphthalenedisulfonic
acid,
4-amino-5-hydroxy-3-[[4'-[(4-hydroxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-6-(phenylazo)-,
disodium salt
CAS
No. 3626-28-6
Direct Green 6
2,7-Naphthalenedisulfonic
acid,
4-amino-5-hydroxy-6-[[4'-[(4-hydroxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-3-[(4-nitrophenyl)azo]-,
disodium salt
CAS
No. 4335-09-5
Direct Red 28 (Congo Red)
1-Naphthalenesulfonic
acid, 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[4-amino-, disodium salt
CAS
No. 573-58-0
Direct Red 37
1,3-Naphthalenedisulfonic
acid, 8-[[4'-[(4-ethoxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-7-hydroxy-,
disodium salt
CAS
No. 3530-19-6
BETACYFLUTHRIN except when
included in Schedule 5 or 6.
BIFENTHRIN except:
(a) when
included in Schedule 6; or
(b) in
preparations containing 0.5 per cent or less of bifenthrin.
BIFLUORIDES (including ammonium,
potassium and sodium salts) except when included in Schedule 5 or 6.
BORON TRIFLUORIDE except
when included in Schedule 5 or 6.
BRODIFACOUM except when
included in Schedule 6.
BROMADIOLONE except when
included in Schedule 6.
BROMETHALIN except when
included in Schedule 6.
BROMINE (excluding its salts and
derivatives).
BRUCINE except in alcohol
containing 0.02 per cent or less of brucine as a denaturant.
CACODYLIC ACID except:
(a) when
included in Schedule 6; or
(b) in animal
feeds containing 75 g/tonne or less of arsenic.
CADUSAFOS except when
included in Schedule 6.
CALCIFEROL for use as a
rodenticide except when included in Schedule 6.
CAPTAFOL.
CARBADOX.
CARBENDAZIM except in
paints, jointing compounds and sealants containing 0.1 per cent or less of carbendazim.
CARBOFURAN.
CARBON TETRACHLORIDE except
in chlorinated rubber based paint containing 1 per cent or less of carbon
tetrachloride.
CARBONYL SULFIDE when packed and
labelled for use as a fumigant.
CARBOPHENOTHION.
CARBOSULFAN.
CHLORDECONE.
CHLORDIMEFORM.
CHLORFENAPYR except when
included in Schedule 5 or 6.
CHLORFENVINPHOS.
CHLORINE (excluding its salts and
derivatives).
CHLORHEXIDINE except:
(a) when
included in Schedule 5 or 6;
(b) in
preparations containing 1 per cent or less of chlorhexidine; or
(c) in solid
preparations.
CHLOROMETHIURON.
5-CHLORO-3-METHYL-4-NITROPYRAZOLE.
4-CHLORO-o-TOLUIDINE.
CHLOROPICRIN except when
included in Schedule 6.
CHLORTHIOPHOS.
COLECALCIFEROL for use as a
rodenticide.
COUMAPHOS except when
included in Schedule 6.
COUMATETRALYL except when
included in Schedule 5 or 6.
CREOSOTE derived from coal.
CREOSOTE derived from beechwood.
CYANIDES, metallic except:
(a) ferricyanides;
(b) ferrocyanides;
or
(c) when
separately specified in these Schedules.
CYANOGEN.
CYHALOTHRIN
(aRS,1R,cis,Z):(aRS,1S,cis,Z) = 50:50.
CYHEXATIN.
DELTAMETHRIN except:
(a)
when included in Schedules 5 or 6;
or
(b)
in factory prepared mosquito nets containing 1 per cent or less of
deltamethrin; or
(c)
in preparations containing 0.1 per
cent or less of deltamethrin.
DEMETON.
DEMETON-O-METHYL.
DEMETON-S-METHYL.
DIALIFOS.
4,4-DIAMINODIPHENYLMETHANE
(Methylene dianiline).
1,2-DIBROMO-3-CHLOROPROPANE.
1,3-DICHLOROPROPENE.
DICHLORVOS except when
included in Schedule 5 or 6.
DICROTOPHOS.
DIFENACOUM except when
included in Schedule 6.
DIFETHIALONE except when
included in Schedule 6.
DIMEFOX.
4-DIMETHYLAMINOAZOBENZENE
(N,N-dimethyl-4-[phenylazo]-benzenamine).
DIMETHYL SULFATE.
DIMETILAN.
DINITROCRESOLS except when
included in Schedule 4 or 6.
DINITROPHENOLS except when
included in Schedule 4 or 6.
DINOCAP.
DINOSEB.
DIQUAT except when
included in Schedule 6.
DISULFOTON except when
included in Schedule 6.
DORAMECTIN except when
included in Schedule 5 or 6.
DSMA except when included
in Schedule 6.
EMAMECTIN except when
included in Schedule 5 or 6.
ENDOSULFAN except when
included in Schedule 6.
ENDOTHAL except when
included in Schedule 6.
ENDRIN.
EPICHLOROHYDRIN.
EPIDERMAL GROWTH FACTOR except in preparations for human
therapeutic use.
EPRINOMECTIN except when
included in Schedule 5.
ETACONAZOLE.
ETHION.
ETHOPROPHOS except when
included in Schedule 6.
ETHYLENE DIBROMIDE.
ETHYLENE OXIDE.
FAMPHUR except when
included in Schedule 6.
FENAMIPHOS except when
included in Schedule 6.
FENOXACRIM except:
(a) when
included in Schedule 6; or
(b) in treated
carpets.
FENSULFOTHION.
FENTHION except when
included in Schedule 5 or 6.
FENTHION-ETHYL.
FLOCOUMAFEN except when
included in Schedule 6.
FLUCOFURON except:
(a) when
included in Schedule 6; or
(b) in treated
carpets.
FLUCYTHRINATE.
FLUMIOXAZIN except when included in
Schedule 6.
FLUOROACETAMIDE.
FLUOROACETIC ACID.
FOLPET.
FORMETANATE.
FURATHIOCARB except when
included in Schedule 5.
GAMMA-CYHALOTHRIN except
when included in Schedule 5.
HALOFUGINONE except when
included in Schedule 4.
HALOGENATED DIBENZODIOXINS AND
DIBENZOFURANS.
HCB.
HYDROCARBONS LIQUID AROMATIC
(including aromatic extract oils), any
fraction of which
boils above 350°C except:
(a) when in
solid polymers;
(b) when
containing 1 per cent or less of total polycyclic aromatic compounds as
measured by IP 346; or
(c) when
having a Mutagenicity Index of zero as measured by ASTM E1687-95.
HYDROCYANIC ACID except:
(a) when
included in Schedule 4; or
(b) its salts
and derivatives other than cyanides separately specified in this Schedule.
HYDROFLUORIC ACID (excluding its
salts and derivatives) except when included in Schedule 5 or 6.
HYDROGEN SULFIDE.
HYDROSILICOFLUORIC ACID
(excluding its salts and derivatives) except when included in Schedule 5
or 6.
IODOMETHANE.
ISOCARBOPHOS.
ISOFENPHOS.
ISOPROTURON.
IVERMECTIN except when
included in Schedule 4 or 5.
LAMBDA-CYHALOTHRIN except
when included in Schedule 5 or 6.
LEPTOPHOS.
LITHIUM PERFLUOROOCTANE SULFONATE
except in sealed bait stations containing 1 per cent or less of lithium
perfluorooctane sulfonate.
MADURAMICIN except:
(a) when
included in Schedule 5; or
(b) in animal
feeds containing 5 mg/kg or less of antibiotic substances.
MALACHITE GREEN for veterinary
use except when included in Schedule 5.
MAZIDOX.
MECARBAM.
MERCURIC CHLORIDE when prepared
for use for agricultural, industrial, pastoral or horticultural purposes.
MERCURY except:
(a) when
separately specified in this Schedule;
(b) when
included in Schedule 2, 4 or 6;
(c) in
preparations containing 0.01 per cent or less of mercury in organic form as a
preservative;
(d) mercury
(metallic) in scientific instruments;
(e) dental
amalgams; or
(f) in a
sealed device, for therapeutic use, which prevents access to the mercury.
METHACRIFOS except when
included in Schedule 6.
METHAMIDOPHOS.
METHAPYRILENE.
METHAZOLE.
METHIDATHION.
METHIOCARB except when
included in Schedule 5 or 6.
METHOMYL except when
included in Schedule 6.
METHOXYETHYLMERCURIC ACETATE.
METHOXYETHYLMERCURIC CHLORIDE.
METHYL BROMIDE.
Methylcyclopentadienyl
Manganese Tricarbonyl except:
(a) when
included in Schedule 6;
(b) when used
in laboratory analysis; or
(c) when
packed for industrial use in containers with a nominal capacity of 100 L or
more.
4,4’-METHYLENEBIS[2-CHLOROANILINE]
(MOCA).
METHYLENE BLUE for veterinary use
except when included in Schedules 4 or 5.
MEVINPHOS.
MIPAFOX.
MIREX.
MOLINATE.
MONOCROTOPHOS.
MOXIDECTIN except when
included in Schedule 4, 5 or 6.
MSMA except when included
in Schedule 6.
NAPHTHALOPHOS except when
included in Schedule 6.
NICOTINE except:
(a) when
included in Schedule 6;
(b) in
preparations for human therapeutic use; or
(c) in
tobacco prepared and packed for smoking.
NIMIDANE except when
included in Schedule 6.
NITROFEN.
NITROPRUSSIDES except when
included in Schedule 4 or 6.
2-NITROTOLUENE.
OMETHOATE except when
included in Schedule 5 or 6.
OXAMYL.
OXYDEMETON METHYL.
PARAQUAT.
PARATHION.
PARATHION-METHYL except
when included in Schedule 6.
PENTACHLOROPHENOL except
when included in Schedule 6.
PHENYLMERCURIC ACETATE except
in preparations containing 0.01 per cent or less of mercury as a preservative.
PHORATE.
PHOSFOLAN.
PHOSPHIDES, METALLIC.
PHOSPHINE.
PHOSPHORUS, YELLOW (excluding its
salts and derivatives).
POTASSIUM NITRITE except:
(a) when
included in Schedule 5 or 6;
(b) in
preparations containing 0.5 per cent or less of potassium nitrite;
(c) when
present as an excipient in preparations for therapeutic use; or
(d) in
aerosols containing 2 per cent or less of potassium nitrite.
PROCYMIDONE.
PROPYLENE OXIDE.
PYRINURON.
QUININE for veterinary use except
when included in Schedule 5.
SAFLUFENACIL except when included in
Schedule 5.
SCHRADAN.
SELENIUM except:
(a) when
included in Schedule 6;
(b) as selenium
arsenide in photocopier drums;
(c) in
preparations for therapeutic use other than:
(i) drench
concentrates containing 2.5 per cent or less of selenium; or
(ii) pour-on
preparations containing 0.5 per cent or less of selenium;
(d) in paints
or tinters containing 0.1 per cent or less of selenium calculated on the
non-volatile content of the paint or tinter; or
(e) in
fertilisers containing 200 g/tonne or less of selenium.
SEMDURAMICIN except:
(a) when
included in Schedule 6; or
(b) in animal
feeds containing 25 mg/kg or less of antibiotic substances.
SODIUM NITRITE except:
(a) when
included in Schedule 2, 5 or 6;
(b) in
preparations containing 0.5 per cent or less of sodium nitrite;
(c) when
present as an excipient in preparations for therapeutic use; or
(d) in
aerosols containing 2 per cent or less of sodium nitrite.
STRYCHNINE except when
included in Schedule 4.
SULCOFURON except:
(a) when
included in Schedule 6; or
(b) in treated
carpets.
SULFENTRAZONE.
SULFOTEP.
TEFLUTHRIN except when
included in Schedule 5.
TEPP.
TERBUFOS.
TETRACHLOROETHANE.
2,2’,6,6’-TETRAISOPROPYL-DIPHENYL-CARBODIIMIDE
except when included in Schedule 6.
THALLIUM.
THIOFANOX.
TIN ORGANIC COMPOUNDS, being
di-alkyl, tri-alkyl and tri-phenyl tin compounds where the alkyl group is
methyl, ethyl, propyl or butyl except:
(a) when
separately specified in this Schedule;
(b) in
plastics;
(c) in
semi-solid sealants, adhesives or elastomers containing 1 per cent or less of
the dialkyl, trialkyl or triphenyl tin component; or
(d) in paint
containing 1 per cent or less of such compounds calculated as tin in the
non-volatile content of the paint.
ortho-TOLIDINE except in
solid-state diagnostic therapeutic reagents.
TRIAMIPHOS.
TRIAZBUTIL.
TRIBUFOS (s,s,s-tributylphosphorotrithioate).
VINCLOZOLIN.
VINYL CHLORIDE.
ZETA-CYPERMETHRIN except
when included in Schedule 6.
ZIRAM except when included
in Schedule 6.
(Substances marked #
are listed in Appendix D.)
ACETYLDIHYDROCODEINE.
ACETYLMETHADOL.
ACETYLMORPHINES.
ALFENTANIL.
ALPHACETYLMETHADOL.
ALPHAPRODINE.
# ALPRAZOLAM.
AMPHETAMINE.
AMYLOBARBITONE except when
included in Schedule 4.
ANILERIDINE.
BENZYLMORPHINE.
BEZITRAMIDE.
BUPRENORPHINE.
BUTOBARBITONE.
BUTORPHANOL.
CARFENTANYL.
COCAINE.
CODEINE except when
included in Schedule 2, 3 or 4.
CODEINE-N-OXIDE.
CONCENTRATE OF POPPY STRAW (the
material arising when poppy straw has entered into a process for concentration
of its alkaloids).
4-CYANO-1-METHYL-4-PHENYLPIPERIDINE
(Pethidine intermediate A).
CYCLOBARBITONE.
DEXAMPHETAMINE.
DEXTROMORAMIDE.
DEXTROPROPOXYPHENE except
when included in Schedule 4.
DIFENOXIN except when
included in Schedule 4.
DIHYDROCODEINE except when
included in Schedule 2, 3 or 4.
DIHYDROMORPHINE.
DIPHENOXYLATE except when
included in Schedule 3 or 4.
DIPIPANONE.
# DRONABINOL (delta-9-tetrahydrocannabinol)
when prepared and packed for therapeutic use.
DROTEBANOL.
ETHYLAMPHETAMINE.
ETHYLMORPHINE except when
included in Schedule 2 or 4.
FENTANYL.
# FLUNITRAZEPAM.
HYDROCODONE.
HYDROMORPHINOL.
HYDROMORPHONE.
KETAMINE.
LEVAMPHETAMINE.
LEVOMETHAMPHETAMINE.
LEVOMORAMIDE.
LEVORPHANOL (excluding its
stereoisomers).
LISDEXAMFETAMINE.
METHADONE.
METHYLAMPHETAMINE.
METHYLDIHYDROMORPHINE.
METHYLPHENIDATE.
1-METHYL-4-PHENYLPIPERIDINE-4-CARBOXYLIC
ACID (Pethidine intermediate C).
MORPHINE.
MORPHINE METHOBROMIDE.
MORPHINE-N-OXIDE.
NABILONE.
# NABIXIMOLS (botanical extract
of Cannabis sativa which includes the following cannabinoids:
tetrahydrocannabinol, cannabidiol, cannabinol, cannabigerol, cannabichromene,
cannabidiolic acid, tetrahydrocannabinolic acid, tetrahydrocannabivarol, and
cannabidivarol, where tetrahydrocannabinol and cannabidiol (in approximately
equal proportions) comprise not less than 90 per cent of the total cannabinoid
content) in a buccal spray for human therapeutic use.
NORCODEINE.
NORMETHADONE.
OPIUM except the alkaloids
noscapine in Schedule 2 and papaverine when included in
Schedule 2 or 4.
OXYCODONE.
OXYMORPHONE.
PENTAZOCINE.
PENTOBARBITONE except when
included in Schedule 4.
PETHIDINE.
PHENDIMETRAZINE.
PHENMETRAZINE.
PHENOPERIDINE.
4-PHENYLPIPERIDINE-4-CARBOXYLIC
ACID ETHYL ESTER (Pethidine intermediate B).
PHOLCODINE except when
included in Schedule 2 or 4.
PIRITRAMIDE.
PROPIRAM.
QUINALBARBITONE.
RACEMORAMIDE.
REMIFENTANIL.
SECBUTOBARBITONE.
# SODIUM OXYBATE for human therapeutic use.
SUFENTANIL.
TAPENTADOL.
THEBACON.
THEBAINE.
TILIDINE.
(Trivial or unofficial
names are marked *)
ACETORPHINE.
ACETYL-ALPHA-METHYLFENTANYL.
ALKOXYAMPHETAMINES and
substituted alkoxyamphetamines except when separately specified in these
schedules.
ALKOXYPHENYLETHYLAMINES and
substituted alkoxyphenylethylamines except when separately specified in
these Schedules.
ALKYLTHIOAMPHETAMINES and
substituted alkylthioamphetamines except when separately specified in
these schedules.
ALLYLPRODINE.
ALPHAMEPRODINE.
ALPHA-METHYLFENTANYL.
ALPHA-METHYLTHIOFENTANYL.
ALPHAMETHADOL.
2-AMINO-1-(2,5-DIMETHOXY-4-METHYL)PHENYLPROPANE *(STP
or DOM).
5-(2-AMINOPROPYL)INDAN and
substituted 5-(2-aminopropyl)indans except when separately specified in
these schedules.
BENZETHIDINE.
BENZOYLINDOLES except when
separately specified in these Schedules.
BENZYLPIPERAZINE *(BZP).
BETACETYLMETHADOL.
BETA-HYDROXYFENTANYL.
BETA-HYDROXY-3-METHYLFENTANYL.
BETAMEPRODINE.
BETAMETHADOL.
BETAPRODINE.
1-(8-BROMOBENZO[1,2-B;4,5-B]DIFURAN-4-YL)-2-AMINOPROPANE *(Bromo-Dragonfly).
4-BROMO-2,5-DIMETHOXYPHENETHYLAMINE *(BDMPEA).
BUFOTENINE.
CANNABIS except:
(a) when
separately specified in these Schedules; or
(b) processed
hemp fibre containing 0.1 per cent or less of tetrahydrocannabinol and products
manufactured from such fibre.
CATHINONE.
CLONITAZENE.
COCA LEAF.
CODOXIME.
4-CYANO-2-DIMETHYLAMINO-4,4’-DIPHENYLBUTANE.
CYCLOHEXYLPHENOLS except
when separately specified in these Schedules.
DESOMORPHINE.
DIAMPROMIDE.
DIBENZOPYRANS except when
separately specified in these Schedules.
3,4-DICHLORO-N-{[1-
(DIMETHYLAMINO)CYCLOHEXYL]METHYL}BENZAMIDE *(AH-7921).
DIETHYLTHIAMBUTENE.
N,N-DIETHYLTRYPTAMINE *(DET).
DIMENOXADOL.
DIMEPHEPTANOL.
2,5-DIMETHOXYAMPHETAMINE *(DMA).
2,5-DIMETHOXY-4-BROMOAMPHETAMINE *(DOB).
2,5-DIMETHOXY-4-ETHYL-a-AMPHETAMINE *(DOET).
2,5-DIMETHOXY-4-ETHYLTHIOPHENETHYLAMINE *(2C-T-2).
2,5-DIMETHOXY-4-IODOPHENETHYLAMINE *(2C-I).
2,5-DIMETHOXY-4-(N)-PROPYLTHIOPHENETHYLAMINE *(2C-T-7).
3-(2-DIMETHYLAMINOETHYL)-4-HYDROXYINDOLE *(PSILOCINE
or PSILOTSIN).
3-(1,2-DIMETHYLHEPTYL)-1-HYDROXY-7,8,9,10-TETRAHYDRO-6,6,9-
TRIMETHYL-6H-DIBENZO (b,d) PYRAN *(DMHP).
N, α -DIMETHYL-3,4-(METHYLENEDIOXY)PHENYLETHYLAMINE *(MDMA).
N,N-DIMETHYLAMPHETAMINE
(Dimetamfetamine).
DIMETHYLTHIAMBUTENE.
N,N-DIMETHYLTRYPTAMINE *(DMT).
DIOXAPHETYL BUTYRATE.
ECGONINE.
N-ETHYL-α-METHYL-3,4-(METHYLENEDIOXY)PHENETHYLAMINE *(N-ETHYL
MDA).
ETHYLMETHYLTHIAMBUTENE.
ETICYCLIDINE *(PCE).
ETONITAZENE.
ETORPHINE.
ETOXERIDINE.
FENETYLLINE.
4-FLUORO-N-METHYLAMPHETAMINE.
1-(5-FLUOROPENTYL)-3-(2-IODOBENZOYL)INDOLE *(AM-694).
FURETHIDINE.
HARMALA ALKALOIDS except
in herbs, or preparations, for therapeutic use:
(a) containing
0.1 per cent or less of harmala alkaloids; or
(b) in divided
preparations containing 2 mg or less of harmala alkaloids per recommended daily
dose.
HEROIN.
3-HEXYL-1-HYDROXY-7,8,9,10-TETRAHYDRO-6,6,9-TRIMETHYL-6H-DIBENZO
(b,d) PYRAN *(PARAHEXYL).
4-HYDROYXBUTANOIC ACID and its salts except for sodium
oxybate when in Schedule 8. *(GAMMA HYDROXYBUTYRATE (GHB)).
2-[(1R,3S)-3-HYDROXYCYCLOHEXYL]-5-(2-METHYLNONAN-2-YL)PHENOL *(Cannabicyclohexanol
or CP 47,497 C8 homologue).
2-[(1R,3S)-3-HYDROXYCYCLOHEXYL]-5-(2-METHYLOCTAN-2-YL)PHENOL *(CP
47,497).
HYDROXYPETHIDINE.
ISOMETHADONE.
KETOBEMIDONE.
LEVOMETHORPHAN (excluding its
stereoisomers).
LEVOPHENACYLMORPHAN.
LYSERGIC ACID.
LYSERGIDE.
MECLOQUALONE.
METAZOCINE.
METHAQUALONE.
METHCATHINONE.
5-METHOXY- α -METHYLTRYPTAMINE *(5-MeO-AMT).
5-METHOXY-3,4-METHYLENEDIOXYAMPHETAMINE *(MMDA).
4-METHOXY- α -METHYLPHENYLETHYLAMINE *(PMA).
2-(2-METHOXYPHENYL)-1-(1-PENTYLINDOL-3-YL)ETHANONE *(JWH-250).
METHYL (2S, 4aR, 6aR,
7R, 9S, 10aS, 10bR)-9-ACETOXY-6a,10b-DIMETHYL-4,10-DIOXO-DODECAHYDRO-2-(3-FURYL)-2H-NAPHTHO[2,1-c]PYRAN-7-CARBOXYLATE *(SALVINORIN
A).
4-METHYLAMINOREX.
METHYLDESORPHINE.
3,4-METHYLENEDIOXYAMPHETAMINE *(MDA).
3,4-METHYLENEDIOXYPYROVALERONE *(MDPV).
3-METHYLFENTANYL.
4-METHYLMETHCATHINONE *(MEPHEDRONE).
N- α -[METHYL-3,4-(METHYLENEDIOXY)PHENETHYL]HYDROXYLAMINE *(N-HYDROXY
MDA).
N-METHYL-1-(3,4-METHYLENEDIOXYPHENYL)-2-BUTANAMINE *(MBDB).
2-METHYL-3-MORPHOLINO-1,
1-DIPHENYLPROPANE CARBOXYLIC ACID (Moramide intermediate).
1-METHYL-4-PHENYL-4-PIPERIDINOL
PROPIONATE *(MPPP).
4-METHYLTHIOAMPHETAMINE.
3-METHYLTHIOFENTANYL.
METOPON.
MITRAGYNA SPECIOSA.
MITRAGYNINE.
MORPHERIDINE.
(1-(2-MORPHOLIN-4-YLETHYL)INDOL-3-YL)-NAPTHALEN-1-YLMETHANONE *(JWH-200).
MUSCIMOL.
MYROPHINE.
NAPHTHOYLINDOLES except
when separately specified in these Schedules.
NAPHTHYLMETHYLINDOLES except
when separately specified in these Schedules.
NAPHTHOYLPYRROLES except
when separately specified in these Schedules.
NAPHTHYLMETHYLINDENES except
when separately specified in these Schedules.
NAPTHALEN-1-YL-(1-BUTYLINDOL-3-YL)METHANONE *(JWH-073).
NICOCODINE.
NICODICODINE.
NICOMORPHINE.
NORACYMETHADOL.
NORLEVORPHANOL.
NORMORPHINE.
NORPIPANONE.
PARA-FLUOROFENTANYL.
1-PENTYL-3-(4-METHYL-1-NAPTHOYL)INDOLE. *(JWH-122).
1-PENTYL-3-(1-NAPHTHOYL)INDOLE *(JWH-018).
PHENADOXONE.
PHENAMPROMIDE.
PHENAZOCINE.
PHENCYCLIDINE *(PCP).
N-PHENETHYL-4-PIPERIDONE.
PHENOMORPHAN.
PHENYLACETYLINDOLES except
when separately specified in these Schedules.
1-PHENYLETHYL-4-PHENYL-4-PIPERIDINOL
ACETATE *(PEPAP).
PIMINODINE.
PROHEPTAZINE.
PROPERIDINE.
PSILOCYBINE.
RACEMETHORPHAN.
RACEMORPHAN.
ROLICYCLIDINE *(PHP or
PCPY).
SALVIA DIVINORUM.
TENOCYCLIDINE *(TCP).
SYNTHETIC CANNABINOMIMETICS except
when separately specified in these Schedules.
TETRAHYDROCANNABINOLS and their
alkyl homologues except:
(a) when
separately specified in this Schedule;
(b) when
included in Schedule 8;
(c) in hemp
seed oil, containing 50 mg/kg or less of tetrahydrocannabinols when labelled
with a warning statement:
Not for
internal use; or
Not to
be taken; or
(d) in
products for purposes other than internal human use containing 50 mg/kg or less
of tetrahydrocannabinols.
THIOFENTANYL.
1-(3-TRIFLUOROMETHYLPHENYL)PIPERAZINE *(TFMPP).
TRIMEPERIDINE.
3,4,5-TRIMETHOXY- α -METHYLPHENYLETHYLAMINE *(TMA).
3,4,5-TRIMETHOXYPHENETHYLAMINE (mescaline)
and other substances structurally derived from methoxy-phenylethylamine except:
(a) methoxyphenamine;
or
(b) when
separately specified in this Schedule.
1-(3,4,5-TRIMETHOXYPHENYL)-2-AMINOBUTANE.
This Standard does not apply to a
poison in any of the following products:
ALGICIDES, BACTERIOCIDES OR
SLIMICIDES for industrial use that do not fit the definition of an agvet
chemical product.
BACTERIAL CULTURE MEDIA
containing antibiotics.
CERAMICS.
CHEMISTRY SETS for toy and
educational use, when complying
with the requirements of Australian Standard AS 8124.4-2003 Safety of
toys entitled Part 4: Experimental sets for chemistry and related
activities.
COPPER COMPOUNDS in paints.
DEXTRANS, GELATIN - SUCCINYLATED & ETHERIFIED
STARCHES used as plasma substitutes/blood volume expanders.
ELECTRICAL ACCUMULATORS,
BATTERIES, COMPONENTS or LAMPS.
ELECTRONIC COMPONENTS.
ENHANCING AGENTS for use in
ultrasonic and magnetic resonance imaging.
EXPLOSIVES.
FOOD except:
(a) food
additives before incorporation into food; or
(b) when used
as a means of administering a poison for therapeutic use.
FRITTED GLAZING OR ENAMELLING
PREPARATIONS in which the poison is confined as a non-migratory component of
glassy solid flakes or granules.
GLASS (including CRYSTAL WARE).
GLAZED POTTERY.
HUMAN BLOOD PRODUCTS including:
(a) whole
blood;
(b) blood
components including red cells, white cells, platelets and plasma (including
cryoprecipitate); and
(c) the following
plasma-derived therapeutic proteins; and their equivalent recombinant
alternatives:
(i) albumin;
(ii) anticoagulation
complex;
(iii) C1
esterase inhibitors;
(iv) clotting
factors;
(v) fibrinogen;
(vi) protein
C;
(vii) prothrombin
complex concentrate (PCC)
; and
(viii) thrombin.
IN VITRO DIAGNOSTIC AND
ANALYTICAL PREPARATIONS containing 0.001 per cent or less of a poison included
in Schedules 1 to 8.
INTRAOCULAR VISCOELASTIC
PRODUCTS.
LUBRICANTS except soluble
oils and solvent-deposited lubricating agents.
MATCHES.
MEDICAL AND VETERINARY ADHESIVES,
GLUES AND CEMENTS.
MEDICAL DEVICES classified as
Class III by the classification rules set out in Schedule 2 to the
Therapeutic Goods (Medical Devices) Regulation 2002, except:
(a) injectable
tissue reconstructive, augmentation and restoration materials, including
collagen;
(b) medical
devices which include anticoagulants;
(c) artificial
tears;
(d) urinary
catheters; or
(e) intra-articular
fluids.
MOTOR, HEATING or FURNACE FUELS
except:
(a) when the
contrary intention appears in any Schedule;
(b) when
containing methanol;
(c) toy or
hobby fuels; or
(d) petrol or
kerosene when packed in containers having a capacity of 20 litres or less.
NUTRITION REPLACEMENT
PREPARATIONS FOR PARENTERAL ADMINISTRATION.
PAPER except:
(a) when
prepared for pesticidal use; or
(b) when
containing a poison included in Schedule 8 or 9.
PHOTOGRAPHIC PAPER or FILM.
PIGMENTS when immobilised in a
polymer.
PORCELAIN.
PRINTING INKS or INK ADDITIVES except:
(a) when
containing a pesticide; or
(b) preparations
containing more than 0.1 per cent of lead calculated on the non-volatile
content of the ink or ink additive.
RADIOGRAPHIC CONTRAST MEDIA (radiopaques)
for therapeutic use.
RADIOISOTOPES for therapeutic
use.
SEEDS treated with seed
protectants.
SINGLE-USE TUBES for the
estimation of alcohol content of breath.
TERMITE BARRIERS consisting of an
active ingredient, other than arsenic, approved by the relevant registration
authority, and laminated between impervious sheeting.
TIMBER or WALLBOARD.
VITREOUS ENAMELS.
WRITING
CORRECTION PENS which do not allow ingestion of the contents and which contain
no scheduled poison other than designated solvents included in Schedule 5.
(This
Appendix should be read in conjunction with Appendix A.)
Substances for which the
available information suggests that inclusion in the Poisons Schedules is not
necessary, or not the most appropriate means of controlling the risk to public
health, have been considered at various times.
Listing in Appendix B indicates
that a decision has been taken not to list substances anywhere in the
Schedules, either for a specific purpose, or generally. It is an inclusive,
but not an exhaustive, list i.e. there may be substances not included in the
Schedules, and not included in Appendix B, which may be hazardous or
non-hazardous, but have not been considered in relation to the need for
scheduling.
Substances may be included in
Appendix B because they have intrinsically low toxicity, or where other factors
suggest that the potential public health risk would be minimal. Factors which
are considered when determining an Appendix B entry include:
• the
toxicology profile was adequately characterised and not consistent with
inclusion in any of the Schedules;
• the
use, purpose or product presentation minimised any hazard to the public such as
to not require scheduling; or
• the
public access was limited such that scheduling was inappropriate or
unnecessary.
The list was developed from
scheduling files and historical records. For transparency, where the reason
for entry and/or purpose or use for the substance was apparent in the
consideration, this has been included in the columns “Reason for Entry” and “Area
of Use”.
Inclusion in Appendix B will not
prevent reconsideration of the scheduling of a substance where adverse
information becomes available about the Appendix B entry for that substance.
Applications are considered for
scheduling. Applications for inclusion in Appendix B will not be accepted.
PART 1
REASONS FOR ENTRY
a Low Toxicity.
b Use
pattern restricts hazard.
c Presentation/packaging
restricts hazard.
d Industrial
use only.
PART
2
AREAS
OF USE
1. Agricultural
1.1 Herbicide
1.2 Insecticide
1.2.1 Insecticide
for codling moth
1.2.2 Termiticide
1.3 Fungicide
1.3.1 On
seed fungicide
1.4 Bird
Repellent
1.5 Fertiliser
1.6 Plant
Growth Regulator
1.7 Insect
Pheromone
1.8 Mushroom
Bactericide
1.9 Acaricide
1.10 Biological
control agent
2. Veterinary
2.1 For
animal use
2.2 Treatment
of mastitis in cows
2.3 Coccidiostat
2.4 Feed
additive
2.5 Antiseptic
2.6 Scabicide
2.7 Anthelmintic
2.8 Vitamin/Mineral
2.9 Growth
Promotant
2.10 Ectoparasiticide
3. Domestic
3.1 Aromatherapy
3.2 Food
additive
3.3 Cosmetic
3.4 Human
use
3.5 Miticide
4. Industrial
4.1 Water
treatment
4.2 Biological
control agent
5. Environmental
5.1 Mosquito
control
6. Human
therapeutic use
6.1 Diagnostic
agent
6.2 Medical
device
6.3 Antiseptic
6.4 Sunscreen
6.5 External
use
6.6 Laxative
6.7 Antiseborrheic
6.8 Cytoprotective
6.9 Vitamin/Mineral
6.10 Eye
Drops
7. General
7.1 Any
use
7.2 Excipient
7.3 Synergist
7.4 Flux
7.5 Pesticide
7.6 Insect
repellent
7.7 Solvent
7.8 Disinfectant
7.9 Preservative
7.10 Antioxidant
7.11 Resin
activator/accelerant
7.12 Sweetener
artificial
7.13 Food
additive
PART 3
SUBSTANCES CONSIDERED NOT TO REQUIRE CONTROL
BY SCHEDULING
_________________________________________________________________________________
REASON AREA
DATE
OF FOR OF
SUBSTANCE ENTRY LISTING USE
_________________________________________________________________________________
4-[4-(ACETYLOXY)PHENYL]-2-
BUTANONE Feb
2005 b 1.7
AGROBACTERIUM
RADIOBACTER Nov
1989 a 1
ALCOHOL, DEHYDRATED Aug
2000 b 6
ALUM May
1997 a 7.1
ALUMINIUM AMMONIUM SULFATE May
1997 a 7.1
ALUMINIUM POTASSIUM SULFATE May
1997 a 7.1
ALUMINIUM SILICATE Nov
1974 a 7.1
ALUMINIUM tris (ETHYLPHOSPHONATE) Aug
1986 a 1
AMETOCTRADIN May
2012 a 1.3
AMMONIUM PHOSPHATE Nov
1974 a 7.1
AMMONIUM THIOSULPHATE Nov
1974 a 7.1
AMPROLIUM Jun
1969 a 2.3
AMYL ACETATE Nov
1974 a 7.1
α -AMYLASE
derived from Aspergillus niger Feb 2005 a 2.4
ANDROSTENEDIONE ALBUMEN
CONJUGATE WITH DEA DEXTRAN
ADJUNCT Jun
2004 a 2.1
ASPARTIC ACID - a 6
ASULAM May
1986 a 1
AZIMSULFURON Jun
2003 a 1.1
BACILLUS SPHAERICUS STRAIN 2362 Feb
2003 a 5.1
BACILLUS THURINGIENSIS May
1992 a 5.1
(excluding endotoxin) Jun
2003 a 2.10
BACILLUS TOYOI Aug
1980 a 2.9
BACULOVIRUS CYDIA POMONELLA Jun
2006 a 1.2
BENFLURALIN - a 1.1
BENSULFURON-METHYL Aug
1987 a 1
BENTONITE Jun
2002 a 7.1
BENZYL BENZOATE Aug
1989 a 1.3.4
BETAINE HYDROCHLORIDE Nov
1974 a 7.1
BIFENAZATE Oct
2002 a 1.9
BISMUTH SUBNITRATE Nov
1999 b, c 2.1
BISTRIFLURON Feb
2014 a 1.2.2
BIURET Nov
1974 a 2.4
BOSCALID June
2003 a 1.3
BOVINE SOMATOTROPHIN May
1992 a 2
BROMACIL Aug
1987 a 1
BROMOPROPYLATE Nov
1994 a 1
BUPIRIMATE Nov
1990 a 1
BUTAFENACIL May
2000 a 1
BUTOXYPOLYPROPYLENE GYLCOL Nov
1974 a 7.7
n-BUTYL BUTYRATE - a 7.1
n-BUTYL LACTATE - a 7.1
CARBETAMIDE Aug
1991 a 1
CARBOXIN Aug
1987 a 1
CARFENTRAZONE-ETHYL Aug
1998 a 1
CELLULASE derived from
Aspergillus niger Feb
2005 a 2.4
CETYL ALCOHOL Nov
1974 a 7.1
CHAMOMILE OIL Feb
2000 a 3.1
CHINA CLAY Nov
1974 a 7.1
CHLORANTRANILIPROLE Sep
2008 a 1.2
CHLORFLUAZURON Oct
2005 a 1.2.2
CHLORFLURENOL Feb
1974 a 1.6
CHLORIDAZON May
1988 a 1
CHLOROXYLENOLS Feb
1975 a 7.8
CITRONELLA OIL Feb
2000 a 7.1
CLARY SAGE OIL Feb
2000 a 7.1
CLOPIDOL Nov
1974 d 2.3
COBALT NAPHTHENATE - d 7.1
COLOPHONY Feb
1997 b 7.4
CROSPOVIDONE Aug
1996 a 2
CULICINOMYCES CLAVOSPORUS Nov
1982 a 5.1
CYCLAMIC ACID Nov
1971 a 7.1
CYCLOHEXANE Nov
1974 a 7.7
CYCLOHEXANOL ACETATE - a 7.7
CYROMAZINE Nov
1980 a 2
DICLAZURIL Nov
2001 a 2.3
DIETHYL CARBONATE - a 7.1
DIFLUFENICAN Feb
1987 a 1
DIKEGULAC-SODIUM Mar
1980 a 1.6
DIMETHICONE a 7.1
DIMETHYL ETHER Nov
1988 d 4
DIPHENYLAMINE Feb
1988 a 1
DIPROPYLENE GLYCOL
MONOMETHYL ETHER Nov 1987 a 4
DIURON Nov
1987 a 1
DOCUSATE SODIUM
(DIOCTYL SODIUM SULFOSUCCINATE) Feb 1970 a 7.1
2,2-DPA Nov
1989 a 1
drometrizole trisiloxane Oct
2003 a 6.4
EPSIPRANTEL Nov
1991 a 2
ETHAMETSULFURON-METHYL Nov
2000 a 1.1
ETHOPABATE Jun
1969 d 2.3
ETHYL ACETATE Nov
1974 a 7.1
ETHYL ALCOHOL Nov
1974 a 7.1
ETHYLBUTYLACETYL-
AMINOPROPRIONATE Aug
2000 a 3.4
ETHYL BUTYRATE - a 7.1
ETHYL LACTATE - a 7.1
ETOXAZOLE Oct
2003 a 1.2
EUBACTERIUM
sp. strain DSM11798 Sep
2013 a 2.4
FENFURAM May
1977 a 1.3.1
FENHEXAMID Feb
1999 a 1
FENOXYCARB Feb
1988 a 1
FLUFENOXURON Feb
1997 a 1
FLUMETSULAM Feb
1992 a 1
FLUOMETURON Aug
1989 a 1
FLUTOLANIL Nov
2001 a 1.3
FLUROXYPYR May
1986 a, c 1
FORCHLORFENURON Feb
2005 a 1.6
FULLERS EARTH Nov
1974 a 7.1
FUNGAL PROTEASE derived from
Aspergillus niger Feb
2005 a 2.4
GERANIUM OIL Feb
2000 a 7.1
GIBBERELLIC ACID Nov
1974 a 1.6
b-GLUCANASE
derived from Aspergillus niger Feb 2005 a 2.4
HALAUXIFEN METHYL Oct
2014 a 1, 1.1
HEXAFLURON Nov
1988 a 1
HEXYL ACETATE - a 7.7
HEXYTHIAZOX Feb
1988 a 1
HUMAN OSTEOGENIC PROTEIN-1 (OP-1) Aug
2001 b 6.2
HYDROPRENE Feb
1988 a 1
HYDROXYPROPYL CELLULOSE Nov
1982 a 7.1
ICODEXTRIN Nov
2000 b 6
INDOLE-3-ACETIC ACID Feb
1985 b 1.6
ISOPRENE ALCOHOL - a 7.1
IPRODIONE Feb
1997 a 1
ISOSTEARYL ALCOHOL ETHOXYLATE Nov
1999 a 5.1
KAOLIN Nov
1974 a 7.1
KRESOXIM-METHYL Aug
1999 a 1
KUNZEA OIL Feb
2000 a 7.1
LAURIC ACID Oct
2005 a 7.1
LAURYL ALCOHOL (1-DODECANOL) Nov
1974 a 7.1
LAVANDIN OIL Feb
2000 a 7.1
LAVENDER OIL Feb
2000 a 7.1
LEAD METALLIC - a 7.1
LEMONGRASS OIL Feb
2000 a 7.1
LEPIDOPTEROUS SEX PHEROMONES Nov
1990 a 1
LIMONENE (DIPENTENE) Jun
2002 a 7.1
LINOLEIC ACID Oct
2005 a 7.1
LINSEED FATTY ACIDS Aug
1990 a 2.1
LINURON Feb
1990 a 1
LIQUORICE, DEGLYCYRRHISINISED May
1999 a 7.1
MALEIC HYDRAZIDE Nov
1992 a 1
MANGANESE DIOXIDE May
1999 b 1
MEGASPHAERA
ELSDENII strain 41125 Sep 2013 a 2.4
MESOLSULFURON-METHYL Feb
2002 a 1.1
METARHIZIUM ANISOPLIAE Feb
2000 b 4.2
METARHIZIUM ANISOPLIAE Jun
2003 a 1.10
METHOPRENE Aug
1987 a 1
METHOXYFENOZIDE Nov
2000 a 1
METHYL ACETATE - a 7.7
METHYL BENZOQUATE Nov
1974 d 2.3
1-METHYLCYCLOPROPENE Jun
2003 a 1.6
METHYL p-HYDROXYBENZOATE Nov
1974 a 7.9
METSULFURONMETHYL Nov
1985 a 1.1
MYRISTIC ACID Oct
2005 a 7.1
NAPROPAMIDE Aug
1987 a 1
NAPTHYL ACETAMIDE Nov
1974 a 1.6
NEROLI OIL Feb
2000 a 7.1
NICARBAZIN Jun
1969 d 2.3
NISIN Jun
2003 a 3.2
NORFLURAZON Nov
1983 a 1.1
NOVALURON Nov
2000 a 1
Nuclear Polyhedrosis Virus of
Helicoverpa armigera occlusion bodies Feb
2004 a 1.2
OCTYL ALCOHOLS Nov
1974 a 7.1
OLEIC ACID Oct
2005 a 7.1
ORANGE OIL, SWEET Aug
2000 a 7.1
OXABETRINIL Feb
1987 a 1
OXYFLUORFEN May
2001 a 1
PALMAROSA OIL Feb
2000 a 7.1
PALMITIC ACID Oct
2005 a 7.1
PATCHOULI OIL Feb
2000 a 7.1
PECTINASE derived from Aspergillus niger Feb
2005 a 2.4
PENCYCURON Aug
1994 a 1
PENTADECANOIC ACID Oct
2005 a 7.1
PEPPERMINT OIL Feb
2000 a 7.1
PHENMEDIPHAM May
1989 a 1.1
d-PHENOTHRIN Feb
1982 a 7.5, 1.2
PHYTASE Feb
1996 a 2.4
PICLORAM Aug
1987 a 1
PICOLINAFEN May
2000 a 1
PIMELIC ACID Oct
2005 a 7.1
PIPERONYL BUTOXIDE Aug
1991 a 7.5
POLOXALENE Nov
1974 a 7.1
POLY DIALLYL DIMETHYL AMMONIUM
CHLORIDE (PolyDADMAC) Nov 1997 a 4.1
POLYHEDROSIS VIRUS of
Helico zea occlusion bodies Nov 1996 a 1
POLY (GNRF) OVALBUMIN Feb
1990 a 2
POLYSORBATE 20 May
2001 a 1
PORCINE SOMATOTROPHIN Nov
1991 c 2
potassium sorbate Oct 2004 a 1.3
POTASSIUM BICARBONATE Jun
2004 a 1
PROPYL ACETATES - a 7.1
PROPYLENE GLYCOL Nov
1974 a 7.1
2-PROPYLENE GLYCOL 1-MONOMETHYL
ETHER Nov
1987 a 4
PROTHIOCONAZOLE June
2005 a 1.3.1
PSEUDOMONAS FLUORESCENS May
1985 a 1.8
PYRIMETHANIL Feb
1996 a 1
PYRIPROXYFEN Aug
1994 a 1
QUASSIA Nov
1974 d 6, 2.1
QUINOXYFEN Nov
2001 a 1.3
ROSEMARY OIL Feb
2000 a 7.1
SAGE OIL (Spanish) Feb
2000 a 7.1
SANDALWOOD OIL Feb
2000 a 7.1
SEAWEED & UNFRACTIONED
SEAWEED EXTRACTS Feb
1985 d 1.5
SIMAZINE Nov
1987 a 1.1
SODIUM BICARBONATE Jun
2004 a 1
sodium propionate Oct 2004 a 1.3
STERIC ACID Oct
2005 a 7.1
SUCRALFATE Aug
1982 a 6.8
SULESOMAB Jun
2002 b 6.1
SULFOSULFURON Feb
1998 a 1
SULPHATED POLYSACCHARIDES - a 7.1
TANNIC ACID Dec
1965 a 7.1
TANNIC ACID/BENZYL ALCOHOL
PRODUCT Nov
1993 a 7.1
TERBACIL Aug
1987 a 1
THAUMATIN Nov
1990 a 3.2
THIDIAZURON Nov
1989 a 1
TRIASULFURON Feb
1988 a 1
TRICHODERMA HARZIANUM May
1996 a 1
(Z)-9-TRICOSENE Aug
1991 a 1
TRIETHYLENE GLYCOL Nov
1974 a 7.1
TRIFLOXYSULFURON Feb
2002 a 1.1
TRIFLURALIN Aug
1990 a 1
TRIFORINE Aug
1987 a 1
Ulocladium oudemansii Oct
2003 a 1.10
UREA Nov
1974 a 7.1
13C-UREA May
2001 a 6.1
VETIVER OIL Feb
2000 a 7.1
VINYL ETHER Nov
1987 b 6
VITAMIN K Jul
1963 a 6.9, 2.8
XANTHOPHYLL (lutein) Nov
1974 a 7.1
XYLANASE derived from Aspergillus niger Feb
2005 a 2.4
YLANG YLANG OIL Feb
2000 a 7.1
ZINC NAPHTHENATE - a 1.3
ABRUS PRECATORIUS (Jequirity)
seed or root for therapeutic use.
ACORUS CALAMUS (calamus) for
human therapeutic use.
ALKALINE SALTS, being the
carbonate, silicate or phosphate salts of sodium or potassium alone or in any
combination for domestic use:
(a) in liquid
or semi-solid food additive preparations, the pH of which is more than 11.5;
(b) in solid
automatic dishwashing preparations, the pH of which in a 500 g/L aqueous
solution or mixture is more than 12.5; or
(b) in liquid
or semi-solid automatic dishwashing preparations, the pH of which is more than
12.5.
ALLYLISOPROPYLACETYLUREA for
therapeutic use.
AMINOPHENAZONE (amidopyrine) and
its derivatives for human therapeutic use.
AMYGDALIN for therapeutic use.
ANCHUSA OFFICINALIS for
therapeutic use.
ARISTOLOCHIA spp. for therapeutic
use.
ARISTOLOCHIC ACID(S) for human
therapeutic use.
ASARUM spp. containing
aristolochic acid(s) for human therapeutic use.
AZADIRACHTA INDICA (neem)
including its extracts and derivatives, in preparations for human internal use except
‘debitterised neem seed oil’.
BASIC ORANGE 31
(2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride) in preparations
for skin colouration and dyeing of eyelashes or eyebrows.
BITHIONOL for human therapeutic
use.
BORAGO OFFICINALIS (Borage) for
therapeutic use except the fixed oil derived from the seeds of Borago
officinalis.
BRAGANTIA spp. containing
aristolochic acid(s) for human therapeutic use.
BUCLOSAMIDE for therapeutic use.
BUNIODYL SODIUM for therapeutic
use.
1,4-BUTANEDIOL (excluding its
derivatives) in non-polymerised form in preparations for domestic use.
CACALIA spp. for therapeutic use.
CARBAMIDE PEROXIDE (excluding its
salts and derivatives) in teeth whitening preparations containing more than 18
per cent of carbamide peroxide except in preparations manufactured for,
and supplied solely by, registered dental practitioners as part of their dental
practice.
CINCHOPHEN and its derivatives
for therapeutic use.
CLIOQUINOL and other halogenated
derivatives of 8-hydroxyquinoline for human internal use except when being used solely for
experimental purposes in humans and where such use:
(a) is in
accordance with:
(i) an
approval granted under paragraph 19(1)(b) of the Therapeutic Goods Act 1989,
including any conditions specified in the notice of approval; and
(ii) any
conditions specified in the Therapeutic Goods Regulations 1990 for the
purposes of subsection 19(1A) of the Therapeutic Goods Act 1989; and
(iii) any
conditions specified in the Therapeutic Goods Regulations 1990 for the
purposes of subsection 19(4A) of the Therapeutic Goods Act 1989; or
(b) is in
accordance with the requirements of item 3 of Schedule 5A to the Therapeutic
Goods Regulations 1990.
COAL TAR for cosmetic use other
than in therapeutic goods.
CONIUM MACULATUM (coniine) for
therapeutic use.
COTARNINE for therapeutic use.
CROTALARIA spp. for therapeutic
use.
CROTON TIGLIUM for therapeutic
use.
CYNOGLOSSUM spp. for therapeutic
use.
DIBUTYLPHTHALATE
for cosmetic use.
DICOPHANE (DDT) for therapeutic
use.
DIETHYLENE GLYCOL for use in
toothpastes or mouthwashes except in preparations containing 0.25 per
cent or less of diethylene glycol.
DIETHYLHEXYL PHTHALATE for cosmetic
use.
DIETHYLPHTHALATE
in
sunscreens, personal insect repellents or body lotion preparations for human
use except in preparations containing 0.5 per cent or less of
diethylphthalate.
5,6-DIHYDROXYINDOLINE for
cosmetic use in preparations containing more than 2 per cent of
5,6-dihydroxyindoline.
1,3-DIMETHYLAMYLAMINE (DMAA).
DIMETHYLPHTHALATE in sunscreens,
personal insect repellents or body lotion preparations for human use except
in preparations containing 0.5 per cent or less of dimethylphthalate.
DULCIN for therapeutic use.
ETHYLENE GLYCOL for use in
toothpastes or mouthwashes except in preparations containing 0.25 per
cent or less of ethylene glycol.
ETHYLHEXANEDIOL for human use.
EUPATORIUM CANNABINUM (Hemp
Agrimony) for therapeutic use.
FARFUGIUM JAPONICUM for
therapeutic use.
FORMALDEHYDE (excluding its
derivatives):
(a)
in
oral hygiene preparations containing more than 0.1 per cent of free
formaldehyde;
(b)
in
aerosol sprays for cosmetic use containing 0.005 per cent or more of free
formaldehyde;
(c)
in
nail hardener cosmetic preparations containing 5 per cent or more of free
formaldehyde; or
(d)
in
all other cosmetic preparations containing 0.05 per cent or more of free
formaldehyde except in preparations containing 0.2 per cent or less of
free formaldehyde when labelled with the warning statement:
CONTAINS
FORMALDEHYDE.
HELIOTROPIUM spp. for therapeutic
use.
HYDROGEN PEROXIDE (excluding its salts and
derivatives) in teeth whitening preparations containing more than 6 per cent
(20 volume) of hydrogen peroxide except in preparations manufactured for,
and supplied solely by, registered dental practitioners as part of their dental
practice.
JUNIPERUS SABINE [savin(e)] for
therapeutic use.
LEAD COMPOUNDS in paints,
tinters, inks or ink additives except in preparations containing
0.1 per cent or less of lead calculated on the non-volatile content of the
paint, tinter, ink or ink additive.
LIGULARIA DENTATA for therapeutic
use.
MELIA AZEDARACH including its
extracts and derivatives.
METHYLDIBROMO GLUTARONITRILE in
preparations intended to be in contact with the skin, including cosmetic use.
METHYL METHACRYLATE for cosmetic
use except in preparations containing 1 per cent or less of methyl
methacrylate as residual monomer in a polymer.
OXYPHENISATIN for therapeutic
use.
PARAFORMALDEHYDE (excluding its
derivatives):
(a) in oral
hygiene preparations containing more than 0.1 per cent of free formaldehyde;
(b) in aerosol
sprays for cosmetic use containing 0.005 per cent or more of free formaldehyde;
(c) in nail
hardener cosmetic preparations containing 5 per cent or more of free formaldehyde;
or
(d) in all
other cosmetic preparations containing 0.05 per cent or more of free
formaldehyde except in preparations containing 0.2 per cent or less of
free formaldehyde when labelled with the warning statement:
CONTAINS
FORMALDEHYDE.
PETASITES spp. for therapeutic
use.
PHENYLENEDIAMINES in preparations
for skin colouration and dyeing of eyelashes or eyebrows except when
included in Schedule 6.
POTASSIUM HYDROXIDE (excluding
its salts and derivatives), in liquid or semi-solid food additive preparations,
for domestic use, the pH of which is more than 11.5.
PTERIDIUM spp. for therapeutic
use.
PULMONARIA spp. for therapeutic
use.
SAFROLE for internal therapeutic
use except in preparations containing 0.1 per cent or less of safrole.
SENECIO spp. for therapeutic use.
SILICONES for injection or
implantation except when included in Schedule 4.
SODIUM HYDROXIDE (excluding its salts
and derivatives), in liquid or semi-solid food additive preparations, for
domestic use, the pH of which is more than 11.5.
SYMPHYTUM spp. (Comfrey) for
therapeutic or cosmetic use except when included in Schedule 5.
TOLUENEDIAMINE in preparations
for skin colouration and dyeing of eyelashes or eyebrows except when
included in Schedule 6.
1,1,1-TRICHLOROETHANE in pressurised
spray packs for therapeutic use.
TRICHODESMA AFRICANA for
therapeutic use.
TRIPARANOL for therapeutic use.
TUSSILAGO FARFARA for therapeutic
use.
(The following controls apply for
the substances shown only when included in Schedule 4 or Schedule 8.)
1. Poisons available
only from or on the prescription or order of an authorised medical
practitioner.
CLOMIPHENE for
human use.
CLOZAPINE for human
use.
CORIFOLLITROPIN
ALFA (recombinant follicle stimulant) for human use.
CYCLOFENIL for
human use.
DINOPROST for human
use.
DINOPROSTONE for
human use.
FOLLITROPIN ALPHA
(recombinant human follicle-stimulating hormone) for human use.
FOLLITROPIN BETA (recombinant
human follicle-stimulating hormone) for human use.
LUTEINISING HORMONE
for human use.
NABIXIMOLS.
SODIUM OXYBATE for human
use.
TERIPARATIDE for
human use.
UROFOLLITROPIN
(human follicle-stimulating hormone) for human use.
2. Poisons available
only from or on the prescription or order of a specialist physician or a
dermatologist and for which the prescriber must, where the patient is a woman
of child-bearing age:
(1) ensure
that the possibility of pregnancy has been excluded prior to commencement of
treatment; and
(2) if the
drug is -
(a) acitretin
or etretinate, advise the patient to avoid becoming pregnant during or for a
period of 24 months after completion of treatment; or
(b) bexarotene,
isotretinoin or thalidomide, advise the patient to avoid becoming pregnant
during or for a period of 1 month after completion of treatment.
ACITRETIN for human
use.
BEXAROTENE for
human use.
ETRETINATE for
human use.
ISOTRETINOIN for
human oral use.
THALIDOMIDE for
human use.
3. Poisons available
only from or on the prescription or order of a medical practitioner authorised
or approved by the Secretary of the Commonwealth Department of Health and
Ageing under section 19 of the Therapeutic Goods Act 1989.
DRONABINOL
(delta-9-tetrahydrocannabinol).
4. Poisons available only from or on the order of a
specialist physician and for which the prescriber must, where the patient is a
woman of child bearing age:
(a) ensure
that the possibility of pregnancy has been excluded prior to commencement of
treatment; and
(b) advise the
patient to avoid becoming pregnant during or for a period of 1 month after
completion of treatment.
LENALIDOMIDE.
TRETINOIN for human
oral use.
5. Poisons for which
possession without authority is illegal (e.g. possession other than in
accordance with a legal prescription).
ANABOLIC STEROIDAL
AGENTS, including those separately specified in Schedule 4.
ANDROGENIC
STEROIDAL AGENTS, including those separately specified in Schedule 4.
BENZODIAZEPINE DERIVATIVES, including those separately
specified in Schedule 4 and Schedule 8.
DARBEPOETIN.
DEXTROPROPOXYPHENE.
EPHEDRINE.
EPOETINS.
ERYTHROPOIETIN.
ERYTHROPOIETINS except
when separately specified in this Appendix.
FOLLISTATIN.
GLUTETHIMIDE.
INSULIN-LIKE GROWTH
FACTORS.
PERAMPANEL for human use.
PHENTERMINE.
SELECTIVE
ANDROGEN RECEPTOR MODULATORS (SARM), including those separately specified in
Schedule 4.
SOMATROPIN (human
growth hormone).
6. Poisons available
only from or on the prescription or order of a specialist physician and for
which the prescriber must, where the patient is a woman of child-bearing age:
(a) ensure
that the possibility of pregnancy has been excluded prior to commencement of
treatment; and
(b) advise the
patient to avoid becoming pregnant during and for a period of 3 months after
completion of treatment.
AMBRISENTAN for
human use.
BOSENTAN for human
use.
SITAXENTAN for
human use.
7. Poisons available
only from or on the prescription or order of a dermatologist.
ALEFACEPT for human
use.
(other than
agricultural and veterinary chemicals (including pesticides) registered by the
Australian Pesticides
and Veterinary Medicines Authority and medicines for human use
when compliant with
the requirements of the Required Advisory Statements for Medicine Labels)
INTRODUCTION
Directions for
First Aid Attention
Under poisons legislation,
scheduled substances and their preparations are required to be labelled with
appropriate directions for first aid attention in case of poisoning. It is the
responsibility of the manufacturer, packer and supplier of a drug or poison to
ensure that the first aid instructions included on the label of a poison are
appropriate for a specific product. The following code has been prepared as a
guide for health authorities and manufacturers in drafting suitable first aid
directions for this purpose. Standard statements specified in this Appendix may
be varied provided that the intent is not changed.
The directions listed for any
particular substance may require modification to take into account combination
of that substance with other substances, both toxic and non toxic, in a
formulation, as well as the physical form and presentation of the product. Any
such modification should be concise and readily understood.
These First Aid Instructions
include action to be taken in case of eye contamination from substances
recognised as causing direct poisoning via the eye, causing severe eye damage
or requiring prolonged flushing to free the absorbed substance from the eye
tissue. However, it is recognised that many other substances or preparations
will require a statement of varying nature depending on the detailed
formulation. While the necessity to flush the eyes in case of accident will be
so self-evident as not to justify label space in many instances, a statement
such as “If in eyes rinse well with water” may be appropriate.
Modified First
Aid Instruction on Primary Pack
Where a primary pack
contains two or more immediate containers of poisons each requiring different
first aid instructions:
(a) each
immediate container must be labelled with first aid instructions appropriate
for its contents; and
(b) the
primary pack must be labelled with the statement:
FIRST AID: See inner
packs.
Exempt
Preparations
This Appendix applies only to
scheduled poisons. The directions are for substances and their preparations at
the concentrations at which the Schedules apply. If it is thought desirable to
show first aid instructions for a substance exempted from the schedules, it is
the responsibility of the manufacturer to ensure they are appropriate.
Poisons
Information Centre Telephone Numbers
Companies should use the Poisons
Information Centre telephone number(s) (Australia 13 11 26; New Zealand 0800 764 766)
appropriate to the country(ies) of sale for the product.
Companies wishing to use a
poisons information centre telephone number other than the national telephone
numbers for Australia and New Zealand must meet the following criteria:
1. the
poisons information service whose number is used must be attended by adequately
trained staff for 24 hour emergency poisons information; and
2. calls must be logged and submitted for
incorporation into the official collection of poisoning data.
STANDARD
STATEMENTS
To be grouped together
and prefaced with the words “FIRST AID” (see subparagraph 7(p) of this
Standard).
Basic
A For advice,
contact a
Poisons
Information Centre (e.g.
phone Australia 13 11 26;
New Zealand 0800 764 766) or a doctor (at once).
Z First aid
is not generally required. If in doubt, contact a Poisons Information Centre (e.g. phone Australia 13 11 26;
New Zealand 0800 764 766) or a doctor.
General
G1 Urgent
hospital treatment is likely to be needed.
(Note - the words ‘at once’
to be added to instruction A).
G2 If
swallowed, give activated charcoal if instructed.
(Note - the words ‘at once’
to be added to instruction A).
G3 If
swallowed, do NOT induce vomiting.
G4 Immediately
give a glass of water.
G5 Avoid
giving milk or oils.
G6 If sprayed
in mouth, rinse mouth with water.
Eyes
E1 If in eyes
wash out immediately with water.
E2 If in eyes,
hold eyelids apart and flush the eye continuously with running water. Continue
flushing until advised to stop by a Poisons Information Centre (e.g. phone Australia 13 11 26;
New Zealand 0800 764 766) or a doctor, or for at least 15
minutes.
Respiratory system
R1 If inhaled,
remove from contaminated area. Apply artificial respiration if not breathing.
R2 If
swallowed or inhaled, remove from contaminated area. Apply artificial respiration
if not breathing. Do not give direct mouth-to-mouth resuscitation. To protect
rescuer, use air-viva, oxy-viva or one-way mask. Resuscitate in a
well-ventilated area.
Skin
S1 If skin or
hair contact occurs, remove contaminated clothing and flush skin and hair with
running water.
S2 If skin or hair
contact occurs, remove contaminated clothing and flush skin and hair with
running water. Continue flushing with water until advised to stop by a Poisons Information
Centre (e.g.
phone Australia 13 11 26;
New Zealand 0800 764 766) or a doctor.
S3 If on skin, remove any
contaminated clothing, wash skin thoroughly with soap and water, then methylated spirit if
available. Contact a
Poisons
Information Centre (e.g.
phone Australia 13 11 26;
New Zealand 0800 764 766) or a doctor.
S4 If on skin,
immediately remove any contaminated clothing, wash skin with methylated spirit
or PEG (polyethylene glycol) 300 or 400 if available, then flush under running
water until advised to stop by a
Poisons Information
Centre (e.g.
phone Australia 13 11 26;
New Zealand 0800 764 766) or a doctor.
S5 If skin contact
occurs, immediately remove contaminated clothing. Flush skin under running
water for 15 minutes. Then apply calcium gluconate gel. Contact a Poisons Information
Centre (e.g.
phone Australia 13 11 26;
New Zealand 0800 764 766).
Special Purpose
SP1 If swallowed, splashed on skin or
in eyes, or inhaled, contact a Poisons Information Centre (e.g. phone
Australia 13 11 26; New Zealand 0800 764 766)
or a doctor at once. Remove any contaminated clothing and wash skin
thoroughly. If swallowed, activated charcoal may be advised. Give atropine if
instructed.
PART
2
FIRST
AID INSTRUCTIONS
Standard statements in this
Appendix apply to poisons other than agricultural and veterinary chemicals
(including pesticides) registered by the Australian Pesticides and Veterinary
Medicines Authority. Labelling is not required at concentrations below scheduled
levels (see the Introduction to this Appendix).
POISON STANDARD
STATEMENTS
Acetic acid A,G3,E2,S1
Acetic anhydride A,G3,E2,S1
Acetone A,G3
Acrolein A,G1,G2,G3,E2,R2,S2
Alkaline salts A,G3,E2,S1
Amines for use as curing agents A,G3,E1,S1
4-Aminopyridine A,G1,G2,E1,S1
Ammonia
• 5 per cent or less A
• above 5 per cent A,G3,E1,R1,S1
Ammonium persulfate A,G3,E2
Ammonium thiocyanate A
Anhydrides, organic acid, for use
as
curing agents for epoxy resins A,G3,E1,S1
Aniline A,E2,R1,S1
Anise oil A,G3
Antimony chloride A,E2,S2
Antimony compounds, except
antimony chloride A
Azadirachta indica (neem)
including its extracts
and derivatives when included in Schedule 6. A,E1
Barium salts, except
barium sulfate A
Basil oil A,G3
Bay oil A,G3
Benzalkonium chloride
• when included in Schedule 5 A,G3,E2
• when included in Schedule 6 A,G3,E2,S1
Benzene A,G3,E1,R1,S1
1,2-Benzenediol
(Catechol) A,E1,S1
Benzoyl peroxide
• above 20 per cent A,E2,S1
• above 10 per cent up to 20
per cent A,E1
• 10 per cent or less A
Bergamot oil A,G3
Bifluorides
(including ammonium, potassium and sodium salts)
• when included in Schedule 5 A
• when included in Schedule 6
or 7 A,G3,E2,S5
Borax A
Boric acid A
Boron trifluoride
• when included in Schedule 5 A
• when included in
Schedule 6 or 7 A,G3,E2,S5
Bromoform A,G3,E2,R1,S2
Brucine A,G1,G2,G3,R2
2-Butoxyethanol and its acetates A,E2,S1
Cadmium compounds A
Cajuput oil A,G3
Camphor A,G1,G3,G5
Carbamide peroxide
• more than 9 per cent up to 60
per cent A,G3,E2,S1
• more than 60 per cent A,G1,G3,G4,E2,S1
Carbon disulfide A,G3,E2,R1,S2
Carbon tetrachloride A,G3,E1,R1,S1
Cassia oil A,G3
Chlorinating compounds, except
when
separately specified, containing
• above 4 per cent and below 10
per cent
of available chlorine A,G3,E1,S1
• 10 per cent or more of
available chlorine A,G3,E2,S1
Chlorine (gas) A,E1,R1
Chlorocresol A,G3,E2,S2
Chloroform A,G3,E1,R1,S1
Chromates A,G3,E2,S1
Chromium trioxide A,G3,E2,S1
Cineole A,G1,G3
Cinnamon bark oil A,G3
Cinnamon leaf oil A,G3
Climbazole A
Clove oil A,G1,G3,E2
Copper sulfate A,G3,E2,S1
Creosote A,G3,E2,S1
Cresols A,G3,E2,S3
Cresols in pressurised spray
packs A,G6,E1,S1
Cyanides A,G1,E1,R2
Cyanoacrylic acid esters A
Cyanuric acid A
Cyclohexanone peroxide A,G3,E2,S1
Cysteamine E1
ortho-Dichlorobenzene A,G3,E1,S1
para-Dichlorobenzene (PDB) A
Dichloroethyl ether A,G3,E1,R1,S1
Dichloroisocyanurates A,G3,E1,S1
Dichloromethane (methylene
chloride) A,G3,G5,E1,R1,S1
• in pressurised spray packs A,G6,S1
Dichromates A,G1,G3,E2,S1
Didecyldimethylammonium salts A,G3
Diesel (distillate) A,G3
Diethanolamine
• when included in Schedule 5 A,G3
• when included in Schedule 6 A,G3,E2,S1
5,6-Dihydroxyindoline E1
Dimethylformamide
• less than 75 per cent A
• 75 per cent or more A,E1,R1,S1
Dimethyl sulfoxide A,G3,E1,S1
Dinitrocresols A,G1,E1,S1
Dinitrophenols A,G1,E1,S1
Dioxane A,G3,E1,R1,S1
Distillate A,G3
N-(N-Dodecyl)-2-pyrrolidone
• when included in Schedule 5 A,G3,E1
• when included in Schedule 6 A,G3,E2,S1
Epoxy resins liquid A,G3,E2,S1
Essential oils containing camphor
as natural
component unless otherwise specified. A,G3
Ethanolamine
• when included in Schedule 5 A,G3,E1
• when included in Schedule 6 A,G3,E2,S1
Ether A,G3,E1,R1
Ethyl bromide A,E2,S1,R1
Ethylene glycol A
Ethylene glycol monoalkyl ethers
and their
acetates, except when separately specified A,G3,E2,S1
Ethylene oxide A,E2,R1
Eucalyptus oil A,G1,G3
Eugenol A,G1,G3,E2
Fluorides except when
separately specified
• when included in Schedule 5 A
• when included in Schedule 6 A,G1,G3,E2,S1
Formaldehyde (see also
paraformaldehyde) A,G3,E2,R1,S1
Formic acid A,G3,E2,S1
Furfural A,E1,S1
Glutaraldehyde
• below 5 per cent A,G3,E1
• 5 per cent or more A,G3,E2,S1
Glycolic acid A,G3,E2
Guanidine when included in Schedule
6 A,G3,E2,S1
Hexachlorophane when included in
Schedule 6 A
Hexyloxyethanol A,G3,E2,S1
Hydrazine A,G1,G3,E2,R1,S1
Hydrocarbons, liquid A,G3
Hydrochloric acid A,G3,E2,S1
• when included in Schedule 5 A,G3
Hydrofluoric acid and admixtures
that
generate hydrofluoric acid
• when included in Schedule 5 A
• when included in Schedule 6
or 7 A,G3,E2,S5
Hydrogen peroxide
• more than 3 per cent up to 20
per cent A,G3,E2,S1
• more than 20 per cent A,G1,G3,G4,E2,S1
Hydroquinone
• when included in Schedule 2 A
• when included in Schedule 4
or 6 A,G2,G3,E2,R2,S1
Hydrosilicofluoric acid
• when included in Schedule 5 A
• when included in Schedule 6
or 7 A,G3,E2,S5
Iodine (excluding salts,
derivatives and iodophors)
• 2.5 per cent or more for
human external use A,E2
• 2.5 per cent or more for
other uses A,E2,S1
• below 2.5 per cent A
Iodophors A
Isocyanates, free organic A,E2,S1
Isophorone A,G3,E2,S1
Kerosene A,G3
Laureth carboxylic acids
• leave-on or wash-off
preparations above 5 per cent E1
• other preparations above 5
per cent E1,S1
Lauryl isoquinolinium bromide A,E1
Lead compounds
• in hair cosmetics A
• in other preparations A,S1
Lemon oil A,G3
Leptospermum scoparium oil (manuka oil) A,G1,G3
Lime oil A,G3
Magnesium chlorate A
Malathion at 20 per cent or less A
Marjoram oil A,G3
Melaleuca oil A,G1,G3
Mercuric chloride
• for external
therapeutic use A
• for other uses A,G1,G3,E2,R2,S1
Mercuric iodide A,G1,G3,E2,R2,S1
Mercuric nitrate A,G1,G3,E2,R2,S1
Mercuric oxide A,G1,G3
Mercuric potassium iodide A,G1,G3,E2,R2,S1
Mercuric thiocyanate A,G1,G3,E2,R2,S1
Mercurochrome A
Mercurous chloride A
Mercury metallic A
Mercury, organic compounds A,S1
• in preparations for human
external use A
Metaldehyde A,E1,S1
Methanol
• above 10 per cent A,G3
• 10 per cent or less A
Methylated spirit A,G3
Methyl ethyl ketone A,G3
Methyl ethyl ketone oxime A,E1,S1
Methyl ethyl ketone peroxide A,G3,E2,S1
Methyleugenol A
Methyl isoamyl ketone A,G3
Methyl isobutyl ketone A,G3
N-Methyl-2-pyrrolidone
• when included in Schedule 5 A,G3,E1
• when included in Schedule 6 A,G3,E2
Methyl salicylate liquid when
included
in Schedule 5 or 6 A,G3,E1
Naphthalene A,G1,G3
Nitric acid A,G3,E2,S1
Nitrobenzene A,G3,E1,S1
Nitrophenol A,G3,E2,S1
Nitroprussides
• in aerosols A,G6,R1
• in other preparations A,G3
Nonoxinol 9 A,E2
Nutmeg oil A,G3
2-Octyl-4-isothiazolin-3-one
(Ocithilinone) A,G3,E2,S1
N-(N-Octyl)-2-pyrrolidone
• when included in Schedule 5 A,G3,E1
• when included in Schedule 6 A,G3,E2
Orange oil (bitter) A,G3
Oxalic acid A,G3,E2,S1
Paraformaldehyde A,G3,E2,R1,S1
Pennyroyal oil A,G3
Peracetic acid
• when included in Schedule 5 A,G3,E1,S1
• when included in Schedule 6 A,G3,E2,S1
Petrol A,G3,R1
2-Phenoxyethanol A,
E1
Phenols
• 25 per cent and less A,G3,E2,S3
• above 25 per cent A,G3,E2,S4
Phenols in pressurised spray
packs A,E1
Phenylenediamines and
alkylated phenylenediamines
• in hair dyes A,E1
• in other preparations A,G1,G3,E1,S1
Phenyl methyl ketone
• as such, or in preparations
of similar viscosity A,G3,E1
N,N-bis(phenylmethylene)-bicyclo
-(2.2.1)heptane-2,5-dimethanamine A,E2,S1
N,N-bis(phenylmethylene)-bicyclo-
(2.2.1)heptane-2,6-dimethanamine A,E2,S1
ortho-Phenylphenol A,G3,E2,S1
• in pressurised spray packs A,G6,E2,S1
Phosphonic acid A,G3,E2,S1
• neutralised to pH 6 (approx) A
• in spray packs A,E2,S1
Phosphoric acid A,G3,E2,S1
Phosphorus, yellow A,G1,G3,E2,R2,S2
ortho-Phthalaldehyde
• when included in Schedule 5 A,E1
• when included in Schedule 6 A,G3,E2,S1
Picric acid A,G1,G3,E2,R1,S1
Polyethanoxy (15) tallow amine A,E2,S1
Poly(oxy-1,2-ethanediyl), α -
[2-[(2-hydroxyethyl)amino]-2-
oxoethyl]- α -hydroxy-,mono-C13-15
-alkyl ethers A,E1
Potassium bromate A
Potassium chlorate A
Potassium cyanate A,E1,S1
Potassium hydroxide A,G3,E2,S1
Potassium metabisulphite A
Potassium nitrite
• when included in Schedule 7 A,G1,G3
• when included in Schedule 5
or 6 A,G3
Potassium peroxomonosulfate
triple salt
• when included in Schedule 5 A,G3,E1
• when included in Schedule 6 A,G3,E2,S1
Potassium persulfate A,G3,E2
Potassium sulfide A,G3,E2,S1
Propionic acid A,G3,E1,S1
d-Pulegone A,G3
Pyrithione zinc A,E1
Quaternary ammonium compounds except
when separately specified
• above 20 per cent A,G3,E2
• 20 per cent and below A,E2
• in pressurised spray packs A,E2,G6
Safrole A,G1,G3
Sage oil (Dalmatian) A,G3
Sassafras oil A,G1,G3
Selenium compounds A,G1,E1,S1
Silicofluorides
• when included in Schedule 5 A
• when included in Schedule 6 A,G1,G3,E2,S1
Silver salts A,E2
Sodium aluminate A,G3,E2,S1
Sodium bromate A,G1
Sodium chlorate A
Sodium diacetate A,G3,E2,S1
Sodium dichloroisocyanurate A,G3,E1,S1
Sodium dodecylbenzene sulfonate A,G3,E2,S1
Sodium hydrogen sulfate A,G3,E1,S1
Sodium hydrosulfite A,G3,E2,S1
Sodium hydroxide A,G3,E2,S1
Sodium laureth-6 carboxylate A
Sodium lauryl sulfate
• leave-on or wash-off
preparations above 5 per cent E1
• other preparations above 5
per cent E1,S1
Sodium metabisulphite A,
G3
Sodium nitrite
• when included in Schedule 7 A,G1,G3
• when included in Schedule 5
or 6 A,G3
Sodium percarbonate
• when included in Schedule 5 A,G3,S1
• when included in Schedule 6 A,G3,E2,S1
Sodium persulfate A,G3,E2
Sodium stannate A,E1
Sodium sulfide A,G3,E2,S1
Sodium trichloroacetate A
Strychnine A,G1,G2,G3,R2
Styrene A,G3,S1,E1
Sulcofuron A
Sulfamic acid A,G3,E2,S1
Sulfuric acid A,G3,E2,S1
Terpenes, chlorinated A,G3
Tetrachloroethane A,G3,E1,R1,S1
Tetrachloroethylene A,G3,E2,R1,S1
Thiourea A
Thujone A,G3
Thyme oil A,G3
ortho-Tolidine A
Toluene
• above 75 per cent A,G3,E1,R1,S1
• 75 per cent and below A,G3
• in pressurised spray packs A
Toluenediamine
• in hair dyes A,E1
• in other preparations A,G1,G3,E1,S1
Trichloroacetic acid A,G3,E2,S1
Trichloroacetic acid alkali salts
A
1,1,1-Trichloroethane A,G3,E1,R1,S1
Trichloroethylene A,G3,E1,R1,S1
Trichloroisocyanuric acid A,G3,E1,S1
Triethanolamine A,G3,E1,S1
Triethyl phosphate A,E1
Trifluoromethanesulfonic acid A,G3,E2
Triisopropanolamine lauryl ether sulfate A,E1,S1
Turpentine (mineral) A,G3
Turpentine oil (vegetable) A,G3,E2
White spirit A,G3
Xylene
• above 75 per cent A,G3,E1,R1,S1
• 75 per cent and below A,G3
• in pressurised spray packs A,G6,E1,S1
Xylenols A,G3,E2,S3
• in pressurised spray packs A,E1
Zinc chloride A,G3,E2,S1
Zinc sulfate A,G3,E2,S1
(other than
agricultural and veterinary chemicals (including pesticides) registered by the
Australian Pesticides
and Veterinary Medicines Authority and medicines for human use
when compliant with
the requirements of the Required Advisory Statements for Medicine Labels)
INTRODUCTION
Warning
Statements and Safety Directions
It is the responsibility of the
manufacturer, packer and supplier of a drug or poison to ensure that the
purchaser or user of a product is given sufficient information to be able to
use it correctly and safely.
Under poisons legislation,
scheduled substances, which may be harmful to the user, must be labelled with
appropriate warning statements and/or safety directions. The selection of
warning statements and safety directions will depend on the formulation of the
product, and the use for which it is sold or supplied. The following code has
been prepared as a guide for this purpose.
The wording of warning statements
and safety directions specified in this Appendix may be varied provided that
the intent is not changed. Additional statements also may be added to ensure
that the user of a product is sufficiently advised of its harmful nature and
how to avoid any deleterious effects.
Poisons
Information Centre Telephone Numbers
Companies should use the Poisons
Information Centre telephone number(s) (Australia 13 11 26; New
Zealand 0800 764 766) appropriate to the country(ies) of sale
for the product.
Companies wishing to use a
poisons information centre telephone number other than the national telephone
numbers for Australia and New Zealand in warning statement No. 99 in Part 1 of
this Appendix must meet the following criteria:
1. the
poisons information service whose number is used must be attended by adequately
trained staff for 24 hour emergency poisons information; and
2. calls
must be logged and submitted for incorporation into the official collection of
poisoning data.
PART
1
WARNING
STATEMENTS
1. Highly corrosive.
2. Corrosive.
3. Corrosive liquid.
4. Strongly alkaline.
5. Irritant.
6. May cause cancer.
7. WARNING -
Causes birth defects.
8. WARNING -
May be fatal to children.
9. Can be fatal to children if sucked or
swallowed.
10. May produce severe burns.
11. WARNING -
Vapour may be harmful.
12. Vapour is harmful to health on prolonged
exposure.
13. May be fatal if inhaled, swallowed or absorbed
through skin.
14. Dust will irritate and burn eyes, nose and
skin.
15. Liquid will cause burns.
16. Forms dangerous gas near radiators or naked
flames.
17. Contact with eyes even for short periods can
cause blindness.
18. Product will irritate the eyes, nose, throat
and skin.
19. WARNING -
Skin contact may be dangerous. Take every precaution to avoid contact - wash
off after spillage and after use.
20. May give off dangerous gas if mixed with other
products.
21. WARNING - This product contains
ingredients which may cause skin irritation to certain individuals. A
preliminary test according to accompanying directions should be made before
use. This product must not be used for dyeing eyelashes or eyebrows; to do so
may be injurious to the eye.
22. Highly reactive oxidising chlorine compound.
23. May cause fire or explosion.
24. For
external washing only. Rinse skin thoroughly after use.
25. Do
not use on broken skin. Wash hands thoroughly after use.
26. (Powder) (and) (concentrated solutions) are
dangerous if swallowed.
27. Not for therapeutic use.
28. (Over) (Repeated) exposure may cause
sensitisation.
29. If congestion persists, consult your doctor or
pharmacist.
30. WARNING - Do not use on face or on anal
or genital areas.
31. WARNING - Do not use on face or on anal or genital areas except on doctor’s
advice.
32. This preparation should be part of an overall
treatment plan regularly assessed with your doctor.
33. Do not take for periods longer than four weeks
except on medical advice.
34. WARNING - This medication may be
dangerous when used in large amounts or for a long time (period).
35. CAUTION - This preparation is for the
relief of minor and temporary ailments and should be used strictly as directed.
Prolonged use without medical supervision could be harmful.
or
CAUTION - This preparation is for the
relief of minor and temporary ailments and should be used strictly as
directed. Prolonged or excessive use without medical supervision could be
harmful.
36. For use under medical supervision only.
37. Consult a doctor before giving this medication
to children or teenagers with chicken pox, influenza or fever.
38. CAUTION - Do not use for children under 2 years old unless a doctor has told you
to.
39. This medication may cause drowsiness. If
affected do not drive a vehicle or operate machinery. Avoid alcohol.
40. This medication may cause drowsiness and may
increase the effects of alcohol. If affected do not drive a motor vehicle or operate
machinery.
41. Do not give to children under 12 years of
age. Do not use beyond 48 hours or in pregnancy or lactation except on
doctor’s advice.
42. WARNING - Overuse may stain the skin or
mouth.
43. Use of this product is not necessary in areas
supplied with fluoridated water.
44. WARNING - May be dangerous,
particularly to children, if you use large amounts on the skin, clothes or
bedding or on large areas of the body, especially if you keep using it for a
long time.
45. WARNING - If a pigmented spot or mole
has recently become darker, changed colour, become enlarged or itchy, or
bleeds, do not use this product, see your doctor immediately. Do not use on
children. Do not use near the eyes. Mild irritation may occur; stop use if it
becomes severe. If fading is not evident in three months, seek doctor’s
advice.
46. WARNING - Contains (name of substance)
which causes birth defects in laboratory animals. Women of child bearing age
should avoid contact with (name of substance).
47. WARNING - This product contains (name
of substance) which causes birth defects in certain laboratory animals. Women
of child bearing age are advised not to mix, load or spray this product. They
should keep out of crops being sprayed.
48. WARNING - This product forms cyhexatin
which causes birth defects in certain laboratory animals. Women of child
bearing age are advised not to mix, load or spray this product. They should
keep out of crops being sprayed.
49. WARNING - Do not mix with other
medication except on veterinarian’s advice.
50. Unless adequately fired, utensils glazed with
this preparation must not be used as containers for food or beverages; to do so
may cause lead poisoning.
51. Irritant to skin, eyes, mucous membranes and
upper respiratory tract.
52. Breathing vapour or spray mist is harmful and
may cause an asthma-like reaction.
53. CAUTION - (Name of substance) should
not be used by pregnant women.
54. Seek medical advice before first course of
treatment.
55 Keep from
eyes, lips, mouth and sensitive areas of the neck. If excessive swelling,
irritation, redness or peeling occurs, discontinue use. If these persist,
consult a physician. Avoid excessive exposure to sunlight and other sources of
ultra violet light.
56. WARNING - Can cause elevated blood
pressure and interact adversely with other medication.
57. Not to be applied to infants under 12 months
of age unless on doctor’s advice.
58. Highly reactive oxidising bromine and chlorine
compound.
59. May cause allergy.
60. Do not mix with detergents or other chemicals.
61. WARNING - Can react with other medicines. Ask your doctor or pharmacist before
taking.
62. Do not use if pregnant.
63. See a doctor if you are pregnant or diabetic.
64. See a doctor (or) (dentist) if no better
after (Insert number of days as per approved Product Information) days.
65. If getting better, keep using for (Insert
number of days as per approved Product Information ) days.
66. See a doctor if problem returns.
67. Do not use if pregnant or likely to become
pregnant.
68. If symptoms persist beyond 5 days consult a
doctor (or) (dentist).
69. If symptoms recur within two weeks of
completing the course, consult a doctor.
70. Use only under medical supervision if you are
taking other medicines.
71. Do not use during the last three months of
pregnancy.
72. Do not use in the eyes.
73. Do not use for acne.
74. Do not use under waterproof bandages unless a
doctor has told you to.
75. Do not use for more than 7 days unless a
doctor has told you to.
76. Do not become pregnant during use or within (Insert
number of months as per approved Product Information) month(s) of stopping
treatment.
77. WARNING -
May cause birth defects.
78. Attacks skin and eyes.
79. Will irritate eyes.
80. (Intentionally blank)
81. (Intentionally blank)
82. (Intentionally blank)
83. This paint is dangerous to health, even when
dry.
For industrial use only.
Do not use on toys or furniture.
Do not use on, in or around the home.
84. Breathing the vapour is dangerous.
Provide adequate ventilation during
application.
Do not use in the presence of a naked
flame.
Do not smoke.
85. This paint contains lead and is dangerous to
health, even when dry.
For industrial use only.
Do not use on toys or furniture.
Do not use for painting any building or
fixed structure.
Do not use where contact with food or
drinking water is possible.
86. This tinter contains lead.
Do not add to any paint which is for
application to any toy, furniture, building (interior or exterior), fixed
structure or to anything which may contact food or drinking water.
87. (Insert brand name) remains in the body
for many months after treatment has stopped. Do not become pregnant or father
a child before consulting your doctor.
88. This product is not recommended for dyeing
eyelashes or eyebrows. To do so may be injurious to the eye.
89. Application to skin may increase sensitivity
to sunlight.
90. This preparation is to aid sleep. Drowsiness
may continue the following day. If affected do not drive or operate machinery.
Avoid alcohol.
91. CAUTION
- Total iodine intake may exceed
recommended level when taking this preparation.
92. WARNING - Contains iodine - do not take when pregnant except
on physician’s advice.
93. Causes
severe burns, which are not likely to be immediately painful or visible.
94. WARNING - Contains nitrite. Substitution for table or cooking
salt may be dangerous,
particularly for young children.
95. CAUTION
- Do not use for children under
12 years old unless a doctor has told you to.
96. CAUTION
- This preparation is for the
relief of minor and temporary ailments and should be used strictly as directed.
If symptoms persist or recur within two weeks, consult a doctor.
97. Adults: Keep to the recommended dose.
Don’t take this medicine for longer than a few days at a time unless advised to
by a doctor.
98. Children and adolescents: Keep to the
recommended dose. Do not give this medicine for longer than 48 hours at a time
unless advised to by a doctor.
99. If an overdose is taken or suspected, ring the
Poisons Information Centre (Australia 13 11 26; New Zealand 0800 764 766)
or go to a hospital straight away even if you feel well because of the risk of
delayed, serious liver damage.
100. Do not take with other products containing
paracetamol, unless advised to do so by a doctor or pharmacist.
101. Don’t use [this product/name
of the product]:
If you have a stomach ulcer
In the last 3
months of pregnancy [This statement may be omitted in preparations used
exclusively for the treatment of dysmenorrhoea.]
If you are
allergic to (name of substance) or anti-inflammatory medicines.
102. Unless a doctor has told you to, don’t use [this
prouct/name of the product]:
For more than a few days at a time
With other medicines containing aspirin or
other anti-inflammatory medicines
If you have asthma
In children under 12 years of age
In children 12-16 years of age with or
recovering from chicken pox, influenza or fever
If you are pregnant.
103. See
a doctor before taking [this product/name of the product] for thinning the
blood or for your heart. [This statement may be omitted in products for
inhibition of platelet aggregation or with additional active ingredients.]
104. Unless
a doctor has told you to, don’t use [this product/name of the product]:
For
more than a few days at a time
With
other medicines containing (name of substance) or other anti-inflammatory
medicines
If
you have asthma
If
you are pregnant [This statement may be omitted in preparations used
exclusively for the treatment of dysmenorrhoea].
105. Do
not use on the bedding or clothing of infants or in the bedrooms of children 3
years of age or less.
106. Contains
formaldehyde.
PART 2
SAFETY DIRECTIONS - GENERAL
To be grouped together and
prefaced with the words “SAFETY DIRECTIONS” (see Part 2, Labels and Containers,
subparagraph 7(n) to this Standard).
1. Avoid contact with eyes.
2. Attacks eyes -
protect eyes when using.
3. Wear eye protection when mixing or using.
4. Avoid contact with skin.
5. Wear protective gloves when mixing or using.
6. Wash hands after use.
7. Wash hands thoroughly after use.
8. Avoid breathing dust (or) vapour (or) spray
mist.
9. Use only in well ventilated area.
10. Ensure adequate ventilation when using.
11. No smoking.
12. Do not allow product to come into contact with
other chemicals, especially acids.
13. Do not allow product to come into contact with
combustible materials such as paper, fabric, sawdust or kerosene.
14. Do not allow to get damp.
15. Store under cover in a dry, clean, cool, well
ventilated place away from sunlight.
16. Store and transport in an upright container.
17. Do not mix with other chemicals.
18. Do not mix with different types of
chlorinating chemicals.
19. Use clean containers for dispensing.
20. Mix with water only.
21. Do not add water to product - add product to water, but in case
of fire drench with water.
22. In case of spillage flush with large
quantities of water.
23. Keep away from heat, sparks and naked flames.
24. Avoid contact of the crystals or strong
solutions with the eyes, mouth, nose and other mucous membranes.
25. Avoid contact with food.
26. Avoid contact with clothing.
27. Wear a positive-pressure air-supplied
full-face respirator whilst spraying and until spray mist has been effectively
dispersed.
28. Do not mix with hot water.
29. Obtain a supply of calcium gluconate gel.
30. (Intentionally blank.)
31. Do not use on broken skin.
32. Do not use under occlusive dressing.
33. Mix strictly according to instructions.
34. May cause fire if it comes into contact with
other chemicals, paper or other flammable materials.
35. Wash gloves thoroughly, immediately after use.
36. Protect
cuticles with grease or oil.
PART
3
POISONS
(other than agricultural and veterinary chemicals)
TO BE LABELLED WITH WARNING STATEMENTS
OR
SAFETY DIRECTIONS
(Where more than one
statement or direction is required, they may be combined to form simple
sentences where appropriate.)
_________________________________________________________________________________
WARNING SAFETY
POISON STATEMENTS DIRECTION
_________________________________________________________________________________
Acetic acid in
concentrations of 80 per cent 2 1,4,8
or more except
when in Schedule 2.
Acetic anhydride 2 1,4,8
Acetone in
concentrations greater than 75 per cent. 1,4,8
Acitretin 7,62,76
Adapalene for topical
use. 62,77
Alclometasone when included
in Schedule 3. 38,72,73,74,75
Alkaline salts 4 1,4
Ambrisentan 7,62,76
Amines used as curing
agentsfor epoxy resins. 1,3,4,5,8
Ammonia/ammonium
hydroxide in concentrations 4 1,4,8
greater
than 20 per cent ammonia except
in
smelling salts.
Ammonium persulfate 5,21,25 1,5,23,33,34
Anhydrides, organic
acid, for use as curing agents 1,3,4,5,8
for epoxy
resins.
Aniline 13 1,4,8
Antihistamines not
separately specified 39
or 40
in this
Appendix except:
(a) dermal, ocular, parenteral and
paediatric preparations;
(b) oral preparations of astemizole,
desloratadine, fexofenadine,
loratadine or terfenadine;
(c) nasal
preparations of azelastine; or
(d) preparations for the treatment of
animals.
Aromatic extract oils 1,3,4,5,6
Aspirin
(a) for inhibition of platelet
aggregation. 36
(b) in sustained release preparations 36
containing 650 mg or more of aspirin.
(c) in
other preparations. 101,102,103
Astemizole 61
Azadirachta indica
(neem) including its extracts
and derivatives when included in Schedule 6. 67
Azocyclotin 48
Benomyl 46
Benzene 12 1,4,9
1,2-Benzenediol (Catechol) 51,59 1,4,8
Benzoyl peroxide when
included in Schedule 2. 55
Benzoyl peroxide when
included in Schedule 5. 1,4,8
Bergamot oil 89
Beryllium 1,4,8
Bexarotene
(a) for
human use. 7,62,76
(b) for
topical use. 62,77
Bifluorides (including
ammonium, potassium and sodium salts)
(a) when
included in Schedule 5. 2 1,4
(b) when included in Schedule 6 or
7. 1,17,93 1,3,4,5,8,29,35
Bithionol for the
treatment of animals. 1,4,8
Boron
trifluoride (including mixtures that
generate
boron trifluoride)
(a) when
included in Schedule 5. 2 1,4
(b) when
included in Schedule 6 or 7. 1,17,93 1,3,4,5,8,29,35
Bosentan 7,62,76
Bromoform 1,4,8
2-Butoxy-2’-thiocyanodiethyl
ether 1,4,8
2-Butoxyethanol and
its acetates 1,4,8
Camphor
(a) in
block, ball, disc, pellet or flake form, 9
enclosed
in a device which, in normal use,
prevents
removal or ingestion of its contents.
(b) in
other forms. 9 1
Carbamide peroxide
(a) more
than 9 per cent up to 30 per cent. 5 1
(b) more
than 30 per cent up to 60 per cent. 5 2
(c) more
than 60 per cent. 2 2,4
Carbon disulphide 12 1,4,8,9,23
Carbon tetrachloride 12 1,4,8,9
Cassia oil 4
Chlorinating compounds
(a) in
household cleaning or bleaching 20
preparations.
(b) in
preparations containing less than 11 1,4,10
10
per cent of available chlorine.
(c) in liquid preparations containing 3,18 1,4,6,8,10, 15,16,
10
per cent or more of available chlorine. 17,18,
19,20,22,26
(d) in
dry preparations containing 10 per cent 10,18,22,23 1,4,8,12,13,
or
more of available chlorine. 14,15,16,17, 18,
19,20,21,
22,26
(e) in
dry preparations containing 10 per cent 10,18,22 1,4,8,12,13,
or more of available chlorine
certified by a 14,15,16,17,
relevant State or
Territory authority as not 18,19,20,21,
being a
Dangerous Good of Class 5, 22,26
Division 5.1:Oxidising
substances,
as
specified in the Australian Code for
the
Transport
of Dangerous Goods by Road
and
Rail.
(f) in
compressed block or tablets containing 10,22,23 12,13,14,15,
10 per cent or more of
available chlorine 17,18,19,21
except
in preparations for use in toilet
cisterns only,
containing 15 g or less of
trichloroisocyanuric
acid.
(g) in other compressed
blocks or tablets 10,22 12,13,14,15,
containing
10 per cent or more of available 17,18,19,21
chlorine
certified by a relevant State or
Territory
authority as not being a Dangerous
Good
of Class 5,
Division 5.1: Oxidising
substances,
as specified in the Australian
Code
for the Transport of Dangerous Goods
by
Road and Rail except in preparations for
use
in toilet cisterns only, containing 15 g or
less
of trichloroisocyanuric acid.
Chloroform when
included in Schedule 6 1,4,8
alpha-Chlorohydrin 13,51 1,4,8,9
Chromates (including
dichromates) of alkali metals or ammonia 1,4,8
Chromium trioxide 2,14,15,23 1,4,8,13
Cimetidine when
included in Schedule 3 70,96
Cinnamon bark oil 4
Clobetasone when
included in Schedule 3. 72,73,74,75,95
Clotrimazole in
vaginal preparations when included 54,63,64,66
in
Schedule 3.
Clove oil 1
Cyanides when included
in Schedule 7. 13 4,8
Cyanuric acid 1,4,8
Cyclohexanone peroxide 1,4,8
Cysteamine 1
4,4-Diaminodiphenylmethane
(methylene dianiline) 1,4,8
ortho-Dichlorobenzene 1,4,8
para-Dichlorobenzene 1,4
Dichloroethylene 1,4,8
Dichloroethyl ether 1,4,8
Dichloroisocyanurates
(a) in
household cleaning or bleaching 20
preparations.
(b) in
preparations containing less than 11 1,4,10
10 per
cent of available chlorine. .
(c) in
liquid preparations containing 10 per cent 3,18 1,4,6,8,10,
or
more of available chlorine. 15,16,17,18,
. 19,20,22,26
(d) in
dry preparations containing 10 per cent 10,18,22,23 1,4,8,12,13,14,
or
more of available chlorine. 15,16,17,18,19,
. 20,21,22,26
(e) in dry
preparations containing 10 per cent 10,18,22 1,4,8,12,13,14,
or
more of available chlorine certified by a 15,16,17,18,19,
relevant
State or Territory authority as not 20,21,22,26
being
a Dangerous Good of Class 5,
Division
5.1: Oxidising
substances, as
specified
in the Australian Code for the
Transport
of Dangerous Goods by Road
and
Rail.
(f) in
anti-bacterial tablets containing 2.5 g or 60
less of sodium dichloroisocyanurate..
(g) in
other compressed blocks or tablets containing 10,22,23 12,13,14,15,
10 per cent or more of available
chlorine except 17,18,19,21
in preparations containing 21 g or
less of sodium
dichloroisocyanurate
for use in toilet cisterns only.
(h) in other compressed
blocks or tablets containing 10,22 12,13,14,15,17,
10
per cent or more of available chlorine 18,19,21
certified
by a relevant State or Territory authority
as
not being a Dangerous Good of Class 5,
Division
5.1: Oxidising
substances, as specified
in the Australian
Code for the Transport of
Dangerous
Goods by
Road and Rail except in
preparations
containing 21 g less of sodium
dichloroisocyanurate
for use in toilet cisterns only.
(i) in
other compressed blocks or tablets containing
10
per cent or more of available chlorine in
preparations
containing 5 g or less of sodium
dichloroisocyanurate
for use in toilet bowls only:
(i) during
storage 10,22,23 12,13,14,15,17,
18,21
(ii) during
use 5 1,4,7,12
(j) in other compressed
blocks or tablets containing
10
per cent or more of available chlorine certified
by
a relevant State or Territory authority as not
being
a Dangerous Good of Class 5,
Division 5.1:
Oxidising substances,
as specified in the
Australian
Code for the Transport of Dangerous
Goods
by Road and Rail
in preparations
containing
5 g or less of sodium dichloroisocyanurate
for
use in toilet bowls only.
(i) during
storage 10,22 12,13,14,15,17,
18,21
(ii) during
use 5 1,4,7,12
Dichloromethane
(methylene chloride)
(a) in
paint or lacquer removers. 12,16 1,4,8,11
(b) other
than in paint or lacquer removers 1,4,8,25
Diclofenac 101,104
Dienestrol 67
Diethanolamine when
included in Schedule 5. 5 1,4
Diethanolamine when
included in Schedule 6. 2,11,18 1,4,8
Diethyltoluamide for
human use. 44
5,6-Dihydroxyindoline 21,28
Dimethylformamide 1,4,8
Dimethyl sulfate 2 1,4,8
Dimethyl sulfoxide
(a) when
not packed and labelled for therapeutic use. 27 1,4,5,8
(b) when
packed and labelled for treatment of animals. 49 1,4,5,8
Dinitrocresols (and
their homologues) except when for 1,4,8
therapeutic
use.
Dinitrophenols (and
their homologues) except when 1,4,8
for therapeutic
use.
Dinocap 47
Dioxane 1,4,8
Diphenoxylate when
included in Schedule 3. 39 or 40,41
Econazole in vaginal
preparations when included 54,63,64,66
in
Schedule 3.
Ephedrine in nasal
preparations for topical use. 29
Epichlorohydrin 2 1,4,8
Epoxy resins, liquid. 1,3,4,5,8
Ethanolamine when
included in Schedule 5. 5 1,4
Ethanolamine when
included in Schedule 6. 2,11,18 1,4,8
Ether when included in
Schedule 5 or 6. 1,4,8
Ethoxyethylmercuric
chloride 1,4
Ethyl bromide 1,4,8
Ethylene chlorohydrin 1,4,8
Ethylene glycol monoalkyl
ethers and their acetates 1,4,8
except when separately specified.
Ethylene oxide 1,4,8
Ethylmercuric chloride 1,4
Ethyl methacrylate 28 4,9,23
Etretinate 7,62,76
Eugenol 1
Famotidine when
included in Schedule 2. 96
Fenoterol in metered
aerosols. 32
Fluconazole in oral
preparations when included in 64
Schedule 3.
Fluorides (including
silicofluorides) when included in 1,4
Schedule
5 or 6 except when separately specified.
Formaldehyde
(a) in
nail hardener cosmetics. 106 1,4,8,36
(b) in
other preparations. 106 1,4,8
Formic acid 1,4,8
Furfural 5 1,4
Glazing preparations
containing lead compounds.. 50
Glutaraldehyde except
when in Schedule 2
(a) 25
per cent or less. 5,59 1,4,5
(b) more
than 25 per cent. 3,59 1,4,5,8
Glycolic acid 79 1,5,6,31
Hexachlorophane in
preparations for skin cleansing 24
purposes containing
3 per cent or less of
hexachlorophane.
Hexyloxyethanol 2 1,4,8
Hydrazine 1,4,8
Hydrochloric acid
(a) 30
per cent or less of HCl. 1,4
(b) more
than 30 per cent of HCl. 1,4,8
Hydrocortisone
(a) for dermal use when
included in 38,72,73,74,75
Schedule
2 or 3.
(b) for topical rectal use
when includeed 38,75
in
Schedule
2 or 3.
Hydrocyanic acid when
included in Schedule 7. 13 4,8
Hydrofluoric acid
(including mixtures that generate
hydrofluoric
acid)
(a) when
included in Schedule 5. 2 1,4
(b) when
included in Schedule 6 or 7. 1,17,93 1,3,4,5,8,29,35
Hydrogen peroxide
(a) more
than 3 per cent up to 10 per cent. 5 1
(b) more
than 10 per cent up to 20 per cent. 5 2
(c) more
than 20 per cent. 2 2,4
Hydroquinone
(a) when
in Schedule 2. 45
(b) except
when in Schedule 2 or 4. 1,4
Hydrosilicofluoric
acid (including mixtures
that
generate hydrosilicofluoric acid)
(a) when
included in Schedule 5. 2 1,4
(b) when
included in Schedule 6 or 7. 1,17,93 1,3,4,5,8,29,35
8-Hydroxyquinoline
(including salts and 33
derivatives)
when prepared for
internal
use.
Ibuprofen 101,104
Iodine
(a) more
than 20 per cent. 1,4,8
(b) in
preparations for human internal therapeutic 91,92
use containing 300
micrograms or more of
iodine
per recommended daily dose.
Ipratropium bromide in
metered aerosols. 32
Isocyanates (free
organic)
(a) when
in paint. 28,52 1,5,8,10,27
(b) other
than in paint. 28,52 1,4,8
Isoprenaline in
metered aerosols 32
Isotretinoin
(a) for
human oral use. 7,62,76
(b) for
topical use. 62,77
Lead
compounds
(a) in
hair cosmetics. 25
(b) when
in Schedule 6. 1,4,8
Leflunomide 7,62,87
Lemon oil 89
Lenalidomide 7,62,76
Levocabastine
(a) in
eye or nasal preparations containing 62
0.5
mg/mL or less of levocabastine.
(b) in
other preparations. 62
and
either
39 or 40
Lime oil 89
Loperamide when in
Schedule 2. 41
Magnesium chlorate 1,4
Mefenamic acid 101,104
Mercuric thiocyanate 1,4
Metacresolsulphonic
acid and formaldehyde 1,4
condensation
product for the treatment of animals.
Methanol except
in methylated spirit. 1,4,8
Methoxamine in nasal
preparations for topical use. 29
Methyl chloride 1,4,8
Methyl ethyl ketone 5 1,4,8
Methyl ethyl ketone oxime 5,28 1,4
Methyl ethyl ketone
peroxide 2 2,3,4,6
Methyl iso-amyl ketone 1,4,8
Methyl iso-butyl ketone 1,4,8
Methyl iso-thiocyanate 5,12 1,4,8
Methyl methacrylate 28 4,9,23
Methyldibromo
glutaronitrile 28 1,4,7
Methylene
bisthiocyanate 1,4
Methyleugenol 1,6
Methylnorbornylpyridine 59
1-(beta-Methyl
sulphonamidoethyl)- 2-amino-3-
N,N-diethylaminobenzene 1,4,8
Miconazole in vaginal
preparations when included 54,63,64,66
in
Schedule 3.
Misoprostol 53
Naphazoline in nasal
preparations for topical use. 29
Naphthalene
(a) in
block, ball, disc, pellet or flake form, 9,105
enclosed
in a device which, in normal
use,
prevents removal or ingestion of its
contents.
(b) in
other forms. 9,105 1
Naproxen 101,104
Nicotine except
when in tobacco or when included 1,4
in Schedule 2.
Nitric acid
(a) 75
per cent or less HNO3. 2 1,4
(b) more
than 75 per cent HNO3. 2 1,4,8
Nitrobenzene 1,4,8
Nitrophenols 1,4
Nitroprussides in
aerosols. 84 8
Nizatidine when
included in Schedule 2. 96
Noradrenaline in
metered aerosols. 32
Nystatin in vaginal
preparations when included 54,63,64,65,66
in
Schedule 3.
Orange oil (bitter) 89
Orciprenaline in
metered aerosols. 32
Oxalates, metallic 4,8
Oxalic acid 2 4,8
Oxymetazoline in nasal
preparations for topical use. 29
Paint
(a) First
Schedule paints. 83
(b) Second
Schedule paints. 84
Paracetamol 97
and/or 98,99,100
Pentachlorophenol 1,4,8
Peracetic acid 2 1,4,8
Permanganates 2 24
2-Phenoxyethanol 5 1
Phenol and any other
homologue of phenol. 1,4
Phenols 5
Phenylenediamines and
alkylated
phenylenediamines
(a) in
hair dyes. 21
(b) in
preparations other than hair dyes. 1,4,8
Phenylephrine in nasal
preparations 29
for
topical use.
N,N-bis(phenylmethylene)-bicyclo-
(2.2.1)heptane-2,5-dimethanamine 5,28 1,4,5,10
N,N-bis(phenylmethylene)-bicyclo-
(2.2.1)heptane-2,6-dimethanamine 5,28 1,4,5,10
ortho-Phenylphenol except
when in 1,4
antiseptics.
Phenylpropanolamine 56
Phenytoin in pastes
for the treatment of horses. 9
Phosphonic acid 1,4
Phosphoric acid 1,4
Phosphorus (yellow) 2 1,4
ortho-Phthalaldehyde
(a) when
included in Schedule 5. 51,52,59 1,4,5,8,10
(b) when
included in Schedule 6. 51,52,59 2,4,5,8,10
Picric
acid (more than 20 per cent). 1,4
Podophyllin
(a) in
preparations specifically for use on 36
anal
or genital area.
(b) in
other liquid preparations when included 31
in
Schedule 2 or Schedule 3.
(c) in
other solid or semi-solid preparations 30
when
included in Schedule 2.
Podophyllotoxin
(a) in
preparations specifically for 36
use
on anal or genital area.
(b)
in other liquid preparations when included 31
in
Schedule 2 or Schedule 3.
(c) in
other solid or semi-solid preparations 30
when
included in Schedule 2.
Polihexanide 1,4,8
Polyethanoxy (15)
tallow amine 1,4
Poly(oxy-1,2-ethanediyl),
α -[2-[(2-hydroxyethyl)amino] 5,88 1,5
-2-oxoethyl]-
α -hydroxy-,mono-C13-15 -alkyl ethers
Potassium hydroxide
(a) in
preparations containing 5 1,4,6
0.5
per cent or less of potassium
hydroxide.
(b) in
solid preparations containing 2,10,78 3,5,28
more
than 0.5 per cent of potassium
hydroxide.
(c) in
liquid preparations containing 2,10,78 3,5
more than 0.5
per cent of potassium
hydroxide.
Potassium
metabisulphite 5,26 1,4
Potassium nitrite in
pickling or curing salts. 94
Potassium persulfate 5,21,25 1,5,23,33,34
Potassium sulfide 2 1,4
Propionic acid when in
Schedule 6. 2 1,4
Ranitidine when
included in Schedule 2. 96
Safrole
(a) in
preparations for therapeutic use. 1
(b) other
than for therapeutic use. 1,4
Salbutamol in metered
aerosols or in dry 32
powder formulations.
Salicylamide 34
or 35
Sassafras oil
(a) in
preparations for therapeutic use. 1
(b) other
than for therapeutic use. 1,4
Selenium compounds except
when for 1,4,8
therapeutic
use (human or animal).
Silver in smoking
deterrents. 42
Sitaxentan 7,
62, 76
Sodium aluminate 2 1,4
Sodium chlorate 1,4
Sodium dodecylbenzene
sulfonate 79 1
Sodium fluoride in
preparations for 43
human
ingestion when in Schedule 2.
Sodium hydrogen sulfate 1,4,8
Sodium hydrosulfite 5,26 1,4,8
(more than 50 per
cent)
Sodium hydroxide
(a) in
preparations containing 0.5 per cent 5 1,4,6
or
less of sodium hydroxide.
(b) in
solid preparations containing more than 2,10,78 3,5,28
0.5 per
cent of sodium hydroxide.
(c) in
liquid preparations containing more than 2,10,78 3,5
0.5 per
cent of sodium hydroxide.
Sodium laureth-6
carboxylate 79 1
Sodium metabisulphite 5,26 1,4
(more
than 50 per cent)
Sodium nitrite in
pickling or curing salts 94
Sodium persulfate 5,21,25 1,5,23,33,34
Sodium sulfide 2 1,4
Styrene 1,4,8
Sulfamic acid 2 1,4
Sulfuric acid 2 1,4
Symphytum spp.
(Comfrey) when included in Schedule 5. 31,32
Tazarotene for topical
use. 77,62
Terbutaline in metered
aerosols or in dry powder formulations. 32
Terfenadine 61
Teriflunomide. 7,62,87
Terpenes, chlorinated 1,4,8
Tetrachloroethane 12 8
Tetrachloroethylene when
in Schedule 5 or 6. 12,16 1,4,8,11
Tetrahydrozoline in
nasal preparations for topical use. 29
Thalidomide 7,62,76
Thiourea 1,4
Toluene 1,4,8
Toluenediamine
(a) in
hair dyes. 21
(b) in
preparations other than hair dyes. 1,4,8
Tramazoline in nasal
preparations for topical use. 29
Tretinoin
(a) for
human oral use. 7,62,76
(b) for
topical use. 62,77
Triamcinolone when in
topical preparations 64 or 68
for the
treatment of mouth ulcers.
Trichloroacetic acid except
when for 2 1,4
therapeutic
use.
1,1,1-trichloroethane 8,9
Trichloroethylene except
when for 12 1,4,5,8,9
therapeutic use.
Trichlorophenol 1,4,8
Triethanolamine 5 1,4
Triethyl phosphate 1,4,8
Trifluoromethanesulfonic
acid
(a) more
than 10 per cent. 1,17 1,4,8
(b) 10
per cent or less. 1,4,8
Triisopropanolamine
lauryl ether sulfate 1,4,6
3,6,9-Trioxaundecanedioic
acid 5 1
Tymazoline in nasal
preparations for topical use. 29
Vinclozolin 46
Xylene 1,4,8
Xylometazoline in
nasal preparations for topical use. 29
Zinc chloride 1,4
Zinc sulfate when in
Schedule 6. 1,4
The requirements of
this Standard do not apply to a poison listed in Column 1 of this Appendix at a
concentration not more than that specified in Column 2 in respect of that
poison.
Column 1 Column
2
Poison Concentration
(quantity
per litre
or
kilogram)
ACETYLCHOLINE 1
mg
ALDOSTERONE 10
micrograms
ANTIMONY COMPOUNDS 1
mg
APOMORPHINE 1
mg
ARSENIC 1
mg
ATROPA BELLADONNA
(belladonna) 300 micrograms
ATROPINE 300
micrograms
CANTHARIDIN 10
micrograms
CHLORINE 5
mg
CROTON TIGLIUM (croton
oil) 1 mg
DIOXANE 100
mg
ERYSIMUM spp. 1
mg
FOLLICLE-STIMULATING
HORMONE 100 micrograms
GELSEMIUM SEMPERVIRENS 1
mg
GLUCAGON 100
micrograms
GLYCERYL TRINITRATE 100
micrograms
GROWTH HORMONE 10
micrograms
HALOPERIDOL 1
mg
HYDROCYANIC ACID 1
microgram
HYOSCINE 300
micrograms
HYOSCYAMINE 300
micrograms
HYOSCYAMUS NIGER 300
micrograms
HYPOTHALAMIC RELEASING
FACTORS 10 micrograms
INDOMETHACIN 1
mg
MERCURY 1
mg
METHYLMERCURY 300
micrograms
NAPHTHALENE 1
mg
NERIUM OLEANDER 1
mg
OESTRADIOL 10
micrograms
OESTRONE 100
micrograms
OXYTOCIN 1
microgram
PHOSPHORUS 1
mg
PODOPHYLLUM RESIN
(podophyllin) 1 mg
PROGESTERONE 1
mg
PROPRANOLOL 1
mg
SELENIUM 100
micrograms
STROPHANTHUS spp. 1
mg
STRYCHNINE 1
mg
TESTOSTERONE 1
mg
THYROXINE 10
micrograms
Butoconazole.
Clotrimazole.
Diclofenac.
Dimenhydrinate for the prevention
and relief of motion sickness.
Diphenoxylate.
Econazole.
Fluconazole.
Hydrocortisone.
Miconazole.
Nystatin.
This Appendix provides regulations for adoption by
the States and Territories.
1. A person must
not manufacture, sell, supply or use a First Schedule Paint for application to:
(1) a roof
or any surface to be used for the collection or storage of potable water; or
(2) furniture;
or
(3) any fence, wall,
post, gate or building (interior or exterior) other than a building which is
used exclusively for industrial purposes or mining or any oil terminal; or
(4) any
premises used for the manufacture, processing, preparation, packing or serving
of products intended for human or animal consumption.
2. A person must not manufacture, sell, supply
or use a Third Schedule paint.
3. A person must not manufacture, sell, supply
or use a paint for application to toys unless the paint complies with the
specification for coating materials contained in Australian/New Zealand
Standard AS/NZS ISO 8124.3:2012 entitled Safety of toys Part 3: Migration of
certain elements (ISO 8124-03:2010, MOD).
4. A person must not manufacture, sell, supply,
or use a paint containing a pesticide except a fungicide, algicide, bactericide
or antifouling agent.
The First Schedule
The proportion of a substance for
the purposes of this Schedule is calculated as a percentage of the element
present in the non-volatile content of the paint.
Substance Proportion
ANTIMONY
or antimony compounds other than more
than 5 per cent
antimony
titanate pigments
BARIUM
salts except barium sulfate or barium metaborate more
than 5 per cent
CADMIUM
or cadmium compounds more
than 0.1 per cent
CHROMIUM
as chromates of ammonia, barium, potassium, more
than 5 per cent
sodium,
strontium or zinc
SELENIUM
or selenium compounds more
than 0.1 per cent
The Second Schedule
Substance Proportion
CHROMIUM
as chromates of ammonia, more
than 5 per cent
barium, calcium, iron,
potassium, sodium,
strontium or zinc
DICHLOROMETHANE
(methylene chloride) more
than 5 per cent by wt
ETHYLENE GLYCOL MONOALKYL ETHERS and their acetates more than 10 per
cent by vol
HEXYLOXYETHANOL more
than 10 per cent by vol
TOLUENE more
than 50 per cent by vol
XYLENE more
than 50 per cent by vol
The Third Schedule
The proportion of a substance for
the purposes of this Schedule is calculated as a percentage of the element
present in the non-volatile content of the paint.
Substance Proportion
LEAD or lead compounds more
than 0.1 per cent
PART
1
CONDITIONS
FOR AVAILABILITY AND USE
The following controls
are recommended for poisons only when included in Schedule 7. These conditions
for availability and use may be implemented through poisons controls or other
State or Territory legislation.
1. Not to be available except to authorised or
licensed persons.
2. Not to be used in printing inks.
3. Not to be used except by or in accordance
with the directions of accredited government vermin control officers.
4. Not
to be used in industries which handle, process or store foods, animal feeds or
packaging materials.
PART 2
A poison listed in this Appendix is to be available
only in accordance with the conditions specified beside it in the “Conditions”
column. The conditions apply only when the poison is included in Schedule 7.
_________________________________________________________________________________
POISONS CONDITIONS
_________________________________________________________________________________
Abamectin 1
Acibenzolar-s-methyl 1
Acrolein 1
Acrylonitrile 1
Alachlor 1
Allyl alcohol 1
4-Aminopyridine 1
Arprinocid 1
Arsenic 1
Azocyclotin 1
Benzene 1
Bifluorides (including
ammonium, potassium and sodium salts) 1
Boron trifluoride 1
Brodifacoum 1
Bromadiolone 1
Bromine 1
Brucine 1
Calciferol 1
Captafol 1
Carbadox 1
Carbon tetrachloride 1
Carbonyl sulphide 1
Chlordecone 1
Chlordimeform 1
Chlorine 1
Chloromethiuron 1
Chloropicrin 1
4-Chloro-o-toluidine 1
Colecalciferol 1
Coumatetralyl 1
Cyanogen 1
Cyhexatin 1
4,4-Diaminodiphenylmethane
(methylene dianiline) 1
1,2-Dibromo-3-chloropropane 1
1,3-Dichloropropene 1
Difenacoum 1
4-Dimethylaminoazobenzene 1
Dinitrocresols 1
Dinitrophenols 1
Dinoseb 1
Epichlorohydrin 1
Epidermal growth
factor 1
Etaconazole 1
Ethylene dibromide 1
Ethylene oxide 1
Fluoracetamide 3
Fluoroacetic acid 3
Folpet 1
Halofuginone 1
Halogenated
dibenzodioxins and dibenzofurans 1
HCB 1
Hydrocyanic acid and
cyanides 1
Hydrofluoric acid 1
Hydrosilicofluoric
acid 1
Iodomethane 1
Maduramicin 1
Mercury 1
Methacrifos 1
Methoxyethylmercuric
acetate 1
Methoxyethylmercuric
chloride 1
Methyl bromide 1
4,4’-Methylenebis[2-chloroaniline] 1
Mirex 1
Molinate 1
Nicotine 1
Nitrofen 1
Phenylmercuric acetate 1
Phosphides, metallic 1
Phosphine 1
Propylene oxide 1
Pyrinuron 1
Strychnine 1
Sulcofuron 1
Tetrachloroethane 1
2,2’,6,6’-Tetraisopropyl-diphenyl-carbodiimide 1
Thallium 3
ortho-Tolidine 1
Trichloroisocyanuric
acid 1
Vinyl
chloride 1
(see Part 2, Labels
and Containers, subparagraph 14(2))
Alprazolam
Amisulpride
Amitriptyline
Amylobarbitone
Aripiprazole
ASENAPINE
Azatadine
Baclofen
Benztropine
Bromazepam
Brompheniramine
Buclizine
Buprenorphine
Butobarbitone
Cetirizine
Chloral
hydrate
Chlordiazepoxide
Chlormethiazole
Chlorpheniramine
Chlorpromazine
Clemastine
Clomipramine
Clonazepam
Clonidine
Clorazepate
Clozapine
Codeine except when
included in Schedule 2 or 3.
Cyclizine
Cyclobarbitone
Cycloserine
Cyproheptadine
Cysteamine
Dantrolene
Desipramine
Dexchlorpheniramine
Dextromoramide
Dextropropoxyphene
Diazepam
Difenoxin
Dihydrocodeine
Dimenhydrinate
Dimethindene
Diphenhydramine
Diphenoxylate
Diphenylpyraline
Dothiepin
Doxepin
Doxylamine
Dronabinol (delta-9-tetrahydrocannabinol)
Droperidol
Duloxetine
Ethylmorphine
Fenfluramine
Flunitrazepam
Flupenthixol
Fluphenazine
Flurazepam
Gabapentin
Gemcitabine
Glutethimide
Haloperidol
Hydrocodone
Hydromorphone
Hydroxyzine
Imipramine
Lamotrigine
Levetiracetam
Levocabastine
Lorazepam
LURASIDONE.
Mazindol
Mebhydrolin
Meclozine
Medazepam
Meprobamate
Mepyramine
Methadone
Methdilazine
Methocarbamol
Methylphenobarbitone
Mianserin
Mirtazapine
Morphine
NABIXIMOLS .
Nalbuphine
Nitrazepam
Normethadone
Nortriptyline
Olanzapine
Opium
in any
form except the alkaloids noscapine and papaverine.
Oxazepam
Oxycodone
Paliperidone
Papaveretum
Pentazocine
Pentobarbitone
PERAMPANEL
Pericyazine
Perphenazine
Pethidine
Phenelzine
Pheniramine
Phenobarbitone
Phenoperidine
Phenyltoloxamine
Pholcodine
Pimozide
Pizotifen
Prazepam
Pregabalin
Prochlorperazine
Promazine
Promethazine
Protriptyline
Quetiapine
Quinalbarbitone
RETIGABINE
Risperidone
Rotigotine
RUPATADINE
Secbutobarbitone
TAPENTADOL
Temazepam
Thenyldiamine
Thiethylperazine
Thiopropazate
Thioridazine
Thiothixene
Tramadol
Tranylcypromine
Trifluoperazine
Trimeprazine
Trimipramine
Triprolidine
Ziprasidone
Zolpidem
Zonisamide
Zopiclone
PART 1
GENERAL
REQUIREMENTS FOR DISPENSING LABELS
(see Part 2, Labels and Containers, subparagraph
14(1))
(1) All
details, words and other required information on a label on a container of a
substance for therapeutic use must be in the English language in letters at
least 1.5 millimetres in height.
(2) All
symbols, numbers and words on a label must be in durable characters.
(3) The
label on a container of a substance for therapeutic use must contain the
following details:
(a) the name,
address and telephone number of the dispenser supplying the substance;
(b) the
approved name of the substance and/or its proprietary name (unless it is a
preparation compounded in accordance with the dispenser’s own formula);
(c) adequate
directions for use;
(d) the
strength and form of the substance;
(e) the total
quantity of the goods in the container;
(f) the
words “KEEP OUT OF REACH OF CHILDREN” in red on a white background;
(g) if the
substance is intended for external use only, the word “POISON”, or the words
“FOR EXTERNAL USE ONLY”, in red on a white background;
(h) if the
substance is a medicine, the name of the person for whom it was dispensed; and
(i) if
the substance is a veterinary chemical, the species of animal, the name of the
animal’s owner and the words “FOR ANIMAL TREATMENT ONLY”.
(4) The
label on a container of a medicine or veterinary chemical that is supplied on
prescription must also include:
(a) the
prescription reference number;
(b) the date
on which the prescription was supplied (unless that date is clear from the
prescription reference number); and
(c) the
directions for use set out in the prescription.
PART 2
ADDITIONAL LABELLING REQUIREMENTS FOR CERTAIN HUMAN
MEDICINES
(see Part 2, Labels and Containers, subparagraph
14(2))
Medicines
required to be labelled with certain warning statements A substance listed in Column 1 of the
following table must be labelled with the warning statement in Appendix F, Part
1, as specified opposite in Column 2.
______________________________________________________________
Column 1 Column
2
Substance Warning
statement
______________________________________________________________
Acitretin:
(i)
for oral use. 7,62
and 76
(ii)
for topical use. 62
and 77
Adapalene:
(i)
for oral use. 7,
62 and 76
(ii)
for topical use. 62
and 77
Ambrisentan. 7,
62 and 76
Bexarotene:
(i)
for oral use. 7,
62 and 76
(ii)
for topical use. 62
and 77
Bosentan. 7,
62 and 76
Dienestrol. 67
Etretinate:
(i)
for oral use. 7,
62 and 76
(ii)
for topical use. 62
and 77
Fingolimod. 76
Isotretinoin:
(i)
for oral use. 7,
62 and 76
(ii)
for topical use. 62
and 77
Leflunomide. 7,
62 and 76
Lenalidomide:
(i)
for oral use. 7,
62 and 76
(ii)
for topical use. 62
and 77
Levocabastine. 62
Misoprostol. 53
Sitaxentan. 7,
62 and 76
Teriflunomide. 7,
62 and 87
Thalidomide:
(i)
for oral use. 7,
62 and 76
(ii)
for topical use. 62
and 77
Tretinoin:
(i)
for oral use. 7,
62 and 76
(ii)
for topical use. 62
and 77