Labelling Drugs Poisons Guide

A GUIDE TO
LABELLING DRUGS AND POISONS

in accordance with the Standard for the Uniform Scheduling of
Drugs And Poisons
October 2007
This Guide is based on the requirements for labelling of scheduled drugs and poisons
which became effective on 1 September 2007. These requirements are constantly
under review and future modifications are to be anticipated.
! CONTENTS "
INTRODUCTION
POISON SCHEDULE CLASSIFICATION
III
INTERPRETATION
IV
LABELLING
General
Legibility
1
1
Elements of a Label
Signal Words
Cautionary Statements
Declaration of the Contents
Directions for Use
Safety Directions
Warning Statements
First Aid
Manufacturer or Distributor
Modified Labelling
Transport Containers and Wrappings
Dispensary, Industrial, Laboratory and Manufacturing Chemicals
Dispensed Medicines
Immediate Wrappers
Selected Containers and Measure Packs
Ampoules, Prefilled Syringes and Injection Vials
Gas Cylinders
Paints and Tinters
Camphor and Naphthalene
Essential Oils
3
3
4
5
6
6
6
7
7
7
7
7
8
8
8
8
9
9
10
10
Schedule 2 Requirements
11
13
15
17
20
22
25
State and Territory Labelling Advice.
28
Reference Books
30
INTRODUCTION
The Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) contains certain legal
requirements for the labelling of poisons and drugs that are for sale to the public. The labelling system
it contains was initially designed to harmonise the requirements of Australia and New Zealand and was
phased in over a five year period which commenced on 1 July 1995 and ended on 30 June 2000. In
July 2004 the Required Advisory Statements for Medicine Labels (RASML) document was established
by the Therapeutic Goods Administration to enable the transfer of all mandatory label advisory
statements from the SUSDP and the Therapeutic Goods Regulations to a new document, separate from
but linked to TGO 69 - General requirements for labels for medicines (the Labelling Order)
[http://www.tga.gov.au/docs/html/tgo/tgo69.htm]. The Labelling Order makes it mandatory for
medicine labels to include any label advisory statements specified in Required Advisory Statements for
Medicine Labels. The RASML provided a one-year transition period for existing products and took
full effect on 1 July 2005. As a consequence the majority of SUSDP medicines advisory labelling
requirements were replaced with references to the RASML, effective May 2006.
This Guide has been prepared to assist manufacturers and packers of poisons to draft labels which
comply with the SUSDP requirements as they exist on 1 January 2007. The information it contains is
not complete nor is it intended to be the sole source of reference. It is essential for users of this Guide
to also refer to the SUSDP and Commonwealth, State or Territory legislation which relate to the
packaging and labelling of drugs, poisons, therapeutic goods, agricultural chemicals and veterinary
chemicals. To assist the reader to refer back to the SUSDP, references to relevant paragraphs and subparagraphs have been included in this Guide.
A separate Guide to the Packaging, Labelling and Regulation of Paints, Tinters and Related Products
is also available.
The following publications also should be used for guidance, where appropriate, when designing labels
for therapeutic goods, agricultural products, veterinary products, paints or dangerous goods:
#
Therapeutic Goods Order No. 69 - General requirements for labels for medicines;
Therapeutic Goods Order No. 69A - Amendment to Therapeutic Goods Order No. 69 General requirements for labels for medicines;
The Required Advisory Statements for Medicine Labels;
Therapeutic Goods Order No. 37 General Requirements for labels for Therapeutic Devices;
Labelling Code of Practice: Designing usable non-prescription medicine labels for consumers;
Best practice guideline on prescription medicine labelling;
Veterinary Labelling Code: The Code of Practice for Labelling Veterinary Chemical Products;
Ag Labelling Code;
FAISD Handbook: Handbook of First Aid Instructions, Safety Directions and Warning
Statements for Agricultural and Veterinary Chemicals;
Australian Dangerous Goods Code (ADG) (Australian Code for the transport of dangerous
goods by road and rail);
National Code of Practice for the Labelling of Workplace Substances; and
NDPSC Guide to the Packaging, Labelling and Regulation of Paints, Tinters and Related
Products. [www.tga.gov.au/ndpsc/paintgui.htm]
A listing of all publications quoted in this Guide, and where they can be obtained from, is included in
the Reference Books section at the end of this document
As poisons labelling is the responsibility of the States and Territories, when further information or
assistance is required reference should be made to these contacts, not to the National Drugs and
Poisons Schedule Committee (NDPSC). A list of State and Territory contacts is included at the end of
this Guide.
ii
POISON SCHEDULE CLASSIFICATION

Before drafting a label for any preparation, it is necessary to determine the poisons schedule
classification for the preparation. This may be done by referring to the SUSDP schedules (Part 4). For
the greater part, the States and Territories have adopted the SUSDP classification for poisons, however
some variation may occasionally occur owing to local circumstances. Therefore, the poisons schedules
of each jurisdiction also should be consulted to ensure compliance with local legal requirements.
Where a preparation contains two or more poisons which are included in different SUSDP schedules
the following order of precedence should be followed and the preparation be classified according to the
ingredient which is in the schedule highest in the following order #
#
#
#
#
#
#
Schedule 8
Schedule 4
Schedule 7
Schedule 3
Schedule 2
Schedule 6
Schedule 5
For example, a preparation containing poisons included in Schedules 5, 6 and 7 is classified as a

Schedule 7 poison and must be labelled accordingly, with the name and quantity of every poison in the
preparation to be declared on the label.
iii
INTERPRETATION
[Taken from SUSDP Part 1.]
In this Guide, unless the contrary intention appears

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 animals food.
'Appropriate authority' means:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
in the Australian Capital Territory, ACT Health;

in New South Wales, the Director-General of New South Wales Health;
in Northern Territory, the Chief Health Officer of the Department of Health and
Community Services;
in Queensland, the Chief Executive of Queensland Health;
in South Australia, the Chief Executive of the Department of Health;
in Tasmania, the Secretary of the Department of Health and Human Services;
in Victoria, Secretary of the Department of Human Services;
in Western Australia, the Chief Executive Officer, Department of Health.
'Approved name' means:

(a)
(b)
in relation to a poison that is for therapeutic use:(i)
the Australian Approved Name for the poison, not including synonyms, as listed
in the publication entitled Therapeutic Goods Administration Approved
Terminology for Medicines, July 1999, or its successor, published by the
Therapeutic Goods Administration, Canberra; or, if the poison is not listed in that
publication,
(ii)
the international non-proprietary name recommended for the poison by the World
Health Organisation; or, if no such name is recommended,
(iii)
the English name, not including synonyms, by which the poison is described in
the British Pharmacopoeia, the British Pharmaceutical Codex, the Australian
Pharmaceutical Formulary and Handbook or the British Pharmacopoeia
(Veterinary); or, if the poison is not described in any of those publications,
(iv)
the approved name given to the poison by the Medicines Commission of Great
Britain; or, if no such name is given,
(v)
the accepted scientific name or the name descriptive of the true nature and origin
of the poison;
in relation to a poison that is not for therapeutic use:

(i)
the English name recommended by the Standards Association of Australia as the

common name for the poison; or, if no such name is recommended,
(ii)
the English name given to the poison by the International Organisation for
Standardisation; or, if no such name is given,
(iii)
the English name given to the poison by the British Standards Institution; or, if no
such name is given,
(iv)
the Australian Approved Name for the poison, not including synonyms, as listed
in the publication entitled Therapeutic Goods Administration Approved
Terminology for Drugs, January 1993 (ISBN 0 644 28628 8),,or its successor,
iv
published by the Australian Government Publishing Service; or, if the poison is

not listed in that publication,
(v)
the English name, not including synonyms, by which the poison is described in
the British Pharmacopoeia, the British Pharmaceutical Codex, the Australian
Pharmaceutical Formulary and Handbook or the British Pharmacopoeia
(Veterinary); or, if the poison is not described in any of those publications,
(vi)
the approved name given to the poison by the Medicines Commission of Great
Britain; or, if no such name is given,
(vii)
the international non-proprietary name recommended for the poison by the World
Health Organisation; or, if no such name is recommended,
(viii) the accepted scientific name or the name descriptive of the true nature and origin
of the poison.
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)
(b)
(c)
a closure that complies with the requirements for a child-resistant closure in the
Australian Standard AS1928-2001 entitled Child-resistant packages as specified or
amended from time to time;
a closure approved by any order made under section 10(3) of the Commonwealth
Therapeutic Goods Act 1989; or
in the case of a can fitted with a press on lid, a lid of the design known as 'double tight'
or 'triple tight'.
Child-resistant packaging means packaging that:

(a)
complies with the requirements of the Australian Standard AS1928-2007 entitled Childresistant packages as specified or amended from time to time;
(b)
is reclosable and complies with the requirements of at least one of the following
standards as specified or amended from time to time.
(c)
(i)
the International Organization for Standardization Standard ISO 8317:1989

entitled Child-resistant packaging - Requirements and testing procedures for
reclosable packages;
(ii)
the British Standards Institution Standard BS EN 28317:1993 entitled Childresistant packaging - Requirements and testing procedures for reclosable
packages;
(iii)
the Canadian Standards Association Standard CSA Z76.1-99 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;
is approved as child-resistant by any order made under section 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 nonreclosable packages) of Australian Standard AS 1928-2001 Child-resistant packages.
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.
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
methyl isobutyl ketone

N-methyl-2-pyrrolidone
N-(N-octyl)-2-pyrrolidone
phenyl methyl ketone
methanol when included in Schedule 5
styrene
methyl ethyl ketone

methyl isoamyl ketone
tetrachloroethylene
1,1,1-trichloroethane.
'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.
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.
vi
'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 statement in writing on a container of a poison.

Main label means, where there are two or more labels on a container or a label is divided into two or
more portions:
(a)
that label or portion of the label on which the name of the product is most prominently
shown and which is primarily designed to attract attention; or
(b)
where the name of the product is equally prominent on two or more labels or portions of
a label, each of those labels or portions of the label on which the name of the product is
equally prominent.
'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.
'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.
'NDPSC' means the National Drugs and Poisons Schedule Committee.
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.
'Non-volatile content' means that portion of a paint or tinter determined to be the non-volatile content
by Method 301.1 of Australian Standard AS 1580.
'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.
Pesticide means any substance or mixture of substances used or intended to be used:
vii
(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 of that name published
by the Therapeutic Goods Administration on 1 July 2004, as in force from time to time.
'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.
'SUSDP' means the Standard for the Uniform Scheduling of Drugs and Poisons.
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 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;

or
(c)
testing the susceptibility of human beings or animals to a disease or ailment.
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.
viii
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.
Writing includes the visible representation or reproduction of words or figures in any form, and to
write and written have corresponding meanings.
ix
LABELLING
[Adapted from SUSDP Part 2]
General
A label is written, printed or graphic matter on or attached to a container to identify its contents and
inform the consumer about its qualities, uses and hazards.
Labels must be written in characters that are durable and be printed on or securely attached to the
outside of the immediate container and, where the immediate container is enclosed in a primary pack,
on the primary pack also. They must not obscure any ribs, embossing or printed words required to be
on a poison container.
As well as the name of the product and its manufacturer, a products label also may be required, by
legislation, to contain one or more of the following elements:
signal word(s) - to warn the consumer of a potential hazard;
cautionary statements - concise general precautions to be observed;
safety directions - precautions to be taken for safe use;
$ warning statements - advice about specific hazards to avoid;
first aid instructions - advice on what to do if poisoned;
Dangerous Goods Classification symbols - Class labels for transport purposes;
name and quantity, proportion or strength of its constituents;
directions for use.
IMPORTANT It is an offence to sell or supply a poison or dangerous good that is not labelled in
accordance with the requirements of State and Territory legislation.
It is the responsibility of the manufacturer, packer or distributor of a poison to ensure that a product is
correctly and adequately labelled.
The following information is provided to assist label designers to comply with the labelling
requirements of the SUSDP which has been made mandatory by adoption into State and Territory
poisons legislation.
When designing a label, the prime concerns should be that it is clear, concise and comprehensible so
that the consumer understands the information that appears on it and that it also complies with the
appropriate labelling regulations.
Legibility
(Paragraphs 3 and 18)
Contrast and colours

As some people have poor sight or colour blindness and the label may have to be read under poorly
lighted conditions, particular attention should be given to the legibility of labels. The colour and
pattern used as the background for a label can have a profound affect on the legibility of the text.
Colours that fade must be avoided when selecting graphic materials for the text on labels. Adequate
contrast must be provided between the writing and the background of the label to maintain legibility
over the widest possible range of reading conditions.
Letter height
All printing, unless otherwise specified, must be 1.5 mm or more in height measured on capital letters
or lower case letters with ascenders or descenders, for example b, d, g, p. Smaller print may be used if
approval has been given by an appropriate authority. Approval will not be given for the use of letters
less than 1mm.
Language
Labels must be written in English and must not include any statement, expression, device, trade name
or description that:
contradicts, qualifies or modifies any expression required by regulation to be on the label;
implies that a poison is safe, harmless, non-toxic or non-poisonous;
implies that the poison is recommended or approved by any government authority;
is false or misleading in relation to the safety of the poison or any of its ingredients;
misrepresents the composition or any property of the poison; or
gives any false or misleading indication of its origin or place of manufacture.
Elements of a Label
Signal Words
[SUSDP sub-paragraphs 7(1)(a)]
The SUSDP requires specific signal words to be placed at the top of the main (front) label of drugs and
poisons. These signal words indicate either the restriction applying to the drug or poison or the relative
danger of the product. The colour of the signal words and the background are no longer specified, but
a distinct contrast with the background is necessary so that these words stand out and are legible even
under poor lighting conditions. The signal words applicable to each schedule are as follows:
Schedule
Signal Words
PHARMACY MEDICINE
PHARMACIST ONLY MEDICINE
PRESCRIPTION ONLY MEDICINE

or
PRESCRIPTION ANIMAL REMEDY
CAUTION
POISON
DANGEROUS POISON
CONTROLLED DRUG
These signal words are required to be:
the first line of the main (front) label. Signal words may be spread over two lines on labels for
small containers;
in bold-face, sanserif, capital letters of uniform thickness; and
not less than half the height of the largest letter or numeral on the label or 1.5 mm
whichever is the larger, however they do not have to be larger than 6 mm on containers
having a capacity of 2 litres or less or 15 mm on containers of more than 2 litres;
The only things permitted to be on the same line of the main label as the signal words are the
Australian Dangerous Goods Code Class labels (e.g. the red diamond 'FLAMMABLE LIQUID' symbol);
and for Schedule 5 poisons, a brief statement about the hazard of the poison which may be placed
alongside the signal word 'CAUTION' (e.g. 'CAUTION' - May irritate eyes). Class labels and hazard
statements are not a mandatory requirement of the SUSDP, but the use of a hazard statement is
encouraged as a means of informing the user of specific problems associated with a product.
Cautionary Statements
[Paragraph 7(1)(b) to (j)]
Unless otherwise specified under the individual statement below, each cautionary statement must:
start on a separate line of the label, but long statements may be spread over two or more
lines if necessary;
be printed in bold-face sanserif capital letters of uniform thickness; and
be printed in letters four-tenths the height of the letters of the signal words.
The only things permitted to be on the same lines as the cautionary statements are the Australian
Dangerous Goods Code Class labels (e.g. the red diamond 'FLAMMABLE LIQUID' symbol). These Class
labels are not a mandatory requirement of the SUSDP, but may be used if the manufacturer so desires.
POSSESSION WITHOUT AUTHORITY ILLEGAL

[Sub-paragraph 7(1)(b)]
This cautionary statement is required on the labels of all Schedule 8 drugs. It is to be placed on the line
immediately below the signal words 'CONTROLLED DRUG' and nothing else can be on the same line.
KEEP OUT OF REACH OF CHILDREN

[Sub-paragraph 7(1)(c)]
This cautionary statement is required on all poison labels and is to be on the line immediately below
the signal words or, in the case of a Schedule 8 drug, immediately below the cautionary statement
'POSSESSION WITHOUT AUTHORITY ILLEGAL'.
FIRE AND EXPLOSION HAZARD

[Sub-paragraph 7(1)(d)]
This cautionary statement is required on all dry chlorinating compounds which have more than 10%
available chlorine. The statement is required to be on the line immediately below the cautionary
statement 'KEEP OUT OF REACH OF CHILDREN'.
BURNS SKIN AND THROAT

[Sub-paragraph 7(1)(e)]
This cautionary statement is required on dish washing machine products which contain alkaline salts
(Schedule 5). It must be placed on the line immediately below the cautionary statement 'KEEP OUT OF
REACH OF CHILDREN'.
CAN KILL IF SWALLOWED

DO NOT PUT IN DRINK BOTTLES
KEEP LOCKED UP
[Sub-paragraph 7(1)(f)]
These cautionary statements are required on the labels of all aqueous solutions containing paraquat
(Schedule 7). Each statement must be on a separate line and the group of statements must be
immediately below the cautionary statement 'KEEP OUT OF REACH OF CHILDREN'.
READ SAFETY DIRECTIONS BEFORE OPENING OR USING

[Sub-paragraph 7(1)(g)]
This cautionary statement is required on the labels of all poisons when safety directions are included on
the label. This may be abbreviated to 'READ SAFETY DIRECTIONS' if there is insufficient room on the
label for the full phrase. It is to be placed either immediately below the cautionary statement 'KEEP
OUT OF REACH OF CHILDREN' or below any other statements that are required to be immediately below
the cautionary statement'KEEP OUT OF REACH OF CHILDREN'.
FLAMMABLE
[Sub-paragraph 7(1)(h)]
Any liquid poison classified as a flammable liquid under the Australian Dangerous Goods Code must
be labelled with the cautionary statement 'FLAMMABLE' in bold-face sanserif capital letters unless it is
already labelled in accordance with that Code.
FOR ANIMAL TREATMENT ONLY

[Sub-paragraph 7(1)(i)]
Any preparation which is intended to be used for the treatment of animals must be labelled with the
cautionary statement 'FOR ANIMAL TREATMENT ONLY'. Apart from being on the main (front) label, the
exact position is not specified.
DO NOT SWALLOW
[Sub-paragraph 7(1)(j)]
This cautionary statement is required on Schedule 5 poisons intended for any purpose other than
internal or pesticidal use. It is to be placed on the main label or as part of the directions for use.
Declaration of the Contents

[Sub paragraphs 7(1)(k), 7(1)(l) and paragraph 8]
Preparations classified as poisons must be labelled with the approved name and quantity, proportion or
strength of each poison they contain. This declaration must be printed in bold-face sanserif capital
letters.
When labelling therapeutic goods, agricultural products or veterinary products refer to the guides
provided by the relevant registration authorities for this purpose noting that all 'active constituents'
must be declared.
Variations of Approved names
'ALKALINE SALTS', ALIPHATIC AMINES, AROMATIC AMINES, LIQUID EPOXY RESINS,
'LIQUID HYDROCARBONS' and 'QUATERNARY AMMONIUM COMPOUNDS' are considered to be approved
names for poisons included in these Schedule 5 class entries.
Where a product contains a mixture of Schedule 5 solvents (designated solvents), which individually
are below the exemption limit of 25% but collectively exceed that specification, 'LIQUID
HYDROCARBONS', 'KETONES', 'SOLVENTS' or 'OTHER SOLVENTS' may be used as approved names for
respective components of the mixture when declaring their content. (See the definition for 'designated
solvent' in SUSDP Part 1.)
If the product is a pesticide or an animal treatment which contains organophosphorus compounds or
carbamates, the declaration of contents must be followed by the statement 'AN ANTICHOLINESTERASE
COMPOUND'. This statement is not required if the poison is dazomet, mancozeb, metiram, propineb,
thiram, tri-allate, ziram or zineb or if the product is a pressurised spray pack for household use.
Strength or Proportion
[paragraph 8]
The strength or proportion of a poison in a preparation is expressed:
for human therapeutic use, in the manner prescribed in Therapeutic Goods Order No. 69
General requirements for labels for medicines; or
for other preparations, as the mass or volume of the poison per stated mass or volume of the
preparation as appropriate.
Directions for Use

[Sub-paragraph 7(1)(m)]
Directions for use must be included on the label for any poison prepared for a specific purpose, except
for a preparation classified as a Schedule 4 or a Schedule 8 poison. Directions for use should be clear
and easy to understand.
Safety Directions
[Sub-paragraph 7(1)(n) and Appendix F]
Safety directions are required on the label of any poison that may be harmful to the user. If a poison is
listed in Appendix F of the SUSDP, the safety directions must include the statements specified for the
poison in that Appendix unless:
the poison is an agricultural or veterinary chemicals (including pesticides) registered by the
Australian Pesticides and Veterinary Medicines Authority, as the safety directions for these
poisons are contained in the FAISD Handbook or will be provided during the registration
process; or
a medicine for human use when compliant with the requirements of the Required Advisory
Statements for Medicine Labels.
The manufacturer or distributor is encouraged to include any additional statements that may be
necessary to ensure that the poison is used safely. 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.
When a preparation contains more than one poison, the safety directions included on the label should
be an appropriate combination of the statements required for each of the poisons.
Safety directions must be grouped together as a distinct section of the label and be preceded by the
words 'SAFETY DIRECTIONS' printed in bold-face sanserif capital letters.
Warning Statements
[Sub-paragraph 7(1)(o) & Appendix F]
If a poison is listed in Appendix F of the SUSDP, the label must include any warning statements
specified for the poison in that Appendix unless:
the poison is an agricultural or veterinary chemicals (including pesticides) registered by the
Australian Pesticides and Veterinary Medicines Authority, as the safety directions for these
poisons are contained in the FAISD Handbook or will be provided during the registration
process; or
a medicine for human use when compliant with the requirements of the Required Advisory
The manufacturer or distributor may include additional warning statements as deemed necessary to
ensure that the user is adequately warned of any hazard associated with the poison.
Warning statements must be grouped together as a distinct section of the label and placed:
immediately after the words 'SAFETY DIRECTIONS' if safety directions are included on the
label; or
immediately before the directions for use if there are no safety directions.
First Aid
[Sub-paragraph 7(1)(p) and Appendix E]
Poisons must 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 directions included on the label of a poison are appropriate for a specific product. These directions
must be preceded by the words 'FIRST AID' printed in bold-face capital letters.
A poison classified as a Schedule 3, 4, or 8 poison, or when packed and labelled for human internal
use, is not required to be labelled with first aid directions.
If a product consists of a primary pack in which two or more smaller containers of poisons need
different first aid directions, the primary pack can be labelled 'FIRST AID: See inner packs', but each of
the inner containers must have the first aid instructions appropriate for its contents.
Appendix E of the SUSDP is a guide for the development of suitable first aid instructions. First aid
instructions for agricultural and veterinary chemicals are not included in the SUSDP, but may be found
in the FAISD Handbook or will be provided during the registration process.
If a preparation consists of a mixture of poisons, the first aid instructions should be adjusted to be
appropriate for the admixture. Any such modification should be concise and readily understood.
Manufacturer or Distributor
[Sub-paragraph 7(1)(q)]
The name and address in Australia of the manufacturer or distributor must be on the label. A post
office box or overseas address is not acceptable.
Modified Labelling
[Paragraphs 6 & 9 to 17]
Modified labelling requirements apply for transport containers, poisons packed and sold for
dispensary, industrial, laboratory and manufacturing use, immediate wrappers, small containers (10 mL
or less), gas cylinders, paint, tinter for paint, camphor and naphthalene. The requirements are:
Transport Containers and Wrappings

[paragraph 12]
There are no requirements in the SUSDP for the labelling of transparent covers or wrappers, hampers,
packing cases, crates or any other containers used solely for transport or delivery.
Dispensary, Industrial, Laboratory and Manufacturing Chemicals

[paragraph 13]
Poisons that are only for dispensary, industrial, laboratory and manufacturing use may be labelled in
accordance with the Australian Safety and Compensation Councils National Code of Practice for the
Labelling of Workplace Substances [NOHSC:2012(1994)] instead of the SUSDP if so desired.
Dispensed Medicines
[Paragraph 14 & 45]
Medicines that have been dispensed on and in accordance with a prescription, supplied by a medical,
dental or veterinary practitioner as part of their respective professional practices, or prepared by a
pharmacist for an individual patient, do not have to be labelled in accordance with the SUSDP
requirements. However, individual State or Territory regulations may apply to dispensed medicines.
If a dispensed medicine is listed in Part 3, paragraph 45 of the SUSDP, then the label must include any
warning statements required (referenced to specific Appendix F warning statements).
Immediate Wrappers
[Paragraph 6]
Examples of immediate wrappers are single dose powder papers, the waxed paper used for wrapping
individual lozenges and the sealed paper envelope which holds a single finger dressing. Poisons in
immediate wrappers must be enclosed in a properly labelled primary pack.
The immediate wrapper must be conspicuously labelled with:
the approved name of the poison;
the quantity or strength of the poison enclosed in the wrapper; and
the name of the manufacturer or distributor or the brand or trade name of the poison.
Selected Containers and Measure Packs

[Paragraph 9]
When packed in a fully labelled primary pack, the labelling requirements for immediate containers that
are measure packs or containers (having a nominal capacity of 10 mL or less) are reduced to
the appropriate signal words;
the approved name and the quantity, proportion or strength of the poison;
the name of the manufacturer or distributor or the specific brand or trade name of the
product; and
the cautionary statement 'FOR ANIMAL TREATMENT ONLY if for the treatment of animals only'.
Ampoules, Prefilled Syringes and Injection Vials

[Paragraphs 10 & 11]
Ampoules or injection vials or pre-filled syringes when packed in fully labelled primary packs are only
required to be labelled with:
the approved name and the quantity, proportion or strength of the poison;
the name of the manufacturer or distributor or the specific brand or trade name of the
product; and
the cautionary statement 'FOR ANIMAL TREATMENT ONLY if for the treatment of animals only'.
Plastic ampoules joined with a strip of plastic and which are opened as they are detached from the strip
are only required to be labelled with the approved name or the trade name of the product and the
quantity, proportion or strength of the poison provided that the strip to which they are attached is
labelled as above and they are contained in a properly labelled primary pack.
Gas Cylinders
[Paragraph 15]
Where the label is affixed to the shoulder of a gas cylinder, the requirements for nothing to be written
on the same line of the main label as the signal words or any cautionary statements are waived.
Paints and Tinters

[Paragraph 16]
For a more extensive guide to the labelling of paints and related products refer to the NDPSC Guide to
the Packaging, Labelling and Regulation of Paints, Tinters and Related Products.
A paint that contains only Schedule 5 poisons does not have to be labelled as a poison.
If a paint contains the proportion (or less) of any of the poisons listed below, it is also exempt from
poison labelling requirements:
5 % antimony as the element or any of its compounds other than titanate pigments;
5 % barium as its salts other than sulfate or metaborate;
0.1 % cadmium as the element or its compounds;
5 % chromium as ammonium, barium, potassium, sodium, strontium or zinc chromate;
0.1 % of selenium as the element or its compounds;
10 % by volume ethylene glycol mono alkyl ethers and their acetates;
5 % by weight methylene chloride (dichloromethane);
50 % by volume toluene;
50 % by volume xylene;
0.1 % lead as the element or its compounds (0.2 % as an impurity in zinc based paint);
If a paint contains one or more of these poisons above the proportion shown, the main (front) label
must have:
the signal word 'WARNING' printed in bold-face sanserif capital letters not less than 5
mm in height on the first line with nothing else on that line;
the cautionary statement 'KEEP OUT OF REACH OF CHILDREN' printed in bold-face
sanserif capital letters not less than 2.5 mm in height on the second line; and
the name and proportion of the poison.
If the paint contains more than the above proportion of antimony, barium, cadmium, chromium or,
selenium the following warning statements must be on the label immediately below the cautionary
statement 'KEEP OUT OF REACH OF CHILDREN':
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.
If the paint contains more than the above proportion of ethylene glycol monoalkyl ethers or their
acetates, methylene chloride, toluene or xylene the following warning statements must be on the label
immediately below the cautionary statement 'KEEP OUT OF REACH OF CHILDREN':
Breathing the vapour is dangerous.
Provide adequate ventilation during application.
Do not use in the presence of a naked flame.
Do not smoke.
If the paint contains more than the above proportion of lead the following warning statements must be
on the label immediately below the cautionary statement 'KEEP OUT OF REACH OF CHILDREN':
This paint contains lead and is dangerous to health, even when dry.
For industrial use only.
10
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.
A tinter that contains more than 0.1 % of lead in the non-volatile content of the tinter must have the
following warning statements on the label immediately below the cautionary statement 'KEEP OUT OF
REACH OF CHILDREN':
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.
The proportion of poisons in paint may be expressed as a range, provided that the limits of the range do
not differ by more than 5 %.
In automotive paints containing lead based pigment, the lead content may be expressed as a maximum
content of the lead in the dried film.
In inorganic pigments the metals content may be expressed as 'contains not more than (10%, 30%)
(name of the metal)' or 'contains more than 30% (name of the metal)'.
Camphor and Naphthalene

[Paragraph 17 & 28]
Devices that contain only camphor or naphthalene in block, ball, disc or pellet form for domestic use
and which prevent removal or ingestion of their contents during normal use, if packed in a fully
labelled primary pack, are only required to have the signal word 'poison' and the approved name of the
poison embossed or indelibly written on them.
Essential Oils
[See schedule entries for specific oils]
Essential oils classified as poisons are listed in either Schedule 5 or Schedule 6 of the SUSDP.
Some of these oils are exempt from the full packaging and labelling requirements of the SUSDP,
subject to restricted packaging and specific warning statements.
11
Label contents
Legal requirements
PHARMACY MEDICINE
Bold sanserif capital letters, uniform thickness.

Height, half that of largest letter or numeral on
the label (minimum 1.5mm, maximum 6mm
on containers of 2 litres or less or 15mm
on larger containers).
First line on label.

Four-tenths height of 'PHARMACY MEDICINE'
with a minimum height of 1.5mm.
Second line on label.

On main label.
(Only on products for animal treatment).
READ SAFETY DIRECTIONS BEFORE

OPENING OR USING
(or READ SAFETY DIRECTIONS)

Four tenths height of 'CAUTION' with a
minimum height of 1.5mm.
Third or subsequent line of label
(If safety directions are included on the label.)
TRADE NAME OF PRODUCT
No specifications.
NAME AND STRENGTH OR PROPORTION

OF ALL ACTIVE INGREDIENTS
If for human therapeutic use, see Therapeutic

Goods Order No. 69- General requirements
for labels for Medicines.
NAME AND ADDRESS OF MANUFACTURER

OR DISTRIBUTOR
Must be an Australian address.

Must be a street address NOT a post office box.
NETT CONTENTS
Required by consumer legislation.

for labels for Medicines..
DIRECTIONS FOR USE

for labels for Medicines..
SAFETY DIRECTIONS
Group together and preface with 'SAFETY

DIRECTIONS' in bold capital letters except:
(i)
for human therapeutic use
regulated by TGA (requirement
replaced by
the Required
Advisory
Required
Advisory
Statements for Medicine Labels);
(ii)
for APVMA registered animal use
(requirement replaced by the
FAISD Handbook).
If not TGA or APVMA regulated then must
comply with SUSDP Appendix F unless
compliant with the Required Advisory
12
WARNING STATEMENTS
Some poisons require warning statements.

These are to be placed immediately before
the directions for use except:
(i)
replaced by
the Required
Advisory
Required
Advisory
(ii)
FAISD Handbook).
In addition, any dispensed medicine for human
use listed in SUSDP Pt 3, paragraph 45 must
be labelled with the referenced Appendix F
warning statement.
FIRST AID INSTRUCTIONS
Preface with the words 'FIRST AID' in bold

capital letters.
Not required on preparations for internal use.
All other writing required on label
Minimum height 1.5mm measured on capital

letters or lower case letters with ascenders
or descenders (e.g. d, b, g, p).
EXAMPLE LAY OUT
For internal use & regulated by the TGA
PHARMACY MEDICINE
PRODUCT NAME
Ingredients g/L, mL/L, g/Kg or mL/Kg
Directions for use
Quantity
Name and address
For external or topical use & regulated by the TGA
PHARMACY MEDICINE
PRODUCT NAME
Directions for use
FIRST AID:
Quantity
Name and address
13
Label contents
Legal requirements


Four tenths height of 'PHARMACIST ONLY
MEDICINE' with minimum height of 1.5mm.
Second line of label.

On main label.

OPENING OR USING

No specifications.


Goods order No. 69- General requirements

OR DISTRIBUTOR

NETT CONTENTS

DIRECTIONS FOR USE

SAFETY DIRECTIONS

(iii)
replaced by
the Required
Advisory
Required
Advisory
(iv)
FAISD Handbook).
14
WARNING STATEMENTS

(iii)
replaced by
the Required
Advisory
Required
Advisory
(iv)
FAISD Handbook).
warning statement.
All other writing required on the label

or descenders (for example d, b, g, p).
EXAMPLE LAY OUT Regulated by the TGA

PRODUCT NAME
Directions for use
Quantity
Name and address
15
Label contents
Legal requirements

or


Four tenths height of 'PRESCRIPTION ONLY
MEDICINE' with minimum height of 1.5mm.

On main label.

OPENING OR USING

No specifications.



OR DISTRIBUTOR

NETT CONTENTS

SAFETY DIRECTIONS

(v)
replaced by
the Required
Advisory
Required
Advisory
(vi)
FAISD Handbook).
WARNING STATEMENTS

16
(v)

replaced by
the Required
Advisory
Required
Advisory
(vi)
FAISD Handbook).
warning statement.

or descenders (for example d, b, g, p).
EXAMPLE LAY OUT
For human therapeutic use regulated by the TGA

PRODUCT NAME
Each tablet contains:(name of poison) mg
Quantity
Name and address
For the treatment of animals regulated by the APVMA

PRODUCT NAME
Each tablet contains:(name of poison) mg
Quantity
Name and address
17
Label contents
Legal requirements
CAUTION
Bold sanserif capital letters, uniform thickness..

on containers of 2 litres or less or 15mm on
larger containers).
A statement of the principal hazard associated
with the poison may be added.

Second line of the label.

Third line of the label.
(Only on dry chlorinating compounds with
more than 10 % available chlorine).

(For alkaline salts in dish washing machine
products).
FLAMMABLE

(Only for flammable liquids).

On main label.
DO NOT SWALLOW
Sanserif capital letters.

On main label or in directions for use.
(Not required on preparations for internal or
pesticide use).

OPENING OR USING

No specifications.

OF ALL POISONS IN THE PRODUCT
Bold sanserif capital letters.

Must be Australian approved name(s).
Expressed in g/L, mL/L or g/kg.
AN ANTICHOLINESTERASE COMPOUND
Immediately under declared name(s) of

poison(s).
18
(Only for organophosphorus compounds or

carbamates)
OR DISTRIBUTOR

NETT CONTENTS
Requirement of consumer legislation.
DIRECTIONS FOR USE
Required on any poison packed for a specific

purpose.
Must be clear (understandable) and sufficient
for the product to be used correctly.
SAFETY DIRECTIONS

DIRECTIONS' in bold capital letters.
(See SUSDP Appendix F or, for registered
agricultural and veterinary chemicals, the
FAISD Handbook)
WARNING STATEMENTS
Group together and include at beginning of the

safety directions
If no safety directions place immediately before
the directions for use.
(See SUSDP Appendix F or, for APVMA
registered agricultural and veterinary
chemicals, the FAISD Handbook)
Group together and preface with 'FIRST AID' in

bold-face capital letters.
(See SUSDP Appendix E or, for APVMA

or descenders (e.g. d, b, g, p).
EXAMPLE LAY OUT

General
CAUTION (Statement of the principal hazard)

PRODUCT NAME
Contains: (NAME OF POISON) g/L, mL/L, g/kg, mL/kg
Directions for use
SAFETY DIRECTIONS:
FIRST AID:
Quantity
Name and address
19
For a dish washing machine product containing alkaline salts
CAUTION
DO NOT SWALLOW
PRODUCT NAME
Contains: ALKALINE SALTS
g/kg, g/L
Directions for use
SAFETY DIRECTIONS: Strongly alkaline. Avoid contact
with eyes and skin
FIRST AID: For advice, contact a Poisons
Information Centre (Phone eg Australia 131 126;
New Zealand 0800 764 766 ) or a doctor .
If swallowed , do NOT induce vomiting.
If in eyes, hold eyelids apart and flush the eye
continuously with running water. Continue flushing
until advised to stop by the Poisons Information Centre
or a doctor, or for at least 15 minutes.
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
the Poisons Information Centre or a doctor.
Quantity
Name and address
20
Label contents
Legal requirements
POISON

larger containers).

Four tenths height of 'POISON' with a
FLAMMABLE

(Only for flammable liquids).

On main label.

OPENING OR USING

Four tenths height of 'POISON' with a
Third or subsequent line of label.
No specifications.



poison(s).
carbamates)

OR DISTRIBUTOR

NETT CONTENTS
Requirement of consumer legislation.
DIRECTIONS FOR USE

purpose.
SAFETY DIRECTIONS

DIRECTIONS' in bold-face capital letters.
chemicals, the FAISD Handbook).
21
WARNING STATEMENTS

safety directions

bold capital letters.

letters or lower case letters with ascenders or
descenders (for example d, b, g, p).
EXAMPLE LAY OUT
General
POISON
PRODUCT NAME
Directions for use
SAFETY DIRECTIONS:
FIRST AID:
Quantity
Name and address
22
Label contents
Legal requirements
DANGEROUS POISON
Bold sanserif capital letters, uniform thickness

larger containers).

Four tenths height of 'DANGEROUS POISON'
CAN KILL IF SWALLOWED

DO NOT PUT IN DRINK BOTTLES
KEEP LOCKED UP

Third to fifth lines of the label
(Only for aqueous paraquat solutions).

(Only on dry chlorinating compounds with
more than 10 % available chlorine).

OPENING OR USING
READ SAFETY DIRECTIONS)

Four tenths height of 'DANGEROUS POISON' (or
with a minimum height of 1.5 mm.
Third or subsequent line of label.
(Only if safety directions are included on the
label.)

On main label.
No specifications.



poison(s).
carbamates)

OR DISTRIBUTOR

NETT CONTENTS
Requirement consumer legislation.
DIRECTIONS FOR USE

purpose.
23

SAFETY DIRECTIONS

DIRECTIONS' in bold capital letters.
WARNING STATEMENTS

safety directions.

bold capital letters.

descenders (e.g. d, b, g, p).
EXAMPLE LAY OUT
General requirements
DANGEROUS POISON
PRODUCT NAME
Directions for use
SAFETY DIRECTIONS:
FIRST AID:
Quantity
Name and address
24
For Schedule 7 Hydrofluoric acid preparations
DANGEROUS POISON
PRODUCT NAME
Active Constituent: HYDROFLUORIC ACID
Directions for use
g/L
SAFETY DIRECTIONS: Avoid contact with eyes. Wear eye protection when mixing or using. Avoid contact with skin. Wear
protective gloves when mixing or using. Avoid breathing vapour or spray mist. Obtain a supply of calcium gluconate gel. Wash
gloves thoroughly immediately after use
Highly corrosive. Contact with eyes even for short periods can cause blindness. Causes severe burns, which are not likely to be
immediately painful or visible.
FIRST AID: For advice, contact a Poisons Information Centre (Phone eg Australia 131 126; New Zealand 0800 764 766) or a
doctor (at once). If swallowed, do NOT induce vomiting. If in eyes, hold eyelids apart and flush the eye continuously with
running water. Continue flushing until advised to stop by the Poisons Information Centre or a doctor, or for at least 15 minutes.
If skin contact occurs, immediately remove contaminated clothing. Flush skin under running water for 15 minutes. Then apply
calcium gluconate gel. Contact the Poisons Information Centre.
Quantity
Name and address
25
Label contents
Legal requirements
CONTROLLED DRUG

larger containers).
POSSESSION WITHOUT AUTHORITY

ILLEGAL

Four tenths height of 'CONTROLLED DRUG' with
a minimum height of 1.5mm.
Second line on label.
Nothing else on same line.

Four tenths height of 'CONTROLLED DRUG' with
a minimum height of 1.5mm.
Third line of label.

On main label.

OPENING OR USING

No specifications.



OR DISTRIBUTOR

NETT CONTENTS

DIRECTIONS FOR USE

SAFETY DIRECTIONS

(vii)
replaced by
the Required
Advisory
Required
Advisory
26
(viii)

FAISD Handbook).
WARNING STATEMENTS

(vii)
replaced by
the Required
Advisory
Required
Advisory
(viii)
FAISD Handbook).
warning statement.

descenders (e.g. d, b, g, p).
27
EXAMPLE LAY OUT TGA or APVMA registered
CONTROLLED DRUG
POSSESSION WITHOUT AUTHORITY ILLEGAL
PRODUCT NAME
Quantity
Name and address
28
State and Territory Labelling Advice.

Advice to assist manufacturers and re-packers ensure that labels will meet the legal requirements in a
particular State or Territory may be obtained from AUSTRALIAN CAPITAL TERRITORY
Pharmaceutical Services
ACT Health,
Locked Bag 5
WESTON ACT 2611
Telephone
(02) 6205 1700
Fax
(02) 6205 0997
Website: http://www.health.act.gov.au/c/health?a=da&did=10054021&pid=1074232898
NEW SOUTH WALES
Pharmaceutical Services Branch

NSW Health
PO Box 103
GLADESVILLE NSW 1675
Telephone: 02 9879 3214
Fax: 02 9859 5165
Website: http://www.health.nsw.gov.au/public-health/psb/
NORTHERN TERRITORY
Poisons Control
Department of Health & Community Services, Northern Territory
PO Box 40596
CASUARINA NT 0811
Telephone: 08 8922 7341
Fax: 08 8922 7200
Website:
http://www.nt.gov.au/health/healthdev/environ_health/application_forms/poisons_control.shtml
QUEENSLAND
Drugs, Poisons and Therapeutic Goods

Environmental Health Unit
Queensland Health
GPO Box 48
BRISBANE QLD 4001
Telephone: 07 3234 0938
Fax: 07 3234 1480
Website: http://www.health.qld.gov.au/healthieryou/default.asp
SOUTH AUSTRALIA
Drugs labelling and scheduling:

Pharmaceutical Services
Drug & Alcohol Services South Australia
PO Box 6
29
RUNDLE MALL SA 5000

Telephone: 08 8274 3420
Fax: 08 8274 3440
Website: http://www.dassa.sa.gov.au/site/page.cfm
Poisons labelling and scheduling:
Public Health
Department of Health
PO Box 6
RUNDLE MALL SA 5000
Telephone: 08 8226 7100
Fax: 08 8226 7102
Website: http://www.dh.sa.gov.au/pehs/branches/branch-environmental.htm
TASMANIA
Pharmaceutical Services Branch

Department of Health and Human Services, Tasmania
GPO Box 125
HOBART TAS 7001
Telephone: 03 6233 2064
Fax: 03 6233 3904
Website: http://www.dhhs.tas.gov.au/publichealth/pharmaceuticals/index.html
VICTORIA
Drugs and Poisons Regulation Group

Department of Human Services, Victoria
PO Box 4057
MELBOURNE VIC 3001
Telephone: 1300 364 545
Fax: 03 9096 9168
Website: http://www.health.vic.gov.au/dpu
WESTERN AUSTRALIA
Drugs, Poisons & Therapeutic Goods Control Branch

Environmental Health Directorate
Department of Health, Western Australia
PO Box 8172
PERTH BUSINESS CENTRE WA 6849
Telephone: 08 9388 4980
Fax: 08 9388 4988
Website: http://www.health.wa.gov.au/services/detail.cfm?Unit_ID=2301
30
Reference Books
.
Guide to Labelling Drugs and Poisons in accordance with the Standard for the Uniform
Scheduling of Drugs and Poisons
NDPSC website: http://www.tga.gov.au/ndpsc/gldap.htm
Therapeutic Goods Order No. 69 - General requirements for labels for medicines
TGA website: http://www.tga.gov.au/docs/html/tgo/tgo69.htm
Therapeutic Goods Order No. 69A - Amendment to Therapeutic Goods Order No. 69 - General
requirements for labels for medicines
TGA website: http://www.tga.gov.au/docs/html/tgo/tgo69a.htm
The Required Advisory Statements for Medicine Labels
TGA website: http://www.tga.gov.au/meds/rasml.htm
Therapeutic Goods Order No. 37 General Requirements for labels for Therapeutic Devices
TGA website: http://www.tga.gov.au/docs/html/tgo/tgo37.htm
Labelling Code of Practice: Designing usable non-prescription medicine labels for consumers
Details for purchasing available from:

http://www.communication.org.au/html/papers_to_read.php#11
Best practice guideline on prescription medicine labelling;
TGA website: http://www.tga.gov.au/pmeds/pmbestpractice.htm
Australian Dangerous Goods Code (ADG) (Australian Code for the transport of dangerous
goods by road and rail)
Department of Transport and Regional Services website:

http://www.dotars.gov.au/transport/australia/dangerous/publications.aspx
Veterinary Labelling Code: The Code of Practice for Labelling Veterinary Chemical Products
APVMA website: http://www.apvma.gov.au/MORAG_vet/vol_5/vet_labelling_code.html
Ag Labelling Code
APVMA website: http://www.apvma.gov.au/MORAG_ag/vol_5/ag_labelling_code.html
FAISD Handbook: Handbook of First Aid Instructions, Safety Directions and Warning
Statements for Agricultural and Veterinary Chemicals;
TGA website: http://www.tga.gov.au/docs/html/faisd.htm
Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP)
Details for purchasing available from: http://www.tga.gov.au/ndpsc/susdp.htm
National Code of Practice for the Labelling of Workplace Substances
ASCC website:
http://www.ascc.gov.au/ascc/AboutUs/Publications/NationalStandards/IndexofNationalSt
andardsCodesofPracticeandrelatedGuidanceNotes.htm
NDPSC Guide to the Packaging, Labelling and Regulation of Paints, Tinters and Related
Products
NDPSC website: http://www.tga.gov.au/ndpsc/paintgui.htm
TGA Approved Terminology for Medicines
TGA website: http://www.tga.gov.au/docs/html/aan.htm
Australian Standard AS 1928-2001 Child-resistant packages
Details for purchasing available from SAI Global website:

http://www.saiglobal.com/shop/script/Details.asp?DocN=AS215811782764
Australian Standard AS 1580.301.1-1992 : Paints and related materials - Methods of test - Nonvolatile content by mass
[This standard has been updated - AS 1580.301.1-2005/Amdt 1-2006]
Details for purchasing available from SAI Global website:

http://www.saiglobal.com/shop/Script/Details.asp?DocN=AS0733773427AT

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A GUIDE TO

LABELLING DRUGS AND POISONS

POISON SCHEDULE CLASSIFICATION

State and Territory Labelling Advice.

The Required Advisory Statements for Medicine Labels;

Best practice guideline on prescription medicine labelling;

National Code of Practice for the Labelling of Workplace Substances; and

POISON SCHEDULE CLASSIFICATION

For example, a preparation containing poisons included in Schedules 5, 6 and 7 is classified as a

In this Guide, unless the contrary intention appears

in the Australian Capital Territory, ACT Health;

'Approved name' means:

in relation to a poison that is for therapeutic use:(i)

in relation to a poison that is not for therapeutic use:

the English name recommended by the Standards Association of Australia as the

published by the Australian Government Publishing Service; or, if the poison is

Child-resistant packaging means packaging that:

the International Organization for Standardization Standard ISO 8317:1989

the Canadian Standards Association Standard CSA Z76.1-99 entitled Reclosable

is approved as child-resistant by any order made under section 10(3) of the

methyl isobutyl ketone

methanol when included in Schedule 5

methyl ethyl ketone

'Distributor' means a person who imports, sells or otherwise supplies a poison.

oils of equivalent composition derived through synthetic means; or

prepared mixtures of oils of equivalent composition comprising a mixture of synthetic

orally, except for topical effect in the mouth; or

for absorption and the production of a systemic effect,

by way of a body orifice other than the mouth; or

parenterally, other than by application to unbroken skin.

'Label' means a statement in writing on a container of a poison.

'Manufacturer' means a person who manufactures, produces or packs a poison.

for preventing, destroying, repelling, attracting, inhibiting or controlling any insects,

as a plant regulator, promoter, defoliant or desiccant for food storage, household,

Poison means any substance or preparation included in a Schedule to this Standard.

cannot readily be removed from the container by manual force; and

an injection vial having a nominal capacity of ten millilitres or less;

a single use syringe; or

Solid is considered to include powder for the purposes of scheduling.

preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in human

influencing, inhibiting or modifying a physiological process in human beings or animals;

testing the susceptibility of human beings or animals to a disease or ailment.

Toy means an object or number of objects manufactured, designed, labelled or marketed as a

signal word(s) - to warn the consumer of a potential hazard;

cautionary statements - concise general precautions to be observed;

safety directions - precautions to be taken for safe use;

$ warning statements - advice about specific hazards to avoid;

first aid instructions - advice on what to do if poisoned;

Dangerous Goods Classification symbols - Class labels for transport purposes;

name and quantity, proportion or strength of its constituents;

directions for use.

Contrast and colours

contradicts, qualifies or modifies any expression required by regulation to be on the label;

implies that a poison is safe, harmless, non-toxic or non-poisonous;

implies that the poison is recommended or approved by any government authority;

misrepresents the composition or any property of the poison; or

gives any false or misleading indication of its origin or place of manufacture.

PHARMACIST ONLY MEDICINE

PRESCRIPTION ONLY MEDICINE

These signal words are required to be:

in bold-face, sanserif, capital letters of uniform thickness; and

be printed in bold-face sanserif capital letters of uniform thickness; and

POSSESSION WITHOUT AUTHORITY ILLEGAL