New South Wales Consolidated Regulations

POISONS AND THERAPEUTIC GOODS REGULATION 2008 - APPENDIX A

Appendix A

(Clauses 7, 26, 69 and 146)

Note : Although this Appendix refers to labels "on" a container, the information required by this Appendix may be shown by tags, brands, marks or statements in writing on the container itself (rather than on something affixed or attached to the container). See the definition of
"Label" in section 4(1) of the Act.

1 General

(1) All details, words and other information that a label on a container of a therapeutic substance must carry must be in the English language (although it may also be in another language).

(2) All symbols, numbers and words on a label must be in durable characters.

(3) The label on a container of a therapeutic substance must contain the following details--

(a) the name and address of the dealer supplying the substance,

(b) the approved name, strength and quantity of the substance,

(c) the substance's proprietary name (unless the substance is a preparation compounded in accordance with the dealer's own formula),

(d) adequate directions for use,

(e) the words "KEEP OUT OF REACH OF CHILDREN" in red on a white background,

(f) 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,

(g) if the substance is intended for the treatment of a person, the name of the person,

(h) if the substance is intended for the treatment of an animal, the species of animal and the name of the animal's owner,

(i) if the substance is supplied in the circumstances referred to in clause 45 or 48, the words "EMERGENCY SUPPLY".

2 Additional labelling requirements for certain substances

(1) The label on a container of a therapeutic substance that is supplied on prescription must also bear--

(a) the prescription reference number, and

(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.

(2) The label on a container of a restricted substance that is supplied in the circumstances referred to in clause 45 or 48 must also bear--

(a) the unique reference number recorded under clause 57 with respect to the supply, and

(b) the date on which the substance was supplied, and

(c) the directions given by the pharmacist for the use of the substance.

3 Warning: therapeutic substances for internal use

The label on a container of a therapeutic substance specified in Appendix F to the current Poisons Standard must bear the warning specified in that Appendix in respect of that substance.
The label on a container of a therapeutic substance specified in Appendix K to the current Poisons Standard (being a therapeutic substance that is supplied on prescription and is intended for internal use in humans) must bear Warning Statement 39, 40 or 90 specified in Part 1 of Appendix F to that Standard. The warning must be immediately preceded by a symbol in the form of an open equilateral triangle at least 4.5 millimetres high in bold print, coloured red.

4 Warning: quinine

The label on a container of quinine must bear the words "WARNING--MAY BE FATAL TO CHILDREN".

5 Warning: other substances

(1) This clause applies to the following substances--

amphetamine

chlorphentermine

dexamphetamine

diethylpropion

ephedrine

lisdexamfetamine

methylphenidate

phentermine

propylhexedrine

(2) The label on a container of such a substance (being a substance that is represented as being for oral use by a person other than a child under 16) must bear the words "THIS MEDICATION (MEDICINE) MAY AFFECT MENTAL ALERTNESS OR CO-ORDINATION OR BOTH. IF AFFECTED, DO NOT DRIVE A MOTOR VEHICLE OR OPERATE MACHINERY".

(3) The warning must be immediately preceded by a symbol in the form of an open equilateral triangle at least 4.5 millimetres high in bold print, coloured red.