REQUIREMENTS FOR DISPENSING LABELS FORREQUIREMENTS FOR DISPENSING LABELS FOR

APPENDIX L

REQUIREMENTS FOR DISPENSING LABELS FOR

HUMAN AND VETERINARY MEDICINES

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.