Queensland Consolidated Regulations

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HEALTH (DRUGS AND POISONS) REGULATION 1996 - REG 85

Labelling dispensed and supplied medicines

85 Labelling dispensed and supplied medicines

(1) A person who sells a controlled drug as a dispensed medicine or supplies a controlled drug on a written instruction (a
"supplied medicine" ), must securely attach to the dispensed or supplied medicine’s container a label as required by this section with the following warnings printed on it—
(a) ‘Keep out of reach of children’;
(b) if the prescriber is a veterinary surgeon—‘For animal treatment only’.
Penalty—
Maximum penalty—40 penalty units.
(2) The warnings must be printed in red on a background of contrasting colour and in bold-faced sans serif capital letters with a face depth of at least 1.5mm.
(3) The label must also have written on it—
(a) for a dispensed or supplied medicine for human use—the name of the person for whose use it is intended; or
(b) if the dispensed medicine is for an animal—the name of the animal’s owner; and
(c) the name and address of—
(i) the person selling the dispensed or supplied medicine; or
(ii) the business from which the dispensed or supplied medicine is sold; and
(d) a description of the name of the dispensed medicine under subsection (4) or (5) ; and
(e) a description of the strength of, and the quantity or volume of, the dispensed or supplied medicine; and
(f) directions about the use of the dispensed or supplied medicine; and
(g) the date the dispensed or supplied medicine is dispensed; and
(h) the dispenser’s initials; and
(i) if the medicine is for internal human therapeutic use and is a substance in appendix K of the current Poisons Standard—the warning statements given for the medicine in appendix F, part 1 of the current Poisons Standard; and
(j) if the medicine’s expiry date is not visible—the medicine’s expiry date.
(3A) However, the warnings mentioned in subsection (1) or (3) (i) need not be printed or written on the label if the warning—
(a) appears on the dispensed or supplied medicine’s container; and
(b) is clearly visible after the label is attached to the container.
(4) The dispensed medicine must be described by—
(a) its approved name; or
Note—
For the definition
"approved name" see part 1 of the current Poisons Standard.
(b) the name the prescriber entered in the prescription or, if a different brand of the medicine is dispensed, the name, if any, of the brand dispensed; or
(c) its trade name; or
(d) the approved name of each controlled drug in the medicine; or
(e) the name of each controlled drug in the medicine as entered in the prescription.
(5) Despite subsection (4) , a doctor may state in a prescription that the contents of a dispensed medicine must be described in another way that is not a false description.



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