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HEALTH (DRUGS AND POISONS) REGULATION 1996 - REG 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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