Australian Capital Territory Numbered Regulations

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MEDICINES, POISONS AND THERAPEUTIC GOODS REGULATION 2008 (NO 42 OF 2008) - REG 32

Additional requirements for prescribing controlled medicines for human use

The following are the additional requirements for prescribing a controlled medicine for human use:

        (a)     the prescriber has a controlled medicines approval to prescribe the medicine;

Note     For controlled medicines approvals, see pt 13.1.

        (b)     if the approval is for a particular form of the medicine—the prescription is for the form of the medicine approved or a bioequivalent form;

Note     Bioequivalent —see the dictionary.

        (c)     if the approval is for a particular strength of the medicine—the prescription is for the strength approved or a weaker strength;

        (d)     if the approval is for a particular quantity of the medicine—the prescription is for not more than the quantity approved;

        (e)     the prescriber complies with each condition (if any) of the approval;

        (f)     if the controlled medicine is dronabinol for human use—

              (i)     the prescriber also has an authorisation under the Therapeutic Goods Act 1989 (Cwlth), section 19 to supply the medicine; and

              (ii)     the prescriber complies with each condition (if any) of the authorisation.

Example—par (b)

If a slow release form of a medicine is approved, the prescriber is not authorised to prescribe an immediate release form of the medicine.

Example—par (c) and par (d)

If a doctor is given an approval to prescribe 25 morphine 20mg capsules, the doctor may prescribe 5 20mg capsules and 10 15mg capsules. Later, if the approval is still in force, the doctor may prescribe not more than 10 morphine capsules of any strength up to and including 20mg.

Note     An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).



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