Poisons and Therapeutic Goods Regulation 2008
Subdivision 4 Supply generally
51 Research drugs
(1) This clause applies to thalidomide other than as registered goods.(2) A dealer must not supply thalidomide unless the person being supplied holds an authority under Part 8 to be supplied with thalidomide.(3) This clause:(a) does not prohibit a dealer from supplying thalidomide to a person who has the approval in writing of the Permanent Head of the Commonwealth Department of Health to import, buy, obtain or otherwise be supplied with thalidomide, and(b) does not prohibit a person holding an authority under Part 8 to be supplied with thalidomide from supplying thalidomide to a person under his or her general supervision, for the purpose of enabling that other person to carry out medical diagnosis, or medical or scientific research or analysis (including the conduct of clinical trials), and(c) does not prohibit a medical practitioner holding an authority under Part 8 to be supplied with thalidomide from supplying thalidomide to another person for the purpose of treating that other person in accordance with the authority.(4) A person being supplied with thalidomide (otherwise than as referred to in subclause (3) (c)) must surrender his or her authority to the dealer.(5) A dealer must keep any authority surrendered to the dealer under this clause.Maximum penalty: 15 penalty units.
52 Authority required to supply certain restricted substances
(1) This clause applies to the following substances:acitretinclomiphenecyclofenildinoprostdinoprostoneetretinatefollitropin betaisotretinoin for oral useluteinising hormonetretinoin for oral useurofollitropin (human follicle stimulating hormone)(2) A person must not supply a substance to which this clause applies unless the person holds an authority under Part 8 to supply the substance.(3) This clause does not apply to the supply of a substance:(a) by wholesale, or(b) by a veterinary practitioner, or(c) by a pharmacist on the prescription of:(i) a medical practitioner holding an authority under Part 8 to prescribe the substance, or(ii) a veterinary practitioner, or(d) by a person who is authorised by the Permanent Head of the Commonwealth Department of Health to supply the substance.Maximum penalty: 15 penalty units.
53 Restricted substances may be supplied by authorised persons
A person who is not an authorised practitioner may supply a restricted substance to another person if the person by whom the substance is supplied holds an authority under Part 8 to supply the substance.
54 Quantity and purpose of supply to be appropriate
An authorised practitioner or pharmacist must not supply any restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.Maximum penalty: 20 penalty units or imprisonment for 6 months, or both.