Poisons and Therapeutic Goods Regulation 2008
Part 5 Supply by wholesale and by holders of wholesaler’s licences and authorities
129 Persons authorised to possess or use substances and to be supplied by holder of wholesaler’s licence or authority
(1) Each person specified in Appendix C is authorised to possess and use the substances specified in relation to that person in that Appendix subject to any conditions or qualifications that may be specified.Note.Section 11 (1) of the Act creates an offence if the holder of a wholesaler’s licence or wholesaler’s authority supplies any Schedule 1, 2, 3 or 7 substance or any restricted substance to a person other than an authorised person. An authorised person includes a person who is authorised by or under the Act to use, or have possession of, the substance concerned.(2) Each person who is specified in Appendix C as being authorised to possess and use a substance is, for the purposes of paragraph (d) of the definition of Supply by wholesale in section 4 (1) of the Act, authorised to be supplied with wholesale quantities of the substance.(3) For the purposes of section 10 (2) (b) of the Act, the holder of a wholesaler’s licence or wholesaler’s authority is authorised to supply a Schedule 1, 2 or 3 substance otherwise than by wholesale to any person who is specified in Appendix C as being authorised to possess and use the substance.Note.Section 10 (1) of the Act creates an offence of supplying a substance specified in Schedule 1, 2 or 3 of the Poisons List otherwise than by wholesale except under a general supplier’s licence or a general supplier’s authority. Section 10 (2) of the Act provides for exceptions to this offence.(4) For the purposes of section 10 (4) (d) of the Act, the holder of a wholesaler’s licence or wholesaler’s authority is authorised to supply a restricted substance otherwise than by wholesale to any person who is specified in Appendix C as being authorised to possess and use the substance.Note.Section 10 (3) of the Act creates an offence of supplying a restricted substance otherwise than by wholesale. Section 10 (4) of the Act provides for exceptions to this offence.
130 Restrictions on supply by wholesale
A person must not supply by wholesale any Schedule 2, 3 or 4 substance that is for therapeutic use:(a) to any person in another State or a Territory, unless the person being supplied with the substance is authorised by a law of that State or Territory to obtain or supply the substance, or(b) to any person outside Australia, unless the person supplying the substance is authorised to do so by a law of the Commonwealth.Maximum penalty: 15 penalty units.
131 Records of supply by wholesale
(1) A person who supplies by wholesale any regulated goods must issue an invoice to the person being supplied and must keep a copy of the invoice.(2) Each invoice must show:(a) the date of the supply, and(b) the name and address of the person being supplied, and(c) the name, strength and quantity of the substance supplied, and(d) the name of the supplier and the address of the premises from which the goods were supplied.Maximum penalty: 20 penalty units.
132 Distribution of free samples
Any person:(a) who is engaged in the manufacture, or supply by wholesale, of any poison or restricted substance for therapeutic use, ormust not supply any such poison or restricted substance by way of distribution of free samples otherwise than in a manner approved for the time being by the Director-General.(b) who is acting as an agent of a person so engaged,Maximum penalty: 20 penalty units.
133 Storage of therapeutic substances for human use
(1) A person who is engaged in the supply by wholesale of therapeutic substances for human use must ensure that the recommendations and requirements of the Wholesaling Code of Practice are complied with.Maximum penalty: 20 penalty units.(2) The Director-General may, by order in writing, exempt any person or substance, or any class of persons or substances, from any or all of the requirements of this clause.(3) Such an exemption may be given unconditionally or subject to conditions.(4) In this clause, Wholesaling Code of Practice means the Code of Practice entitled Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use, published by the Commonwealth Government, as in force from time to time or a code of practice that replaces that Code.
134 Pharmacists authorised to supply by wholesale in certain circumstances
(1) A pharmacist is authorised to supply a substance by wholesale to another pharmacist if:(a) the pharmacist is requested to do so in writing signed by the other pharmacist, and(b) the other pharmacist is making the request to satisfy an order of a customer, and(c) the pharmacist, as far as is reasonably practicable supplies to that other pharmacist only the minimum amount of the substance that is necessary to satisfy the order of that customer.(2) A pharmacist is authorised to supply a substance by wholesale to another pharmacist if the pharmacist has previously been supplied an amount of the substance in accordance with subclause (1) and is supplying a similar amount of the substance as a replacement for that earlier supply.