35Standards of composition and purity of pharmaceutical benefits and additives

35 Standards of composition and purity of pharmaceutical benefits and additives

(1) If: (a) under the Therapeutic Goods Act 1989, a drug, medicine or substance must be of a particular standard of composition or purity; and (b) the drug, medicine or substance is to be supplied as a pharmaceutical benefit; the standard of composition or purity of the drug, medicine or substance is the standard for the purposes of the Act. (2) If: (a) under the Therapeutic Goods Act 1989, a drug, medicine or substance must be of a particular standard of composition or purity; and (b) the drug, medicine or substance is used as an additive in another drug, medicine or substance (in this subregulation called ‘the finished product’); and (c) the finished product is to be supplied as a pharmaceutical benefit; the standard of composition or purity of the drug, medicine or substance used as an additive is the standard for the purposes of the Act.

Note: See also paragraph 103(5)(f) of the Act.