Pharmacopoeias

Pharmacopoeias provide standards for pharmaceutical substances and medicinal products. Standards are an important tool in the regulation of the quality of medicines.

Note: If you intend to rely on any legislation referred to on this website, you should access copies of the official versions on the Attorney General's Department's Federal Register of Legislation (FRL) website. Instruments are amended from time to time and may, on occasions, be replaced or new instruments made.

Default standards

As from 1 July 2009, the Therapeutic Goods Act 1989 (Chapter 1, section 3) refers to default standards. 'Default standard' means any of the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopoeia-National Formulary.

Therapeutic goods (exempting monographs of pharmacopoeias) determinations

Definition of the British Pharmacopoeia

Before July 2009, the Therapeutic Goods Act 1989 referred to the 'British Pharmacopoeia' instead of 'default standard'. A new edition of the British Pharmacopoeia was published annually, so a legal order was made annually to redefine the edition of the British Pharmacopoeia used by the TGA.