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.

• Questions & answers relating to the additional default standards legislation
  'Default standard' means any of the British Pharmacopoeia (BP), European Pharmacopoeia (Ph Eur), and United States Pharmacopoeia-National Formulary (USP)

Therapeutic goods (exempting monographs) determination

• Therapeutic Goods (Exempt Monographs) Determination 2021
  Exempts unregistered nicotine vaping products that are subject to the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order from monographs in the British Pharmacopoeia, European Pharmacopoeia and United States Pharmacopoeia-National Formulary (USP) that would otherwise apply to those products as default standards. Therapeutic Goods (Exempt Monographs) Amendment Determination 2022 amends this Determination to also set out specific monographs of the USP that are not accepted as standards.

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.

• Definition of British Pharmacopoeia (BP 2009) - 8 May 2009
• Definition of British Pharmacopoeia (BP 2008) - 9 April 2008
• Definition of British Pharmacopoeia (BP 2007) - 30 May 2007
• Definition of British Pharmacopoeia (BP 2005) - 15 May 2006
• Definition of British Pharmacopoeia (BP 2004) -19 May 2005
• Definition of British Pharmacopoeia (BP 2003) - 12 March 2004