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Compositional guidelines

Compositional guidelines are intended to provide clarity to the specific form or type of substances that the Therapeutic Goods Administration (TGA) approves for use in listed medicines, as either an active substance or an excipient, where there is no standard in the British Pharmacopoeia (BP) or other acceptable monographs.

However, substances to which a BP monograph applies must meet the specifications of the BP unless an exemption is granted under Section 14 of the Therapeutic Goods Act 1989.

On 9 April 2008, the National Manager of the TGA specified that from 1 July 2008 the British Pharmacopoeia (BP) 2008 <http://www.tga.gov.au/legis/bp2008.htm> would be the default material standard used by the TGA.

Current compositional guidelines

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