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 30 May 2007, the National Manager of the TGA specified that from 1 July 2007 the British Pharmacopoeia (BP) 2007 <http://www.tga.gov.au/legis/bp2007.htm> would be the default material standard used by the TGA.
As a result of the adoption of the 2007 edition of the BP, chondroitin sulfate shark and bovine (sodium) and R,S-alpha-lipoic acid are now both the subject of BP monographs. Therefore, the compositional guidelines have been removed from the TGA website and compliance with the BP is mandatory unless an exemption is held.
More information about the BP 2007 monographs for chondroitin sulfate and alpha-lipoic acid are available at: British Pharmacopoeia 2007 - impact on complementary medicines <http://www.tga.gov.au/cm/bp07-listmed.htm>
Current compositional guidelines
- Compositional guideline: Ademetionine ((S)-S-adenosylmethionine ('SAMe'))
<http://www.tga.gov.au/docs/html/compguid/same.htm> - Compositional guideline: Arthrospira maxima
<http://www.tga.gov.au/docs/html/compguid/maxima.htm> - Compositional guideline: Arthrospira platensis
<http://www.tga.gov.au/docs/html/compguid/platensis.htm> - Compositional guideline: Black boned chicken powder
<http://www.tga.gov.au/docs/html/compguid/bbchickp.htm> - Compositional guideline: Bovine colostrum powder
<http://www.tga.gov.au/docs/html/compguid/bovinecp.htm> - Compositional guideline: Conifer phytosterol complex
<http://www.tga.gov.au/docs/html/compguid/conifphy.htm> - Compositional guideline: Demineralised fish proteoglycan extract
<http://www.tga.gov.au/docs/html/compguid/demfish.htm> - Compositional guideline: Fish oil from the liver of fish
<http://www.tga.gov.au/docs/html/compguid/fishliveroil.htm> - Compositional guideline: Fish oil from the whole body of fish
<http://www.tga.gov.au/docs/html/compguid/wholefishoil.htm> - Compositional guideline: Hydroxycitrate complex
<http://www.tga.gov.au/docs/html/compguid/hydroxycitrate.htm> - Compositional guideline: Sugar cane wax alcohols
<http://www.tga.gov.au/docs/html/compguid/sugarcwa.htm>