DRAFT Compositional guidelines
A compositional guideline is a summary of descriptions, tests and limits that define the composition and characteristics of a substance approved for use in Listed medicines as either an active substance or an excipient. Compositional guidelines are required where there is no standard for the substance in the British Pharmacopoeia (BP).
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/frli/bp2007.htm> would be the default material standard used by the TGA.
DRAFT compositional guidelines - open for comment
Draft compositional guidelines are open for comment for 6 months after being made available on this website. Comments on draft compositional guidelines should be submitted in writing to:
The Compositional Guidelines Officer
Office of Complementary Medicines
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
AUSTRALIA
Or email: TGA_Comp_Guidelines@tga.gov.au
- Draft compositional guideline - Larix arabinogalactan (pdf,56kb)
comments close 11 February 2009 - Draft compositional guideline - Rhodiola rosea powdered root extract (pdf,51kb)
comments close 7 February 2009 - Draft compositional guideline - Rhodiola rosea root dry/powder (pdf,56kb)
comments close 7 February 2009
DRAFT compositional guidelines - comment period closed
- Draft compositional guideline - Amylase derived from Aspergillus oryzae (pdf,85kb)
- Draft compositional guideline - Asparagus racemosus dried root (pdf,44kb)
- Draft compositional guideline - Bovine lactoferrin (pdf,10kb)
- Draft compositional guideline - Calcium-β-hydroxy-β-methylbutyrate (monohydrate) (pdf,16kb)
- Draft compositional guideline - Calcium lactate gluconate (pdf,14kb)
- Draft compositional guideline - Canarium indicum oil (pdf,32kb)
- Draft compositional guideline - Cellulase derived from Trichoderma longibrachiatum (pdf,85kb)
- Draft compositional guideline - Conifer green needle complex (pdf,34kb)
- Draft compositional guideline - Refined emu oil (pdf,15kb)
- Draft compositional guideline - Euphausia superba oil (pdf,36kb)
- Draft compositional guideline - Glucosamine sulfate (pdf,12kb)
- Draft compositional guideline - Levocarnitine and its salts and derivatives (pdf,16kb)
- Draft compositional guideline - Lipase derived from Rhizopus oryzae (pdf,32kb)
- Draft compositional guideline - Lutein (pdf,11kb)
- Draft compositional guideline - Lycopene (pdf,13kb)
- Draft compositional guideline - Molybdenum trioxide (pdf,11kb)
- Draft compositional guideline - Morinda citrifolia dried fruit powder (pdf,71kb)
- Draft compositional guideline - Morinda citrifolia juice (pdf,54kb)
- Draft compositional guideline - Proteases derived from Aspergillus oryzae (pdf,32kb)
- Draft compositional guideline - Pseudowintera colorata leaf (pdf,13kb)
- Draft compositional guideline - Royal jelly and derivatives (pdf,13kb)
- Draft compositional guideline - Santalum spicatum (Australian Sandalwood) (pdf,88kb)
- Draft compositional guideline - Shark cartilage (pdf,10kb)
- Draft compositional guideline - Streptococcus thermophilus (pdf,10kb)
- Draft compositional guideline - Thiamine phosphoric acid ester chloride (pdf,14kb)
- Draft compositional guideline - Tilactase derived from Aspergillus oryzae (pdf,85kb)
- Draft compositional guideline - Tocotrienols complex - palm (pdf,52kb)
- Draft compositional guideline - Trametes versicolor hyphae aqueous extract - powder (pdf,76kb)
- Draft compositional guideline - Trametes versicolor proteoglycan concentrate (pdf,45kb)
- Draft compositional guideline - Undaria pinnatifida powder (pdf,15kb)
- Draft compositional guideline - Zeaxanthin (pdf,15kb)