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.
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
- Wheat dextrin - draft compositional guideline
<http://www.tga.gov.au/docs/html/compguid/drwheatdextrin.htm>
comments close 9 November 2010 - Caralluma adscendens var. fimbriata - draft compositional guideline
<http://www.tga.gov.au/docs/html/compguid/drcaralluma.htm>
comments close 5 November 2010 - Quercetin - draft compositional guideline
<http://www.tga.gov.au/docs/html/compguid/drquercetin.htm>
comments close 1 October 2010 - Rutin trihydrate - draft compositional guideline
<http://www.tga.gov.au/docs/html/compguid/drrutin.htm>
comments close 1 October 2010 - Hesperidin - draft compositional guideline
<http://www.tga.gov.au/docs/html/compguid/drhesperidin.htm>
comments close 1 October 2010 - Citrus bioflavonoids extract - draft compositional guideline
<http://www.tga.gov.au/docs/html/compguid/drhesperidin.htm>
comments close 1 October 2010
DRAFT compositional guidelines - comment period closed
- Alpha-casozepine enriched hydrolysed milk protein - draft compositional guideline (pdf,46kb)
- Amylase derived from Aspergillus oryzae - draft compositional guideline (pdf,85kb)
- Asparagus racemosus dried root - draft compositional guideline (pdf,44kb)
- Bovine lactoferrin - draft compositional guideline (pdf,10kb)
- bovine whey Ig-rich fraction - draft compositional guideline (pdf,48kb)
- Calcium-β-hydroxy-β-methylbutyrate (monohydrate) - draft compositional guideline (pdf,16kb)
- Calcium lactate gluconate - draft compositional guideline (pdf,14kb)
- Canarium indicum oil - draft compositional guideline (pdf,32kb)
- Cellulase derived from Trichoderma longibrachiatum - draft compositional guideline (pdf,85kb)
- Chlorella vulgaris powder - draft compositional guideline (pdf,48kb)
- Conifer green needle complex - draft compositional guideline (pdf,34kb)
- Dimethyl sulfone - This substance has a monograph in the United States Pharamacopeia, which became a legally recognised default standard in 2009. The compositional guideline for the substance previously presented here has therefore been withdrawn. Please consult the current edition of the USP-NF for the monograph of this product.
- Euphausia superba oil - draft compositional guideline
<http://www.tga.gov.au/docs/html/compguid/dreuphausia.htm> - Refined emu oil - draft compositional guideline (pdf,15kb)
- Fish oil - natural - draft compositional guideline
<http://www.tga.gov.au/docs/html/compguid/drfishoil1.htm> - Fish oil - natural - draft compositional guideline (pdf,56kb)
Please note: This draft compositional guideline has been revised to reflect suggestions provided through this consultation process (1 April 2010). See: Fish oil - natural - draft compositional guideline - Glucosamine sulfate - This substance has a monograph in the United States Pharamacopeia, which became a legally recognised default standard in 2009. The compositional guideline for the substance previously presented here has therefore been withdrawn. Please consult the current edition of the USP-NF for the monograph of this product.
- Larix arabinogalactan - draft compositional guideline (pdf,56kb)
- Levocarnitine and its salts and derivatives - draft compositional guideline (pdf,16kb)
- Lipase derived from Rhizopus oryzae - draft compositional guideline (pdf,32kb)
- Lutein - This substance has a monograph in the United States Pharamacopeia, which became a legally recognised default standard in 2009. The compositional guideline for the substance previously presented here has therefore been withdrawn. Please consult the current edition of the USP-NF for the monograph of this product.
- Lycopene - This substance has a monograph in the United States Pharamacopeia, which became a legally recognised default standard in 2009. The compositional guideline for the substance previously presented here has therefore been withdrawn. Please consult the current edition of the USP-NF for the monograph of this product.
- Molybdenum trioxide - draft compositional guideline (pdf,11kb)
- Morinda citrifolia dried fruit powder - draft compositional guideline (pdf,71kb)
- Morinda citrifolia juice - draft compositional guideline (pdf,54kb)
- Proteases derived from Aspergillus oryzae - draft compositional guideline (pdf,32kb)
- Omega-3 fish oil phytosterol esters - draft compositional guideline (pdf,96kb)
- Pseudowintera colorata leaf - draft compositional guideline (pdf,13kb)
- Rhodiola rosea powdered root extract - draft compositional guideline (pdf,51kb)
- Rhodiola rosea root dry/powder - draft compositional guideline (pdf,56kb)
- Royal jelly and derivatives - draft compositional guideline (pdf,13kb)
- Santalum spicatum (Australian Sandalwood) - draft compositional guideline (pdf,88kb)
- Shark cartilage - draft compositional guideline (pdf,10kb)
- Streptococcus thermophilus - draft compositional guideline (pdf,10kb)
- Terminalia bellirica - draft compositional guideline (pdf,52kb)
- Thiamine phosphoric acid ester chloride - draft compositional guideline (pdf,14kb)
- Tilactase derived from Aspergillus oryzae - draft compositional guideline (pdf,85kb)
- Tocotrienols complex - palm - draft compositional guideline (pdf,52kb)
- Trametes versicolor hyphae aqueous extract - powder - draft compositional guideline (pdf,76kb)
- Trametes versicolor proteoglycan concentrate - draft compositional guideline (pdf,45kb)
- Trefriw Wells mineral water - draft compositional guideline (pdf,102kb)
- Undaria pinnatifida powder - draft compositional guideline (pdf,15kb)
- Vegetable oil phytosterol esters - draft compositional guideline (pdf,63kb)
- Zeaxanthin - draft compositional guideline (pdf,15kb)