Compositional guidelines

8 November 2016

The following is a list of compositional guidelines for ingredients permitted for use in listed medicines.

In addition, you should refer to the default standards recognised in the Therapeutic Goods Act 1989, that is, the British Pharmacopoeia, United States Pharmacopoeia - National Formulary and the European Pharmacopoeia. If the ingredient is subject to a default standard, you have to comply with applicable standard. If an ingredient is not subject to a default standard or has a compositional guideline, a list of tests with acceptance criterion and analytical procedures references, should be established as a part of total control strategy to ensure quality for the intended use.

For information on what compositional guidelines, standards refer to the Australian Regulatory Guidelines for Complementary Medicines.

Compositional guidelines finalised prior to May 2011 are also listed.

A

B

C

F

H

L

M

P

Q

R

S

U

Z

Compositional guidelines finalised prior to May 2011

Compositional guidelines finalised prior to May 2011 are not consistent with the current compositional guideline format and as such, do not include the same level of detail. If you require one of these compositional guidelines, they are available upon request from the TGA (email: TGA.Comp.Guidelines@tga.gov.au).

  • Pre 2011 compositional guideline: Asparagus racemosus dried root
  • Pre 2011 compositional guideline: Bovine lactoferrin
  • Pre 2011 compositional guideline: Bovine whey Ig-rich fraction
  • Pre 2011 compositional guideline: Calcium-beta-hydroxy-beta-methylbutyrate monohydrate
  • Pre 2011 compositional guideline: Calcium lactate gluconate
  • Pre 2011 compositional guideline: Canarium indicum oil
  • Pre 2011 compositional guideline: Caralluma adscendens var. fimbriata
  • Pre 2011 compositional guideline: Chlorella vulgaris
  • Pre 2011 compositional guideline: Citrus bioflavonoids extract
  • Pre 2011 compositional guideline: Conifer green needle complex
  • Pre 2011 compositional guideline: Emu oil
  • Pre 2011 compositional guideline: Levocarnitine salts and derivatives
  • Pre 2011 compositional guideline: Morinda citrifolia dried fruit powder
  • Pre 2011 compositional guideline: Morinda citrifolia juice
  • Pre 2011 compositional guideline: Omega-3 fish oil phytosterol esters
  • Pre 2011 compositional guideline: Pseudowintera colorata leaf
  • Pre 2011 compositional guideline: Royal jelly
  • Pre 2011 compositional guideline: Santalum spicatum oil
  • Pre 2011 compositional guideline: Shark cartilage
  • Pre 2011 compositional guideline: Streptococcus thermophilus
  • Pre 2011 compositional guideline: Trametes versicolor
  • Pre 2011 compositional guideline: Trametes versicolor proteoglycan concentrate
  • Pre 2011 compositional guideline: Undaria pinnatifida
  • Pre 2011 compositional guideline: Vegetable oil phytosterol esters
  • Pre 2011 compositional guideline: Wheat dextrin