Compositional guidelines

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.

See Compositional guidelines finalised prior to May 2011 for access to older compositional guidelines.