Compositional guidelines

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.

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