Compounding pharmacies formulate medicines to order , combining, mixing, or altering ingredients to produce a preparation tailored to a particular patient's clinical requirements as documented by a prescriber. Common reasons for compounding include the need for an alternative dose form (for example, a liquid instead of a tablet), the exclusion of a specific excipient to which a patient is sensitive, or the preparation of a strength not available in a registered product.
In Australia, pharmacy compounding is regulated under the Therapeutic Goods Act 1989 (Cth) and associated state and territory pharmacy legislation. The Therapeutic Goods Administration (TGA) distinguishes between standard compounding (preparations made on a patient-specific prescription in small quantities) and non-standard compounding, which requires additional TGA authorisation. The Pharmacy Board of Australia sets professional standards for compounding practice under its guidelines, and accreditation bodies such as the Australian Pharmacy Council provide further quality frameworks.
Compounded preparations are not evaluated for safety, quality, or efficacy by the TGA in the same way as registered products. They do not appear on the Australian Register of Therapeutic Goods (ARTG) and are supplied under the exemption provisions of the Therapeutic Goods Act 1989. The TGA has issued guidance specifically addressing compounding of medicines that are otherwise available as registered products, and enforcement action has been taken where compounding has been found to circumvent the registration pathway without appropriate justification.
Compounding is distinct from manufacturing. Large-scale production of compounded preparations without TGA manufacturing authorisation (a licence issued under Part 3-3 of the Act) may constitute unlicensed manufacturing and attract regulatory penalties. The TGA's Guidance on Compounding of Medicines outlines the boundary between the two activities and the conditions under which compounding exemptions apply.
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