The Pharmacy Council of New South Wales has released a fact sheet about raw materials used in compounding. This comes in response to a number of complaints received by the Council in relation to the authenticity of raw materials used in compounded preparations.

The fact sheet seeks to provide guidance for pharmacists by clarifying their professional obligations and includes a Manufacturer assessment flowchart to support pharmacists in their decision-making process.

Key points:

• All raw materials used should comply with pharmacopoeial standards and be produced by acceptable manufacturers.
• A Certificate of Analysis should not be solely relied upon to assess the suitability of the raw material. Where one is not available or not provided by the manufacturer, or appears dubious, pharmacists should have raw materials independently tested to confirm their compliance with pharmacopoeial standards prior to use in compounding.
• Independent testing of raw materials should be conducted by a laboratory holding appropriate accreditation for testing e.g. National Association of Testing Authorities (NATA) or the Therapeutic Goods Administration (TGA).
• When sourcing raw materials via a supplier or third-party, pharmacists are still responsible for ensuring the original manufacturer engaged by the supplier or third-party is acceptable.
• When procuring raw materials, pharmacists must consider whether the manufacturer has implemented appropriate controls for the manufacture of the raw materials, and has effective processes in place to assure the quality of the raw materials supplied.
• In Australia, acceptable manufacturers of active pharmaceutical ingredients will hold a manufacturing licence for the manufacture of a particular raw material from the TGA.
• Overseas manufacturers will hold certification relevant to the manufacture of raw materials, e.g. a certificate of Good Manufacturing Practice (GMP) compliance or equivalent accreditation from a regulatory or accrediting authority equivalent to the TGA.

A wholesale licence or an import licence (which some suppliers may hold) is not relevant in determining the quality of the raw materials produced or the acceptability of the manufacturer.

You can access the fact sheet in full on the Council website.