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PCNSW Compounding Fact Sheet and FAQs - September 2018 Update

Wed, 26/09/2018

The Pharmacy Council of New South Wales has announced that based on feedback received from the industry, they have updated the Fact Sheet on raw materials used in compounding and released accompanying Frequently Asked Questions (FAQs). The fact sheet was released to support pharmacists in procuring the best quality raw materials for their compounding products. 

Further clarification of the fact sheet has been welcomed by pharmacists as it further ensures that they can complete full due diligence of their suppliers and where they source their materials. Materials produced under GMP conditions in GMP compliant facilities give pharmacists the best assurance of quality without the requirement of further testing. PCNSW in their most recent publication have made an important clarification that the GMP license must be applicable to the specific ingredient being sourced.

“The manufacturing licence will detail the steps in the manufacturing process the manufacturer is licensed to carry out (e.g. repackaging, labelling etc.) and is only applicable to materials manufactured under the terms of the licence.” Other materials that are not under the terms of the license are to be assessed using the supplier/wholesaler/third party pathway of the flow chart supplied with the fact sheet.

Fagron Australia supplies high-quality pharmaceutical raw materials as a wholesaler licensed by NSW Health.

To ensure quality through our supply chain, all pharmaceutical raw materials procured by Fagron Australia come from manufacturers audited by the Fagron Global Quality team to ensure they hold a GMP manufacturing license (or other appropriate certification) from a regulatory authority which is acceptable to the TGA.

All Fagron branded products are manufactured or repackaged under GMP conditions at our Fagron GMP manufacturing sites, licensed by the USFDA, where all raw materials undergo testing by an appropriately accredited, independent laboratory to confirm identity, purity and conformity of raw materials against pharmacopoeia standards (e.g. USP, BP or PhEur) before being released for sale.

Fagron’s unique Quality Innovation System (QIS) means that all ingredients sourced by Fagron are able to be traced back to their original source matching with all audit documentation and raw material analysis for every batch received.

All Certificates of Analysis (CoAs) are available to customers via our website www.fagron.com.au. If you require any assistance with your due diligence and risk assessment of raw materials you use in your compounded medications, please contact the team at Fagron Australia and we can provide any further documentation that may assist you in your decision making. If required original manufacturer documentation is also available to Fagron customers upon request through our QIS Global Quality System.