The FDA recently updated the FDA to Compounders: Know Your Bulks and Excipients Suppliers page, which now includes links to guidance documents, examples of past quality issues, and a log of FDA actions against trading partners for violations of Good Manufacturing Practice Requirements (GMP).
Additional updates focus on the quality assurance of bulk substances, often referred to as active pharmaceutical ingredients (APIs), in compounding. More specifically, the agency is urging compounders to ensure that their suppliers are testing APIs for purity and quality prior to purchasing.
The focus on API quality assurance stems from a common practice by repackagers, who often transfer bulk API received from manufacturers to different containers, leaving room for errors or safety issues to arise. This is not to say that repackagers inherently introduce quality issues; rather, that it is in the best interest of compounders to do their due diligence in researching who they secure product from, to ensure supplier qualifications are being met.
As a reminder, both sections 503A and 503B include provisions on API compliance in accordance with both United States Pharmacopeia (USP) and National Formulary (NF) monograph standards.
Compounders may only use bulk substances that satisfy the following criteria:
- Must have USP or NF Monograph
- Must be Supplied by an FDA Registered Facility
- Must contain valid Certificate of Analysis
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