In September 2025, the Food and Drug Administration issued over 50 Warning Letters to companies for marketing compounded GLP’s as ‘generic versions’ or that make comparative claims to FDA-approved versions. This has long been the focus of Cease & Desist letters from the brand manufacturers to 503A compounders. FDA also issued a series of letters regarding mostly peptides being sold as ‘research use only’ (RUO) where the advertising indicated the product was intended for human use. The Warning Letters targeted mostly semaglutide, tirzepatide and retatrutide as well as other peptides such as BPC-157 and selective androgen receptor or anabolic steroids (SARMS) such as trendione. Retatrutide cannot be compounded at all because it is an investigational drug. Other Warning Letters pertained to insanitary conditions for 503A compounders. FDA inspects 503A compounders pursuant to its insanitary guidance standards rather than USP and compounders need to be fluent in the requirements of that Guidance.

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In September 2025, the Food and Drug Administration issued over 50 Warning Letters to companies for marketing compounded GLP’s as ‘generic versions’ or that make comparative claims to FDA-approved versions.

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Warning Letters issued to 503B Outsourcing Facilities were for cGMP violations, failure to submit Adverse Drug Reaction (ADR) reports to FDA (which 503B facilities are required to report), compounding unapproved drug products. Some 503B Warning letters involved mislabeling where the compounded product did not bear the label ‘this is a compounded drug’ or ‘this is a repackaged drug.’ Others pertained to inadequate Policies & Procedures (P&P) for the Quality Control units.

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Also in September 2025, FDA established a ‘Green List Import Alert’ (66-80) to help stop GLP-1 API’s that have potential quality concerns from entering the U.S. supply chain. Concurrently, FDA has increased unannounced inspections of foreign API manufacturers and is also stepping up Remote Inspections via FDA form 4003.

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FDA has increased unannounced inspections of foreign API manufacturers and is also stepping up Remote Inspections via FDA form 4003.

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Whether you are a 503A pharmacy compounder or a 503B Outsourcing Facility you should have your labeling, Website and Social Media advertising, P&P and compounded products reviewed for compliance with current FDA Guidance. If you are facing either an FDA or Board of Pharmacy inspection or just need to get up to speed on the latest compounding requirements, contact us today.