FDA warns compounder for putting consumers at risk with misbranded drug ingredients

The US Food and Drug Administration issued a warning letter to Professional Compounding Centers of America (PCCA) for receiving and distributing adulterated and misbranded active pharmaceutical ingredients (APIs).

The warning letter details that PCCA received drug ingredients from at least one API supplier whose drugs had been placed on import alert at the time they were imported by PCCA. The letter also requests information from PCCA on 23 of its suppliers with a history of non-compliance and asks PCCA to provide the FDA with their proposed plan to ensure they do not receive or distribute additional adulterated drugs in interstate commerce. Firms are responsible for ensuring that the drugs they receive and distribute are manufactured in compliance with all relevant FDA requirements, including CGMP requirements.

The agency urges compounders to know their bulk drug substance (or API) supplier because compounding finished drugs starting from API presents risks to patients. The FDA recommends PCCA’s customers contact PCCA to verify the identity of original API manufacturers for API they have purchased and to ensure the drugs they received met applicable statutory standards.