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FDA in Brief: FDA Warns Company for Putting Consumers at Risk Through Distribution of Non-Compliant and Misbranded Drug Ingredients |
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The U.S. Food and Drug Administration issued a warning letter to Professional Compounding Centers of America Inc. (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 their 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.
Following an inspection and review of import data, the FDA determined that drugs from PCCA’s suppliers had been placed on import alert due to, among other issues, the suppliers’ failure to ensure proper and scientifically sound test procedures for quality or purity; failure to maintain complete data; not adequately investigating drug test failures or quality-related complaints; and denying the FDA’s attempts for inspection. Additionally, certain PCCA APIs did not identify that other companies were involved in the manufacturing of the API. This caused the repackaged/relabeled API to be misbranded because the labels are false or misleading. The warning letter also outlines PCCA’s failure to ensure that the glycerin API it repackages conforms to applicable standards of identity, quality and purity. This failure causes the glycerin API to be adulterated and misbranded.
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