January 27, 2021
The following quote is attributed to Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research Donald D. Ashley, J.D.:
“FDA standards are designed to help ensure the quality of drugs distributed to American patients. We expect all companies to follow the law and ensure the drugs they distribute meet these standards and are of high quality. Producing or distributing drugs that are non-compliant or make false or misleading claims poses a serious risk of harm to patient health and cannot be tolerated.
“While most companies comply with applicable FDA requirements and follow the law, we do find some violations. When the agency finds manufacturers, including repackagers, that fail to comply with current good manufacturing practices (CGMP), we take action and work to bring them into compliance.
“Through actions— like the warning letter issued today— we will continue to highlight identity and transparency issues in our drug production and supply chain so as to help ensure drugs distributed in the United States meet the required standards for drug quality that American consumers expect.”
- 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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.