Home>News> FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk with significant violations of manufacturing quality standards

FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk with significant violations of manufacturing quality standards

The U.S. Food and Drug Administration has issued warning letters to three repackers of active pharmaceutical ingredients (API), B&B Pharmaceuticals, Inc., Asclemed USA, Inc., doing business as Enovachem and Spectrum Laboratory Products, Inc., for significant violations of current good manufacturing practice (CGMP) requirements. “Repackers play a role in the pharmaceutical supply chain, and some distribute bulk API to drug manufacturers and pharmacy compounders. The U.S. drug supply chain remains one of the safest in the world, yet because of the various players and increased globalization, it has become increasingly complex. The FDA remains vigilant in our inspections and oversight of the supply chain and as part of this effort, we inspect API repackers to help identify and prevent any weaknesses in the legitimate supply chain – this is especially important within the context of the opioid crisis for those who handle opioids,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The supply chain issues we have found in the API repacking industry broadly pose a real threat to the public health and we’re calling on them to address these issues as quickly as possible. For patient safety and supply chain transparency, repackers must follow all quality standards pertaining to them – including clearly identifying the original manufacturer of the drugs, such as opioids, to their customers who use them to make the finished drugs patients take every day. This information is vitally important to ensure the drugs patients take meet high quality standards that patients deserve.”

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