FDA warns opioid repackers

July 9, 2019

FDA warns opioid repackers for "significant violations."

FDA is warning 3 repackers of opioids active pharmaceutical ingredients (API) over “significant violations” of current good manufacturing practice (CGMP) requirements.

FDA sent warning letters to B&B Pharmaceuticals, Inc., Asclemed USA doing business as Enovachem, and Spectrum Laboratory Products, Inc., the agency said in a press release.

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“Repackers play a role in the pharmaceutical supply chain, and some distribute bulk API to drug manufacturers and pharmacy compounders. 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, MD, director of FDA’s Center for Drug Evaluation and Research, in the statement.

“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,” Woodcock added.

Improper repackaging or lack of supply chain oversight of API can cause serious vulnerabilities in the supply chain and may lead to adverse events in patients, FDA said.

The agency’s warning letter to B&B Pharmaceuticals describes failures to conform to CGMPs, including failure to thoroughly investigate complaints regarding sub-potent API. The repacker also failed to conduct cleaning validation studies to demonstrate that their cleaning procedures for non-dedicated production equipment are adequate to prevent potential cross-contamination between repackaged API, including highly potent drugs such as testosterone, progesterone, estrogen and opioids.

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The warning letter issued to Enovachem said the company distributed API, including opioids, to its customers with incomplete certificates of analysis, which compromises supply chain accountability and traceability and may put consumers at risk. The customers included compounding pharmacies which use the API for prescription compounding.

The FDA issued a warning letter to Spectrum for “significant deviations” from CGMPs. Spectrum repackages various opioid APIs, but did not provide complete information in its certificates of analysis provided to its customers, including compounding pharmacies. Spectrum failed to properly investigate and resolve critical CGMP deviations, including cracked bottles of repackaged opioids, among other violations.

The FDA has issued separate warning letters to other API repackers for similar violations, including: Vipor Chemicals Private Ltd.Lumis Global Pharmaceuticals Co. Ltd.Sal PharmaHuron Pharmaceuticals, Inc. and Fagron, Inc. The agency also added Lumis Global Pharmaceuticals Co. Ltd. and Sal Pharma to import alerts for failure to meet CGMPs, to keep their API from ultimately reaching US patients.

“The FDA will continue to inspect and take action as appropriate against repackers, particularly those in the opioid API supply chain,” the agency said.

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