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FDA warns opioid repackers for ‘significant violations’
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The FDA announced it issued warnings letters to three companies that repackage opioids — Asclemed USA Inc., doing business as Enovachem, B&B Pharmaceuticals Inc., and Spectrum Laboratory Products Inc. — for “significant violations” of current good manufacturing practice requirements.
According to a press release, the warning letter to Enovachem pointed out failure to acquire and hold onto documents with the identity of the original manufacturer and certificates of analysis from the original manufacturer. The company also distributed active pharmaceutical ingredients, including opioids, to its customers, without complete certificates of analysis.
The FDA also indicated that B&B Pharmaceuticals neglected to “thoroughly investigate complaints” regarding sub-potent active pharmaceutical ingredients, and did not perform cleaning validation studies to show that its cleaning procedures for nondedicated production equipment are sufficient to prevent potential cross-contamination between repackaged active pharmaceutical ingredients, including highly potent drugs such as opioids, testosterone, progesterone and estrogen. B&B Pharmaceuticals also failed to provide adequate certificates of analysis for active pharmaceutical ingredients, the FDA claimed.
The press release stated that Spectrum did not provide all the required information in its certificates of analysis that it provided to its customers, including compounding pharmacies, and did not properly investigate and resolve critical current good manufacturing practice deviations, including damaged bottles of repackaged opioids.
Spectrum’s and Enovachem’s warning letters stated that these companies list glycerin as one of the products they repackage, according to the FDA. Twelve years ago, the FDA issued an alert that warned of the “potential public health hazard” of glycerin tainted with diethylene glycol, a potentially fatal poison. Some of the violations these companies are accused of were “one of the factors that allowed contaminated drugs to enter the supply chain in the past,” the FDA stated.
“The FDA remains vigilant in our inspections and oversight of the supply chain and as part of this effort, we inspect active pharmaceutical ingredients 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,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the press release.
“The supply chain issues we have found in the active pharmaceutical ingredients 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,” she continued.
Each company has 15 working days to submit responses to the FDA. Their failure to correct the violations could result in limitation, seizure and injunction, the press release stated.
According to the FDA, separate warning letters to other active pharmaceutical ingredient repackers for similar violations were also recently issued, including Vipor Chemicals Private Ltd., Lumis Global Pharmaceuticals Co. Ltd., Sal Pharma, Huron Pharmaceuticals Inc. and Fagron Inc. The agency also added Lumis Global Pharmaceuticals Co. Ltd. and Sal Pharma to import alerts, including 66-40, for failure to meeting current good manufacturing practice requirements, to keep their active pharmaceutical ingredients from reaching U.S. patients. The FDA also recently put out alerts about safety issues with repackaged baclofen porcine and thyroid active pharmaceutical ingredients.
Disclosures: Woodcock works for the FDA.