FDA warns repackers for cGMP violations on opioids

By Vassia Barba

- Last updated on GMT

(Image: Getty/Shidlovski)
(Image: Getty/Shidlovski)

Related tags Fda Food and drug administration Warning letter Inspection

B&B, Asclemed and Spectrum receive warnings from the FDA regarding issues in the supply chain of APIs that ‘pose a real threat to public health’.

According to the US Food and Drug Administration (FDA), B&B Pharmaceuticals​ failed to thoroughly investigate complaints regarding sub-potent active pharmaceutical ingredients (APIs).

A warning from the FDA to the company states that there was a possibility of cross-contamination between the repackaged APIs, which included testosterone, progesterone, estrogen and opioids, due to insufficient cleaning procedures by B&B.

The FDA stated that during an inspection, B&B failed to provide critical information about the quality and sourcing of drugs, “compromising supply chain accountability and traceability.”

Asclemed​, which is doing business under name Enovachem, also received a warning from the regulatory agency. The FDA announced that Asclemed did not retain documents with the identity of the drugs’ original manufacturer and certificates of analysis.

Spectrum​ was also given a warning after an inspection revealed incomplete information in its certificates of analysis and ‘critical’ current good manufacturing process (cGMP) deviations, including cracked bottles of repackaged opioids.

Warning letters to both Spectrum and Asclemed state that these companies list glycerin among the products they repackage and detail the potential dangers of glycerin contamination with diethylene glycol, without the complete certificates of analysis for the repackaged APIs, a threat of this danger increases. 

“Repackers must follow all quality standards pertaining to them – including clearly identifying the original manufacturer of the drugs, such as opioids, to their customers,”​ commented Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

She added, “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.”

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