FDA strives to tighten API repackaging operations

Cross-contamination and missing documentation are cited in warning letters


Some repackagers produce cartons or vials of prescription drugs, ready to be provided to patients; others are intermediaries in delivering active pharmaceutical ingredients (APIs) to manufacturers, compounding pharmacies and others. Several businesses in the latter category have been issued warning letters by FDA for alleged violations of cGMP standards, missing documentation on certificates of quality, failure to investigate flawed packages and a variety of other complaints. Many of the warning letters focus on processes being carried out in handling opioid-based APIs.

Companies mentioned in the FDA announcement include B&B Pharmaceuticals, Inc., Asclemed USA, Inc., doing business as Enovachem and Spectrum Laboratory Products, Inc. Related warning letters have been sent to Vipor Chemicals Private Ltd., Lumis Global Pharmaceuticals Co. Ltd., Sal Pharma, Huron Pharmaceuticals, Inc. and Fagron, Inc.

As has been widely reported, some 80% of pharmaceutical ingredients are imported into the US; in addition, FDA oversight of foreign drug manufacturing is less rigorous than US facilities. One assumes that US manufacturers using imported APIs (whether repackaged or not) have their own rigorous quality checks. But the ability of compounding pharmacies (some of which amount to an individual pharmacist) or so-called outsourcing facilities (which compound pharmaceutical products, for patients, on a high-volume basis) is open to question.

“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,” stated Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.