In an ongoing crackdown on repackers, the FDA recently issued warning letters to three repackers of active pharmaceutical ingredients (API) – B&B Pharmaceuticals Inc., of Englewood, Colo.; Asclemed USA Inc., doing business as Enovachem, of Torrance, Calif.; and Spectrum Laboratory Products Inc., of Gardena, Calif. – for significant violations of current good manufacturing practice requirements. All three companies were cited for providing incomplete certificates of analysis for the opioids and other APIs they repackage. B&B also was cited for failure to thoroughly investigate complaints of subpotent API and to conduct cleaning validation studies to ensure no cross-contamination. The letter to Enovachem faults the company for failure to ensure traceabaility throughout the supply chain. The Spectrum letter said the company had failed to investigate manufacturing problems such as cracked bottles of repackaged opioids. Since both Enovachem and Spectrum list glycerin among the products they repackage, they were cautioned about the potential for glycerin to be contaminated with diethylene glycol, a poison that may be deadly. "Lapses in supply chain oversight, including incomplete information on certificates of analysis, was one of the factors that allowed contaminated drugs to enter the supply chain in the past," the FDA said. The agency noted that it has sent similar warnings to other repackers, with some of them being put on import alert. "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," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
The U.K.'s Medicines and Healthcare Products Regulatory Authority updated its guidance on managing authorization and reporting safety issues in clinical trials of drugs. The updated part of the guidance covers the reference safety information for a trial. It follows detailed discussions between national competent authorities and trial sponsors stemming from trial applications, substantial amendment procedures and good clinical practice inspections.
Japan's Pharmaceutical and Medical Devices Agency will hold a symposium July 25 on the draft revision of the International Council for Harmonisation's E8 guideline, "General considerations for clinical trials." The symposium will cover why the guideline needs revising and regulatory and stakeholder expectations for the revision.