FDA Global Supply Chain Concerns Prompt Glycerin DEG Testing Guidance
This article was originally published in The Tan Sheet
Pharmaceutical manufacturing facilities and compounding pharmacists should include tests for diethylene glycol content in the identity testing of all lots of glycerin they receive, according to an FDA guidance reflecting growing concern about vulnerabilities in the global supply chain
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Most of the foreign OTC drug firms targeted in latest warnings FDA published, including the GUM oral care brand manufacturer, were placed on import alert due to GMP violations. Each was inspected by FDA during June, July or May 2019, when the agency was wrapping up an initiative to inspect all previously uninspected drug manufacturers.
The good news: 75% of firms not previously inspected were in compliance with US drug GMP requirements; the bad news, 25% weren't. CDER Office of Manufacturing Quality director Francis Godwin says FDA remains concerned about vulnerabilities in supply chain when OTC firms don't test products for impurities that have harmed and killed consumers in the past.
The good news: 75% of never-before-inspected firms complied with US drug GMP requirements. The bad news: 25% did not.