Are your bulk drug substance suppliers on FDA’s hit list?

FDA is keeping a running list of Active Pharmaceutical Ingredient suppliers who are in violation of current good manufacturing practices (CGMP). This is because compounding finished drugs starting from active pharmaceutical ingredients (APIs) presents risks to patients if substandard materials are used. Some of the suppliers named are well-known and respected in the compounding industry.

Amy SummersOctober 29, 2020FDA, Bulk Drug Substances, API Supplier Qualification

FDA Removes Two Bulk Drug Substances Nominated for Use in 503B Outsourcing Facilities

This month, the FDA published final guidance for the list of bulk drug substances 503B facilities may use in compounding. The FDA decided to remove two substances from the previous version. This is a huge win for Big Pharma and a major loss for the compounding industry.

Amy SummersMarch 15, 2019Bulk Drug Substances, Vasopressin, Compounding Bulk Drug Substances

503A + 503B Compounding News

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