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.
Read MoreLast week, the Food and Drug Administration announced the release of a revised draft guidance describing current good manufacturing practice (CGMP) requirements for 503B outsourcing facilities. The document provides direction and details as to how 503B’s can stay compliant with the Agency. Are you compliant?
Read MoreMany 503A compounders inspected by the FDA are cited for insanitary conditions. To help 503A pharmacies understand how to recognize insanitary conditions at their facilities, the FDA released an updated draft guidance. Many of the examples cited are stricter than USP recommendations. Is your pharmacy in compliance?
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