FDA lays out some cGMP guidance for drug compounders

The FDA has published 5 new documents to help compounders understand the agency's expectations for both those that volunteer for oversight and those that don't. They include draft interim guidance on cGMP requirements for those facilities that register as outsourcing facilities under section 503B and explains FDA requirements for keeping drug products sterile. Among the other items is a new list of what drugs can be compounded, adding 25 more. The new rules came through the passage last year of the Drug Quality and Security Act after a fatal outbreak of bacterial meningitis was tracked to a Massachusetts compounding pharmacy. Announcement | More