FDA announces drug compounding policy priorities, recall guidance

The Food and Drug Administration yesterday issued a plan and related guidance outlining how it will implement certain aspects of the Drug Quality and Security Act relevant to drug compounding outsourcing facilities and compounding pharmacies. The plan details how the FDA will address manufacturing standards for outsourcing facilities; regulate compounding from bulk drug substances; restrict compounding of drugs that are essentially copies of FDA-approved drugs; solidify the FDA’s partnership with state regulatory authorities; and provide guidance on other activities that compounders undertake. In other news yesterday, the FDA issued draft guidance clarifying its policy on public warning and notification of recalled products, including drugs, medical devices and cosmetics. Specifically, the guidance outlines circumstances when a company should issue a public warning about a recall; describes the general timeline for companies to issue such a warning; discusses what information should be included in a public warning; and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient.