The U.S. Food and Drug Administration (FDA) has issued its long-awaited final Guidance for Industry on how it intends to enforce the Insanitary Conditions provisions of the Federal Food, Drug, and Cosmetic Act with respect to compounding. Following advocacy by the College, the agency announced it does not intend to take action against physicians who compound drugs or biological products in their offices for administration to their own patients. This is great news for allergists.
FDA action in this area started in response to the 2012 fungal meningitis outbreak that occurred because of contaminated compounded injectable products, resulting in 60 deaths. The proposed guidance was first issued in 2018 and the Advocacy Council and College, together with other allergy organizations, submitted a letter to the FDA urging it to adopt a non-enforcement policy for physicians compounding allergen immunotherapy for administration to their own patients. We are pleased the FDA listened to our views.