FDA To Allow Certain Office-Use Compounding, In Exchange For GMP Oversight

FDA will release guidance within two months green lighting certain office-use compounding, so long as those 503A pharmacies register as 503B outsourcing facilities, and in exchange these compounders will be subject to “more tailored” manufacturing standards, an agency spokesperson tells Inside Health Policy . The level of 503B Good Manufacturing Practice requirements imposed on this new category of compounders -- which one lobbyist deemed “503B-lite” -- will depend on the size of the firm, an agency spokesperson tells Inside Health...