503B Outsourcing Facility
A compounding facility voluntarily registered with the FDA that can produce drugs in larger quantities without individual prescriptions, subject to cGMP requirements and FDA inspections. Created after a 2012 compounding-related meningitis outbreak, 503B facilities have produced compounded semaglutide and other peptides.
Technical Context
503B requirements include: FDA registration (voluntary but irrevocable), cGMP compliance (verified by FDA inspections), reporting of adverse events to FDA, product labelling with outsourcing facility name and 'This is a compounded drug' statement, and restriction to compounds on the FDA's 'bulk drug substance' list for 503B use. 503B facilities can produce and distribute compounded drugs without individual prescriptions, enabling hospital systems and clinics to stock compounded products. FDA inspection findings at 503B facilities have included: insanitary conditions, failure to verify sterility, inadequate quality testing, and use of unapproved bulk drug substances. Several 503B facilities producing compounded semaglutide received FDA warning letters for various violations. The regulatory distinction between 503A and 503B determines the allowable scale and oversight level for compounded peptide products.