Section 503B of the U.S. Federal Food, Drug, and Cosmetic Act governs outsourcing facilities that compound sterile drugs for distribution without patient-specific prescriptions.
A 503B outsourcing facility is directly registered with the FDA, must comply with Current Good Manufacturing Practices (cGMP), and is inspected on a cGMP basis. It compounds without the patient-specific prescription requirement that defines 503A.
The two frameworks are legally distinct. A pharmacy operating under 503B is regulated more like a drug manufacturer than like a traditional compounding pharmacy: cGMP, FDA inspections, and ongoing facility registration are the baseline.
US Peptide Clinic does not currently supply 503B outsourcing facilities. Our model is API supply to 503A pharmacies. Buyers operating under 503B require a different supplier with cGMP-grade processes and FDA registration on file. We say so up front so buyers know whether we are a fit.