Compounding Pharmacy
A pharmacy that creates customised medications by mixing or altering ingredients to meet individual patient needs. Compounding pharmacies have become significant in the peptide market because they have produced versions of FDA-approved peptides, notably semaglutide, during drug shortage periods.
Technical Context
The regulatory landscape for compounded peptides is complex and evolving. Key legal framework: Section 503A (traditional compounding — requires individual prescription, state pharmacy board regulation, no FDA pre-approval) and Section 503B (outsourcing facilities — voluntary FDA registration, cGMP requirements, can compound without individual prescriptions). FDA enforcement actions: the FDA's 2023-2024 determination that semaglutide is no longer in shortage triggered enforcement against compounders producing semaglutide copies. The FDA's position: compounding of commercially available drugs is only permitted during genuine shortages; once the shortage is resolved, compounders must cease production. Industry groups have challenged this position. The compounding debate highlights tensions between drug access, quality assurance, intellectual property, and patient safety.