The shortage of brand-name semaglutide (Ozempic, Wegovy) created a significant market for compounded semaglutide from licensed 503A and 503B compounding pharmacies. Understanding the regulatory landscape and quality standards for compounded semaglutide is essential for anyone considering this option.
503A vs. 503B Compounding Pharmacies
503A pharmacies compound for individual patients based on a physician prescription — they can compound semaglutide for a specific patient with a valid prescription. 503B outsourcing facilities compound in bulk for healthcare providers and must meet cGMP standards similar to pharmaceutical manufacturers. Both require a physician prescription for semaglutide. "Research chemical" semaglutide sold without a prescription is not legally compounded semaglutide — it is an unregulated product with no pharmaceutical oversight.
FDA Enforcement Status
The FDA has issued guidance on compounded semaglutide during the shortage period. As brand-name supply normalizes, the FDA is increasing enforcement against compounders who do not meet the legal requirements. Physician-supervised protocols through licensed compounding pharmacies like those used by Alukard operate within the legal framework and are not subject to this enforcement risk.
Quality Standards for Compounded Semaglutide
Pharmaceutical-grade compounded semaglutide must meet USP standards: ≥99% purity, sterile manufacturing (USP 797), proper pH and tonicity for subcutaneous injection, and full COA documentation. Alukard sources from licensed 503A compounding pharmacies that meet these standards.