In February 2025, the U.S. Food and Drug Administration officially declared that the shortage of semaglutide (marketed as Ozempic and Wegovy by Novo Nordisk) had been resolved. This declaration triggered regulatory provisions under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act that restrict compounding pharmacies from producing copies of commercially available FDA-approved drugs when no shortage exists.
Background
During the period of semaglutide shortages that began in 2022, compounding pharmacies were permitted under FDA guidance to produce semaglutide preparations to meet patient demand. This created a substantial secondary market for compounded semaglutide, with hundreds of compounding pharmacies across the United States producing the peptide. The shortage had been driven by unprecedented demand for GLP-1 receptor agonists for weight management following expanded FDA approvals and widespread clinical adoption.
Regulatory Impact
With the shortage resolved, compounding pharmacies face restrictions on continuing to produce semaglutide. The FDA has provided a transition period for patients currently using compounded versions, but the long-term regulatory position is that compounded copies of FDA-approved drugs should not be produced when the commercial product is available in adequate supply.
This regulatory action is part of a broader pattern of increased FDA scrutiny of the peptide compounding sector. The agency has stepped up oversight of peptides commonly produced by compounding pharmacies, including enhanced enforcement actions and warning letters to facilities found to be operating outside regulatory boundaries.
Market Context
The peptide therapeutics market has grown substantially, reaching an estimated $140 billion globally in 2025 according to industry analyses, with projections of $300 billion by 2033. The metabolic and obesity segment has been growing at approximately 20% year over year, largely driven by GLP-1 receptor agonist demand.
A separate investigation by the Associated Press in December 2025 found that hundreds of "research use only" peptide listings had been removed from major online retail platforms including Amazon, Alibaba, and Walmart, reflecting broader regulatory attention to how peptide compounds are marketed and distributed.
Implications for Researchers
These regulatory developments highlight the importance of sourcing peptide compounds through properly licensed and regulated channels. Researchers and practitioners should verify that their peptide suppliers maintain appropriate registrations, provide Certificates of Analysis (COA) with third-party verification, and comply with applicable jurisdiction-specific regulations.
For official FDA guidance on drug shortages and compounding regulations, visit FDA Drug Shortages. Additional regulatory analysis is available from the Peptide Drug Summit.