The FDA’s updated compounding guidance, released this week, tightens the framework governing which peptide bulk substances compounding pharmacies may legally use — and signals where enforcement attention will fall as branded GLP-1 shortages formally end.
The practical impact splits by compound class. For GLP-1s, the end of shortage-based compounding flexibility means the large compounded-semaglutide market must contract or shift channels. For research peptides like BPC-157, the guidance reiterates Category 2 status without adding new restrictions.
The Peptide Institute will track enforcement actions under the new framework in our regulation hub as they emerge.
