FDA’s Pep(tide) Rally! What Compounders and Industry Need to Know (Post 2 of 2) By Charles D. Snow & Karla L. Palmer —

FDA’s Pep(tide) Rally! What Compounders and Industry Need to Know (Post 2 of 2) By Charles D. Snow & Karla L. Palmer — https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-2-of-2/?utm_source=rss&utm_medium=rss&utm_campaign=fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-2-of-2 As promised and teased in yesterday’s blog post, we discuss other practical implications of and compliance concerns surrounding the ongoing shift in peptide policy below. Supply Chain Complications There is also a supply chain issue that sits upstream of any FDA regulatory authorization of their use in compounding. Pursuant to Section 503A, these peptides must be manufactured at an FDA-registered drug establishment, and accompanied by a Certificate of Analysis. Similarly, because they are likely sterile injectable products, they should be pharmaceutical-grade. As the Alliance for Pharmacy Compounding’s (APC) CEO Scott Brunner put it: Even if FDA acted tomorrow, pharmacies would still have to turn away those prescriptions because they couldn’t acquire the compliant API to prepare the drugs. Compounding industry representatives have argued that the Agency must provide clearer forward-looking regulatory signals to incentivize the investment in pharmaceutical-grade supply chains. Without that signal, manufacturers have little economic reason to build the infrastructure the market will need.