FDA Status

Is BPC-157 Legal Right Now? What the July 2026 FDA Vote Changed
Last verified: 20 August 2026 The short answer is no. As of 20 August 2026, BPC-157 cannot lawfully be compounded or sold for human use in the United States. It is not an FDA-approved drug. It is not on the 503A Bulks List. It is not in Category 1 of FDA's interim enforcement-discretion policy. The 23–24 July 2026 advisory committee vote that produced the "peptides are legal again" headlines did not change any of that, and the April 2026 removal from Category 2 — the other event people cite —... Read more...
Is Sermorelin FDA Approved? FDA Withdrew the Approval in 2009
Last verified: 20 August 2026 Sermorelin is not an FDA-approved drug. It used to be. FDA withdrew the approval of both sermorelin new drug applications effective 18 June 2009, at the request of the company that held them, announcing it at 74 FR 23407 (19 May 2009). Seventeen years later it is the most widely sold peptide in the American telehealth market, appearing in the catalog of nearly every provider we have examined. The industry's answer to "is sermorelin legal?" rests on one sentence: that sermorelin is a component of... Read more...
GHK-Cu, Melanotan II, LL-37: FDA's February 2027 Peptide Review
Last verified: 20 August 2026 FDA's Pharmacy Compounding Advisory Committee is scheduled to consider five substances before the end of February 2027: GHK-Cu, Dihexa acetate, Cathelicidin LL-37, PEG-MGF and Melanotan II. That is all that is scheduled. No date has been set, no Federal Register notice has published, and no public docket has opened. Whatever the committee decides will not change what is legal. A PCAC vote is a recommendation. The list that governs compounding — 21 CFR 216.23 — has not been amended since 19 February 2019, holds six... Read more...