FDA Peptide Regulation Tracker: What Changed and When

BPC-157 is not an FDA-approved drug, and its removal from Category 2 in April 2026 did not change that. The removal means FDA no longer flags it as a specific significant-safety-risk substance, because the nominations were withdrawn. It is still not on the 503A Bulks List as of this page's publish date, so it is not yet eligible for lawful compounding under section 503A. It is still sold to consumers as an unapproved research chemical.

The Pharmacy Compounding Advisory Committee met on 23 and 24 July 2026 to evaluate BPC-157, KPV, TB-500, MOTS-c, Emideltide/DSIP, Semax and Epitalon for the 503A Bulks List. For BPC-157 it voted 8-6, with one abstention, to recommend adding it (ABC News). News outlets and law firm alerts reported votes in favor for most of the other peptides. I have found no FDA transcript, minutes or Federal Register notice with those vote counts. The vote is advice, not approval. FDA has not published a final decision and has not added any of these substances to the 503A Bulks List.

They are opposite ends of the same review process. The 503A Bulks List (21 CFR 216.23) lists the substances a pharmacy may compound from bulk under section 503A. Category 2 is a separate list, published in FDA guidance, of nominated substances FDA has identified as possibly presenting significant safety risks. Nomination, review, removal from Category 2 and formal addition to the Bulks List are four separate regulatory steps.

On 30 April 2026 FDA proposed not to include semaglutide, tirzepatide or liraglutide on the 503B Bulks List, the separate list that governs bulk compounding by outsourcing facilities. The comment period was extended to 30 July 2026. As of this page's publish date I found no Federal Register document recording a final determination. The proposal does not affect the FDA-approved injectable pens for these drugs either way.

This is a living tracker. I add a dated row to the changelog table whenever I can verify a change against a primary FDA or Federal Register source, rather than rewriting the page each time.

Not as one single category. FDA controls peptides through several separate mechanisms, depending on the compound and how it is sold. Approved peptides are prescription drugs. Nominated substances sit on its Category 1 or Category 2 compounding-safety lists. Bulk substances either are or are not on the 503A or 503B Bulks List that a pharmacy must check before compounding. One peptide can be an FDA-approved branded drug while an unapproved "research use only" version of the same molecule is sold online outside that control. See the changelog above for where each reviewed peptide currently sits.

There is no FDA-reviewed clinical safety data on this, because BPC-157 is not an FDA-approved drug and has not been through the trials that would produce it. Its removal from FDA's Category 2 table in April 2026 followed a nomination withdrawal, not a safety finding either way. The page still carries FDA's original safety-risk description. For what is documented about BPC-157 in humans, see Are Peptides Safe? at /safety/.

The one peptide Joe Rogan has named in a statement confirmed by two sources is BPC-157. In July 2021 he said on his podcast that it cleared elbow tendonitis within two weeks. He also said he had an NAD drip, which is not a peptide, while ill with COVID-19. Neither statement says what he takes now; see /joe-rogan-peptides/. BPC-157, KPV, TB-500 and MOTS-c are among the substances FDA's Pharmacy Compounding Advisory Committee reviewed for the 503A Bulks List in July 2026. None is an FDA-approved drug, and as of this page's publish date none has been added to that list, so none is currently eligible for lawful pharmacy compounding. They are sold online as unapproved research chemicals. See the changelog above for where each one sits, and Are Peptides Safe? at /safety/ for what is documented about them.

Yes. More than forty peptide medicines have current or historical FDA approval, including semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro, Zepbound), tesamorelin (Egrifta), bremelanotide (Vyleesi), teriparatide (Forteo) and abaloparatide (Tymlos). None of the research peptides tracked on this page, such as BPC-157 or TB-500, is FDA-approved. The full list is at /fda-approved-peptides/.