FDA advisory committee reviews BPC-157, TB-500 and five other peptides for compounding

The Pharmacy Compounding Advisory Committee (PCAC) met at FDA's White Oak campus in Silver Spring, Maryland, on 23 and 24 July 2026, with online participation for the public ^[1]. The question in front of it was narrow: should each peptide be placed on the 503A bulks list, the list of bulk drug substances that state-licensed pharmacists and physicians may use to compound medicines when the substance has no USP monograph and is not part of an approved drug ^[1][4].

On 23 July the committee discussed four substances, each in free base and acetate form, against specific uses FDA reviewed: BPC-157 for ulcerative colitis, KPV for wound healing and inflammatory conditions, TB-500 for wound healing, and MOTs-C for obesity and osteoporosis ^[1]. On 24 July it discussed emideltide, also called delta sleep-inducing peptide (DSIP), for opioid withdrawal, chronic insomnia and narcolepsy; Semax for cerebral ischaemia, migraine and trigeminal neuralgia; and epitalon for insomnia ^[1].

The meeting was about compounding, not approval. No company had applied to market any of these peptides as a drug, and the committee was not asked whether any of them is safe or effective for general use.

FDA's briefing document set out its own position for every substance on the agenda. For each of the fourteen forms under review, the agency wrote that it was proposing the substance NOT be included on the 503A bulks list ^[2]. That covers BPC-157, KPV, TB-500, MOTs-C, emideltide, epitalon and Semax, in both free base and acetate forms ^[2].

The briefing document also records that the original nominations had been withdrawn. The nominators named for the peptides were Wells Pharmacy Network and, for BPC-157, emideltide, epitalon and Semax, LDT Health Solutions on behalf of the International Peptide Society. Footnotes against each nomination say it was withdrawn, and that FDA was electing to proceed with the presentation to the committee anyway ^[2].

FDA judges nominations against four criteria set in regulation: the substance's physical and chemical characterisation, any safety issues, the available evidence of effectiveness, and its historical use in compounding ^[2][5]. The agency says it balances these substance by substance ^[2].

FDA's published questions show that the committee was asked to vote separately on each form, for example whether BPC-157 free base should be placed on the list and whether BPC-157 acetate should be ^[3]. The same pair of questions was put for KPV, TB-500, MOTs-C, emideltide, epitalon and Semax ^[3].

Searches for the BPC-157 pharmacy compounding vote usually lead to press coverage of the result. As of 24 September 2026, FDA's meeting page lists briefing documents, presentations, the questions, the agenda and the roster, but it posts no vote results, minutes or outcome ^[1]. We do not report tallies that FDA itself has not published.

Advisory committees give FDA non-binding recommendations. The agency's own description says FDA generally follows them but is not legally bound to do so ^[1]. Any vote, whichever way it went, is advice to FDA, not a change in the law.

Is BPC-157 FDA approved? No. Nothing on the July agenda was an application for approval, and the meeting did not approve any peptide as a medicine. The same is true of the other six substances. The answer to "is Semax FDA approved?" is also no, and epitalon FDA approval status did not change either: none of the seven was approved in July 2026.

Adding a substance to the 503A bulks list is done by regulation. The list sits in 21 CFR 216.23, and the current text names only six substances, none of them a peptide: Brilliant Blue G, cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine, squaric acid dibutyl ester and thymol iodide ^[5]. We found no proposed rule adding BPC-157 or any other peptide from the July agenda. Until FDA publishes one, and then a final rule, the list is unchanged.

Compounding is also a separate question from what online vendors sell. Even a listed substance could only be compounded by a licensed pharmacy or physician for an individual patient under section 503A, and only from a bulk substance with a valid certificate of analysis made at an FDA-registered establishment ^[4]. None of that applies to vials sold as "research peptides". Our guide to what research peptides are explains how that market differs from pharmacy compounding.

The next formal step, if FDA acts, would be a Federal Register notice proposing to place or not place these substances on the 503A list, followed by a comment period and a final rule. FDA's briefing document says it does not intend to issue a final determination until the committee's input has been considered and all reviews are finalised ^[2].

For the current legal position in the United States, including FDA warning letters to sellers of unapproved peptides, see our US legal status guide. The BPC-157 price comparison and TB-500 price comparison pages track what suppliers list, not whether any product is lawful to use. We will update this report if FDA publishes minutes, a proposed rule or a final decision.