A citizen petition asks FDA to keep BPC-157 and six other peptides out of pharmacy compounding. FDA has not ruled on it.

What was filed, and when

FDA's Division of Dockets wrote to PSM on October 27, 2026 that its petition, dated October 23, was received that day and assigned docket number FDA-2026-P-13366.[3] The petition and that letter were the only two documents in the docket when pepmg queried it on October 28, and no public comments had been posted.[4] PSM's own announcement, headed October 26, says the petition was filed "on October 16"; the docket record and FDA's letter both say October 23, which is the date this note uses.[5][3] The announcement also describes "six peptides" and lists emideltide but not Epitalon; the petition itself covers seven.[5][1]

The petition is 25 pages, signed by PSM executive director Shabbir Imber Safdar, and filed under FDA's citizen petition rule, 21 CFR 10.30.[1][2][6] PSM describes itself as "a public health group committed to the safety of prescription drugs" made up of more than 45 nonprofit organizations; pepmg did not find a list of funders on that page.[17]

The requests

Seven peptides, three routes it wants closed, one meeting set aside

The petition covers the seven peptides FDA's Pharmacy Compounding Advisory Committee considered on July 23 and 24, 2026: BPC-157 , KPV , TB-500 , MOTS-c , emideltide (sold as DSIP ), Semax and Epitalon .[1][9]

It asks FDA to refrain from allowing compounding with any of them "whether through regulation, addition to 'Category 1'" of FDA's 503A interim policy "or otherwise through exercise of enforcement discretion or any other action."[1] Separately, it asks FDA not to rely on the July meeting to satisfy the law's requirement to consult an advisory committee before adding substances to the list, because it says the committee was constituted in violation of the Federal Advisory Committee Act and the Ethics in Government Act.[1]

The three routes matter because they are different things. The 503A bulks list is built by notice-and-comment rulemaking. Category 1 of FDA's interim policy holds nominated substances for which FDA "does not intend to take action against" compounders while it evaluates them, which is itself a form of declining to enforce.[12] The petition's third route covers any other exercise of enforcement discretion.[1] The petition asks FDA to close all three for these seven peptides.[1]

The evidence it uses

FDA's own staff are the petition's main witness

FDA's briefing document for the July meeting proposed that none of the 14 substances reviewed, the free base and acetate forms of each peptide, be added to the 503A bulks list.[7] It also records that every nomination for the seven had been withdrawn by its nominator, and that FDA elected to present them to the committee anyway.[7] The committee nonetheless recommended six of the seven; it did not recommend emideltide.[10][1]

The petition quotes FDA's staff conclusion on BPC-157 as "illustrative" of all seven, and pepmg checked the quotation against the briefing document: the factors "weigh against" listing, BPC-157 is "not well characterized from a physiochemical perspective," there is "insufficient evidence to make a conclusion on the effectiveness" for ulcerative colitis, and FDA-approved treatments for that disease exist.[1][8] The same FDA review says it found no studies giving BPC-157 to humans by the oral, subcutaneous, nasal or transdermal routes proposed, only two rectal-enema studies of at most two weeks.[8]

FDA's public safety-risk page says much the same about the others. For KPV and TB-500, FDA writes that it has not identified any human exposure data, and for emideltide and Epitalon it has not identified safety-related information for the proposed route.[14] Those are FDA's findings about what evidence exists, not findings that the peptides cause harm. The petition's case rests on those gaps and on risks FDA names, chiefly immunogenicity; it cites no case reports of injury.[14][1]

The legal arguments

A conflicts claim, and a date in FDA's own guidance

The petition argues that several members newly added to the committee before the July meeting have businesses that offer peptides, citing STAT reporting that names five of them, and says PSM is "not aware of any waiver" for any member.[1] STAT's June 29 article, in its publicly visible portion, reports that FDA named eight new panelists and that "The majority of new members are involved with businesses that promote and prescribe peptides."[11] FDA's page for the July meeting, last updated August 6 and read October 28, lists briefing documents, questions, an agenda, a roster and FDA's slides; pepmg found no conflict-of-interest waiver posted there.[9] Whether that amounts to a violation of the two statutes is a legal question this note does not answer.

The second argument is narrower and checkable. FDA's 503A page says the agency "does not intend to place bulk drug substances nominated on or after January 7, 2025, into these categories."[12] Because the original nominations were withdrawn, the petition argues any new nomination would postdate that cutoff, so category 1 is unavailable under FDA's own policy.[1][7] That is PSM's reading. FDA has not said how it would treat these peptides, and the petition also calls the interim policy itself unlawful.[1]

The petition also answers arguments made by supporters of compounding, at the July meeting and in public comments: that it would pull an existing gray market into regulated channels, generate real-world data, or allow guardrails, and that few adverse events have been reported. PSM's reply is that the first three are not among FDA's four listing criteria, that the remedy for illegal sales is "enforcement—not legalization," and that low adverse-event reporting reflects an unlawful market rather than safety.[1] Those are an advocacy group's arguments, reported here as its arguments.

What happens next

FDA's 180-day clock, and a policy still at the White House

Under 21 CFR 10.30, any interested person may comment on a filed petition, and the Commissioner "shall furnish a response to each petitioner within 180 days of receipt," subject to stated exceptions.[6] The response may approve, deny or dismiss the petition, or be a tentative response explaining why FDA has not reached a decision.[6] For a petition received October 23, 2026, 180 days runs to April 21, 2027.[3][6]

The petition lands while FDA's own peptide document is pending. The White House's list of regulatory actions under review, run October 27, 2026, still shows FDA's "Interim Access Policy for Compounding Using Certain Peptides," RIN 0910-ZD94, received October 14 at the notice stage.[15] Its text is not public; pepmg's October 16 note covers what was reported about it. A Federal Register search on October 28 found no FDA document mentioning peptides published since October 1, 2026.[16]

Status, checked Oct. 28, 2026

Where the seven peptides sit on FDA's lists today

In FDA's 503A nominations document, still dated May 14, 2026, none of the seven appears in category 1; category 2 lists six substances, none of them these peptides.[13] FDA's safety-risk page, current as of April 22, 2026, lists all seven among substances "previously in category 2" whose nominations "were withdrawn by the nominators."[14] FDA's meeting page describes advisory committee recommendations as non-binding, so the July votes changed no list on their own; our July note covers that meeting.[9]

What this note is not saying

It is not saying FDA agrees with the petition. FDA's letter says accepting it "in no way reflects the Agency's decision on the substantive merits."[3]

It is not saying the committee members acted improperly. That is the petition's allegation, built on press reporting; pepmg found no waiver posted on FDA's meeting page, which is a narrower fact.[1][9]

It is not saying anything about research-labeled vials sold online. The petition concerns pharmacy compounding under section 503A. PSM's announcement says it bought five vials from telehealth services, which this note reports as PSM's account.[1][5] This note reports regulatory status, not medical or legal advice.

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