Developments

An interim access policy goes to the White House — the first FDA movement since the vote

On October 14 the FDA sent a document titled “Interim Access Policy for Compounding Using Certain Peptides” to the White House Office of Management and Budget for review under Executive Order 12866. The entry on OMB’s own register (RIN 0910-ZD94) gives the stage as “Notice,” records no legal deadline and says nothing about the contents. Nothing has been issued: a submission to OMB is the step before publication, not publication, and review of a notice runs to no fixed clock. The Associated Press, citing two people familiar with the matter, reported that the policy would let pharmacies compound some of the peptides the committee recommended in July, BPC-157 among them; the FDA and HHS have not confirmed that, and we do not repeat it as fact. The title does carry information of its own. “Interim” and “access policy” are the vocabulary of enforcement discretion — the instrument the FDA already uses for nominated substances in Category 1 of its interim policy — not the vocabulary of rulemaking. Nothing under review would place a substance on the 503A bulks list; that still requires a proposed rule, a comment period and a final rule, none of which has begun.

The rest of the record since September 5 is enforcement rather than access. On August 24 the FDA’s Center for Drug Evaluation and Research issued warning letters to five online peptide sellers — Peptide Partners, Peak Performance Peptides, Royal Peptides, NuScience Peptides and TXP Innovations (Tex Peptides) — treating “research use only” labels as no defense where the websites showed the products were intended for human use, and noting that the bacteriostatic water sold alongside them supplies the means to prepare an injection. The substances named are semaglutide, tirzepatide and retatrutide, with SS-31, PT-141, tesamorelin, survodutide, mazdutide and a tesamorelin–ipamorelin blend; none of the seven peptides the committee reviewed appears in any of the five letters. On the 503B side, the comment period on the May 1 notice proposing to leave semaglutide, tirzepatide and liraglutide off the 503B bulks list closed July 30 after a one-month extension, with no final determination since. The second committee meeting — GHK-Cu, Cathelicidin LL-37, Dihexa acetate, PEG-MGF and Melanotan II — is still due before the end of February 2027, and no date has been set.

Six weeks on: no FDA action, and the timeline slips into 2027

Since the July 23–24 votes the FDA has issued no proposed rule, made no statement accepting or rejecting the committee’s recommendations, and announced no interim enforcement policy. Every read-out published since — law-firm client alerts in early August, trade press through this week — arrives at the same line: final agency action remains pending. The silence has a practical consequence. Rulemaking cannot be compressed into what is left of 2026: a proposed rule has to be published in the Federal Register, a public comment period run, comments reviewed, and a final rule issued. Estimates on offer run from eight to twelve months at the fast end to twelve to twenty-four at the slow one, and the agency’s historical pace on the 503A bulks list has been slower still: since nominations opened in 2015, a single final rule in February 2019 placed six substances on the list, and a further proposed rule from September 2019 was still not final as of May 2026. The second-batch meeting on LL-37, GHK-Cu, Dihexa acetate, Melanotan II and PEG-MGF remains on the calendar for before the end of February 2027. In the meantime the enforcement map is being drawn at state level, though the documented record is narrower than it is usually described: Connecticut sued a distributor selling “research grade” semaglutide and tirzepatide direct to consumers in May 2025 and settled with it in August, Alabama obtained a restraining order against a clinic injecting the same material in November 2025, and in May 2026 the Alabama Board of Medical Examiners directed every physician, physician assistant and nurse practitioner in the state not to prescribe, supply or administer non-FDA-approved research-grade peptides of any kind. Both court actions concerned GLP-1 drugs rather than the peptides under 503A review; the Alabama notice is the only state measure so far that plainly reaches them.

An approved drug arrives for narcolepsy — twelve days after the committee turned down DSIP for it

The FDA approved Orzeyful (oveporexton) tablets, from Takeda, for narcolepsy type 1 in adults. It is the first medicine approved for narcolepsy type 1 as a complete disorder rather than for individual symptoms, and the first to act on the loss of orexin signalling that causes the disease: rather than stimulating or sedating, it activates the receptor the body’s own orexin would normally reach. Two randomised, placebo-controlled 12-week studies enrolling 273 adults supported the approval, with improvements in daytime wakefulness and a reduction in cataplexy episodes. The FDA lists insomnia, increased urinary frequency and urgency, and increased saliva production as the most common adverse reactions. The drug has been recommended for scheduling under the Controlled Substances Act and becomes lawful to market once the DEA issues its scheduling decision.

Day 2: Epitalon and Semax recommended, Emideltide rejected — six of seven clear the committee

On the meeting’s closing day the committee recommended Epitalon for insomnia, 7–4 with one abstention, and Semax for cerebral ischemia, migraine and trigeminal neuralgia, 8–5 with one abstention. It declined to recommend Emideltide (DSIP) for opioid withdrawal, chronic insomnia and narcolepsy, which failed 6–7 — the single substance of the seven to be turned down, and the panel’s only break from a two-day pattern of voting against the FDA’s own review staff. The rejection carries an irony: Emideltide has the longest human research record of the group, with published trials going back to 1981, but the agency’s reviewers judged those studies small, poorly controlled and contradictory, and flagged a theoretical dependence risk in the way the peptide acts on endorphin release. One member who had backed every earlier substance broke with the majority over what he described as dangerous downstream consequences. Semax’s supporters argued it has more evidence behind it than most of the group because it is approved for clinical use in Russia; FDA staff still found that evidence insufficient.

Day 1: the committee recommends all four peptides — against the FDA’s own review

The Pharmacy Compounding Advisory Committee recommended all four of Thursday’s substances for the 503A bulks list. BPC-157, KPV and TB-500 each carried 8–6 with one abstention; MOTS-c carried 7–5 with two abstentions. Each substance drew separate votes on its free base and acetate forms. The recommendations run against the FDA’s own review staff, whose briefing documents concluded that the evidence supported adding none of the seven. Members voting yes leaned on the gray market — one described a patient arriving with research-grade material that turned out to be adulterated — while members voting no warned that a place on the FDA’s list would read to the public as an endorsement the human data cannot support. Emideltide (DSIP), Epitalon and Semax are before the committee on Friday.

Pre-vote check: agenda and briefing documents confirmed

With the committee vote six days out, we re-checked the docket against the FDA’s live agenda. The July 23–24 meeting is confirmed at the FDA’s White Oak Campus, the agenda is final, and all seven of the FDA’s scientific briefing documents — plus the introduction — are now posted on the FDA’s meeting page. For the record, the committee is reviewing each peptide for the specific uses the FDA evaluated: BPC-157 (ulcerative colitis); KPV (wound healing and inflammatory conditions); TB-500 (wound healing); MOTS-c (obesity and osteoporosis); Emideltide/DSIP (opioid withdrawal, chronic insomnia, and narcolepsy); Semax (cerebral ischemia, migraine, and trigeminal neuralgia); Epitalon (insomnia).

FDA review staff recommend against all seven peptides

Ahead of the July 23–24 meeting, the FDA released its briefing materials, and the agency’s own review staff concluded that the available evidence does not support adding the seven peptides to the 503A bulks list — pointing to limited human data and unresolved safety questions for several of the substances. The assessment is notable because it runs against the publicly stated position of HHS Secretary Robert F. Kennedy Jr., who has favored broader peptide access.

Advisory committee seated — and its membership draws scrutiny

The FDA named the members who will sit for the July meeting, bringing the panel to 14. Reporting noted that roughly half of the seated members have professional ties to businesses or clinics involved in peptide therapies, prompting conflict-of-interest questions; HHS said every member completed the same ethics review required of all advisory-committee members. Later reporting (Health Affairs, August 4) put the panel at 11 standing voting members plus eight temporary members added shortly before the meeting, with between 12 and 15 members voting on each peptide. The FDA confirmed the eight new appointments on 29 June but has not published the standing-versus-temporary breakdown, so that split rests on the reporting alone.

The meeting is formally noticed

The FDA published a Federal Register notice scheduling the PCAC meeting for July 23–24, 2026 and opening a public docket (FDA-2025-N-6895). Day 1 covers BPC-157, KPV, TB-500 and MOTS-c; Day 2 covers Emideltide (DSIP), Semax and Epitalon. A separate meeting before the end of February 2027 is slated to review five more substances, including GHK-Cu and Melanotan II.

The peptides leave Category 2 — but not because they were cleared

The FDA noticed the removal of the same seven peptides from 503A Category 2, effective after seven days. The removal followed the withdrawal of the underlying nominations — by LDT Health Solutions (a consulting firm representing the International Peptide Society) and the Wells Pharmacy Network — not any safety finding. The FDA said it would review the substances at PCAC regardless.