FDA’s peptide interim access policy: what is known on October 15, 2026
As of October 15, 2026, an HHS/FDA notice titled “Interim Access Policy for Compounding Using Certain Peptides” (RIN 0910-ZD94) has been under White House regulatory review since October 14; its text, the peptides it covers and its start date are not public, so nothing has changed yet for patients or pharmacies.
Qualification: the only first-party record is the review listing on reginfo.gov; everything about the policy’s content comes from press reports.
For six months the legal position of BPC-157, TB-500 and a dozen other peptides has been unusual: off FDA’s safety-risk list, but not on any list that lets a pharmacy compound them. This week the administration moved toward a temporary fix. Here is what the public record shows, what has only been reported, and what you can sensibly do while the policy is under review.
What does the official record show?
The Office of Information and Regulatory Affairs (OIRA), the White House office that reviews agency actions, lists the filing on its pending-review page. We read the entry on October 15, 2026.
| Field | What the record says |
|---|---|
| Title | “Interim Access Policy for Compounding Using Certain Peptides” |
| Agency | HHS / FDA |
| RIN | 0910-ZD94 |
| Stage | Notice |
| Received for review | October 14, 2026 |
| Status | Pending EO 12866 regulatory review |
| Economically significant | No |
| Legal deadline | None |
| Text, abstract or list of peptides | Not shown |
| Unified Agenda | “This rule has not been published in a Unified Agenda.” |
“Notice” as a stage, together with “not economically significant”, points to a guidance-style announcement rather than a binding regulation, but the record does not say so and we will not guess at the wording. The absence of a Unified Agenda entry means the action was not on FDA’s published regulatory plan.
What has been reported about its content?
Reuters, October 15 (via Yahoo News): HHS and FDA submitted an “interim access policy for compounding using certain peptides” for review, and “the filing does not provide any details of the policy.” Reuters cited the Associated Press, which, quoting two people, said the policy would let pharmacies make “some popular peptides, including BPC-157.” HHS did not immediately respond to Reuters. We could not read the AP story itself.
The Washington Post, October 7 (via the Anchorage Daily News): the administration was drafting plans to allow temporary sale of some previously restricted peptides through compounding pharmacies while new rules are written. “It was not immediately clear which peptides” would be covered, and “timing was unclear.”
No statement from FDA or HHS had been posted on their press pages when we checked on October 15.
How did we get here?
| Date | Event | Confidence |
|---|---|---|
| April 2026 | FDA lists 17 peptide nominations as withdrawn from Category 2 (page current as of April 22), including BPC-157, TB-500, CJC-1295, ipamorelin and AOD-9604 | Confirmed (FDA) |
| May 14, 2026 | FDA’s interim categories updated; non-injectable GHK-Cu back in Category 1; none of the withdrawn peptides placed in a category | Confirmed (FDA) |
| July 23–24, 2026 | Advisory committee reviews seven peptides; reported votes favour six | Meeting confirmed; votes reported |
| August 24, 2026 | FDA warning letters to five “research use only” peptide sellers | Confirmed (FDA) |
| October 7–8, 2026 | Washington Post: administration drafting a temporary plan to allow some restricted peptides through compounding pharmacies | Reported |
| October 14, 2026 | OIRA receives the HHS/FDA “Interim Access Policy for Compounding Using Certain Peptides” (RIN 0910-ZD94) | Confirmed (reginfo.gov) |
| October 15, 2026 | Reuters reports the filing; cites AP that BPC-157 would be among the peptides | Reported |
Our peptide status table shows where each of 16 substances stands today, and the regulatory ledger carries every dated item with its source.
What did the July advisory committee vote, by the numbers?
Reuters linked the new policy to the committee’s July review. The votes were narrow. Counting yes votes as a share of all members who voted or abstained:
| Peptide | Use FDA evaluated | Reported vote (yes–no–abstain) | Share voting yes | FDA staff position |
|---|---|---|---|---|
| BPC-157 | Ulcerative colitis | 8–6–1 | 8 of 15 = 53% | Proposed not adding |
| TB-500 | Wound healing | 8–6–1 | 8 of 15 = 53% | Proposed not adding |
| KPV | Wound healing, inflammatory conditions | 8–6–1 | 8 of 15 = 53% | Not read |
| Semax | Cerebral ischemia, migraine, trigeminal neuralgia | 8–5–1 | 8 of 14 = 57% | Not read |
| MOTs-C | Obesity, osteoporosis | 7–5–2 | 7 of 14 = 50% | Not read |
| Epitalon | Insomnia | 7–4–1 | 7 of 12 = 58% | Not read |
| DSIP (emideltide) | Opioid withdrawal, insomnia, narcolepsy | 6–7–1 (against) | 6 of 14 = 43% | Not read |
Three of the six recommendations passed 8–6 with one abstention, a two-vote margin; one switched vote would have tied them 7–7, and FDA’s own staff had proposed against adding BPC-157 and TB-500. The committee advises; FDA decides. Seven of the 17 withdrawn nominations went to the July meeting, which is 41%; five more (GHK-Cu, dihexa, LL-37, PEG-MGF and melanotan II) are due at a meeting before the end of February 2027, according to the same law-firm account.
What could an interim policy do, and what could it not?
It could tell 503A pharmacies that FDA will not take enforcement action, for a time and under conditions, if they compound named peptides for individual patients with a prescription. That is how FDA’s existing Category 1 works for substances such as NAD and glutathione. The Washington Post reported that officials want guardrails; an industry group proposed patient disclosures, adverse-event reporting and data collection.
It could not make any peptide an FDA-approved drug, show that it works, or make a research-chemical website lawful. Adding a substance to the permanent 503A bulks list is a separate rulemaking with public comment. A temporary policy can also be withdrawn.
It also would not change sport rules. WADA’s 2027 Prohibited List, published September 21, 2026, names BPC-157 under S0 and adds “peptides” to the examples of non-approved substances banned at all times; TB-500 sits under S2.
What this means for you
- Do not prepay for a peptide the law does not yet cover. If a clinic offers BPC-157 or TB-500 today, ask which pharmacy compounds it and on what legal basis. A clear answer names a licensed 503A pharmacy and its state licence.
- Expect conditions. If the policy appears, it will likely name specific peptides, routes and pharmacy duties. A peptide left off the list stays where it is.
- Skip the research-chemical sites. FDA warned five of them on August 24, 2026; a pharmacy policy would not cover them.
- Check approved options first. For weight loss, approved GLP-1s start at $149 a month at their lowest dose; see the pricing database. Tesamorelin is approved, but only for HIV-associated abdominal fat; see tesamorelin.
- Athletes: none of this changes WADA status. See BPC-157 and TB-500.
Frequently asked questions
Is BPC-157 legal to compound now?
Not yet. As of October 15, 2026, BPC-157 is in none of FDA’s interim compounding categories and is not on the 503A bulks list. The interim access policy under White House review has not been published, so it has no effect until FDA releases it and says which peptides and conditions it covers.
What is an interim access policy?
The title on reginfo.gov is all that is public. Reporting describes a temporary arrangement that would let some pharmacies make certain peptides without immediate enforcement while permanent rules are written. FDA already uses a similar tool, its interim Category 1, under which it does not intend to act against compliant 503A pharmacies.
Which peptides will it cover?
Unknown. The OIRA record lists no substances. Reuters, citing the AP, reported that BPC-157 would be included, and noted that FDA’s advisory committee backed six of seven peptides in July: BPC-157, TB-500, KPV, Semax, MOTs-C and Epitalon. Treat any list you see before publication as a guess.
How long does White House review take?
There is no fixed clock for a review like this, and the record shows no legal deadline. After review, FDA would still need to publish the policy, most likely on fda.gov or in the Federal Register. We will add the publication date to our regulatory ledger when it happens.
Should I buy BPC-157 from a research-peptide website while I wait?
No. FDA treats “research use only” peptides sold for human use as unapproved new drugs; it warned five such sellers on August 24, 2026. Nobody checks their sterility, identity or dose, and a future policy for pharmacies would not make those products lawful.
Sources
- OIRA, reginfo.gov — Pending EO 12866 review: Interim Access Policy for Compounding Using Certain Peptides (RIN 0910-ZD94) — read October 15, 2026
- Reuters via Yahoo News — FDA takes step to change peptide access — October 15, 2026
- The Washington Post via Anchorage Daily News — temporary sale of some unapproved peptides — October 7, 2026
- FDA — Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026 — read October 15, 2026
- FDA briefing document — BPC-157 — July 2026
- FDA briefing document — TB-500 — July 2026
- McDermott Will & Schulte — reported PCAC votes — July 27, 2026
- FDA — Bulk drug substances withdrawn from Category 2 — current as of April 22, 2026
- FDA — Interim 503A categories (PDF) — updated May 14, 2026
- WADA — 2027 Prohibited List — published September 21, 2026