HHS will not enforce against pharmacies compounding six peptides. They are still not approved, and FDA's lists have not changed.

What HHS published

The White House review of the document, listed as "Interim Access Policy for Compounding Using Certain Peptides" under RIN 0910-ZD94, concluded on October 27, 2026 with the outcome "Consistent with Change."[4] The notice was filed on October 28 and published on October 30, under the same RIN, as an action of the Office of the Secretary, signed by Secretary Robert F. Kennedy Jr.[1] That closes the open item in our October 16 and October 28 notes.

The notice calls the document a "draft" policy that "does not establish any rights for any person and is not binding on HHS or the public."[1] The policy PDF itself calls it an "interim policy" and does not use the word draft for it. Neither document states an effective date or an end date.[1][2] The notice tells readers to use the HHS website for the most current version, so the text may change; this note describes the copy downloaded on November 2.[1][2]

The scope

Six peptides, one form each, and only the listed routes

The law generally limits 503A compounding to bulk substances with a USP or NF monograph, those that are components of FDA-approved drugs, or those on the list set by regulation.[5][2] The six fall outside all three, which is why HHS frames this as enforcement discretion, a decision not to act, rather than as eligibility.[2] The covered parties are State-licensed pharmacies, Federal facilities and licensed physicians; the policy does not list outsourcing facilities among them.[2] Emideltide (DSIP) , which failed its July committee vote 6 to 7, is not included.[2][13]

Sources: HHS Appendix B[2]; FDA evaluations[7][8][9][10][11][12]; votes as reported by STAT[13].

HHS's coverage goes beyond the nominated routes FDA reviewed in four of the six rows, adding intramuscular use for BPC-157, Epitalon and MOTS-c and oral use for KPV. It also narrows some rows, leaving out rectal and nasal BPC-157 and subcutaneous Semax.[2][7][9][10][11][12] The form matters as well: free-base BPC-157, Epitalon, KPV, MOTS-c and TB-500 and Semax acetate fall outside the identities Appendix B describes.[2]

The ten conditions

What a compounder has to show

Condition by condition, the policy asks for: a substance listed in Appendix A; the identity and route limits in Appendix B; a valid certificate of analysis (COA) from a section 510 registered facility; an original manufacturer that is itself registered and in compliance with current good manufacturing practice, with its location on the COA; reporting of products, serious adverse events and quality problems; the label statement "This is a compounded drug product. Not for resale."; a single active ingredient; documentation of oral bioavailability for oral products; no delivery device other than a 510(k)-cleared syringe; and compliance with the rest of the Act, including the patient-specific prescription requirement.[2] A BPC-157 and TB-500 blend in one product falls outside the single-ingredient condition.[2]

Serious adverse events must be reported "regardless of whether or not considered drug related," which is stricter than the usual position: FDA's briefing notes that 503A compounders generally do not report adverse events to it.[2][10] The policy does not say how the product reports reach FDA or the States, or how often.[2]

The COA standard is long. It runs from orthogonal identity testing through peptide-related impurities, nitrosamines, residual solvents, elemental impurities, bioburden and endotoxin, and it requires the batch number, the manufacturer's FDA establishment number, a stated grade of "Intended for human drug compounding" and a dated quality-unit signature.[2] Many rows, however, give the acceptance criterion only as "Comply," with no numeric limit in the document.[2] Law firm Frier Levitt considers it unlikely that most suppliers now in the research-use-only market will participate.[20] That is a forecast, not a finding.

The oral condition carries a visible tension. The same appendix that covers oral BPC-157 and KPV says in a footnote that injectable forms "should be the standard route of administration (ROA) for peptides due to their low oral bioavailability."[2] Compounders must keep documentation that the formulation reaches "an adequate level of oral bioavailability in humans," but the policy does not define adequate, and FDA found no human pharmacokinetic data for oral BPC-157 and no study of KPV in humans by any route.[2][7][11]

HHS versus the FDA review

Each justification says the record has changed. None shows the record.

FDA's briefing for the July meeting proposed that none of these substances be added to the list.[6] Appendix B acknowledges that the Center for Drug Evaluation and Research (CDER) recommended against every one, then offers a three-part justification for each: better characterization, documented use and a reframing of the safety concern.[2] It refers to "lot-specific certificates," to use that is "documented and quantified" and, for BPC-157, to "multiple human studies." It names no lot, manufacturer, dataset or study.[2] The two entries the Regulations.gov record listed on November 2 are both the two-page notice.[3] The material may exist and may be sound, but as published pepmg could not check it. Where a claim can be compared with FDA's review, the comparison looks like this:

Semax. HHS says the intranasal record CDER compiled "covers several hundred subjects with no reported adverse outcome."[2] The count holds: FDA lists 33 to 47 healthy adults, 69 adults with medical conditions and 451 children.[10] The rest is thinner than it sounds. FDA writes that in one reference the authors report no adverse events "and in the other references AEs were not discussed," that three references were meeting abstracts, and that there is "insufficient clinical information to characterize the safety profile."[10] Not discussing harm is not the same as finding none. FDA's adverse-event database search, a separate record, also returned one consumer report of eye pain and hospitalization after Semax nasal drops bought online; a single report like this does not establish that the product caused the problem.[10]

TB-500. HHS cites a parent protein with "a controlled human safety record."[2] FDA's review says plainly that "thymosin beta-4 and TB-500 are not the same substance," and that it found no articles in which TB-500 was given to humans.[8] We covered that difference in our TB-500 note.

MOTS-c. HHS points to a randomized placebo-controlled trial of "a MOTS-c analogue" that reported no serious adverse events, without naming it.[2] FDA found no clinical studies or human exposure data for MOTS-c itself by any route.[12] An analogue is a different molecule. The closest match pepmg knows of is CohBar's CB4211, a subcutaneous phase 1a/1b study registered with 88 participants, which we discussed in our MOTS-c note; whether HHS means that trial is pepmg's inference.[18][19]

Epitalon. HHS says "the limited controlled human exposure reported no side effects."[2] FDA traces a "no side effects" statement to a 2007 abstract that gave no route, dose, duration or subject count, and concludes that "there are no clinical data to support the safety" of Epitalon in humans.[9] A randomized placebo-controlled study FDA describes elsewhere used a sublingual spray, not the injected routes HHS covers.[9]

BPC-157. HHS cites "multiple human studies."[2] FDA identified two rectal-enema studies lasting at most two weeks, a route HHS does not cover, and none by the oral, subcutaneous, nasal or transdermal routes proposed.[7] HHS may be relying on later or different material, but it does not say so. See our BPC-157 evidence note.

KPV. This is the closest fit between the two documents. HHS says CDER's conclusion "reflects an absence of information rather than an observed signal," and FDA does describe a lack of human data.[2][11] But FDA's conclusion from the same gap is that "potential safety risks associated with the use in humans are unknown."[11]

What did not change

FDA's own pages still read as they did

As read on November 2, FDA's 503A nominations document is still dated May 14, 2026, and none of the six appears in it.[14] FDA's safety-risk page, current as of April 22, still carries its risk language for BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500.[15] A reader checking FDA's pages will not find the HHS policy reflected there yet. The 503A page was last updated May 14, and the July meeting page August 6.[16][17]

The Federal Register search pepmg ran on November 2, for documents since October 1 mentioning peptides, returned this notice and two unrelated proposed rules, and no proposed rule adding any peptide to the 503A list.[26] The notice says only that FDA's "future rulemakings may propose adding some or all of these peptides."[1] Foley describes such rulemaking as taking many months to years, and Frier Levitt estimates 12 to 24 months; neither is an official timetable.[21][20]

The Partnership for Safe Medicines petition asking FDA to rule out exactly this kind of enforcement discretion also remains open: its docket still showed only the petition and FDA's acknowledgment on November 2.[27] The group said the decision "leaves Americans in a grey area as to whether peptides are safe or not."[22] On the other side, Lee Rosebush of the American Academy of Peptide Medicine, described by TIME as a new advocacy group, said it is "a vital step toward eliminating the unsafe gray and black markets."[23] Holland & Knight noted before the policy issued that drug-industry trade groups had argued FDA cannot authorize compounding this way; pepmg's November 2 web search found no court filing it could verify against the policy.[24]

What this note is not saying

It is not saying the six peptides are unsafe. FDA's findings are mostly about missing evidence, and HHS is right that many of the stated concerns are not observed harms.[2][15]

It is not saying research-labeled vials became acceptable. HHS says the policy aims to "discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers," and it covers only 503A compounding on a prescription.[2] Holland & Knight reports that FDA issued five warning letters to online peptide vendors on August 24.[24]

It is not saying a compounded product is available or lawful in any given state. The policy describes HHS's own enforcement intent; law firm LumaLex points out that it does not override state pharmacy law.[25] TIME saw telehealth sites advertising the six at $199 to $249 a month soon after the notice, which pepmg did not verify and which does not show that any seller meets the ten conditions.[23] This note reports regulatory status, not medical or legal advice.

Questions people are asking