HHS Published Its Peptide Compounding Policy: Six Peptides, Ten Conditions, and What the Text Leaves Out
The short version
- HHS has published the text of its peptide compounding policy. The Federal Register ran the notice on 30 October 2026 (91 FR 68526, docket HHS-OASH-2026-0496) after it was filed on 28 October. The 16-page policy is on hhs.gov, and the notice is signed by Health Secretary Robert F. Kennedy Jr.
- Appendix A lists six peptides: BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. HHS says it does not intend to take enforcement action against a State-licensed pharmacy, Federal facility or licensed physician that compounds a single-ingredient product from one of them, when ten conditions are met.
- Each peptide is tied to named routes: BPC-157 by injection, orally or topically; TB-500, epitalon and MOTS-c by subcutaneous or intramuscular injection; KPV orally or topically; semax intranasally. Emideltide (DSIP) is not on the list.
- It is interim and not binding. The notice says it "does not establish any rights for any person and is not binding on HHS or the public", and HHS may revisit it if a safety signal or product quality issue arises. Comments are open on regulations.gov until 13 November 2026.
- The policy mentions research-use-only peptides once, as the practice HHS wants to discourage. It sets no rule or relief for sellers of them. It is not an FDA approval: compounded drugs, it says, are not FDA-approved.
On 28 October the US Department of Health and Human Services (HHS) filed a notice with the Federal Register announcing its "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances", and the Federal Register printed it on 30 October. It carries the identifier (RIN 0910-ZD94) of the FDA item that White House reviewers cleared on 27 October, the text our earlier pieces reported as missing. Here is what it says, what it requires and what it leaves out, as of 31 October 2026.
What HHS published
| Question | Answer, from the documents |
|---|---|
| What is it? | A "notice of availability" of an enforcement discretion policy on pharmacy compounding of certain peptides, while the list of bulk drug substances that can be used in 503A compounding "is developed through rulemaking" |
| Who issued it? | The Office of the Secretary, HHS. The notice is signed by Robert F. Kennedy, Jr., Secretary of Health and Human Services |
| Where is it? | Federal Register, volume 91, number 209, pages 68526 to 68527 (FR Doc. 2026-22192), stamped "Filed 10-28-26" and published 30 October. The 16-page policy, with Appendices A and B, is a PDF on hhs.gov. The docket is HHS-OASH-2026-0496 on regulations.gov |
| Is it open for comment? | Yes. The notice accepts written comments on the docket "until 2 weeks after date of publication in the Federal Register". Regulations.gov lists the period as ending on 13 November 2026 (04:59 UTC on 14 November) |
| Is it final? | No. The notice's background paragraph calls the document a "draft" and says it "does not establish any rights for any person and is not binding on HHS or the public". The policy itself calls itself an "interim policy" |
Source: Federal Register notice 2026-22192, the HHS policy PDF and the regulations.gov records for docket HHS-OASH-2026-0496, all read on 31 October 2026. The notice points readers to the HHS website "to find the most current version of the policy", so the text can change. Reuters wrote on 28 October that the policy was "published in the Federal Register"; the Federal Register's own record shows it was filed that day and published on 30 October.
The six peptides and the routes HHS names
Appendix A is a list of six peptide bulk drug substances. Appendix B gives each one's identity (sequence, formula, molecular weight) and the dosage forms HHS has in mind, so the discretion is tied to a form and a route, not to the peptide in general. For all six, HHS's own appendix records that the FDA's drug center (CDER) recommended against listing the substance and that the advisory committee (PCAC) voted in favor. It also records that each sat in the FDA's "Category 2" list from September 2023 until 22 April 2026, a placement and removal that, HHS notes, did not change its status under section 503A.
| Peptide | Form and routes named in Appendix B | What HHS says has changed since CDER's review, in its words |
|---|---|---|
| BPC-157 | Acetate. Subcutaneous, intramuscular, oral and topical dosage forms | Historical use is "documented and quantified", with multiple human studies; a lot-specific certificate from an FDA-registered facility; risks addressed by "lot-level testing, single-active pharmaceutical ingredient (API) products, and MedWatch reporting" |
| TB-500 | Acetate. Subcutaneous or intramuscular injection | Lot certificates from FDA-registered manufacturers now supply the results CDER found missing; use is documented; CDER's safety concerns are "inferential rather than observed" |
| Epitalon | Acetate. Subcutaneous or intramuscular injection, "dispensed in intermittent courses" | Lot certificates now report endotoxin, microbial and residual solvent results; CDER's safety concerns are "mechanistic rather than based on observed harm"; limited controlled human exposure "reported no side effects" |
| Semax | Free base. Intranasal | Certificates supply the endotoxin result CDER called the principal deficiency for injectable use; the intranasal human record CDER compiled covers "several hundred subjects with no reported adverse outcome" |
| KPV | Acetate. Topical and oral | Lots supplied to 503A pharmacies confirm the active moiety by mass spectrometry; CDER's safety conclusion reflects "an absence of information rather than an observed signal" |
| MOTS-c | Acetate. Subcutaneous or intramuscular injection | A randomized placebo-controlled trial of a MOTS-c analogue "reported no serious adverse events at an exposure well above the compounded regimen"; rodent studies "reported metabolic benefit without systemic toxicity" |
Source: HHS policy PDF, Appendices A and B, read on 31 October 2026. The right-hand column is HHS's own account of the evidence. We have not tested it against the underlying studies. The FDA's briefing documents for the July advisory meeting are covered on our advisory committee page.
The ten conditions
HHS says it does not intend to take enforcement action against a State-licensed pharmacy, Federal facility or licensed physician compounding with one of these substances "when all of the following circumstances are present":
- On the list. The peptide is in Appendix A, which the policy calls the "503A Interim Access List".
- Right identity and route. The substance has the identity, and stays within the limits on route, described in Appendix B.
- Registered source and a certificate. It comes from a facility registered under section 510 of the FD&C Act, with a valid certificate of analysis showing tests for identity, purity, potency and contaminants such as endotoxins, heavy metals and microbes.
- Original manufacturer. The original manufacturer, not a later packer, repacker, labeler or distributor, is FDA-registered and in compliance with current good manufacturing practice, and its facility location is on the certificate. A repacker, relabeler or reseller must itself have validated the manufacturer and its certificate.
- Reporting. The compounder reports products compounded, serious adverse events and product quality issues to the FDA's MedWatch program and to the states involved.
- Label. The label carries the statement "This is a compounded drug product. Not for resale."
- One active ingredient. The product contains only a single active ingredient from Appendix A, so adverse events can be attributed to one substance.
- Oral forms. If a peptide is compounded in an oral form, the compounder is expected to keep documentation that the specific formulation reaches adequate oral bioavailability in humans.
- Device. The only delivery device packed with the drug is an FDA 510(k)-cleared syringe.
- Everything else. The product meets all other requirements of the FD&C Act, including not being compounded under insanitary conditions, and section 503A's requirement for a patient-specific prescription.
Source: HHS policy PDF, pages 2 to 4, read on 31 October 2026. Appendix B adds a testing standard for the certificate of analysis, with listed methods and limits for identity, assay, peptide-related impurities, nitrosamines, residual solvents, elemental impurities, water content, bioburden and bacterial endotoxins.
What the text does not do
- It does not approve anything. The policy says compounded drugs "are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed", and that they "may pose risks to patients".
- It does not cover emideltide (DSIP). The Partnership for Safe Medicines petition, covered in our earlier piece, named seven peptides. Appendix A lists six of them and leaves out emideltide, the one the advisory committee voted against in July.
- It names no other substance. Appendix A is the whole list.
- It sets no rule for research-use-only sellers. The words "research-use-only" appear once, in the rationale. HHS says the policy "will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients" by giving patients "a more controlled alternative". The text sets no condition, deadline or relief for sellers of such products and says nothing else about them.
- It does not override the states. It describes what HHS does not intend to do. Reuters quoted Jeff Cohen, co-founder of the American Peptide Association, saying states may not follow the federal move, and The Hill wrote that state compounding rules differ and could clash with the federal ones. Our legal guide and state pages cover the state side.
- It names three kinds of compounder. The relief is for "a State-licensed pharmacy, Federal facility, or licensed physician". Outsourcing facilities appear only in the policy's general description of compounding, not among those HHS says it will not act against.
- It names no pharmacy. It does not say which pharmacies will choose to compound these peptides.
Who has said what
These are statements by the parties, as reported. None is a finding.
| Who | What they said | Reported by |
|---|---|---|
| Robert Steinbrook, Public Citizen's Health Research Group | Kennedy acted "recklessly and unilaterally". He said the policy could expose patients to risks such as contamination, impurities and unknown side effects, and that peptides should go through the standard FDA approval process | Reuters, 28 October |
| Lee Rosebush, American Academy of Peptide Medicine | Called it a "landmark regulatory milestone" | Reuters, 28 October |
| Jeff Cohen, American Peptide Association | Said the policy could amplify tension between federal and state regulators, and that states may not follow | Reuters, 28 October |
| Alliance for Pharmacy Compounding | "An important step for patients" | BioSpace, 29 October |
| Shabbir Imber Safdar, Partnership for Safe Medicines | The policy "leaves Americans in a gray area as to whether peptides are safe or not" | BioSpace, 29 October |
| Jim Stansel, PhRMA | "It is deeply concerning that HHS is telling the FDA they should ignore the law and allow illegal compounding of unapproved peptides" | BioSpace, 29 October |
Reuters also wrote that HHS "did not respond to a request for comment on the policy".
What to watch
- The comment docket, HHS-OASH-2026-0496 on regulations.gov, open until 13 November 2026, and any change HHS makes. The policy says HHS "may revisit application of this interim policy (in whole or in part) if, among other things, a safety signal or product quality issue arises".
- FDA rulemaking. The notice says "FDA's future rulemakings may propose adding some or all of these peptides to the 503A bulks list based on the available evidence."
- The Partnership for Safe Medicines petition, now docket FDA-2026-P-13366 on regulations.gov, where an acknowledgment letter from the FDA was posted on 27 October. It asks the FDA not to allow compounding of these peptides by any route, enforcement discretion included. We found no FDA decision on it.
- Recalls, warning letters and state actions involving compounded peptides, which we log in the enforcement tracker.
We update this piece the day a further document is published.
Questions readers ask
Has HHS published its peptide compounding policy?
Yes. HHS filed a notice with the Federal Register on 28 October 2026 and the Federal Register published it on 30 October (91 FR 68526, docket HHS-OASH-2026-0496). The 16-page policy, with a list of six peptides in Appendix A and their identities and routes in Appendix B, is on hhs.gov.
Which peptides does the HHS policy cover?
BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. Appendix B ties each to named forms and routes: BPC-157 to subcutaneous, intramuscular, oral and topical forms; TB-500, epitalon and MOTS-c to subcutaneous or intramuscular injection; KPV to topical and oral forms; semax to intranasal use. Emideltide (DSIP), the seventh peptide the advisory committee reviewed in July, is not on the list.
Does the policy make these peptides FDA-approved or legal?
No. It describes what HHS does not intend to enforce against a State-licensed pharmacy, Federal facility or licensed physician that meets ten conditions. The policy itself says compounded drugs are not FDA-approved. The notice says the document is not binding on HHS or the public, and HHS may revisit it if a safety signal or product quality issue arises.
Does the policy change anything for research-use-only peptides?
The policy mentions research-use-only peptides once, as the practice HHS says it wants to discourage. It sets no rule or relief for sellers of them and says nothing else about them.
Does this mean pharmacies are selling these peptides now?
The policy only says what HHS does not intend to enforce. It names no pharmacy, requires a patient-specific prescription and ten conditions, including FDA-registered sources and testing certificates, and leaves state rules in place. We have not verified that any pharmacy is offering these peptides.
How can the public comment on the HHS peptide policy?
On regulations.gov, docket HHS-OASH-2026-0496. The notice accepts written comments until two weeks after publication, and regulations.gov lists the period as ending on 13 November 2026.
Sources
- Federal Register: Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (91 FR 68526, FR Doc. 2026-22192), published 30 October 2026; read 31 October 2026
- HHS: Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, with Appendices A and B (PDF, 16 pages), read 31 October 2026
- Regulations.gov: docket HHS-OASH-2026-0496 and documents HHS-OASH-2026-0496-0001 and -0002, read 31 October 2026
- reginfo.gov: EO 12866 regulatory reviews completed in the last 30 days (XML report), RIN 0910-ZD94, concluded 27 October 2026, Consistent with Change, read 31 October 2026
- Reuters: US Health Secretary Kennedy Opens Access to Some Unapproved Peptides (Sneha S K), via U.S. News, 28 October 2026
- The Hill: HHS to allow sale of unapproved peptides under review (Joseph Choi), 28 October 2026
- BioSpace: HHS clears compounding pharmacies to manufacture 6 unapproved peptides (Nick Paul Taylor), 29 October 2026
- Partnership for Safe Medicines: Citizen Petition to the FDA (PDF), for the seven peptides and the committee vote on emideltide, headed 23 October 2026; read 27 October 2026
- Federal Register API: documents mentioning peptide, compounding or compounded drug published since 24 October 2026, queried 31 October 2026