HHS Opens a Compounding Path for Six Peptides: What the Oct 28 Notice Does and Doesn’t Do

HHS says it does not intend to take enforcement action against state-licensed pharmacies, Federal facilities and licensed physicians compounding these six peptides under section 503A when the stated conditions are met, while FDA’s 503A bulks-list rulemaking continues. That is the whole of the change announced in Federal Register document 2026-22192, filed for public inspection on Oct 28, 2026 and scheduled for publication on Oct 30, 2026.

It is not FDA approval, it does not add any of the six to the 503A bulks list, it covers 503A compounding only, and it is an interim policy that HHS says it may revisit. Research-use-only vials, dietary supplements and 503B outsourcing facilities are outside it.

Regulatory news, not legal or medical advice. Checked Oct 28, 2026. No dosing information is given on this page or in the policy summary below.

The Office of the Secretary of the Department of Health and Human Services filed a “Notice of availability” for the interim “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances” (Docket HHS-OASH-2026-0496, RIN 0910-ZD94), signed by Secretary Robert F. Kennedy, Jr. The notice was filed at 11:15 am on Oct 28, 2026 and publishes on Oct 30, 2026 (public-inspection PDF).

The operative sentence: “HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance found in Appendix A.”

On approval it is explicit: “Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed.”

HHS gives its reason as demand and the lack of approved products: “based on the Pharmacy Compounding Advisory Committee meetings and data regarding utilization of peptides, HHS believes that there is significant interest in the use of these peptides in compounding given the lack of availability of approved products.”

The notice points to the policy’s Appendix A, which the HHS policy document calls the “503A Interim Access List”: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500, the six that FDA’s advisory committee voted for in July. The committee voted against a seventh, emideltide (DSIP).

The policy document states the scope and duration: “Until a peptide bulk drug substance is addressed in a final rule as being included or not included on the 503A bulks list, HHS does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance that is not a component of an FDA-approved drug product, the subject of an applicable USP or NF monograph, or on the 503A bulks list codified at 21 CFR 216.23(a), when all of the following circumstances are present” (HHS policy document).

HHS also gives its reasoning: it 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” and provides “a more controlled alternative”. For each peptide, Appendix B sets out why HHS disagrees with FDA staff, citing new certificates of analysis from FDA-registered facilities and documented historical use.

Form and route per the HHS policy document (Oct 28, 2026), Appendix B. Vote tallies are as reported by the press; FDA has not posted minutes.

Anything else is outside: other salts or forms (BPC-157 free base or the arginine salt sold as pentadeca arginate, semax acetate), other routes (nasal BPC-157, injected KPV, oral TB-500), and analogs such as N-acetyl semax.

• It is not FDA approval: compounded drugs are not FDA-approved, and these remain unapproved drugs.
• It does not add anything to the 503A bulks list, and it is not FDA’s “Category 1”; FDA’s categories list (updated May 14, 2026) does not name these six.
• It is an interim policy: it lasts until FDA addresses each peptide in a final rule on the 503A bulks list, HHS says it may revisit it if a safety signal or product-quality problem arises, and it is not binding.
• It covers section 503A compounding only: not 503B outsourcing facilities, not research-use-only products and not dietary supplements.
• It is not a “Category 1” listing. FDA’s 503A categories list is a separate interim policy run by FDA; its current version, updated May 14, 2026, does not name BPC-157, TB-500, MOTS-c, epitalon, semax or KPV in any category. Posts saying the six “moved to Category 1” or are “now legal to compound” are wrong on both counts.
• It is not binding: the notice says the policy “does not establish any rights for any person and is not binding on HHS or the public.”
• Blends are outside it. Per the HHS policy document: “The compounded drug product contains only a single Active Pharmaceutical Ingredient (API) listed in Appendix A.” So “Wolverine” (BPC-157 plus TB-500), GLOW and KLOW mixes are not covered.

Per the HHS policy document (Oct 28, 2026), all of these must be met, in the document’s order:

1. Appendix A: the peptide is on the policy’s “503A Interim Access List” (BPC-157, Epitalon, KPV, MOTS-c, Semax, TB-500).
2. Identity and route: the bulk peptide has the identity (amino acid sequence, chemical structure, molecular weight and formula) and the route limits set out in Appendix B.
3. Characterization: it comes from an FDA-registered (section 510) facility with a valid certificate of analysis (COA) whose test results meet the Appendix B testing standard.
4. Original manufacturer: registered under section 510, compliant with CGMP, and its physical location listed on the COA; a registered repacker, relabeler or reseller must have validated the manufacturer and its COA.
5. Reporting: compounded products, serious adverse events (whether or not considered drug-related) and product-quality problems are reported to FDA MedWatch and to the states involved; the patient label explains how to report.
6. Label: “This is a compounded drug product. Not for resale.”
7. One active ingredient: the product contains only a single API listed in Appendix A, so no blends.
8. Oral forms: the compounder keeps documentation that the specific oral formulation achieves an adequate level of oral bioavailability in humans.
9. Device: the only drug delivery device co-packaged with, or containing, the drug is an FDA 510(k)-cleared syringe.
10. Everything else in the FD&C Act still applies, including no insanitary conditions and section 503A’s patient-specific prescription requirement.

On oral forms the document is specific: “if a peptide is compounded in an oral dosage form, the compounder is expected to maintain documentation confirming that the specific formulation provided to a patient achieves an adequate level of oral bioavailability in humans.”

Section 503A itself, which the policy works within, applies to a drug that “is compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient” (21 U.S.C. 353a(a)). In plain terms: a prescription for a named patient.

Commentary, not part of the policy: Hyman, Phelps & McNamara’s FDA Law Blog notes that the policy “makes no mention of FDA’s position or perspective at all and is wholly framed as authored by HHS”, and that “a big unknown is whether states will follow” it.

FDA’s Pharmacy Compounding Advisory Committee met on July 23-24, 2026 and voted to recommend adding all six to the 503A bulks list. Committee votes are advisory. FDA’s own staff had recommended the opposite: each of the six briefing documents ends with “a balancing of the criteria weighs against” listing the substance. CNN reported on Oct 28 that FDA scientists opposed the move.

BPC-157 (reviewed for ulcerative colitis; vote 8–6 (1 abstention)): “We found no studies that administered BPC-157 to humans via the proposed oral, SC, nasal, or transdermal ROA.” (FDA briefing)

TB-500 (reviewed for wound healing; vote 8–6 (1 abstention)): “The nomination did not include, and FDA did not find any information in the medical literature where TB-500 was administered to patients to treat any disease or condition including its use in wound healing.” (FDA briefing)

MOTS-c (reviewed for nominated uses including obesity and osteoporosis; vote 7–5 (2 abstentions)): “FDA is particularly concerned about the lack of human data on drug products containing this substance delivered via any route of administration.” (FDA briefing)

Epitalon (reviewed for insomnia; vote 7–4 (1 abstention)): “Based on available information, we conclude that there are no clinical data to support the safety of epitalon (free base) or epitalon acetate when used in humans.” (FDA briefing)

Semax (reviewed for cerebral ischemia, migraine and trigeminal neuralgia; vote 8–5 (1 abstention)): “One reference (Cherkasova et al. 2002) discussed possible anti-thrombotic properties of semax and this raises concern about the risk of bleeding, particularly in certain populations at risk for bleeding or if combined with other medications that increase bleeding risk.” (FDA briefing)

KPV (reviewed for wound healing and inflammatory conditions; vote 8–6 (1 abstention)): “The nomination did not include, and FDA did not find any information on the use of these substances administered in humans.” (FDA briefing)

Common threads in the six reviews: the substances were not well characterized chemically, there were no or almost no human safety data, injected peptides carry a risk of immune reactions made worse by aggregation and impurities, and FDA-approved treatments exist for most of the uses reviewed.

FDA’s reviewers found no adequate evidence of effectiveness for any of the uses they reviewed, and little or no human safety data. In their reviews and the studies our peptide pages cite:

• BPC-157: Mostly rat studies. In people: two short rectal-enema studies that FDA reviewed, a 53-person ulcerative colitis trial reported only as a meeting abstract, and small uncontrolled reports of 2 to 16 people. FDA found no human study by the injected, oral, nasal or skin routes it reviewed, and no human pharmacokinetic data.
• TB-500: No published human study of TB-500 itself. FDA found no animal toxicity studies, and a cell study it cited found that TB-500 did not speed closure of scratch wounds. Human trials exist only for the full-length parent protein, thymosin beta-4, a different molecule.
• MOTS-c: Cell and rodent studies only. FDA found no study that gave MOTS-c to people and no human pharmacokinetic data. The human finding often quoted measured the MOTS-c the body makes during exercise; nobody was given the peptide.
• Epitalon: Cell and rodent studies, much of it from one Russian research group, plus small studies of melatonin levels. FDA found no study of epitalon in people with insomnia and no human safety data, and called the mouse cancer studies too limited to rule out a cancer risk.
• Semax: Sold as a prescription nasal drug in Russia, not in the US. For the uses FDA reviewed it found two small human references with too little detail to judge, and they did not show the drug worked; most of the rest is animal work.
• KPV: Cell and mouse studies, such as mouse colitis models. FDA found no human data by any route.

An enforcement-discretion policy does not change any of this. It decides whom HHS will not act against, not whether a peptide is safe or effective.

1. A licensed clinician reviews your history and decides whether a compounded peptide is appropriate; if so, they write a prescription for you.
2. A state-licensed pharmacy (or a licensed physician or Federal facility) compounds it under section 503A, from a bulk peptide in Appendix A, in a covered form and route, meeting the policy’s conditions.
3. Ask the pharmacy which salt form and route it compounds, who made the bulk peptide, and for the certificate of analysis. Expect one active ingredient and the label line “This is a compounded drug product. Not for resale.” For an oral form, the policy expects documentation of adequate oral bioavailability in humans.
4. Check your state. A state board of pharmacy can be stricter than federal policy.
5. Report serious side effects or product problems to FDA MedWatch.

Red flags:

• “Research use only”, “not for human consumption” or “for laboratory use” on the vial or website.
• No prescription, no clinician review, or a “prescription” that comes automatically with checkout.
• Two or more peptides in one vial or product (“Wolverine”, GLOW, KLOW and other stacks).
• No certificate of analysis, or one that does not name the manufacturer and where it is made.
• A route the policy does not cover for that peptide, such as nasal BPC-157 or injected KPV.
• Claims that a peptide is “FDA approved”, “now legal” or proven to work for a condition.

We do not list or link sellers of these six peptides. As of Oct 28, 2026 none of our partners sells them.

• Oct 30, 2026: the notice publishes in the Federal Register.
• Comments: “Written comments can be submitted until 2 weeks after date of publication in the Federal Register via regulations.gov on Docket No. HHS-OASH-2026-0496”. Two weeks from Oct 30 is Nov 13, 2026 by our count; regulations.gov will show the official close date.
• Rulemaking: “FDA’s future rulemakings may propose adding some or all of these peptides to the 503A bulks list based on the available evidence.” Listing requires notice-and-comment rulemaking, which has no deadline.
• Revisions: “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 with a compounded drug product within the scope of this policy.”
• States: each state board decides how its own pharmacy rules apply.

On Oct 28, 2026 we read the Federal Register public-inspection PDF and its record on federalregister.gov (filed 10/28/2026 11:15 am, publication date 10/30/2026); the HHS policy document with Appendices A and B; FDA’s 503A categories list (updated May 14, 2026); FDA’s July 23-24, 2026 PCAC page and the six FDA briefing documents; and section 503A of the FD&C Act. Quotes are copied word for word.

Vote tallies come from RAPS, ABC News, Pharmacy Times and Fierce Pharma because FDA has not posted minutes, so they are as reported. News coverage (CNN, STAT, The Hill) and law-firm commentary are context only.

Per-peptide detail, with FDA reviewers’ concerns and the evidence, is on each page: BPC-157, TB-500, MOTS-c, Epitalon, Semax and KPV. For the background on 503A, 503B and FDA’s categories, see FDA peptide reclassification 2026 and which peptides a US pharmacy can compound.