# HHS's draft peptide compounding policy: the six peptides, the conditions, and what did not change > On October 28, 2026, HHS filed a draft, non-binding policy for the Federal Register (publication scheduled October 30). It says HHS does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding one of six peptides (BPC-157, epitalon, KPV, MOTS-c, semax, TB-500), alone, when every condition is met. It is not an FDA approval, not a final rule, and it does not cover blends or any other peptide. _Last updated: 2026-11-03_ --- This page covers a draft federal policy filed for public inspection on October 28, 2026, with Federal Register publication scheduled for October 30, 2026. We will update it when the Federal Register posts the final notice and its comment deadline. Educational information only, not medical or legal advice. On October 28, 2026, the Department of Health and Human Services filed a notice announcing a draft policy on six peptides that are not on the federal list of bulk substances pharmacies may compound from. In plain terms, HHS says it does not intend to take enforcement action against licensed compounding of BPC-157, epitalon, KPV, MOTS-c, semax or TB-500, one at a time, when a long list of conditions is met. That is a statement about enforcement, not an approval, and the details decide who it actually affects. This page sets out what the two primary documents say, what they do not say, and what is still unknown. Every regulatory statement here comes from the [Federal Register public-inspection notice](https://public-inspection.federalregister.gov/2026-22192.pdf) or the [HHS policy text and its appendices](https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf). For where every peptide on our site stands, see our [peptide status explainer](/peptide-status-explained). ## What happened on October 28, 2026? HHS filed a notice of availability for a draft policy titled "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances." The notice is FR Doc. 2026-22192, Docket No. HHS-OASH-2026-0496, and it was filed for public inspection at 11:15 am on October 28, 2026, with publication in the Federal Register scheduled for October 30, 2026, according to [the notice itself](https://public-inspection.federalregister.gov/2026-22192.pdf). It is signed by Robert F. Kennedy, Jr., as Secretary of HHS. The policy comes from the Secretary's office, not from FDA: the HHS text says it "describes the Secretary of the Department of Health and Human Services' (HHS) enforcement policy." The core sentence is that HHS "does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product" using one of the listed peptides, when all conditions are met. HHS says it wants to "discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers" and to give patients "a more controlled alternative," according to [the HHS policy text](https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf). ## Which six peptides are covered, and by which routes? Appendix A of the HHS policy lists exactly six peptides, and Appendix B limits each one to specific routes of administration. Not all six are injectables: semax is limited to intranasal use, and KPV to topical or oral forms. The table below follows [Appendix B](https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf); each name links to our overview of that substance. | Peptide (Appendix B form) | Routes allowed under the draft | | ------------------------------- | ---------------------------------------------------------------- | | [BPC-157](/bpc-157) (acetate) | Subcutaneous, intramuscular, oral, topical | | [Epitalon](/epitalon) (acetate) | Subcutaneous or intramuscular injection, in intermittent courses | | [KPV](/kpv) (acetate) | Topical and oral only | | [MOTS-c](/mots-c) (acetate) | Subcutaneous or intramuscular injection | | [Semax](/semax) (free base) | Intranasal only | | [TB-500](/tb-500) (acetate) | Subcutaneous or intramuscular injection | Appendix B also records that each of the six had been in FDA's Category 2 from September 2023 until April 22, 2026. Our substance pages cover what the research on each one does and does not show; the policy does not change that evidence. ## What the policy is, and what it is not The policy is a draft statement of enforcement discretion, and nothing more. The Federal Register notice says HHS "is announcing the availability of a draft" policy, and that the policy "does not establish any rights for any person and is not binding on HHS or the public," per [FR Doc. 2026-22192](https://public-inspection.federalregister.gov/2026-22192.pdf). The HHS text calls itself an "interim policy" and 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." What it is not: - **Not an FDA approval.** Both documents say "Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed." HHS spokesperson Emily Hilliard reportedly said the policy "does not grant FDA approval or establish clinical safety and effectiveness" (The New York Times, as summarized by [Newser](https://www.newser.com/story/398980/kennedy-opens-door-to-unproven-peptide-injections.html); second-hand). - **Not a rule, and not a change to the bulks list.** The document is a notice of availability. The federal list of bulk substances that 503A pharmacies may compound from, [21 CFR 216.23](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23), still contains no peptide. The notice says FDA's "future rulemakings may propose adding some or all of these peptides" to that list. - **Not permanent.** HHS says the policy applies until each peptide is "addressed in a final rule as being included or not included on the 503A bulks list." - **Not a blend or stack policy.** Only single-ingredient products qualify (see the conditions below). - **Not a policy on research-use-only products.** HHS frames the policy as an alternative to them and says such peptides "pose a safety risk to US patients." ## What conditions must be met? Every condition must be met, or the policy does not apply. The HHS Interim Policy lists them, summarized here from [the HHS text](https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf): 1. **On the list.** The peptide appears in Appendix A. 2. **Identity and route.** It matches "the identity and limitations in route of administration described in Appendix B." 3. **Tested source.** The bulk ingredient comes from an FDA-registered facility and has a valid certificate of analysis meeting the testing table in Appendix B (identity, purity, potency, endotoxin, microbial limits, impurities, heavy metals). 4. **Registered manufacturer.** The original manufacturer is registered with FDA and follows current good manufacturing practice; any repacker or reseller must have documented vendor validation. 5. **Reporting.** Compounders report products made, serious adverse events and quality problems to FDA (MedWatch) and to the states involved. 6. **Label.** The product carries the line "This is a compounded drug product. Not for resale." 7. **Single active ingredient.** "The compounded drug product contains only a single Active Pharmaceutical Ingredient (API) listed in Appendix A." 8. **Oral bioavailability.** Oral forms need documentation that the specific formulation "achieves an adequate level of oral bioavailability in humans." 9. **Syringe only.** The only co-packaged delivery device allowed is an FDA 510(k)-cleared syringe. 10. **Everything else still applies,** including the patient-specific prescription requirement of section 503A. The single-ingredient rule matters for the blends sold online. Applying it is our reading, since the documents name no blend: the Wolverine stack (BPC-157 plus TB-500), the GLOW blend (GHK-Cu, BPC-157 and TB-500) and the KLOW blend (GLOW plus KPV) each contain more than one active ingredient, and GLOW and KLOW also contain GHK-Cu, which is not on the list. None of them is covered. Our sister sites describe those compositions in the [Wolverine stack guide](https://therecoverydose.com/wolverine-stack-bpc-157-tb-500) and the [KLOW vs GLOW comparison](https://complexionscience.com/klow-vs-glow). Who is covered matters too. The covered entities are state-licensed pharmacies, federal facilities and licensed physicians. Outsourcing facilities (503B) are not among the covered entities; the documents mention them only in the general definition of compounding. ## Which peptides are not covered? Any peptide outside the six is not covered, because the policy applies only to Appendix A. That includes CJC-1295, ipamorelin, AOD-9604, selank, LL-37, melanotan II, PEG-MGF, dihexa, thymosin alpha-1, injectable GHK-Cu and DSIP, as well as tesamorelin, retatrutide and 5-Amino-1MQ. The policy does not name these; they are simply absent from the list. Our overviews of [CJC-1295](/cjc-1295), [ipamorelin](/ipamorelin), [selank](/selank), [GHK-Cu](/ghk-cu), [thymosin alpha-1](/thymosin-alpha-1) and [melanotan II](/melanotan-ii) each carry a dated note saying so. ## Timeline: how we got here The policy follows a three-year sequence recorded in Appendix B and the Federal Register. Dates below come from [the HHS appendices](https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf) and [the FR notice](https://public-inspection.federalregister.gov/2026-22192.pdf). | Date | Event | | ---------------------------- | ----------------------------------------------------------------------------------------------------- | | September 2023 | The six peptides are placed in Category 2 (September 29, 2023 for TB-500, epitalon, semax and MOTS-c) | | April 22, 2026 | The six leave Category 2, per Appendix B | | July 23-24, 2026 | FDA's Pharmacy Compounding Advisory Committee meets on the peptides | | October 28, 2026, 11:15 am | Draft policy filed for public inspection (FR Doc. 2026-22192) | | October 30, 2026 (scheduled) | Federal Register publication | | Two weeks after publication | Written comments close on regulations.gov, Docket HHS-OASH-2026-0496 | | No date set | FDA rulemaking on the 503A bulks list "may propose adding some or all of these peptides" | We have not printed a comment deadline date, because it depends on the actual publication date; we will add it once the [Federal Register document](https://www.federalregister.gov/d/2026-22192) posts. ## What did FDA's drug center and the advisory committee say? They disagreed. For every one of the six, Appendix B states that FDA's Center for Drug Evaluation and Research (CDER) recommended against listing the peptide, and the Pharmacy Compounding Advisory Committee voted in favor, according to [the HHS policy's Appendix B](https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf). The appendix does not give vote counts, and we do not either. For all six peptides, [Appendix B](https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf) records the same split: FDA's drug center recommended against listing the peptide, and the Pharmacy Compounding Advisory Committee voted in favor. Press coverage added context that the documents do not contain, so we attribute each item to the outlet that reported it: - [NBC News](https://www.nbcnews.com/health/health-news/rfk-jr-takes-shortcut-make-peptides-widely-available-rcna606133) described the committee vote as narrow and reported panel members' industry ties; Reuters also reported ties and that HHS said members cleared ethics checks. - The [Associated Press](https://fox8.com/business/ap-business/ap-fda-scientists-opposed-the-trump-administrations-effort-to-ease-peptides-access/), citing six unnamed people, reported that FDA scientists had little input and opposed the policy, and that HHS moved from a formal rule to enforcement discretion after FDA pushback. That is one outlet's reporting, not a finding in the documents. ## How have supporters and critics reacted? Reaction split along familiar lines. Supporters: - Lee Rosebush of the American Academy of Peptide Medicine called it a "landmark regulatory milestone" (Reuters). The AP noted the group "is not a medical professional society." - Scott Brunner of the Alliance for Pharmacy Compounding described a "more accountable alternative" but said dispensing may take time ([NPR](https://www.npr.org/2026/10/28/nx-s1-6021030/peptides-compounding-enforcement)). The Alliance also said it is unclear when the policy takes effect (AP). Critics: - Peter Lurie of the Center for Science in the Public Interest, a former FDA official, said FDA was "turning a blind eye" ([NBC News](https://www.nbcnews.com/health/health-news/rfk-jr-takes-shortcut-make-peptides-widely-available-rcna606133)). - Robert Steinbrook of Public Citizen said Kennedy acted "recklessly and unilaterally" (Reuters). - Willie Underwood III of the American Medical Association said the policy "puts patients at risk" ([Scientific American](https://www.scientificamerican.com/article/rfk-jr-loosens-restrictions-for-six-popular-peptides-bypassing-the-fda/)). - Fred Mills of Americans for Safe and Effective Medicines said consumers "should not be treated like guinea pigs" ([TIME](https://time.com/article/2026/10/28/peptide-rush-has-begun/)). HHS spokesperson Emily Hilliard said the department is "confronting the risks of black-market peptides" (NBC News, AP). One correction to the coverage: Scientific American described the policy as allowing some combinations of peptides, but condition 7 limits it to a single active ingredient. ## What does this mean for readers? For most readers, nothing changes today. The policy is a draft, it sets no effective date, and it only describes when HHS will not act against licensed compounders who meet all ten conditions. How many pharmacies can meet the sourcing, testing, bioavailability and reporting requirements, and how soon, is unknown. A few points hold regardless: - **The evidence has not changed.** The policy is an enforcement position, not a review of whether these peptides work or are safe. What we report on each substance page stays as written. - **A prescription is still required.** Section 503A compounding is patient-specific, so the policy describes prescribed, pharmacy-compounded products, not over-the-counter sales. - **State rules still apply and vary.** The federal draft does not change them. In Mississippi, the boards of nursing, pharmacy and medical licensure said in an [August 19, 2026 joint statement](https://www.msbn.ms.gov/sites/default/files/2026-08/1_Joint_Statement_SIGNED_Accessible_0.pdf) that it is not permissible for a provider to compound, administer or dispense a non-FDA-approved or research-grade peptide; how they will treat the federal draft is unknown. Louisiana's [Act 374](https://www.legis.la.gov/Legis/ViewDocument.aspx?d=1482494), effective August 1, 2026, goes the other way: it bars licensing boards from prohibiting prescribers from providing peptides from a compliant 503A pharmacy or 503B outsourcing facility, or pharmacists from compounding and dispensing peptides in line with federal compounding law. - **Sport rules are separate.** The policy says nothing about anti-doping. BPC-157 is [prohibited under WADA's S0 category](https://www.usada.org/spirit-of-sport/bpc-157-peptide-prohibited/), TB-500 is [named under S2](https://www.usada.org/athlete-advisory/2018-prohibited-list-summary-of-major-changes/), and a pharmacy label makes no difference to a drug test. Check the current [WADA Prohibited List](https://www.wada-ama.org/en/prohibited-list) for any other substance. None of this is a recommendation to use or avoid any peptide. Anyone considering one should raise it with a licensed clinician who knows their history. ## What peptides did RFK approve? None. Secretary Kennedy signed a notice for a draft enforcement-discretion policy, which is different from an approval: approval of a drug is FDA's process, and the policy itself says compounded drugs are not FDA-approved. The draft covers six peptides, not 14 (the 14 figure came from earlier podcast remarks covered on our [status explainer](/peptide-status-explained)). Reuters, NBC News, the AP and TIME all reported that Kennedy has called himself a "big fan" of peptides. ## Can I get BPC-157 prescribed? Possibly, in time, but the draft does not create a ready route. If a licensed clinician decides it is appropriate, a covered pharmacy would still need a qualifying bulk source with a tested certificate of analysis, oral bioavailability documentation for oral forms, MedWatch reporting and the required label, plus compliance with your state's rules. The Alliance for Pharmacy Compounding said it is unclear when the policy takes effect (AP), and dispensing may take time (NPR). Whether any particular pharmacy can meet the conditions is not yet known. ## Is the Wolverine stack covered? No. The Wolverine stack combines BPC-157 and TB-500, and the draft covers products with "only a single Active Pharmaceutical Ingredient." By the same rule, GLOW and KLOW blends are not covered either, and both also contain GHK-Cu, which is not one of the six. The documents do not name any blend; this is a direct application of condition 7. ## When does the policy take effect? The documents give no effective date. The notice was filed on October 28, 2026, and its publication in the Federal Register is scheduled for October 30, 2026; the dates line in the public-inspection copy reads "as of [INSERT DATE OF PUBLICATION IN THE FEDERAL REGISTER]." Written comments are open until two weeks after publication. The policy is a draft, it can be revisited, and it lasts only until a final rule addresses each peptide. We will update this page when the Federal Register posts. ## What is still unknown? Several questions have no answer in the documents yet: - Whether, when and in what form the policy is finalized, and when it is treated as in effect. - The exact comment deadline. - Whether and when FDA proposes adding any of the six to the 503A bulks list. - How state boards, including Mississippi's, respond. - How many pharmacies can meet the conditions, and how soon. - Any federal position on 503B outsourcing facilities for these peptides. - FDA's own committee minutes and vote counts. - Whether peptides left out of Appendix A get any later review. ## Sources Primary documents: the [Federal Register public-inspection notice, FR Doc. 2026-22192](https://public-inspection.federalregister.gov/2026-22192.pdf) and the [HHS policy text with Appendices A and B](https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf) (hhs.gov may block automated downloads; it opens in a normal browser). The bulks list: [21 CFR 216.23](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23). State documents: the [Mississippi joint statement](https://www.msbn.ms.gov/sites/default/files/2026-08/1_Joint_Statement_SIGNED_Accessible_0.pdf) and [Louisiana SB 253](https://www.legis.la.gov/legis/BillInfo.aspx?i=250428). Press: Reuters, NBC News, NPR, the Associated Press, Scientific American and TIME, each linked where cited above. _Educational information only, not medical or legal advice. Based on the draft as filed on October 28, 2026; not reviewed by an attorney. Updated October 28, 2026._ --- _Affiliate disclosure: some links on the web version of this site go to Bodybuilding Peptides (trybbpeptides.com), an affiliate destination, and we may earn a commission if you buy there. Our coverage is independent of that relationship. Details: https://thetreatmentreport.com/affiliate-disclosure/_