Peptides and the FDA in 2026: what changed, and what didn't
In 2026, three US government documents about compounding with peptides came out between April and October: an update to an FDA list in April, an FDA advisory committee meeting in July and a draft HHS notice on October 30. Headlines have called the changes a ban, or said these peptides are legal or approved now. The documents themselves are narrower than that. This guide sets them side by side, with a link to each one. Sources checked November 2, 2026.
This page explains public documents. It isn't legal or medical advice, and it doesn't say whether any product is safe, effective or right for you. The HHS policy is a draft and may change.
The short version
- April 22, 2026: FDA's Category 2 page listed BPC-157, TB-500, epitalon, Semax, KPV and MOTS-c, among others, in a table of substances "previously in category 2" whose nominations were withdrawn by the nominators.
- July 23 and 24, 2026: FDA's Pharmacy Compounding Advisory Committee discussed seven peptides being considered for the 503A bulks list. Its advice isn't binding on FDA.
- October 30, 2026: HHS published notice of a draft policy: it doesn't intend to take enforcement action against 503A compounding with six named peptides, under conditions, while the 503A bulks list is developed through rulemaking.
- November 2, 2026: none of these peptides is FDA-approved. In the Peptimes Library, BPC-157 is still "Not FDA-Approved".
Three kinds of document, three different weights
An FDA list, an advisory committee's advice and a draft HHS policy carry different weight. The terms they use (503A, 503B, Category 2) are explained in What FDA approved, investigational and compounded mean; this page doesn't repeat them.
| Date | From | What it is | Binding? | Who it’s about | Source |
|---|---|---|---|---|---|
| April 22, 2026 | FDA | An update to its Category 2 page, under its interim compounding policies | A compounding status, not an approval | Substances nominated for 503A or 503B compounding | FDA’s Category 2 page |
| July 23–24, 2026 | FDA’s Pharmacy Compounding Advisory Committee | A public advisory committee meeting | No. FDA says advisory committees “make non-binding recommendations” | Seven peptides being considered for the 503A bulks list | FDA’s meeting page |
| October 30, 2026 | HHS, Office of the Secretary | Notice of availability of a draft enforcement-discretion policy | No. The notice says it “is not binding on HHS or the public” | 503A compounding by State-licensed pharmacies, Federal facilities and licensed physicians | Federal Register notice |
April 2026: FDA's Category 2 list
FDA keeps a page of bulk drug substances (active ingredients) that "may present significant safety risks" in compounding, its Category 2 under its interim policies. The page, content current as of April 22, 2026, now has a second table: "Bulk drug substances nominated but withdrawn", substances "previously in category 2" whose nominations "were withdrawn by the nominators".
That table includes BPC-157, TB-500 (FDA lists it as thymosin beta-4, fragment (LKKTETQ)), epitalon, Semax (heptapeptide), KPV, MOTs-C, emideltide (DSIP), CJC-1295 and GHK-Cu, with others.
What leaving Category 2 means
Leaving Category 2 is a change in a compounding status. It's never an approval, and it didn't put any of these substances on the 503A bulks list. HHS's draft policy says the same of each of its six peptides: neither the placement in Category 2 nor the removal changed its status under section 503A.
What stayed: ipamorelin acetate
Ipamorelin acetate is still in Category 2 under the 503B interim policy (outsourcing facilities), added September 29, 2023. It appears in both tables on FDA's page. See ipamorelin.
July 2026: the Pharmacy Compounding Advisory Committee
Which substances it discussed
FDA's Pharmacy Compounding Advisory Committee met on July 23 and 24, 2026, to discuss bulk drug substances "being considered for inclusion on the 503A Bulks List". FDA's agenda names seven, each in its free-base and acetate forms: BPC-157, KPV, TB-500 and MOTS-c on July 23, and emideltide (DSIP), Semax and epitalon on July 24. FDA posted a briefing document for each, including one for BPC-157.
What a vote is and isn't
An advisory committee advises FDA. FDA's meeting page says advisory committees "make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so". FDA's briefing document says it "will not issue a final determination" until the committee's input has been considered and all reviews are finalized.
As of November 2, 2026, FDA's meeting page doesn't post minutes or a vote summary, so this page doesn't report how the committee voted. When FDA posts them, they'll be on the meeting page.
October 30, 2026: HHS's draft enforcement-discretion notice
What it says
On October 30, 2026, the Federal Register published a notice from the Office of the Secretary of the Department of Health and Human Services (HHS), FR Doc. 2026-22192, docket HHS-OASH-2026-0496. It announces a draft "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances".
Enforcement discretion here means HHS saying it "does not intend to take enforcement action" in the circumstances the policy describes. The notice says that applies to "a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance found in Appendix A", while the 503A bulks list is developed through rulemaking.
Appendix A of the policy lists six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. Emideltide (DSIP), which the committee also discussed in July, isn't in it.
The policy applies only under conditions it sets out for compounders, and its Appendix B limits the forms and routes it covers for each peptide. Both are in the HHS policy itself.
Who it covers
The policy is about 503A compounding: State-licensed pharmacies, Federal facilities and licensed physicians. It doesn't name 503B outsourcing facilities among the compounders it covers.
What it isn't
- Not an FDA approval. The notice says it directly: "Compounded drugs are not FDA-approved." FDA doesn't review their safety, effectiveness or quality before they're marketed.
- Not final. It's a draft, open for comment.
- Not binding. It "does not establish any rights for any person and is not binding on HHS or the public."
- Not a rule. It doesn't add anything to the 503A bulks list. That list is developed through rulemaking.
- Not permanent. HHS "may revisit" the policy, in whole or in part, if a safety signal or product quality issue arises.
Comments and what comes next
The notice takes written comments on regulations.gov, docket HHS-OASH-2026-0496, "until 2 weeks after" publication. The docket shows comments closing November 13, 2026 (checked November 2, 2026). The notice adds that "FDA's future rulemakings may propose adding some or all of these peptides to the 503A bulks list". Until a final rule, nothing here changes whether a product is FDA-approved.
The compounds named, and their Peptimes Library labels
Each label is the one the Peptimes Library gives the compound; the compound page has its US status, sources and check date. FDA columns checked November 2, 2026, against the pages linked above.
| Compound | Library label | Left FDA’s Category 2 (April 22, 2026) | Discussed at the July committee | In the HHS draft’s Appendix A |
|---|---|---|---|---|
| BPC-157 | Not FDA-Approved | Yes | Yes | Yes |
| TB-500 | Not FDA-Approved | Yes | Yes | Yes |
| Epithalon (epitalon) | Not FDA-Approved | Yes | Yes | Yes |
| Semax | Approved outside the US | Yes | Yes | Yes |
| KPV | Not FDA-Approved | Yes | Yes | Yes |
| MOTS-c | Not FDA-Approved | Yes | Yes | Yes |
| DSIP (emideltide) | Approved outside the US | Yes | Yes | No |
| Ipamorelin | Compounding Restricted | No: still in Category 2 for 503B | No | No |
None of these has an FDA-approved product. "Approved outside the US" means approved by a regulator in another country, not by the FDA. Appendix B limits the forms and routes the policy covers; read it on hhs.gov.
How to check the current status yourself
These documents can change quickly. Before relying on any of them, check the source and its date:
- The HHS policy: the notice in the Federal Register (FR Doc. 2026-22192), and the policy on hhs.gov, which the notice names as the place to find its most current version.
- Comments and later documents: regulations.gov, docket HHS-OASH-2026-0496.
- FDA's compounding lists: the Category 2 page and the 503A bulk drug substances page, each with its "Content current as of" date.
- The committee: FDA's meeting page for July 23–24, 2026, for briefing documents and, once posted, minutes.
- Approvals: Drugs@FDA. Reading an FDA drug labelwalks through it.
How Peptimes helps
Peptimes is a tracking app for the peptides, GLP-1 medications and other compounds you already use. Its Library gives each entry a status label, such as "Not FDA-Approved" or "Compounding Restricted", as a starting point (how the Library works). You enter your own amounts and schedules, and Peptimes never suggests an amount. Export your records as CSV or JSON, for yourself or an appointment. See how to track peptides and Peptimes as a peptide tracker.
Peptimes is a tracking app. We don't sell peptides.
Sources
- Federal Register, FR Doc. 2026-22192, "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances" (Office of the Secretary, HHS; notice of availability; 91 FR 68526-68527, October 30, 2026; docket HHS-OASH-2026-0496), checked 2 Nov 2026: a draft policy; who it covers; Appendix A; "Compounded drugs are not FDA-approved"; not binding; may be revisited; comments for 2 weeks; future rulemaking.
- HHS, "HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances" (PDF, with Appendices A and B), checked 2 Nov 2026: the six peptides in Appendix A; the conditions; the forms and routes in Appendix B; for each of the six, neither the Category 2 placement nor the removal changed its status under section 503A.
- Regulations.gov, docket HHS-OASH-2026-0496, checked 2 Nov 2026: posted October 30, 2026; comments close November 13, 2026.
- FDA, "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks" (content current as of 04/22/2026), checked 2 Nov 2026: the table "Bulk drug substances nominated but withdrawn", with the compounds named here; ipamorelin acetate in Category 2 under the 503B interim policy since September 29, 2023.
- FDA, "July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee" (content current as of 08/06/2026), checked 2 Nov 2026: the agenda and the substances discussed each day; advisory committees make non-binding recommendations; no minutes or vote summary posted.
- FDA, briefing document for BPC-157-related bulk drug substances (PDF, Pharmacy Compounding Advisory Committee, July 2026), checked 2 Nov 2026: FDA "will not issue a final determination" until the committee's input has been considered and all reviews are finalized.
- FDA, "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act" (content current as of 05/14/2026), checked 2 Nov 2026: FDA's 503A bulks list pages.
- FDA, "Compounding and the FDA: Questions and Answers", checked 2 Nov 2026: compounded drugs are not FDA-approved.