The short answer. Most peptides sold to clinics have no lawful compounding pathway. Three things decide it: FDA approval, 503A eligibility for a pharmacy, and 503B eligibility for an outsourcing facility. The table below gives the status of each compound, and each row links to a page with the dates, the FDA documents behind it and its own verification date.
Status by compound
| Compound | FDA status | 503A pharmacy | 503B outsourcing | Latest FDA action |
|---|---|---|---|---|
| Semaglutide | Approved (Ozempic, Rybelsus, Wegovy, Wegovy tablets) | Component of an approved drug, limited by the copy rules | No bulk pathway; exclusion proposed May 2026 | Warning letters to 30 telehealth firms, Mar 3, 2026 |
| Tirzepatide | Approved (Mounjaro, Zepbound) | Component of an approved drug, limited by the copy rules | No bulk pathway; exclusion proposed May 2026 | Warning letters to 30 telehealth firms, Mar 3, 2026 |
| BPC-157 | Not approved | None. In no category since Apr 22, 2026 | None | PCAC Jul 23, 2026; FDA briefing recommended against listing |
| TB-500 | Not approved | None. In no category since Apr 22, 2026 | None | PCAC Jul 23, 2026; FDA briefing recommended against listing |
| Ipamorelin | Not approved | None. Committee voted 0-12 against, Oct 2024 | 503B Category 2 (acetate) | Warning letter naming an ipamorelin blend, Aug 24, 2026 |
| CJC-1295 | Not approved | None. Committee voted against all five forms, Dec 2024 | None | PCAC Dec 4, 2024 |
| Sermorelin | Formerly approved (Geref); withdrawn 2009, not for safety | Compounded as an approved-drug component; see caveat | 503B Category 1 (acetate) | Warning letter on “research” sermorelin, Dec 10, 2024 |
| Tesamorelin | Approved (Egrifta); a biologic since Mar 23, 2020 | None. Biologics are outside 503A | None | Warning letters to five research-peptide sellers, Aug 24, 2026 |
| GHK-Cu | Not approved | Topical: returning to Category 1. Injectable: none | None | FDA to consult PCAC by end of Feb 2027 |
| NAD+ | Not approved | Category 1 (NAD, NADH), under interim policy | Unresolved: list vs Jan 2026 warning letter | Warning letter to a 503B facility, Jan 20, 2026 |
| Retatrutide | Investigational (Lilly) | None. FDA: cannot be compounded | None | Warning letter to Peptide Partners, Aug 24, 2026 |
| PT-141 (bremelanotide) | Approved (Vyleesi, 2019) | Component of an approved drug, limited by the copy rules | None | Warning letters naming “PT-141 peptide”, Aug 24, 2026 |
| MOTS-c | Not approved | None. In no category since Apr 22, 2026 | None | PCAC Jul 23, 2026; FDA briefing recommended against listing |
| Epitalon | Not approved | None. In no category since Apr 22, 2026 | None | PCAC Jul 24, 2026; FDA briefing recommended against listing |
| Semax | Not approved in the US | None. In no category since Apr 22, 2026 | None | PCAC Jul 24, 2026; FDA briefing recommended against listing |
| Selank | Not approved | None. In no category since Sep 2024 | None | Still on FDA’s safety-risk page; no committee review |
| Thymosin alpha-1 | Not approved in the US | None. Committee voted 4-17 against, Dec 2024 | Category 3 (not eligible) | PCAC Dec 4, 2024 |
| AOD-9604 | Not approved | None. Committee voted 0-12 against, Dec 2024 | None | PCAC Dec 4, 2024 |
| Oxytocin | Approved (Pitocin and generic injections) | Component of an approved drug, limited by the copy rules | Category 1 (approved-drug component) | Warning letters to two outsourcing facilities, 2024 |
Table last updated September 26, 2026. Every entry is sourced to FDA, the Federal Register or the eCFR. We update this page when FDA acts, and the log at the bottom records each change.
Four rules that decide most rows
- A 503A pharmacy may compound from a bulk substance only by one of three routes. The substance meets a USP or NF monograph, it is a component of an FDA-approved drug, or it is on the 503A bulks list at 21 CFR 216.23. That list currently holds six substances, and none of them is a peptide.
- FDA’s interim policy covers Category 1 only. While FDA evaluates nominated substances, it does not intend to act against a pharmacy compounding from a Category 1 substance that meets the policy’s conditions. A substance in Category 2, Category 3 or no category gets no discretion.
- Absence is not permission. Leaving Category 2 because a nominator withdrew, as BPC-157 and TB-500 did in April 2026, puts a substance in no category. FDA’s guidance says a withdrawn nomination reflects no FDA determination.
- An approved drug brings the copy rules with it. Where the approved product is on the market, a compounded version is limited by FDA’s essentially-a-copy guidance. The semaglutide page explains the three tests.
What the tracker does not cover
This page covers federal regulatory status only. It does not cover dosing, clinical use or what any compound does. State pharmacy and medical boards add their own rules on top, and your marketing claims create separate exposure: see the eight layers that decide peptide legality.
What this means for you
Put every peptide on your menu against this table. Anything without an approval, a monograph, an approved-drug component or a Category 1 listing comes off. For what remains, get the supplying pharmacy’s basis in writing and keep it on file, and check back here before you add anything new. If you want the formulary reviewed for you, that is part of how we run peptide programs under our clinical standards.
Read next
Frequently asked questions
Which peptides can legally be compounded in 2026?
As of September 26, 2026, those that are components of approved drugs, such as semaglutide, tirzepatide, bremelanotide and sermorelin, subject to the copy rules, and 503A Category 1 substances such as NAD and non-injectable GHK-Cu under FDA’s interim policy. Oxytocin is also an approved-drug component. BPC-157, TB-500, ipamorelin, CJC-1295, MOTS-c, epitalon, semax, selank, thymosin alpha-1, AOD-9604 and retatrutide have no pathway.
What is 503A Category 2?
Category 2 is FDA’s list of nominated bulk substances that raise significant safety risks. FDA does not extend its interim enforcement discretion to them. Substances leave Category 2 either by FDA decision or, as happened with several peptides in 2024 and 2026, when the nominator withdraws.
Is BPC-157 legal now that it left Category 2?
No. BPC-157 left Category 2 in April 2026 because its nominators withdrew, which puts it in no category. It is not on the 503A bulks list, and FDA’s own July 2026 briefing recommended against listing it. No rulemaking had started as of September 2026.
How often is this tracker updated?
We check the FDA category lists, the Federal Register and FDA warning letters and update the page when anything changes. Each compound page shows the date it was last verified against primary sources, and the update log at the bottom of this page records each change.
Update log
- September 26, 2026. Seven compounds added: oxytocin, MOTS-c, epitalon, semax, selank, thymosin alpha-1 and AOD-9604, each verified against primary sources.
- September 25, 2026. Tracker published: 12 compounds, all verified against primary sources.
Primary sources. Last verified September 26, 2026. Corrections are welcome: contact us.
- 21 CFR 216.23, the 503A bulks list
- FDA, 503A bulk drug substance categories (updated May 14, 2026)
- FDA, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A (Jan 2025)
- FDA, Certain bulk drug substances that may present significant safety risks (updated Apr 22, 2026)
- FDA, 503B bulk drug substance categories (updated Mar 21, 2025)
- FDA, 503B bulk drug substances list
- FDA guidance, Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A (Jan 2018)
- 91 FR 23431 (May 1, 2026), proposal to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, Docket FDA-2018-N-3240
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.