Regulation desk · Reference table
FDA status by peptide: approval, compounding category, advisory votes and sport
One table for 25 peptides: FDA approval, 503A category, advisory committee votes and WADA status, checked against primary records on Oct 19, 2026.
The short answer ·
As of October 19, 2026, none of the popular 'research' peptides, including BPC-157, TB-500, KPV, MOTS-c, CJC-1295, ipamorelin and AOD-9604, is FDA-approved or on the 503A bulks list, which contains six substances and no peptides. Most were moved off FDA's active Category 2 list to 'nominated but withdrawn.'
Advisers voted for six peptides in July 2026, but that is advice, not a rule. Kisspeptin-10 and ibutamoren remain in 503A Category 2. Glutathione, vasoactive intestinal peptide and non-injectable GHK-Cu are in Category 1.
How to read this table
Each column answers a different legal question, and they are often confused:
- FDA approval: has FDA approved a drug product containing it? Approval is the only route to lawful marketing as a medicine.
- 503A category: where FDA has placed the substance in its interim compounding categories (Category 1, Category 2, or 3), or “withdrawn” if the nomination was withdrawn and FDA moved it to its “previously in category 2” table.
- Advisory vote: the most recent Pharmacy Compounding Advisory Committee (PCAC) vote. Votes are advice (how the process works).
- WADA 2026: where the substance appears on the World Anti-Doping Agency’s 2026 Prohibited List, if named.
Being on none of the lists does not make a peptide lawful to sell. A peptide that is not approved and not compoundable is an unapproved new drug when sold for human use.
Status table (checked October 19, 2026)
| Peptide | FDA approval | 503A category | Latest PCAC vote | WADA 2026 |
|---|---|---|---|---|
| BPC-157 | Not approved | Withdrawn (was Cat. 2) | Jul 23, 2026: 8-6 for listing | S0, named |
| TB-500 (thymosin beta-4 fragment) | Not approved | Withdrawn (was Cat. 2) | Jul 23, 2026: 8-6 for | S2.3, named |
| KPV | Not approved | Withdrawn (was Cat. 2) | Jul 23, 2026: 8-6 for | Not named |
| MOTS-c | Not approved | Withdrawn (was Cat. 2) | Jul 23, 2026: 7-5 for | S4.4.1, named |
| Semax | Not approved | Withdrawn (was Cat. 2) | Jul 24, 2026: 8-5 for | Not named |
| Epitalon | Not approved | Withdrawn (was Cat. 2) | Jul 24, 2026: recommended (tallies reported differently) | Not named |
| Emideltide (DSIP) | Not approved | Withdrawn (was Cat. 2) | Jul 24, 2026: 6-7, not recommended | Not named |
| Cathelicidin (LL-37) | Not approved | Withdrawn (was Cat. 2) | Scheduled before end of Feb 2027 | Not named |
| GHK-Cu | Not approved | Non-injectable: Cat. 1. Injectable: withdrawn | Scheduled before end of Feb 2027 | Not named |
| Dihexa acetate | Not approved | Withdrawn (was Cat. 2) | Scheduled before end of Feb 2027 | Not named |
| Melanotan II | Not approved | Withdrawn (was Cat. 2) | Scheduled before end of Feb 2027 | Not named |
| PEG-MGF | Not approved | Withdrawn (was Cat. 2) | Scheduled before end of Feb 2027 | S2.3 (mechano growth factors) |
| AOD-9604 | Not approved | Withdrawn (was Cat. 2) | Dec 4, 2024: 0-12 against | S2.2.3, named |
| CJC-1295 (all forms) | Not approved | Withdrawn (was Cat. 2) | Dec 4, 2024: 0-13 against (acetate 1-12) | S2.2.4, named |
| Thymosin alpha-1 | Not approved | Withdrawn (was Cat. 2) | Dec 4, 2024: 4-17 against | Not named |
| Ipamorelin | Not approved | Acetate: withdrawn for 503A; Cat. 2 for 503B | Oct 29, 2024: 0-12 against | S2.2.4, named |
| Kisspeptin-10 | Not approved | Cat. 2 | Oct 29, 2024: 0-11 against | S2.2.1 (kisspeptin and analogs) |
| Ibutamoren (MK-677, not a peptide) | Not approved | Cat. 2 (also 503B) | Oct 29, 2024: 1-13 against | S2.2.4, named |
| GHRP-2 | Not approved | Cat. 3 (503A); Cat. 2 (503B) | None found | S2.2.4, named |
| GHRP-6 | Not approved | Cat. 3 (503A); Cat. 2 (503B) | None found | S2.2.4, named |
| Selank | Not approved | Withdrawn (was Cat. 2) | None found | Not named |
| Glutathione | Not checked (see note) | Cat. 1 | None found | Not named |
| Vasoactive intestinal peptide | Not checked (see note) | Cat. 1 | None found | Not named |
| Thymulin acetate | Not approved | Cat. 3 | None found | Not named |
| Retatrutide | Investigational; not approved | Not in FDA’s 503A category lists | None | S0 applies to non-approved substances generally |
Notes on the table:
- “Withdrawn” means the substance is in FDA’s table of bulk drug substances “previously in category 2” whose nominations were withdrawn. FDA’s safety summaries stay on that page. Most moved there on April 15, 2026 (report).
- The 503B column is mentioned only where it differs. Our Category 2 explainer has full 503A/503B detail.
- “Not named” means the 2026 Prohibited List does not name the substance. It may still fall under a general class, such as S0, which covers any pharmacological substance without a current regulatory approval for human therapeutic use.
- “Not approved” refers to FDA only. Some substances have regulatory histories in other countries, which this table does not cover.
- For the Category 1 substances (glutathione, vasoactive intestinal peptide) we did not check approval history. Category 1 placement means FDA is evaluating them for 503A compounding.
- Vote sources: October 2024, December 2024, July 2026, 2027 meeting.
The 503A bulks list itself
As of October 19, 2026, the list in 21 CFR 216.23(a) has six substances: Brilliant Blue G, cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine, squaric acid dibutyl ester and thymol iodide. None is a peptide. FDA has also decided, in 216.23(b), that oxitriptan, piracetam, silver protein mild and tranilast will not be listed.
Approved peptide drugs
Many approved medicines are peptides, including semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound). Approval covers the branded product made by the approved manufacturer. It does not cover powders or vials sold online with the same name. Compounding copies of these drugs became much narrower after FDA declared the shortages over (explainer).
What changes this table
- FDA action on the July 2026 votes (proposed rule to list, or a decision not to).
- The interim access policy sent to OMB on October 14, 2026 (explainer).
- The PCAC meeting planned before the end of February 2027.
We update this page when one of those records changes. Each change is dated on the page’s revision line.
In the news
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Frequently asked questions
Is any research peptide FDA approved?
None of the peptides commonly sold online as 'research peptides' (BPC-157, TB-500, KPV, MOTS-c, CJC-1295, ipamorelin, AOD-9604, Semax, Epitalon and others) is FDA-approved. Retatrutide is investigational. Semaglutide and tirzepatide are approved only as branded products.
Which peptides are on the 503A bulks list?
None. As of October 19, 2026, 21 CFR 216.23(a) lists six substances: Brilliant Blue G, cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine, squaric acid dibutyl ester and thymol iodide.
What does 'nominated but withdrawn' mean?
The nominator withdrew its request to add the peptide to the bulks list, so FDA moved it out of the active Category 2 table. FDA kept its safety concerns on the page. It is not Category 1 and gives pharmacies no enforcement discretion.
Did the FDA approve BPC-157 in 2026?
No. An FDA advisory committee voted 8-6 in July 2026 to recommend BPC-157 for the 503A bulks list. FDA has not acted on that recommendation, and listing requires rulemaking.
Sources
7 linked records- [1] Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (category lists, updated May 14, 2026) U.S. FDA · Primary record
- [2] Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks U.S. FDA (checked Oct 19, 2026) Primary record
- [3] 21 CFR 216.23: Bulk drug substances that can be used to compound under section 503A eCFR Primary record
- [4] Final summary minutes, PCAC meeting of October 29, 2024 U.S. FDA Primary record
- [5] Final summary minutes, PCAC meeting of December 4, 2024 U.S. FDA Primary record
- [6] Meeting of the Pharmacy Compounding Advisory Committee (2027 meeting page) U.S. FDA Primary record
- [7] WADA 2026 Prohibited List (PDF) World Anti-Doping Agency Primary record
This explainer is general information about law and laboratory methods, not legal or medical advice. Amino Wire does not provide dosing information. Spotted an error? See our corrections policy.