The short answer. MOTS-c is not FDA-approved and, as of September 26, 2026, has no lawful compounding pathway. It left FDA’s Category 2 in April 2026 because the nominator withdrew. FDA’s advisory committee reviewed it on July 23, 2026, and FDA’s own briefing recommended against listing it.
| FDA approved | No. No USP monograph, and not a component of any approved drug. |
|---|---|
| 503A pharmacy | No pathway. Not on 21 CFR 216.23 and in no category since Apr 22, 2026. |
| 503B outsourcing facility | No pathway. Never in a 503B category. |
| Latest FDA action | Advisory committee, Jul 23, 2026 (obesity and osteoporosis). FDA’s briefing recommended against listing both forms. |
| Sport | WADA prohibited (S4.4.1, metabolic modulators, named as an AMPK activator). |
| MDside position | Our providers do not prescribe it. |
| Last verified | 2026-09-26 |
What happened, in order
| Date | What happened |
|---|---|
| Sep 29, 2023 | FDA placed MOTS-c in 503A Category 2, substances that may present significant safety risks. |
| Apr 14, 2026 | Wells Pharmacy Network’s withdrawal letter posted to the docket. |
| Apr 22, 2026 | Removed from Category 2 after seven days’ notice. It now sits in no category. |
| Jul 23, 2026 | The advisory committee reviewed the free base and the acetate. FDA proposed that neither be listed. |
No category means no discretion
FDA’s interim policy lets a 503A pharmacy compound from a nominated substance only while that substance sits in Category 1. MOTS-c sits in no category, so it gets no enforcement discretion. The BPC-157 page explains why leaving Category 2 through a withdrawn nomination is not permission.
What FDA told the committee
FDA’s briefing found no applicable monograph and no approved drug containing MOTS-c. Its safety-risk page cites a possible immunogenicity risk and complexities with peptide-related impurities, and says FDA found no human exposure data for MOTS-c by any route. FDA proposed that neither MOTS-c free base nor MOTS-c acetate be added to the 503A list.
Market reports say the committee voted in favor. FDA had not posted minutes as of September 26, 2026, so we cannot confirm the tally from an FDA source. Each compound also had two separate votes, one for the free base and one for the acetate. A committee vote is advice to FDA. Only notice-and-comment rulemaking adds a substance to 21 CFR 216.23, and none has started.
What this means for you
Keep MOTS-c off your menu. A favorable committee vote, if FDA’s minutes confirm one, would still need a proposed rule, a comment period and a final rule before any pharmacy could compound it, and you would see each step on this page. If you serve competitive athletes, note that WADA names MOTS-c on its prohibited list. For what a metabolic program can lawfully include, see our weight management program.
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Frequently asked questions
Is MOTS-c legal to compound?
No. As of September 26, 2026 MOTS-c is not on the 503A bulks list, is in no FDA category, has no monograph and is not part of an approved drug. It left Category 2 in April 2026 because the nominator withdrew, which did not create a compounding pathway.
Did the FDA committee approve MOTS-c in July 2026?
No. An advisory committee cannot approve or list anything. It reviewed MOTS-c on July 23, 2026, and FDA’s briefing recommended against listing it. FDA had not posted minutes or started rulemaking as of September 2026, so no pharmacy may compound it on the strength of that meeting.
Is MOTS-c banned by WADA?
Yes. The 2026 WADA Prohibited List names MOTS-c under S4.4.1, metabolic modulators, as an activator of AMP-activated protein kinase. It is prohibited at all times, in and out of competition. Clinics that serve athletes subject to the Code carry a doping risk as well as a compounding one.
Primary sources. Last verified September 26, 2026. Corrections are welcome: contact us.
- FDA, 503A bulk drug substance categories (updated May 14, 2026)
- FDA, Certain bulk drug substances that may present significant safety risks (updated Apr 22, 2026)
- FDA, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A (Jan 2025)
- 21 CFR 216.23, the 503A bulks list
- FDA, Pharmacy Compounding Advisory Committee, July 23-24, 2026
- 91 FR 20465 (Apr 16, 2026), Pharmacy Compounding Advisory Committee meeting notice, Docket FDA-2025-N-6895
- FDA briefing document, MOTS-c (July 2026 PCAC)
- FDA, voting questions, July 2026 PCAC
- Regulations.gov, withdrawal of nominations by Wells Pharmacy Network, FDA-2015-N-3534-0484 (posted Apr 14, 2026)
- WADA 2026 Prohibited List
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.