MOTS-c Regulatory Status: What the July 2026 FDA Advisory Committee Vote Means
By Evergreen Editorial · 7/25/2026
Medically reviewed by Dr. Casey Greene, PharmD, FMCP, Senior Director of Clinical Informatics
MOTS-c Regulatory Status: What the July 2026 FDA Advisory Committee Vote Means
Is MOTS-c legal to compound right now?
Not yet. Compounding MOTS-c is not currently legal or authorized, and here's exactly where things stand. On July 23, 2026, the FDA's Pharmacy Compounding Advisory Committee (PCAC) voted to recommend MOTS-c for the list of bulk drug substances licensed pharmacies can legally compound. The vote is a recommendation only. The FDA reviewed MOTS-c specifically for obesity and osteoporosis-related indications. Formal FDA rulemaking must happen before compounding becomes legal. Evergreen Telehealth will update this page as that regulatory process moves forward.
CURRENT REGULATORY STATUS — Last updated: July 24, 2026 PCAC voted 7-5, with two abstentions, to recommend MOTS-c for inclusion on the FDA's Section 503A Bulks List. This is a recommendation to the FDA, not a legal change. Compounding MOTS-c is not currently authorized under Section 503A. FDA rulemaking to formally add MOTS-c to the list has not started. Section 503A of the FD&C Act, together with FDA's general rulemaking authority under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), is the legal authority FDA would use. FDA would first publish a Notice of Proposed Rulemaking under 21 CFR 216.23, followed by a public comment period of typically 60 to 90 days, then review and respond to comments before issuing a final rule, which typically takes effect 30 days after publication. Those phases each have an established time frame. The one variable that cannot be predicted is how long FDA itself takes internally to draft the proposed rule and respond to comments.
What is MOTS-c?
MOTS-c is a mitochondrial-derived peptide studied for its role in metabolic regulation. The FDA's Pharmacy Compounding Advisory Committee reviewed MOTS-c specifically for obesity and osteoporosis-related indications. Inclusion on the Bulks List, if it happens, does not evaluate specific use. The FDA may still limit the compoundable form or route.
Most available data on MOTS-c comes from preclinical and animal studies. Human clinical trial data remains limited. Public reporting on this vote also noted that MOTS-c carries a World Anti-Doping Agency prohibited status, which several committee members raised as a concern. This page describes the peptide's regulatory status. It does not make claims about safety or effectiveness beyond what the FDA committee reviewed.
| Question | Answer |
|---|---|
| Did PCAC vote to recommend MOTS-c? | Yes, on July 23, 2026, by a vote of 7-5 with two abstentions. |
| Does this vote mean MOTS-c is safe and effective? | The vote reflects the committee's assessment of MOTS-c against the compounding statute's four-factor test (21 CFR 216.23(c)): historical use, characterization, safety, and effectiveness for compounding purposes. That is a different and lower evidentiary bar than full FDA drug approval, which MOTS-c has not received for any use. |
| Is MOTS-c legal to compound today? | No. |
| Has the FDA approved MOTS-c as a drug? | No. This vote does not constitute FDA approval of MOTS-c for any use. |
| Does this vote bind the FDA? | No. PCAC is advisory. The FDA is not required to follow its recommendation. |
What happens next?
The FDA reviews the PCAC recommendation and decides whether to proceed with rulemaking. If it proceeds, Section 503A of the FD&C Act and FDA's general rulemaking authority under section 701(a) (21 U.S.C. 371(a)) is the legal basis for adding MOTS-c to the Bulks List. Some phases of that process have known, established time frames. The variable that cannot be predicted is how long FDA itself takes internally to draft the proposed rule and respond to public comments.
| Stage | Known time frame |
|---|---|
| PCAC advisory vote | Complete. Voted 7-5, two abstentions, to recommend inclusion. |
| FDA decision on whether to pursue rulemaking, and drafting of the Notice of Proposed Rulemaking (21 CFR 216.23) | Not predictable; depends on FDA's internal process. |
| Public comment period | Typically 60 to 90 days once the proposed rule publishes. |
| FDA review and response to comments, and drafting of the final rule | Not predictable; depends on FDA's internal process. |
| Final rule effective date | Typically 30 days after the final rule publishes. |
| Legal compounding under Section 503A | Not currently authorized. |
How do I access MOTS-c through a licensed pharmacy?
You cannot legally access compounded MOTS-c through any licensed 503A pharmacy today, because it is not currently authorized for compounding. Evergreen Telehealth does not compound, dispense, or facilitate access to MOTS-c while it remains outside the 503A Bulks List.
If the FDA completes rulemaking and adds MOTS-c to the 503A Bulks List, Evergreen's existing licensed compounding pathway would apply the same clinical evaluation, prescribing, and pharmacy oversight standards it uses for every substance it compounds.
| Access path | Legal status today | Practitioner and quality oversight |
|---|---|---|
| Licensed 503A compounding pharmacy (Evergreen's pathway, once available) | Not available until FDA rulemaking is complete | Physician evaluation, licensed pharmacist compounding, fulfillment through top 1% national PCAB/ASHP-accredited partner pharmacies |
| Unregulated online "research chemical" sellers | Outside the legal compounding framework regardless of the PCAC vote | No standardized purity testing, no prescription requirement, no pharmacist oversight |
PCAB/ASHP-accredited facility standards reflect Evergreen's own partner-pharmacy requirement. They are not a mandatory condition of any FDA final rule, if and when one is issued.
Common questions about MOTS-c right now
Can I still buy MOTS-c online today? You can find it sold online as a "research chemical," but that market sits outside the licensed pharmacy system. It carries no standardized purity testing, no prescription requirement, and no pharmacist oversight. The July 23 vote does not change that. We would rather you have the full picture than a partial one.
Does the FDA committee's vote mean MOTS-c has been proven to work? No. The vote is a recommendation about whether MOTS-c belongs on a list pharmacies are allowed to compound from. The vote does reflect the committee's assessment of MOTS-c against the compounding statute's four-factor test, which weighs historical use, characterization, safety, and effectiveness for compounding purposes. That is a different and lower evidentiary bar than full FDA drug approval, which MOTS-c has not received for any use. The FDA's own scientific staff had recommended against inclusion, and this particular vote was closer than the votes on BPC-157, KPV, and TB-500.
Will my doctor be able to prescribe compounded MOTS-c soon? Not yet. The FDA still has to decide whether to move forward with formal rulemaking, then run a public comment period, then issue a final rule. That process has not started. The comment period and final-rule effective date have known time frames, typically 60 to 90 days and 30 days respectively, but how long FDA itself takes to draft the rule and respond to comments is not predictable.
What's actually different now that the committee voted yes? Nothing changes today for what pharmacies can legally compound. What changed is that the FDA now has an advisory recommendation on record. The FDA still has to act on it.
How will I know when this actually changes? We will keep this page updated as the FDA's process moves forward, so you do not have to track it yourself. Check the status box at the top of this page any time for the most current information.
Medically reviewed by Dr. Casey Greene, PharmD, FMCP, Director of Consultative Services, Evergreen Telehealth, on July 24, 2026.
Regulatory disclosures
This page describes a regulatory process in progress. It is not medical advice. It does not claim that MOTS-c is safe or effective for any use beyond what the FDA committee reviewed. It does not claim or imply FDA approval of MOTS-c. This page will be updated as the FDA's rulemaking process moves forward.