Is MOTS-c legal? Yes, by prescription. Here is how to get it.
The short answer
Yes, with a prescription. Since October 28, 2026, HHS says it will not take enforcement action against licensed 503A pharmacies and physicians that compound MOTS-c acetate for injection for a patient with a prescription, if ten conditions are met. It is not FDA approval. At Peptides.build a licensed US provider reviews your intake, and a licensed 503A pharmacy compounds single-ingredient MOTS-c and ships it already reconstituted, from $158/mo.
Which kind of MOTS-c is legal?
MOTS-c is a mitochondrial-derived peptide studied mostly in preclinical research. The HHS policy is narrow: it names one form of MOTS-c, one route and one device. Everything else is outside it.
| What you get | Status | Why |
|---|---|---|
| Prescribed, single-ingredient MOTS-c acetate from a licensed 503A pharmacy | Covered by the HHS policy | Injection (SC or IM) |
| MOTS-c blended with other peptides | Outside the policy | The policy covers one active ingredient only |
| Oral or nasal MOTS-c, or a different salt form | Outside the policy | Only the acetate form, by injection, is listed |
| Pre-filled pens and auto-injectors | Outside the policy | The only covered device is an FDA 510(k)-cleared syringe |
| "Research use only" vials sold online | Not for human use | No prescription, no licensed pharmacy, no adverse-event reporting |
Single-ingredient MOTS-c, prescribed and pharmacy-mixed. The version the HHS policy covers.
Why was MOTS-c hard to get before?
| Date | What happened |
|---|---|
| Sept 29, 2023 | FDA places MOTS-c on its Category 2 list. Pharmacies stop compounding it. |
| Apr 22, 2026 | FDA takes it off Category 2. On its own, that did not make it compoundable under 503A. |
| Jul 23 to 24, 2026 | FDA's Pharmacy Compounding Advisory Committee votes for MOTS-c. FDA's drug center (CDER) had recommended against it. |
| Oct 28, 2026 | HHS files the enforcement-discretion policy, FR Doc 2026-22192. |
The policy is interim. It lasts until FDA rulemaking decides MOTS-c's permanent status, and HHS can withdraw it if a safety or quality problem appears. Read the ten conditions in our HHS peptide policy explainer, or see every peptide's status on the legal status page.
How do I get MOTS-c prescribed online?
- Online intake. About five minutes: your health history and goals.
- Provider review. A licensed US provider decides whether MOTS-c is appropriate for you and, if so, writes a patient-specific prescription.
- Pharmacy compounding. A licensed US 503A pharmacy compounds single-ingredient MOTS-c acetate and mixes it for you.
- Delivered ready to draw. Shipped cold-chain to your door, already reconstituted and labeled with the concentration.
No powder, no BAC water, no syringe math: the pharmacy has already mixed it. Plans, who it is for and the full FAQ are on the MOTS-c protocol page.
How much does legal MOTS-c cost?
| Plan | You pay | Per month | |
|---|---|---|---|
| Monthly | $199 | $199 | Start |
| 3 months | $499 | $166 | Start |
| 6 months | $949 | $158 | Start |
Includes the provider review, single-ingredient compounding by a licensed 503A pharmacy and cold-chain shipping. No membership fee. Compare every protocol on the pricing page.
Prescribed by a provider. Made by a pharmacy. Verified.
Ready? The intake takes about five minutes. A licensed US provider decides what is appropriate.
FAQ
Is MOTS-c legal in the US?
Prescribed MOTS-c acetate for injection, compounded by a licensed 503A pharmacy, falls under the HHS enforcement-discretion policy of October 28, 2026, if its ten conditions are met. It is still not FDA-approved, and research-use-only MOTS-c is still not sold for human use.
Is MOTS-c FDA-approved?
No. Compounded medications are not FDA-approved, and the HHS policy says it does not establish safety or effectiveness.
Do I need a prescription for MOTS-c?
Yes. The policy requires a patient-specific prescription from a licensed clinician, filled by a state-licensed 503A pharmacy.
Is MOTS-c safe?
Its safety has not been established by FDA. FDA's drug center recommended against listing it, citing limited human data, and much of the research on MOTS-c is preclinical. A licensed provider reviews your health history before deciding whether it is appropriate.
How much does prescribed MOTS-c cost?
At Peptides.build, $199 month to month, $499 for 3 months or $949 for 6 months ($158/mo), including the provider review, compounding and cold-chain shipping.
Are MOTS-c capsules or nasal sprays covered?
No. The policy lists MOTS-c acetate by injection only (subcutaneous or intramuscular). Other routes and other salt forms are outside it.
How long can you be on MOTS-c?
That is decided by the prescribing provider and written on your prescription. This site does not publish dosing, frequency or course lengths.
How long does the policy last?
Until FDA issues a final rule for MOTS-c or HHS withdraws the policy. There is no fixed end date.
Can state law still restrict MOTS-c?
Yes. State pharmacy and medical boards can set their own rules. The federal policy does not override them.
Tired of reconstituting?
A licensed US provider reviews a short online intake. If a prescription is appropriate, a licensed US 503A pharmacy fills it and ships it cold-chain, already reconstituted and labeled with the concentration.
This page is educational and is not medical advice. Compounded medications are not FDA-approved. No results are implied or guaranteed. A licensed provider decides whether any protocol is appropriate for you, and sets any dose.