MOTS-c: FDA and compounding status

Quick answer

MOTS-c is not an FDA-approved drug and is not on FDA's 503A Bulks List. Section 503A records it as "Nominated, then withdrawn" (April 22, 2026) and section 503B as "Not nominated" (March 21, 2025). PCAC voted in favor on July 23, 2026 — advisory only, with rulemaking still required; verified September 16, 2026.

By Peptides.NYC Editorial TeamPublished September 16, 2026

Verified against FDA's bulk substances page on September 16, 2026. Every field below links the document it came from.

Current status

MOTS-c

FDA approval

Not FDA approved

MOTS-c is not an FDA-approved drug. FDA has evaluated it only as a bulk drug substance nominated for use in compounding, and it is not among the six substances on the 503A Bulks List at 21 CFR 216.23(a).

Sources

FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: MOTS-c-related bulk drug substances (U.S. Food and Drug Administration, retrieved 2026-09-16)
FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus "bulk drug substances nominated but withdrawn"), content current as of April 22, 2026 (U.S. Food and Drug Administration, retrieved 2026-09-16)
21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides) (Office of the Federal Register, retrieved 2026-09-16)
FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (U.S. Food and Drug Administration, retrieved 2026-09-16)

Section 503A

Nominated, then withdrawn

As stated on the cited document, dated April 22, 2026.

The nomination was withdrawn by the nominator, so FDA is no longer evaluating it. The substance came off the category it was in; it did not move onto the Bulks List.

Sources

FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus "bulk drug substances nominated but withdrawn"), content current as of April 22, 2026 (U.S. Food and Drug Administration, retrieved 2026-09-16)

Section 503B

Not nominated

As stated on the cited document, dated March 21, 2025.

The substance appears in none of the categories on that nomination document, as of the document's own date.

Appears in none of the three categories on FDA's section 503B nomination document as of that document's own date.

Sources

FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025 (U.S. Food and Drug Administration, retrieved 2026-09-16)

Verified against FDA's bulk substances page on September 16, 2026.

Timeline

Every dated event on file for MOTS-c, newest first, with the document it came from.

July 23, 2026Advisory committee
On July 23, 2026, PCAC considered MOTS-c. PCAC voted in favor of including MOTS-c on the 503A Bulks List. The recommendation is advisory: FDA must still complete notice-and-comment rulemaking, and MOTS-c is not among the six substances on the list at 21 CFR 216.23(a). FDA has published no minutes or transcript, so no vote tally is recorded here.
Sources
- FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (U.S. Food and Drug Administration, retrieved 2026-09-16)
- FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: MOTS-c-related bulk drug substances (U.S. Food and Drug Administration, retrieved 2026-09-16)
- 21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides) (Office of the Federal Register, retrieved 2026-09-16)
- Reported by NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026 (National Community Pharmacists Association, retrieved 2026-09-16)
July 23, 2026Status change
PCAC discussed MOTS-c and voted in favor of adding it to the 503A Bulks List; the recommendation is advisory and MOTS-c has not been added to that list.
Sources
- FDA, July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (U.S. Food and Drug Administration, retrieved 2026-09-16)
- 21 CFR 216.23(a), Bulk drug substances that can be used to compound drug products in accordance with section 503A of the FD&C Act (six substances, no peptides) (Office of the Federal Register, retrieved 2026-09-16)
- Reported by NCPA, FDA advisory committee nominates six peptides for pharmacies to compound, July 31, 2026 (National Community Pharmacists Association, retrieved 2026-09-16)
April 22, 2026Status change
FDA's bulk drug substances page, content current as of this date, listed MOTS-c among the substances nominated but withdrawn rather than in category 2.
Sources
- FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus "bulk drug substances nominated but withdrawn"), content current as of April 22, 2026 (U.S. Food and Drug Administration, retrieved 2026-09-16)
April 16, 2026Status change
FDA published a Federal Register notice setting the July 23-24, 2026 PCAC meeting on substances nominated for the 503A Bulks List, MOTS-c among them, and opened a public docket for comment.
Sources
- Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 91 FR (Doc. 2026-07361), April 16, 2026 (Office of the Federal Register, retrieved 2026-09-16)
April 15, 2026Status change
FDA gave notice that after seven days it would remove 12 peptide bulk drug substances from category 2 of its section 503A list, because the nominators had withdrawn the nominations. The page as revised April 22, 2026 lists which substances now sit in the withdrawn group.
Sources
- Reported by Orrick, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List, April 2026 (Orrick, Herrington & Sutcliffe LLP, retrieved 2026-09-16)
- FDA, Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A and 503B category 2, plus "bulk drug substances nominated but withdrawn"), content current as of April 22, 2026 (U.S. Food and Drug Administration, retrieved 2026-09-16)

Related guides

MOTS-c: Mitochondrial-Derived Peptide Protocol

Frequently asked questions

Is MOTS-c legal to compound?

On FDA's section 503A list, MOTS-c is recorded as "Nominated, then withdrawn" as of April 22, 2026. On FDA's section 503B list, MOTS-c is recorded as "Not nominated" as of March 21, 2025. MOTS-c is not on FDA's 503A Bulks List: that list is established by notice-and-comment rulemaking, and none of the categories above is inclusion on it. Compounding is governed by federal and state law together, and a pharmacy or outsourcing facility answers to both. This page reports what FDA has published; it is not legal or medical advice.

Was MOTS-c reviewed by PCAC?

On July 23, 2026, PCAC considered MOTS-c. PCAC voted in favor of including MOTS-c on the 503A Bulks List. The recommendation is advisory: FDA must still complete notice-and-comment rulemaking, and MOTS-c is not among the six substances on the list at 21 CFR 216.23(a). FDA has published no minutes or transcript, so no vote tally is recorded here.

Is MOTS-c FDA-approved?

Disclaimer: This page is a record of what regulators have published about MOTS-c. It is for educational purposes only, it is not medical or legal advice, and it is not a recommendation to use or compound any substance. Regulatory status changes; check the linked primary sources and consult your healthcare provider.