MOTS-c Compounding Pharmacy FDA and State Board Enforcement History

What does the federal record show for MOTS-c?

MOTS-c is not an FDA-approved drug and is not a component of one; FDA's July 2026 review found no USP or National Formulary monograph, no European or Japanese pharmacopeia listing and no European Medicines Agency authorization [1].

MOTS-c was previously listed in FDA's category 2 safety-risk table. Its nominators later withdrew it, so it now appears in the 'nominated but withdrawn' table on FDA's page about bulk substances that may present significant safety risks (content dated 04/22/2026); removal from category 2 was not a finding that it is safe [2]. FDA's stated concerns were that it had not identified any human exposure data on products containing MOTS-c given by any route, that important safety information is missing, and that injectable peptides may pose immunogenicity risk from aggregation and peptide-related impurities [2].

MOTS-c appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians (updated May 14, 2026) or on FDA's list for outsourcing facilities (updated March 21, 2025), so the category 1 policy does not cover it [3][4][5]. No outsourcing facility reported compounding it from January 2017 to December 2025 [1].

Why did FDA staff recommend against adding it?

FDA staff proposed that neither the free base nor the acetate be added to the bulks list, citing inconsistent naming, missing impurity, aggregate and endotoxin data, unknown use in compounding, no human safety or effectiveness data, no animal toxicity studies, and approved treatments for obesity and osteoporosis, two of the nominated uses [1]. FDA's searches found no clinical study in which MOTS-c was given to a human, the 12 papers the nominator cited were not clinical studies, and adverse-event database searches through March 9, 2025 retrieved no MOTS-c reports [1].

What did the July 2026 advisory committee vote change?

FDA's Pharmacy Compounding Advisory Committee reviewed MOTS-c on July 23, 2026 and voted in favor of adding it to the bulks list, against staff's recommendation [6][7]. The advice is not binding, MOTS-c is not on the list, and adding it takes formal rulemaking [5][7].

What does the HHS draft policy do?

HHS filed a draft enforcement-discretion policy on October 28, 2026 (Federal Register document 2026-22192, publication scheduled October 30, 2026, comments due two weeks after publication) [7][8]. It names MOTS-c among six peptides, covers MOTS-c acetate by subcutaneous or intramuscular injection, and says HHS 'does not intend to take enforcement action' against a state-licensed pharmacy, federal facility or licensed physician compounding with it when conditions such as a patient-specific prescription and material from an FDA-registered manufacturer with a certificate of analysis are met [7][8]. The notice says the policy 'does not establish any rights for any person and is not binding on HHS or the public', may be revisited if a safety signal arises, and is neither an approval nor a listing [7].

Where do state pharmacy boards fit?

State boards of pharmacy generally have primary responsibility for day-to-day oversight of state-licensed pharmacies that are not registered with FDA as outsourcing facilities. FDA conducts surveillance and for-cause inspections of those pharmacies, and it primarily oversees outsourcing facilities on a risk-based schedule [9]. Compounded drugs are not FDA-approved, which means FDA does not verify their safety, effectiveness or quality before they are marketed [9].