HHS allows temporary compounding of six unapproved peptides

On October 28, 2026, the Department of Health and Human Services announced an enforcement discretion policy temporarily permitting compounding pharmacies to manufacture and sell six unapproved peptides, including BPC-157 and TB-500. Strongly backed by Health Secretary Robert F. Kennedy Jr. under the Make America Healthy Again agenda, the decision bypasses FDA staff concerns over unproven safety, requiring pharmacies to report adverse events while permanent rules remain under review.

Overview of the HHS peptide policy

• ▪The Department of Health and Human Services limited enforcement discretion to temporarily allow compounding pharmacies, federal facilities, and licensed physicians to manufacture and sell six unapproved peptides: BPC-157, TB-500, Epitalon, KPV, MOTS-c, and Semax
• ▪The Department of Health and Human Services stated its enforcement discretion policy aims to discourage the widespread use of research-use-only peptides supplied by foreign manufacturers that present safety risks to U.S. patients

Advisory Committee backing and political support

• ▪Health Secretary Robert F. Kennedy Jr. has enthusiastically endorsed peptide products, while Food and Drug Administration staff scientists have urged greater caution because the unapproved compounds have not undergone strict drug testing
• ▪Health Secretary Robert F. Kennedy Jr. added new members to the Food and Drug Administration's Pharmacy Compounding Advisory Committee in 2025, including several who own wellness clinics or pharmacies and share his favorable view on peptides
• ▪In July 2026, a majority of external advisers on the Food and Drug Administration's Pharmacy Compounding Advisory Committee voted in favor of expanding availability for six peptides, despite agency staff findings of insufficient safety and efficacy evidence