The Department of Health and Human Services submitted an interim access policy on October 15, 2026, to allow specialty pharmacies to compound unapproved peptide drugs like BPC-157. Supported by Health Secretary Robert F. Kennedy Jr., the measure aims to curb gray-market sales from China. While external advisers endorsed easing restrictions on six peptides in July 2026, FDA staff scientists caution against safety risks including contamination and tumor growth.
Interim policy for peptide compounding
- ▪The Department of Health and Human Services submitted an interim access policy for peptide compounding to the White House Office of Management and Budget on October 15, 2026
- ▪HHS's proposed interim access policy uses enforcement discretion to assure specialty compounding pharmacies that they will not face regulatory action for producing certain popular peptides, including BPC-157
- ▪Formally adding peptides to the FDA list of drugs safe for compounding requires federal rulemaking, a process involving public comments that can take years
RFK Jr. leads push for peptide access
- ▪Health and Human Services Secretary Robert F. Kennedy Jr. directed the Food and Drug Administration earlier in 2026 to reconsider restrictions on peptides such as BPC-157 that are widely promoted by wellness influencers
- ▪Health Secretary Robert F. Kennedy Jr. stated that US compounding pharmacies should be permitted to make peptides to prevent consumers from purchasing gray-market products manufactured in China
- ▪Prior to taking office, Health Secretary Robert F. Kennedy Jr. declared that the Food and Drug Administration's opposition to peptides and wellness products would end
HHS advisory panel recommends easing restrictions
- ▪In July 2026, an external advisory panel selected by the Department of Health and Human Services recommended that the FDA remove compounding restrictions on six out of seven reviewed peptides, including BPC-157
- ▪The external FDA advisory panel assembled by HHS in July 2026 included doctors, pharmacists, and consultants working in the peptide industry
FDA and scientists raise peptide safety concerns
- ▪Food and Drug Administration staff scientists concluded that available data, mostly from animal studies, is insufficient to establish the safety and effectiveness of unapproved peptides such as BPC-157
- ▪The Food and Drug Administration previously categorized BPC-157 and more than a dozen other injectable peptides as too risky to compound due to concerns over contamination, allergic reactions, and tumor growth
Demand for unapproved peptides
- ▪Use of the peptide BPC-157, also known as Wolverine, is soaring despite lacking Food and Drug Administration approval
- ▪Unapproved peptides such as BPC-157, targeted for muscle building, anti-aging, and injury recovery, remain widely available online through social media platforms like TikTok
Story comments
Loading comments…