U.S. health officials are moving to let specialty pharmacies compound some peptide injections, a move backed by Robert F. Kennedy Jr. and welcomed by allies who sell them.
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01Summary
- 01Kennedy's Department of Health and Human Services sent a peptides “interim access policy” to the White House and the Office of Management and Budget on Thursday.
- 02The plan could allow pharmacies to temporarily compound popular peptides including BPC-157, which is promoted for muscle-building and injury recovery.
- 03The FDA has previously listed BPC-157 and more than a dozen other injectable peptides as too risky to compound because of possible contamination, allergic reactions and tumour growth.
- 04In July, external FDA advisers recommended dropping restrictions on six of seven peptides, despite staff scientists saying the products had not been studied enough for safety and effectiveness.
- 05Telehealth firms including Hims & Hers and Noom have said they may offer peptides if access is eased, and analysts estimate the market could reach $2 billion to $3 billion.
02Why it matters
The proposal could widen access to a fast-growing but unproven product category and create new revenue opportunities for pharmacies, telehealth firms and peptide sellers. It also signals a potential shift in how the FDA enforces rules on compounded drugs.
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