HHS peptide compounding policy splits pharmacists and pharmacologists
Pharmacists say the HHS policy offers a safer route than the gray market for six unapproved peptides. Pharmacologists say none has passed FDA testing, and it is unclear how long the policy lasts or whether outsourcing facilities are covered.
WASHINGTON
6Unapproved peptides HHS will let 503A pharmacies compound under enforcement discretion
- What's newAn HHS policy dated October 28 says the agency will not act against licensed pharmacies that compound six unapproved peptides, including BPC 157 and Semax, on patient prescriptions. A compounding trade group backed it and pharmacologists warned against it.
- Why it mattersNone of the six is FDA approved and the policy cites no new research. Pharmacists argue it moves users away from gray market vials, while critics say it exposes patients to products with no proven benefit.
- What's nextThe reported text gives no end date, and it is unclear whether outsourcing facilities are covered. No final FDA decision on adding the peptides to the 503A Bulks List was found in the sources reviewed.
