FDA Panel Recommends Six Peptides for 503A Compounding List
FDA's Pharmacy Compounding Advisory Committee voted to recommend BPC-157, TB-500, KPV, MOTS-c, Semax, and Epitalon for the 503A Bulks List, overriding agency staff on all six.
Category Regulation
FDA Warns Empower Pharmacy Over GLP-1 Compounding Violations
FDA issued a warning letter to Empower Pharmacy for compounding tirzepatide and semaglutide under insanitary conditions, calling the products essentially copies of approved drugs.
Forbes Opinion: End Mass-Market GLP-1 Compounding As Shortage Ends
A Forbes opinion piece argues FDA should restrict mass-market compounded GLP-1 drugs as the shortage ends, citing a Fifth Circuit ruling on FDA authority.
FDA Warns Five Peptide Vendors: RUO Labels No Legal Shield
FDA issued five Warning Letters to online peptide vendors for unapproved drug sales. ArentFox Schiff analysis confirms RUO labeling offers no legal protection.
FDA Warns 30 Telehealth Firms Over Misleading Compounded GLP-1 Marketing
The FDA issued warning letters to 30 telehealth companies for false or misleading claims about compounded GLP-1 weight-loss drugs, signaling intensified enforcement.
CDC and FDA Warn Dozens Poisoned by Contaminated IV Glutathione
CDC and FDA warn contaminated IV glutathione from three Texas compounding pharmacies sickened dozens, with three hospitalized and one in intensive care.
WIRED Tests Find NYC Bodega Peptides Contained No Active Ingredient
Independent lab testing commissioned by WIRED found peptide vials sold at NYC bodegas labeled as BPC-157 contained no detectable active ingredient.
Six Peptides Await FDA Rulemaking After PCAC Vote
PCAC recommended six peptides for the FDA's 503A Bulks List, but formal rulemaking must be completed before compounding pharmacies can legally prepare them.
Counterfeit Retatrutide Caused Torn Esophagus, TGA Testing Reveals
TGA testing found a counterfeit retatrutide product contained undeclared semaglutide at 8x normal dose, causing a patient's torn esophagus.
Thai FDA Seizes 52M Baht in Unregistered Peptide Injections
Thai authorities seized unregistered peptide injection products worth over 52 million baht from a Nonthaburi house, the second major peptide crackdown in 2026.
