FDA Career Scientists Oppose Interim Peptide Dispensing Plan
FDA career scientists formally oppose the administration's interim plan to allow temporary compounding of certain unapproved peptides, splitting the agency internally.
Category Regulation
FDA Conducting Own Study on NAION Vision-Loss Risks With GLP-1 Drugs
The FDA confirmed to NPR it is running its own study to assess NAION risks linked to GLP-1 drugs including Ozempic. No warning-label changes have been requested yet.
Trump Administration Weighs Temporary Pathway for Some Unapproved Peptides
The Trump administration is reportedly preparing a stopgap that could let compounding pharmacies temporarily sell certain unapproved peptides while new federal rules are drafted.
Trump Administration Weighs Compounding Access for Seven Peptides
Reported plan would let compounding pharmacies prepare seven peptide treatments for insomnia, obesity, and wound healing under interim enforcement discretion.
Trump Administration Weighs Temporary Path for Unapproved Peptides
The administration is reportedly drafting plans to let compounding pharmacies temporarily produce seven restricted peptide treatments under FDA enforcement discretion. Nothing is finalized.
Brazil’s ANVISA Orders Seizure of Unregistered Peptide Pens Sold Online
Brazil's health regulator has ordered the immediate seizure of unregistered tirzepatide and retatrutide pens and other injectable peptides sold through online storefronts.
FDA Calls Empower’s Vitamin-Added GLP-1s ‘Pretextual’ Copies of Approved Drugs
FDA's warning letter to Empower Pharmacy marks the first known use of 'pretextual' to describe vitamin-added compounded GLP-1s, a novel enforcement theory.
FDA Expands Peptide Enforcement Beyond GLP-1s
FDA warning letters to Empower Pharmacy and five online peptide vendors signal enforcement is widening beyond GLP-1 copycats to the broader peptide market.
Alabama Medical Board Prohibits Physicians From Using Non-FDA-Approved Peptides
Alabama's medical board has issued an explicit prohibition on physicians compounding, administering, or dispensing non-FDA-approved or research-grade peptides to patients.
20 State AGs Warn on Chinese GLP-1 Suppliers, Fentanyl Links
A 20-state coalition led by Tennessee AG Skrmetti warned Secretary of State Rubio that Chinese GLP-1 suppliers may be tied to fentanyl precursor manufacturers.
