Six people told the AP that HHS drove the policy with limited FDA input, and that it dropped a formal rule after staff raised safety concerns.
Recap by typeshit. Full story at The Guardian.
Per @pamelajeannoble, the letter flags contamination risks, manufacturing conditions and compounded copies resembling approved drugs.
Gounder notes the policy requires no testing of finished vials or deadline for side effect reports, and public comments on the draft run through November 13.
Healio
Durrani tells Healio the move bypassed rulemaking and FDA scientists, and warns patients may wrongly read it as FDA approval while long-term data is missing.
AP sources say FDA scientists opposed the HHS draft telling the agency not to act against pharmacies compounding six wellness peptides. Comments are open for two weeks.
Research director Brianna Cartwright presented the oral semaglutide findings at AMCP Nexus in San Diego, using patient data through September 2026.
8:45
Mueller weighs in on when retatrutide might become available and what recent policy changes mean for peptide legality.
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