Six people told AP that FDA staff had little input and pushed back. HHS first sought a formal rule, then switched to non-enforcement when FDA would not back it.
Recap by typeshit. Full story at WHEC.com.
Experts debate how regulators should separate real patient customization from mass-produced copies, citing recent tirzepatide sterility recalls and impurity findings.
A legal walkthrough of the 503A rules behind the October 28 policy, the July advisory vote, and the HHS note that it may revisit the policy if safety signals appear.
The recall came after an FDA warning letter. The Regulatory Review uses it to dig into how compounded GLP-1s stayed on sale after shortages officially ended.
The peptide item sits among gene therapy, Neuralink and Medicare news. The Alliance for Safe Biologic Medicines has asked HHS to pause the policy, citing FDA scientists.
8:45
Mueller weighs in on when retatrutide might become available and what recent policy changes mean for peptide legality.
Healio
Speaking at OMED, Frye names melanotan as the riskiest, citing ED cases of priapism and rhabdomyolysis, and describes the BPC-157 and TB-500 Wolverine Stack.
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