FDA has not opened rulemaking two months after peptide compounding vote
The Pharmacy Compounding Advisory Committee backed returning six of seven peptides to compounding in late July, against FDA staff objections.
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By Maren Holt · Senior Reporter, GLP-1
Oct 6 07:06 ETSource: Independent Institute
The wire
- 01An FDA advisory panel voted in late July to let compounding pharmacies make six of seven peptides removed from compounding in 2023; emideltide was voted down.
- 02The vote was close and non-binding, and compounders and telehealth platforms cannot act until FDA changes the list through rulemaking.
- 03More than two months on, the agency has not opened that rulemaking; panel members also raised contamination, sourcing and thin-evidence concerns.
From the source
Read at independent.orgCopycat Pharmacies and the Peptide Market: News Article
The emerging compounding ecosystem can drive faster development and wider availability when allowed.
