FDA compounding advisers back six of seven peptides despite safety concerns
The panel flagged oversight and production risks even as it supported most of the peptide nominations under review.
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By Daniel Okafor · Regulatory Correspondent
Oct 20 13:00 ETSource: Pharmacy Practice News
The wire
- 01An FDA compounding advisory panel supported six of seven peptides reviewed, while raising concerns about oversight and manufacturing quality, Pharmacy Practice News reports.
- 02Committee positions shape which peptides compounders can legally prepare, making this a direct signal for 503A and 503B pharmacies and the prescribers who rely on them.
- 03Advisory committee views are non-binding; the agency's final determinations and the specific peptides and conditions attached have yet to be confirmed.
From the source
Read at pharmacypracticenews.comFDA Compounding Panel Backs 6 of 7 Peptides Despite Safety Risks in Oversight and Production
