An FDA panel on Friday continued to recommend loosening compounding restrictions for all but one of the peptides it reviewed, despite safety concerns from agency scientists for all of them.
During the second day of deliberations, the FDA's Pharmacy Compounding Advisory Committee (PCAC) voted to add two out of three peptides in question to the 503A bulk drugs list: epitalon and semax received favorable votes of 7-5 and 8-5 (with one abstention each), respectively, for both free base and acetate versions. Epitalon has been proposed for insomnia, and semax has been proposed for cerebral ischemia, migraine, and trigeminal neuralgia.
Only emideltide received a majority of no votes at 7-6 (with one abstention) for both its free base and acetate versions. Emideltide has been proposed for opioid withdrawal, chronic insomnia, and narcolepsy.
On the first day of the PCAC meeting, a majority on the committee voted in favor of putting the free base and acetate forms of BPC-157, KPV, TB-500, and MOTS-c on the 503A list of substances that can be used in compounding.
Altogether, six of seven peptides were bolstered by the newly appointed PCAC, which includes publicly known peptide promoters and producers among its ranks.
