The Food and Drug Administration’s Pharmacy Compounding Advisory Committee (PCAC) voted to recommend that the FDA include peptides BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax on the 503A Bulks List, which outlines the bulk drug substances that compounding pharmacies can use in creating medications. The committee also rejected adding emideltide to the list.
PCAC’s votes are recommendations and are not binding on the FDA. Secretary of Health and Human Services Robert F. Kennedy, Jr. will still need to formally approve the substances’ addition to the 503A Bulks List. Pharmacies will not be permitted to compound them until the final rulemaking is in place, even if companies release pharmaceutical-grade active pharmaceutical ingredients. Kennedy has expressed support for compounding peptides.
For details on the meeting, including links to the full video recordings, click here.
