The Food and Drug Administration's (FDA) Pharmacy Compounding Advisory Committee (PCAC) voted on Thursday to recommend adding several peptides to the list of substances that compounding pharmacies are permitted to produce. In a split decision, the committee voted 8-6, with one abstention, to include the peptides BPC-157, KPV, and TB-500 on the 503A bulks list. At the time of the report, the committee was still deliberating on a fourth substance, MOTS-c.
The committee's recommendation contradicts the findings of FDA staff scientists. In briefing materials and presentations provided before and during the meeting, agency staffers stated that the peptides lacked sufficient clinical data to demonstrate safety or efficacy for their intended uses. Supporters of the peptides stated that there was insufficient evidence to disprove their benefits, while opponents cited a lack of standardized manufacturing and clinical evidence as primary concerns.
Peptides such as BPC-157, KPV, and TB-500 are often marketed for conditions including ulcerative colitis, wound healing, obesity, and osteoporosis. The 503A bulks list identifies the raw drug substances that compounding pharmacies may use to create customized medications for individual patients when an FDA-approved drug is not available or appropriate.