FDA advisory panel votes 8-6-1 to back BPC-157 for 503A bulks list
The narrow split leaves compounders waiting on the agency's final decision for a peptide it previously placed in Category 2.
DO
By Daniel Okafor · Regulatory Correspondent
Sep 8 14:45 ETSource: StreetInsider
The wire
- 01An FDA advisory committee voted 8-6-1 in favor of adding BPC-157 to the 503A bulk drug substances list, according to a Promise analysis reported by StreetInsider.
- 02BPC-157 is among the most-tracked recovery peptides in compounding; bulks-list inclusion would give 503A pharmacies a lawful basis to compound it.
- 03Advisory votes are non-binding and the margin was close; FDA has not issued a final determination, and details beyond the vote tally are limited.
From the source
Read at streetinsider.comFDA Advisory Panel Backs BPC-157 for 503A Bulks List in 8-6-1 Vote, Promise Analysis Finds