Safe Medicines group petitions FDA to void peptide compounding vote
The petition argues the July advisory committee was seated in violation of federal conflict-of-interest laws and should be disregarded.
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By Daniel Okafor · Regulatory Correspondent
Oct 21 23:08 ETSource: Partnership for Safe Medicines
The wire
- 01The Partnership for Safe Medicines filed a citizen petition asking FDA to block bulk compounding of BPC-157, KPV, TB-500, MOTS-c, emideltide, semax and epitalon, and to set aside July's PCAC vote.
- 02FDA scientists had recommended against all seven substances, but the committee voted to allow six; PSM says members had financial ties to the peptide industry.
- 03PSM says test purchases arrived from four 503A pharmacies in Texas and Pennsylvania, shipped to California with syringes and no research-use-only labeling; FDA has not responded to the petition.
From the source
Read at safemedicines.orgfiles Citizen Petition urging FDA to block compounding of unapproved and uncharacterized peptides – Partnership for Safe Medicines
Partnership for Safe Medicines Files Citizen Petition Urging FDA to Block Compounding of Unapproved and Uncharacterized Peptides
