Safe Medicines group petitions FDA to bar compounding of seven peptides
The petition targets BPC-157, KPV, TB-500, MOTS-c, emideltide, semax and epitalon, and documents test purchases shipped from four licensed pharmacies.
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By Daniel Okafor · Regulatory Correspondent
Oct 21 19:07 ETSource: Partnership for Safe Medicines
The wire
- 01The Partnership for Safe Medicines filed a citizen petition on October 16 asking FDA not to permit compounding of seven peptide bulk substances through regulation, Category 1 listing or enforcement discretion.
- 02PSM says it bought five peptide vials in 45 days via telehealth vendors; four pharmacies in Texas and Pennsylvania compounded and shipped them to California, three without findable California licenses.
- 03FDA briefing documents to the Pharmacy Compounding Advisory Committee in July said none of the substances have been adequately tested in humans; the agency has not yet responded to the petition.
From the source
Read at safemedicines.orgPSM files Citizen Petition with FDA to stop unsafe compounding of untested peptides
On Friday October 16th, the Partnership for Safe Medicines filed a citizen petition (CP) with the FDA asking them to refrain from taking action, whether through regulation, addition to “Category 1” of the Interim Bulk Compounding policy, or exercise of enforcement discretion to allow for compounding of drug products using seven peptide bulk drug substances (BPC-157, KPV, TB-500, MOTS-c, emideltide
