Houston clinic warns FDA peptide panel vote is not approval
The July advisory recommendation on six peptides still requires FDA review, a proposed rule, public comment and a final rule before compounding is permitted.
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By Daniel Okafor · Regulatory Correspondent
Sep 18 15:55 ETSource: apg-wi.com
The wire
- 01The FDA's Pharmacy Compounding Advisory Committee voted July 23-24 to recommend BPC-157, KPV, TB-500, MOTS-c, Semax and epitalon for the 503A Bulks List, rejecting only emideltide.
- 02Physicians at Houston Regenerative Medicine say patients who stopped protocols after gray-market closures may read the vote as clearance and turn to overseas research-use-only sellers with no sterility or content testing.
- 03The rulemaking process has not begun, and the panel voted against FDA staff scientists who advised excluding all seven substances; the clinic issuing the warning sells peptide protocols.
From the source
Read at apg-wi.comFDA Panel Backs Six Peptides; Houston Clinic Urges Caution
Houston Regenerative Medicine, a physician-supervised peptide therapy and regenerative medicine clinic in North Houston's Greenspoint District, is asking patients not to treat a July federal advisory vote on six peptides as clearance to resume treatment.