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Panel expresses concerns The white paper discusses background on compounding pharmacies, and the limits placed on both 503A compounding pharmacies and 503B outsourcing facilities
Jones H, Sprung VS, Pugh CJ, Daousi C, Irwin A, Aziz N, Adams VL, Thomas EL, Bell JD, Kemp GJ, Cuthbertson DJ
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For a category of medicine that has spent years in regulatory limbo, that is a real milestone the first time a federal advisory panel has formally recommended that these peptides be made available through licensed pharmacies. The votes werent unanimous, and they went against the recommendation of FDAs own staff reviewers, who wanted more data on manufacturing consistency and human trials before signing off
