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Davis RE, Ruvolo V, Z-Q W, Ma W, Schober W, James Rolke J, Tidmarsh G, Andreeff M , Ruvolo PP

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If the peptide restrictions are reversed through formal FDA rulemaking, compounding pharmacies would be legally allowed to prepare those peptides, but only as traditional, patient-specific compounded drugs, not as mass-market or FDA-approved therapies. If the peptides are formally added to the 503A bulk list, he says, pharmacies would have to follow the traditional 503A compounding rules

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