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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

[DOI] [PubMed] [Google Scholar] 88.Kumar S.T., Mahul-Mellier A.L., Hegde R.N., Riviere G., Moons R., Ibanez de Opakua A., Magalhaes P., Rostami I., Donzelli S., Sobott F., et al