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"I don't believe for one moment that what's going on here is an honest investigation of whether these products should be compounded." Scott Brunner of the Alliance for Pharmacy Compounding said the coming meeting will be the start of a "protracted process." Even if the panel votes to make the peptides available, and FDA agrees, the agency will still have to draft and publish rules on the change, he noted

Now, he says, the interest in peptides puts compounding pharmacies in an area where they start to act like mass drug producers. He says compounding pharmacies have been inspected and regulated by states more than the FDA, and in some cases there have been outcomes where theres been bacterial contamination and issues with quality control and dosing that would typically be caught in a larger manufacturing process but are missed. Our system works really well There isnt enough efficacy and safety data to approve these peptide injectables as traditional drugs, but Zuckerman says that the FDA is facing the reality that a lot of Americans are interested in drugs that they feel probably work and are probably safe

The publication underscores the need for transparent, independent human clinical trials before any medical conclusions can be drawn