Comment from Pinciaro Carol
AnonymousOpposeIndividual
Summary: The commenter opposes the inclusion of bulk drug substances on the Section 503A list, arguing that it facilitates an unregulated market without physician oversight. They express concern that this action prioritizes revenue over patient safety, particularly regarding popular weight reduction drugs.
Patients need to be kept safe and regulated, physician-supervised access continues to be the safest means to do so. This is about money going the unregulated gray market with no oversight, no quality control, and no doctor in the room. It is not in the best interest of the patients who may have co-morbid conditions and use of weight reduction drugs, for instance, very popular right now, becomes the new focus of revenue without consideration of safety.