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Because 5-amino-1MQ is not a compounding-pharmacy-accessible substance and is not an FDA-approved therapy, the safety discussion is primarily about what physicians should tell patients asking about it, rather than about clinical monitoring parameters for active therapy

Food and Drug Administration (FDA) for medical use in humans

As the OPPS acquires claims data regarding hospital costs associated with new procedures, we regularly examine the claims data and any available new information regarding the clinical aspects of new procedures to confirm that our OPPS payments remain appropriate for procedures as they transition into mainstream medical practice (77 FR 68314)