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(2) In the event a manufacturer requests a hearing, pursuant to 42 CFR part 423, subpart T, the manufacturer must pay the amount in full within 60 calendar days after the date of a final decision by the Departmental Appeal Board, to uphold, in whole or in part, the civil money penalty

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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