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It is also worth knowing that FDA has not authorized AOD 9604 for compounding under section 503A: it is not on the bulks list at 21 CFR 216.23(a) and no longer sits in any category of the agency’s interim compounding policy, which makes it unauthorized rather than prohibited, and unauthorized is not a green light
Performance
Size:[1] 20ml Home Kit (20 uses)
High-cost drugs — particularly biologics, chemotherapy agents, and specialty infusions — frequently require prior authorization before the payer will approve reimbursement
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