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or (2) for devices for which pass-through status will begin on or after January 1, 2020, as an alternative to the substantial clinical improvement criterion, the device is part of the FDA's Breakthrough Devices Program and has received FDA marketing authorization for the indication covered by the Breakthrough Device designation

Benzyl alcohol maintains sterility for multi-use access within this window

Tirzepatide is an FDA-approved medication for type 2 diabetes and chronic weight management, available exclusively as pre-filled injection pens under the brand names Mounjaro and Zepbound

6 hours, at a cost of $332, across all participating REHs (89 FR 94530)

It boosts myelin production

Dispose of expired or unused tirzepatide according to FDA guidelinesmost pharmacies offer mail-back disposal programs at no cost