Applicable drug
Applicable drug means a Part D drug that is (1) (i) Approved under a new drug application under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FDCA); or (ii) In the case of a biological product, licensed under section 351 of the Public Health Service Act (other than, with respect to a plan year before 2019, a product licensed under subsection (k) of such section 351). (2) (i) If the PDP sponsor of the prescription drug plan or the MA organization offering the MA-PD plan uses a formulary, which is on the formulary of the prescription drug plan or MA-PD plan that the applicable beneficiary is enrolled in; (ii) If the PDP sponsor of the prescription drug plan or the MA organization offering the MA-PD plan does not use a formulary, for which benefits are available under the prescription drug plan or MA-PD plan that the applicable beneficiary is enrolled in; (iii) Is provided to a particular applicable beneficiary through an exception or appeal for that particular applicable beneficiary; or (iv) For the purposes of the Manufacturer Discount Program, is provided to a particular applicable beneficiary as a transition fill under 423.120(b)(3) or as an emergency supply as may be required for an applicable beneficiary who is a long-term care resident. (3) Not a compounded drug product (as described in 423.120(d)) that contains an applicable drug; and (4) For the purposes of the Manufacturer Discount Program, not a selected drug during a price applicability period with respect to such drug.