Applicable Drug definition
Applicable Drug means a drug (as defined in section 201
Applicable Drug means, with respect to an applicable beneficiary, a covered Part D drug--
1. Approved under a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) or, in the case of a biological product, licensed under section 351 of the Public Health Service Act (PHSA) (other than a product licensed under subsection (k) of such section 351 of PHSA); and
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;
Applicable Drug means, with respect to an applicable beneficiary, a Part D drug that is:
More Definitions of Applicable Drug
Applicable Drug has the meaning given such term in section 1860D-14A(g)(2)(A) of the
Applicable Drug has the meaning given such term in 42 CFR §423.100.