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At 428.101(a), we proposed to identify a Part D rebatable drug [683] for each applicable period by determining which covered Part D drugs, as defined in section 1860D-2(e) of the Act, meet the requirements in section 1860D-14B(g)(1)(C) of the Act (that is, are brand name drugs approved under an NDA, biologicals licensed under a biologics license application (BLA), or generic drugs approved under an ANDA)

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