Section 1927(k)(1)(C) of the Act requires that in the case of a manufacturer that approves, allows, or otherwise permits any drug of the manufacturer to be sold under a new drug application (NDA) approved under section 505(c) of Federal Food, Drug and Cosmetic Act (FFDCA), AMP shall be inclusive of the average price paid for such drug by wholesalers for drugs distributed to retail community pharmacies. Therefore, as stated in a comment and response in the final rule, when a manufacturer is selling two versions of a product (both the AG and the brand) under the same NDA, in such cases the price of the drug would be blended for AMP, even if the manufacturer distinguishes the two products using different NDCs (81 FR 5260). Furthermore, as discussed in the final rule (81 FR 5260), CMS does not believe the manufacturer should determine a separate best price for each NDC simply because the two manufacturers of the same company identify the same drug using different NDCs.
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