Regulations at 42 CFR 447.506(c) indicate that a primary manufacturer holding the NDA must include the best price of an authorized generic drug in its computation of best price for a single source or an innovator multiple source drug during a rebate period to any manufacturer, wholesaler, retailer, provider, HMO, non-profit entity, or governmental entity in the United States, only when such drugs are being sold by the manufacturer holding the NDA.
Transfer sales that take place between two manufacturers would be included in AMP only to the extent the secondary manufacturer is acting as a wholesaler in accordance with section 1927(k)(11) of the Act.
Supplemental Links:
- This FAQ was released as part of a larger set. View the full set. (PDF, 205.53 KB)
Date
Sub Topic
FAQ ID
94816
FAQ Page
FAQ Question
In the case when two manufacturers sell the same product under different NDCs, but the manufacturers are part of the same parent company, CMS indicated that the same Best Price should be reported for both NDCs. Under these circumstances, would the transfer sales be included in the AMP or would the transfer sales to the AG not be included in the AMP calculation?