§ 447.506 Authorized generic drugs.

(a)

Definitions.

For the purpose of this section, the following definitions apply:

Primary manufacturer

means a manufacturer that holds the NDA of the authorized generic drug.

Secondary manufacturer of an authorized generic drug

means a manufacturer that is authorized by the primary manufacturer to sell the drug.

(b)

Exclusion of authorized generic drugs from AMP by a primary manufacturer.

The primary manufacturer must exclude from its calculation of AMP any sales of authorized generic drugs to wholesalers for drugs distributed to retail community pharmacies when reporting the AMP of the brand name drug of that authorized generic drug.

(c)

Inclusion of authorized generic drugs in best price by a primary manufacturer.

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.

(d)

Inclusion of authorized generic in AMP and best price by a secondary manufacturer.

The secondary manufacturer of an authorized generic drug must provide a rebate based on its sales of authorized generics, and must calculate AMP and best price, consistent with the requirements specified in §§ 447.504 and 447.505.

[81 FR 5347, Feb. 1, 2016, as amended at 85 FR 87102, Dec. 31, 2020]