42 CFR 447.506 - Authorized generic drugs.

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There are 2 Updates appearing in the Federal Register for 42 CFR 447. View below or at eCFR (GPOAccess)
§ 447.506 Authorized generic drugs.
(a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug means any drug sold, licensed, or marketed under an NDA approved by the FDA under section 505(c) of the FFDCA; and marketed, sold, or distributed under a different labeler code, product code, trade name, trademark, or packaging (other than repackaging the listed drug for use in institutions) than the brand drug.
(b) Inclusion of authorized generic drugs in AMP. A manufacturer holding title to the original NDA of the authorized generic drug must include the sales of this drug in its AMP only when such drugs are being sold by the manufacturer holding title to the original NDA directly to a wholesaler.
(c) Inclusion of authorized generic drugs in best price. A manufacturer holding title to the original NDA must include best price of an authorized generic drug in its computation of best price for a single source or 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 title to the original NDA.

Title 42 published on 2013-10-01

The following are only the Rules published in the Federal Register after the published date of Title 42.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-08-04; vol. 79 # 149 - Monday, August 4, 2014
    1. 79 FR 45124 - Payments for Services
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services
      42 CFR Part 447

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United States Code

Title 42 published on 2013-10-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR 447 after this date.

  • 2014-08-04; vol. 79 # 149 - Monday, August 4, 2014
    1. 79 FR 45124 - Payments for Services
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services
      42 CFR Part 447