# 42 C.F.R. § 447.506 (2026): Authorized generic drugs

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_506

## Section

- **Citation:** 42 C.F.R. § 447.506 (2026)
- **Heading:** Authorized generic drugs
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 42 CFR: Public Health / Chapter IV: CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 447: PAYMENTS FOR SERVICES / Subpart I: Payment for Drugs / § 447.506: § 447.506   Authorized generic drugs.

## Text

(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]

## Nearby sections

- [42 C.F.R. § 447.500 (2026) § 447.500   Basis and purpose.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_500.md)
- [42 C.F.R. § 447.502 (2026) § 447.502   Definitions.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_502.md)
- [42 C.F.R. § 447.504 (2026) § 447.504   Determination of average manufacturer price.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_504.md)
- [42 C.F.R. § 447.505 (2026) § 447.505   Determination of best price.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_505.md)
- [42 C.F.R. § 447.506 (2026) § 447.506   Authorized generic drugs.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_506.md)
- [42 C.F.R. § 447.507 (2026) § 447.507   Identification of inhalation, infusion, instilled, implanted, or injectable drugs (5i drugs).](https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_507.md)
- [42 C.F.R. § 447.508 (2026) § 447.508   Exclusion from best price of certain sales at a nominal price.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_508.md)
- [42 C.F.R. § 447.509 (2026) § 447.509   Medicaid drug rebates (MDR).](https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_509.md)
- [42 C.F.R. § 447.510 (2026) § 447.510   Requirement and penalties for manufacturers.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_510.md)
- [42 C.F.R. § 447.511 (2026) § 447.511   Requirements for States.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_511.md)
- [42 C.F.R. § 447.512 (2026) § 447.512   Drugs: Aggregate upper limits of payment.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_512.md)
- [42 C.F.R. § 447.514 (2026) § 447.514   Upper limits for multiple source drugs.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_514.md)
- [42 C.F.R. § 447.516 (2026) § 447.516   Upper limits for drugs furnished as part of services.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_516.md)
- [42 C.F.R. § 447.518 (2026) § 447.518   State plan requirements, findings, and assurances.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_518.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_506. Check the current official text before relying on it. Not legal advice.