# 42 C.F.R. § 447.507 (2026): Identification of inhalation, infusion, instilled, implanted, or injectable drugs (5i drugs)

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T42_P447_S447_507

## Section

- **Citation:** 42 C.F.R. § 447.507 (2026)
- **Heading:** Identification of inhalation, infusion, instilled, implanted, or injectable drugs (5i 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 / § 447.507: § 447.507   Identification of inhalation, infusion, instilled, implanted, or injectable drugs (5i drugs).

## Text

(a)
Identification of a 5i drug.
A manufacturer must identify to CMS each covered outpatient drug that qualifies as a 5i drug.
(b)
Not generally dispensed through a retail community pharmacy.
A manufacturer must determine if the 5i drug is not generally dispensed through a retail community pharmacy based on the percentage of sales to entities other than retail community pharmacies.
(1) A 5i drug is not generally dispensed through a retail community pharmacy if 70 percent or more of the sales (based on units at the NDC-9 level) of the 5i drug, were to entities other than retail community pharmacies or wholesalers for drugs distributed to retail community pharmacies.
(2) A manufacturer is responsible for determining and reporting to CMS whether a 5i drug is not generally dispensed through a retail community pharmacy on a monthly basis.

## 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_507. Check the current official text before relying on it. Not legal advice.