---
kind: "section"
citation: "42 C.F.R. § 447.507"
title: "42"
number: "447.507"
heading: "Identification of inhalation, infusion, instilled, implanted, or injectable drugs (5i drugs)."
url: "https://uscodex.org/cfr/42/447.507"
---

# §447.507. Identification of inhalation, infusion, instilled, implanted, or injectable drugs (5i drugs).

- (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.

## Notes

### Source

Source: 81 FR 5347, Feb. 1, 2016, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 1302, and 1396r-8, and Pub. L. 111-148.

### Source

Source: 43 FR 45253, Sept. 29, 1978, unless otherwise noted.