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

---
identifier: "/us/cfr/t42/s447.507"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 447.507 - Identification of inhalation, infusion, instilled, implanted, or injectable drugs (5i drugs)."
title_number: 42
title_name: "Public Health"
section_number: "447.507"
section_name: "Identification of inhalation, infusion, instilled, implanted, or injectable drugs (5i drugs)."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "MEDICAL ASSISTANCE PROGRAMS"
part_number: "447"
part_name: "PAYMENTS FOR SERVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 1302, and 1396r-8, and Pub. L. 111-148."
regulatory_source: "43 FR 45253, Sept. 29, 1978, unless otherwise noted."
cfr_part: "447"
---


# 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.