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

Regulations last checked for updates: Oct 17, 2024

Title 42 - Public Health last revised: Oct 15, 2024

View all text of Subpart I [§ 447.500 - § 447.522]

§ 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.

authority: 42 U.S.C. 1302,and,and. L. 111-148

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

cite as: 42 CFR 447.507