§447.507. Identification of inhalation, infusion, instilled, implanted, or injectable drugs (5i drugs).
42 C.F.R. § 447.507
Identification of a 5i drug. A manufacturer must identify to CMS each covered outpatient drug that qualifies as a 5i drug.
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.
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.
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, amendments, and revision history
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.