{"data":{"id":"us/42-cfr-447.507","jurisdiction":"us","citation":"42 CFR 447.507","heading":"Identification of inhalation, infusion, instilled, implanted, or injectable drugs (5i drugs).","body":"(a) Identification of a 5i drug. A manufacturer must identify to CMS each covered outpatient drug that qualifies as a 5i drug.\n(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.\n(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.\n(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.","path":["Title 42—Public Health","CHAPTER IV—CENTERS FOR MEDICARE \u0026 MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER C—MEDICAL ASSISTANCE PROGRAMS","PART 447—PAYMENTS FOR SERVICES","Subpart I—Payment for Drugs"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-42.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:26:11Z","sha256":"65fba9e24ff79585bcba58f0a3b45cf8311cc30b82517d04b181daf372098dad","source_id":"us-cfr","stale":true,"prev":"us/42-cfr-447.506","next":"us/42-cfr-447.508"},"notice":"GroundRules: Original legal text. Not legal advice."}