§ 447.507 Identification of inhalation, infusion, instilled, implanted, or injectable drugs (5i drugs).
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Title 42 CFR: Public Health › Chapter IV: CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › Part 447: PAYMENTS FOR SERVICES › Subpart I: Payment for Drugs › § 447.507: § 447.507 Identification of inhalation, infusion, instilled, implanted, or injectable drugs (5i drugs).
Text
(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.
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