447.508—Exclusion from best price of certain sales at a nominal price.

(a) Exclusion from best price. Sales of covered outpatient drugs by a manufacturer at nominal prices are excluded from best price when purchased by the following entities:

(1) A covered entity described in section 340B(a)(4) of the PHSA;

(2) An ICF/MR providing services as set forth in § 440.150 of this chapter; or

(3) A State-owned or operated nursing facility providing services as set forth in § 440.155 of this chapter.

(b) Nonapplication. This restriction shall not apply to sales by a manufacturer of covered outpatient drugs that are sold under a master agreement under 38, U.S.C. 8126.

CFR

447.508—Exclusion from best price of certain sales at a nominal price.