C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—MEDICARE PROGRAM › PART 428—MEDICARE PART D DRUG INFLATION REBATE PROGRAM › Subpart C—Determination of the Rebate Amount for Part D Rebatable Drugs

42 C.F.R. § 428.200

Definitions

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As used in this subpart, the following definitions apply:

340B Program is the program under section 340B of the PHS Act.

Line extension has the meaning set forth in § 447.502 of this chapter.

New formulation has the meaning set forth in § 447.502 of this chapter.

Oral solid dosage form has the meaning set forth in § 447.502 of this chapter.