§428.200. Definitions.
42 C.F.R. § 428.200
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.
Notes, amendments, and revision history
Authority
Authority: 42 U.S.C. 1395w-114b, 1302, and 1395hh.
Source
Source: 89 FR 98588, Dec. 9, 2024, unless otherwise noted.