§ 428.200 Definitions.
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.