1. Regulations
  2. title 42
  3. chapter IV-i1
  4. part 428
  5. subpart C
  6. § 428.200

View all text of Subpart C [§ 428.200 - § 428.204]

§ 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.

AUTHORITY: 42 U.S.C. 1395w-114b, 1302, and 1395hh.

SOURCE: 89 FR 98588, Dec. 9, 2024, unless otherwise noted.

CITE AS: 42 CFR 428.200