---
kind: "section"
citation: "42 C.F.R. § 428.200"
title: "42"
number: "428.200"
heading: "Definitions."
url: "https://uscodex.org/cfr/42/428.200"
---

# §428.200. Definitions.


As used in this subpart, the following definitions apply:

340B Program is the program under [section 340B](/cfr/42/340B.md) of the PHS Act.

Line extension has the meaning set forth in [§ 447.502](/cfr/42/447.502.md) of this chapter.

New formulation has the meaning set forth in [§ 447.502](/cfr/42/447.502.md) of this chapter.

Oral solid dosage form has the meaning set forth in [§ 447.502](/cfr/42/447.502.md) of this chapter.


## Notes

### Authority

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

### Source

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