---
kind: "section"
citation: "21 C.F.R. § 3.3"
title: "21"
number: "3.3"
heading: "Scope."
url: "https://uscodex.org/cfr/21/3.3"
---

# §3.3. Scope.


This section applies to:

- (a) Any combination product, or
- (b) **Any product where the agency component with primary jurisdiction is unclear or in dispute.**

## Notes

### Authority

Authority: 21 U.S.C. 321, 351, 353, 355, 360, 360c-360f, 360h-360j, 360gg-360ss, 360bbb-2, 371(a), 379e, 381, 394; 42 U.S.C. 216, 262, 264.

### Source

Source: 56 FR 58756, Nov. 21, 1991, unless otherwise noted.