---
kind: "section"
citation: "21 C.F.R. § 4.100"
title: "21"
number: "4.100"
heading: "What is the scope of this subpart?"
url: "https://uscodex.org/cfr/21/4.100"
---

# §4.100. What is the scope of this subpart?

- (a) This subpart identifies postmarketing safety reporting requirements for combination product applicants and constituent part applicants.
- (b) This subpart does not apply to investigational combination products, combination products that have not received marketing authorization, or to persons other than combination product applicants and constituent part applicants.
- (c) This subpart supplements and does not supersede other provisions of this chapter, including the provisions in parts [314](/cfr/21/part314.md), [600](/cfr/21/part600.md), 606, 803, and 806 of this chapter, unless a regulation explicitly provides otherwise.

## Notes

### Source

Source: 81 FR 92624, Dec. 20, 2016, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 360l, 360hh-360ss, 360aaa-360bbb, 360ddd, 360ddd-1, 371(a), 372-374, 379e, 381, 383, 394; 42 U.S.C. 216, 262, 263a, 264, 271.

### Source

Source: 78 FR 4321, Jan. 22, 2013, unless otherwise noted.