---
kind: "section"
citation: "21 C.F.R. § 1309.21"
title: "21"
number: "1309.21"
heading: "Persons required to register."
url: "https://uscodex.org/cfr/21/1309.21"
---

# §1309.21. Persons required to register.

- (a) Unless exempted by law or under [§§ 1309.24 through 1309.26](/cfr/21/1309.24..1309.26.md) or [§§ 1310.12 through 1310.13](/cfr/21/1310.12..1310.13.md) of this chapter, the following persons must annually obtain a registration specific to the List I chemicals to be handled:
  - (1) Every person who manufactures or imports or proposes to manufacture or import a List I chemical or a drug product containing ephedrine, pseudoephedrine, or phenylpropanolamine.
  - (2) Every person who distributes or exports or proposes to distribute or export any List I chemical, other than those List I chemicals contained in a product exempted under paragraph (1)(iv) of the definition of regulated transaction in [§ 1300.02](/cfr/21/1300.02.md) of this chapter.
- (b) Only persons actually engaged in the activities are required to obtain a registration; related or affiliated persons who are not engaged in the activities are not required to be registered. (For example, a stockholder or parent corporation of a corporation distributing List I chemicals is not required to obtain a registration.)
- (c) **The registration requirements are summarized in the following table—**

## Notes

### Amendments

[75 FR 4980, Feb. 1, 2010, as amended at 77 FR 4236, Jan. 27, 2012; 77 FR 15250, Mar. 15, 2012; 85 FR 44734, July 24, 2020]

### Authority

Authority: 21 U.S.C. 802, 821, 822, 823, 824, 830, 871(b), 875, 877, 886a, 952, 953, 957, 958.

### Source

Source: 60 FR 32454, June 22, 1995, unless otherwise noted.

### Amendments

[75 FR 4980, Feb. 1, 2010, as amended at 77 FR 4236, Jan. 27, 2012; 77 FR 15250, Mar. 15, 2012; 85 FR 44734, July 24, 2020]