21 CFR § 1309.21 - Persons required to register.

---
identifier: "/us/cfr/t21/s1309.21"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1309.21 - Persons required to register."
title_number: 21
title_name: "Food and Drugs"
section_number: "1309.21"
section_name: "Persons required to register."
chapter_name: "DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE"
part_number: "1309"
part_name: "REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 802, 821, 822, 823, 824, 830, 871(b), 875, 877, 886a, 952, 953, 957, 958."
regulatory_source: "60 FR 32454, June 22, 1995, unless otherwise noted."
cfr_part: "1309"
---


# 1309.21 Persons required to register.

(a) Unless exempted by law or under §§ 1309.24 through 1309.26 or §§ 1310.12 through 1310.13 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 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:

Summary of Registration Requirements and Limitations

| Business activity | Chemicals | DEA forms | Application fee | Registration period(years) | Coincident activities allowed |
| --- | --- | --- | --- | --- | --- |
| (1) Manufacturing | List I,Drug products containing ephedrine, pseudoephedrine, phenylpropanolamine | New-510Renewal-510a | 3,699 | 1 | May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered. |
| (2) Distributing | List I,Scheduled listed chemical products | New-510Renewal-510a | 1,850 | 1 |  |
| (3) Importing | List I,Drug Products containing ephedrine, pseudoephedrine, phenylpropanolamine | New-510Renewal-510a | 1,850 | 1 | May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered. |
| (4) Exporting | List I,Scheduled listed chemical products | New-510Renewal-510a | 1,850 | 1 |  |

[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]