Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 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-510 Renewal-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-510 Renewal-510a 1,850 1
(3) Importing List I, Drug Products containing ephedrine, pseudoephedrine, phenylpropanolamine New-510 Renewal-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-510 Renewal-510a 1,850 1

Where this section sits in the code

Title 21—Food and Drugs
CHAPTER II—DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
PART 1309—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS

(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.)

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-510 Renewal-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-510 Renewal-510a 1,850 1

(3) Importing List I, Drug Products containing ephedrine, pseudoephedrine, phenylpropanolamine New-510 Renewal-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-510 Renewal-510a 1,850 1

Collected 2026-08-27T02:24:47Z. Source file · JSON

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