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Code of Federal Regulations Title 21. Food and Drugs § 21.1309.21 Persons required to register

Current as of January 02, 2025 | Updated by Findlaw Staff

(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,․․․․․․․․․․․․

New-510․․․․․․․

3,699

1

May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered.

Drug products containing ephedrine, pseudoephedrine, phenylpropanolamine

Renewal-510a

(2) Distributing․․․

List I,․․․․․․․․․․․․

New-510․․․․․․․

1,850

1

Scheduled listed chemical products

Renewal-510a

(3) Importing․․․․․․

List I,․․․․․․․․․․․․

New-510․․․․․․․

1,850

1

May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered.

Drug Products containing ephedrine, pseudoephedrine, phenylpropanolamine

Renewal-510a

(4) Exporting․․․․․․

List I,․․․․․․․․․․․․

New-510․․․․․․․

1,850

1

Scheduled listed chemical products

Renewal-510a
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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.1309.21 Persons required to register - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-1309-21/

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