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Title 21

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Title 21

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Editorial codification of the general and permanent rules published in the Federal Register.

§ 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

[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]