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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 9]
[CITE: 21CFR1309.21]



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

Requirements for Registration

Sec. 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) ManufacturingList I,
Drug products containing ephedrine, pseudoephedrine, phenylpropanolamine		New-510
Renewal-510a		3,6991May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered.
(2) DistributingList I,
Scheduled listed chemical products		New-510
Renewal-510a		1,8501
(3) ImportingList I,
Drug Products containing ephedrine, pseudoephedrine, phenylpropanolamine		New-510
Renewal-510a		1,8501May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered.
(4) ExportingList I,
Scheduled listed chemical products		New-510
Renewal-510a		1,8501

[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]

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