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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter II - Drug Enforcement Administration, Department of Justice |
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Part 1309 - Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals |
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Requirements for Registration |
§ 1309.21 - Persons required to register.
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§ 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 forms Application fee Registration period
(years)Coincident activities allowed (1) Manufacturing List I,
Drug products containing ephedrine, pseudoephedrine, phenylpropanolamineNew-510 $3,047
Renewal-510a3,699 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 3,047 (2) Distributing List I New-510 1, 5231 Scheduled listed chemical products New-510
Renewal-510a1,523 850 1 (3) Importing List I,
Drug Products containing ephedrine, pseudoephedrine, phenylpropanolamineNew-510
Renewal-510a1,523850 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 1,523 (4) Exporting List I New-510 1, 5231 Scheduled listed chemical products New-510
Renewal-510a1,523850 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]