21 C.F.R. § 1309.21

Persons required to register

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(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.)

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]

Notes of Decisions

Cited in 4 cases, 2005–2009 · leading case: Malladi Drugs & Pharmaceuticals, Ltd. v. Tandy

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Malladi Drugs & Pharmaceuticals, Ltd. v. Tandy (2009) cadc “§ 822; 21 C.F.R. § 1309.21 , and such persons must follow detailed reporting requirements, 21 C.”

United States v. Merkosky (2005) ca6 · cites it 2× “See 21 C.F.R. § 1309.21 (a). In response to Merkosky’s application, Janice Margreta, a diversion investigator with the DEA met with Merkosky to explain the problems with diversion of these chemicals from legal to illegal use, and also to explain the record-keeping requirements.”

NOVELTY DISTRIBUTORS, INC. v. Leonhart (2008) dcd “§§ 802 (38), 843(a)(9); see also 21 C.F.R. § 1309.21 . Collectively, these statutes require list I chemical distributors to take affirmative steps to prevent illegal diversion of their products by proper handling, storage, and tracking.”

Malladi Drugs & Pharmaceuticals, Ltd. v. Tandy (2008) dcd “§ 822 ; 21 C.F.R. § 1309.21 . Once imported, List I Chemicals are subject to detailed reporting requirements to ensure that they are used solely for legitimate purposes.”

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