21 C.F.R. § 1309.21

Persons required to register.

Last amended: 2020Year: 2026Length: 301 wordsSubsections: 3Official source

Cite as 21 C.F.R. § 1309.21 (2026)

(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]
Cross-references to the CFR
1300.021309.241310.12