Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Title 21 Code of Federal Regulations

PART 1309 — REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS

REQUIREMENTS FOR REGISTRATION

§1309.21 Persons required to register.

  1. Unless exempted by law or under Sec. Sec. 1309.24 through 1309.26 or Sec. Sec. 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.

  2. 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.)
  3. 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
Manufacturing List I Drug products containing ephedrine, pseudoephedrine, phenylpropanolamine. New–510 Renewal–510a $3,047 3,047 1 May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered.
Distributing List I Scheduled listed chemical products. New–510 Renewal–510a 1,523 1,523 1  
Importing List I Drug Products containing ephedrine, pseudoephedrine, phenylpropanolamine. New–510 Renewal–510a 1,523 1,523 1 May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered.
Exporting List I Scheduled listed chemical products. New–510 Renewal–510a 1,523 1,523 1  

[75 FR 4980, Feb. 1, 2010, as amended at 77 FR 4236, Jan. 27, 2012; 77 FR 15250, March 15, 2012]

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Printing Office (GPO).

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