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.
- 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.
- 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.)
- The registration requirements are summarized in the following table:
|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 Publishing Office (GPO).