Link to an amendment published at 85 FR 44734, July 24, 2020.

1. (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. (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. (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. (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.)

3. (c) The registration requirements are summarized in the following table:

   Summary of Registration Requirements and LimitationsBusiness activity Chemicals DEA Forms Application fee Registration period (years) Coincident activities allowed ManufacturingList INew-510$3,0471May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered. Drug products containing ephedrine, pseudoephedrine, phenylpropanolamineRenewal-510a3,047 DistributingList INew-5101,5231 Scheduled listed chemical productsRenewal-510a1,523 ImportingList INew-5101,5231May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered. Drug Products containing ephedrine, pseudoephedrine, phenylpropanolamineRenewal-510a1,523 ExportingList INew-5101,5231 Scheduled listed chemical productsRenewal-510a1,523

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