(a) 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 Sec. 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----------------------------------------------------------------------------------------------------------------
Registration Coincident
Business activity Chemicals DEA Forms Application period activities
fee (years) allowed----------------------------------------------------------------------------------------------------------------Manufacturing................ List I.......... New-510......... $3,047 1 May distribute
that chemical
for which
registration
was issued;
may not
distribute any
chemical for
which not
registered.
Drug products Renewal-510a.... 3,047
containing
ephedrine,
pseudoephedrine
,
phenylpropanola
mine.Distributing................. List I.......... New-510......... 1,523 1
Scheduled listed Renewal-510a.... 1,523
chemical
products.Importing.................... List I.......... New-510......... 1,523 1 May distribute
that chemical
for which
registration
was issued;
may not
distribute any
chemical for
which not
registered.
Drug Products Renewal-510a.... 1,523
containing
ephedrine,
pseudoephedrine
,
phenylpropanola
mine.Exporting.................... List I.......... New-510......... 1,523 1
Scheduled listed Renewal-510a.... 1,523
chemical
products.---------------------------------------------------------------------------------------------------------------- [75 FR 4980, Feb. 1, 2010, as amended at 77 FR 4236, Jan. 27, 2012; 77 FR 15250, Mar. 15, 2012]