[Title 21 CFR 1301.12]
[Code of Federal Regulations (annual edition) - April 1, 2002 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE]
[Part 1301 - REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES]
[Sec. 1301.12 - Separate registrations for separate locations.]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS92002-04-012002-04-01false1301.12Sec. 1301.12FOOD AND DRUGSDRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICEREGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
Sec. 1301.12  Separate registrations for separate locations.

    (a) A separate registration is required for each principal place of 
business or professional practice at one general physical location where 
controlled substances are manufactured, distributed, imported, exported, 
or dispensed by a person.
    (b) The following locations shall be deemed not to be places where 
controlled substances are manufactured, distributed, or dispensed:
    (1) A warehouse where controlled substances are stored by or on 
behalf of a registered person, unless such substances are distributed 
directly from such warehouse to registered locations other than the 
registered location from which the substances were delivered or to 
persons not required to register by virtue of subsection 302(c)(2) or 
subsection 1007(b)(1)(B) of the Act (21 U.S.C. 822(c)(2) or 
957(b)(1)(B));
    (2) An office used by agents of a registrant where sales of 
controlled substances are solicited, made, or supervised but which 
neither contains such substances (other than substances for display 
purposes or lawful distribution as samples only) nor serves as a 
distribution point for filling sales orders; and
    (3) An office used by a practitioner (who is registered at another 
location) where controlled substances are prescribed but neither 
administered nor otherwise dispensed as a regular part of the 
professional practice of the practitioner at such office, and where no 
supplies of controlled substances are maintained.
    (4) A freight forwarding facility, as defined in Sec. 1300.01 of 
this part, provided that the distributing registrant operating the 
facility has submitted written notice of intent to operate the facility 
by registered mail, return receipt requested (or other suitable means of 
documented delivery) and such notice has been approved. The notice shall 
be submitted to the Special Agent in Charge of the Administration's 
offices in both the area in which the facility is located and each area 
in

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which the distributing registrant maintains a registered location that 
will transfer controlled substances through the facility. The notice 
shall detail the registered locations that will utilize the facility, 
the location of the facility, the hours of operation, the individual(s) 
responsible for the controlled substances, the security and 
recordkeeping procedures that will be employed, and whether controlled 
substances returns will be processed through the facility. The notice 
must also detail what state licensing requirements apply to the facility 
and the registrant's actions to comply with any such requirements. The 
Special Agent in Charge of the DEA Office in the area where the freight 
forwarding facility will be operated will provide written notice of 
approval or disapproval to the person within thirty days after confirmed 
receipt of the notice. Registrants that are currently operating freight 
forwarding facilities under a memorandum of understanding with the 
Administration must provide notice as required by this section no later 
than September 18, 2000 and receive written approval from the Special 
Agent in Charge of the DEA Office in the area in which the freight 
forwarding facility is operated in order to continue operation of the 
facility.

[62 FR 13945, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000; 
65 FR 45829, July 25, 2000]