[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1301.12]

[Page 14-15]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1301_REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS 
OF CONTROLLED SUBSTANCES--Table of Contents
 
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

[[Page 15]]

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 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]