[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1301.76]

[Page 44-45]
 
                         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. 1301.76  Other security controls for practitioners.

    (a) The registrant shall not employ, as an agent or employee who has 
access to controlled substances, any person who has been convicted of a 
felony offense relating to controlled substances or who, at any time, 
had an application for registration with the DEA denied, had a DEA 
registration revoked or has surrendered a DEA registration for cause. 
For purposes of this subsection, the term ``for cause'' means a 
surrender in lieu of, or as a consequence of, any federal or state 
administrative, civil or criminal action resulting from an investigation 
of the individual's handling of controlled substances.
    (b) The registrant shall notify the Field Division Office of the 
Administration in his area, in writing, of the theft or significant loss 
of any controlled substances within one business day of discovery of 
such loss or theft. The registrant shall also complete, and submit to 
the Field Division Office in his area, DEA Form 106 regarding the loss 
or theft. When determining whether a loss is significant, a registrant 
should consider, among others, the following factors:
    (1) The actual quantity of controlled substances lost in relation to 
the type of business;

[[Page 45]]

    (2) The specific controlled substances lost;
    (3) Whether the loss of the controlled substances can be associated 
with access to those controlled substances by specific individuals, or 
whether the loss can be attributed to unique activities that may take 
place involving the controlled substances;
    (4) A pattern of losses over a specific time period, whether the 
losses appear to be random, and the results of efforts taken to resolve 
the losses; and, if known,
    (5) Whether the specific controlled substances are likely candidates 
for diversion;
    (6) Local trends and other indicators of the diversion potential of 
the missing controlled substance.
    (c) Whenever the registrant distributes a controlled substance 
(without being registered as a distributor, as permitted in Sec. 
1301.13(e)(1) and/or Sec. Sec. 1307.11-1307.12) he/she shall comply 
with the requirements imposed on nonpractitioners in Sec. 1301.74 (a), 
(b), and (e).
    (d) Central fill pharmacies must comply with Sec. 1301.74(e) when 
selecting private, common or contract carriers to transport filled 
prescriptions to a retail pharmacy for delivery to the ultimate user. 
When central fill pharmacies contract with private, common or contract 
carriers to transport filled prescriptions to a retail pharmacy, the 
central fill pharmacy is responsible for reporting in-transit losses 
upon discovery of such loss by use of a DEA Form 106. Retail pharmacies 
must comply with Sec. 1301.74(e) when selecting private, common or 
contract carriers to retrieve filled prescriptions from a central fill 
pharmacy. When retail pharmacies contract with private, common or 
contract carriers to retrieve filled prescriptions from a central fill 
pharmacy, the retail pharmacy is responsible for reporting in-transit 
losses upon discovery of such loss by use of a DEA Form 106.

[36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 
37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973; 
47 FR 41735, Sept. 22, 1982; 56 FR 36728, Aug. 1, 1991; 62 FR 13957, 
Mar. 24, 1997; 68 FR 37409, June 24, 2003; 70 FR 47097, Aug. 12, 2005]