[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1301.71]

[Page 34-35]
 
                         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. 1301.71  Security requirements generally.

    (a) All applicants and registrants shall provide effective controls 
and procedures to guard against theft and diversion of controlled 
substances. In order to determine whether a registrant has provided 
effective controls against diversion, the Administrator shall use the 
security requirements set forth in Secs. 1301.72-1301.76 as standards 
for the physical security controls and operating procedures necessary to 
prevent diversion. Materials and construction which will provide a 
structural equivalent to the physical security controls set forth in 
Secs. 1301.72, 1301.73 and 1301.75 may be used in lieu of the materials 
and construction described in those sections.
    (b) Substantial compliance with the standards set forth in 
Secs. 1301.72-1301.76 may be deemed sufficient by the Administrator 
after evaluation of the overall security system and needs of the 
applicant or registrant. In evaluating the overall security system of a 
registrant or applicant, the Administrator may consider any of the 
following factors as he may deem relevant to the need for strict 
compliance with security requirements:
    (1) The type of activity conducted (e.g., processing of bulk 
chemicals, preparing dosage forms, packaging, labeling, cooperative 
buying, etc.);
    (2) The type and form of controlled substances handled (e.g., bulk 
liquids or dosage units, usable powders or nonusable powders);
    (3) The quantity of controlled substances handled;
    (4) The location of the premises and the relationship such location 
bears on security needs;
    (5) The type of building construction comprising the facility and 
the general

[[Page 35]]

characteristics of the building or buildings;
    (6) The type of vault, safe, and secure enclosures or other storage 
system (e.g., automatic storage and retrieval system) used;
    (7) The type of closures on vaults, safes, and secure enclosures;
    (8) The adequacy of key control systems and/or combination lock 
control systems;
    (9) The adequacy of electric detection and alarm systems, if any 
including use of supervised transmittal lines and standby power sources;
    (10) The extent of unsupervised public access to the facility, 
including the presence and characteristics of perimeter fencing, if any;
    (11) The adequacy of supervision over employees having access to 
manufacturing and storage areas;
    (12) The procedures for handling business guests, visitors, 
maintenance personnel, and nonemployee service personnel;
    (13) The availability of local police protection or of the 
registrant's or applicant's security personnel, and;
    (14) The adequacy of the registrant's or applicant's system for 
monitoring the receipt, manufacture, distribution, and disposition of 
controlled substances in its operations.
    (c) When physical security controls become inadequate as a result of 
a controlled substance being transferred to a different schedule, or as 
a result of a noncontrolled substance being listed on any schedule, or 
as a result of a significant increase in the quantity of controlled 
substances in the possession of the registrant during normal business 
operations, the physical security controls shall be expanded and 
extended accordingly. A registrant may adjust physical security controls 
within the requirements set forth in Secs. 1301.72-1301.76 when the need 
for such controls decreases as a result of a controlled substance being 
transferred to a different schedule, or a result of a controlled 
substance being removed from control, or as a result of a significant 
decrease in the quantity of controlled substances in the possession of 
the registrant during normal business operations.
    (d) Any registrant or applicant desiring to determine whether a 
proposed security system substantially complies with, or is the 
structural equivalent of, the requirements set forth in Secs. 1301.72-
1301.76 may submit any plans, blueprints, sketches or other materials 
regarding the proposed security system either to the Special Agent in 
Charge in the region in which the system will be used, or to the 
Diversion Operations Section, Drug Enforcement Administration, 
Department of Justice, Washington, DC 20537.
    (e) Physical security controls of locations registered under the 
Harrison Narcotic Act or the Narcotics Manufacturing Act of 1960 on 
April 30, 1971, shall be deemed to comply substantially with the 
standards set forth in Secs. 1301.72, 1301.73 and 1301.75. Any new 
facilities or work or storage areas constructed or utilized for 
controlled substances, which facilities or work or storage areas have 
not been previously approved by the Administration, shall not 
necessarily be deemed to comply substantially with the standards set 
forth in Secs. 1301.72, 1301.73 and 1301.75, notwithstanding that such 
facilities or work or storage areas have physical security controls 
similar to those previously approved by the Administration.

[36 FR 18729, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
l973, and amended at 46 FR 28841, May 29, 1981; 47 FR 41735, Sept. 22, 
1982; 51 FR 5319, Feb. 13, 1986]