[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: 21CFR1309.71]

[Page 119-120]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1309_REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND 
EXPORTERS OF LIST I CHEMICALS--Table of Contents
 
Sec. 1309.71  General security requirements.

    (a) All applicants and registrants shall provide effective controls 
and procedures to guard against theft and diversion of List I chemicals. 
Specific attention shall be paid to storage of and controlling access to 
List I chemicals as follows:
    (1) Chemicals shall be stored in containers sealed in such a manner 
as to indicate any attempts at tampering with the container. Where 
chemicals cannot be stored in sealed containers, access to the chemicals 
should be controlled through physical means or through human or 
electronic monitoring.
    (2) In retail settings open to the public where drugs containing 
ephedrine as the sole active medicinal ingredient are distributed, such 
drugs will be stocked behind a counter where only employees have access.
    (b) In evaluating the effectiveness of security controls and 
procedures, the Administrator shall consider the following factors:

[[Page 120]]

    (1) The type, form, and quantity of List I chemicals handled;
    (2) The location of the premises and the relationship such location 
bears on the security needs;
    (3) The type of building construction comprising the facility and 
the general characteristics of the building or buildings;
    (4) The availability of electronic detection and alarm systems;
    (5) the extent of unsupervised public access to the facility;
    (6) The adequacy of supervision over employees having access to List 
I chemicals;
    (7) The procedures for handling business guests, visitors, 
maintenance personnel, and nonemployee service personnel in areas where 
List I chemicals are processed or stored;
    (8) The adequacy of the registrant's or applicant's systems for 
monitoring the receipt, distribution, and disposition of List I 
chemicals in its operations.
    (c) Any registrant or applicant desiring to determine whether a 
proposed system of security controls and procedures is adequate may 
submit materials and plans regarding the proposed security controls and 
procedures either to the Special Agent in Charge in the region in which 
the security controls and procedures will be used, or to the Chemical 
Operations Section Office of Diversion Control, Drug Enforcement 
Administration, Washington, D.C. 20537.

[60 FR 32454, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997; 
67 FR 14861, Mar. 28, 2002]