part_subject: "REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS"
subpart_code: "A"
subpart_subject: "General Requirements"
section_number: "1309.71"
section_subject: "General security requirements."
cfr_reference: "21 CFR 1309.71"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Part 1300 to End"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)All applicants and registrants must provide effective controls and procedures to guard against theft and diversion of List I chemicals. Chemicals must 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.
(b)In evaluating the effectiveness of security controls and procedures, the Administrator shall consider the following factors:
(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; and
(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 Regulatory Section, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.