S.C. Code Regs. 61-4.400.401 - 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 Bureau Director shall use
the security requirements set forth in §§402-406 as standards for the
physical security controls and operating procedures necessary to diversion.
Materials and construction which will provide a structural equivalent to the
physical security controls set forth in §§
402, 403, and 405 may be used in
lieu of the materials and construction described in those sections.
(b) Substantial compliance with the standards
set forth in §§402-406 may be deemed sufficient by the Bureau
Director 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 Bureau Director 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
non-usable 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 characteristics of the building or
buildings;
(6) The type of vault,
safe, and secure enclosures or other storage systems (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 system;
(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 area;
(12) The procedures for handling business
guests, visitors, maintenance personnel, and non-employees 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 scientific schedule, or as a result
of a non-controlled 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
§§402-406 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 §§402-406
may submit any plans, blueprints, sketches or other materials regarding the
proposed security system either to the Bureau Director or to the Compliance
Investigations Division, DEA, Department of Justice, Washington, DC
20537.
(e) Physical security
controls of locations registered under the Harrison Act or the Narcotics
Manufacturing Act of 1960 on April 30, 1971, shall be deemed to comply
substantially with the standards set forth in §§
402,
403, and 405. 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
Bureau of Drug Control, shall not necessarily be deemed to comply substantially
with the standards set forth in §§
402, 403, and 405 notwithstanding
that such facilities or work or storage areas have physical security controls
similar to those previously approved.
Notes
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No prior version found.