856 IAC 2-3-30 - Security requirements; approval of security system
Authority: IC 35-48-3-1
Affected: IC 35-48-3-7
Sec. 30.
Security requirements generally.
(a) All applicants and registrants shall
provide and maintain 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 Indiana Board
of Pharmacy shall use the security requirements set forth in Sections 3.72-3.76
[856 IAC 2-3-31 T
856 IAC 2-3-35] 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 Sections
3.72 [856 IAC 2-3-31] , 3.73
[856 IAC 2-3-32] , and
3.75 [856 IAC 2-3-34] may be
used in lieu of the materials and construction described in those
sections.
(b) Substantial
compliance with the standards set forth in Sections 3.72-3.76
[856 IAC 2-3-31 T
856 IAC 2-3-35] may be
deemed sufficient by the Indiana Board of Pharmacy after evaluation of the
overall security system and needs of a registrant or applicant. In evaluating
the overall security system of a registrant or applicant, the Indiana Board of
Pharmacy may consider any of the following factors as it 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 substance
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 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 non-employee 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
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 Sections
3.72-3.76 [856 IAC 2-3-31 T
856 IAC 2-3-35] 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 Sections 3.72-3.76
[856 IAC 2-3-31 T
856 IAC 2-3-35] may
submit any plans, blueprints, sketches or other materials regarding the
proposed security system to the Indiana Board of Pharmacy.
(e) Approval by the Drug Enforcement
Administration of any security system, proposed security system, plans,
blueprints, sketches or other material as being in substantial compliance with
the requirements as set forth in 301.72-301.76 of Title 21 of the Code of
Federal Regulations shall be deemed in compliance with Sections 3.71 through
3.75 [856 IAC 2-3-30 T
856 IAC 2-3-34] of
these regulations, where applicable.
(f) Physical security controls of locations
registered under the Harrison Narcotic Act or the Narcotics Manufacturing Act
of 1960 on April 20, 1971, shall be deemed to comply substantially with the
standards set forth in Sections 3.71 [this section], 3.72
[856 IAC 2-3-31] , 3.73
[856 IAC 2-3-32] , and
3.75 [856 IAC 2-3-34]
.
Notes
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