Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-30 - Security requirements; approval of security system

Current through July 10, 2024
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.