Ohio Admin. Code 4729:5-3-14 - General security requirements
(A)
All terminal
distributors of dangerous drugs shall provide effective controls and procedures
to:
(1)
Deter
and detect the theft and diversion of dangerous drugs; and
(2)
Ensure
supervision and control of dangerous drugs, as required in division (B) of
section 4729.55 of the Revised Code, and
adequate safeguards to ensure that dangerous drugs are being distributed in
accordance with all state and federal laws, as required in section
4729.55 of the Revised
Code.
(B)
Substantial compliance with the standards set forth in
this division of the Administrative Code may be deemed sufficient by the state
board of pharmacy after evaluation of the overall security system and needs of
the licensee or applicant. In evaluating the overall security system of a
licensee or applicant, the state board of pharmacy may consider any of the
following factors, as deemed relevant, for compliance with security
requirements:
(1)
The type of activity conducted;
(2)
Type and form of
dangerous drugs handled;
(3)
Quantity of dangerous drugs handled;
(4)
Location of the
premises and the relationship such location bears on security
needs;
(5)
Type of building construction comprising the facility
and the general characteristics of the building or buildings;
(6)
Type of vaults,
safes, and secure enclosures or other storage system (e.g. automatic storage
and retrieval system) used;
(7)
Type of closures
on vaults, safes, and secure enclosures;
(8)
Adequacy of key
control systems and/or combination lock control systems;
(9)
Adequacy of
electronic detection and alarm systems, if any, including use of supervised
transmittal lines and standby power sources;
(10)
Extent of
unsupervised public access to the facility, including the presence and
characteristics of perimeter fencing, if any;
(11)
Adequacy of
supervision over authorized employees having access to areas containing
dangerous drugs;
(12)
Procedures for handling business guests, visitors,
maintenance personnel, and non-employee service personnel; and
(13)
Adequacy of the
licensee's or applicant's system for monitoring the receipt, manufacture,
distribution, and disposition of dangerous drugs in its
operation.
(C)
When physical security controls become inadequate as a
result of a significant increase in the quantity of dangerous drugs in the
possession of the licensee during normal business operation, the physical
security controls shall be expanded and extended accordingly.
(D)
Any applicant
seeking to determine whether a proposed security system substantially complies
with, or is the structural equivalent of, the requirements set forth in this
division of the Administrative Code may submit any plans, blueprints, sketches,
or other materials regarding the proposed security system to the state board of
pharmacy.
Replaces: 4729-9-05
Notes
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.05, 3719.09, 3719.172, 4729.27, 4729.28, 4729.51, 4729.531, 4729.55, 4729.57
Prior Effective Dates: 09/10/1976, 02/01/1998, 03/01/1999, 09/15/2017
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