Lawriter - OAC - 4729-9-05 Security requirements.

4729-9-05 Security requirements.

(A) All licensees and registrants shall provide effective and approved controls and procedures to deter and detect theft and diversion of dangerous drugs. In order to determine whether a licensee or registrant has provided effective and approved controls against diversion, the state board of pharmacy shall use the security requirements set forth in rule 4729-9-11 of the Administrative Code as standards for the security controls and operating procedures necessary to deter and detect diversion.

(B) Substantial compliance with the standards set forth in rule 4729-9-11 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 applicant, licensee or registrant. In evaluating the overall security system of a licensee, registrant 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;

(13) Availability of local police protection or of the licensee's, registrant's or applicant's security personnel, and;

(14) Adequacy of the licensee's, registrant'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 or registrant during normal business operation, the physical security controls shall be expanded and extended accordingly.

(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 rule 4729-9-11 of the Administrative Code may submit any plans, blueprints, sketches, or other materials regarding the proposed security system to the state board of pharmacy.

(E) The state board of pharmacy shall be notified of any new facilities, work or storage areas to be constructed or utilized for dangerous drugs or of any changes in operation of the licensee or registrant before being used or implemented.

(F) No licensed terminal distributor of dangerous drugs shall engage in the sale or other distribution of dangerous drugs at retail or maintain possession, custody, or control of dangerous drugs for any purpose at any establishment or place other than that or those described in the license issued by the state board of pharmacy to such terminal distributor, except as follows:

(1) A licensed health professional authorized to prescribe drugs may temporarily remove dangerous drugs from a licensed terminal distributor of dangerous drugs in order to treat current or prospective patients. The dangerous drugs shall be maintained in accordance with the manufacturer's instructions and shall be returned to the licensed terminal distributor of dangerous drugs within twenty-four hours, unless otherwise approved by the board. The licensed health professional shall maintain personal supervision and control over the dangerous drugs and any hypodermics removed from the terminal distributor. If personal supervision is not provided, the dangerous drugs and any hypodermics shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. The responsible person on the terminal distributor of dangerous drugs license pursuant to rule 4729-5-11 of the Administrative Code shall be responsible for compliance with the requirements of this paragraph.

(2) A person authorized to personally furnish or dispense naloxone in accordance with a physician approved protocol. The naloxone shall be maintained in accordance with the manufacturer's instructions and shall be returned to the licensed terminal distributor of dangerous drugs within twenty-four hours, unless otherwise approved by the board. The authorized person shall maintain personal supervision and control over the naloxone removed from the terminal distributor. If personal supervision is not provided, the naloxone shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. The responsible person on the terminal distributor of dangerous drugs license pursuant to rule 4729-5-11 of the Administrative Code shall be responsible for compliance with the requirements of this paragraph.

(3) A licensed health care professional, in accordance with their applicable scope of practice, who provides immunizations or any other non-controlled drugs that may be administered in accordance with a protocol or valid prescriber's order may temporarily remove dangerous drugs from a licensed terminal distributor of dangerous drugs in order to treat current or prospective patients. The dangerous drugs shall be maintained in accordance with the manufacturer's instructions and shall be returned to the licensed terminal distributor of dangerous drugs within twenty-four hours, unless otherwise approved by the board. The licensed health professional shall maintain personal supervision and control over the dangerous drugs and any hypodermics removed from the terminal distributor. If personal supervision is not provided, the dangerous drugs and any hypodermics shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. The responsible person on the terminal distributor of dangerous drugs license pursuant to rule 4729-5-11 of the Administrative Code shall be responsible for compliance with the requirements of this paragraph.

(4) An emergency medical service (EMS) organization providing emergency medical services and in accordance with Chapter 4729-33 of the Administrative Code.

(5) A veterinarian licensed pursuant to Chapter 4741. of the Revised Code may maintain a supply of dangerous drugs obtained from a licensed terminal distributor of dangerous drugs in order to treat current or prospective patients that cannot be reasonably treated at the location licensed as a terminal distributor of dangerous drugs. The dangerous drugs shall be maintained in accordance with the manufacturer's instructions. A veterinarian shall maintain personal supervision and control over the dangerous drugs and any hypodermics removed from the terminal distributor. If personal supervision is not provided, the dangerous drugs and any hypodermics shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. Any drugs maintained pursuant to this paragraph are subject to inspection by a board of pharmacy agent and shall be subject to all recordkeeping, labeling, disposal and inventory requirements of agency 4729 of the Administrative Code. Records shall be maintained by the terminal distributor of dangerous drugs in accordance with rule 4729-9-14 of the Administrative Code and rule 4729-9-22 of the Administrative Code. The responsible person on the terminal distributor of dangerous drugs license from which the drugs are obtained pursuant to rule 4729-5-11 shall be responsible for compliance with the requirements of this paragraph. A veterinarian maintaining dangerous drugs in accordance with this rule shall only obtain the drugs from single terminal distributor and shall not co-mingle drug stock from another terminal distributor of dangerous drugs.

Effective: 9/15/2017
Five Year Review (FYR) Dates: 05/26/2017 and 09/15/2022
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.26
Prior Effective Dates: 9/10/76, 2/1/98, 3/1/99