856 Ind. Admin. Code 2-3-30

Current through December 12, 2024

Section 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] .

856 IAC 2-3-30

Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.71; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed November 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA

Readopted filed 2/15/2024, 1:16 p.m.: 20240313-IR-856230795RFA