856 IAC 2-7-4 - Storage, handling, and use of controlled substances

Authority: IC 35-48-3-2

Affected: IC 35-48-3-2

Sec. 4.

(a) Limited permit holders and their agents, representatives, and employees must comply with the requirements of this rule for the storage and handling of controlled substances.

(b) All facilities at which controlled substances are stored, handled, or used shall:

(1) be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(2) have storage areas large enough to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

(3) have a quarantine area for storage of controlled substances that are:

(A) outdated, damaged, deteriorated, misbranded, or adulterated; or

(B) in immediate or sealed secondary containers that have been opened;

(4) be maintained in a clean and orderly condition; and

(5) be free from infestation by insects, rodents, birds, or vermin of any kind.

(c) All facilities used for storage of controlled substances by registrants under this section shall comply with the security requirements as provided by 856 IAC 2-3-31.

(d) All controlled substances shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such controlled substances or with requirements in the current edition of an official compendium of drug information.

(e) If no storage requirements are established for a controlled substance, the controlled substance may be held at a controlled room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.

(f) Controlled substances that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other controlled substances until they are destroyed by a designated agent of the board or returned to their supplier.

(g) Any controlled substance whose immediate or sealed outer or sealed secondary containers have been opened or used shall be:

(1) identified as such; and

(2) quarantined and physically separated from other controlled substances until they are either destroyed by a designated agent of the board or returned to the supplier.

(h) Limited permit holders shall establish and maintain inventories and records of all controlled substances stored or used at the facility.

(i) Inventories and records shall be made available for inspection and photocopying by any authorized official of any governmental agency charged with enforcement of this rule for a period of two (2) years following disposition of the controlled substances.

(j) Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two (2) working days of a request by an authorized official of any governmental agency charged with enforcement of this rule.

Notes

856 IAC 2-7-4

Indiana Board of Pharmacy; 856 IAC 2-7-4; filed Aug 21, 2003, 4:45 p.m.: 27 IR 182; readopted filed Dec 1, 2009, 9:13 a.m.: 20091223-IR-856090782RFA; readopted filed November 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA Readopted filed 2/15/2024, 1:16 p.m.: 20240313-IR-856230795RFA