Ill. Admin. Code tit. 77 § 3100.310

Current through Register Vol. 48, No. 43, October 25, 2024

Section 3100.310 - Security Requirements Generally

a) All applicants and licensees shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a person has provided effective controls against diversion, the Division shall use the security requirements set forth in this Section as standards for the physical security controls and operating procedures necessary to prevent diversion. Substantial compliance with these standards may be deemed sufficient by the Division after evaluation of the overall security system and needs of the applicant or licensee.

b) Physical security controls shall be commensurate with the Schedules, and quantity, type and form of controlled substances (e.g., bulk liquids or dosage units, usable powders or non-usable powders) in the possession of the licensee in normal business operations. When physical 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 licensee during normal business operations, the physical security controls shall be expanded and extended accordingly. A licensee may adjust physical security controls within the requirements set forth in this Section when the need for those controls decreases as a result of a controlled substance being transferred to a different Schedule, or as a result of a controlled substance being removed from control, or as a result of a significant decrease in the quantity of a controlled substance in the possession of the licensee during normal business operations.

c) Any additional security evidence, including but not limited to: video surveillance, computer access logs or records, or falsified prescription/medical documentation that demonstrates or captures diversion or other illicit activity involving controlled substances shall be made available to the Division upon request, along with a copy of any DEA Form 106 filed pursuant to Section 3100.360(e).

d) Personal bags of any kind, including but not limited to purses, handbags and backpacks, are prohibited in any area where controlled substances are handled and/or stored.

e) A basic alarm system that detects unauthorized entry into the pharmacy area. This does not apply to 24-hour pharmacies that never close.

f) All pharmacies are required to maintain a key to the licensed pharmacy area held by an employee of the pharmacy who is a licensed pharmacist or a registered pharmacy technician or certified pharmacy technician.

Ill. Admin. Code tit. 77, § 3100.310

Amended at 39 Ill. Reg. 3656, effective 2/27/2015