856 IAC 2-3-32 - Manufacturing areas; security controls for nonpractitioners

Authority: IC 35-48-3-1

Affected: IC 35-48-3-7

Sec. 32.

Physical security controls for nonpractitioners: Manufacturing areas. All manufacturing activities (including processing, packaging, and labeling) involving controlled substances listed in any schedule shall be conducted in accordance with the following:

(a) All in-process substances shall be returned to the controlled substances storage area at the termination of the process. If the process is not terminated at the end of a workday (except where a continuous process or other normal manufacturing operation should not be interrupted), the processing area or tanks, vessels, bins or bulk containers containing such substances shall be securely locked, with adequate security for the area or building. If such security requires an alarm, such alarm, upon unauthorized entry, shall transmit a signal directly to a central station protection company, or a local or State Police agency which has a legal duty to respond, or a 24-hour control station operated by registrant.

(b) Manufacturing activities with controlled substances shall be conducted in an area or areas of clearly defined limited access which is under surveillance by an employee or employees designated in writing as responsible for the area. "Limited access" may be provided in the absence of physical dividers such as walls or partitions, by traffic control lines or restricted space designation. The employee designated as responsible for the area may be engaged in the particular manufacturing operation being conducted: Provided: that he is able to provide continuous surveillance of the area in order that unauthorized persons may not enter or leave the area without his knowledge.

(c) During the production of controlled substances, the manufacturing areas shall be accessible to only those employees required for efficient operation. When it is necessary for employee maintenance personnel, non-employee maintenance personnel, business guests, or visitors to be present in or pass through manufacturing areas during production of controlled substances, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.

(d) Compliance with the requirements prescribed in Part 301, Section 301.73 of Title 21 of the Code of Federal Regulations, effective April 1, 1973, shall be deemed in compliance with this section.

Notes

856 IAC 2-3-32

Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.73; 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