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Title: Section 80.19 - Security controls for nonpractitioners; manufacturing areas

80.19 Security controls for nonpractitioners; manufacturing areas. All manufacturing activities, including processing, packaging, and labeling, involving controlled substances listed in any schedule shall conform to the following security controls:

(a) All substances in process of manufacture shall be returned to the controlled substances storage area at the termination of the process. If the process is not completed 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 controlled substances shall be securely locked inside an area or building which affords adequate security.

(b) Manufacturing activities with controlled substances shall be conducted in an area or areas with limited access and shall be kept under surveillance by an employee or employees designated in writing by the licensee to be responsible for the area. The designated employee or employees shall be able to provide continuous surveillance of the area in order that unauthorized persons may not enter or leave the area without his knowledge. Limited access may be accomplished by use of physical dividers such as walls or partitions, by traffic control lines or by restricted space designations.

(c) During the production of controlled substances, the manufacturing area shall be accessible only to those employees necessary for efficient operation. If it is necessary for maintenance personnel, visitors or others to be present or pass through the manufacturing areas during production, the licensee shall have an employee designated in writing as being responsible for providing surveillance of the area.


VOLUME A-1a (Title 10)