La. Admin. Code tit. 46 § LIII-2713

Current through Register Vol. 50, No. 11, November 20, 2024

Section LIII-2713 - General Requirements

A. A licensee shall provide effective controls and procedures to guard against theft or diversion of controlled substances. In evaluating the overall security system of a licensee or applicant, the board may consider any of the following factors:

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 substances handled;

4. the physical location of the premises;

5. the type of building construction comprising the facility and the general characteristics of the building(s);

6. the type of vault, safe, and secure enclosures or other storage system(s) used;

7. the adequacy of key control systems, combination lock control systems, or both;

8. the adequacy of electric detection and alarm systems, if any, including use of supervised transmittal lines and standby power sources;

9. the extent of unsupervised public and visitor access to the facility including maintenance personnel and non-employee service personnel;

10. the adequacy of supervision of employee access;

11. local police protection or security personnel;

12. the adequacy for monitoring the receipt, manufacture, distribution, procurement, and disposition of controlled substances; and

13. the applicability of the security requirements contained in all federal, state, and local laws and regulations governing the management of waste.

B. When physical security controls become inadequate, the physical security controls shall be expanded and extended accordingly.

La. Admin. Code tit. 46, § LIII-2713

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2134 (October 2008).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:972.