Controlled Substances Security Manual
A Message from the Administrator
The safeguarding of controlled substances is a problem confronting all manufacturers, distributors, pharmacies, and other drug handlers. Federal law limits the handling of these substances and by regulation requires that they be properly safeguarded at all times. The drug Enforcement Administration (DEA) is responsible for ensuring that effective security is maintained. The drug industry is responsible for establishing and maintaining effective controls and procedures to prevent diversion.
This manual outlines the steps needed to establish a competent security system which deters diversion and reduces accessibility for potential abusers. Further guidance may be obtained from one of DEA's Field Divisions (listed at the end of this manual) or from the Office of Diversion Control located at our Headquarters in Washington, D.C.
Robert C. Bonner
Administrator of Drug Enforcement
Over 770,000 manufactures, distributes, pharmacies, and other handlers of controlled substances are registered with DEA. The vast majority of this group complies with controlled substances laws and regulations in a responsible and law abiding manner, and has self-regulation programs consistent with the highest standards. DEA relies upon these programs and concentrates its resources on the more serious problems of both practitioner and non-practitioner diversion.
Handlers of controlled substances must be aware of the various diversion methods, which include illegal sale, falsified prescription orders, burglary, employee theft, loss in-transit, robbery, and customer/patient theft. However, willful and intentional diversion by manufacturers, distributors and dispensers is another source of diversion.
A critical first step in diversion prevention is employee screening; concern with personnel security must start before and employee is hired. Pre-employment screening to identify potential security problems is important when choosing new employees to work in or around areas where controlled substances are handled. The screening program should include a careful evaluation of the applicant's personal and previous employment references. Criminal background checks with local law enforcement authorities and with DEA are equally important. Similar precautionary measures should be taken before transferring established employees to new jobs in areas where controlled substances are manufactured, processed, stored, shipped, dispensed, or handled in any way.
The areas which must be protected against theft and diversion vary greatly depending on the type of business. Manufacturers must be alert for pilferage at every level of drug handling, from the receipt of raw material, through all phases of manufacturing and processing, to finished product storage and shipping. They must be watchful for pilferage of production rejects and of returned of damaged merchandise. They must be alert to the theft of dosage form drugs, bulk raw material, equipment, and even chemical precursors. They must be certain that all controlled substances are secure throughout the entire manufacturing and distribution process. Many of the concerns also apply to controlled substance distributors.
Security problems confronting a pharmacist are no less serious. The pharmacist must secure the controlled substances storage and prescription compounding areas. As in the case of larger drug handlers, a key factor in protecting against theft and diversion is limiting employee access. Access to all controlled substances should be restricted to the minimum number of employees needed to perform the tasks related to these drugs.