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Controlled Substance Compliance Program White Paper

30 October 2014

The Pharmaceutical Security Council has released a white paper that examines the challenges of developing an effective controlled substance compliance program and offers best practices to enhance operations and meet DEA regulations.

The misuse and abuse of prescription drugs has been referred to as an epidemic in the United States. The Drug Enforcement Administration (DEA) is responsible for the enforcement of the Controlled Substances Act and its corresponding regulations. These regulations mandate that the pharmaceutical industry maintain a closed system of distribution, thereby preventing the illicit diversion of controlled substances.

This paper examines the basics of DEA Compliance and the general security requirements set forth in the Code of Federal Regulations, as well as offers suggested policies and procedures and best practices.


Controlled Substance Compliance Program (PDF)


About the ASIS Pharmaceutical Security Council
Promotes security leadership and cooperation between all segments of the pharmaceutical industry. Serves as a progressive source of information, as well as sponsors and supports program on security issues affecting the industry. Ensures representation of the entire supply chain, from manufacturing all the way to the patient.