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DEA inspections and audits warrant compliance plan, Part 1

Michael A. Dowell (mdowell@hinshawlaw.com) is Health Law Partner in the Downtown Los Angeles office of Hinshaw & Culbertson, LLP.

The federal law governing the manufacture, distribution, and use of prescription and illicit opioids is the Controlled Substances Act (CSA),[1] a statute that the Drug Enforcement Administration (DEA) is principally responsible for administering and enforcing. The DEA is an agency within the U.S. Department of Justice (DOJ). The mission of the DEA is: (1) to provide guidance on compliance with the CSA to ensure an adequate supply of controlled substances for legitimate needs; (2) to prevent, detect, and investigate the diversion of controlled substances; and (3) to engage in administrative, civil, and criminal enforcement actions against parties that violate the CSA or are otherwise involved in the diversion of controlled substances.[2] Drug diversion is the act of illegally obtaining or using prescription medications not intended by the prescriber, dispenser, manufacturer, or distributor of the controlled substances.

The CSA places controlled substances into one of five schedules based on the substance’s medical use, potential for abuse, and safety or dependence liability.[3] The current list of controlled substances within their designated schedules may be found in 21 C.F.R. § 1308.11-15 . The order of the five schedules in which controlled substances are categorized reflects substances that are progressively less dangerous and addictive. Schedule I contains substances, such as heroin, that have “a high potential for abuse” with “no currently accepted medical use in treatment in the United States” and that cannot safely be dispensed under a prescription. Schedule II contains substances such as prescription opioids that have recognized medical uses but may lead to severe psychological or physical dependence. Schedules III, IV, and V include substances that have recognized medical uses, such as Xanax, Ambien, and products containing codeine, that have low potential for abuse relative to controlled substances in Schedules I and II.[4]

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