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DEA inspections and audits warrant compliance plan, Part 2

Michael A. Dowell ( is Health Law Partner in the Los Angeles office of Hinshaw & Culbertson, LLP.

Part 1 of this two-part article was published in the November 2019 issue of Compliance Today.

Last month we looked at how the Drug Enforcement Administration (DEA) administers and enforces the federal law governing the manufacture, distribution, and use of prescription and illicit opioids under the Controlled Substances Act (CSA). Part 1 covers the record-keeping requirements, security requirements, and dispensing requirements for pharmacies under the CSA. Part 2 reviews the reporting requirements as well as issues involved in the development of a controlled substance compliance program.

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