By Larry K. Houck –
Deputy Assistant Administrator Joseph Rannazzisi, Office of Diversion Control, Drug Enforcement Administration (“DEA”), told the House of Representatives Energy and Commerce’s Subcommittee on Oversight and Investigations on April 29, 2014 that his agency “has steadily increased the frequency of compliance inspections” of manufacturers, distributors, pharmacies, importers, exporters and narcotic treatment programs. Statement of Joseph T. Rannazzisi, Deputy Administrator, Office of Diversion Control, Drug Enforcement Administration, Before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce, U.S. House of Representatives, “Examining the Growing Problems of Prescription Drug and Heroin Abuse,” Apr. 29, 2014. We can attest that Mr. Rannzzisi’s assertion is not only accurate, but understated. The current DEA cyclic inspections are more frequent and more in-depth as well.
Many aspects of DEA inspections are beyond registrants’ control, but there are certain actions that registrants can and should take to prepare for and manage the inevitable DEA inspection. This article offers practical guidance on some of those actions.
Non-practitioner registrants (manufacturers, distributors, importers, exporters and narcotic treatment programs) can expect to be inspected about once every three years, and Drug Addiction Treatment Act (“DATA”)-waived practitioners approximately once every five years. (DATA-waived practitioners are physicians administering, dispensing, and prescribing specific FDA-approved controlled substances for narcotic treatment. DEA-registered physicians who apply and are qualified pursuant to DATA are issued a waiver, and are then able to conduct maintenance and detoxification treatment using specifically approved schedule III, IV, or V narcotic medications for either 30 or 100 patients at any one time.) Registrants must understand that although the diversion investigators who conduct the inspections are within DEA’s Office of Diversion Control, the regulatory arm governing legitimate controlled substance handlers, the focus of the Agency, and thus of the investigators, is primarily law enforcement. Diversion investigators typically prepare for the inspections by reviewing previous inspection reports and Automation of Reports and Consolidated Orders System (“ARCOS”) data (to the extent available). Investigators will also consider areas of prior non-compliance during the current inspection to ensure that registrants have remedied past deficiencies.
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Deputy Assistant Administrator Joseph Rannazzisi, Office of Diversion Control, Drug Enforcement Administration (“DEA”), told the House of Representatives Energy and Commerce’s Subcommittee on Oversight and Investigations on April 29, 2014 that his agency “has steadily increased the frequency of compliance inspections” of manufacturers, distributors, pharmacies, importers, exporters and narcotic treatment programs. Statement of Joseph T. Rannazzisi, Deputy Administrator, Office of Diversion Control, Drug Enforcement Administration, Before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce, U.S. House of Representatives, “Examining the Growing Problems of Prescription Drug and Heroin Abuse,” Apr. 29, 2014. We can attest that Mr. Rannzzisi’s assertion is not only accurate, but understated. The current DEA cyclic inspections are more frequent and more in-depth as well.
Many aspects of DEA inspections are beyond registrants’ control, but there are certain actions that registrants can and should take to prepare for and manage the inevitable DEA inspection. This article offers practical guidance on some of those actions.
Non-practitioner registrants (manufacturers, distributors, importers, exporters and narcotic treatment programs) can expect to be inspected about once every three years, and Drug Addiction Treatment Act (“DATA”)-waived practitioners approximately once every five years. (DATA-waived practitioners are physicians administering, dispensing, and prescribing specific FDA-approved controlled substances for narcotic treatment. DEA-registered physicians who apply and are qualified pursuant to DATA are issued a waiver, and are then able to conduct maintenance and detoxification treatment using specifically approved schedule III, IV, or V narcotic medications for either 30 or 100 patients at any one time.) Registrants must understand that although the diversion investigators who conduct the inspections are within DEA’s Office of Diversion Control, the regulatory arm governing legitimate controlled substance handlers, the focus of the Agency, and thus of the investigators, is primarily law enforcement. Diversion investigators typically prepare for the inspections by reviewing previous inspection reports and Automation of Reports and Consolidated Orders System (“ARCOS”) data (to the extent available). Investigators will also consider areas of prior non-compliance during the current inspection to ensure that registrants have remedied past deficiencies.
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