us-doj-guidance-DEA-DC-042•Civil Unrest QA, Bulk Destruction
Civil Unrest QA, Bulk Destruction
us-doj-guidance-DEA-DC-042Civil Unrest QA, Bulk DestructionGuidance
Drug Enforcement Administration Diversion Control Division Guidance Document Title: QA Civil Unrest – Destruction of Controlled Substances Question: Some pharmacies have experienced looting and extreme damage during recent rioting. Medications were thrown on the floor, and bottles were broken, making it unsafe and difficult to identify loose pills. How can we safely destroy controlled substances and maintain recordkeeping compliance? Answer: DEA regulations authorize pharmacies to destroy controlled substances, or cause controlled substances to be destroyed, in a variety of ways, so long as the pharmacy acts in accordance with all other applicable federal, state, tribal, and local laws and regulations, and the controlled substances are rendered non-retrievable. See, e.g., 21 CFR 1317.05(a), 1317.90, 1317.95. In most circumstances, however, DEA recommends that a pharmacy take the following steps to allow for the safe destruction of controlled substances and maintain records: 1) Contact a DEA-registered reverse distributor who will work with you to receive the controlled substances you need destroyed. 2) Safely transfer the controlled substances (and any debris mixed in with them) into containers, and seal the containers. 3) Sealed containers should be given a serial number or item number for tracking purposes. 4) You should document your transfer of these sealed containers to a reverse distributor on an invoice. The invoice should note the number of sealed containers and each container’s serial number. This will act as the record of receipt for the reverse distributor. 21 CFR 1304.21(d). 5) Sealed containers should then be sent to a reverse distributor through a common or contract carrier or picked up by a reverse distributor under their standard operating procedures. 21 CFR 1317.05(a)(2). If a common or contract carrier is used, sealed containers must only be delivered to the reverse distributor’s registered location. 21 CFR 1317.15(b)(2)(i). 6) The reverse distributor will destroy entire sealed containers and document the destruction on a DEA Form 41. 21 CFR 1304.21(e). 7) To account for lost, damaged, or stolen controlled substances (including through looting) that need to be destroyed, you should file a DEA Form 106 (report of Theft or Loss of Controlled Substances) based on pre-riot inventories and other pharmacy records. 21 CFR 1301.76(b). Forms may be accessed through this DEA link: https://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html. You are required to maintain complete and accurate records. 21 U.S.C. 827(a)(3). Guidance documents, like this document, are not binding and lack the force and effect of law, unless expressly authorized by statute or expressly incorporated into a contract, grant, or cooperative agreement. Consistent with Executive Order 13891 and the Office of Management and Budget implementing memoranda, the Department will not cite, use, or rely on any guidance
document that is not accessible through the Department’s guidance portal, or similar guidance portals for other Executive Branch departments and agencies, except to establish historical facts. To the extent any guidance document sets out voluntary standards (e.g., recommended practices), compliance with those standards is voluntary, and noncompliance will not result in enforcement action. Guidance documents may be rescinded or modified in the Department’s complete discretion, consistent with applicable laws. EO-DEA210, July 13, 2020, DEA-DC-042
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