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
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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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