Reporting Controlled Substance Breakage, Spillage, and/or Damage to DEA

Drug Enforcement Administration
Diversion Control Division
Guidance Document
Title: Reporting Controlled Substance Breakage, Spillage, and/or Damage to DEA
Summary: This guidance document addresses the question of whether controlled substances that
are broken and/or spilled at a DEA registrant’s registered location need to be reported to DEA.
Activity: Reporting Breakage, Spillage, and/or Damage of Controlled Substances
To Whom it Applies: DEA Registrants
Question: Do controlled substances that are broken, spilled, and/or damaged need to be reported
to the Drug Enforcement Administration (DEA)?
Answer: While neither the Controlled Substances Act nor DEA’s regulations specifically
address reporting the breakage and/or spillage of a controlled substance, on August 12, 2005,
DEA published in the Federal Register (FR) a Final Rule, Reports by Registrants of Theft or
Significant Loss of Controlled Substances,70 FR 47094. In that rule, DEA remarked that
previous guidance on the topic, given in a July 8, 2003 Notice of Proposed Rulemaking and
Guidance Document, Reports by Registrants of Theft or Significant Loss of Controlled
Substances, 68 FR 40576, was adequate and sufficiently clear: the witnessed breakage or spillage
of a controlled substance does not constitute a loss of controlled substances because the
registrant can account for the controlled substances; these types of incidents do not require
notification to DEA. 70 FR 47096; see also 68 FR 40578. DEA also stated that registrants
“should continue to employ common sense, good faith approaches to their reporting and
recordkeeping obligations in the case of breakage and spillage.” 70 FR 47096. DEA registrants
are also reminded of their recordkeeping obligations with respect to controlled substances that
are disposed of by destruction. See 21 CFR 1304.22(a)(2)(ix).
The contents of this document do not have the force and effect of law and are not meant
to bind the public in any way. This document is intended only to provide clarity to the public
regarding existing requirements under the law or Department policies.
EO-DEA144, DEA-DC-051, June 17, 2021