Civil Unrest Q&A Suspicious Order Reporting

Drug Enforcement Administration
Diversion Control Division
Civil Unrest Emergency Guidance Document
Title: Civil Unrest Q&A Suspicious Order Reporting
Question: Could the DEA provide distributors with guidance on reporting of suspicious orders
for pharmacies that need to replenish stocks of controlled substances lost or damaged due to
looting/rioting or pharmacies that may need to acquire additional stocks due to closure of
neighboring pharmacies?
Answer: The Controlled Substances Act requires that all DEA registrants that distribute
controlled substances report suspicious orders to DEA. 21 U.S.C. § 832(a)(3). The term
suspicious order “may include, but is not limited to-- (A) an order of a controlled substance of
unusual size; (B) an order of a controlled substance deviating substantially from a normal
pattern; and (C) orders of controlled substances of unusual frequency.” 21 U.S.C. § 802(57) and
21 CFR § 1301.74(b).
DEA recognizes that a pharmacy may need to replace a substantial portion, or all, of its
controlled substance stock due to losses caused by looting or rioting. 	DEA also recognizes that a
pharmacy may need to order additional stocks of controlled substances that exceed its normal
ordering patterns due to increased legitimate customer demand arising from the closure of
neighboring pharmacies.
Upon receiving orders falling within the definition of “suspicious order,” registrants must
conduct appropriate due diligence by considering all relevant circumstances to determine if there
is a legitimate basis for the order. 21 CFR 1301.74(c). If the registrant cannot determine that the
order is legitimate, the order must be reported as suspicious. 21 CFR 1301.74(b).
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-DEA159, June 9, 2020.