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The Drug Enforcement Administration is revising its regulations relating to suspicious orders of controlled substances. The proposed rule defines the term suspicious order and specifies the procedures a registrant must follow upon receiving such orders.

Statement of Need:

DEA intends to publish a proposed regulation to revise its regulations relating to suspicious orders of controlled substances found at 21 CFR 1301.74 and 21 CFR 1301.76. The draft regulation proposes to define the term suspicious order and specify the procedures a registrant must follow upon receiving such orders.  DEA published an NPRM titled Suspicious Orders of Controlled Substances in November of 2020.  Due to the large volume of public comments, DEA reopened the comment period until March 29, 2021 (RIN 1117-AB47).

Summary of the Legal Basis:

DEA implements and enforces the CSA and the Controlled Substances Import and Export Act, (21 U.S.C. 801-971), as amended.  DEA publishes the implementing regulations for these statutes in 21 CFR parts 1300 to end.  These regulations are designed to ensure a sufficient supply of controlled substances for medical, scientific, and other legitimate purposes, and to deter the diversion of controlled substances for illicit purposes.

As mandated by the CSA, DEA establishes and maintains a closed system of control for manufacturing, distribution, and dispensing of controlled substances, and requires any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances to register with DEA, unless they meet an exemption, pursuant to 21 U.S.C. 822.  The CSA further authorizes the Administrator to promulgate regulations necessary and appropriate to execute the functions of subchapter I (Control and Enforcement) and subchapter II (Import and Export) of the CSA.  21 U.S.C. 871(b), 958(f).

Alternatives:

DEA is reviewing and taking into consideration the comments received in response to the November, 2020, NPRM.

Anticipated Costs and Benefits:

DEA anticipates this rule will not be economically significant (that is, that the rule will not have an annual effect on the economy of $200 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities). DEA anticipates there will be a cost savings for registrants who are over-reporting, as they will report fewer suspicious order reports to SORS, and will allow for more accurate tracking, investigatory and data collection by the Administration.