Question: Are DEA-registered manufacturers or distributors required by the CSA or DEA regulations to establish limits (quantitative thresholds) on the amounts of controlled substances, including MOUD, that another DEA registrant can order or dispense?

Answer: No. Neither the CSA nor DEA regulations establish quantitative thresholds or limits on the amounts of controlled substances, including MOUD, that DEA registrants may order or dispense, nor do they require registrants to set such thresholds or limits.

The CSA, as amended by the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment Act (SUPPORT Act) requires each DEA registrant to: 1) design and operate a system to identify suspicious orders for the registrant; 2) ensure that the system complies with applicable Federal and State privacy laws; and 3) upon discovering a suspicious order or series of orders, notify the Administrator of the DEA and the Special Agent in Charge of the Division Office of the DEA for the area in which the registrant is located or conducts business. 21 U.S.C. 832(a). Suspicious orders may include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency. 21 U.S.C. 802(57). Furthermore, all applicants and registrants must maintain effective controls and procedures to guard against theft and diversion. 21 CFR 1301.71(a).

To comply with these statutory and regulatory requirements, many DEA-registered manufacturers and distributors establish controlled substance monitoring systems that set thresholds that may limit the amount of a customer’s controlled substance purchases and may prompt a report of a suspicious order to DEA. However, whether to set such thresholds (if any) and at what levels are decisions that each manufacturer or distributer may make in the design and implementation of its controlled substance monitoring system. DEA does not have a role in establishing or revising thresholds for controlled substances that manufacturers or distributors may set for their customers as part of the required monitoring systems.

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 of Justice policies. DEA-DC-065, EO-DEA258, January 20, 2023

Disclaimer: 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.