Diversion Control Division | Administering and Dispensing Q&A

Question: Must practitioners who receive controlled medications from a pharmacy, in accordance with 21 U.S.C. 829a(a), be registered with DEA at every location at which they receive such controlled medications?

Answer: Yes. One of the conditions imposed by the statute authorizing the delivery of opioids for maintenance or detoxification treatment of an opioid use disorder is that the controlled medication be delivered to the location that is listed on the practitioner’s certificate of registration. 21 U.S.C. 829a(a)(1). Thus, unless the practitioner is registered at a particular location, there is no authorization for delivery of the controlled medication to that location. Moreover, the CSA requires a separate registration "at each principal place of business or professional practice where the [registrant] . . . dispenses controlled substances." 21 U.S.C. 822(e)(1); see also 21 CFR 1301.12(a). The term "dispense," as defined in 21 U.S.C. 802(10), means to "deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance." EO-DEA285, DEA-DC82, February 21, 2024

Question: Can a physician transport controlled substances and administer at the patient's home residence (the so-called "black bag exception")?

Answer: Yes, with a limit. DEA will permit a physician who is registered with DEA to dispense controlled substances at a particular location in a state to travel to other unregistered locations in the same state to dispense controlled substances on an "as-needed and random basis," so long as the physician does not maintain a principal place of professional practice at any of those unregistered locations. See Jeffery J. Becker, D.D.S., 77 FR 72387, 72388 (Dec. 05, 2012); see also 21 U.S.C. 822(e)(1), 21 CFR 1301.12(b)(3). If a physician intends to dispense controlled substances from a particular location several times a week or month, he must first file a separate registration for the location. See Moore Clinical Trials, L.L.C., 79 FR 40145-02, 40155 (July 11, 2014) citing United States v. Clinical Leasing Serv., Inc., 930 F.2d 394, 395 (5th Cir. 1991). Registrants should keep themselves apprised of state and local laws otherwise consistent with DEA regulations regarding the dispensing of controlled substances in a patient's home residence. EO-DEA212, DEA-DC-047, October 8, 2020

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.