QA Black Bag Exception

Drug Enforcement Administration
Diversion Control Division
Guidance Document
Title: Practice of Medicine
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.
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 Guidance documents may be rescinded or modified in the Department’s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-DEA212, DEA-DC-047, October 8, 2020