Answer: Individual states may have educational requirements in order to obtain and maintain a valid license in that state. DEA requires that all state licensing requirements be met in order to obtain a DEA registration in that state. 21 U.S.C. 823(g)(1) and (4).
In addition, all practitioners, who are not solely veterinarians, when applying for a new registration or renewing their registration, must satisfy either the training, credentialing or educational requirements identified in section 1263 of the CAA 2023. [1] Please see the Q&A that DEA posted on its website in reference to the training, credentialing, or educational requirements, and related attestation. Practitioners can find additional information on SAMHSA’s website at Recommendations for Curricular Elements in Substance Use Disorders Training | SAMHSA. EO-DEA182R1, DEA-DC-076, September 21, 2023
[1] Pub. L. No. 117-328, div. FF, tit. I(B), ch. 6, § 1263(a), 136 Stat. 4459 (2022).
Answer: No action is needed on the part of registrants, as a result of the statutory repeal of 21 U.S.C. 823(h)(2). On December 29, 2022, with the signing of the CAA[i], Congress eliminated the DATA-Waiver requirement. Specifically, Pub. L. No. 117-328, div. FF, tit. I(B), ch. 6, § 1262(a)(1), 136 Stat. 4459, 5681 (2022) removed the federal requirement for practitioners to apply for a special waiver prior to prescribing buprenorphine for the treatment of Opioid Use Disorder (OUD). It also removed the requirement for the assignment of an identification number (i.e., X-waiver number) associated with being a DATA-waived provider, for inclusion with the registration issued to the practitioner. 21 U.S.C. 823(h)(2)(D)(ii). EO-DEA260, DEA-DC-067, March 22, 2023
Answer: Yes. An individual practitioner is a physician, dentist, veterinarian, or other individual licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, a pharmacy, or an institutional practitioner. A mid-level practitioner means an individual practitioner, other than a physician, dentist, veterinarian, or podiatrist, who is licensed, registered, or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice. Examples of mid-level practitioners include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists and physician assistants who are authorized to dispense controlled substances by the State in which they practice. See 21 CFR 1300.01(b). In addition, individual and mid-level practitioners must also be in compliance with applicable State, local or tribal laws.
DEA regulations require a separate registration for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person. 21 CFR 1301.12(a). DEA regulations do not prohibit individual and mid-level practitioners from using their home address.
If an individual practitioner or mid-level practitioner does choose to use their home address as a principal place of business or professional practice, the location becomes a "controlled premises" and is subject to unannounced inspections and administrative warrants under existing DEA regulations. See 21 CFR 1316.01–1316.13. An individual practitioner or mid-level practitioner whose DEA-registered location is a home must comply with the established recordkeeping requirements (see 21 CFR 1304 and 1305) and security requirements. See 21 CFR 1301.71, 1301.75 – 1301.76.
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, regulations, or Department of Justice policies. EO-DEA183, DEA-DC-052, November 3, 2021 (Revised #1), Original Posted July 8, 2021
Answer: Your registered address must be the physical location of your principal place of business or professional practice where controlled substances are manufactured, distributed, imported, exported, or dispensed. 21 CFR 1301.12(a). In limited circumstances, a PO Box may be included in addition to the physical business address, but a PO Box alone is not a registered address. You may, however, use a different address for your mailing address for DEA correspondence, which may be a PO Box or a PMB address. EO-DEA206, DEA-DC-050, December 12, 2020
Answer: Yes, you can change the address on your current DEA Registration. If you prefer, you can also call your Local Diversion Field Office for assistance, or you can ask a Registration Specialist for assistance by calling 1-800-882-9539 or by emailing your request to DEARegistrationHelp@dea.gov. EO-DEA185, November 2, 2020
Answer: Yes. Since DEA's authority to register practitioners to dispense (including to prescribe) controlled substances is contingent, in part, upon the applicant's authorization in the state in which he or she practices, his or her controlled substance privileges and limits are determined by that specific state. The Controlled Substances Act requires a separate registration at each principal place of business or professional practice where the controlled substances are distributed or dispensed. See 21 U.S.C. 822(e)(1), 21 CFR 1301.12(a). Therefore, a practitioner who maintains a professional practice location in multiple states has established, for registration purposes, a principal place of business in each of those states. Consequently, DEA requires that the practitioner obtain a separate DEA registration in each state. Further, to do so the practitioner must first obtain authorization to handle controlled substances in each state where he or she has an office. For additional information please see the Final Rule titled: Clarification of Registration Requirements for Individual Practitioners, which DEA published in the Federal Register on December 1, 2006. EO-DEA181, November 2, 2020
Answer: No. A DEA individual practitioner registration is based on a State license to practice medicine and prescribe controlled substances. DEA relies on State licensing boards to determine whether a practitioner is qualified to dispense, prescribe, or administer controlled substances and to determine which schedules he/she may dispense, prescribe, or administer. State authority to conduct the above-referenced activities only confers rights and privileges within the issuing State. Thus, a DEA registration based on a State license cannot authorize controlled substance dispensing outside the State. See Registration Requirements for Individual Practitioners Operating in a "Locum Tenens" Capacity, 75 FR 55499, 55501 (Oct. 28, 2009); 21 U.S.C. 823(f); 21 CFR 1306.03(a). EO-DEA089, October 21, 2020
Answer: Yes. 21 CFR 1301.12(a), "A separate location is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person." EO-DEA090, October 9, 2020
Answer: No. Under specific circumstances a separate DEA registration as a chemical importer is not required if you hold a registration to import controlled substances. DEA regulations provide a waiver to the separate registration requirement for certain List I chemical activities if the person is already registered with DEA to import controlled substances. 21 CFR 1309.24. Specifically, any person who imports or exports an SLCP or other product containing a List I chemical described and included in the definition of a regulated transaction found at 21 CFR 1300.02(1)(iv) is not required to obtain a separate registration for those activities if already registered to import controlled substances. See 21 CFR 1309.24(c). EO-DEA225, October 5, 2020
Answer: No. DEA regulations require that "only persons actually engaged in" the "dispens[ing] . . . of any controlled substance" hold a registration. 21 CFR 1301.11(a); see 21 U.S.C. 802(10) (defining "dispense" to include "the prescribing and administering of a controlled substance"). EO-DEA191, June 23, 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.