U.S. Department of Justice
Drug Enforcement Administration
Washington, DC 20537
October 27, 2006
The Honorable Tom A. Coburn
United States Senator
Spirit Bank Tower Building, Suite 800
Tulsa, OK 74119
ATTN: Toni Williams
Dear Senator Coburn:
Thank you for your letter dated September 14, 2006, to the Drug Enforcement Administration (DEA), on behalf of your constituent, Rev. Ronald V. Myers, Sr., M.D. Dr. Myers requested your assistance relative to a visit made to his Roland, Oklahoma medical practice on September 13, 2006,by investigators of the DEA Tulsa, Oklahoma Resident Office, and questions which arose concerning his need to possess a DEA registration in Oklahoma. Dr. Myers practices medicine in Mississippi and in Roland, Oklahoma. At the time of his inquiry to you, he had a DEA controlled substances registration in Mississippi, but did not have one for Oklahoma. DEA informed him that, because he practiced medicine in Oklahoma, he was required to have a DEA controlled substances registration in Oklahoma. Subsequently, he contacted your office and this agency questioning this requirement.
On September 22, 2006, DEA representatives participated in a conference call with Dr. Myers and Joni Williams of your staff. That conference call was very productive, and DEA agreed to memorialize the information provided, and answer additional questions which Dr. Myers submitted through your office. This letter responds to those questions as well as the other letters Dr. Myers has submitted to DEA.
As a preliminary matter, please note that, since his initial contact with your office, Dr. Myers applied for and has received a DEA controlled substance registration in Oklahoma. Consequently, he is now in compliance with the registration requirements of the Controlled Substance Act (CSA) with respect to his practice in Oklahoma.
Dr. Myers' concerns center around why he is required to have a controlled substances registration in Oklahoma, given that he already had one in another state. The CSA states. "A separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances or list I chemicals." See: 21 U.S.C. - 822(e). According to Dr. Myers, he writes prescriptions from his office in Roland, Oklahoma, but he does not "manufacture, store, dispense, or administer" them from that location.
The CSA defines the term "dispense," however, to mean "to deliver a controlled substance to an ultimate user of research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery." Sec: 21 U.S.C. - 802(10). Accordingly, a physician who prescribes a controlled substance is, in fact, "dispensing" that controlled substance within the meaning of the CSA.
Furthermore, DEA's authority to register practitioners to "dispense" (including to prescribe) controlled substances is contingent upon the applicant's authorization in the state in which he or she practices, and his or her controlled substance privileges are determined by that specific state. See: 21 U.S.C. - 823(f) "The Attorney General shall register practitioners ... to dispense , or conduct research with, controlled substances in schedule II, III, IV, or V, if the applicant is authorized to dispense, or conduct research with respect to, controlled substances under the laws of the State in which he practices." See also: 21 C.F.R. - 1306.03(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 and requires a separate DEA registration for each state. The practitioner must also maintain authorization to practice medicine in each state where an office is maintained. Accordingly, because Dr. Myers practices controlled substances in Oklahoma, albeit on a part-time basis, he is required to have a DEA registration in that state.
Dr. Myers also raises a number of situations in which he asserts that other practitioners practice in multiple states without multiple registrations. The situations to which he refers appear to be among those for which the DEA regulations expressly exempt the practitioner from the requirement of registration. For example, an individual practitioner who is an agent or employee of a hospital or other institution may, when acting in the normal course of business or employment, administer, dispense or prescribe controlled substances under the registration of the hospital or other institution in lieu of being registered him or herself, provided certain conditions are met. See: 21 C.F.R. - 1301.22(c). Similarly, military medical personnel are authorized to prescribe, dispense or administer controlled substances without a DEA registration under certain circumstances. See: 21 C.F.R. - 1301.23. With regard to the practice of locum tenens, whereby a registered practitioner substitutes for another practitioner on a temporary basis at that other practitioner's registered place of business, DEA expects to publish a notice in the Federal Register concerning this practice in the near future. None of these exemptions apply to Dr. Myers' situation.
Please be assured that the DEA is obligated to enforce the CSA and its implementing regulations in an even-handed manner. DEA has always applied the foregoing registration requirements to all practitioners in the United States. Whenever the DEA becomes aware of activity contrary to the law and regulation, we investigate and take necessary action.
Finally, Dr. Myers expresses the view that there is confusion and misunderstanding about the registration requirements, and he asks if DEA will take steps to address this situation. The DEA published a Notice of Proposed Rulemaking in the Federal Register titled Clarification of Registration Requirements for Individual Practitioners on December 7, 2004 (copy enclosed). This notice stated that, "an individual practitioner must have a separate DEA registration, predicated on a separate state license, if he/she practices in offices that are located in different states and administers, dispenses directly, or prescribes controlled substances from both states." The proposed rule sought to clarify an exception to this requirement for practitioners who maintain multiple offices within a single state. DEA will soon publish a Final Rule on this issue in the Federal Register, which will remind the regulated population of the requirements. This information will be disseminated through the DEA Web site www.deadiversion.usdoj.gov, state medical boards, and through professional organizations.
I trust this information will assist you in responding to Dr. Myers. If I may be of further assistance, please do not hesitate to contact me.
Eric J. Akers, Chief
Congressional Affairs Section