On July 25, 2017, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration, issued an Order to Show Cause to Linda M. Shuck (Registrant), of Dobson, North Carolina. The Show Cause Order proposed the revocation of Registrant's Certificate of Registration, on the ground that she Start Printed Page 55640“do[es] not have authority to handle controlled substances in the State of North Carolina, the [S]tate in which [she is] registered with the” Agency. GX 2, at 1 (citing 21 U.S.C. 823(f) and 824(a)(3)).
As to the jurisdictional basis for the proceeding, the Show Cause Order alleged that Registrant is the holder of a practitioner's registration with authority in schedules II through V, under Certificate of Registration No. BP4154023, at the registered location of Carolina Heart Care, 651 S. Main Street, Dobson, North Carolina. Id. The Order further alleged that this registration “expires . . . on February 28, 2018.” Id.
As to the substantive ground for the proceeding, the Show Cause Order alleged that on June 23, 2017, the North Carolina Medical Board suspended Registrant's medical license for six months. Id. The Order alleged that because of the Board's action, Registrant is “without authority to handle controlled substances in . . . North Carolina, the [S]tate in which [she is] registered,” and that as a consequence, her registration is subject to revocation. Id. at 1-2 (citing cases).
The Show Cause Order notified Registrant of her right to request a hearing on the allegations or to submit a written statement while waiving her right to a hearing, the procedure for electing either option, and the consequence for failing to elect either option. Id. at 2 (citing 21 CFR 1301.43). In addition, the Show Cause Order notified Registrant of her right to submit a corrective action plan under 21 U.S.C. 824(c)(2)(C). Id. at 2-3.
On August 1, 2017, a DEA Special Agent assigned to the Charlotte District Office personally served the Show Cause Order on Registrant. GX 3, at 1-2 (Declaration of Special Agent). In a letter dated August 3, 2017, Registrant stated that she was “aware of the current law regarding [her] DEA Certificate” and that she did “not wish to have a hearing on the issue.” GX 4. Registrant further stated that her “medical license is suspend[ed] until 12-23-2017” and that she “will reapply for [her] DEA certification after [her] suspension is completed.” Id.
On September 8, 2017, the Government submitted a Request for Final Agency Action. Therein, the Government seeks the revocation of Registrant's registration. As support for the proposed action, the Government submitted various exhibits, including a Consent Order entered into by Registrant and the North Carolina Medical Board on May 23, 2017. See GX3A, at 8.
Based on Registrant's letter of August 3, 2017, I find that Registrant has waived her right to a hearing on the allegations of the Show Cause Order. 21 CFR 1301.43. I therefore issue this Decision and Order based on relevant evidence submitted by the Government. I make the following findings.
Registrant is the holder of DEA Certificate of Registration No. BP4154023, pursuant to which she is authorized to dispense controlled substances in schedules II through V, at the registered address of Carolina Heart Care, 651 S. Main St., Dobson, North Carolina. GX 1. Registrant is also the holder of DATA-Waiver Identification No. XP4154023, pursuant to which she is authorized to prescribe schedule III through V “narcotic drug[s] approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment” to up to 100 patients. GX 1; see also 21 CFR 1306.04(c).
Registrant is also the holder of a license to practice medicine and surgery issued by the North Carolina Medical Board. However, on May 23, 2017, Registrant entered into a Consent Order with the Board. GX 3, Appendix A, at 8. The Board's Order found that in September 2014, Registrant and the Board had entered a previous Consent Order “based on findings that [she] had failed to conform to the standards of acceptable and prevailing medical practice in her care of five patients that she treated for chronic pain.” Id. at 2. The Board further found that while Registrant “underwent the required [comprehensive professional] assessment, [she] still has failed to complete any remediation recommended by the assessment center in a timely manner.” Id.
The Board's Order also found that, in April 2016, it had received information regarding Registrant's prescribing of opiates to four patients, including one who died due to “opioid toxicity.” Id. The Board further found that “an independent medical expert” had reviewed the medical records of the four patients and opined that Registrant's “diagnosis, treatment, and overall care in all four . . . cases failed to conform to the standards of acceptable and prevailing medical practice in North Carolina.” Id.
Finally, the Board found that, “[o]n December 6, 2016, [Registrant] entered into an Interim Partial Non-Practice Agreement restricting her prescribing of all controlled substances.” Id. at 3. The Board further found that Registrant issued controlled substance prescriptions to patients in violation of the Interim Partial Non-Practice Agreement. Id.
With respect to her “care and treatment of” the four patients, the Board concluded as a matter of law that Registrant “fail[ed] to conform to the standards of acceptable and prevailing medical practice.” Id. at 4 (citing N.C. Gen. Stat. SEC. 90-14(a)(6)). The Board also concluded as a matter of law that Registrant's “issuance of controlled substance prescriptions in violation of a restriction contained in the December 2016 Interim Partial Non-Practice Agreement . . . constitutes unprofessional conduct.” Id. (citing N.C. Gen. Stat. SEC. 90-14(a)(6)).
The Board and Registrant agreed to resolve the matter by suspending her medical license for a period of six months “from June 23, 2017 until December 23, 2017.” Id. at 5. While the Board and Registrant agreed that she “may return to the active practice of medicine on December 24, 2017, subject to the provisions contained in this . . . Order,” the provisions include that she “shall not prescribe controlled substances except for a patient who has been admitted to a hospital where [she] has active clinical privileges.” Id. The provisions also include that “[o]nce the patient has been discharged, [she] shall not prescribe controlled substances for those patients who received such medications pursuant to” the above provision. Id. at 6.
Moreover, Registrant's ability to resume practicing medicine is also subject to the condition that she “complete a five . . . day board certification review course in Internal Medicine.” 
Id. Thus, while the suspension may expire in less than six weeks, it is far from certain that she will be able to resume practicing medicine (even subject to the limitations on her authority to prescribe), and absent evidence that she has completed the board certification review course, the restriction on her ability to resume practicing takes on the characteristic of a suspension of indefinite duration. Based on the above, I find that Registrant is currently without authority Start Printed Page 55641to dispense controlled substances under the laws of the State of North Carolina.
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823, “upon a finding that the Registrant . . . has had his State license . . . suspended [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” Also, DEA has held repeatedly that the possession of authority to dispense controlled substances under the laws of the State in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration. See, e.g.,
James L. Hooper, 76 FR 71371 (2011), pet. for rev. denied, 481 Fed Appx. 826 (4th Cir. 2012); Frederick Marsh Blanton, 43 FR 27616 (1978).
This rule derives from the text of two provisions of the CSA. First, Congress defined “the term `practitioner' [to] mean a . . . physician . . . or other person licensed, registered or otherwise permitted, by . . . the jurisdiction in which [s]he practices . . . to distribute, dispense, [or] administer . . . a controlled substance in the course of professional practice.” 21 U.S.C. 802(21). Second, in setting the requirements for obtaining a practitioner's registration, Congress directed that “[t]he Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which [s]he practices.” 21 U.S.C. 823(f). Because Congress has clearly mandated that a physician possess state authority in order to be deemed a practitioner under the Act, DEA has held that revocation of a practitioner's registration is the appropriate sanction whenever she is no longer authorized to dispense controlled substances under the laws of the State in which she practices medicine. See, e.
g., Calvin Ramsey, 76 FR 20034, 20036 (2011); Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988); see also Hooper v. Holder, 481 Fed. Appx. at 828.
As a consequence of the Consent Order which Registrant entered into with the Board, she is not currently authorized to dispense controlled substances in North Carolina, the State in which she is registered with the Agency. Because the CSA makes clear that the possession of authority to dispense controlled substances under the laws of the State in which a practitioner engages in professional practice is a fundamental condition for both obtaining and maintaining a practitioner's registration, it is of no consequence that the suspension is of a finite duration. See Hooper v. Holder, 481 F. App'x at 828 (upholding revocation of a physician's registration as based on a reasonable interpretation of the CSA, notwithstanding that the physician's medical license was subject to a suspension of known duration); see also James L. Hooper, 76 FR 71371, 71371-72 (2011). Rather, what matters for the purposes of the CSA is that Registrant is not currently authorized to dispense controlled substances in North Carolina. See Hooper, 76 FR at 71371 (quoting Anne Lazar Thorn, 62 FR 12847, 12848 (1997) (“the controlling question . . . is whether the Respondent is currently authorized to handle controlled substances in the state”)). Indeed, it is by no means clear that Registrant will even be able to resume the practice of medicine following the ending date of the suspension given the requirement that she complete the required five-day board certification review course.
Therefore, she is not entitled to maintain her registration in that State. Accordingly, I will order that her registration and her DATA-Waiver Identification number be revoked.
Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 28 CFR 0.100(b), I order that DEA Certificate of Registration No. BP4154023, issued to Linda M. Shuck, be, and it hereby is, revoked. I further order that DATA-Waiver Identification No. XP4154023, issued to Linda M. Shuck, be, and it hereby is, revoked. This order is effective immediately.
Dated: November 13, 2017.
Robert W. Patterson,
[FR Doc. 2017-25286 Filed 11-21-17; 8:45 am]
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