82 FR 55639 - Linda M. Shuck, D.O.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 224 (November 22, 2017)

[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)]
[Notices]
[Pages 55639-55641]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25286]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Linda M. Shuck, D.O.; Decision and Order

    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

[[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.

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.'' \1\ 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

[[Page 55641]]

to dispense controlled substances under the laws of the State of North 
Carolina.
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    \1\ According to the online records of the North Carolina 
Medical Board, of which I take official notice, the suspension of 
Registrant's medical license remains in effect as of the date of 
this Decision and Order. See 5 U.S.C. 556(e). Registrant may dispute 
this finding by filing a properly supported motion for 
reconsideration within 10 business days of the date of this Order 
with the Office of the Administrator. Registrant may also provide 
evidence that she has completed the five-day board certification 
review course. Registrant must serve a copy of any such motion on 
the Government.
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Discussion

    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.\2\ 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.
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    \2\ Indeed, as found above, even if she completes the course and 
returns to practice, under the Consent Order, she is prohibited from 
prescribing controlled substances outside of a hospital where she 
``has active clinical privileges.'' GX 3, Appendix A, at 5. As this 
revocation does not impose any time bar on Registrant's ability to 
reapply, she can apply for a new registration upon being allowed to 
return to practice.
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Order

    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.\3\
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    \3\ Based on the North Carolina Board's findings that Registrant 
prescribed controlled substances in violation of the Interim Partial 
Non-Practice Agreement, I find that the public interest necessitates 
that this Order be effective immediately. 21 CFR 1316.67.

    Dated: November 13, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017-25286 Filed 11-21-17; 8:45 am]
 BILLING CODE 4410-09-P