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)
Drug Enforcement Administration
Federal Register Volume 82, Issue 224 (November 22, 2017)
| Page Range | 55639-55641 | |
| FR Document | 2017-25286 |
[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] ----------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \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. --------------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \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. --------------------------------------------------------------------------- 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\ --------------------------------------------------------------------------- \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
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While Congress also amended section that Respondent is not currently DEPARTMENT OF JUSTICE
‘‘824(a) to add to the current bases for authorized to dispense controlled
denial, revocation, or suspension of substances in Mississippi, the State in Drug Enforcement Administration
registration a finding that registration which he holds the DEA registration at [Docket No. DEA–392]
would be inconsistent with the public issue in this proceeding, I will adopt the
interest on the grounds specified in ALJ’s recommended order that I revoke Importer of Controlled Substances
[section] 823, which will include his registration. Registration
consideration of the new factors added
by’’ the amendment, id. at 266–67, Order ACTION: Notice of registration.
Congress did not otherwise alter the text
Pursuant to the authority vested in me SUMMARY: Registrants listed below have
of section 824(a), which makes clear
that the various paragraphs of this by 21 U.S.C. 824(a), as well as 28 CFR applied for and been granted
provision are findings, each of which 0.100(b), I order that DEA Certificate of registration by the Drug Enforcement
provides an independent and adequate Registration No. AF2451261 issued to Administration as importers of various
ground to support agency action against Arnold E. Feldman, M.D., be, and it classes of schedule I or II controlled
a registration, and not discretionary hereby is, revoked. This Order is substances.
factors to be considered by the Agency. effective immediately.9 SUPPLEMENTARY INFORMATION: The
Indeed, Respondent points to nothing in Dated: November 13, 2017. companies listed below applied to be
the language of section 824 or the CSA’s Robert W. Patterson, registered as importers of various basic
legislative history to support his classes of controlled substances.
Acting Administrator.
position, which would fundamentally Information on previously published
[FR Doc. 2017–25287 Filed 11–21–17; 8:45 am]
alter the scope of the Agency’s authority notices is listed in the table below. No
under section 824. BILLING CODE 4410–09–P
comments or objections were submitted
I therefore reject Respondent’s and no requests for hearing were
contentions. Based on the ALJ’s finding submitted for these notices.
Company FR Docket Published
Almac Clinical Services Incorp (ACSI) ........................................................................................................ 82 FR 37114 August 8, 2017.
Stepan Company ......................................................................................................................................... 82 FR 41054 August 29, 2017.
Fresenius Kabi USA, LLC ........................................................................................................................... 82 FR 41053 August 29, 2017.
Cambrex Charles City ................................................................................................................................. 82 FR 41055 August 29, 2017.
Spex Certiprep Group, LLC ......................................................................................................................... 82 FR 42120 September 6, 2017.
Akorn, Inc .................................................................................................................................................... 82 FR 42117 September 6, 2017.
Fisher Clinical Services, Inc ........................................................................................................................ 82 FR 42121 September 6, 2017.
Siegfried USA, LLC ..................................................................................................................................... 82 FR 42117 September 6, 2017.
Mylan Pharmaceuticals, Inc ........................................................................................................................ 82 FR 42120 September 6, 2017.
KVK-Tech, Inc ............................................................................................................................................. 82 FR 42119 September 6, 2017.
Cerilliant Corporation ................................................................................................................................... 82 FR 43404 September 15, 2017.
Unither Manufacturing LLC ......................................................................................................................... 82 FR 43571 September 18, 2017.
Mylan Pharmaceuticals, Inc ........................................................................................................................ 82 FR 43572 September 18, 2017.
Catalent Centers, LLC ................................................................................................................................. 82 FR 43569 September 18, 2017.
Specgx LLC ................................................................................................................................................. 82 FR 43571 September 18, 2017.
Sharp Clinical Services, Inc ........................................................................................................................ 82 FR 43572 September 18, 2017.
Cody Laboratories, Inc ................................................................................................................................ 82 FR 45612 September 29, 2017.
Bellwyck Clinical Services ........................................................................................................................... 82 FR 45613 September 29, 2017.
The Drug Enforcement security systems, verifying each DEPARTMENT OF JUSTICE
Administration (DEA) has considered company’s compliance with state and
the factors in 21 U.S.C. 823, 952(a) and local laws, and reviewing each Drug Enforcement Administration
958(a) and determined that the company’s background and history.
registration of the listed registrants to Therefore, pursuant to 21 U.S.C. Linda M. Shuck, D.O.; Decision and
import the applicable basic classes of 952(a) and 958(a), and in accordance Order
schedule I or II controlled substances is with 21 CFR 1301.34, the DEA has
granted a registration as an importer for On July 25, 2017, the Assistant
consistent with the public interest and
schedule I or II controlled substances to Administrator, Diversion Control
with United States obligations under
the above listed persons. Division, Drug Enforcement
international treaties, conventions, or Administration, issued an Order to
protocols in effect on May 1, 1971. The Dated: November 16, 2017. Show Cause to Linda M. Shuck
DEA investigated each company’s Demetra Ashley, (Registrant), of Dobson, North Carolina.
maintenance of effective controls Acting Assistant Administrator.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
The Show Cause Order proposed the
against diversion by inspecting and [FR Doc. 2017–25284 Filed 11–21–17; 8:45 am] revocation of Registrant’s Certificate of
testing each company’s physical BILLING CODE 4410–09–P Registration, on the ground that she
9 While the Mississippi Board Order was based on that Respondent violated state law by Mot. for Summ. Disp., Appendix B, at 22, 24
the Louisiana Board’s Order, as noted in the former ‘‘[p]rescribing, dispensing, or administering legally (Louisiana Board Order at 12, 14). For the same
Acting Administrator’s Decision and Order which controlled substances or any dependency-inducing reasons as those cited by the former Acting
revoked Respondent’s Louisiana registration, the medication without legitimate medical justification Administrator, I find that the public interest
Louisiana Board found proved the sixth charge of thereof or in other than a legal or legitimate necessitates that this Order be effective
the Administrative Complaint in that proceeding, in manner.’’ See 82 FR at 39618 n.8 (2017); see also immediately. See also 21 CFR 1316.67.
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‘‘do[es] not have authority to handle Based on Registrant’s letter of August prescriptions to patients in violation of
controlled substances in the State of 3, 2017, I find that Registrant has the Interim Partial Non-Practice
North Carolina, the [S]tate in which [she waived her right to a hearing on the Agreement. Id.
is] registered with the’’ Agency. GX 2, allegations of the Show Cause Order. 21 With respect to her ‘‘care and
at 1 (citing 21 U.S.C. 823(f) and CFR 1301.43. I therefore issue this treatment of’’ the four patients, the
824(a)(3)). Decision and Order based on relevant Board concluded as a matter of law that
As to the jurisdictional basis for the evidence submitted by the Government. Registrant ‘‘fail[ed] to conform to the
proceeding, the Show Cause Order I make the following findings. standards of acceptable and prevailing
alleged that Registrant is the holder of Findings medical practice.’’ Id. at 4 (citing N.C.
a practitioner’s registration with Gen. Stat. SEC. 90–14(a)(6)). The Board
authority in schedules II through V, Registrant is the holder of DEA also concluded as a matter of law that
under Certificate of Registration No. Certificate of Registration No. Registrant’s ‘‘issuance of controlled
BP4154023, at the registered location of BP4154023, pursuant to which she is
substance prescriptions in violation of a
Carolina Heart Care, 651 S. Main Street, authorized to dispense controlled
restriction contained in the December
Dobson, North Carolina. Id. The Order substances in schedules II through V, at
2016 Interim Partial Non-Practice
further alleged that this registration the registered address of Carolina Heart
Agreement . . . constitutes
‘‘expires . . . on February 28, 2018.’’ Id. Care, 651 S. Main St., Dobson, North
unprofessional conduct.’’ Id. (citing N.C.
As to the substantive ground for the Carolina. GX 1. Registrant is also the
Gen. Stat. SEC. 90–14(a)(6)).
proceeding, the Show Cause Order holder of DATA-Waiver Identification
No. XP4154023, pursuant to which she The Board and Registrant agreed to
alleged that on June 23, 2017, the North resolve the matter by suspending her
is authorized to prescribe schedule III
Carolina Medical Board suspended medical license for a period of six
through V ‘‘narcotic drug[s] approved by
Registrant’s medical license for six months ‘‘from June 23, 2017[] until
the Food and Drug Administration
months. Id. The Order alleged that December 23, 2017.’’ Id. at 5. While the
specifically for use in maintenance or
because of the Board’s action, Registrant Board and Registrant agreed that she
detoxification treatment’’ to up to 100
is ‘‘without authority to handle ‘‘may return to the active practice of
patients. GX 1; see also 21 CFR
controlled substances in . . . North medicine on December 24, 2017, subject
1306.04(c).
Carolina, the [S]tate in which [she is] Registrant is also the holder of a to the provisions contained in this . . .
registered,’’ and that as a consequence, license to practice medicine and surgery Order,’’ the provisions include that she
her registration is subject to revocation. issued by the North Carolina Medical ‘‘shall not prescribe controlled
Id. at 1–2 (citing cases). Board. However, on May 23, 2017, substances except for a patient who has
The Show Cause Order notified Registrant entered into a Consent Order been admitted to a hospital where [she]
Registrant of her right to request a with the Board. GX 3, Appendix A, at has active clinical privileges.’’ Id. The
hearing on the allegations or to submit 8. The Board’s Order found that in provisions also include that ‘‘[o]nce the
a written statement while waiving her September 2014, Registrant and the patient has been discharged, [she] shall
right to a hearing, the procedure for Board had entered a previous Consent not prescribe controlled substances for
electing either option, and the Order ‘‘based on findings that [she] had those patients who received such
consequence for failing to elect either failed to conform to the standards of medications pursuant to’’ the above
option. Id. at 2 (citing 21 CFR 1301.43). acceptable and prevailing medical provision. Id. at 6.
In addition, the Show Cause Order practice in her care of five patients that Moreover, Registrant’s ability to
notified Registrant of her right to submit she treated for chronic pain.’’ Id. at 2. resume practicing medicine is also
a corrective action plan under 21 U.S.C. The Board further found that while subject to the condition that she
824(c)(2)(C). Id. at 2–3. Registrant ‘‘underwent the required ‘‘complete a five . . . day board
On August 1, 2017, a DEA Special [comprehensive professional] certification review course in Internal
Agent assigned to the Charlotte District assessment, [she] still has failed to Medicine.’’ 1 Id. Thus, while the
Office personally served the Show complete any remediation suspension may expire in less than six
Cause Order on Registrant. GX 3, at 1– recommended by the assessment center weeks, it is far from certain that she will
2 (Declaration of Special Agent). In a in a timely manner.’’ Id. be able to resume practicing medicine
letter dated August 3, 2017, Registrant The Board’s Order also found that, in (even subject to the limitations on her
stated that she was ‘‘aware of the April 2016, it had received information authority to prescribe), and absent
current law regarding [her] DEA regarding Registrant’s prescribing of evidence that she has completed the
Certificate’’ and that she did ‘‘not wish opiates to four patients, including one board certification review course, the
to have a hearing on the issue.’’ GX 4. who died due to ‘‘opioid toxicity.’’ Id. restriction on her ability to resume
Registrant further stated that her The Board further found that ‘‘an practicing takes on the characteristic of
‘‘medical license is suspend[ed] until independent medical expert’’ had a suspension of indefinite duration.
12–23–2017’’ and that she ‘‘will reapply reviewed the medical records of the four Based on the above, I find that
for [her] DEA certification after [her] patients and opined that Registrant’s Registrant is currently without authority
suspension is completed.’’ Id. ‘‘diagnosis, treatment, and overall care
On September 8, 2017, the in all four . . . cases failed to conform 1 According to the online records of the North
Government submitted a Request for to the standards of acceptable and Carolina Medical Board, of which I take official
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Final Agency Action. Therein, the prevailing medical practice in North notice, the suspension of Registrant’s medical
Government seeks the revocation of Carolina.’’ Id. license remains in effect as of the date of this
Decision and Order. See 5 U.S.C. 556(e). Registrant
Registrant’s registration. As support for Finally, the Board found that, ‘‘[o]n may dispute this finding by filing a properly
the proposed action, the Government December 6, 2016, [Registrant] entered supported motion for reconsideration within 10
submitted various exhibits, including a into an Interim Partial Non-Practice business days of the date of this Order with the
Consent Order entered into by Agreement restricting her prescribing of Office of the Administrator. Registrant may also
provide evidence that she has completed the five-
Registrant and the North Carolina all controlled substances.’’ Id. at 3. The day board certification review course. Registrant
Medical Board on May 23, 2017. See Board further found that Registrant must serve a copy of any such motion on the
GX3A, at 8. issued controlled substance Government.
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to dispense controlled substances under longer authorized to dispense controlled Therefore, she is not entitled to
the laws of the State of North Carolina. substances under the laws of the State maintain her registration in that State.
in which she practices medicine. See, Accordingly, I will order that her
Discussion
e.g., Calvin Ramsey, 76 FR 20034, 20036 registration and her DATA-Waiver
Pursuant to 21 U.S.C. 824(a)(3), the (2011); Sheran Arden Yeates, M.D., 71 Identification number be revoked.
Attorney General is authorized to FR 39130, 39131 (2006); Dominick A.
suspend or revoke a registration issued Ricci, 58 FR 51104, 51105 (1993); Bobby Order
under section 823, ‘‘upon a finding that Watts, 53 FR 11919, 11920 (1988); see Pursuant to the authority vested in me
the Registrant . . . has had his State also Hooper v. Holder, 481 Fed. Appx. by 21 U.S.C. 824(a) and 28 CFR 0.100(b),
license . . . suspended [or] revoked at 828. I order that DEA Certificate of
. . . by competent State authority and is As a consequence of the Consent Registration No. BP4154023, issued to
no longer authorized by State law to Order which Registrant entered into Linda M. Shuck, be, and it hereby is,
engage in the . . . dispensing of with the Board, she is not currently revoked. I further order that DATA-
controlled substances.’’ Also, DEA has authorized to dispense controlled Waiver Identification No. XP4154023,
held repeatedly that the possession of substances in North Carolina, the State issued to Linda M. Shuck, be, and it
authority to dispense controlled in which she is registered with the hereby is, revoked. This order is
substances under the laws of the State Agency. Because the CSA makes clear effective immediately.3
in which a practitioner engages in that the possession of authority to
professional practice is a fundamental Dated: November 13, 2017.
dispense controlled substances under
condition for obtaining and maintaining the laws of the State in which a Robert W. Patterson,
a practitioner’s registration. See, e.g., practitioner engages in professional Acting Administrator.
James L. Hooper, 76 FR 71371 (2011), practice is a fundamental condition for [FR Doc. 2017–25286 Filed 11–21–17; 8:45 am]
pet. for rev. denied, 481 Fed Appx. 826 both obtaining and maintaining a BILLING CODE 4410–09–P
(4th Cir. 2012); Frederick Marsh practitioner’s registration, it is of no
Blanton, 43 FR 27616 (1978). consequence that the suspension is of a
This rule derives from the text of two finite duration. See Hooper v. Holder, DEPARTMENT OF JUSTICE
provisions of the CSA. First, Congress 481 F. App’x at 828 (upholding
defined ‘‘the term ‘practitioner’ [to] revocation of a physician’s registration Drug Enforcement Administration
mean[] a . . . physician . . . or other as based on a reasonable interpretation
person licensed, registered or otherwise of the CSA, notwithstanding that the [Docket No. DEA–392]
permitted, by . . . the jurisdiction in physician’s medical license was subject
which [s]he practices . . . to distribute, to a suspension of known duration); see Bulk Manufacturer of Controlled
dispense, [or] administer . . . a also James L. Hooper, 76 FR 71371, Substances Registration
controlled substance in the course of 71371–72 (2011). Rather, what matters
professional practice.’’ 21 U.S.C. for the purposes of the CSA is that ACTION: Notice of registration.
802(21). Second, in setting the Registrant is not currently authorized to
requirements for obtaining a dispense controlled substances in North SUMMARY: Registrants listed below have
practitioner’s registration, Congress Carolina. See Hooper, 76 FR at 71371 applied for and been granted
directed that ‘‘[t]he Attorney General (quoting Anne Lazar Thorn, 62 FR registration by the Drug Enforcement
shall register practitioners . . . if the 12847, 12848 (1997) (‘‘the controlling Administration as bulk manufacturers of
applicant is authorized to dispense . . . question . . . is whether the various classes of schedule I and II
controlled substances under the laws of Respondent is currently authorized to controlled substances.
the State in which [s]he practices.’’ 21 handle controlled substances in the SUPPLEMENTARY INFORMATION: The
U.S.C. 823(f). Because Congress has state’’)). Indeed, it is by no means clear companies listed below applied to be
clearly mandated that a physician that Registrant will even be able to registered as manufacturers of various
possess state authority in order to be resume the practice of medicine basic classes of controlled substances.
deemed a practitioner under the Act, following the ending date of the Information on previously published
DEA has held that revocation of a suspension given the requirement that notices is listed in the table below. No
practitioner’s registration is the she complete the required five-day comments or objections were submitted
appropriate sanction whenever she is no board certification review course.2 for these notices.
Company FR Docket Published
Cayman Chemical Company ....................................................................................................................... 82 FR 34691 July 26, 2017.
AMRI Rensselaer, Inc ................................................................................................................................. 82 FR 34695 July 26, 2017.
Organic Consultants, Inc ............................................................................................................................. 82 FR 34696 July 26, 2017.
Isosciences, LLC ......................................................................................................................................... 82 FR 35546 July 31, 2017.
Cody Laboratories, Inc ................................................................................................................................ 82 FR 41054 August 29, 2017.
Noramco, Inc ............................................................................................................................................... 82 FR 41055 August 29, 2017.
Stepan Company ......................................................................................................................................... 82 FR 42119 September 6, 2017.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
2 Indeed, as found above, even if she completes bar on Registrant’s ability to reapply, she can apply violation of the Interim Partial Non-Practice
the course and returns to practice, under the for a new registration upon being allowed to return Agreement, I find that the public interest
Consent Order, she is prohibited from prescribing to practice. necessitates that this Order be effective
controlled substances outside of a hospital where 3 Based on the North Carolina Board’s findings immediately. 21 CFR 1316.67.
she ‘‘has active clinical privileges.’’ GX 3, Appendix
A, at 5. As this revocation does not impose any time that Registrant prescribed controlled substances in
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Document Created: 2017-11-22 00:48:46
Document Modified: 2017-11-22 00:48:46
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 82 FR 55639 |
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