Elizabeth C. Korcz, M.D.; Decision and Order, 27659-27661 [2019-12506]
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Federal Register / Vol. 84, No. 114 / Thursday, June 13, 2019 / Notices
comments or objections were submitted
for the notice.
Company
FR docket
Navinta, LLC ...............
84 FR 5498
Published
February 21, 2019.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of this registrant to
manufacture the applicable basic class
of controlled substances is consistent
with the public interest and with United
States obligations under international
treaties, conventions, or protocols in
effect on May 1, 1971. The DEA
investigated the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
physical security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the DEA has granted a
registration as a bulk manufacturer to
the above listed company.
Dated: June 3, 2019.
John J. Martin,
Assistant Administrator.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
[FR Doc. 2019–12504 Filed 6–12–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Sigma Aldrich
Research
ACTION:
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before August 12, 2019.
DATES:
Notice of application.
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 7, 2019, Sigma
Aldrich Research, Biochemicals, Inc.,
400–600 Summit Drive, Burlington,
Massachusetts 01803 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Cathinone ........................................................................................................................................................................
Mephedrone (4-Methyl-N-methylcathinone) ....................................................................................................................
Lysergic acid diethylamide ..............................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
3,4-Methylenedioxymethamphetamine ............................................................................................................................
Alpha-methyltryptamine ...................................................................................................................................................
Dimethyltryptamine ..........................................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine .............................................................................................................................
N-Benzylpiperazine ..........................................................................................................................................................
2-(2,5-Dimethoxyphenyl) ethanamine (2C-H) .................................................................................................................
MDPV (3,4-Methylenedioxypyrovalerone) .......................................................................................................................
Methylone (3,4-Methylenedioxy-N-methylcathinone) ......................................................................................................
Heroin ..............................................................................................................................................................................
Normorphine ....................................................................................................................................................................
Norlevorphanol ................................................................................................................................................................
Amphetamine ...................................................................................................................................................................
Nabilone ...........................................................................................................................................................................
Phencyclidine ...................................................................................................................................................................
Cocaine ............................................................................................................................................................................
Codeine ...........................................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Meperidine .......................................................................................................................................................................
Methadone .......................................................................................................................................................................
Morphine ..........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Levo-alphacetylmethadol .................................................................................................................................................
Noroxymorphone .............................................................................................................................................................
Remifentanil .....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Carfentanil .......................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
khammond on DSKBBV9HB2PROD with NOTICES
The company plans to manufacture
reference standards.
Dated: June 3, 2019.
John J. Martin,
Assistant Administrator.
BILLING CODE 4410–09–P
16:55 Jun 12, 2019
Drug Enforcement Administration
[Docket No. 18–29]
[FR Doc. 2019–12503 Filed 6–12–19; 8:45 am]
VerDate Sep<11>2014
DEPARTMENT OF JUSTICE
Elizabeth C. Korcz, M.D.; Decision and
Order
On March 28, 2018, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
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Government), issued an Order to Show
Cause (hereinafter, OSC) to Elizabeth C.
Korcz, M.D. (hereinafter, Respondent),
who is registered in Hoover, Alabama.
The OSC proposed to revoke
Respondent’s DEA Certificate of
Registration (hereinafter, COR) No.
FK0505428, pursuant to 21 U.S.C.
§§ 823(f) and 824(a)(3), on the ground
that she does not have authority to
handle controlled substances in
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khammond on DSKBBV9HB2PROD with NOTICES
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Alabama, the State in which she is
registered with the DEA. OSC, at 1.
With respect to the DEA’s
jurisdiction, the OSC alleged that
Respondent is registered with the DEA
as a practitioner authorized to handle
controlled substances in schedules II
through V under DEA COR No.
FK0505428 at the registered address of
3421 S. Shades Crest Road, Suite 111,
Hoover, Alabama 35244. Id. The OSC
stated that Respondent’s registration
was current and not due to expire until
December 31, 2019. Id.
Regarding the substantive grounds for
the proceeding, the OSC specifically
alleged that Respondent agreed to
voluntarily surrender her Alabama
Controlled Substance Certificate
(hereinafter, CSC) No. ACSC.28343
pending the resolution of an
investigation undertaken by the
Alabama State Board of Medical
Examiners (hereinafter, State Board)
alleging Respondent dispensed
controlled substances for no legitimate
purpose. Id. Furthermore, the OSC
alleged that the status of Respondent’s
CSC was listed as ‘‘inactive-failed to
renew.’’ Id. at 2. The OSC stated: ‘‘[T]he
DEA must revoke . . . [her] COR based
upon . . . [her] lack of authority to
handle controlled substances in the
State of Alabama.’’ Id., citing 21 U.S.C.
§§ 823(f) and 824(a)(3).
The OSC then notified Respondent of
her right to request a hearing on the
allegations, or to submit a written
statement in lieu of a hearing, the
procedure for doing either, and the
consequence for failing to elect either
option. Id. at 2, citing 21 CFR 1301.43.
It also notified her of her right to submit
a corrective action plan in accordance
with 21 U.S.C. 824(c)(2)(C). Id. at 2–3.
By letter dated May 2, 2018,
Respondent timely requested a hearing.1
Hearing Request (hereinafter, HR), at 1.
According to the HR, ‘‘[Respondent’s]
license to practice medicine and
prescribe controlled substances was
under review [by the State Board] when
the United States Government raided
her practice and served her with a target
letter.’’ Id. The HR continued: ‘‘In light
of the federal investigation, . . .
[Respondent] requested a stay of the
[State Board’s] scheduled hearing. In
order for the Board to agree to a stay,
they requested she voluntarily surrender
her ability to prescribe controlled
substances. On advice of counsel, she
voluntarily agreed.’’ Id. Furthermore,
the HR stated that Respondent ‘‘objects
1 Based on the undisputed evidence in the record
regarding the date the OSC was served on
Respondent, April 2, 2018, I find that Respondent
timely requested a hearing.
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to the revocation of her DEA
registration’’ and requested that the
hearing ‘‘be stayed pending the outcome
of the investigation.’’ Id.
The Office of Administrative Law
Judges put the matter on the docket and
assigned it to Administrative Law Judge
Mark M. Dowd (hereinafter, ALJ). On
May 3, 2018, the ALJ issued an Order
Directing the Filing of Government
Evidence of Lack of State Authority
Allegation and Briefing Schedule.
On May 17, 2018, the Government
filed a timely Motion for Summary
Disposition (hereinafter, MSD) based on
Respondent’s lack of State authority to
handle controlled substances. MSD, at
1. The Government attached five
documents to its MSD. The Government
attached a Certification of Registration
Status, dated April 12, 2018, with a
copy of DEA COR No. FK0505428. Id. at
Att. 1. In addition, the Government
attached a copy of Respondent’s
voluntary surrender of her Alabama CSC
(hereinafter, Voluntary Surrender),
which was dated August 23, 2017. Id. at
Att. 2. Further, the Government attached
a copy of the Medical Licensure
Commission of Alabama’s Order on
Motion to Stay, which was dated August
25, 2017. Id. at Att. 3. Furthermore, the
Government attached a copy of
Respondent’s License Details from the
State Board, which was printed on May
7, 2018. Id. at Att. 4. Finally, the
Government attached the Declaration of
a DEA Diversion Investigator, which
was dated May 8, 2018. Id. at Att. 5.
According to the MSD, ‘‘DEA’s
investigation reveals that Respondent
has agreed to the voluntary surrender of
her Alabama . . . [CSC] pending
resolution of a current investigation by
the [State Board].’’ MSD, at 3.
Furthermore, according to the MSD,
Respondent’s License Details shows that
‘‘the status of the Respondent’s [CSC] is
listed as ‘Inactive-Failed to Renew,’ and
that [the CSC] expired on December 31,
2017.’’ Id. Citing 21 U.S.C. 802(21),
823(f), and 824(a)(3), the Government
argues that the DEA ‘‘cannot register or
maintain the registration of a
practitioner not duly authorized to
handle controlled substances in the
state in which . . . [the practitioner]
conducts business.’’ Id. Furthermore,
the Government contends: ‘‘Respondent
is currently not authorized to handle
controlled substances in the state in
which she currently holds a DEA COR.’’
Id. at 4. Thus, according to the
Government, Respondent is not
authorized to possess a DEA COR in
Alabama unless she is authorized to
dispense controlled substances in the
State of Alabama. Id. at 3.
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Respondent did not file any response
to the Government’s MSD or evidence.
Order Granting the Government’s
Motion for Summary Disposition and
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge dated
June 6, 2018 (hereinafter, R.D.), at 3.
The ALJ granted the MSD and
recommended that Respondent’s
registration be revoked. Id. at 6. The ALJ
determined: ‘‘At this juncture, no
dispute exists over the fact that the
Respondent currently lacks state
authority to handle controlled
substances in Alabama due to the
voluntary surrender of her . . . [CSC] on
August 23, 2017, and the Alabama State
Board of Medical Examiner’s acceptance
of the Respondent’s voluntary surrender
on August 25, 2017.’’ Id. at 5–6. The ALJ
continued: ‘‘Because the Respondent
lacks state authority at the present time,
. . . [DEA] precedent dictates that she is
not entitled to maintain her DEA
registration.’’ Id. at 6. The ALJ
concluded: ‘‘Simply put, there is no
contested factual matter that could be
introduced at a hearing that would, in
the Agency’s view, provide authority to
allow Respondent to continue to hold
her DEA COR.’’ Id. The ALJ
recommended that Respondent’s
registration be revoked and that pending
applications for renewal be denied. Id.
By letter dated July 3, 2018, the ALJ
certified and transmitted the record to
me for final Agency action. In that letter,
the ALJ stated that no exceptions were
filed by either party.
I issue this Decision and Order based
on the entire record before me. 21 CFR
§ 1301.43(e). I make the following
findings of fact.
Findings of Fact
Respondent’s DEA Registration
Respondent holds DEA COR No.
FK0505428, pursuant to which she is
authorized to handle controlled
substances in schedules II through V as
a practitioner, at the registered address
of 3421 S. Shades Crest Road, Suite 111,
Hoover, Alabama 35244. MSD, at Att. 1.
This registration is in an active pending
status and expires on December 31,
2019. Id.
The Status of Respondent’s State
License
On August 23, 2017, Respondent
voluntarily surrendered her Alabama
CSC after the State Board filed an Order
to Show Cause whose allegations
include excessive dispensing of
controlled substances, dispensing
controlled substances for no legitimate
medical purpose, and dispensing
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controlled substances in amounts not
reasonably related to the proper medical
management of patients’ illnesses or
conditions. Id. at Att. 2. In her
Voluntary Surrender, Respondent
stated: ‘‘I understand and acknowledge
I will have no authority to order,
dispense, distribute, administer or
prescribe controlled substances in the
state of Alabama.’’ Id. Thus, there is no
dispute that Respondent voluntarily
surrendered her authority to handle
controlled substances in Alabama.
Further, as recorded by the State Board,
the status of Respondent’s CSC is
‘‘Inactive-Failed to Renew.’’ Id. at Att. 4.
Based on my review of the website of
the State Board and the Medical
Licensure Commission of Alabama, the
status of Respondent’s CSC has not
changed.2 Alabama Board of Medical
Examiners and Medical Licensure
Commission of Alabama Online License
Verification, https://
abme.igovsolution.com/online/Lookups/
Individual_Lookup.aspx (last visited
May 22, 2019).
Accordingly, I find that Respondent
currently is without authority to
dispense controlled substances in
Alabama, the State in which she is
registered.
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 of the Controlled
Substances Act (hereinafter, CSA),
‘‘upon a finding that the registrant . . .
has had [her] State license or
registration suspended . . . [or] revoked
. . . by competent State authority and is
no longer authorized by State law to
engage in the . . . dispensing of
controlled substances.’’ With respect to
a practitioner, the DEA has long held
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, M.D., 76 FR 71,371
(2011), pet. for rev. denied, 481 Fed.
Appx. 826 (4th Cir. 2012); Frederick
Marsh Blanton, M.D., 43 FR 27,616,
27,617 (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 practitioner
possess State authority in order to be
deemed a practitioner under the CSA,
the DEA has held repeatedly that
revocation of a practitioner’s registration
is the appropriate sanction whenever a
practitioner is no longer authorized to
dispense controlled substances under
the laws of the State in which she
practices. See, e.g., Hooper, supra, 76
FR at 71,371–72; Sheran Arden Yeates,
M.D., 71 FR 39,130, 39,131 (2006);
Dominick A. Ricci, M.D., 58 FR 51,104,
51,105 (1993); Bobby Watts, M.D., 53 FR
11,919, 11,920 (1988), Blanton, supra,
43 FR at 27,617.
Here, the undisputed evidence in the
record is that Respondent voluntarily
surrendered her Alabama CSC. The fact
that Respondent may, some day, regain
her State registration to dispense
controlled substances does not change
the salient fact that Respondent is not
currently authorized to handle
controlled substances in the State in
which she is registered. Mehdi
Nikparvarfard, M.D., 83 FR 14,503,
14,504 (2018). Respondent, therefore, is
not eligible for a DEA COR.
Accordingly, I will order that
Respondent’s DEA COR be revoked and
that any pending application for the
renewal or modification of that COR be
denied. 21 U.S.C. §§ 823(f) and
824(a)(3).
Order
Pursuant to 28 CFR § 0.100(b) and the
authority vested in me by 21 U.S.C.
§ 824(a), I order that DEA COR No.
FK0505428 issued to Elizabeth C. Korcz,
M.D., be, and it hereby is, revoked.
Pursuant to 28 CFR § 0.100(b) and the
authority vested in me by 21 U.S.C.
§ 823(f), I further order that any pending
application of Elizabeth C. Korcz, M.D.,
to renew or modify this registration, as
well as any other pending application
by her for registration in the State of
Alabama be, and it hereby is, denied.
This Order is effective July 15, 2019.
Dated: May 22, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019–12506 Filed 6–12–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Eli-Elsohly
Laboratories
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before August 12, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 14, 2019, EliElsohly Laboratories, Mahmoud A.
Elsohly Ph.D., 5 Industrial Park Drive,
Oxford, Mississippi 38655 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
khammond on DSKBBV9HB2PROD with NOTICES
Controlled substance
Drug code
Marihuana Extract ...........................................................................................................................................................
Marihuana ........................................................................................................................................................................
2 Under the Administrative Procedure Act, an
agency ‘‘may take official notice of facts at any stage
in a proceeding—even in the final decision.’’
United States Department of Justice, Attorney
General’s Manual on the Administrative Procedure
Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
1979). Pursuant to 5 U.S.C. § 556(e), ‘‘[w]hen an
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agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a
party is entitled, on timely request, to an
opportunity to show the contrary.’’ Accordingly,
Respondent may dispute my finding by filing a
properly supported motion for reconsideration
within 15 calendar days of the date of this Order.
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Any such motion shall be filed with the Office of
the Administrator and a copy shall be served on the
Government; in the event Respondent files a
motion, the Government shall have 15 calendar
days to file a response.
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]]>Agencies
[Federal Register Volume 84, Number 114 (Thursday, June 13, 2019)]
[Notices]
[Pages 27659-27661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12506]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 18-29]
Elizabeth C. Korcz, M.D.; Decision and Order
On March 28, 2018, the Assistant Administrator, Diversion Control
Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause (hereinafter, OSC) to
Elizabeth C. Korcz, M.D. (hereinafter, Respondent), who is registered
in Hoover, Alabama. The OSC proposed to revoke Respondent's DEA
Certificate of Registration (hereinafter, COR) No. FK0505428, pursuant
to 21 U.S.C. Sec. Sec. 823(f) and 824(a)(3), on the ground that she
does not have authority to handle controlled substances in
[[Page 27660]]
Alabama, the State in which she is registered with the DEA. OSC, at 1.
With respect to the DEA's jurisdiction, the OSC alleged that
Respondent is registered with the DEA as a practitioner authorized to
handle controlled substances in schedules II through V under DEA COR
No. FK0505428 at the registered address of 3421 S. Shades Crest Road,
Suite 111, Hoover, Alabama 35244. Id. The OSC stated that Respondent's
registration was current and not due to expire until December 31, 2019.
Id.
Regarding the substantive grounds for the proceeding, the OSC
specifically alleged that Respondent agreed to voluntarily surrender
her Alabama Controlled Substance Certificate (hereinafter, CSC) No.
ACSC.28343 pending the resolution of an investigation undertaken by the
Alabama State Board of Medical Examiners (hereinafter, State Board)
alleging Respondent dispensed controlled substances for no legitimate
purpose. Id. Furthermore, the OSC alleged that the status of
Respondent's CSC was listed as ``inactive-failed to renew.'' Id. at 2.
The OSC stated: ``[T]he DEA must revoke . . . [her] COR based upon . .
. [her] lack of authority to handle controlled substances in the State
of Alabama.'' Id., citing 21 U.S.C. Sec. Sec. 823(f) and 824(a)(3).
The OSC then notified Respondent of her right to request a hearing
on the allegations, or to submit a written statement in lieu of a
hearing, the procedure for doing either, and the consequence for
failing to elect either option. Id. at 2, citing 21 CFR 1301.43. It
also notified her of her right to submit a corrective action plan in
accordance with 21 U.S.C. 824(c)(2)(C). Id. at 2-3.
By letter dated May 2, 2018, Respondent timely requested a
hearing.\1\ Hearing Request (hereinafter, HR), at 1. According to the
HR, ``[Respondent's] license to practice medicine and prescribe
controlled substances was under review [by the State Board] when the
United States Government raided her practice and served her with a
target letter.'' Id. The HR continued: ``In light of the federal
investigation, . . . [Respondent] requested a stay of the [State
Board's] scheduled hearing. In order for the Board to agree to a stay,
they requested she voluntarily surrender her ability to prescribe
controlled substances. On advice of counsel, she voluntarily agreed.''
Id. Furthermore, the HR stated that Respondent ``objects to the
revocation of her DEA registration'' and requested that the hearing
``be stayed pending the outcome of the investigation.'' Id.
---------------------------------------------------------------------------
\1\ Based on the undisputed evidence in the record regarding the
date the OSC was served on Respondent, April 2, 2018, I find that
Respondent timely requested a hearing.
---------------------------------------------------------------------------
The Office of Administrative Law Judges put the matter on the
docket and assigned it to Administrative Law Judge Mark M. Dowd
(hereinafter, ALJ). On May 3, 2018, the ALJ issued an Order Directing
the Filing of Government Evidence of Lack of State Authority Allegation
and Briefing Schedule.
On May 17, 2018, the Government filed a timely Motion for Summary
Disposition (hereinafter, MSD) based on Respondent's lack of State
authority to handle controlled substances. MSD, at 1. The Government
attached five documents to its MSD. The Government attached a
Certification of Registration Status, dated April 12, 2018, with a copy
of DEA COR No. FK0505428. Id. at Att. 1. In addition, the Government
attached a copy of Respondent's voluntary surrender of her Alabama CSC
(hereinafter, Voluntary Surrender), which was dated August 23, 2017.
Id. at Att. 2. Further, the Government attached a copy of the Medical
Licensure Commission of Alabama's Order on Motion to Stay, which was
dated August 25, 2017. Id. at Att. 3. Furthermore, the Government
attached a copy of Respondent's License Details from the State Board,
which was printed on May 7, 2018. Id. at Att. 4. Finally, the
Government attached the Declaration of a DEA Diversion Investigator,
which was dated May 8, 2018. Id. at Att. 5.
According to the MSD, ``DEA's investigation reveals that Respondent
has agreed to the voluntary surrender of her Alabama . . . [CSC]
pending resolution of a current investigation by the [State Board].''
MSD, at 3. Furthermore, according to the MSD, Respondent's License
Details shows that ``the status of the Respondent's [CSC] is listed as
`Inactive-Failed to Renew,' and that [the CSC] expired on December 31,
2017.'' Id. Citing 21 U.S.C. 802(21), 823(f), and 824(a)(3), the
Government argues that the DEA ``cannot register or maintain the
registration of a practitioner not duly authorized to handle controlled
substances in the state in which . . . [the practitioner] conducts
business.'' Id. Furthermore, the Government contends: ``Respondent is
currently not authorized to handle controlled substances in the state
in which she currently holds a DEA COR.'' Id. at 4. Thus, according to
the Government, Respondent is not authorized to possess a DEA COR in
Alabama unless she is authorized to dispense controlled substances in
the State of Alabama. Id. at 3.
Respondent did not file any response to the Government's MSD or
evidence. Order Granting the Government's Motion for Summary
Disposition and Recommended Rulings, Findings of Fact, Conclusions of
Law, and Decision of the Administrative Law Judge dated June 6, 2018
(hereinafter, R.D.), at 3.
The ALJ granted the MSD and recommended that Respondent's
registration be revoked. Id. at 6. The ALJ determined: ``At this
juncture, no dispute exists over the fact that the Respondent currently
lacks state authority to handle controlled substances in Alabama due to
the voluntary surrender of her . . . [CSC] on August 23, 2017, and the
Alabama State Board of Medical Examiner's acceptance of the
Respondent's voluntary surrender on August 25, 2017.'' Id. at 5-6. The
ALJ continued: ``Because the Respondent lacks state authority at the
present time, . . . [DEA] precedent dictates that she is not entitled
to maintain her DEA registration.'' Id. at 6. The ALJ concluded:
``Simply put, there is no contested factual matter that could be
introduced at a hearing that would, in the Agency's view, provide
authority to allow Respondent to continue to hold her DEA COR.'' Id.
The ALJ recommended that Respondent's registration be revoked and that
pending applications for renewal be denied. Id.
By letter dated July 3, 2018, the ALJ certified and transmitted the
record to me for final Agency action. In that letter, the ALJ stated
that no exceptions were filed by either party.
I issue this Decision and Order based on the entire record before
me. 21 CFR Sec. 1301.43(e). I make the following findings of fact.
Findings of Fact
Respondent's DEA Registration
Respondent holds DEA COR No. FK0505428, pursuant to which she is
authorized to handle controlled substances in schedules II through V as
a practitioner, at the registered address of 3421 S. Shades Crest Road,
Suite 111, Hoover, Alabama 35244. MSD, at Att. 1. This registration is
in an active pending status and expires on December 31, 2019. Id.
The Status of Respondent's State License
On August 23, 2017, Respondent voluntarily surrendered her Alabama
CSC after the State Board filed an Order to Show Cause whose
allegations include excessive dispensing of controlled substances,
dispensing controlled substances for no legitimate medical purpose, and
dispensing
[[Page 27661]]
controlled substances in amounts not reasonably related to the proper
medical management of patients' illnesses or conditions. Id. at Att. 2.
In her Voluntary Surrender, Respondent stated: ``I understand and
acknowledge I will have no authority to order, dispense, distribute,
administer or prescribe controlled substances in the state of
Alabama.'' Id. Thus, there is no dispute that Respondent voluntarily
surrendered her authority to handle controlled substances in Alabama.
Further, as recorded by the State Board, the status of Respondent's CSC
is ``Inactive-Failed to Renew.'' Id. at Att. 4. Based on my review of
the website of the State Board and the Medical Licensure Commission of
Alabama, the status of Respondent's CSC has not changed.\2\ Alabama
Board of Medical Examiners and Medical Licensure Commission of Alabama
Online License Verification, https://abme.igovsolution.com/online/Lookups/ Individual_Lookup.aspx (last visited May 22, 2019).
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\2\ Under the Administrative Procedure Act, an agency ``may take
official notice of facts at any stage in a proceeding--even in the
final decision.'' United States Department of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. Sec.
556(e), ``[w]hen an agency decision rests on official notice of a
material fact not appearing in the evidence in the record, a party
is entitled, on timely request, to an opportunity to show the
contrary.'' Accordingly, Respondent may dispute my finding by filing
a properly supported motion for reconsideration within 15 calendar
days of the date of this Order. Any such motion shall be filed with
the Office of the Administrator and a copy shall be served on the
Government; in the event Respondent files a motion, the Government
shall have 15 calendar days to file a response.
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Accordingly, I find that Respondent currently is without authority
to dispense controlled substances in Alabama, the State in which she is
registered.
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 of the
Controlled Substances Act (hereinafter, CSA), ``upon a finding that the
registrant . . . has had [her] State license or registration suspended
. . . [or] revoked . . . by competent State authority and is no longer
authorized by State law to engage in the . . . dispensing of controlled
substances.'' With respect to a practitioner, the DEA has long held
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,
M.D., 76 FR 71,371 (2011), pet. for rev. denied, 481 Fed. Appx. 826
(4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617
(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. Sec. 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. Sec. 823(f). Because Congress has clearly
mandated that a practitioner possess State authority in order to be
deemed a practitioner under the CSA, the DEA has held repeatedly that
revocation of a practitioner's registration is the appropriate sanction
whenever a practitioner is no longer authorized to dispense controlled
substances under the laws of the State in which she practices. See,
e.g., Hooper, supra, 76 FR at 71,371-72; Sheran Arden Yeates, M.D., 71
FR 39,130, 39,131 (2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105
(1993); Bobby Watts, M.D., 53 FR 11,919, 11,920 (1988), Blanton, supra,
43 FR at 27,617.
Here, the undisputed evidence in the record is that Respondent
voluntarily surrendered her Alabama CSC. The fact that Respondent may,
some day, regain her State registration to dispense controlled
substances does not change the salient fact that Respondent is not
currently authorized to handle controlled substances in the State in
which she is registered. Mehdi Nikparvarfard, M.D., 83 FR 14,503,
14,504 (2018). Respondent, therefore, is not eligible for a DEA COR.
Accordingly, I will order that Respondent's DEA COR be revoked and that
any pending application for the renewal or modification of that COR be
denied. 21 U.S.C. Sec. Sec. 823(f) and 824(a)(3).
Order
Pursuant to 28 CFR Sec. 0.100(b) and the authority vested in me by
21 U.S.C. Sec. 824(a), I order that DEA COR No. FK0505428 issued to
Elizabeth C. Korcz, M.D., be, and it hereby is, revoked. Pursuant to 28
CFR Sec. 0.100(b) and the authority vested in me by 21 U.S.C. Sec.
823(f), I further order that any pending application of Elizabeth C.
Korcz, M.D., to renew or modify this registration, as well as any other
pending application by her for registration in the State of Alabama be,
and it hereby is, denied. This Order is effective July 15, 2019.
Dated: May 22, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-12506 Filed 6-12-19; 8:45 am]
BILLING CODE 4410-09-P
