Andrzej Kazimierz Zielke, M.D.; Decision and Order, 5987-5989 [2020-01968]
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Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices
According to the website of the
Wisconsin Department of Safety and
Professional Services, of which I take
official notice, Registrant’s RN license
and her APNP certificate remain
suspended.3 Wisconsin Credential/
License Search, https://
licensesearch.wi.gov/ (last visited
January 3, 2020). The website also states
that Registrant’s RN license expired on
February 28, 2018 and that her APNP
certificate expired on September 30,
2018. Thus, neither Registrant’s
Wisconsin RN license nor her APNP
certificate was current on the date the
Assistant Administrator issued the OSC,
and neither is current today.
Discussion
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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 CSA ‘‘upon a
finding that the registrant . . . has had
his 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 also 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 27616,
27617 (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
3 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
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,
Registrant may dispute my finding by filing a
properly supported motion for reconsideration
within fifteen 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 Registrant
files a motion, the Government shall have fifteen
calendar days to file a response. Any such motion
and response may be filed and served by email
(dea.addo.attorneys@dea.usdoj.gov) or by mail to
Office of the Administrator, Attn: ADDO, Drug
Enforcement Administration, 8701 Morrissette
Drive, Springfield, VA 22152.
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permitted, by . . . the jurisdiction in
which 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 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 he
is no longer authorized to dispense
controlled substances under the laws of
the state in which he practices. See, e.g.,
James L. Hooper, 76 FR at 71371–72;
Sheran Arden Yeates, M.D., 71 FR
39130, 39131 (2006); Dominick A. Ricci,
M.D., 58 FR 51104, 51105 (1993); Bobby
Watts, M.D., 53 FR 11919, 11920 (1988);
Frederick Marsh Blanton, 43 FR at
27617.
In Wisconsin, an ‘‘advanced practice
nurse’’ is a registered nurse who ‘‘has a
current license to practice professional
nursing’’ in Wisconsin. Wis. Admin.
Code N § 8.02(1) (West, Westlaw current
through Wisconsin Register 767B,
published November 25, 2019). An
‘‘advanced practice nurse prescriber’’ is
‘‘an advanced practice nurse who has
been granted a certificate to issue
prescription orders’’ under Wis. Stat
§ 441.16(2). Wis. Admin. Code N
§ 8.02(2) (West, Westlaw current
through Wisconsin Register 767B,
published November 25, 2019).4
Under the Wisconsin Uniform
Controlled Substances Act (hereinafter,
Act), a person must have a federal
controlled substances registration in
order to lawfully dispense controlled
substances in Wisconsin.5 Wis. Stat.
§ 961.32(1m)(a) (West, Westlaw current
through 2019 Act 21, published
November 14, 2019). The Act further
provides that a ‘‘practitioner’’ includes
an ’’ advanced practice nurse . . .
licensed, registered, certified or
otherwise permitted to . . . dispense
4 An advanced practice nurse (hereinafter, APN)
who meets the requisite education, training and
examination requirements, and who pays the
required fee, ‘‘shall [be] grant[ed] a certificate to
issue prescription orders.’’ Wis. Stat. § 441.16(2)
(West, Westlaw current through 2019 Act 21,
published November 14, 2019).
5 Under Wisconsin law, ‘‘dispensing’’ a controlled
substance includes ‘‘prescribing’’ a controlled
substance. Wis. Stat. § 961.01(7) (West, Westlaw
current through 2019 Act 21, published November
14, 2019).
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5987
. . . a controlled substance in the
course of professional practice.’’ Wis.
Stat. § 961.01(19)(a) (West, Westlaw
current through 2019 Act 21, published
November 14, 2019).
Here, the undisputed evidence in the
record is that Registrant is not currently
licensed as a RN or an APN,
prerequisites for her to be licensed as an
APNP. As such, she is not authorized to
dispense controlled substances in
Wisconsin, the state in which she is
registered with the DEA. Since
Registrant lacks authority to dispense
controlled substances in Wisconsin, she
is not eligible to hold a DEA
registration. 21 U.S.C. 823(f).
Accordingly, I will order that
Registrant’s DEA registration be
revoked.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby revoke DEA Certificate
of Registration MW2120006 issued to
Theresa L. Wendt, N.P. I further hereby
deny any pending application of
Theresa L. Wendt, N.P. to renew or
modify this registration, as well as any
other applications of Theresa L. Wendt,
N.P. for an additional registration in
Wisconsin. This Order is effective
March 4, 2020.
Dated: January 3, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020–01970 Filed 1–31–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Andrzej Kazimierz Zielke, M.D.;
Decision and Order
On December 1, 2017, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (hereinafter, OSC) to Andrzej
Kazimierz Zielke, M.D. (hereinafter,
Registrant), of North Huntingdon,
Pennsylvania. OSC, at 1. The OSC
proposed the revocation of Registrant’s
DEA Certificate of Registration No.
BZ6248199 on the ground that
Registrant does not have authority to
handle controlled substances in the
Commonwealth of Pennsylvania, the
state in which Registrant is registered
with the DEA. Id. (citing 21 U.S.C.
823(f) and 824(a)(3)).
Specifically, the OSC alleged that on
October 11, 2017, the Pennsylvania
State Board of Medicine issued an
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Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices
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‘‘Order of Temporary Suspension and
Notice of Hearing in which it suspended
[Registrant’s] license to practice
medicine and surgery,’’ and that
Registrant is ‘‘without authority to
practice medicine or handle controlled
substances in the Commonwealth of
Pennsylvania, the state in which [he is]
registered with DEA.’’ Id. at 1–2. The
OSC asserts that ‘‘[c]onsequently, DEA
must revoke [his] DEA registration
based on [his] lack of authority to
handle controlled substances in the
Commonwealth of Pennsylvania.’’ Id. at
2 (citing 21 U.S.C. 824(a)(3); 21 CFR
1301.37(b)).
The OSC notified Registrant of the
right to request a hearing on the
allegations or to submit a written
statement, while waiving the right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. OSC, at 2 (citing
21 CFR 1301.43). The OSC also notified
Registrant of the opportunity to submit
a corrective action plan. OSC, at 2–3
(citing 21 U.S.C. 824(c)(2)(C)).
Adequacy of Service
The Government submitted its
Request for Final Agency Action
(hereinafter, RFAA) in this matter to my
office on February 6, 2018, representing
that since the service of the Order to
Show Cause, Registrant ‘‘has not
requested a hearing and has not
otherwise corresponded or
communicated with DEA.’’ RFAA, at 1.
The Government’s initial RFAA
included only a Form DEA–12 Receipt
as evidence of service of the Show
Cause Order on Registrant. A former
Acting Administrator issued an Order
directing the Government to provide a
declaration setting forth the
circumstances regarding how it
accomplished service. May 17, 2018,
Order of the Acting Administrator. On
February 26, 2019, the Government filed
its Response to my office, including
therein the Declaration of the Special
Agent detailing how service was
effectuated. Government’s Response to
Acting Administrator’s Order
(hereinafter, Government’s Response).
On December 6, 2017, a DEA Special
Agent (hereinafter, SA) and a Diversion
Investigator (hereinafter, DI) with the
DEA Pittsburgh District Office,
Philadelphia Field Division, personally
served Registrant with the OSC at his
residence. Government’s Response,
Declaration of Service of Order to Show
Cause (hereinafter, SA’s Declaration).
The SA stated that upon arrival at the
registered address, Registrant identified
himself as Dr. Zielke. Id. The SA then
‘‘personally served the [OSC] on
Registrant.’’ Id. Registrant signed a DEA
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Form 12, Receipt for Cash or Other
Items, to acknowledge his receipt of the
Show Cause Order. Id.; see also
Government’s Response, EX B.
Based on the SA’s Declaration, the
Government’s written representations,
and my review of the record, I find that
the Government accomplished service
of the OSC on Registrant on December
6, 2017. I also find that more than thirty
days have now passed since the
Government accomplished service of
the OSC. Further, based on the
Government’s written representations, I
find that neither Registrant, nor anyone
purporting to represent the Registrant,
requested a hearing, submitted a written
statement while waiving Registrant’s
right to a hearing, or submitted a
corrective action plan. Accordingly, I
find that Registrant has waived the right
to a hearing and the right to submit a
written statement and corrective action
plan. 21 CFR 1301.43(d) and 21 U.S.C.
824(c)(2)(C). I, therefore, issue this
Decision and Order based on the record
submitted by the Government, which
constitutes the entire record before me.
21 CFR 1301.43(e).
Findings of Fact
Registrant’s DEA Registration
Registrant is the holder of DEA
Certificate of Registration No.
BZ6248199 at the registered address of
8775 Norwin Avenue, Suite 114, North
Huntingdon, Pennsylvania. OSC, at 1.
Pursuant to this registration, Registrant
is authorized to dispense controlled
substances in schedules II through V as
a practitioner. Id. Registrant’s
registration expires on May 31, 2020,
and is ‘‘in an active pending status.’’ Id.
On October 11, 2017, the State Board
of Medicine for the Commonwealth of
Pennsylvania (hereinafter, the Board),
issued Registrant an Order of Temporary
Suspension and Notice of Hearing
(hereinafter, Suspension Order),
suspending his state license to practice
medicine and surgery. RFAA, EX 3, at
2.
The Government contends that
Registrant currently lacks state authority
to practice medicine and surgery on the
basis of the Suspension Order issued by
Board. RFAA, at 3. Upon review of the
Petition for Temporary Suspension of
Registrant’s license (hereinafter,
Petition), filed by the Prosecuting
Attorney for the Commonwealth of
Pennsylvania’s Department of State, the
Board found that the ‘‘alleged facts . . .
if taken as true,’’ establish that
‘‘[Registrant’s] continued practice of
medicine and surgery . . . makes
[Registrant] an immediate and clear
danger to the public health and safety.’’
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Frm 00062
Fmt 4703
Sfmt 4703
EX 3, at 1 (Suspension Order).
According to the Petition, on October 4,
2017, a criminal complaint and arrest
warrant were filed in the U.S. District
Court for the Western District of
Pennsylvania, charging Respondent
with: Illegal distribution of Schedule II
prescription narcotics and conspiracy to
illegally distribute schedule II
prescription narcotics in violation of 21
U.S.C 841(a)(1) and 846, mail fraud in
violation of 18 U.S.C. 1341, and health
care fraud, in violation of 18 U.S.C.
1347. EX 3, at 9 (Petition). Therefore,
the Board ordered that the ‘‘license to
practice medicine and surgery issued to
the Respondent . . . along with any
other authorizations to practice the
profession issued by the Board to
Respondent, are temporarily suspended
upon service of [the] Order.’’ Id. at 1–
2 (Suspension Order) (emphasis
omitted).
According to Pennsylvania’s online
records, of which I take official notice,
Registrant’s license is still suspended.1
Pennsylvania Department of State,
Bureau of Professional and
Occupational Affairs, https://
www.pals.pa.gov/ (last visited January 3,
2020).
Therefore, I find that Registrant
currently is not licensed to engage in the
practice of medicine in the
Commonwealth of Pennsylvania, the
state in which Registrant is registered
with the DEA.
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 his 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 also long held
that the possession of authority to
dispense controlled substances under
the laws of the State in which a
practitioner engages in professional
1 Under the Administrative Procedure Act (APA),
an agency ‘‘may take official notice of facts at any
stage in a proceeding—even in the final decision.’’
U.S. Dept. of Justice, Attorney General’s Manual on
the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). In accordance
with the APA and DEA’s regulations, Respondent
is ‘‘entitled on timely request to an opportunity to
show to the contrary.’’ 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). To allow Respondent the
opportunity to refute the facts of which I take
official notice, Respondent may file a motion for
reconsideration within 15 calendar days of service
of this order which shall commence on the date this
order is mailed.
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Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices
practice is a fundamental condition for
obtaining and maintaining a
practitioner’s registration. See, e.g.,
James L. Hooper, M.D., 76 FR 71371
(2011), pet. for rev. denied, 481 Fed.
Appx. 826 (4th Cir. 2012); Frederick
Marsh Blanton, M.D., 43 FR 27616,
27617 (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 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 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 he
is no longer authorized to dispense
controlled substances under the laws of
the State in which he practices. See,
e.g., James L. Hooper, M.D., 76 FR at
71371–72; Sheran Arden Yeates, M.D.,
71 FR 39130, 39131 (2006); Dominick A.
Ricci, M.D., 58 FR 51104, 51105 (1993);
Bobby Watts, M.D., 53 FR 11919, 11920
(1988); Frederick Marsh Blanton, M.D.,
43 FR at 27617.
Pennsylvania law defines a
‘‘practitioner’’ as a ‘‘(i) a physician . . .
licensed, registered or otherwise
permitted to distribute, dispense . . . or
to administer a controlled substance
. . . in the course of professional
practice or research in the
Commonwealth of Pennsylvania.’’ 35
Pa. Stat. and Cons. Stat. Ann. § 780–102
(West 2019). Pennsylvania law further
defines a ‘‘physician,’’ as a ‘‘medical
doctor,’’ and a ‘‘medical doctor,’’ as an
‘‘individual who has acquired’’ a license
‘‘to practice medicine and surgery
issued by the board.’’ 63 Pa. Stat. and
Cons. Stat. Ann. § 422.2 (West 2019).
State law prohibits ‘‘[t]he
administration, dispensing, delivery,
gift or prescription of any controlled
substance by any practitioner . . .
unless done (i) in good faith in the
course of his professional practice; (ii)
within the scope of the patient
relationship; (iii) in accordance with
treatment principles accepted by a
responsible segment of the medical
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16:47 Jan 31, 2020
Jkt 250001
profession.’’ 35 Pa. Stat. and Cons. Stat.
Ann. § 780–113(14). Additionally, the
statute prohibits ‘‘knowingly or
intentionally possessing a controlled
. . . substance by a . . . practitioner not
registered or licensed by the appropriate
state board.’’ Id. at § 780–113(15). Here,
the undisputed evidence in the record is
that Registrant currently lacks authority
to practice medicine and surgery in
Pennsylvania. A practitioner, who is a
physician and a medical doctor, must be
licensed and cannot prescribe
controlled substances in his
professional practice or possess
controlled substances without a license
to practice medicine and surgery. Id. at
§ 780–113(14), (15). Because Registrant
lacks authority to practice medicine in
Pennsylvania and, therefore, is not
authorized to possess or prescribe
controlled substances in Pennsylvania,
Registrant is not eligible to maintain a
DEA registration. Accordingly, I will
order that Registrant’s DEA registration
be revoked.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby revoke DEA Certificate
of Registration No. BZ6248199, issued
to Andrjez Kazimierz Zielke, M.D.
Further, I hereby deny any pending
application of Andrjez Kazimierz
Zielke, M.D. to renew or modify this
registration, as well as any pending
application of Andrjez Kazimierz
Zielke, M.D., for registration in the
Commonwealth of Pennsylvania. This
Order is effective March 4, 2020.
Dated: January 3, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020–01968 Filed 1–31–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Kambiz Haghighi, M.D.; Decision and
Order
On May 22, 2019, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter,
Government), issued an Order to Show
Cause to Kambiz Haghighi, M.D.
(hereinafter, Registrant) of Long Beach,
California. Order to Show Cause
(hereinafter, OSC), at 1. The OSC
proposed the revocation of Registrant’s
Certificate of Registration No.
BH6439714 on the ground that
Registrant ‘‘is without authority to
handle controlled substances in the
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5989
State of California, the state in which
[Registrant is] registered with the DEA.’’
Id. at 2 (citing 21 U.S.C. 824(a)(3)).
Specifically, the OSC alleged that on
April 20, 2018, the Medical Board of
California (hereinafter, Board) issued a
Decision and Order directing that,
effective May 18, 2018, Registrant
‘‘ ‘shall not order, prescribe, dispense,
administer, furnish, or possess any
controlled substances.’ ’’ Id. (quoting
Board’s Order). The OSC further alleged
that ‘‘on July 23, 2018, [Registrant]
surrendered [his] Physician’s and
Surgeon’s Certificate to the Board in
accordance with an ‘Agreement for
Surrender of License’ that [he] entered
into with the Board on that same date.’’
Id. at 1–2.
The OSC notified Registrant of the
right to request a hearing on the
allegations or to submit a written
statement while waiving the right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. at 2 (citing 21
CFR 1301.43). The OSC also notified
Registrant of the opportunity to submit
a corrective action plan. Id. at 1, 3
(citing 21 U.S.C. 824(c)(2)(C)).
Adequacy of Service
In a Declaration dated July 17, 2019,
a Diversion Investigator (hereinafter, DI)
assigned to the Los Angeles Field
Division stated that on May 29, 2019,
she and a Special Agent (hereinafter,
SA) traveled to Registrant’s home
address, which she had obtained during
a prior telephone conversation with
Registrant. Request for Final Agency
Action (hereinafter, RFAA), EX 4 (DI’s
Declaration), at 1. The DI stated
Registrant was not at home when they
arrived at the home address, but she
spoke with him on his cell phone and
he arrived several minutes later. Id.
Registrant identified himself, the DI
verified his identity by looking at his
driver’s license, and the DI then
personally served the OSC on
Registrant. RFAA, EX 4, at 1–2.
Registrant signed a DEA–12, Receipt for
Cash or Other Items, acknowledging his
receipt of the OSC, which the SA signed
as a witness. Id. at 2, see also RFAA, EX
4B (DEA–12).
The Government forwarded its RFAA,
along with the evidentiary record, to
this office on July 26, 2019. Therein, the
Government represents that ‘‘at least
[thirty] days have passed since the time
the [OSC] was served on Registrant’’ and
he ‘‘has not requested a hearing and has
not otherwise corresponded or
communicated with DEA.’’ RFAA, at 1–
2. The Government requests that
‘‘Registrant’s DEA Registration [ ] be
revoked based on 21 U.S.C. 824(a)(3)
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[Federal Register Volume 85, Number 22 (Monday, February 3, 2020)]
[Notices]
[Pages 5987-5989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01968]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Andrzej Kazimierz Zielke, M.D.; Decision and Order
On December 1, 2017, the Assistant Administrator, Diversion Control
Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause (hereinafter, OSC) to
Andrzej Kazimierz Zielke, M.D. (hereinafter, Registrant), of North
Huntingdon, Pennsylvania. OSC, at 1. The OSC proposed the revocation of
Registrant's DEA Certificate of Registration No. BZ6248199 on the
ground that Registrant does not have authority to handle controlled
substances in the Commonwealth of Pennsylvania, the state in which
Registrant is registered with the DEA. Id. (citing 21 U.S.C. 823(f) and
824(a)(3)).
Specifically, the OSC alleged that on October 11, 2017, the
Pennsylvania State Board of Medicine issued an
[[Page 5988]]
``Order of Temporary Suspension and Notice of Hearing in which it
suspended [Registrant's] license to practice medicine and surgery,''
and that Registrant is ``without authority to practice medicine or
handle controlled substances in the Commonwealth of Pennsylvania, the
state in which [he is] registered with DEA.'' Id. at 1-2. The OSC
asserts that ``[c]onsequently, DEA must revoke [his] DEA registration
based on [his] lack of authority to handle controlled substances in the
Commonwealth of Pennsylvania.'' Id. at 2 (citing 21 U.S.C. 824(a)(3);
21 CFR 1301.37(b)).
The OSC notified Registrant of the right to request a hearing on
the allegations or to submit a written statement, while waiving the
right to a hearing, the procedures for electing each option, and the
consequences for failing to elect either option. OSC, at 2 (citing 21
CFR 1301.43). The OSC also notified Registrant of the opportunity to
submit a corrective action plan. OSC, at 2-3 (citing 21 U.S.C.
824(c)(2)(C)).
Adequacy of Service
The Government submitted its Request for Final Agency Action
(hereinafter, RFAA) in this matter to my office on February 6, 2018,
representing that since the service of the Order to Show Cause,
Registrant ``has not requested a hearing and has not otherwise
corresponded or communicated with DEA.'' RFAA, at 1. The Government's
initial RFAA included only a Form DEA-12 Receipt as evidence of service
of the Show Cause Order on Registrant. A former Acting Administrator
issued an Order directing the Government to provide a declaration
setting forth the circumstances regarding how it accomplished service.
May 17, 2018, Order of the Acting Administrator. On February 26, 2019,
the Government filed its Response to my office, including therein the
Declaration of the Special Agent detailing how service was effectuated.
Government's Response to Acting Administrator's Order (hereinafter,
Government's Response).
On December 6, 2017, a DEA Special Agent (hereinafter, SA) and a
Diversion Investigator (hereinafter, DI) with the DEA Pittsburgh
District Office, Philadelphia Field Division, personally served
Registrant with the OSC at his residence. Government's Response,
Declaration of Service of Order to Show Cause (hereinafter, SA's
Declaration). The SA stated that upon arrival at the registered
address, Registrant identified himself as Dr. Zielke. Id. The SA then
``personally served the [OSC] on Registrant.'' Id. Registrant signed a
DEA Form 12, Receipt for Cash or Other Items, to acknowledge his
receipt of the Show Cause Order. Id.; see also Government's Response,
EX B.
Based on the SA's Declaration, the Government's written
representations, and my review of the record, I find that the
Government accomplished service of the OSC on Registrant on December 6,
2017. I also find that more than thirty days have now passed since the
Government accomplished service of the OSC. Further, based on the
Government's written representations, I find that neither Registrant,
nor anyone purporting to represent the Registrant, requested a hearing,
submitted a written statement while waiving Registrant's right to a
hearing, or submitted a corrective action plan. Accordingly, I find
that Registrant has waived the right to a hearing and the right to
submit a written statement and corrective action plan. 21 CFR
1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, therefore, issue this
Decision and Order based on the record submitted by the Government,
which constitutes the entire record before me. 21 CFR 1301.43(e).
Findings of Fact
Registrant's DEA Registration
Registrant is the holder of DEA Certificate of Registration No.
BZ6248199 at the registered address of 8775 Norwin Avenue, Suite 114,
North Huntingdon, Pennsylvania. OSC, at 1. Pursuant to this
registration, Registrant is authorized to dispense controlled
substances in schedules II through V as a practitioner. Id.
Registrant's registration expires on May 31, 2020, and is ``in an
active pending status.'' Id.
On October 11, 2017, the State Board of Medicine for the
Commonwealth of Pennsylvania (hereinafter, the Board), issued
Registrant an Order of Temporary Suspension and Notice of Hearing
(hereinafter, Suspension Order), suspending his state license to
practice medicine and surgery. RFAA, EX 3, at 2.
The Government contends that Registrant currently lacks state
authority to practice medicine and surgery on the basis of the
Suspension Order issued by Board. RFAA, at 3. Upon review of the
Petition for Temporary Suspension of Registrant's license (hereinafter,
Petition), filed by the Prosecuting Attorney for the Commonwealth of
Pennsylvania's Department of State, the Board found that the ``alleged
facts . . . if taken as true,'' establish that ``[Registrant's]
continued practice of medicine and surgery . . . makes [Registrant] an
immediate and clear danger to the public health and safety.'' EX 3, at
1 (Suspension Order). According to the Petition, on October 4, 2017, a
criminal complaint and arrest warrant were filed in the U.S. District
Court for the Western District of Pennsylvania, charging Respondent
with: Illegal distribution of Schedule II prescription narcotics and
conspiracy to illegally distribute schedule II prescription narcotics
in violation of 21 U.S.C 841(a)(1) and 846, mail fraud in violation of
18 U.S.C. 1341, and health care fraud, in violation of 18 U.S.C. 1347.
EX 3, at 9 (Petition). Therefore, the Board ordered that the ``license
to practice medicine and surgery issued to the Respondent . . . along
with any other authorizations to practice the profession issued by the
Board to Respondent, are temporarily suspended upon service of [the]
Order.'' Id. at 1-2 (Suspension Order) (emphasis omitted).
According to Pennsylvania's online records, of which I take
official notice, Registrant's license is still suspended.\1\
Pennsylvania Department of State, Bureau of Professional and
Occupational Affairs, https://www.pals.pa.gov/ (last visited January 3,
2020).
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\1\ Under the Administrative Procedure Act (APA), an agency
``may take official notice of facts at any stage in a proceeding--
even in the final decision.'' U.S. Dept. of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and
DEA's regulations, Respondent is ``entitled on timely request to an
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). To allow Respondent the opportunity to refute the
facts of which I take official notice, Respondent may file a motion
for reconsideration within 15 calendar days of service of this order
which shall commence on the date this order is mailed.
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Therefore, I find that Registrant currently is not licensed to
engage in the practice of medicine in the Commonwealth of Pennsylvania,
the state in which Registrant is registered with the DEA.
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 his 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 also long
held that the possession of authority to dispense controlled substances
under the laws of the State in which a practitioner engages in
professional
[[Page 5989]]
practice is a fundamental condition for obtaining and maintaining a
practitioner's registration. See, e.g., James L. Hooper, M.D., 76 FR
71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012);
Frederick Marsh Blanton, M.D., 43 FR 27616, 27617 (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 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 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
he is no longer authorized to dispense controlled substances under the
laws of the State in which he practices. See, e.g., James L. Hooper,
M.D., 76 FR at 71371-72; Sheran Arden Yeates, M.D., 71 FR 39130, 39131
(2006); Dominick A. Ricci, M.D., 58 FR 51104, 51105 (1993); Bobby
Watts, M.D., 53 FR 11919, 11920 (1988); Frederick Marsh Blanton, M.D.,
43 FR at 27617.
Pennsylvania law defines a ``practitioner'' as a ``(i) a physician
. . . licensed, registered or otherwise permitted to distribute,
dispense . . . or to administer a controlled substance . . . in the
course of professional practice or research in the Commonwealth of
Pennsylvania.'' 35 Pa. Stat. and Cons. Stat. Ann. Sec. 780-102 (West
2019). Pennsylvania law further defines a ``physician,'' as a ``medical
doctor,'' and a ``medical doctor,'' as an ``individual who has
acquired'' a license ``to practice medicine and surgery issued by the
board.'' 63 Pa. Stat. and Cons. Stat. Ann. Sec. 422.2 (West 2019).
State law prohibits ``[t]he administration, dispensing, delivery, gift
or prescription of any controlled substance by any practitioner . . .
unless done (i) in good faith in the course of his professional
practice; (ii) within the scope of the patient relationship; (iii) in
accordance with treatment principles accepted by a responsible segment
of the medical profession.'' 35 Pa. Stat. and Cons. Stat. Ann. Sec.
780-113(14). Additionally, the statute prohibits ``knowingly or
intentionally possessing a controlled . . . substance by a . . .
practitioner not registered or licensed by the appropriate state
board.'' Id. at Sec. 780-113(15). Here, the undisputed evidence in the
record is that Registrant currently lacks authority to practice
medicine and surgery in Pennsylvania. A practitioner, who is a
physician and a medical doctor, must be licensed and cannot prescribe
controlled substances in his professional practice or possess
controlled substances without a license to practice medicine and
surgery. Id. at Sec. 780-113(14), (15). Because Registrant lacks
authority to practice medicine in Pennsylvania and, therefore, is not
authorized to possess or prescribe controlled substances in
Pennsylvania, Registrant is not eligible to maintain a DEA
registration. Accordingly, I will order that Registrant's DEA
registration be revoked.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
BZ6248199, issued to Andrjez Kazimierz Zielke, M.D. Further, I hereby
deny any pending application of Andrjez Kazimierz Zielke, M.D. to renew
or modify this registration, as well as any pending application of
Andrjez Kazimierz Zielke, M.D., for registration in the Commonwealth of
Pennsylvania. This Order is effective March 4, 2020.
Dated: January 3, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-01968 Filed 1-31-20; 8:45 am]
BILLING CODE 4410-09-P
