[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
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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 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]
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