William S. Husel, D.O.; Decision and Order, 13929-13931 [2020-04837]
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Federal Register / Vol. 85, No. 47 / Tuesday, March 10, 2020 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 19–21]
khammond on DSKJM1Z7X2PROD with NOTICES
William S. Husel, D.O.; Decision and
Order
On April 9, 2019, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter,
Government), issued an Order to Show
Cause (hereinafter, OSC) to William S.
Husel, D.O. (hereinafter, Respondent) of
Columbus, Ohio. OSC, at 1. The OSC
proposed the revocation of
Respondent’s Certificate of Registration
No. FH4036667. It alleged that
Respondent is without ‘‘authority to
handle controlled substances in the
State of Ohio, the state in which
[Respondent is] registered with the
DEA.’’ Id. at 2 (citing 21 U.S.C.
824(a)(3)).
Specifically, the OSC alleged that the
State Medical Board of Ohio
(hereinafter, Board) summarily
suspended Respondent’s certificate to
practice osteopathic medicine and
surgery on January 25, 2019. Id. at 2.
The OSC notified Respondent 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. (citing 21 CFR
1301.43). The OSC also notified
Respondent of the opportunity to
submit a corrective action plan. OSC, at
1, 3 (citing 21 U.S.C. 824(c)(2)(C)).
Respondent, through his counsel,
timely requested a hearing via an email
dated April 30, 2019.1 Hearing Request,
at 1. In his hearing request, Respondent
admitted that his Ohio Medical License
was summarily suspended on January
25, 2019, and stated that he was
preparing for his hearing before the
State Medical Board of Ohio. Id. He also
stated that ‘‘he ha[d] not prescribed any
controlled substances while on
suspension.’’ Id.
The Office of Administrative Law
Judges (hereinafter, OALJ) put the
matter on the docket and assigned it to
Administrative Law Judge Charles
Dorman (hereinafter, ALJ). The ALJ
issued a briefing schedule to both
parties on May 1, 2019, directing the
Government ‘‘to file evidence to support
its allegation that Respondent lacks state
1 The Hearing Request was filed with the Office
of Administrative Law by email after 5 p.m. on
April 30, 2019, therefore the ALJ deemed the filing
date to be May 1, 2019. Briefing Order, at 1.
Respondent’s Hearing Request was also filed by
U.S. Mail, received on May 9, 2019.
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authority to handle controlled
substances, or any other grounds upon
which it seeks summary disposition,’’
and any motion for summary
disposition, by May 15, 2019. Briefing
Schedule for Lack of State Authority
Allegations (hereinafter, Briefing Order),
at 1. The ALJ directed that ‘‘if the
Government files a motion for summary
disposition, Respondent’s reply is due
on May 29, 2019.’’ Id. The ALJ also
noted that Respondent’s counsel’s email
address was included in Respondent’s
Hearing Request, and provided
instructions in the event Respondent’s
counsel declined to participate in future
electronic receipt of orders from the
OALJ. Id. at 2.
The Government timely complied
with the Briefing Order by filing a
Motion for Summary Disposition on
May 15, 2019. Government’s Motion for
Summary Disposition (hereinafter,
MSD). In its MSD, the Government
stated that Respondent ‘‘lacks authority
to handle controlled substances in the
State of Ohio, the jurisdiction where he
is licensed to practice osteopathic
medicine and where he is registered
with DEA, because his osteopathic
medical license is suspended,’’ and
therefore, he ‘‘does not have state
authority to prescribe, administer, or
dispense controlled substances in the
State of Ohio.’’ Id. at 3. Thus, the
Government contends, ‘‘Respondent is
not authorized to possess a DEA
registration’’ in Ohio. Id. In support of
its assertion, the Government provided
a copy of the Board’s ‘‘Entry of Order’’
(hereinafter, Order) dated January 25,
2019, which ordered that ‘‘effective
immediately,’’ Respondent’s ‘‘certificate
. . . to practice osteopathic medicine and
surgery in the State of Ohio be
summarily suspended,’’ and that
Respondent ‘‘shall immediately cease
the practice of osteopathic medicine and
surgery in Ohio.’’ MSD, Exhibit
(hereinafter, EX) 2, at 7.
The Government’s MSD included the
Board’s certification that the Order and
Notice 1, dated January 25, 2019, and
Notice 2, dated February 13, 2019, are
‘‘true and correct copies’’ of the
proceedings of the Board. MSD, EX2, at
1, 6.
Respondent failed to file a response to
the MSD by the filing deadline in the
ALJ’s Briefing Order, nor did he file a
response by the date of the ALJ’s
recommended decision, and the ALJ
deemed the Government’s motion
unopposed. Order Granting Summary
Disposition and Recommended
Findings of Fact, Conclusions of Law,
and Decision (hereinafter, SD), at 4.
The ALJ granted the MSD, finding
that ‘‘‘there is no factual dispute of
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13929
substance’’’ and that the Government
‘‘has provided ‘reliable and probative
evidence’ of ‘appropriate evidentiary
quality’ that Respondent lacks state
authority to handle controlled
substances in Ohio.’’ SD, at 8. (Citations
omitted). The ALJ also found that
‘‘summary disposition is additionally
warranted because the Government
carried its burden and [Respondent]
failed to respond.’’ Id.
The ALJ recommended revocation of
Respondent’s registration because ‘‘the
Government has presented sufficient
evidence to establish that [Respondent]
lacks state authority to dispense
controlled substances in Ohio, the state
in which [he] holds his DEA
registration.’’ Id. at 9.
By letter dated June 24, 2019, the ALJ
certified and transmitted the record to
me for final Agency action. In that letter,
the ALJ advised that neither party filed
exceptions and that the time period to
do so had expired.
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
On September 10, 2016, Respondent
renewed DEA Certificate of Registration
No. FH4036667, at the registered
address of 793 West State Street,
Columbus, Ohio. MSD, EX1
(Certification of Registration History), at
1. Pursuant to this registration,
Respondent is authorized to dispense
controlled substances in schedules II
through V as a practitioner. Id.
Respondent’s registration expired on
October 31, 2019.2 Id. at 1.
The Status of Respondent’s State
License
On January 25, 2019, the Board issued
an Order and Notice summarily
suspending Respondent’s certificate to
practice osteopathic medicine and
surgery in the State of Ohio, finding that
there was ‘‘clear and convincing
evidence’’ that Respondent violated
Ohio law. MSD, EX2 at 7; see also MSD,
EX2, at 9–11. In its Order, the Board
found that Respondent’s ‘‘continued
practice presents a danger of immediate
and serious harm to the public.’’ MSD,
EX2, at 7. On the same date, the Board
also issued a Notice of Summary
Suspension and Opportunity for
2 The fact that Respondent allowed his
registration to expire during the pendency of an
OSC does not impact my jurisdiction or prerogative
under the Controlled Substances Act (hereinafter,
CSA) to adjudicate the OSC to finality. Jeffrey D.
Olsen, MD, 84 FR 68,474 (2019).
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Federal Register / Vol. 85, No. 47 / Tuesday, March 10, 2020 / Notices
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Hearing (hereinafter, Notice) to
Respondent, notifying him that his
‘‘certificate/license to practice
osteopathic medicine and surgery in the
State of Ohio is summarily suspended’’
and that ‘‘at this time [he is] no longer
authorized to practice osteopathic
medicine and surgery in Ohio.’’ Id. at 9.
In its Notice, the Board specifically
alleged that Respondent’s employer
hospital terminated his employment
‘‘after determining that the medical
treatment [Respondent] provided was
below the standard of care and
jeopardized the safety of patients’’
because ‘‘at least twenty-seven patients
received doses of controlled substances
that significantly exceeded the
acceptable dose range and were at fatal
levels.’’ Id.
The Notice alleged that Respondent’s
conduct constituted a ‘‘ ‘failure to
maintain minimal standards applicable
to the selection or administration of
drugs’ ’’ and ‘‘ ‘a departure from . . .
minimal standards of care of similar
practitioners under the same or similar
circumstances,’ ’’ and his actions ‘‘were
in bad faith, and/or outside the scope of
[his] authority, and/or not in accordance
with reasonable medical standards.’’ Id.
at 10 (quoting Ohio Rev. Code Ann.
§§ 4731.22(B)(2) and (B)(6).
The Notice also informed Respondent
that he was entitled to a hearing on the
Board’s allegations. MSD, EX2, at 11.
The Government also provided a copy
of a second Notice of Opportunity for
Hearing (hereinafter, Notice 2) issued by
the Board on February 13, 2019, which
contained additional allegations of
violations of Ohio law and advised
Respondent of his right to a hearing
before the Board. Id. at 2–4. Respondent
was ordered to ‘‘immediately cease the
practice of osteopathic medicine and
surgery in Ohio.’’ Id. at 7.
According to Ohio’s online records, of
which I take official notice,
Respondent’s license is still
suspended. 3 https://elicense.ohio.gov/
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,
Respondent 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 Respondent
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
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oh_verifylicense?firstName=&last
Name=Husel&licenseNumber=&search
Type=individual (last visited January
30, 2020).
Accordingly, I find that Respondent
currently is not licensed to engage in the
practice of medicine in Ohio, the state
in which Respondent 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 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, MD, 76 FR 71,371
(2011), pet. for rev. denied, 481 Fed.
Appx. 826 (4th Cir. 2012); Frederick
Marsh Blanton, MD, 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 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 71,371–72;
Sheran Arden Yeates, MD, 71 FR
Office of the Administrator, Attn: ADDO, Drug
Enforcement Administration, 8701 Morrissette
Drive, Springfield, VA 22152.
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39,130, 39,131 (2006); Dominick A.
Ricci, MD, 58 FR 51,104, 51,105 (1993);
Bobby Watts, MD, 53 FR 11,919, 11,920
(1988); Frederick Marsh Blanton, 43 FR
at 27,617.
Under Ohio law, ‘‘No person shall
knowingly obtain, possess, or use a
controlled substance or a controlled
substance analog,’’ except 4 pursuant to
a ‘‘prescription issued by a licensed
health professional authorized to
prescribe drugs if the prescription was
issued for a legitimate medical
purpose.’’ Ohio Rev. Code Ann.
§§ 2925.11(A), (B)(1)(d) (West, Westlaw
current through File 21 of the 133rd
General Assembly (2019–2020)).
Ohio law further states that a
‘‘ ‘[l]icensed health professional
authorized to prescribe drugs’ or a
‘prescriber’ means an individual who is
authorized by law to prescribe drugs or
dangerous drugs . . . in the course of the
individual’s professional practice.’’
Ohio Rev. Code Ann. § 4729.01(I) (West,
Westlaw current through Files 1 to 20 of
the 133rd General Assembly (2019–
2020)). The definition further provides a
limited list of authorized prescribers,
the relevant provision of which is ‘‘[a]
physician authorized under Chapter
4731[ ] of the Revised Code to practice
medicine and surgery, osteopathic
medicine and surgery, or podiatric
medicine and surgery.’’ Id. at
§ 4729.01(I)(4). In addition, the Ohio
Uniform Controlled Substances Act
permits ‘‘[a] licensed health professional
authorized to prescribe drugs, if acting
in the course of professional practice, in
accordance with the laws regulating the
professional’s practice’’ to prescribe or
administer schedule II, III, IV, and V
controlled substances to patients. Ohio
Rev. Code Ann. § 3719.06(A)(1)(a)–(b)
(West, Westlaw current through Files 1
to 20 of the 133rd General Assembly
(2019–2020)).
Here, the undisputed evidence in the
record is that Respondent currently
lacks authority to practice medicine in
Ohio. As already discussed, a physician
is authorized by law to prescribe or
administer drugs in Ohio only when
authorized to practice medicine and
surgery under Ohio law. Thus, because
Respondent lacks authority to practice
medicine in Ohio and, therefore, is not
authorized to handle controlled
substances in Ohio, Respondent is not
eligible to maintain a DEA registration.
Accordingly, I will order that
Respondent’s DEA registration be
revoked.
4 Other
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Federal Register / Vol. 85, No. 47 / Tuesday, March 10, 2020 / Notices
Order
DEPARTMENT OF JUSTICE
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. FH4036667 issued to
William S. Husel, D.O. Further,
pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(f), I hereby deny any pending
application of William S. Husel to
renew or modify this registration, as
well as any other applications of
William S. Husel for an additional
registration in Ohio. This Order is
effective April 9, 2020.
Drug Enforcement Administration
Dated: January 29, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020–04837 Filed 3–9–20; 8:45 am]
BILLING CODE 4410–09–P
[Docket No. DEA–592]
Importer of Controlled Substances
Application: Johnson Matthey Inc.
ACTION:
Notice of application.
Registered importers 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 April
9, 2020. Such persons may also file a
written request for a hearing on the
application on or before April 9, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
DATES:
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All request for a hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
In
accordance with 21 CFR 1301.34(a), this
is notice that on September 11, 2019,
Johnson Matthey Inc., Pharmaceutical
Materials, 2003 Nolte Drive, West
Deptford, New Jersey 08066–1742
applied to be registered as an importer
of the following basic classes of
controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Coca Leaves ....................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Opium, raw ......................................................................................................................................................................
Noroxymorophone ...........................................................................................................................................................
Poppy Straw Concentrate ...............................................................................................................................................
Fentanyl ...........................................................................................................................................................................
The company plans to import Coca
Leaves (9040), Opium, raw (9600), and
Poppy Straw Concentrate (9670) in
order to bulk manufacture active
pharmaceutical ingredients (API) for
distribution to its customers. The
company plans to also import Thebaine
(9333), Noroxymorophone (9668), and
Fentanyl (9801) to use as analytical
reference standards, both internally and
to be sold to their customers to support
testing of Johnson Matthey Inc.’s active
pharmaceutical ingredients (API’s) only.
Dated: February 10, 2020.
William T. McDermott,
Assistant Administrator.
November 22, 2019, concerning a notice
of application. As that document
correctly indicated, the applicant, S&B
Pharma, Inc., DBA Norac Pharma, 405
South Motor Avenue, Azusa, California
91702–3232 applied to be registered as
a bulk manufacturer of a number of
controlled substances, to include
applying for authorization in order to
synthetically manufacture using drug
code 7360 (marihuana). However, on the
notice of application published, drug
code 7360 was inadvertently identified
and listed as Gamma Hydroxybutyric
Acid instead of Marihuana.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2020–04836 Filed 3–9–20; 8:45 am]
Correction
BILLING CODE 4410–09–P
In the Federal Register of November
22, 2019, in FR Doc. 2019–25402 (84 FR
64563), on page 64564, correct the
listing of drug code 7360 to be identified
as Marihuana, as is shown below.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
khammond on DSKJM1Z7X2PROD with NOTICES
[Docket No. DEA–582]
Bulk Manufacturer of Controlled
Substances Application: S&B Pharma,
Inc.; Correction
Notice of application;
correction.
ACTION:
The Drug Enforcement
Administration (DEA) published a
document in the Federal Register on
SUMMARY:
VerDate Sep<11>2014
17:20 Mar 09, 2020
Jkt 250001
Controlled substance
Drug
code
Schedule
Marihuana .................
7360
I
Dated: February 11, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–04829 Filed 3–9–20; 8:45 am]
BILLING CODE 4410–09–P
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Sfmt 4703
9040
9333
9600
9668
9670
9801
Schedule
II
II
II
II
II
II
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–594]
Importer of Controlled Substances
Application: Arizona Department of
Corrections
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic class, and applicants
therefore, may file written comments on
or objections to the issuance of the
proposed registration on or before April
9, 2020. Such persons may also file a
written request for a hearing on the
application on or before April 9, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
DATES:
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[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Notices]
[Pages 13929-13931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04837]
[[Page 13929]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 19-21]
William S. Husel, D.O.; Decision and Order
On April 9, 2019, the Assistant Administrator, Diversion Control
Division, Drug Enforcement Administration (hereinafter, Government),
issued an Order to Show Cause (hereinafter, OSC) to William S. Husel,
D.O. (hereinafter, Respondent) of Columbus, Ohio. OSC, at 1. The OSC
proposed the revocation of Respondent's Certificate of Registration No.
FH4036667. It alleged that Respondent is without ``authority to handle
controlled substances in the State of Ohio, the state in which
[Respondent is] registered with the DEA.'' Id. at 2 (citing 21 U.S.C.
824(a)(3)).
Specifically, the OSC alleged that the State Medical Board of Ohio
(hereinafter, Board) summarily suspended Respondent's certificate to
practice osteopathic medicine and surgery on January 25, 2019. Id. at
2.
The OSC notified Respondent 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. (citing 21 CFR
1301.43). The OSC also notified Respondent of the opportunity to submit
a corrective action plan. OSC, at 1, 3 (citing 21 U.S.C. 824(c)(2)(C)).
Respondent, through his counsel, timely requested a hearing via an
email dated April 30, 2019.\1\ Hearing Request, at 1. In his hearing
request, Respondent admitted that his Ohio Medical License was
summarily suspended on January 25, 2019, and stated that he was
preparing for his hearing before the State Medical Board of Ohio. Id.
He also stated that ``he ha[d] not prescribed any controlled substances
while on suspension.'' Id.
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\1\ The Hearing Request was filed with the Office of
Administrative Law by email after 5 p.m. on April 30, 2019,
therefore the ALJ deemed the filing date to be May 1, 2019. Briefing
Order, at 1. Respondent's Hearing Request was also filed by U.S.
Mail, received on May 9, 2019.
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The Office of Administrative Law Judges (hereinafter, OALJ) put the
matter on the docket and assigned it to Administrative Law Judge
Charles Dorman (hereinafter, ALJ). The ALJ issued a briefing schedule
to both parties on May 1, 2019, directing the Government ``to file
evidence to support its allegation that Respondent lacks state
authority to handle controlled substances, or any other grounds upon
which it seeks summary disposition,'' and any motion for summary
disposition, by May 15, 2019. Briefing Schedule for Lack of State
Authority Allegations (hereinafter, Briefing Order), at 1. The ALJ
directed that ``if the Government files a motion for summary
disposition, Respondent's reply is due on May 29, 2019.'' Id. The ALJ
also noted that Respondent's counsel's email address was included in
Respondent's Hearing Request, and provided instructions in the event
Respondent's counsel declined to participate in future electronic
receipt of orders from the OALJ. Id. at 2.
The Government timely complied with the Briefing Order by filing a
Motion for Summary Disposition on May 15, 2019. Government's Motion for
Summary Disposition (hereinafter, MSD). In its MSD, the Government
stated that Respondent ``lacks authority to handle controlled
substances in the State of Ohio, the jurisdiction where he is licensed
to practice osteopathic medicine and where he is registered with DEA,
because his osteopathic medical license is suspended,'' and therefore,
he ``does not have state authority to prescribe, administer, or
dispense controlled substances in the State of Ohio.'' Id. at 3. Thus,
the Government contends, ``Respondent is not authorized to possess a
DEA registration'' in Ohio. Id. In support of its assertion, the
Government provided a copy of the Board's ``Entry of Order''
(hereinafter, Order) dated January 25, 2019, which ordered that
``effective immediately,'' Respondent's ``certificate . . . to practice
osteopathic medicine and surgery in the State of Ohio be summarily
suspended,'' and that Respondent ``shall immediately cease the practice
of osteopathic medicine and surgery in Ohio.'' MSD, Exhibit
(hereinafter, EX) 2, at 7.
The Government's MSD included the Board's certification that the
Order and Notice 1, dated January 25, 2019, and Notice 2, dated
February 13, 2019, are ``true and correct copies'' of the proceedings
of the Board. MSD, EX2, at 1, 6.
Respondent failed to file a response to the MSD by the filing
deadline in the ALJ's Briefing Order, nor did he file a response by the
date of the ALJ's recommended decision, and the ALJ deemed the
Government's motion unopposed. Order Granting Summary Disposition and
Recommended Findings of Fact, Conclusions of Law, and Decision
(hereinafter, SD), at 4.
The ALJ granted the MSD, finding that ```there is no factual
dispute of substance''' and that the Government ``has provided
`reliable and probative evidence' of `appropriate evidentiary quality'
that Respondent lacks state authority to handle controlled substances
in Ohio.'' SD, at 8. (Citations omitted). The ALJ also found that
``summary disposition is additionally warranted because the Government
carried its burden and [Respondent] failed to respond.'' Id.
The ALJ recommended revocation of Respondent's registration because
``the Government has presented sufficient evidence to establish that
[Respondent] lacks state authority to dispense controlled substances in
Ohio, the state in which [he] holds his DEA registration.'' Id. at 9.
By letter dated June 24, 2019, the ALJ certified and transmitted
the record to me for final Agency action. In that letter, the ALJ
advised that neither party filed exceptions and that the time period to
do so had expired.
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
On September 10, 2016, Respondent renewed DEA Certificate of
Registration No. FH4036667, at the registered address of 793 West State
Street, Columbus, Ohio. MSD, EX1 (Certification of Registration
History), at 1. Pursuant to this registration, Respondent is authorized
to dispense controlled substances in schedules II through V as a
practitioner. Id. Respondent's registration expired on October 31,
2019.\2\ Id. at 1.
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\2\ The fact that Respondent allowed his registration to expire
during the pendency of an OSC does not impact my jurisdiction or
prerogative under the Controlled Substances Act (hereinafter, CSA)
to adjudicate the OSC to finality. Jeffrey D. Olsen, MD, 84 FR
68,474 (2019).
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The Status of Respondent's State License
On January 25, 2019, the Board issued an Order and Notice summarily
suspending Respondent's certificate to practice osteopathic medicine
and surgery in the State of Ohio, finding that there was ``clear and
convincing evidence'' that Respondent violated Ohio law. MSD, EX2 at 7;
see also MSD, EX2, at 9-11. In its Order, the Board found that
Respondent's ``continued practice presents a danger of immediate and
serious harm to the public.'' MSD, EX2, at 7. On the same date, the
Board also issued a Notice of Summary Suspension and Opportunity for
[[Page 13930]]
Hearing (hereinafter, Notice) to Respondent, notifying him that his
``certificate/license to practice osteopathic medicine and surgery in
the State of Ohio is summarily suspended'' and that ``at this time [he
is] no longer authorized to practice osteopathic medicine and surgery
in Ohio.'' Id. at 9. In its Notice, the Board specifically alleged that
Respondent's employer hospital terminated his employment ``after
determining that the medical treatment [Respondent] provided was below
the standard of care and jeopardized the safety of patients'' because
``at least twenty-seven patients received doses of controlled
substances that significantly exceeded the acceptable dose range and
were at fatal levels.'' Id.
The Notice alleged that Respondent's conduct constituted a ``
`failure to maintain minimal standards applicable to the selection or
administration of drugs' '' and `` `a departure from . . . minimal
standards of care of similar practitioners under the same or similar
circumstances,' '' and his actions ``were in bad faith, and/or outside
the scope of [his] authority, and/or not in accordance with reasonable
medical standards.'' Id. at 10 (quoting Ohio Rev. Code Ann. Sec. Sec.
4731.22(B)(2) and (B)(6).
The Notice also informed Respondent that he was entitled to a
hearing on the Board's allegations. MSD, EX2, at 11. The Government
also provided a copy of a second Notice of Opportunity for Hearing
(hereinafter, Notice 2) issued by the Board on February 13, 2019, which
contained additional allegations of violations of Ohio law and advised
Respondent of his right to a hearing before the Board. Id. at 2-4.
Respondent was ordered to ``immediately cease the practice of
osteopathic medicine and surgery in Ohio.'' Id. at 7.
According to Ohio's online records, of which I take official
notice, Respondent's license is still suspended. \3\ https://elicense.ohio.gov/oh_verifylicense?firstName=&lastName=Husel&licenseNumber=&searchType=individual (last visited January 30, 2020).
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\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, Respondent 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 Respondent 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
([email protected]) or by mail to Office of the
Administrator, Attn: ADDO, Drug Enforcement Administration, 8701
Morrissette Drive, Springfield, VA 22152.
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Accordingly, I find that Respondent currently is not licensed to
engage in the practice of medicine in Ohio, the state in which
Respondent 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 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, MD, 76 FR 71,371 (2011), pet.
for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); Frederick Marsh
Blanton, MD, 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 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 71,371-72; Sheran Arden Yeates, MD, 71 FR 39,130, 39,131 (2006);
Dominick A. Ricci, MD, 58 FR 51,104, 51,105 (1993); Bobby Watts, MD, 53
FR 11,919, 11,920 (1988); Frederick Marsh Blanton, 43 FR at 27,617.
Under Ohio law, ``No person shall knowingly obtain, possess, or use
a controlled substance or a controlled substance analog,'' except \4\
pursuant to a ``prescription issued by a licensed health professional
authorized to prescribe drugs if the prescription was issued for a
legitimate medical purpose.'' Ohio Rev. Code Ann. Sec. Sec.
2925.11(A), (B)(1)(d) (West, Westlaw current through File 21 of the
133rd General Assembly (2019-2020)).
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\4\ Other irrelevant exceptions omitted.
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Ohio law further states that a `` `[l]icensed health professional
authorized to prescribe drugs' or a `prescriber' means an individual
who is authorized by law to prescribe drugs or dangerous drugs . . . in
the course of the individual's professional practice.'' Ohio Rev. Code
Ann. Sec. 4729.01(I) (West, Westlaw current through Files 1 to 20 of
the 133rd General Assembly (2019-2020)). The definition further
provides a limited list of authorized prescribers, the relevant
provision of which is ``[a] physician authorized under Chapter 4731[ ]
of the Revised Code to practice medicine and surgery, osteopathic
medicine and surgery, or podiatric medicine and surgery.'' Id. at Sec.
4729.01(I)(4). In addition, the Ohio Uniform Controlled Substances Act
permits ``[a] licensed health professional authorized to prescribe
drugs, if acting in the course of professional practice, in accordance
with the laws regulating the professional's practice'' to prescribe or
administer schedule II, III, IV, and V controlled substances to
patients. Ohio Rev. Code Ann. Sec. 3719.06(A)(1)(a)-(b) (West, Westlaw
current through Files 1 to 20 of the 133rd General Assembly (2019-
2020)).
Here, the undisputed evidence in the record is that Respondent
currently lacks authority to practice medicine in Ohio. As already
discussed, a physician is authorized by law to prescribe or administer
drugs in Ohio only when authorized to practice medicine and surgery
under Ohio law. Thus, because Respondent lacks authority to practice
medicine in Ohio and, therefore, is not authorized to handle controlled
substances in Ohio, Respondent is not eligible to maintain a DEA
registration. Accordingly, I will order that Respondent's DEA
registration be revoked.
[[Page 13931]]
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.
FH4036667 issued to William S. Husel, D.O. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby
deny any pending application of William S. Husel to renew or modify
this registration, as well as any other applications of William S.
Husel for an additional registration in Ohio. This Order is effective
April 9, 2020.
Dated: January 29, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-04837 Filed 3-9-20; 8:45 am]
BILLING CODE 4410-09-P