Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc., 4943-4944 [2022-01817]
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Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
Look Up, https://elicense.ohio.gov/oh_
verifylicense (last visited date of
signature of this Order). Accordingly, I
find that Respondent is not currently
licensed to practice medicine in Ohio,
the state in which he 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
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 F. App’x
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, 76 FR 71371–72;
Sheran Arden Yeates, M.D., 71 FR
date of this Order. Any such motion and response
shall be filed and served by email to the other party
and to Office of the Administrator, Drug
Enforcement Administration at
dea.addo.attorneys@dea.usdoj.gov.
VerDate Sep<11>2014
17:38 Jan 28, 2022
Jkt 256001
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 27617.
Moreover, because ‘‘the controlling
question’’ in a proceeding brought
under 21 U.S.C. 824(a)(3) is whether the
holder of a practitioner’s registration ‘‘is
currently authorized to handle
controlled substances in the [S]tate,’’
Hooper, 76 FR 71371 (quoting Anne
Lazar Thorn, 62 FR 12847, 12848
(1997)), the Agency has also long held
that revocation is warranted even where
a practitioner is still challenging the
underlying action. Bourne Pharmacy, 72
FR 18273, 18274 (2007); Wingfield
Drugs, 52 FR 27070, 27071 (1987). Thus,
it is of no consequence that the final
outcome of the underlying action may
still be pending. What is consequential
is my finding that Respondent is not
currently authorized to dispense
controlled substances in Ohio, the state
in which he is registered with the DEA.
Under Ohio law, ‘‘[n]o person shall
knowingly obtain, possess, or use a
controlled substance or a controlled
substance analog,’’ except 6 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 2021).
Ohio law further states that a
‘‘‘[l]icensed health professional
authorized to prescribe drugs’ or
‘prescriber’ means an individual who is
authorized by law to prescribe drugs or
dangerous drugs . . . in the course of
the individual’s professional practice.’’
Id. at § 4729.01(I). 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)(5). 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. Id. at
§ 3719.06(A)(1)(a)–(b).
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
6 Other
PO 00000
irrelevant exceptions omitted.
Frm 00112
Fmt 4703
Sfmt 4703
4943
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.
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. FK6714504 issued to
Austin J. Kosier, M.D. 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
Austin J. Kosier, M.D. to renew or
modify this registration, as well as any
other pending application of Austin J.
Kosier, M.D., for additional registration
in Ohio. This Order is effective March
2, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2022–01834 Filed 1–28–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–946]
Importer of Controlled Substances
Application: Mylan Pharmaceuticals
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Mylan Pharmaceuticals Inc.
has applied to be registered as an
importer of basic class(es) of controlled
substance(s). Refer to Supplementary
Information listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before March 2, 2022. Such persons
may also file a written request for a
hearing on the application on or before
March 2, 2022.
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,
SUMMARY:
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4944
Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices
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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on December 7, 2021,
Mylan Pharmaceuticals Inc., 2898
Manufacturers Road, Greensboro, North
Carolina 27406–4600, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled
substance
Remifentanil ...................
Drug
code
9739
Schedule
II
The company plans to import the
above controlled substance as a Federal
Drug Administration-approved drug
product in finished dosage form for
commercial distribution to its
customers.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2022–01817 Filed 1–28–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 21–11]
khammond on DSKJM1Z7X2PROD with NOTICES
Michael E. Smith, D.V.M.; Decision and
Order
On December 3, 2020, a former
Assistant Administrator, Diversion
Control Division, of the Drug
Enforcement Administration
(hereinafter, DEA or Government),
issued an Order to Show Cause
(hereinafter, OSC) to Michael E. Smith,
D.V.M. (hereinafter, Respondent) of
Zanesville, Ohio. Administrative Law
Judge Exhibit (hereinafter, ALJX) 1
(OSC), at 1 and 5. The OSC proposed
the denial of Respondent’s application
for DEA Certificate of Registration No.
W20010614C (hereinafter, COR or
registration) and the denial of any
applications for any other DEA
registrations pursuant to 21 U.S.C.
824(a)(2) and 824(a)(4) because
Respondent was convicted of a felony
related to controlled substances and
because ‘‘[Respondent’s] registration
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17:38 Jan 28, 2022
Jkt 256001
would be inconsistent with the public
interest, as that term is defined in 21
U.S.C. 823(f).’’ Id. at 1.
On January 1, 2021, the Respondent
timely requested a hearing, which
commenced (and ended) on April 19,
2021, at the DEA Hearing Facility in
Arlington, Virginia with the parties,
counsel, and witnesses participating via
video teleconference (VTC). On June 30,
2021, Administrative Law Judge Paul E.
Soeffing (hereinafter, the ALJ) issued his
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
(hereinafter, Recommended Decision or
RD).
By letter dated August 5, 2021, the
ALJ certified and transmitted the record
to me for final Agency action. In the
letter, the ALJ advised that the
Respondent filed untimely exceptions to
the Recommend Decision on July 26,
2021. The ALJ stated that the
Respondent had received an extension
of time to file his exceptions by 2:00
p.m. ET on July 26, but did not file them
until 2:58 p.m. ET. The ALJ also advised
that the Government filed its Response
to the Respondent’s Exceptions on
August 5, 2021.
Having reviewed the entire record, I
find Respondent’s Exceptions without
merit and I adopt the ALJ’s rulings,
findings of fact as modified, conclusions
of law and recommended sanction with
minor modifications, where noted
herein.*A Although Respondent’s
Exceptions were untimely, in this case,
I decided to nonetheless consider and
address each of Respondent’s
Exceptions, and issue my final Order in
this case following the Recommended
Decision.
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
Paul E. Soeffing
U.S. Administrative Law Judge
June 30, 2021
*B The issue in this case is whether
the record as a whole establishes by a
preponderance of the evidence that the
Respondent’s application for a DEA
*A I have made minor, nonsubstantive,
grammatical changes to the RD and nonsubstantive
conforming edits. Where I have made substantive
changes, omitted language for brevity or relevance,
or where I have added to or modified the Chief
ALJ’s opinion, I have noted the edits in brackets,
and I have included specific descriptions of the
modifications in brackets or in footnotes marked
with an asterisk and a letter. Within those brackets
and footnotes, the use of the personal pronoun ‘‘I’’
refers to myself—the Administrator.
*BI have omitted the RD’s discussion of the
procedural history to avoid repetition with my
introduction.
PO 00000
Frm 00113
Fmt 4703
Sfmt 4703
COR, Control No. W20010614C, should
be denied, and any other pending
applications for additional registrations
should be denied, pursuant to 21 U.S.C.
824(a)(2) and (a)(4), because the
Respondent has been convicted of a
felony relating to controlled substances,
and because his registration would be
inconsistent with the public interest, as
that term is defined in 21 U.S.C. 823(f).
After carefully considering the
testimony elicited at the hearing, the
admitted exhibits, the arguments of
counsel, and the record as a whole, I
have set forth my recommended
findings of fact and conclusions of law
below.
I. Findings of Fact
A. Allegations
The Government alleges that the
Respondent’s application for a DEA
COR, Control No. W20010614C, should
be denied and any applications by the
Respondent for any other DEA
registrations should be denied, pursuant
to 21 U.S.C. 824, because (1)
Respondent has been convicted of a
felony relating to controlled substances;
and (2) that registration would be
inconsistent with the public interest, as
that term is defined in 21 U.S.C. 823(f).
B. Stipulations
The Government and the Respondent
agreed to fourteen stipulations, which I
recommend be accepted as fact in these
proceedings:
1. Respondent was previously registered
with the DEA to handle controlled
substances in Schedules II through V under
DEA COR No. FS1126146 at 100 Sally Road,
Zanesville, Ohio 43701.
2. Respondent surrendered DEA COR No.
FS1126146 for cause on or about July 20,
2015, pursuant to his plea agreement in Case
CR2015–0052, State of Ohio v. Michael E.
Smith.
3. Respondent submitted an electronic
application for a new DEA COR on or about
February 3, 2020.
4. Government Exhibit No. 1 is a true and
correct copy of Respondent’s February 3,
2020 application for a DEA COR.
5. Government Exhibit No. 2 is a true and
correct copy of the Certification of
Registration History showing Respondent’s
answers to the liability questions from his
February 3, 2020 application for a DEA COR.
6. Government Exhibit No. 3 is a true and
correct copy of the docket sheet in Case
CR2015–0052, State of Ohio v. Michael E.
Smith.
7. Government Exhibit No. 4 is a true and
correct copy of Respondent’s signed plea
agreement, dated July 20, 2015, in Case
CR2015–0052, State of Ohio v. Michael E.
Smith.
8. Government Exhibit No. 5 is a true and
correct copy of the court’s entry of
Respondent’s plea agreement, dated July 23,
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]]>Agencies
[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4943-4944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01817]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-946]
Importer of Controlled Substances Application: Mylan
Pharmaceuticals Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Mylan Pharmaceuticals Inc. has applied to be registered as an
importer of basic class(es) of controlled substance(s). Refer to
Supplementary Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before March 2, 2022.
Such persons may also file a written request for a hearing on the
application on or before March 2, 2022.
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,
[[Page 4944]]
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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on December 7, 2021, Mylan Pharmaceuticals Inc., 2898
Manufacturers Road, Greensboro, North Carolina 27406-4600, applied to
be registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Remifentanil............................ 9739 II
------------------------------------------------------------------------
The company plans to import the above controlled substance as a
Federal Drug Administration-approved drug product in finished dosage
form for commercial distribution to its customers.
Approval of permit applications will occur only when the
registrant's business activity is consistent with what is authorized
under 21 U.S.C. 952(a)(2).
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2022-01817 Filed 1-28-22; 8:45 am]
BILLING CODE 4410-09-P
