Importer of Controlled Substances Application: United States Pharmacopeial Convention, 35338-35339 [2021-14210]
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35338
Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / 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. FS7068249 issued to
Spring Valley Family Pharmacy.
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 Spring Valley Family
Pharmacy to renew or modify this
registration, as well as any other
pending application of Spring Valley
Family Pharmacy for additional
registration in Ohio. This Order is
effective August 2, 2021.
Drug Enforcement Administration
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021–14165 Filed 7–1–21; 8:45 am]
BILLING CODE 4410–09–P
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
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
ADDRESSES:
[Docket No. DEA–829]
Importer of Controlled Substances
Application: United States
Pharmacopeial Convention
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
United States Pharmacopeial
Convention has applied to be registered
as an importer of basic class(es) of
controlled substance(s). Refer to
Supplemental 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 August 2, 2021. Such persons
may also file a written request for a
hearing on the application on or before
August 2, 2021.
SUMMARY:
In
accordance with 21 CFR 1301.34(a), this
is notice that on March 24, 2021, United
States Pharmaceopeial Convention,
7135 English Muffin Way, Frederick,
Maryland 21704, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
Controlled substance
Drug code
Cathinone ................................................................................................................................................................
Methcathinone .........................................................................................................................................................
Methaqualone ..........................................................................................................................................................
Lysergic acid diethylamide ......................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine .....................................................................................................................
3,4-Methylenedioxyamphetamine ............................................................................................................................
4-Methoxyamphetamine ..........................................................................................................................................
Codeine-N-oxide ......................................................................................................................................................
Difenoxin ..................................................................................................................................................................
Heroin ......................................................................................................................................................................
Morphine-N-oxide ....................................................................................................................................................
Norlevorphanol ........................................................................................................................................................
Methamphetamine ...................................................................................................................................................
Phenmetrazine ........................................................................................................................................................
Methylphenidate ......................................................................................................................................................
Amobarbital .............................................................................................................................................................
Pentobarbital ...........................................................................................................................................................
Secobarbital .............................................................................................................................................................
Glutethimide ............................................................................................................................................................
Phencyclidine ..........................................................................................................................................................
ANPP (4-Anilino-N-phenethyl-4-piperidine) .............................................................................................................
Phenylacetone .........................................................................................................................................................
Alphaprodine ...........................................................................................................................................................
Anileridine ................................................................................................................................................................
Cocaine ...................................................................................................................................................................
Dihydrocodeine ........................................................................................................................................................
Diphenoxylate ..........................................................................................................................................................
Levomethorphan ......................................................................................................................................................
Levorphanol .............................................................................................................................................................
Meperidine ...............................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ......................................................................................................
Thebaine ..................................................................................................................................................................
Oxymorphone ..........................................................................................................................................................
Noroxymorphone .....................................................................................................................................................
Alfentinil ...................................................................................................................................................................
Sufentanil .................................................................................................................................................................
The company plans to import the bulk
control substances for distribution as
analytical reference standards to its
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17:12 Jul 01, 2021
Jkt 253001
customers for analytical testing of raw
materials.
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1235
1237
2565
7315
7395
7400
7411
9053
9168
9200
9307
9634
1105
1631
1724
2125
2270
2315
2550
7471
8333
8501
9010
9020
9041
9120
9170
9210
9220
9230
9273
9333
9652
9668
9737
9740
Schedule
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Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
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02JYN1
Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–14210 Filed 7–1–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 19–22]
Keith A. Jenkins, N.P.; Decision and
Order
On February 19, 2020, the Drug
Enforcement Administration
(hereinafter, DEA or Government)
Administrative Law Judge Mark M.
Dowd (hereinafter, ALJ), issued a
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
(hereinafter, RD) on the action to revoke
the DEA Certificate of Registration
Numbers MJ3401609 and MJ4509331 of
Keith A. Jenkins, N.P. The ALJ
transmitted the record to me on March
10, 2020. Having reviewed and
considered the entire administrative
record before me, I adopt the ALJ’s RD
with modifications, where noted
herein.*A
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby dismiss the Order to
Show Cause issued to Keith A. Jenkins,
N.P. I further order that any pending
applications for renewal of DEA
Certificates of Registration MJ3401609
and MJ4509331 be granted. This Order
is effective immediately.
D. Christopher Evans,
Acting Administrator.
Paul Soeffing, Esq., for the Government
Robert W. Liles, Esq. and Meaghan K.
McCormick, Esq., for the Respondent
lotter on DSK11XQN23PROD with NOTICES1
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
The Assistant Administrator,
Diversion Control Division, Drug
Enforcement Administration (DEA),
*A I have made minor, nonsubstantive,
grammatical changes to the RD. Where I have made
any substantive changes, omitted language for
brevity or relevance, or where I have added to or
modified the ALJ’s opinion, I have bracketed the
modified language and explained the edit in a
footnote marked with an asterisk and a letter in
alphabetical order.
VerDate Sep<11>2014
17:12 Jul 01, 2021
Jkt 253001
issued an Order to Show Cause (OSC),1
dated April 23, 2019, seeking to revoke
the Respondent’s Certificates of
Registration (COR), numbers
‘‘MJ3401609 and MJ4509331, pursuant
to 21 U.S.C. 824(a)(5), and deny any
applications for renewal or modification
of such registration and any
applications for any other DEA
registrations pursuant to 21 U.S.C.
824(a)(5),’’ because the Respondent has
been excluded from participation in a
program pursuant to section 1320a–7(a)
of Title 42. OSC, at 1. The Respondent
requested a hearing on May 16, 2019,2
and prehearing proceedings were
initiated.3 A hearing was conducted in
this matter on November 20, 2019, at the
DEA Hearing Facility in Arlington,
Virginia.
The issue ultimately to be adjudicated
by the Acting Administrator, with the
assistance of this recommended
decision, is whether the record as a
whole establishes by a preponderance of
the evidence that the Respondent’s
subject registration with the DEA should
be revoked pursuant to 21 U.S.C.
824(a)(5).
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.
The Allegations
In the OSC, the Government contends
that the DEA should revoke the
Respondent’s DEA COR because he has
been excluded from participation in a
program pursuant to section 1320a–7(a)
of Title 42.
Specifically, the Government alleges
the following:
1. Respondent is registered with the
DEA as an MLP-nurse practitioner in
Schedules II through V under DEA
Certificate of Registration MJ3401609, at
105 Vanner Rd., Mt. Juliet, TN 37122.
Respondent is also registered with the
DEA under DEA Certificate of
Registration MJ4509331, at 3909
Woodley Rd., Toledo, OH 43606, with a
mailing address of 105 Vanner Rd., Mt.
Juliet, TN 37122. Respondent’s
registrations both expire by their terms
on December 31, 2020. Id. Prior to the
current action, Respondent’s DEA
Certificates of Registration have not
been the subject of disciplinary or other
adverse action by the DEA.
2. On August 7, 2017, Respondent
entered an ‘‘Alford Plea of Guilty to a
PO 00000
1 ALJ
Ex. 1.
Ex. 2.
3 ALJ Ex. 3.
2 ALJ
Frm 00081
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35339
Felony’’ to the offense of ‘‘False
Statement to Medicaid.’’ On August 1l,
2017, the Circuit Court of Fairfax
County, Virginia entered its sentencing
Order for Respondent’s offense of ‘‘False
Statement for Payment (F)’’ in violation
of Va. Code Section 32.1–314(F) FRD
3337F9. See Commonwealth of Virginia
v. Keith Allen Jenkins, No. FE–2017–
0000711 (Fairfax Cty. Cir. Ct.).
3. Based on Respondent’s conviction,
the U.S. Department of Health and
Human Services, Office of Inspector
General (‘‘HHS/OIG’’), by letter dated
February 28, 2018, mandatorily
excluded Respondent from participation
in Medicare, Medicaid and all federal
health care programs for a minimum
period of five years pursuant to 42
U.S.C. 1320a–7(a), effective March 20,
2018. Notwithstanding the fact that the
underlying conduct for which the
Respondent was convicted had no
nexus to controlled substances, the
Respondent’s mandatory exclusion from
Medicare, Medicaid, and all federal
health care programs by HHS/OIG
warrants revocation of the Respondent’s
registration pursuant to 21 U.S.C.
824(a)(5). See, e.g., Richard Hauser,
M.D., 83 FR 26308 (2018).
The Hearing
Government’s Opening Statement
The Government outlined its case in
its Opening Statement. The Government
seeks the revocation of the Respondent’s
registrations pursuant to 21 U.S.C.
824(a)(5), as the Respondent has been
excluded from a program pursuant to
§ 1320a–7a of Title 2. Tr. 12. The
Government explained that in 2017, the
Respondent entered an Alford plea of
guilty, to the felony offense of false
statement to Medicaid, in the Circuit
Court of Fairfax County, Virginia. On
the basis of that conviction, in 2018, the
Department of Health and Human
Resources, Office of Inspector General
mandatorily excluded the Respondent
from participation in Medicare,
Medicaid and all federal health care
programs pursuant to 42 U.S.C. 1320a7(a). The Respondent’s exclusion
remains in effect. Id.
Respondent’s Opening Statement
In his Opening Statement, the
Respondent noted he has stipulated to
all of the operative facts of the case. Id.
at 13. The Respondent conceded he was
convicted as charged, he was excluded
from participation from Medicare,
Medicaid and all federal health benefit
programs, as alleged. Acknowledging
the evidentiary burden shift to him,
upon the prima facie showing of these
facts, the Respondent argued that his
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]]>Agencies
[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35338-35339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14210]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-829]
Importer of Controlled Substances Application: United States
Pharmacopeial Convention
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: United States Pharmacopeial Convention has applied to be
registered as an importer of basic class(es) of controlled
substance(s). Refer to Supplemental 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 August 2, 2021.
Such persons may also file a written request for a hearing on the
application on or before August 2, 2021.
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 Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on March 24, 2021, United States Pharmaceopeial
Convention, 7135 English Muffin Way, Frederick, Maryland 21704, applied
to be registered as an importer of the following basic class(es) of
controlled substance(s):
----------------------------------------------------------------------------------------------------------------
Controlled substance Drug code Schedule
----------------------------------------------------------------------------------------------------------------
Cathinone................................................. 1235 I
Methcathinone............................................. 1237 I
Methaqualone.............................................. 2565 I
Lysergic acid diethylamide................................ 7315 I
4-Methyl-2,5-dimethoxyamphetamine......................... 7395 I
3,4-Methylenedioxyamphetamine............................. 7400 I
4-Methoxyamphetamine...................................... 7411 I
Codeine-N-oxide........................................... 9053 I
Difenoxin................................................. 9168 I
Heroin.................................................... 9200 I
Morphine-N-oxide.......................................... 9307 I
Norlevorphanol............................................ 9634 I
Methamphetamine........................................... 1105 II
Phenmetrazine............................................. 1631 II
Methylphenidate........................................... 1724 II
Amobarbital............................................... 2125 II
Pentobarbital............................................. 2270 II
Secobarbital.............................................. 2315 II
Glutethimide.............................................. 2550 II
Phencyclidine............................................. 7471 II
ANPP (4-Anilino-N-phenethyl-4-piperidine)................. 8333 II
Phenylacetone............................................. 8501 II
Alphaprodine.............................................. 9010 II
Anileridine............................................... 9020 II
Cocaine................................................... 9041 II
Dihydrocodeine............................................ 9120 II
Diphenoxylate............................................. 9170 II
Levomethorphan............................................ 9210 II
Levorphanol............................................... 9220 II
Meperidine................................................ 9230 II
Dextropropoxyphene, bulk (non-dosage forms)............... 9273 II
Thebaine.................................................. 9333 II
Oxymorphone............................................... 9652 II
Noroxymorphone............................................ 9668 II
Alfentinil................................................ 9737 II
Sufentanil................................................ 9740 II
----------------------------------------------------------------------------------------------------------------
The company plans to import the bulk control substances for
distribution as analytical reference standards to its customers for
analytical testing of raw materials.
Approval of permit applications will occur only when the
registrant's business activity is consistent with what
[[Page 35339]]
is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend
to the import of Food and Drug Administration-approved or non-approved
finished dosage forms for commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-14210 Filed 7-1-21; 8:45 am]
BILLING CODE 4410-09-P
