Bulk Manufacturer of Controlled Substances Application: Benuvia Operations LLC, 33910-33911 [2023-11158]
Download as PDF
<![CDATA[
33910
Federal Register / Vol. 88, No. 101 / Thursday, May 25, 2023 / Notices
significant factors in determining the
appropriate sanction. Id. The Agency
has also considered the need to deter
similar acts by an applicant and by the
community of registrants. Id.
Applicant posits that the RD
‘‘prejudge[s]’’ him and ‘‘misinterprets’’
his approach by not ‘‘distinguish[ing]
between a person who explains what
took place,’’ as he argues he did, ‘‘as
opposed to someone who seeks to offer
an excuse for what took place.’’
Applicant Exceptions, at 2; supra
section II.B. Applicant also argues that
he stated, ‘‘truthfully,’’ ‘‘how the grow
houses became used for marijuana’’ and
‘‘admit[ted] his responsibility in same.’’
Applicant Exceptions, at 2. Citing his
‘‘remarkable’’ CME compliance and reissued Texas medical license, Applicant
also claims that he ‘‘has demonstrated,
through his actions since, that he is
worthy of any discretion the Court
could provide.’’ Id.; but see RD, at 19.
Even if the Agency were to credit
Applicant’s arguments, they do not
change the fact that he did not
unequivocally accept responsibility for
the founded violations. Supra sections
III.B. and III.C. For example, regarding
the allegation that he prescribed
controlled substances after the 2013
suspension of his registration, Applicant
even refused to admit that the signatures
on the controlled substance orders were
his. Supra section II.B. The RD credits
the DI’s testimony over Applicant’s
steadfast refusal to acknowledge his
signatures, and the Agency agrees. RD,
at 14–15; see also supra sections II.A.,
II.B., and II.D.
This record evidence also shows that
Applicant, despite his ‘‘remarkable’’
CME compliance, does not understand
the responsibilities the CSA places on
practitioners. Applicant posits that,
‘‘throughout his practice, he has
provide[d] medical[ly] necessary
assistance with prescribed, controlled
substances when the patient’s
condition(s) suggest that such a
treatment would be in the patient’s best
interest.’’ Applicant’s Closing
Argument, at 2; see also Applicant
Exceptions, at 2–4. Such statements
attempt to minimize, or divert attention
from, his unlawful activity, and show
Applicant’s lack of understanding of the
CSA’s requirements. Accordingly, the
Agency finds that Applicant did not
unequivocally accept responsibility for
the unlawful acts he committed and has
not convinced the Agency that he can be
entrusted with a registration.10
The interests of specific and general
deterrence weigh in favor of denying
Applicant’s registration application.
See, e.g., Garrett Howard Smith, M.D.,
83 FR at 18910 (collecting cases) (‘‘The
egregiousness and extent of the
misconduct are significant factors in
determining the appropriate sanction.’’).
Given the seriousness and extent of
Applicant’s founded violations, a
sanction less than application denial
would tell prospective registrants that
compliance with the law is not a
condition precedent to the issuance of a
registration.
Accordingly, the Agency shall order
the sanction the Government requested.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(g)(1), I hereby deny the DEA
registration application of Keith Ly,
M.D. (Control No. W21134341C).
Further, pursuant to 28 CFR 0.100(b)
and the authority vested in me by 21
U.S.C. 823(g)(1), I hereby deny any
pending application of Keith Ly, M.D.,
for a DEA Registration in Texas. This
Order is effective June 26, 2023.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on May 16, 2023, by Administrator
Anne Milgram. That document with the
original signature and date is
maintained by DEA. For administrative
purposes only, and in compliance with
requirements of the Office of the Federal
Register, the undersigned DEA Federal
Register Liaison Officer has been
authorized to sign and submit the
document in electronic format for
publication, as an official document of
DEA. This administrative process in no
way alters the legal effect of this
document upon publication in the
Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2023–11131 Filed 5–24–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1181]
Bulk Manufacturer of Controlled
Substances Application: Benuvia
Operations LLC
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
Benuvia Operations LLC. has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUPPLEMENTARY INFORMATION listed
below for further drug information.
SUMMARY:
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before July 24, 2023. Such persons
may also file a written request for a
hearing on the application on or before
July 24, 2023.
DATES:
The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 9, 2023, Benuvia
Operations, LLC., 3950 North Mays
Street, Round Rock, Texas 78665,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
Controlled substance
Drug code
Ibogaine .................................................................................................................................................................................
Lysergic Acid Diethylamide ...................................................................................................................................................
Tetrahydrocannabinols ..........................................................................................................................................................
Mescaline ...............................................................................................................................................................................
10 Remedial measures are insufficient without an
unequivocal acceptance of responsibility. Brenton
VerDate Sep<11>2014
18:04 May 24, 2023
Jkt 259001
D. Wynn, M.D., 87 FR 24228, 24261 (2022); see also
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
7260
7315
7370
7381
Schedule
I
I
I
I
Michael T. Harris, M.D., 87 FR 30276, 30278 (2022)
(collecting Agency decisions).
E:\FR\FM\25MYN1.SGM
25MYN1
33911
Federal Register / Vol. 88, No. 101 / Thursday, May 25, 2023 / Notices
Controlled substance
Drug code
3, 4-Methylenedioxyamphetamine .........................................................................................................................................
3, 4-Methylenedioxymethamphetamine .................................................................................................................................
5-Methoxy-N-N-dimethyltryptamine .......................................................................................................................................
Dimethyltryptamine ................................................................................................................................................................
Psilocybin ...............................................................................................................................................................................
Psilocyn .................................................................................................................................................................................
5-Methoxy-N, N-diisopropyltryptamine ..................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances for the internal use
intermediates or for sale to its
customers. In reference to dug codes
7370 (Tetrahydrocannabinols), the
company plans to bulk manufacture this
drug as synthetic. No other activities for
these drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–11158 Filed 5–24–23; 8:45 am]
BILLING CODE P
Controlled substance
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Lysergic acid
diethylamide.
Mescaline ........................
Peyote .............................
Diethyltryptamine .............
Dimethyltryptamine ..........
Psilocybin ........................
Psilocyn ...........................
[Docket No. DEA–1206]
Bulk Manufacturer of Controlled
Substances Application: Irvine Labs,
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Irvine Labs, Inc. has applied
to be registered as a bulk manufacturer
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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before July 24, 2023. Such persons
may also file a written request for a
hearing on the application on or before
July 24, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:04 May 24, 2023
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on April 5, 2023, Irvine
Labs, Inc., 7305 Murdy Drive, Hunting
Beach, California 92647–3533, applied
to be registered as a bulk manufacturer
of the following basic class(es) of
controlled substance(s):
Jkt 259001
Drug
code
Schedule
7315
I
7381
7415
7434
7435
7437
7438
I
I
I
I
I
I
The company plans to bulk
manufacture the listed controlled
substances to support their internal
research, clinical trials, and analytical
purposes as well as to distribute to their
customers. No other activities for these
drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–11178 Filed 5–24–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
7400
7405
7431
7435
7437
7438
7439
Schedule
I
I
I
I
I
I
I
SUPPLEMENTARY INFORMATION listed
below for further drug information.
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before July 24, 2023. Such persons
may also file a written request for a
hearing on the application on or before
July 24, 2023.
DATES:
The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 31, 2023,
Patheon API Manufacturing, Inc., 309
Delaware Street, Greenville, South
Carolina 29605–5420, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Drug Enforcement Administration
Controlled substance
[Docket No. DEA–1191]
Bulk Manufacturer of Controlled
Substances Application: Patheon API
Manufacturing, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
Dimethyltryptamine ..........
Psilocybin ........................
Psilocyn ...........................
Drug
code
Schedule
7435
7437
7438
I
I
I
AGENCY:
Patheon API Manufacturing,
Inc. has applied to be registered as a
bulk manufacturer of basic class(es) of
controlled substance(s). Refer to
SUMMARY:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
The company plans to bulk
manufacture the listed controlled
substances as an Active Pharmaceutical
Ingredient (API) for distribution to its
customers. No other activities for these
E:\FR\FM\25MYN1.SGM
25MYN1
]]>Agencies
[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33910-33911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11158]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1181]
Bulk Manufacturer of Controlled Substances Application: Benuvia
Operations LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Benuvia Operations LLC. has applied to be registered as a bulk
manufacturer 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 submit electronic comments on or
objections to the issuance of the proposed registration on or before
July 24, 2023. Such persons may also file a written request for a
hearing on the application on or before July 24, 2023.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on March 9, 2023, Benuvia Operations, LLC., 3950 North
Mays Street, Round Rock, Texas 78665, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Ibogaine............................. 7260 I
Lysergic Acid Diethylamide........... 7315 I
Tetrahydrocannabinols................ 7370 I
Mescaline............................ 7381 I
[[Page 33911]]
3, 4-Methylenedioxyamphetamine....... 7400 I
3, 4-Methylenedioxymethamphetamine... 7405 I
5-Methoxy-N-N-dimethyltryptamine..... 7431 I
Dimethyltryptamine................... 7435 I
Psilocybin........................... 7437 I
Psilocyn............................. 7438 I
5-Methoxy-N, N-diisopropyltryptamine. 7439 I
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances for the internal use intermediates or for sale to its
customers. In reference to dug codes 7370 (Tetrahydrocannabinols), the
company plans to bulk manufacture this drug as synthetic. No other
activities for these drug codes are authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-11158 Filed 5-24-23; 8:45 am]
BILLING CODE P
