Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC, 4941 [2022-01816]
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Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices
denial. Careless or negligent handling of
controlled substances creates the
opportunity for diversion and [can]
justify the revocation of an existing
registration . . .’’ Bobby D. Reynolds,
N.P., Tina L. Killebrew, N.P., & David R.
Stout, N.P., 80 FR 28643, 28662 (2015)
(quoting Paul J. Caragine, Jr. 63 FR
51592, 51601 (1998). In fact, the Agency
has found in favor of revocation in cases
where registrants have failed to
document their prescribing decisions—
a violation which has been clearly
established in this case. The Agency has
repeatedly emphasized that
‘‘[c]onscientious documentation is . . .
not just a ministerial act, but a key
treatment tool and vital indicator to
evaluate whether the physician’s
prescribing practices are within the
usual course of professional practice.’’
Cynthia M. Cadet, M.D., 76 FR 19,450,
19,464 (2011) (internal citation and
quotation omitted); see also Kaniz F.
Khan-Jaffery, M.D., 85 FR 45,667, 45,686
(2020) (‘‘DEA’s ability to assess whether
controlled substances registrations are
consistent with the public interest is
predicated upon the ability to consider
the evidence and rationale of the
practitioner at the time that she
prescribed a controlled substance—
adequate documentation is critical to
that assessment.’’).
The case at hand demonstrates
prescribing beneath the applicable
standard of care and outside the usual
course of professional practice in
California to multiple patients over the
course of many years. I agree with the
Chief ALJ that this conduct was
egregious and I agree with his rationale
for sanction. As stated above, for many
reasons, I cannot find that I can entrust
Respondent with a registration.
Accordingly, I reject Respondent’s
Exceptions and affirm the RD’s
conclusion that Respondent’s
registration should be revoked.
in California. This Order is effective
March 2, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2022–01838 Filed 1–28–22; 8:45 am]
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VerDate Sep<11>2014
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–947]
Bulk Manufacturer of Controlled
Substances Application: Siegfried
USA, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Jkt 256001
9333
9630
9652
9780
Schedule
II
II
II
II
The company plans to manufacture
the above-listed controlled substance in
bulk for development of a new active
pharmaceutical ingredient (API) and
validation for a Drug Master File
submission to the Food and Drug
Administration. No other activity for
this drug code is authorized for this
registration.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2022–01816 Filed 1–28–22; 8:45 am]
BILLING CODE P
Siegfried USA, 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 file written
comments on or objections to the
issuance of the proposed registration on
or before April 1, 2022 Such persons
may also file a written request for a
hearing on the application on or before
April 1, 2022.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
In
accordance with 21 CFR 1301.33(a), this
is notice that on December 8, 2021,
Siegfried USA, LLC., 33 Industrial Park
Road, Pennsville, New Jersey 08070–
3244, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug
code
Controlled substance
17:38 Jan 28, 2022
Thebaine .................................
Opium tincture ........................
Oxymorphone .........................
Tapentadol ..............................
Drug
code
BILLING CODE 4410–09–P
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a)(4) and 21 U.S.C. 823(f), I hereby
revoke DEA Certificate of Registration
No. BC1317165 issued to Bradley H.
Chesler, M.D. Pursuant to 28 CFR
0.100(b) and the authority vested in me
by 21 U.S.C. 824(a) and 21 U.S.C. 823(f),
I further hereby deny any pending
application of Bradley H. Chesler, M.D.,
to renew or modify this registration, as
well as any other pending application of
Bradley H. Chesler, M.D. for registration
Controlled substance
Gamma Hydroxybutyric Acid ..
Dihydromorphine .....................
Hydromorphinol .......................
Amphetamine ..........................
Lisdexamfetamine ...................
Methylphenidate ......................
Amobarbital .............................
Pentobarbital ...........................
Secobarbital ............................
Phenylacetone ........................
Codeine ...................................
Oxycodone ..............................
Hydromorphone ......................
Hydrocodone ...........................
Methadone ..............................
Methadone intermediate .........
Morphine .................................
Oripavine .................................
PO 00000
Frm 00110
Fmt 4703
Schedule
2010
9145
9301
1100
1205
1724
2125
2270
2315
8501
9050
9143
9150
9193
9250
9254
9300
9330
Sfmt 4703
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 22–4]
Austin J. Kosier, M.D.; Decision and
Order
On September 30, 2021, the Acting
Assistant Administrator, Diversion
Control Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (hereinafter, OSC) to Austin J.
Kosier, M.D. (hereinafter, Respondent)
of Zanesville, Ohio. OSC, at 1 and 3.
The OSC proposed the revocation of
Respondent’s Certificate of Registration
No. FK6714504. It alleged that
Respondent ‘‘[does] not have authority
to dispense or prescribe controlled
substances in the [s]tate of Ohio, the
state in which [Respondent is]
registered with DEA.’’ Id. at 1 (citing 21
U.S.C. 824(a)(3)).
Specifically, the OSC alleged that on
or about May 12, 2021, the State
Medical Board of Ohio issued an Order
suspending Respondent’s state license
to practice medicine and surgery. Id. at
2. The Order was effective immediately
and ordered that Respondent
‘‘immediately cease the practice of
medicine and surgery in Ohio.’’ Id.
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. at 2 (citing 21
CFR 1301.43). The OSC also notified
Respondent of the opportunity to
submit a corrective action plan. Id. at 3
(citing 21 U.S.C. 824(c)(2)(C)).
E:\FR\FM\31JAN1.SGM
31JAN1
]]>Agencies
[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Page 4941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01816]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-947]
Bulk Manufacturer of Controlled Substances Application: Siegfried
USA, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Siegfried USA, 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 file written comments on or objections to
the issuance of the proposed registration on or before April 1, 2022
Such persons may also file a written request for a hearing on the
application on or before April 1, 2022.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on December 8, 2021, Siegfried USA, LLC., 33 Industrial
Park Road, Pennsville, New Jersey 08070-3244, applied to be registered
as a bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid............... 2010 I
Dihydromorphine......................... 9145 I
Hydromorphinol.......................... 9301 I
Amphetamine............................. 1100 II
Lisdexamfetamine........................ 1205 II
Methylphenidate......................... 1724 II
Amobarbital............................. 2125 II
Pentobarbital........................... 2270 II
Secobarbital............................ 2315 II
Phenylacetone........................... 8501 II
Codeine................................. 9050 II
Oxycodone............................... 9143 II
Hydromorphone........................... 9150 II
Hydrocodone............................. 9193 II
Methadone............................... 9250 II
Methadone intermediate.................. 9254 II
Morphine................................ 9300 II
Oripavine............................... 9330 II
Thebaine................................ 9333 II
Opium tincture.......................... 9630 II
Oxymorphone............................. 9652 II
Tapentadol.............................. 9780 II
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substance in bulk for development of a new active pharmaceutical
ingredient (API) and validation for a Drug Master File submission to
the Food and Drug Administration. No other activity for this drug code
is authorized for this registration.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2022-01816 Filed 1-28-22; 8:45 am]
BILLING CODE P
