Bulk Manufacturer of Controlled Substances Application: Alcami Wisconsin Corporation, 39016 [2019-17002]
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39016
Federal Register / Vol. 84, No. 153 / Thursday, August 8, 2019 / Notices
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., Hooper, supra, 76 FR at 71,371–72;
Sheran Arden Yeates, M.D., 71 FR
39,130, 39,131 (2006); Dominick A.
Ricci, M.D., 58 FR 51,104, 51,105 (1993);
Bobby Watts, M.D., 53 FR 11,919, 11,920
(1988); Blanton, supra, 43 FR at 27,617.
Under the Pennsylvania Controlled
Substance, Drug, Device and Cosmetic
Act, ‘‘no controlled substance . . . may
be dispensed without the written
prescription of a practitioner.’’ 35 Pa.
Stat. and Const. Stat. Ann. § 780–111(a)
(West April 7, 2014 to October 23,
2019). Further, the definition of
‘‘practitioner,’’ as used in the Act,
includes a ‘‘physician . . . or other
person licensed, registered or otherwise
permitted to distribute, dispense,
conduct research with respect to or to
administer a controlled substance . . .
in the course of professional practice
. . . in the Commonwealth of
Pennsylvania.’’ Id. at 780–102(b).
Here, the undisputed evidence in the
record is that Respondent currently
lacks authority to practice medicine in
the Commonwealth of Pennsylvania. As
already discussed, a physician must be
a licensed practitioner to dispense a
controlled substance in Pennsylvania.
Thus, because Respondent lacks
authority to practice medicine in the
Commonwealth of Pennsylvania and,
therefore, is not authorized to handle
controlled substances in the
Commonwealth of Pennsylvania,
Respondent is not eligible to maintain a
DEA registration. Accordingly, I will
order that Respondent’s DEA
registration be revoked.
VerDate Sep<11>2014
16:51 Aug 07, 2019
Jkt 247001
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. BB3258034 issued to
Parth S. Bharill, M.D. This Order is
effective September 9, 2019.
Dated: July 29, 2019.
Uttam Dhillon,
Acting Administrator.
Dated: July 30, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–17002 Filed 8–7–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[FR Doc. 2019–17004 Filed 8–7–19; 8:45 am]
Anthony Schapera, M.D.; Decision and
Order
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Alcami
Wisconsin Corporation
ACTION:
Notice of application.
Registered bulk manufacturers 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 October 7, 2019.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 12 2019, Alcami
Wisconsin Corporation, W130N10497
Washington Drive, Germantown,
Wisconsin 53022 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug
code
Marihuana Extract .....................
Marihuana .................................
Tetrahydrocannabinols .............
5-Methoxy-N-Ndimethyltryptamine.
Thebaine ...................................
Alfentanil ...................................
7350
7360
7370
7431
I
I
I
I
9333
9737
II
II
Schedule
The company plans to provide bulk
active pharmaceutical ingredient to
support clinical trials. In reference to
drug codes 7350 marihuana extract,
7360 marihuana, and 7360 THC, the
company plans to manufacturer these
substances synthetically. No other
activity for these drug codes is
authorized for this registration.
PO 00000
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On December 31, 2018, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (hereinafter, OSC) to Anthony
Schapera, M.D. (hereinafter, Registrant),
of Bishop, California. OSC, at 1. The
OSC proposes the revocation of
Registrant’s Certificate of Registration
No. AS3008213, the denial of any
applications for renewal or modification
of his registration, and the denial of
‘‘any applications for any other DEA
registrations’’ on the ground that he
‘‘has no state authority to handle
controlled substances.’’ Id. (citing 21
U.S.C. 824(a)(3)).
The substantive ground for the
proceeding, as alleged in the OSC, is
that Registrant is ‘‘without authority to
handle controlled substances in the
State of California, the state in which
. . . [he is] registered with DEA.’’ Id.
Specifically, the OSC alleges that the
Medical Board of California revoked
Registrant’s medical license effective
June 22, 2018. Id.
The Show Cause Order notified
Registrant of his right to request a
hearing on the allegations or to submit
a written statement while waiving his
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 Registrant of the
opportunity to submit a corrective
action plan. OSC, at 2–3 (citing 21
U.S.C. 824(c)(2)(C)).
Adequacy of Service
In a Declaration dated March 19, 2019
(hereinafter, Declaration), a Diversion
Investigator (hereinafter, DI) assigned to
the Newark Field Division declared
under penalty of perjury that he and
another DI ‘‘personally served’’ the OSC
on Registrant. Declaration, at 1.
Attached to the DI’s Declaration is a
DEA–12, Receipt for Cash or Other
Items. According to the DI, Registrant
acknowledged receipt of the OSC by
signing this DEA–12 on January 17,
2019. Id.
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]]>Agencies
[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Notices]
[Page 39016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17002]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Alcami
Wisconsin Corporation
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers 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 October 7, 2019.
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 March 12 2019, Alcami Wisconsin Corporation,
W130N10497 Washington Drive, Germantown, Wisconsin 53022 applied to be
registered as a bulk manufacturer of the following basic classes of
controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana Extract....................... 7350 I
Marihuana............................... 7360 I
Tetrahydrocannabinols................... 7370 I
5-Methoxy-N-N-dimethyltryptamine........ 7431 I
Thebaine................................ 9333 II
Alfentanil.............................. 9737 II
------------------------------------------------------------------------
The company plans to provide bulk active pharmaceutical ingredient
to support clinical trials. In reference to drug codes 7350 marihuana
extract, 7360 marihuana, and 7360 THC, the company plans to
manufacturer these substances synthetically. No other activity for
these drug codes is authorized for this registration.
Dated: July 30, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-17002 Filed 8-7-19; 8:45 am]
BILLING CODE 4410-09-P
