Bulk Manufacturer of Controlled Substances Application: Purisys, LLC, 64165 [2020-22442]
Download as PDF
<![CDATA[
Federal Register / Vol. 85, No. 197 / Friday, October 9, 2020 / Notices
collection: The estimated annual public
burden associated with this collection is
540 hours, which is equal to 300 (# of
respondents) * 1 (# of responses per
respondents) * 1.8 (1 hour and 48
minutes).
If additional information is required
contact: Melody Braswell, Department
Clearance Officer, United States
Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
Square, 145 N Street NE, 3E.405A,
Washington, DC 20530.
Dated: October 6, 2020.
Melody Braswell,
Department Clearance Officer for PRA, U.S.
Department of Justice.
Controlled
substance
Drug code
5-Methoxy-N-Ndimethyltryptamine.
Norlevorphanol
Schedule
7431
I
9634
I
The company plans to manufacture
the above-listed controlled substances
as clinical trial and starting materials to
make compounds for distribution to its
customers. No other activity for these
drug codes is authorized for this
registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–22442 Filed 10–8–20; 8:45 am]
BILLING CODE P
[FR Doc. 2020–22453 Filed 10–8–20; 8:45 am]
BILLING CODE 4410–30–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
Steven A. Holper, M.D.; Decision and
Order
[Docket No. DEA–720]
Bulk Manufacturer of Controlled
Substances Application: Purisys, LLC
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
Purisys, LLC has applied to be
registered as a bulk manufacturer of
basic class(es) of controlled
substance(s). Refer to Supplemental
Information listed below for further
drug information.
SUMMARY:
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 December 8, 2020. Such
persons may also file a written request
for a hearing on the application on or
before December 8, 2020
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 August 27, 2020,
Purisys, LLC, 1550 Olympic Drive,
Athens, Georgia 30601–1602, applied to
be registered as an bulk manufacturer of
the following basic class(es) of
controlled substances:
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:26 Oct 08, 2020
Jkt 253001
On October 22, 2019, the Acting
Assistant Administrator, Diversion
Control Division, Drug Enforcement
Administration (hereinafter,
Government or DEA), issued an Order to
Show Cause (hereinafter, OSC) to
Steven A. Holper, M.D., (hereinafter,
Registrant), of Las Vegas, Nevada.
Government’s Request for Final Agency
Action Exhibit (hereinafter, RFAAX) 5
(OSC), at 1. The OSC proposed the
revocation of Registrant’s Certificate of
Registration No. BH2498106. It alleged
that Registrant is without ‘‘authority to
handle controlled substances in Nevada,
the state in which [Registrant is]
registered with the DEA.’’ Id. (citing 21
U.S.C. 823(f) and 824(a)(3)).
Specifically, the OSC alleged that
Registrant’s state controlled substance
license expired on October 21, 2018. Id.
at 1–2. The OSC also alleged that
Registrant’s state medical license was
revoked by the Board of Medical
Examiners of the State of Nevada on
September 6, 2019. Id. at 2. The OSC
further alleged that Registrant is not
eligible to obtain or retain a DEA
registration because he lacks state
authority to handle controlled
substances in the state of Nevada. Id.
The OSC notified Registrant of the
right to either request a hearing on the
allegations or submit a written
statement in lieu of exercising the right
to a hearing, the procedures for electing
each option, and the consequences for
failing to elect either option. Id. (citing
21 CFR 1301.43). The OSC also notified
Registrant of the opportunity to submit
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
64165
a corrective action plan. Id. at 3 (citing
21 U.S.C. 824(c)(2)(C)).
A DEA Diversion Investigator
personally served Registrant with the
OSC on December 16, 2019. RFAAX 12,
at 2–3 (Declaration of Diversion
Investigator One). I find that more than
thirty days have now passed since the
Government accomplished service of
the OSC. Further, based on the
Government’s written representations, I
find that neither Registrant, nor anyone
purporting to represent Registrant,
requested a hearing, submitted a written
statement while waiving Registrant’s
right to a hearing, or submitted a
corrective action plan. RFAAX 11, at 3–
4 (Declaration of Diversion Investigator
Two). Accordingly, I find that Registrant
has waived the right to a hearing and
the right to submit a written statement
and corrective action plan. 21 CFR
1301.43(d) and 21 U.S.C. 824(c)(2)(C). I,
therefore, issue this Decision and Order
based on the record submitted by the
Government, which constitutes the
entire record before me. 21 CFR
1301.46.
Findings of Fact
Registrant’s DEA Registration
Registrant is the holder of DEA
Certificate of Registration No.
BH2498106 at the registered address of
3233 W. Charleston Blvd. 202, Las
Vegas, NV 89102. RFAAX 1 (Registrant’s
DEA Certificate of Registration).
Pursuant to this registration, Registrant
is authorized to dispense controlled
substances in schedules II through V as
a practitioner. Id. Registrant’s
registration will expire on its own terms
on October 31, 2020. Id.
DEA Investigation and the Status of
Registrant’s State Licenses
On July 22, 2019, Registrant was
sentenced in the United States District
Court for the District of Nevada on a
matter related to his conviction on one
count of unlawful distribution of a
controlled substance. RFAAX 11, at 2.
On August 12, 2019, a DEA Diversion
Investigator (hereinafter, DI Two) asked
Registrant, through his legal counsel, to
voluntarily surrender his DEA
registration. Id. Registrant declined. Id.
The General Counsel for the Nevada
State Board of Pharmacy (hereinafter,
Pharmacy Board) sent DI Two a letter
dated September 17, 2019, stating that
Registrant did not renew his Nevada
controlled substance license and did not
hold an active controlled substance
license with the Pharmacy Board.
RFAAX 4. According to the online
records of the Pharmacy Board,
Registrant’s controlled substance
E:\FR\FM\09OCN1.SGM
09OCN1
]]>Agencies
[Federal Register Volume 85, Number 197 (Friday, October 9, 2020)]
[Notices]
[Page 64165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22442]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-720]
Bulk Manufacturer of Controlled Substances Application: Purisys,
LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Purisys, LLC has applied to be registered as a bulk
manufacturer 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 December 8,
2020. Such persons may also file a written request for a hearing on the
application on or before December 8, 2020
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 August 27, 2020, Purisys, LLC, 1550 Olympic Drive,
Athens, Georgia 30601-1602, applied to be registered as an bulk
manufacturer of the following basic class(es) of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
5-Methoxy-N-N-dimethyltryptamine... 7431 I
Norlevorphanol..................... 9634 I
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances as clinical trial and starting materials to make compounds
for distribution to its customers. No other activity for these drug
codes is authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-22442 Filed 10-8-20; 8:45 am]
BILLING CODE P
