Importer of Controlled Substances Application: SpecGx LLC, 13954-13955 [2019-06852]
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13954
Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–392]
[Docket No. DEA–392]
Importer of Controlled Substances
Registration
Importer of Controlled Substances
Registration
[Docket No. DEA–392]
ACTION:
Notice of registration.
ACTION:
SUMMARY:
The applicant listed below
has submitted an application for
registration to the Drug Enforcement
Administration (DEA) to become an
importer of a schedule I controlled
substance.
SUMMARY:
The
company listed below applied to be
registered as an importer of a basic class
of controlled substance. Information on
the previously published notice is listed
in the table below. No comments or
objections were submitted and no
requests for a hearing were submitted
for this notice.
SUPPLEMENTARY INFORMATION:
Company
FR docket
Almac Clinical Services Incorp (ACSI).
84 FR 3253
The
company listed below applied to be
registered as an importer of various
basic classes of controlled substances.
Information on the previously published
notice is listed in the table below. No
comments or objections were submitted
and no requests for hearing were
submitted for this notice.
Published
February 11, 2019.
Company
FR docket
Usona Institute .......................
83 FR 64365
ACTION:
Notice of registration.
The registrant listed below
has submitted an application for
registration to the Drug Enforcement
Administration (DEA) to become a bulk
manufacturer of various classes of
schedule I controlled substances.
SUPPLEMENTARY INFORMATION: The
company listed below applied to be
registered as a bulk manufacturer of
basic classes of schedule I controlled
substances. Information on a previously
published notice is listed below. No
comments or objections were submitted
for the notice.
SUMMARY:
The applicant listed below
has submitted an application for
registration to the Drug Enforcement
Administration (DEA) to become an
importer of schedule I controlled
substances.
SUPPLEMENTARY INFORMATION:
jbell on DSK30RV082PROD with NOTICES
Notice of registration.
Bulk Manufacturer of Controlled
Substances Registration
Published
December
14, 2018.
Company
FR docket
Usona Institute ..........
83 FR 64364
Published
December 14, 2018.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of this applicant to
manufacture the applicable basic classes
of controlled substances is consistent
with the public interest and with United
States obligations under international
treaties, conventions, or protocols in
effect on May 1, 1971. The DEA
investigated the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
physical security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the DEA has granted a
registration as a bulk manufacturer to
the above listed company.
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of the
listed applicant to import the applicable
basic class of schedule I controlled
substance is consistent with the public
interest and with United States
obligations under international treaties,
conventions, or protocols in effect on
May 1, 1971. The DEA investigated the
company’s maintenance of effective
controls against diversion by inspecting
and testing the company’s physical
security system, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the DEA has
granted a registration as an importer of
a schedule I controlled substance to the
above listed company.
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of the
listed applicant to import the applicable
basic classes of schedule I controlled
substances is consistent with the public
interest and with United States
obligations under international treaties,
conventions, or protocols in effect on
May 1, 1971. The DEA investigated the
company’s maintenance of effective
controls against diversion by inspecting
and testing the company’s physical
security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the DEA has
granted a registration as an importer for
schedule I controlled substances to the
above listed company.
Dated: March 21, 2019.
John J. Martin,
Assistant Administrator.
Dated: March 21, 2019.
John J. Martin,
Assistant Administrator.
Drug Enforcement Administration
[FR Doc. 2019–06845 Filed 4–5–19; 8:45 am]
[FR Doc. 2019–06847 Filed 4–5–19; 8:45 am]
BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
Importer of Controlled Substances
Application: SpecGx LLC
Dated: March 21, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–06848 Filed 4–5–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
DATES:
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Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices
comments on or objections to the
issuance of the proposed registration on
or before May 8, 2019. Such persons
may also file a written request for a
hearing on the application on or before
May 8, 2019.
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.
Comments and requests for hearings on
applications to import narcotic raw
materials are not appropriate. 72 FR
3417 (January 25, 2007).
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on
February 1, 2019, SpecGx LLC, 3600
North Second Street, Saint Louis,
Missouri 63147 applied to be registered
as an importer of the following basic
classes of controlled substances:
jbell on DSK30RV082PROD with NOTICES
Controlled
substance
Drug code
Marihuana ..............
Phenylacetone .......
Coca Leaves .........
Opium, raw ............
Poppy Straw Concentrate.
7360
8501
9040
9600
9670
Schedule
I
II
II
II
II
The company plans to import the
listed controlled substances to bulk
manufacture into Active Pharmaceutical
VerDate Sep<11>2014
17:45 Apr 05, 2019
Jkt 247001
Ingredients (API) for distribution to its
customers. In reference to drug code
7360 (marihuana), the company plans to
import synthetic cannabidiol. No other
activity for this drug code is authorized
for this registration. Placement of these
codes onto the company’s registration
does not translate into automatic
approval of subsequent permit
applications to import controlled
substances. Approval of permit
applications will occur only when the
registrant’s business activity is
consistent with what is authorized
under 21 U.S.C. 952 (a)(2).
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
Dated: March 21, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–06852 Filed 4–5–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 19–3]
Martin A. Barrios, M.D.; Decision and
Order
On October 22, 2018, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause to Martin A. Barrios, M.D.
(hereinafter, Respondent), of Jackson,
Kentucky. Order to Show Cause
(hereinafter, OSC), at 1. The Show
Cause Order proposes the revocation of
Respondent’s Certificate of Registration
on the ground that he does ‘‘not have
authority to handle controlled
substances in the State of Kentucky, the
state in which . . . [he is] registered
with the DEA.’’ Id. (citing 21 U.S.C.
823(f) and 824(a)(3)).
Regarding jurisdiction, the Show
Cause Order alleges that Respondent
holds DEA Certificate of Registration
No. FB0348563 at the registered address
of 540 Jett Drive, Jackson, Kentucky
41339. OSC, at 1. This registration is
alleged to authorize Respondent to
dispense controlled substances in
schedules II through V as a practitioner.
The Show Cause Order alleges that this
registration expires on July 31, 2019. Id.
The substantive ground for the
proceeding, as alleged in the Show
Cause Order, is that Respondent is
‘‘without authority to handle controlled
substances in the State of Kentucky, the
state in which . . . [he is] registered
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13955
. . . with the DEA.’’ Id. at 2.
Specifically, the Show Cause Order
alleges that, on or about May 18, 2018,
the Commonwealth of Kentucky Board
of Medical Licensure (hereinafter,
Kentucky Board) issued an Amended
Emergency Order of Restriction
prohibiting Respondent from
‘‘prescribing, dispensing, or otherwise
professionally utilizing controlled
substances until the Board’s hearing
panel has finally resolved the Complaint
after receipt of the court documents
resolving the criminal charges in the
[criminal] indictment . . . or until such
further Order of the Board.’’ Id.
The Show Cause Order notifies
Respondent 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 2–3 (citing 21 CFR
1301.43). The Show Cause Order also
notifies Respondent of the opportunity
to submit a corrective action plan. OSC,
at 3 (citing 21 U.S.C. 824(c)(2)(C)).
By letter dated November 12, 2018,
Respondent timely requested a hearing.1
Hearing Request, at 1. According to the
Hearing Request, Respondent’s ‘‘interest
in the proceedings is to defend . . .
[his] innocence.’’ Id. Respondent’s
Hearing Request ‘‘acknowledge[s] . . .
the actions taken by both the Kentucky
medical board and American Board of
[S]urgery.’’ Id. at 2. It states that
Respondent is ‘‘in the process of
appealing the American Board of
Surgery’s action.’’ Id.
The Office of Administrative Law
Judges put the matter on the docket and
assigned it to Administrative Law Judge
Charles Wm. Dorman (hereinafter, ALJ).
The ALJ issued a Briefing Schedule for
Lack of State Authority Allegations
dated November 16, 2018. The
Government timely complied with the
Briefing Schedule by filing a Motion for
Summary Disposition on November 30,
2018 (hereinafter, Government Motion).
Order Granting Summary Disposition
and Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
dated December 20, 2018 (hereinafter,
R.D.), at 2. In its motion, the
Government stated that Respondent
lacks authority to handle controlled
substances in Kentucky, the State in
which he is registered with the DEA and
argued that, therefore, DEA must revoke
his registration. Id. Respondent did not
1 The Hearing Request was filed on November 15,
2018. Briefing Schedule for Lack of State Authority
Allegations dated November 16, 2018, at 1. I, thus,
find that the Government’s service of the OSC was
adequate.
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]]>Agencies
[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Pages 13954-13955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06852]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: SpecGx LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written
[[Page 13955]]
comments on or objections to the issuance of the proposed registration
on or before May 8, 2019. Such persons may also file a written request
for a hearing on the application on or before May 8, 2019.
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. Comments and requests for hearings on
applications to import narcotic raw materials are not appropriate. 72
FR 3417 (January 25, 2007).
SUPPLEMENTARY INFORMATION: The Attorney General has delegated his
authority under the Controlled Substances Act to the Administrator of
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority
to exercise all necessary functions with respect to the promulgation
and implementation of 21 CFR part 1301, incident to the registration of
manufacturers, distributors, dispensers, importers, and exporters of
controlled substances (other than final orders in connection with
suspension, denial, or revocation of registration) has been redelegated
to the Assistant Administrator of the DEA Diversion Control Division
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0,
appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on
February 1, 2019, SpecGx LLC, 3600 North Second Street, Saint Louis,
Missouri 63147 applied to be registered as an importer of the following
basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Marihuana............................ 7360 I
Phenylacetone........................ 8501 II
Coca Leaves.......................... 9040 II
Opium, raw........................... 9600 II
Poppy Straw Concentrate.............. 9670 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances to
bulk manufacture into Active Pharmaceutical Ingredients (API) for
distribution to its customers. In reference to drug code 7360
(marihuana), the company plans to import synthetic cannabidiol. No
other activity for this drug code is authorized for this registration.
Placement of these codes onto the company's registration does not
translate into automatic approval of subsequent permit applications to
import controlled substances. Approval of permit applications will
occur only when the registrant's business activity is consistent with
what is authorized under 21 U.S.C. 952 (a)(2). Authorization will not
extend to the import of FDA approved or non-approved finished dosage
forms for commercial sale.
Dated: March 21, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-06852 Filed 4-5-19; 8:45 am]
BILLING CODE 4410-09-P
