Importer of Controlled Substances Application: United States Pharmacopeial Convention, 54611-54612 [2018-23701]
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Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices
Dated: October 11, 2018.
John J. Martin,
Assistant Administrator.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[FR Doc. 2018–23684 Filed 10–29–18; 8:45 am]
54611
Dated: October 22, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–23696 Filed 10–29–18; 8:45 am]
BILLING CODE 4410–09–P
[Docket No. DEA–392]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: Insys
Manufacturing, LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
ACTION:
Notice of application.
[Docket No. DEA–392]
[Docket No. DEA–392]
ACTION:
Notice of registration.
Registrants listed below have
applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as bulk
manufacturers of various classes of
schedule I and II controlled substances.
SUPPLEMENTARY INFORMATION: The
companies listed below applied to be
registered as bulk manufacturers of
various basic classes of controlled
substances. Information on previously
published notices is listed in the table
below. No comments or objections were
submitted for these notices.
SUMMARY:
Company
khammond on DSK30JT082PROD with NOTICES
Johnson Matthey
Pharmaceutical
Materials Inc.
Alcami Wisconsin
Corporation.
FR docket
Published
83 FR
27632.
June 13,
2018.
83 FR
27628.
June 13,
2018.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of these registrants 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 each of the company’s
maintenance of effective controls
against diversion by inspecting and
testing each company’s physical
security systems, verifying each
company’s compliance with state and
local laws, and reviewing each
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 companies.
Dated: October 22, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–23698 Filed 10–29–18; 8:45 am]
BILLING CODE 4410–09–P
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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 December 31, 2018.
DATES:
Bulk Manufacturer of Controlled
Substances Registration
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
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
1301.33(a), this is notice that on August
22, 2018, Insys Manufacturing, LLC,
2700 Oakmont Drive, Round Rock,
Texas 78665–1019 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Marihuana .........
Tetrahydrocannabinols.
7360
7370
Schedule
I
I
The company plans to manufacture
bulk synthetic active pharmaceutical
ingredients (APIs) for product
development and distribution to its
customers. No other activity for these
drug codes are authorized for this
registration.
PO 00000
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Sfmt 4703
Importer of Controlled Substances
Application: United States
Pharmacopeial Convention
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 November 29, 2018. Such
persons may also file a written request
for a hearing on the application on or
before November 29, 2018.
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 hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for 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.
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 August
17, 2018, United States Pharmacopeial
DATES:
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54612
Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices
Convention, 12601 Twinbrook Parkway,
Rockville, Maryland 20852–1717,
applied to be registered as an importer
of the following basic class of the
controlled substance:
Controlled
substance
Drug code
Oxymorphone .........
9652
Schedule
II
The company plans to import the bulk
controlled substance for distribution of
analytical reference standards to its
customers for research and analytical
purposes.
Dated: October 22, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–23701 Filed 10–29–18; 8:45 am]
BILLING CODE 4410–09–P
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 August
30, 2018, Sharp (Bethlehem), LLC, 2400
Baglyos Circle, Bethlehem,
Pennsylvania 18020, applied to be
registered as an importer of the
following basic class of controlled
substances:
Controlled
substance
DEPARTMENT OF JUSTICE
Gamma Hydroxybutyric Acid.
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Sharp (Bethlehem), LLC
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 November 29, 2018. Such
persons may also file a written request
for a hearing on the application on or
before November 29, 2018.
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 hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for 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.
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
khammond on DSK30JT082PROD with NOTICES
DATES:
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19:27 Oct 29, 2018
Jkt 247001
Drug code
2010
Schedule
I
The company plans to import dosage
forms of the listed controlled substances
to conduct clinical trials.
Approval of permit applications will
occur only when the registrant’s activity
is consistent with what is authorized
under to 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: October 22, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–23705 Filed 10–29–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Fisher Clinical Services,
Inc.
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 November 29, 2018. Such
persons may also file a written request
for a hearing on the application on or
before November 29, 2018.
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 hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for 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.
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.
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR
1301.34(a), this is notice that on August
17, 2018, Fisher Clinical Services Inc.,
7554 Schantz Road, Allentown,
Pennsylvania 18106, applied to be
registered as an importer of the
following basic classes of controlled
substances:
Controlled
substance
Drug code
Psilocybin .........
Methylphenidate
Levorphanol ......
Noroxymorphone.
Tapentadol ........
Schedule
7437
1724
9220
9668
I
II
II
II
9780
II
DATES:
PO 00000
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The company plans to import the
listed controlled substances for clinical
trials.
Dated: October 22, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–23702 Filed 10–29–18; 8:45 am]
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]]>Agencies
[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Pages 54611-54612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23701]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: United States
Pharmacopeial Convention
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 November 29, 2018.
Such persons may also file a written request for a hearing on the
application on or before November 29, 2018.
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
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for 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.
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 August
17, 2018, United States Pharmacopeial
[[Page 54612]]
Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852-1717,
applied to be registered as an importer of the following basic class of
the controlled substance:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Oxymorphone.......................... 9652 II
------------------------------------------------------------------------
The company plans to import the bulk controlled substance for
distribution of analytical reference standards to its customers for
research and analytical purposes.
Dated: October 22, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-23701 Filed 10-29-18; 8:45 am]
BILLING CODE 4410-09-P
