Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City, 49579 [2018-21351]
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49579
Federal Register / Vol. 83, No. 191 / Tuesday, October 2, 2018 / Notices
as a bulk manufacturer of the following
basic classes of controlled substances:
Controlled substance
Methylphenidate .......
Levomethorphan ......
Levorphanol ..............
Thebaine ..................
Remifentanil .............
Tapentadol ...............
Drug
code
Schedule
II
II
II
II
II
II
[FR Doc. 2018–21348 Filed 10–1–18; 8:45 am]
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.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Registration
ACTION:
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.
SUMMARY:
BILLING CODE 4410–09–P
1724
9210
9220
9333
9739
9780
The company plans to manufacture
the listed controlled substances in bulk
for distribution to its customers.
Notice of registration.
Company
FR docket
Published
American Radiolabeled Chem .................................................................................................................................
Cerilliant Corporation ...............................................................................................................................................
83 FR 28664
83 FR 28664
June 20, 2018.
June 20, 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: September 20, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–21353 Filed 10–1–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
amozie on DSK3GDR082PROD with NOTICES1
Dated: September 20, 2018.
John J. Martin,
Assistant Administrator.
Bulk Manufacturer of Controlled
Substances Application: Cambrex
Charles City
ACTION:
Controlled substance
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
DATES:
VerDate Sep<11>2014
18:39 Oct 01, 2018
Jkt 247001
issuance of the proposed registration on
or before December 3, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: 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
1301.33(a), this is notice that on June 8,
2018, Cambrex Charles City, 1205 11th
Street, Charles City, Iowa 50616 applied
to be registered as a bulk manufacturer
of the basic classes of controlled
substances:
Gamma Hydroxybutyric
Acid.
Amphetamine .................
Lisdexamfetamine ..........
Methylphenidate .............
4-Anilino-N-phenethyl-4piperidine (ANPP).
Phenylacetone ................
Cocaine ..........................
PO 00000
Frm 00050
Fmt 4703
Drug code
Drug code
Codeine ..........................
Oxycodone .....................
Hydromorphone ..............
Hydrocodone ..................
Morphine ........................
Oripavine ........................
Thebaine ........................
Opium extracts ...............
Opium fluid extract .........
Opium tincture ................
Opium, powdered ...........
Oxymorphone .................
Noroxymorphone ............
Fentanyl ..........................
9050
9143
9150
9193
9300
9330
9333
9610
9620
9630
9639
9652
9668
9801
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for conversion to other controlled
substances and sale to its customers, for
dosage form development, for clinical
trials, and for use in stability
qualification studies.
Dated: September 20, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–21351 Filed 10–1–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration
Schedule
2010
I
1100
1205
1724
8333
II
II
II
II
8501
9041
II
II
Sfmt 4703
Controlled substance
ACTION:
Notice of registration.
Registrants listed below have
applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as importers of
various classes of schedule I or II
controlled substances.
SUMMARY:
E:\FR\FM\02OCN1.SGM
02OCN1
]]>Agencies
[Federal Register Volume 83, Number 191 (Tuesday, October 2, 2018)]
[Notices]
[Page 49579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21351]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Cambrex
Charles City
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 December 3, 2018.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: 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 1301.33(a), this is notice that on June
8, 2018, Cambrex Charles City, 1205 11th Street, Charles City, Iowa
50616 applied to be registered as a bulk manufacturer of the basic
classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid......... 2010............. I
Amphetamine....................... 1100............. II
Lisdexamfetamine.................. 1205............. II
Methylphenidate................... 1724............. II
4-Anilino-N-phenethyl-4-piperidine 8333............. II
(ANPP).
Phenylacetone..................... 8501............. II
Cocaine........................... 9041............. II
Codeine........................... 9050............. II
Oxycodone......................... 9143............. II
Hydromorphone..................... 9150............. II
Hydrocodone....................... 9193............. II
Morphine.......................... 9300............. II
Oripavine......................... 9330............. II
Thebaine.......................... 9333............. II
Opium extracts.................... 9610............. II
Opium fluid extract............... 9620............. II
Opium tincture.................... 9630............. II
Opium, powdered................... 9639............. II
Oxymorphone....................... 9652............. II
Noroxymorphone.................... 9668............. II
Fentanyl.......................... 9801............. II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk for conversion to other controlled substances and sale to its
customers, for dosage form development, for clinical trials, and for
use in stability qualification studies.
Dated: September 20, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-21351 Filed 10-1-18; 8:45 am]
BILLING CODE 4410-09-P
