Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals, 2457 [2021-00351]
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Federal Register / Vol. 86, No. 7 / Tuesday, January 12, 2021 / Notices
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.
In
accordance with 21 CFR 1301.34(a), this
is notice that on December 15, 2020,
Medi-Physics, Inc. dba GE Healthcare,
3350 North Ridge Avenue, Arlington
Heights, Illinois 60004–1412, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Cocaine ........................
Drug
code
9041
Schedule
II
The company plans to import small
quantities of Ioflupane, in the form of
three separate analogues of Cocaine, to
validate production and quality control
systems, for a reference standard, and
for producing material for a future
investigational new drug submission.
Supplies of this particular controlled
substance are not available in the form
needed within the current domestic
supply of the United States. No other
activity for this drug code is authorized
for this registration.
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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–00353 Filed 1–11–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–756]
Bulk Manufacturer of Controlled
Substances Application: Cedarburg
Pharmaceuticals
William T. McDermott,
Assistant Administrator.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
[FR Doc. 2021–00351 Filed 1–11–21; 8:45 am]
Cedarburg Pharmaceuticals
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 March 15, 2021. Such persons
may also file a written request for a
hearing on the application on or before
March 15, 2021.
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 October 16, 2020,
Cedarburg Pharmaceuticals 870 Badger
Circle, Grafton, Wisconsin 53024,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUMMARY:
Controlled substance
Tetrahydrocannabinols
3, 4Methylenedioxymethamphetamine.
Dimethyltryptamine .......
Psilocybin .....................
Methylphenidate ...........
Nabilone .......................
4-Anilino-N-phenethyl-4piperidine (ANPP).
Fentanyl ........................
Drug
code
The company plans to manufacture
bulk active pharmaceutical ingredients
(API) for distribution to its customers. In
reference to the drug code 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture as synthetic.
No other activity for this drug code is
authorized for this registration.
Schedule
7370
7405
I
I
7435
7437
1724
7379
8333
I
I
II
II
II
9801
II
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–765]
Bulk Manufacturer of Controlled
Substances Application: Organix, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Organix, Inc. 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 March 15, 2021. Such persons
may also file a written request for a
hearing on the application on or before
March 15, 2021.
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 September 22, 2020,
Organix, Inc., 240 Salem Street,
Woburn, Massachusetts 01801, applied
to be registered as an bulk manufacturer
of the following basic class(es) of
controlled substance(s):
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Controlled substance
Drug code
Gamma Hydroxybutyric Acid ...........................................................................................................................................
Lysergic acid diethylamide ..............................................................................................................................................
Marihuana ........................................................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
5-Methoxy-N-N-dimethyltryptamine .................................................................................................................................
Bufotenine ........................................................................................................................................................................
Dimethyltryptamine ..........................................................................................................................................................
Psilocybin .........................................................................................................................................................................
Psilocyn ...........................................................................................................................................................................
Heroin ..............................................................................................................................................................................
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7315
7360
7370
7431
7433
7435
7437
7438
9200
Schedule
I
I
I
I
I
I
I
I
I
I
]]>Agencies
[Federal Register Volume 86, Number 7 (Tuesday, January 12, 2021)]
[Notices]
[Page 2457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00351]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-756]
Bulk Manufacturer of Controlled Substances Application: Cedarburg
Pharmaceuticals
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Cedarburg Pharmaceuticals 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 March 15, 2021.
Such persons may also file a written request for a hearing on the
application on or before March 15, 2021.
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 October 16, 2020, Cedarburg Pharmaceuticals 870
Badger Circle, Grafton, Wisconsin 53024, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols.................. 7370 I
3, 4-Methylenedioxymethamphetamine..... 7405 I
Dimethyltryptamine..................... 7435 I
Psilocybin............................. 7437 I
Methylphenidate........................ 1724 II
Nabilone............................... 7379 II
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
Fentanyl............................... 9801 II
------------------------------------------------------------------------
The company plans to manufacture bulk active pharmaceutical
ingredients (API) for distribution to its customers. In reference to
the drug code 7370 (Tetrahydrocannabinols), the company plans to bulk
manufacture as synthetic. No other activity for this drug code is
authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-00351 Filed 1-11-21; 8:45 am]
BILLING CODE P
