Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals
| Published date | 12 January 2021 |
| Record Number | 2021-00351 |
| Section | Notices |
| Court | Drug Enforcement Administration,Justice Department |
2457
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.
SUPPLEMENTARY INFORMATION
: 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):
Controlled substance Drug
code Schedule
Cocaine ........................ 9041 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 non-
approved 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
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):
Controlled substance Drug
code Schedule
Tetrahydrocannabinols 7370 I
3, 4-
Methylenedioxymeth-
amphetamine.
7405 I
Dimethyltryptamine ....... 7435 I
Psilocybin ..................... 7437 I
Methylphenidate ........... 1724 II
Nabilone ....................... 7379 II
4-Anilino-N-phenethyl-4-
piperidine (ANPP). 8333 II
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
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–765]
Bulk Manufacturer of Controlled
Substances Application: Organix, Inc.
AGENCY
: Drug Enforcement
Administration, Justice.
ACTION
: Notice of application.
SUMMARY
: 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):
Controlled substance Drug code Schedule
Gamma Hydroxybutyric Acid ........................................................................................................................................... 2010 I
Lysergic acid diethylamide .............................................................................................................................................. 7315 I
Marihuana ........................................................................................................................................................................ 7360 I
Tetrahydrocannabinols .................................................................................................................................................... 7370 I
5-Methoxy-N-N-dimethyltryptamine ................................................................................................................................. 7431 I
Bufotenine ........................................................................................................................................................................ 7433 I
Dimethyltryptamine .......................................................................................................................................................... 7435 I
Psilocybin ......................................................................................................................................................................... 7437 I
Psilocyn ........................................................................................................................................................................... 7438 I
Heroin .............................................................................................................................................................................. 9200 I
VerDate Sep<11>2014 18:51 Jan 11, 2021 Jkt 253001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\12JAN1.SGM 12JAN1
khammond on DSKJM1Z7X2PROD with NOTICES
