Importer of Controlled Substances Application: Mylan Technologies, Inc., 66589 [2021-25575]
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Federal Register / Vol. 86, No. 223 / Tuesday, November 23, 2021 / Notices
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The authority for this action is the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Kirk Malstrom,
Chief, Regulations and Standards Branch.
[FR Doc. 2021–25538 Filed 11–22–21; 8:45 am]
BILLING CODE 4310–VH–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–924]
Importer of Controlled Substances
Application: Mylan Technologies, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Mylan Technologies, Inc. has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY
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 December 23, 2021. Such
persons may also file a written request
for a hearing on the application on or
before December 23, 2021.
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:
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:09 Nov 22, 2021
Jkt 256001
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 October 22, 2021,
Mylan Technologies, Inc., 110 Lake
Street, Saint Albans, Vermont 05478–
2266, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
Drug
code
Controlled substance
Methylphenidate .......
Fentanyl ....................
I
1724
9801
Schedule
I
II
II
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically manufactured FDF. This
analysis is required to allow the
company to export domestically
manufactured finished dosage form to
foreign markets. No other activity for
these drug codes 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.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–25575 Filed 11–22–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–925]
Bulk Manufacturer of Controlled
Substances Application: Noramco
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Noramco, has applied to be
registered as a bulk manufacturer of
basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY
INFORMATION listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
SUMMARY:
PO 00000
Frm 00075
Fmt 4703
Sfmt 9990
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before January 24, 2022. Such
persons may also file a written request
for a hearing on the application on or
before January 24, 2022.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on October 19, 2021,
Noramco, 500 Swedes Landing Road,
Wilmington, Delaware 19801–4417,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Marihuana .................................
Tetrahydrocannabinols .............
Dihydromorphine .......................
Hydromorphinol .........................
Amphetamine ............................
Lisdexamfetamine .....................
Methylphenidate ........................
Nabilone ....................................
Codeine .....................................
Dihydrocodeine .........................
Oxycodone ................................
Hydromorphone ........................
Hydrocodone .............................
Morphine ...................................
Oripavine ...................................
Thebaine ...................................
Opium extracts ..........................
Opium fluid extract ....................
Opium, tincture .........................
Opium, powdered .....................
Opium, granulated ....................
Oxymorphone ...........................
Noroxymorphone ......................
Tapentadol ................................
Drug
code
Schedule
7360
7370
9145
9301
1100
1205
1724
7379
9050
9120
9143
9150
9193
9300
9330
9333
9610
9620
9630
9639
9640
9652
9668
9780
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to bulk
manufacture the listed controlled
substances as an Active Pharmaceutical
Ingredient (API) for supply to its
customers. In reference to dug codes
7360 (Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–25578 Filed 11–22–21; 8:45 am]
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]]>Agencies
[Federal Register Volume 86, Number 223 (Tuesday, November 23, 2021)]
[Notices]
[Page 66589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25575]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-924]
Importer of Controlled Substances Application: Mylan
Technologies, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Mylan Technologies, Inc. has applied to be registered as an
importer of basic class(es) of controlled substance(s). Refer to
Supplementary 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 December 23,
2021. Such persons may also file a written request for a hearing on the
application on or before December 23, 2021.
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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on October 22, 2021, Mylan Technologies, Inc., 110 Lake
Street, Saint Albans, Vermont 05478-2266, applied to be registered as
an importer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Methylphenidate....................... 1724 II
Fentanyl.............................. 9801 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances in
finished dosage form (FDF) from foreign sources for analytical testing
and clinical trials in which the foreign FDF will be compared to the
company's own domestically manufactured FDF. This analysis is required
to allow the company to export domestically manufactured finished
dosage form to foreign markets. No other activity for these drug codes
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.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-25575 Filed 11-22-21; 8:45 am]
BILLING CODE P
