Importer of Controlled Substances Application: Myonex Inc., 10388 [2022-03903]
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10388
Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on December 15, 2021,
Mylan Inc., 3711 Collins Ferry Road,
Morgantown, West Virginia 26505–
2362, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
Controlled substance
Amphetamine ..................
Methylphenidate ..............
Oxycodone ......................
Hydromorphone ...............
Methadone ......................
Morphine ..........................
Fentanyl ...........................
Drug
code
Schedule
1100
1724
9143
9150
9250
9300
9801
II
II
II
II
II
II
II
The company plans to import finished
dosage forms for analytical testing and
distribution for clinical trials. 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 the Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
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 28, 2022. Such persons
may also file a written request for a
hearing on the application on or before
March 28, 2022.
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 request 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 10, 2021,
Myonex Inc., 100 Progress Drive,
Horsham, Pennsylvania 19044, applied
to be registered as an importer of the
following basic class(es) of controlled
substance(s):
[FR Doc. 2022–03907 Filed 2–23–22; 8:45 am]
Controlled substance
BILLING CODE P
Amphetamine ..................
Lisdexamfetamine ...........
Methylphenidate ..............
Nabilone ..........................
Oxycodone ......................
Hydromorphone ...............
Hydrocodone ...................
Morphine ..........................
Oxymorphone ..................
Fentanyl ...........................
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–960]
Importer of Controlled Substances
Application: Myonex Inc.
Drug
code
Schedule
1100
1205
1724
7379
9143
9150
9193
9300
9652
9801
II
II
II
II
II
II
II
II
II
II
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–03903 Filed 2–23–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–953]
Bulk Manufacturer of Controlled
Substances Application: Benuvia
Therapeutics Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Benuvia Therapeutics 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 April 25, 2022. Such persons
may also file a written request for a
hearing on the application on or before
April 25, 2022.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
In
accordance with 21 CFR 1301.33(a), this
is notice that on November 16, 2021,
Benuvia Therapeutics Inc., 2700
Oakmont Drive, Round Rock, Texas
78665, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Myonex Inc. has applied to be
registered as an importer of basic
class(es) of controlled substance(s).
Refer to SUPPLEMENTAL INFORMATION
SUMMARY:
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.
The company plans to import the
listed controlled substances for clinical
trials, research, and analytical purposes.
No other activity for these drug codes is
authorized for this registration.
Approval of permit applications will
occur only when the registrant’s
jspears on DSK121TN23PROD with NOTICES1
Controlled substance
Drug code
Tetrahydrocannabinols ....................................................................................................................................................
3,4-Methylenedioxyamphetamine ....................................................................................................................................
3,4-Methylenedioxymethamphetamine ............................................................................................................................
5-Methoxy-N-N-dimethyltryptamine .................................................................................................................................
Dimethyltryptamine ..........................................................................................................................................................
Psilocybin .........................................................................................................................................................................
Psilocyn ...........................................................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine .............................................................................................................................
VerDate Sep<11>2014
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Agencies
[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Notices]
[Page 10388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03903]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-960]
Importer of Controlled Substances Application: Myonex Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Myonex Inc. has applied to be registered as an importer 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 28, 2022.
Such persons may also file a written request for a hearing on the
application on or before March 28, 2022.
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
request 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 10, 2021, Myonex Inc., 100 Progress Drive,
Horsham, Pennsylvania 19044, applied to be registered as an importer of
the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Amphetamine............................. 1100 II
Lisdexamfetamine........................ 1205 II
Methylphenidate......................... 1724 II
Nabilone................................ 7379 II
Oxycodone............................... 9143 II
Hydromorphone........................... 9150 II
Hydrocodone............................. 9193 II
Morphine................................ 9300 II
Oxymorphone............................. 9652 II
Fentanyl................................ 9801 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
clinical trials, research, and analytical purposes. 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.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-03903 Filed 2-23-22; 8:45 am]
BILLING CODE 4410-09-P