Bulk Manufacturer of Controlled Substances Application: Restek Corporation, 67362-67363 [2023-21401]
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67362
Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices
Controlled substance
Drug code
Para-Methoxymethamphetamine (PMMA), 1-(4- methoxyphenyl)-N-methylpropan-2-amine .................................
Aminorex .................................................................................................................................................................
Etizolam (4-(2-chlorophenyl)-2-ethyl-9-methyl-6Hthieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine .........................
Flualprazolam (8-chloro-6-(2-fluorophenyl)-1-methyl-4Hbenzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) ....................
Clonazolam (6-(2-chlorophenyl)-1-methyl-8-nitro-4Hbenzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine ...........................
Flubromazolam (8-bromo-6-(2-fluorophenyl)-1-methyl4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine ...................
Diclazepam (7-chloro-5-(2-chloro-5-(2-chlorophenyl)-1-methyl-1,3-dihydro-2H-benzo[e][1,4]diazepin-2-one ........
Piritramide ...............................................................................................................................................................
Lisdexamfetamine ...................................................................................................................................................
Oliceridine (N-[(3-methoxythiophen-2yl)methyl] ({2-[9r)-9-(pyridin-2-yl)-6-oxaspiro[4.5] decan-9-yl] ethyl
{time})amine fumarate).
Levo-alphacetylmethadol .........................................................................................................................................
Remifentanil .............................................................................................................................................................
Tapentadol ...............................................................................................................................................................
The company plans to import the
listed controlled substances for
distribution for analytical testing
purposes. No other activities for these
drug codes are 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.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–21398 Filed 9–28–23; 8:45 am]
BILLING CODE P
Drug Enforcement Administration
[Docket No. DEA–1272]
Bulk Manufacturer of Controlled
Substances Application: Restek
Corporation
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Restek Corporation 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
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before November 28, 2023. Such
persons may also file a written request
for a hearing on the application on or
before November 28, 2023.
lotter on DSK11XQN23PROD with NOTICES1
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Drug code
Gamma Hydroxybutyric Acid ...................................................................................................................................
Methaqualone ..........................................................................................................................................................
JWH–018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) ......................................................................
JWH–200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) ..................................................................................
CP–47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol) ........................................................
CP–47,497 C8 Homologue (5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl-phenol) ..................................
Lysergic acid diethylamide ......................................................................................................................................
Marihuana ................................................................................................................................................................
Tetrahydrocannabinols ............................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine .....................................................................................................................
3,4-Methylenedioxyamphetamine ............................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine ...............................................................................................................
3,4-Methylenedioxymethamphetamine ....................................................................................................................
Bufotenine ...............................................................................................................................................................
Psilocybin ................................................................................................................................................................
Psilocyn ...................................................................................................................................................................
Cyprenorphine .........................................................................................................................................................
Dihydromorphine .....................................................................................................................................................
Heroin ......................................................................................................................................................................
Normorphine ............................................................................................................................................................
Beta-hydroxyfentanyl ...............................................................................................................................................
Beta-hydroxy-3-methylfentanyl ................................................................................................................................
21:46 Sep 28, 2023
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The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on June 21, 2023, Restek
Corporation, 110 Benner Circle,
Bellefonte, Pennsylvania 16823–8433,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Controlled substance
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DEPARTMENT OF JUSTICE
SUMMARY:
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67363
Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices
The company plans to bulk
manufacture the listed controlled
substances for DEA exempted certified
reference materials. In-house synthesis
gives access to compounds that are
difficult to source. No other activities
for these drug codes are authorized for
this registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–21401 Filed 9–28–23; 8:45 am]
BILLING CODE P
of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY
INFORMATION listed below for further
drug information.
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before October 30, 2023. Such
persons may also file a written request
for a hearing on the application on or
before October 30, 2023.
DATES:
The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
ADDRESSES:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1277]
Importer of Controlled Substances
Application: Restek Corporation
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Restek Corporation has
applied to be registered as an importer
SUMMARY:
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must 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. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
In
accordance with 21 CFR 1301.34(a), this
is notice that on August 24, 2023, Restek
Corporation, 110 Benner Circle,
Bellefonte, Pennsylvania 16823–8433,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
Controlled substance
Drug code
Amineptine .......................................................................................................................................................................
Mesocarb .........................................................................................................................................................................
3-Fluoro-N-methylcathinone (3–FMC) .............................................................................................................................
Cathinone ........................................................................................................................................................................
Methcathinone .................................................................................................................................................................
4-Fluoro-N-methylcathinone (4–FMC) .............................................................................................................................
Para-Methoxymethamphetamine (PMMA), 1-(4–1245 I N methoxyphenyl)-N-methylpropan-2-amine ..........................
Pentedrone (a-methylaminovalerophenone) ...................................................................................................................
Mephedrone (4-Methyl-N-methylcathinone .....................................................................................................................
4-Methyl-N-ethylcathinone (4–MEC) ...............................................................................................................................
Naphyrone .......................................................................................................................................................................
N-Ethylamphetamine .......................................................................................................................................................
Methiopropamine (N-methyl-1-(thiophen-2-yl)propan-2- 1478 I N amine) ......................................................................
N,N-Dimethylamphetamine ..............................................................................................................................................
Fenethylline .....................................................................................................................................................................
Aminorex ..........................................................................................................................................................................
4-Methylaminorex (cis isomer) ........................................................................................................................................
4,4′-Dimethylaminorex .....................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Gamma Hydroxybutyric Acid ...........................................................................................................................................
Methaqualone ..................................................................................................................................................................
Mecloqualone ..................................................................................................................................................................
JWH–250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) ..................................................................................................
SR–18 (Also known as RCS–8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole) ................................................
ADB–FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) .............
5-Fluoro-UR–144 and XLR11 [1-(5-Fluoro-pentyl)1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone ................
AB–FUBINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) .....................
FUB–144 (1-(4-fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone) ...............................................
JWH–019 (1-Hexyl-3-(1-naphthoyl)indole) ......................................................................................................................
MDMB–FUBINACA (Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ......................
FUB–AMB, MMB- FUBINACA, AMB–FUBINACA (2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3methylbutanoate).
AB–PINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) .........................................
THJ–2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) .................................................................
5F–AB–PINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluropentyl)-1H-indazole-3-carboximide) ........................
AB–CHMINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) ...............
MAB–CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) ........
5F–AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) ..............................................
5F–ADB, 5F–MDMB–PINACA (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ......
ADB–PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) .................................
5F–EDMB–PINACA (ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) .........................
5F–MDMB–PICA (methyl 2-(1-(5-fluoropentyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) ..............................
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]]>Agencies
[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Notices]
[Pages 67362-67363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21401]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1272]
Bulk Manufacturer of Controlled Substances Application: Restek
Corporation
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Restek Corporation 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 applicants therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
November 28, 2023. Such persons may also file a written request for a
hearing on the application on or before November 28, 2023.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on June 21, 2023, Restek Corporation, 110 Benner Circle,
Bellefonte, Pennsylvania 16823-8433, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled
substance(s):
----------------------------------------------------------------------------------------------------------------
Controlled substance Drug code Schedule
----------------------------------------------------------------------------------------------------------------
Gamma Hydroxybutyric Acid................................. 2010 I
Methaqualone.............................................. 2565 I
JWH-018 (also known as AM678) (1-Pentyl-3-(1- 7118 I
naphthoyl)indole).
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) 7200 I
CP-47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3- 7297 I
hydroxycyclohexyl-phenol).
CP-47,497 C8 Homologue (5-(1,1-Dimethyloctyl)-2-[(1R,3S)3- 7298 I
hydroxycyclohexyl-phenol).
Lysergic acid diethylamide................................ 7315 I
Marihuana................................................. 7360 I
Tetrahydrocannabinols..................................... 7370 I
4-Methyl-2,5-dimethoxyamphetamine......................... 7395 I
3,4-Methylenedioxyamphetamine............................. 7400 I
3,4-Methylenedioxy-N-ethylamphetamine..................... 7404 I
3,4-Methylenedioxymethamphetamine......................... 7405 I
Bufotenine................................................ 7433 I
Psilocybin................................................ 7437 I
Psilocyn.................................................. 7438 I
Cyprenorphine............................................. 9054 I
Dihydromorphine........................................... 9145 I
Heroin.................................................... 9200 I
Normorphine............................................... 9313 I
Beta-hydroxyfentanyl...................................... 9830 I
Beta-hydroxy-3-methylfentanyl............................. 9831 I
----------------------------------------------------------------------------------------------------------------
[[Page 67363]]
The company plans to bulk manufacture the listed controlled
substances for DEA exempted certified reference materials. In-house
synthesis gives access to compounds that are difficult to source. No
other activities for these drug codes are authorized for this
registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-21401 Filed 9-28-23; 8:45 am]
BILLING CODE P
