Bulk Manufacturer of Controlled Substances Application: Restek Corporation

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Published

September 29, 2023

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

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.

Full Text

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<title>Federal Register, Volume 88 Issue 188 (Friday, September 29, 2023)</title>
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[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Notices]
[Pages 67362-67363]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-21401]


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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.

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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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):

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                   Controlled substance                        Drug code                  Schedule
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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
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[[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


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