Bulk Manufacturer of Controlled Substances Application: Restek Corporation

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Published

April 18, 2025

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 90 Issue 74 (Friday, April 18, 2025)</title>
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[Federal Register Volume 90, Number 74 (Friday, April 18, 2025)]
[Notices]
[Pages 16556-16557]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06709]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1530]


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 
June 17, 2025. Such persons may also file a written request for a 
hearing on the application on or before June 17, 2025.

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 February 19, 2025, 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-              7118  I
 Pentyl-3-(1naphthoyl)indole).
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-           7200  I
 3-(1- naphthoyl)indole.
CP-47,497 (5-(1,1-Dimethylheptyl)-2-           7297  I
 [(1R,3S)-3-hydroxycyclohexy]-
 phenol).
CP-47,497 C8 Homologue (5-(1,1-                7298  I
 Dimethyloctyl)-2- [(1R,3S)3-
 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

[[Page 16557]]

 
3,4-Methylenedioxy-N-                          7404  I
 ethylamphetamine.
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
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances for the Drug Enforcement Administration-exempted certified 
reference materials. In-house synthesis gives access to compounds that 
are difficult to source. In reference to drug 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.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-06709 Filed 4-17-25; 8:45 am]
BILLING CODE 4410-09-P


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