Notice2025-04044

Bulk Manufacturer of Controlled Substances Application: Sigma Aldrich Research Biochemicals Inc.

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published
March 13, 2025

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

Sigma Aldrich Research Biochemicals Inc. 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 48 (Thursday, March 13, 2025)</title>
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[Federal Register Volume 90, Number 48 (Thursday, March 13, 2025)]
[Notices]
[Pages 11998-11999]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-04044]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 1507]


Bulk Manufacturer of Controlled Substances Application: Sigma 
Aldrich Research Biochemicals Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Sigma Aldrich Research Biochemicals Inc. 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 
May 12, 2025. Such persons may also file a written request for a 
hearing on the application on or before May 12, 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 December 23, 2024, Sigma Aldrich Research 
Biochemicals Inc., 400-600 Summit Drive, Burlington, Massachusetts 
01803, applied to be registered as a bulk manufacturer of the following 
basic class(es) of controlled substance(s):

------------------------------------------------------------------------
         Controlled substance            Drug code         Schedule
------------------------------------------------------------------------
Cathinone.............................         1235  I
Mephedrone (4-Methyl-N-                        1248  I
 methylcathinone).
Methaqualone..........................         2565  I
JWH-018 (also known as AM678) (1-              7118  I
 Pentyl-3-(1-naphthoyl)indole).
AM2201 (1-(5-Fluoropentyl)-3-(1-               7201  I
 naphthoyl) indole).
Lysergic acid diethylamide............         7315  I
Tetrahydrocannabinols.................         7370  I
Mescaline.............................         7381  I
2,5-Dimethoxyamphetamine..............         7396  I
3,4-Methylenedioxymethamphetamine.....         7405  I
Alpha-methyltryptamine................         7432  I
Dimethyltryptamine....................         7435  I
5-Methoxy-N,N-diisopropyltryptamine...         7439  I
N-Benzylpiperazine....................         7493  I
2C-H 2-(2,5-Dimethoxyphenyl)                   7517  I
 ethanamine).
MDPV (3,4-Methylenedioxypyrovalerone).         7535  I
Methylone (3,4-Methylenedioxy-N-               7540  I
 methylcathinone).
Heroin................................         9200  I
Normorphine...........................         9313  I
Norlevorphanol........................         9634  I
Acetyl Fentanyl (N-(1-                         9821  I
 phenethylpiperidin-4-yl)-N-
 phenylacetamide).
Amphetamine...........................         1100  II
Lisdexamfetamine......................         1205  II
Methylphenidate.......................         1724  II

[[Page 11999]]

 
Nabilone..............................         7379  II
Phencyclidine.........................         7471  II
Cocaine...............................         9041  II
Codeine...............................         9050  II
Ecgonine..............................         9180  II
Levorphanol...........................         9220  II
Meperidine............................         9230  II
Methadone.............................         9250  II
Morphine..............................         9300  II
Thebaine..............................         9333  II
Levo-alphacetylmethadol...............         9648  II
Noroxymorphone........................         9668  II
Remifentanil..........................         9739  II
Sufentanil............................         9740  II
Carfentanil...........................         9743  II
Tapentadol............................         9780  II
Fentanyl..............................         9801  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
as reference standards. No other activities for these drug codes are 
authorized for this registration.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-04044 Filed 3-12-25; 8:45 am]
BILLING CODE 4410-09-P


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Indexed from Federal Register on March 13, 2025.

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