Notice2026-04655
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 10, 2026
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
<html>
<head>
<title>Federal Register, Volume 91 Issue 46 (Tuesday, March 10, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 46 (Tuesday, March 10, 2026)]
[Notices]
[Pages 11562-11563]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-04655]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 1642]
Bulk Manufacturer of Controlled Substances Application: Sigma
Aldrich Research Biochemicals Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
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 11, 2026. Such persons may also file a written request for a
hearing on the application on or before May 11, 2026.
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 18, 2025, 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):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Cathinone.............................. 1235 I
Mephedrone (4-Methyl-N-methylcathinone) 1248 I
Methaqualone........................... 2565 I
JWH-018 (also known as AM678) (1-Pentyl- 7118 I
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
Nabilone............................... 7379 II
Phencyclidine.......................... 7471 II
Cocaine................................ 9041 II
Codeine................................ 9050 II
[[Page 11563]]
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.
Thomas Prevoznik,
Deputy Assistant Administrator.
[FR Doc. 2026-04655 Filed 3-9-26; 8:45 am]
BILLING CODE P
</pre></body>
</html>Indexed from Federal Register on March 10, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.