Bulk Manufacturer of Controlled Substances Application: Purisys, LLC

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

February 18, 2025

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

Purisys, LLC 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 90 Issue 31 (Tuesday, February 18, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 31 (Tuesday, February 18, 2025)]
[Notices]
[Pages 9733-9735]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-02731]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1492]


Bulk Manufacturer of Controlled Substances Application: Purisys, 
LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

-----------------------------------------------------------------------

SUMMARY: Purisys, LLC 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 
April 21, 2025. Such persons may also file a written request for a 
hearing on the application on or before April 21, 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

[[Page 9734]]

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 10, 2024, Purisys, LLC, 1550 Olympic Drive, 
Athens, Georgia 30601-1602, 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
Ethylphenidate (ethyl 2-phenyl-2-(piperidin-        1727  I
 2-yl)acetate).
Gamma Hydroxybutyric Acid...................        2010  I
Ibogaine....................................        7260  I
Lysergic acid diethylamide..................        7315  I
Marihuana Extract...........................        7350  I
Marihuana...................................        7360  I
Tetrahydrocannabinols.......................        7370  I
Mescaline...................................        7381  I
2,5-Dimethoxyamphetamine....................        7396  I
3,4-Methylenedioxyamphetamine...............        7400  I
3,4-Methylenedioxy-N-ethylamphetamine.......        7404  I
3,4-Methylenedioxymethamphetamine...........        7405  I
5-Methoxy-N-N-dimethyltryptamine............        7431  I
Diethyltryptamine...........................        7434  I
Dimethyltryptamine..........................        7435  I
Psilocybin..................................        7437  I
Psilocyn....................................        7438  I
5-Methoxy-N,N-diisopropyltryptamine.........        7439  I
Methylone (3,4-Methylenedioxy-N-                    7540  I
 methylcathinone).
Codeine-N-oxide.............................        9053  I
Dihydromorphine.............................        9145  I
Heroin......................................        9200  I
Hydromorphinol..............................        9301  I
Morphine-N-oxide............................        9307  I
Normorphine.................................        9313  I
Norlevorphanol..............................        9634  I
Amphetamine.................................        1100  II
Lisdexamfetamine............................        1205  II
Methylphenidate.............................        1724  II
Pentobarbital...............................        2270  II
Nabilone....................................        7379  II
Cocaine.....................................        9041  II
Codeine.....................................        9050  II
Dihydrocodeine..............................        9120  II
Oxycodone...................................        9143  II
Hydromorphone...............................        9150  II
Ecgonine....................................        9180  II
Hydrocodone.................................        9193  II
Levorphanol.................................        9220  II
Meperidine..................................        9230  II
Meperidine intermediate-A...................        9232  II
Meperidine intermediate-B...................        9233  II
Meperidine intermediate-C...................        9234  II
Methadone...................................        9250  II
Methadone intermediate......................        9254  II
Morphine....................................        9300  II
Oripavine...................................        9330  II
Thebaine....................................        9333  II
Opium tincture..............................        9630  II
Opium, powdered.............................        9639  II
Opium, granulated...........................        9640  II
Oxymorphone.................................        9652  II
Noroxymorphone..............................        9668  II
Alfentanil..................................        9737  II
Sufentanil..................................        9740  II
Carfentanil.................................        9743  II
Tapentadol..................................        9780  II
Fentanyl....................................        9801  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances for the production of active pharmaceutical ingredients 
(API) and analytical reference standards for sale to its customers. The 
company plans to manufacture the above listed controlled substances as 
clinical trial and starting materials to make compounds for 
distribution to its customers. No other activities for these drug codes 
are authorized for this registration.


[[Page 9735]]


Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-02731 Filed 2-14-25; 8:45 am]
BILLING CODE P


</pre></body>
</html>

View on FederalRegister.gov →Plain-text source

Indexed from Federal Register on February 18, 2025.

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.