Bulk Manufacturer of Controlled Substances Application: SpecGx LLC

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Published

April 4, 2023

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

SpecGx 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

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<title>Federal Register, Volume 88 Issue 64 (Tuesday, April 4, 2023)</title>
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[Federal Register Volume 88, Number 64 (Tuesday, April 4, 2023)]
[Notices]
[Page 19990]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-06952]



[[Page 19990]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1176]


Bulk Manufacturer of Controlled Substances Application: SpecGx 
LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: SpecGx 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 
June 5, 2023. Such persons may also file a written request for a 
hearing on the application on or before June 5, 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 February 14, 2023, SpecGx LLC, 3600 North 2nd Street, 
Saint Louis, Missouri 63147-3457, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..............    2010  I
Tetrahydrocannabinols..................    7370  I
Psilocybin.............................    7437  I
Codeine-N-oxide........................    9053  I
Noroxymorphone.........................    9145  I
Difenoxin..............................    9168  I
Morphine-N-oxide.......................    9307  I
Normorphine............................    9313  I
Alphamethadol..........................    9605  I
Betamethadol...........................    9609  I
Norlevorphanol.........................    9634  I
Acetyl Fentanyl (N-(1-                     9821  I
 phenethylpiperidin-4-yl)-N-
 phenylacetamide).
Butyryl Fentanyl.......................    9822  I
Fentanyl related-compounds as defined      9850  I
 in 21 CFR 1308.11(h).
Amphetamine............................    1100  II
Methamphetamine........................    1105  II
Lisdexamfetamine.......................    1205  II
Methylphenidate........................    1724  II
Nabilone...............................    7379  II
ANPP (4-Anilino-N-phenethyl-4-             8333  II
 piperidine).
Phenylacetone..........................    8501  II
Codeine................................    9050  II
Dihydrocodeine.........................    9120  II
Oxycodone..............................    9143  II
Hydromorphone..........................    9150  II
Diphenoxylate..........................    9170  II
Ecgonine...............................    9180  II
Hydrocodone............................    9193  II
Levorphanol............................    9220  II
Isomethadone...........................    9226  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
Dextropropoxyphene, bulk (non-dosage       9273  II
 forms).
Morphine...............................    9300  II
Oripavine..............................    9330  II
Thebaine...............................    9333  II
Opium tincture.........................    9630  II
Opium, powdered........................    9639  II
Oxymorphone............................    9652  II
Noroxymorphone.........................    9668  II
Alfentanil.............................    9737  II
Remifentanil...........................    9739  II
Sufentanil.............................    9740  II
Tapentadol.............................    9780  II
Fentanyl...............................    9801  II
Amphetamine............................    1100  II
Methamphetamine........................    1105  II
Lisdexamfetamine.......................    1205  II
Methylphenidate........................    1724  II
Pentobarbital..........................    2270  II
4-Anilino-N-Phenethyl-4-Piperidine         8333  II
 (ANPP).
Tapentadol.............................    9780  II
Fentanyl...............................    9801  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances for sale to its customers as Active Pharmaceutical 
Ingredients (APIs) and Analytical Research Standards (ARS) for 
formulation and analytical development purposes. In reference to dug 
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. 2023-06952 Filed 4-3-23; 8:45 am]
BILLING CODE 4410-09-P


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