[Federal Register Volume 90, Number 79 (Friday, April 25, 2025)]
[Notices]
[Pages 17450-17452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07154]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1520]
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
[[Page 17451]]
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 24, 2025. Such persons may also file a written request for a
hearing on the application on or before June 24, 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 https://www.regulations.gov 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 https://www.regulations.gov. 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 17, 2025, 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):
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Controlled substance Drug code Schedule
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Gamma Hydroxybutyric Acid................ 2010 I
Tetrahydrocannabinols.................... 7370 I
Psilocybin............................... 7437 I
Codeine-N-oxide.......................... 9053 I
Dihydromorphine.......................... 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-phenethylpiperidin- 9821 I
4-yl)-N-phenylacetamide).
Butyryl Fentanyl......................... 9822 I
Fentanyl related compounds as defined in 9850 I
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-piperidine) 8333 II
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
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The company plans to bulk manufacture the listed controlled
substances for sale to its customers as Active Pharmaceutical
Ingredients and Analytical Research Standards for formulation and
analytical development purposes. In reference to drug code 7370
(Tetrahydrocannabinols), the company plans to bulk manufacture this
drug code as synthetic. No other activity for
[[Page 17452]]
this drug code is authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-07154 Filed 4-24-25; 8:45 am]
BILLING CODE P