Notice2022-09035
Bulk Manufacturer of Controlled Substances Application: SpecGx 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
April 28, 2022
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 Supplemental Information listed below for further drug information.
Full Text
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<title>Federal Register, Volume 87 Issue 82 (Thursday, April 28, 2022)</title>
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[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25299-25300]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09035]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-995]
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 Supplemental
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 27, 2022. Such persons may also file a written request for a
hearing on the application on or before June 27, 2022.
ADDRESSES: The Drug Enforcement Administration requires that all
[[Page 25300]]
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 January 26, 2022, SpecGx LLC, 3600 North Second
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
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
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 the internal use intermediates or for sale to its
customers. In reference to dug code 7370 (Tetrahydrocannabinols), the
company plans to bulk manufacture this drug as synthetic. No other
activities for these drug codes are authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-09035 Filed 4-27-22; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on April 28, 2022.
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