[Federal Register Volume 84, Number 109 (Thursday, June 6, 2019)]
[Notices]
[Pages 26447-26448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11877]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: SpecGx
LLC
ACTION: Notice of application.
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DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before August 5, 2019.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on February 1, 2019, SpecGx LLC, 3600 North 2nd Street,
Saint Louis, Missouri 63147 applied to be registered as a bulk
manufacturer of the following basic class of controlled substances:
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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
Dihydromorphine.................... 9145 I
Difenoxin.......................... 9168 I
Morphine-N-oxide................... 9307 I
Normorphine........................ 9313 I
Norlevorphanol..................... 9634 I
Acetyl Fentanyl (N-(1- 9821 I
phenethylpiperidin-4-yl)-N-
phenylacetamide).
Butyryl Fentanyl................... 9822 I
Fentanyl related-compounds as 9850 I
defined in 21 CFR 1308.11(h).
Amphetamine........................ 1100 II
Methamphetamine.................... 1105 II
Lisdexamfetamine................... 1205 II
Methylphenidate.................... 1724 II
Nabilone........................... 7379 II
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
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
Methadone.......................... 9250 II
Methadone intermediate............. 9254 II
Dextropropoxyphene, bulk (non- 9273 II
dosage 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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[[Page 26448]]
The company plans to manufacture bulk active pharmaceutical
ingredients (APIs) for distribution to its customers.
Dated: May 23, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-11877 Filed 6-5-19; 8:45 am]
BILLING CODE 4410-09-P