[Federal Register Volume 85, Number 96 (Monday, May 18, 2020)]
[Notices]
[Pages 29741-29742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10601]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-610]
Bulk Manufacturer of Controlled Substances Application: SpecGx
LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before July 17, 2025.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration (DEA), 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 January 29, 2020, 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
substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid................. 2010 I
[[Page 29742]]
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-phenethylpiperidin-4- 9821 I
yl)-N-phenylacetamide).
Butyryl Fentanyl.......................... 9822 I
Fentanyl related-substances 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
4-Anilino-N-phenethyl-4-piperidine (ANPP). 8333 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
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
------------------------------------------------------------------------
The company plans to manufacture bulk active pharmaceutical
ingredients (APIs) for distribution to its customers. In reference to
drug code 7370 (Tetrahydrocannabinols), the company plans to bulk
manufacture this drug as synthetic. No other activities for this drug
code is authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-10601 Filed 5-15-20; 8:45 am]
BILLING CODE 4410-09-P