Document

Bulk Manufacturer of Controlled Substances Application: SpecGx LLC

Department of Justice Drug Enforcement Administration [Docket No. DEA-392] ACTION: Notice of application. DATES: Registered bulk manufacturers of the affected basic classes, and...

PDF version Source Record

Department of Justice

Drug Enforcement Administration

[Docket No. DEA-392]

ACTION:

Notice of application.

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:

Controlled substance	Drug code	Schedule
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-phenethylpiperidin-4-yl)-N-phenylacetamide)	9821	I
Butyryl Fentanyl	9822	I
Fentanyl related-compounds as defined in 21 CFR 1308.11(h)	9850	I
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 forms)	9273	II
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

( printed 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

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

84 FR 26447

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“Bulk Manufacturer of Controlled Substances Application: SpecGx LLC,” thefederalregister.org (June 6, 2019), https://thefederalregister.org/documents/2019-11877/bulk-manufacturer-of-controlled-substances-application-specgx-llc.