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Notice

Bulk Manufacturer of Controlled Substances Application: SpecGx LLC

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Start Preamble

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.

End Preamble Start Supplemental Information

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 substanceDrug codeSchedule
Gamma Hydroxybutyric Acid2010I
Tetrahydrocannabinols7370I
Codeine-N-oxide9053I
Dihydromorphine9145I
Difenoxin9168I
Morphine-N-oxide9307I
Normorphine9313I
Norlevorphanol9634I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide)9821I
Butyryl Fentanyl9822I
Fentanyl related-compounds as defined in 21 CFR 1308.11(h)9850I
Amphetamine1100II
Methamphetamine1105II
Lisdexamfetamine1205II
Methylphenidate1724II
Nabilone7379II
4-Anilino-N-phenethyl-4-piperidine (ANPP)8333II
Codeine9050II
Dihydrocodeine9120II
Oxycodone9143II
Hydromorphone9150II
Diphenoxylate9170II
Ecgonine9180II
Hydrocodone9193II
Levorphanol9220II
Meperidine9230II
Methadone9250II
Methadone intermediate9254II
Dextropropoxyphene, bulk (non-dosage forms)9273II
Morphine9300II
Oripavine9330II
Thebaine9333II
Opium tincture9630II
Opium, powdered9639II
Oxymorphone9652II
Noroxymorphone9668II
Alfentanil9737II
Remifentanil9739II
Sufentanil9740II
Tapentadol9780II
Fentanyl9801II
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The company plans to manufacture bulk active pharmaceutical ingredients (APIs) for distribution to its customers.

Start Signature

Dated: May 23, 2019.

John J. Martin,

Assistant Administrator.

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[FR Doc. 2019-11877 Filed 6-5-19; 8:45 am]

BILLING CODE 4410-09-P