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Notice

Bulk Manufacturer of Controlled Substances Application: IsoSciences, 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 April 8, 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:

The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

In accordance with 21 CFR 1301.33(a), this is notice that on November 1, 2017, IsoSciences, LLC, 340 Mathers Road, Ambler, Pennsylvania 19002, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

Controlled substanceDrug codeSchedule
Cathinone1235I
Methcathinone1237I
Lysergic acid diethylamide7315I
Marihuana7360I
Tetrahydrocannabinols7370I
3,4-Methylenedioxyamphetamine7400I
3,4-Methylenedioxy-N-ethylamphetamine7404I
5-Methoxy-N-N-dimethyltryptamine7431I
Alpha-methyltryptamine7432I
Bufotenine7433I
Diethyltryptamine7434I
Dimethyltryptamine7435I
Psilocybin7437I
Psilocyn7438I
5-Methoxy-N,N-diisopropyltryptamine7439I
Dihydromorphine9145I
Heroin9200I
Nicocodeine9309I
Nicomorphine9312I
Normorphine9313I
Thebacon9315I
Normethadone9635I
Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide)9811I
Para-Fluorofentanyl9812I
3-Methylfentanyl9813I
Alpha-methylfentanyl9814I
Acetyl-alpha-methylfentanyl9815I
N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide9816I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide)9821I
Butyryl Fentanyl9822I
4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide)9824I
2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide9825I
Beta-hydroxyfentanyl9830I
Beta-hydroxy-3-methylfentanyl9831I
Alpha-methylthiofentanyl9832I
3-Methylthiofentanyl9833I
Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide)9834I
Thiofentanyl9835I
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Beta-hydroxythiofentanyl9836I
N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide9843I
Amphetamine1100II
Methamphetamine1105II
Codeine9050II
Dihydrocodeine9120II
Oxycodone9143II
Hydromorphone9150II
Hydrocodone9193II
Isomethadone9226II
Methadone9250II
Methadone intermediate9254II
Morphine9300II
Thebaine9333II
Levo-alphacetylmethadol9648II
Oxymorphone9652II
Thiafentanil9729II
Alfentanil9737II
Sufentanil9740II
Carfentanil9743II
Fentanyl9801II

The company plans to manufacture the listed controlled substances to make reference standards which will be distributed to their customers.

Start Signature

Dated: December 21, 2018.

John J. Martin,

Assistant Administrator.

End Signature End Supplemental Information

[FR Doc. 2019-01510 Filed 2-6-19; 8:45 am]

BILLING CODE 4410-09-P