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Code · REGISTER · 2019-02-07 · DEPARTMENT OF JUSTICE · Rules and Regulations

Rules and Regulations. Notice of application

444 words·~2 min read·/register/2019/02/07/2019-01510

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BILLING CODE 4410-11-P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: IsoSciences, LLC 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. 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 substance Drug code Schedule Cathinone 1235 I Methcathinone 1237 I Lysergic acid diethylamide 7315 I Marihuana 7360 I Tetrahydrocannabinols 7370 I 3,4-Methylenedioxyamphetamine 7400 I 3,4-Methylenedioxy-N-ethylamphetamine 7404 I 5-Methoxy-N-N-dimethyltryptamine 7431 I Alpha-methyltryptamine 7432 I Bufotenine 7433 I Diethyltryptamine 7434 I Dimethyltryptamine 7435 I Psilocybin 7437 I Psilocyn 7438 I 5-Methoxy-N,N-diisopropyltryptamine 7439 I Dihydromorphine 9145 I Heroin 9200 I Nicocodeine 9309 I Nicomorphine 9312 I Normorphine 9313 I Thebacon 9315 I Normethadone 9635 I Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide) 9811 I Para-Fluorofentanyl 9812 I 3-Methylfentanyl 9813 I Alpha-methylfentanyl 9814 I Acetyl-alpha-methylfentanyl 9815 I N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide 9816 I Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) 9821 I Butyryl Fentanyl 9822 I 4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide) 9824 I 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide 9825 I Beta-hydroxyfentanyl 9830 I Beta-hydroxy-3-methylfentanyl 9831 I Alpha-methylthiofentanyl 9832 I 3-Methylthiofentanyl 9833 I Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide) 9834 I Thiofentanyl 9835 I Beta-hydroxythiofentanyl 9836 I N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide 9843 I Amphetamine 1100 II Methamphetamine 1105 II Codeine 9050 II Dihydrocodeine 9120 II Oxycodone 9143 II Hydromorphone 9150 II Hydrocodone 9193 II Isomethadone 9226 II Methadone 9250 II Methadone intermediate 9254 II Morphine 9300 II Thebaine 9333 II Levo-alphacetylmethadol 9648 II Oxymorphone 9652 II Thiafentanil 9729 II Alfentanil 9737 II Sufentanil 9740 II Carfentanil 9743 II Fentanyl 9801 II The company plans to manufacture the listed controlled substances to make reference standards which will be distributed to their customers.
Dated: December 21, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2019-01510 Filed 2-6-19; 8:45 am]
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  • 21 CFR 1301
  • 28 CFR 0
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