Bulk Manufacturer of Controlled Substances Application: Organix, Inc., 59645 [2019-24107]

Download as PDF 59645 Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Notices Authority: 42 U.S.C. 6213; and 30 CFR 556.511–556.515. company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration. Walter D. Cruickshank, Acting Director, Bureau of Ocean Energy Management. Dated: October 18, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–24052 Filed 11–4–19; 8:45 am] BILLING CODE 4310–MR–P [FR Doc. 2019–24107 Filed 11–4–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration DEPARTMENT OF JUSTICE [Docket No. DEA–536] Drug Enforcement Administration Bulk Manufacturer of Controlled Substances Application: Organix, Inc. ACTION: Bulk Manufacturer of Controlled Substances Application: Noramco Inc. Notice of application. 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 January 6, 2020. 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 September 9, 2019, Organix, Inc., 240 Salem Street, Woburn, Massachusetts 01801–2029 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: DATES: Controlled substance Gamma Hydroxybutyric Acid ... Lysergic acid diethylamide ...... Marihuana ................................ Tetrahydrocannabinols ............ Dimethyltryptamine .................. Psilocybin ................................. Psilocyn .................................... Heroin ...................................... Morphine .................................. Drug code 2010 7315 7360 7370 7435 7437 7438 9200 9300 [Docket No. DEA–526] Schedule I I I I I I I I II ACTION: Notice of application. Registered bulk manufacturer 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 January 6, 2020. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: In accordance with 21 CFR 1301.33(a), this is notice that on August 6, 2019, Noramco Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801– 4417 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Hydromorphone ....................... Hydrocodone ............................ Morphine .................................. Oripavine .................................. Thebaine .................................. Opium extracts ......................... Opium fluid extract ................... Opium tincture ......................... Opium, powdered .................... Opium, granulated ................... Oxymorphone .......................... Noroxymorphone ..................... Tapentadol ............................... khammond on DSKJM1Z7X2PROD with NOTICES 16:34 Nov 04, 2019 Jkt 250001 II II II II II II II II II II II II II Dated: October 22, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–24106 Filed 11–4–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug code Marihuana ................................ Tetrahydrocannabinols ............ Codeine-N-oxide ...................... Dihydromorphine ...................... Hydromorphinol ........................ Morphine-N-oxide .................... Amphetamine ........................... Methylphenidate ....................... Nabilone ................................... Phenylacetone ......................... Codeine .................................... Dihydrocodeine ........................ Oxycodone ............................... 7360 7370 9053 9145 9301 9307 1100 1724 7379 8501 9050 9120 9143 Schedule I I I I I I II II II II II II II [Docket No. DEA–530] Importer of Controlled Substances Registration ACTION: schedule I and II controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 Notice of registration. The registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of schedule I and II controlled substances. The companies listed below applied to be registered as an importers of various basic classes of schedule I and II controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted and no requests for a hearing were submitted for these notices. SUMMARY: Catalent Pharma Solutions, LLC ....................................................................................................................... Research Triangle Institute ............................................................................................................................... VerDate Sep<11>2014 9150 9193 9300 9330 9333 9610 9620 9630 9639 9640 9652 9668 9780 Schedule The company plans to manufacture the listed controlled substances as an Active Pharmaceutical Ingredient (API) for supply to its customers. In reference to drug codes 7360 (marihuana) and 7370 (tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration. Companies The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrants to import the applicable various basic classes of Drug code SUPPLEMENTARY INFORMATION: Controlled substance The company plans to synthesize the listed controlled substances for distribution to its customers. In reference to drug codes 7360 (marihuana) and 7370 (THC), the Controlled substance FR docket Published 84 FR 36945 84 FR 36941 July 30, 2019. July 30, 2019. May 1, 1971. The DEA investigated each of the company’s maintenance of effective controls against diversion by inspecting and testing each company’s physical security systems, verifying E:\FR\FM\05NON1.SGM 05NON1

Agencies

[Federal Register Volume 84, Number 214 (Tuesday, November 5, 2019)]
[Notices]
[Page 59645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24107]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-536]


Bulk Manufacturer of Controlled Substances Application: Organix, 
Inc.

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 January 6, 2020.

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 September 9, 2019, Organix, Inc., 240 Salem Street, 
Woburn, Massachusetts 01801-2029 applied to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid...............    2010  I
Lysergic acid diethylamide..............    7315  I
Marihuana...............................    7360  I
Tetrahydrocannabinols...................    7370  I
Dimethyltryptamine......................    7435  I
Psilocybin..............................    7437  I
Psilocyn................................    7438  I
Heroin..................................    9200  I
Morphine................................    9300  II
------------------------------------------------------------------------

    The company plans to synthesize the listed controlled substances 
for distribution to its customers. In reference to drug codes 7360 
(marihuana) and 7370 (THC), the company plans to bulk manufacture these 
drugs as synthetics. No other activities for these drug codes are 
authorized for this registration.

    Dated: October 18, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-24107 Filed 11-4-19; 8:45 am]
 BILLING CODE 4410-09-P
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