Bulk Manufacturer of Controlled Substances Registration, 5499-5500 [2019-02867]

Download as PDF 5499 Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices Dated: February 11, 2019. John J. Martin, Assistant Administrator. Controlled substance [FR Doc. 2019–02877 Filed 2–20–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Noramco, Inc. ACTION: 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 April 22, 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 October 30, 2018, Noramco, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: DATES: amozie on DSK3GDR082PROD with NOTICES1 Controlled substance Marihuana ................. Tetrahydrocannabinols. Codeine-N-oxide ....... Dihydromorphine ...... Hydromorphinol ........ Morphine-N-oxide ..... Amphetamine ........... VerDate Sep<11>2014 Drug code Schedule 7360 7370 I I 9053 9145 9301 9307 1100 I I I I II 17:08 Feb 20, 2019 Jkt 247001 Drug code Methylphenidate ....... Nabilone ................... Phenylacetone .......... Codeine .................... Dihydrocodeine ......... Oxycodone ............... Hydromorphone ........ Hydrocodone ............ Morphine ................... Oripavine .................. Thebaine ................... Opium extracts ......... Opium fluid extract ... Opium tincture .......... Opium, powdered ..... Opium, granulated .... Oxymorphone ........... Noroxymorphone ...... Tapentadol ................ 1724 7379 8501 9050 9120 9143 9150 9193 9300 9330 9333 9610 9620 9630 9639 9640 9652 9668 9780 Schedule II II II II II II II II II II II II II II II II II II II The company plans to manufacture bulk active pharmaceutical ingredients (APIs) and reference standards for distribution to their 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. 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 1301.34(a), this is notice that on December 7, 2018, Stepan Company, 100 W Hunter Ave, Maywood, New Jersey 07607, re-applied to be registered as a bulk manufacturer of the following basic classes of controlled substances. Controlled substance Drug code Cocaine .................... Ecgonine ................... 9041 9180 Schedule II II Dated: February 11, 2019. John J. Martin, Assistant Administrator. The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. [FR Doc. 2019–02883 Filed 2–20–19; 8:45 am] Dated: February 11, 2019. John J. Martin, Assistant Administrator. BILLING CODE 4410–09–P [FR Doc. 2019–02878 Filed 2–20–19; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P Drug Enforcement Administration [Docket No. DEA–392] DEPARTMENT OF JUSTICE Bulk Manufacturer of Controlled Substances Application: Stepan Company Drug Enforcement Administration ACTION: 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 March 25, 2019. Such persons may also file a written request for a hearing on the application on or before March 25, 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 DATES: PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration ACTION: Notice of registration. The registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of various classes of schedule I and II controlled substances. SUPPLEMENTARY INFORMATION: The company listed below applied to be registered as a bulk manufacturer of various basic classes of controlled substances. Information on a previously published notice is listed below. No comments or objections were submitted for the notice. SUMMARY: E:\FR\FM\21FEN1.SGM 21FEN1 5500 Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices Company FR docket Chattem Chemicals .......................................................... 83 FR 56103 ................................................................... The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of this registrant to manufacture the applicable basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a Dated: January 29, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–02867 Filed 2–20–19; 8:45 am] The registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of various classes of schedule II controlled substances. The company listed below applied to be registered as a bulk manufacturer of various basic classes of controlled substances. Information on a previously published notice is listed below. No comments or objections were submitted for the notice. SUPPLEMENTARY INFORMATION: BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration ACTION: Notice of registration. FR docket Janssen Pharmaceuticals, Inc .......................................... 83 FR 55205 ................................................................... registration as a bulk manufacturer to the above listed company. Dated: January 7, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–02868 Filed 2–20–19; 8:45 am] BILLING CODE 4410–09–P Published November 2, 2018. Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of schedule I or schedule II controlled substances. SUMMARY: The companies listed below applied to be registered as importers of various basic classes of controlled substances. Information on the previously published notices is listed in the table below. No comments or objections were submitted and no requests for hearing were submitted for these notices. SUPPLEMENTARY INFORMATION: DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration ACTION: November 9, 2018. SUMMARY: Company The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of this registrant to manufacture the applicable basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a amozie on DSK3GDR082PROD with NOTICES1 registration as a bulk manufacturer to the above listed company. Published Notice of registration. Company FR docket Mylan Pharmaceuticals, Inc ......................................................................................................................... Siegfried USA, LLC ...................................................................................................................................... 83 FR 64158 83 FR 64158 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 basic classes of schedule I or II controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated each of the company’s maintenance of effective controls VerDate Sep<11>2014 17:08 Feb 20, 2019 Jkt 247001 against diversion by inspecting and testing each company’s physical security systems, verifying each company’s compliance with state and local laws, and reviewing each company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted registrations as importers for schedule II controlled substances to the above listed companies. PO 00000 Frm 00097 Fmt 4703 Sfmt 9990 Published December 13, 2018. December 13, 2018. Dated: January 29, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–02874 Filed 2–20–19; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\21FEN1.SGM 21FEN1

Agencies

[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Notices]
[Pages 5499-5500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02867]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Registration

ACTION: Notice of registration.

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SUMMARY: The registrant listed below has applied for and been granted 
registration by the Drug Enforcement Administration (DEA) as a bulk 
manufacturer of various classes of schedule I and II controlled 
substances.

SUPPLEMENTARY INFORMATION: The company listed below applied to be 
registered as a bulk manufacturer of various basic classes of 
controlled substances. Information on a previously published notice is 
listed below. No comments or objections were submitted for the notice.

[[Page 5500]]



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            Company                    FR docket            Published
------------------------------------------------------------------------
Chattem Chemicals.............  83 FR 56103...........  November 9,
                                                         2018.
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    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of this registrant to manufacture the 
applicable basic classes of controlled substances is consistent with 
the public interest and with United States obligations under 
international treaties, conventions, or protocols in effect on May 1, 
1971. The DEA investigated the company's maintenance of effective 
controls against diversion by inspecting and testing the company's 
physical security systems, verifying the company's compliance with 
state and local laws, and reviewing the company's background and 
history.
    Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 
CFR 1301.33, the DEA has granted a registration as a bulk manufacturer 
to the above listed company.

    Dated: January 29, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-02867 Filed 2-20-19; 8:45 am]
 BILLING CODE 4410-09-P
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