Bulk Manufacturer of Controlled Substances Registration, 8114 [2019-04027]

Download as PDF 8114 Federal Register / Vol. 84, No. 44 / Wednesday, March 6, 2019 / Notices 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 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. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer for schedule I controlled substances to the above listed company. Dated: February 22, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–04026 Filed 3–5–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, 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 5, 2019. Such persons may also file a written request for a DATES: hearing on the application on or before April 5, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. into a new product for development. The company plans to manufacture the above listed controlled substance as Active Pharmaceutical Ingredient (API) that will be further synthesized into dosage forms of a new product. No other activities for this drug code are authorized for this registration. 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 1301.34(a), this is notice that on December 24, 2018, Patheon Pharmaceuticals, Inc., 2110 E Galbraith Road, Cincinnati, Ohio 45237, has reapplied to be registered as a bulk manufacturer of the Schedule I controlled substance Gamma Hydroxybutyric Acid (2010), a basic class of controlled substance. The Gamma Hydroxybutyric Acid will be produced during the process of converting gamma-butyrolactone (GBL) Dated: February 18, 2019. John J. Martin, Assistant Administrator. SUPPLEMENTARY INFORMATION: [FR Doc. 2019–04029 Filed 3–5–19; 8:45 am] 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. The registrant listed below has applied for and has been granted a 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 the previously published notice is listed in the table below. No comments or objections were submitted for this notice. SUMMARY: Company FR Docket Cambrex Charles City ........................................................... 83 FR 49579 ........................................................................ 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 their physical security systems, verifying their compliance with state and local laws, and reviewing their 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 VerDate Sep<11>2014 18:35 Mar 05, 2019 Jkt 247001 registration as a bulk manufacturer to the above listed company. Dated: February 22, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–04027 Filed 3–5–19; 8:45 am] DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration PO 00000 Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of schedule I or schedule II controlled substances. SUMMARY: The companies listed below applied to be registered as bulk manufacturers of schedule I or schedule II controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices. Notice of registration. Frm 00044 Fmt 4703 October 2, 2018. SUPPLEMENTARY INFORMATION: BILLING CODE 4410–09–P ACTION: Published Sfmt 4703 E:\FR\FM\06MRN1.SGM 06MRN1

Agencies

[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Notices]
[Page 8114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04027]


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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 has been 
granted a 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 the previously published notice 
is listed in the table below. No comments or objections were submitted 
for this notice.

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                 Company                             FR Docket                          Published
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Cambrex Charles City.....................  83 FR 49579.................  October 2, 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 their physical 
security systems, verifying their compliance with state and local laws, 
and reviewing their 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: February 22, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-04027 Filed 3-5-19; 8:45 am]
BILLING CODE 4410-09-P