Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals, Inc., 8246 [2016-03350]

Download as PDF 8246 Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices [Docket No. DEA–392] controlled substance in bulk from a domestic source in order to manufacture other controlled substances in bulk for distribution to its customers. Manufacturer of Controlled Substances Registration: Euticals, Inc. Dated: February 10, 2016. Louis J. Milione, Deputy Assistant Administrator. DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals, Inc. ACTION: ACTION: Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before April 18, 2016. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: The Attorney General has delegated her 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy 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 4, 2015, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024 applied to be registered as a bulk manufacturer of nabilone (7379), a basic class of controlled substance listed in schedule II. The company plans to manufacturer bulk active pharmaceutical ingredients (API) for distribution to its customers. mstockstill on DSK4VPTVN1PROD with NOTICES Dated: February 10, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–03350 Filed 2–17–16; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 19:03 Feb 17, 2016 Jkt 238001 Euticals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Euticals, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated September 16, 2015, and published in the Federal Register on September 23, 2015, 80 FR 57391, Euticals, Inc., 2460 W. Bennett Street, Springfield, Missouri 65807–1229 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Euticals, Inc. to manufacture the 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 above-named company is granted registration as a bulk manufacturer of the following basic classes of controlled substances: BILLING CODE 4410–09–P SUMMARY: Notice of application. SUPPLEMENTARY INFORMATION: [FR Doc. 2016–03355 Filed 2–17–16; 8:45 am] Notice of registration. Controlled substance Gamma Hydroxybutyric Acid (2010). Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Phenylacetone (8501) .................. Methadone (9250) ........................ Methadone intermediate (9254) ... Oripavine (9330) ........................... Tapentadol (9780) ........................ Schedule I II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers. In reference to oripavine (9330), the company plans to acquire the listed PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Catalent Pharma Solutions, LLC ACTION: Notice of registration. Catalent Pharma Solutions, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Catalent Pharma Solutions, LLC registration as an importer of this controlled substance. SUPPLEMENTARY INFORMATION: By notice dated August 21, 2015, and published in the Federal Register on August 31, 2015, 80 FR 52510, Catalent Pharma Solutions, LLC, 3031 Red Lion Road, Philadelphia, Pennsylvania 19114 applied to be registered as an importer of a certain basic class of controlled substance. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Catalent Pharma Solutions, LLC to import the basic class of controlled substance 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. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of hydromorphone (9150), a basic class of controlled substance listed in schedule II. The company plans to import the above listed controlled substance for a clinical trial study. Approval of permit applications will occur only when the SUMMARY: E:\FR\FM\18FEN1.SGM 18FEN1

Agencies

[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Page 8246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03350]



[[Page 8246]]

-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Cedarburg 
Pharmaceuticals, Inc.

ACTION: Notice of application.

-----------------------------------------------------------------------

DATES: Registered bulk manufacturers of the affected basic class, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.33(a) on or before April 18, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 
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 Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy 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 4, 2015, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, 
Grafton, Wisconsin 53024 applied to be registered as a bulk 
manufacturer of nabilone (7379), a basic class of controlled substance 
listed in schedule II.
    The company plans to manufacturer bulk active pharmaceutical 
ingredients (API) for distribution to its customers.

    Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-03350 Filed 2-17-16; 8:45 am]
 BILLING CODE 4410-09-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.