Bulk Manufacturer of Controlled Substances Registration, 49579 [2018-21353]

Download as PDF 49579 Federal Register / Vol. 83, No. 191 / Tuesday, October 2, 2018 / Notices as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Methylphenidate ....... Levomethorphan ...... Levorphanol .............. Thebaine .................. Remifentanil ............. Tapentadol ............... Drug code Schedule II II II II II II [FR Doc. 2018–21348 Filed 10–1–18; 8:45 am] The companies listed below applied to be registered as bulk manufacturers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices. SUPPLEMENTARY INFORMATION: DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration ACTION: Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of schedule I and II controlled substances. SUMMARY: BILLING CODE 4410–09–P 1724 9210 9220 9333 9739 9780 The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. Notice of registration. Company FR docket Published American Radiolabeled Chem ................................................................................................................................. Cerilliant Corporation ............................................................................................................................................... 83 FR 28664 83 FR 28664 June 20, 2018. June 20, 2018. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants 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 each of the company’s maintenance of effective controls 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. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed companies. Dated: September 20, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–21353 Filed 10–1–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] amozie on DSK3GDR082PROD with NOTICES1 Dated: September 20, 2018. John J. Martin, Assistant Administrator. Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City ACTION: Controlled substance Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the DATES: VerDate Sep<11>2014 18:39 Oct 01, 2018 Jkt 247001 issuance of the proposed registration on or before December 3, 2018. 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 June 8, 2018, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616 applied to be registered as a bulk manufacturer of the basic classes of controlled substances: Gamma Hydroxybutyric Acid. Amphetamine ................. Lisdexamfetamine .......... Methylphenidate ............. 4-Anilino-N-phenethyl-4piperidine (ANPP). Phenylacetone ................ Cocaine .......................... PO 00000 Frm 00050 Fmt 4703 Drug code Drug code Codeine .......................... Oxycodone ..................... Hydromorphone .............. Hydrocodone .................. Morphine ........................ Oripavine ........................ Thebaine ........................ Opium extracts ............... Opium fluid extract ......... Opium tincture ................ Opium, powdered ........... Oxymorphone ................. Noroxymorphone ............ Fentanyl .......................... 9050 9143 9150 9193 9300 9330 9333 9610 9620 9630 9639 9652 9668 9801 Schedule II II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for conversion to other controlled substances and sale to its customers, for dosage form development, for clinical trials, and for use in stability qualification studies. Dated: September 20, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–21351 Filed 10–1–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration Schedule 2010 I 1100 1205 1724 8333 II II II II 8501 9041 II II Sfmt 4703 Controlled substance ACTION: Notice of registration. Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of various classes of schedule I or II controlled substances. SUMMARY: E:\FR\FM\02OCN1.SGM 02OCN1

Agencies

[Federal Register Volume 83, Number 191 (Tuesday, October 2, 2018)]
[Notices]
[Page 49579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21353]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Registration

ACTION: Notice of registration.

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

SUMMARY: Registrants listed below have applied for and been granted 
registration by the Drug Enforcement Administration (DEA) as bulk 
manufacturers of various classes of schedule I and II controlled 
substances.

SUPPLEMENTARY INFORMATION: The companies listed below applied to be 
registered as bulk manufacturers of various basic classes of controlled 
substances. Information on previously published notices is listed in 
the table below. No comments or objections were submitted for these 
notices.

------------------------------------------------------------------------
            Company                  FR docket            Published
------------------------------------------------------------------------
American Radiolabeled Chem....  83 FR 28664         June 20, 2018.
Cerilliant Corporation........  83 FR 28664         June 20, 2018.
------------------------------------------------------------------------

    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of these registrants 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 each of the company's maintenance of 
effective controls 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. 823(a), and in accordance with 21 
CFR 1301.33, the DEA has granted a registration as a bulk manufacturer 
to the above listed companies.

    Dated: September 20, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-21353 Filed 10-1-18; 8:45 am]
 BILLING CODE 4410-09-P