Importer of Controlled Substances Application: United States Pharmacopeial Convention, 54611-54612 [2018-23701]

Download as PDF Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices Dated: October 11, 2018. John J. Martin, Assistant Administrator. DEPARTMENT OF JUSTICE Drug Enforcement Administration [FR Doc. 2018–23684 Filed 10–29–18; 8:45 am] 54611 Dated: October 22, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–23696 Filed 10–29–18; 8:45 am] BILLING CODE 4410–09–P [Docket No. DEA–392] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration ACTION: Notice of application. [Docket No. DEA–392] [Docket No. DEA–392] ACTION: Notice of registration. 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. SUMMARY: Company khammond on DSK30JT082PROD with NOTICES Johnson Matthey Pharmaceutical Materials Inc. Alcami Wisconsin Corporation. FR docket Published 83 FR 27632. June 13, 2018. 83 FR 27628. June 13, 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: October 22, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–23698 Filed 10–29–18; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 17:34 Oct 29, 2018 Jkt 247001 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 December 31, 2018. DATES: Bulk Manufacturer of Controlled Substances Registration Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: 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 August 22, 2018, Insys Manufacturing, LLC, 2700 Oakmont Drive, Round Rock, Texas 78665–1019 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Drug code Marihuana ......... Tetrahydrocannabinols. 7360 7370 Schedule I I The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for product development and distribution to its customers. No other activity for these drug codes are authorized for this registration. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Importer of Controlled Substances Application: United States Pharmacopeial Convention 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 November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: 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 1301.34(a), this is notice that on August 17, 2018, United States Pharmacopeial DATES: E:\FR\FM\30OCN1.SGM 30OCN1 54612 Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852–1717, applied to be registered as an importer of the following basic class of the controlled substance: Controlled substance Drug code Oxymorphone ......... 9652 Schedule II The company plans to import the bulk controlled substance for distribution of analytical reference standards to its customers for research and analytical purposes. Dated: October 22, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–23701 Filed 10–29–18; 8:45 am] BILLING CODE 4410–09–P 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 August 30, 2018, Sharp (Bethlehem), LLC, 2400 Baglyos Circle, Bethlehem, Pennsylvania 18020, applied to be registered as an importer of the following basic class of controlled substances: Controlled substance DEPARTMENT OF JUSTICE Gamma Hydroxybutyric Acid. Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Sharp (Bethlehem), LLC 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 November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: 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 khammond on DSK30JT082PROD with NOTICES DATES: VerDate Sep<11>2014 19:27 Oct 29, 2018 Jkt 247001 Drug code 2010 Schedule I The company plans to import dosage forms of the listed controlled substances to conduct clinical trials. Approval of permit applications will occur only when the registrant’s activity is consistent with what is authorized under to 21 U.S.C. 952 (a)(2). Authorization will not extend to the import of FDA approved or nonapproved finished dosage forms for commercial sale. Dated: October 22, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–23705 Filed 10–29–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Fisher Clinical Services, 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 November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. 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. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on August 17, 2018, Fisher Clinical Services Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106, applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Drug code Psilocybin ......... Methylphenidate Levorphanol ...... Noroxymorphone. Tapentadol ........ Schedule 7437 1724 9220 9668 I II II II 9780 II DATES: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 The company plans to import the listed controlled substances for clinical trials. Dated: October 22, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–23702 Filed 10–29–18; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\30OCN1.SGM 30OCN1

Agencies

[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Pages 54611-54612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23701]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: United States 
Pharmacopeial Convention

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 November 29, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before November 29, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: 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 1301.34(a), this is notice that on August 
17, 2018, United States Pharmacopeial

[[Page 54612]]

Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852-1717, 
applied to be registered as an importer of the following basic class of 
the controlled substance:

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Oxymorphone..........................        9652  II
------------------------------------------------------------------------

    The company plans to import the bulk controlled substance for 
distribution of analytical reference standards to its customers for 
research and analytical purposes.

    Dated: October 22, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-23701 Filed 10-29-18; 8:45 am]
 BILLING CODE 4410-09-P