Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals, 2457 [2021-00351]

Download as PDF 2457 Federal Register / Vol. 86, No. 7 / Tuesday, January 12, 2021 / Notices Virginia 22152. All requests for a 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. In accordance with 21 CFR 1301.34(a), this is notice that on December 15, 2020, Medi-Physics, Inc. dba GE Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004–1412, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Cocaine ........................ Drug code 9041 Schedule II The company plans to import small quantities of Ioflupane, in the form of three separate analogues of Cocaine, to validate production and quality control systems, for a reference standard, and for producing material for a future investigational new drug submission. Supplies of this particular controlled substance are not available in the form needed within the current domestic supply of the United States. No other activity for this drug code is authorized for this registration. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. William T. McDermott, Assistant Administrator. [FR Doc. 2021–00353 Filed 1–11–21; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–756] Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals William T. McDermott, Assistant Administrator. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: [FR Doc. 2021–00351 Filed 1–11–21; 8:45 am] Cedarburg Pharmaceuticals has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before March 15, 2021. Such persons may also file a written request for a hearing on the application on or before March 15, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on October 16, 2020, Cedarburg Pharmaceuticals 870 Badger Circle, Grafton, Wisconsin 53024, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUMMARY: Controlled substance Tetrahydrocannabinols 3, 4Methylenedioxymethamphetamine. Dimethyltryptamine ....... Psilocybin ..................... Methylphenidate ........... Nabilone ....................... 4-Anilino-N-phenethyl-4piperidine (ANPP). Fentanyl ........................ Drug code The company plans to manufacture bulk active pharmaceutical ingredients (API) for distribution to its customers. In reference to the drug code 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture as synthetic. No other activity for this drug code is authorized for this registration. Schedule 7370 7405 I I 7435 7437 1724 7379 8333 I I II II II 9801 II BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–765] Bulk Manufacturer of Controlled Substances Application: Organix, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Organix, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before March 15, 2021. Such persons may also file a written request for a hearing on the application on or before March 15, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on September 22, 2020, Organix, Inc., 240 Salem Street, Woburn, Massachusetts 01801, applied to be registered as an bulk manufacturer of the following basic class(es) of controlled substance(s): SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES Controlled substance Drug code Gamma Hydroxybutyric Acid ........................................................................................................................................... Lysergic acid diethylamide .............................................................................................................................................. Marihuana ........................................................................................................................................................................ Tetrahydrocannabinols .................................................................................................................................................... 5-Methoxy-N-N-dimethyltryptamine ................................................................................................................................. Bufotenine ........................................................................................................................................................................ Dimethyltryptamine .......................................................................................................................................................... Psilocybin ......................................................................................................................................................................... Psilocyn ........................................................................................................................................................................... Heroin .............................................................................................................................................................................. VerDate Sep<11>2014 18:51 Jan 11, 2021 Jkt 253001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\12JAN1.SGM 12JAN1 2010 7315 7360 7370 7431 7433 7435 7437 7438 9200 Schedule I I I I I I I I I I

Agencies

[Federal Register Volume 86, Number 7 (Tuesday, January 12, 2021)]
[Notices]
[Page 2457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00351]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-756]


Bulk Manufacturer of Controlled Substances Application: Cedarburg 
Pharmaceuticals

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Cedarburg Pharmaceuticals has applied to be registered as a 
bulk manufacturer of basic class(es) of controlled substance(s). Refer 
to Supplemental Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before March 15, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before March 15, 2021.

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

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on October 16, 2020, Cedarburg Pharmaceuticals 870 
Badger Circle, Grafton, Wisconsin 53024, applied to be registered as a 
bulk manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols..................     7370  I
3, 4-Methylenedioxymethamphetamine.....     7405  I
Dimethyltryptamine.....................     7435  I
Psilocybin.............................     7437  I
Methylphenidate........................     1724  II
Nabilone...............................     7379  II
4-Anilino-N-phenethyl-4-piperidine          8333  II
 (ANPP).
Fentanyl...............................     9801  II
------------------------------------------------------------------------

    The company plans to manufacture bulk active pharmaceutical 
ingredients (API) for distribution to its customers. In reference to 
the drug code 7370 (Tetrahydrocannabinols), the company plans to bulk 
manufacture as synthetic. No other activity for this drug code is 
authorized for this registration.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-00351 Filed 1-11-21; 8:45 am]
BILLING CODE P