80 FR 22553 - Manufacturer of Controlled Substances Registration: Cedarburg Pharmaceuticals, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 77 (April 22, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 77 (April 22, 2015)
| Page Range | 22553-22553 | |
| FR Document | 2015-09350 |
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)] [Notices] [Page 22553] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09350] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Manufacturer of Controlled Substances Registration: Cedarburg Pharmaceuticals, Inc. ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Cedarburg Pharmaceuticals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Cedarburg Pharmaceuticals, Inc. registration as a manufacturer of the controlled substances. SUPPLEMENTARY INFORMATION: By notice dated June 10, 2014, and published in the Federal Register on June 17, 2014, 79 FR 34553, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted to this notice. The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Cedarburg Pharmaceuticals, 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 basic classes of controlled substances listed: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333)............. II Remifentanil (9739).......................................... II Fentanyl (9801).............................................. II ------------------------------------------------------------------------ The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. Regarding the drug code (8333), the company plans to manufacture this listed controlled substance for commercial sale. Dated: April 14, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-09350 Filed 4-21-15; 8:45 am] BILLING CODE P
![Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 22553
Controlled substance Schedule applications to import narcotic raw manufacturer of certain basic classes of
material are not appropriate. 72 FR 3417 controlled substances. No comments or
Nabilone (7379) ............................ II (January 25, 2007). objections were submitted to this notice.
Phencyclidine (7471) .................... II SUPPLEMENTARY INFORMATION: The The Drug Enforcement
Cocaine (9041) ............................. II Administration (DEA) has considered
Attorney General has delegated his
Codeine (9050) ............................. II the factors in 21 U.S.C. 823(a) and
Oxycodone (9143) ........................ II authority under the Controlled
Hydromorphone (9150) ................ II Substances Act to the Administrator of determined that the registration of
Diphenoxylate (9170) ................... II the Drug Enforcement Administration Cedarburg Pharmaceuticals, Inc. to
Ecgonine (9180) ........................... II (DEA), 28 CFR 0.100(b). Authority to manufacture the basic classes of
Ethylmorphine (9190) ................... II exercise all necessary functions with controlled substances is consistent with
Hydrocodone (9193) ..................... II respect to the promulgation and the public interest and with United
Levorphanol (9220) ...................... II implementation of 21 CFR part 1301, States obligations under international
Meperidine (9230) ........................ II incident to the registration of treaties, conventions, or protocols in
Methadone (9250) ........................ II effect on May 1, 1971. The DEA
manufacturers, distributors, dispenser,
Morphine (9300) ........................... II investigated the company’s maintenance
Thebaine (9333) ........................... II importers, and exporters of controlled
Opium, powdered (9639) ............. II substances (other than final orders in of effective controls against diversion by
Levo-alphacetylmethadol (9648) .. II connection with suspension, denial, or inspecting and testing the company’s
Oxymorphone (9652) ................... II revocation of registration) has been physical security systems, verifying the
Fentanyl (9801) ............................ II redelegated to the Deputy Assistant company’s compliance with state and
Administrator of the DEA Office of local laws, and reviewing the company’s
The company plans to import the Diversion Control (‘‘Deputy Assistant background and history.
listed controlled substances for sale to Administrator’’) pursuant to section 7 of Therefore, pursuant to 21 U.S.C.
research facilities for drug testing and 28 CFR part 0, appendix of subpart R. 823(a), and in accordance with 21 CFR
analysis. In accordance with 21 CFR 1301.33, the above-named company is
In reference to drug codes 7360 and 1301.34(a), this is notice that on August granted registration as a bulk
7370, the company plans to import a 29, 2014, Pharmacore, 4180 Mendenhall manufacturer of the basic classes of
synthetic cannabidiol and a synthetic Oaks Parkway, High Point, North controlled substances listed:
tetrahydrocannabinol. No other activity Carolina 27265 applied to be registered
for this drug code is authorized for this as an importer of poppy straw Controlled substance Schedule
registration. concentrate (9670), a basic class of
4-Anilino-N-phenethyl-4-piperidine
Dated: April 14, 2015. controlled substance listed in schedule (ANPP) (8333) .......................... II
Joseph T. Rannazzisi, II. Remifentanil (9739) ...................... II
Deputy Assistant Administrator. The company plans to import the Fentanyl (9801) ............................ II
listed controlled substance to
[FR Doc. 2015–09344 Filed 4–21–15; 8:45 am]
manufacture bulk controlled substance The company plans to manufacture
BILLING CODE 4410–09–P
intermediates for sale to its customers. the listed controlled substances in bulk
Dated: April 14, 2015. for distribution to its customers.
DEPARTMENT OF JUSTICE Joseph T. Rannazzisi, Regarding the drug code (8333), the
Deputy Assistant Administrator. company plans to manufacture this
Drug Enforcement Administration [FR Doc. 2015–09332 Filed 4–21–15; 8:45 am]
listed controlled substance for
[Docket No. DEA–392] commercial sale.
BILLING CODE 4410–09–P
Dated: April 14, 2015.
Importer of Controlled Substances Joseph T. Rannazzisi,
Application: PHARMACORE DEPARTMENT OF JUSTICE Deputy Assistant Administrator.
ACTION: Notice of application. [FR Doc. 2015–09350 Filed 4–21–15; 8:45 am]
Drug Enforcement Administration
BILLING CODE P
DATES: Registered bulk manufacturers of [Docket No. DEA–392]
the affected basic class, and applicants
therefore, may file written comments on Manufacturer of Controlled DEPARTMENT OF JUSTICE
or objections to the issuance of the Substances Registration: Cedarburg
proposed registration in accordance Pharmaceuticals, Inc. Drug Enforcement Administration
with 21 CFR 1301.34(a) on or before ACTION: Notice of registration. [Docket No. DEA–392]
May 22, 2015. Such persons may also
file a written request for a hearing on SUMMARY: Cedarburg Pharmaceuticals, Importer of Controlled Substances
the application pursuant to 21 CFR Inc. applied to be registered as a Application: Meridian Medical
1301.43 on or before May 22, 2015. manufacturer of certain basic classes of Technologies
ADDRESSES: Written comments should controlled substances. The DEA grants
be sent to: Drug Enforcement Cedarburg Pharmaceuticals, Inc. ACTION: Notice of application.
Administration, Attention: DEA Federal registration as a manufacturer of the
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Register Representative/ODXL, 8701 controlled substances. DATES: Registered bulk manufacturers of
Morrissette Drive, Springfield, Virginia SUPPLEMENTARY INFORMATION: By notice the affected basic class, and applicants
22152. Request for hearings should be dated June 10, 2014, and published in therefore, may file written comments on
sent to: Drug Enforcement the Federal Register on June 17, 2014, or objections to the issuance of the
Administration, Attention: Hearing 79 FR 34553, Cedarburg proposed registration in accordance
Clerk/LJ, 8701 Morrissette Drive, Pharmaceuticals, Inc., 870 Badger with 21 CFR 1301.34(a) on or before
Springfield, Virginia 22152. Comments Circle, Grafton, Wisconsin 53024 May 22, 2015. Such persons may also
and requests for any hearings on applied to be registered as a file a written request for a hearing on
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Document Created: 2015-12-16 08:28:25
Document Modified: 2015-12-16 08:28:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of registration. | |
| FR Citation | 80 FR 22553 |
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