80 FR 57390 - Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 184 (September 23, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 184 (September 23, 2015)
| Page Range | 57390-57390 | |
| FR Document | 2015-24127 |
[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)] [Notices] [Page 57390] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24127] ----------------------------------------------------------------------- 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 classes, 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 November 23, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 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 June 16, 2015, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Marihuana (7360)........................... I Tetrahydrocannabinols (7370)............... I 4-Anilino-N-phenethyl-4-piperidine (ANPP) II (8333). Remifentanil (9739)........................ II Fentanyl (9801)............................ II ------------------------------------------------------------------------ The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. In reference to drug code (7360) marihuana, the company plans to bulk manufacture cannabidiol as a synthetic intermediate. This controlled substance will be further synthesized to bulk manufacture synthetic tetrahydrocannabinols (7370). No other activity for this drug code is authorized for this registration. Dated: September 16, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-24127 Filed 9-22-15; 8:45 am] BILLING CODE 4410-09-P
![57390 Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices
registration as an importer of those DATES: Registered bulk manufacturers of Dated: September 16, 2015.
controlled substances. the affected basic classes, and Joseph T. Rannazzisi,
SUPPLEMENTARY INFORMATION: By notice applicants therefore, may file written Deputy Assistant Administrator.
dated April 14, 2015, and published in comments on or objections to the [FR Doc. 2015–24127 Filed 9–22–15; 8:45 am]
the Federal Register on April 22, 2015, issuance of the proposed registration in BILLING CODE 4410–09–P
80 FR 22556, Rhodes Technologies, 498 accordance with 21 CFR 1301.33(a) on
Washington Street, Coventry, Rhode or before November 23, 2015.
Island, 02816 applied to be registered as ADDRESSES: Written comments should DEPARTMENT OF JUSTICE
an importer of a certain basic classes of be sent to: Drug Enforcement
controlled substances. Comments and Drug Enforcement Administration
Administration, Attention: DEA Federal
request for hearings on applications to Register Representative/ODXL, 8701
import narcotic raw material are not Morrissette Drive, Springfield, Virginia [Docket No. DEA–392]
appropriate. 72 FR 3417 (January 25, 22152. Request for hearings should be
2007). Importer of Controlled Substances
sent to: Drug Enforcement
The DEA has considered the factors in Registration: Wildlife Laboratories, Inc.
Administration, Attention: Hearing
21 U.S.C. 823, 952(a) and 958(a) and Clerk/LJ, 8701 Morrissette Drive,
determined that the registration of Springfield, Virginia 22152. ACTION: Notice of registration.
Rhodes Technologies to import the basic
classes of controlled substances is SUPPLEMENTARY INFORMATION: The SUMMARY: Wildlife Laboratories, Inc.,
consistent with the public interest and Attorney General has delegated her applied to be registered as an importer
with United States obligations under authority under the Controlled of certain basic classes of controlled
international treaties, conventions, or Substances Act to the Administrator of substances. The Drug Enforcement
protocols in effect on May 1, 1971. The the Drug Enforcement Administration Administration (DEA) grants Wildlife
DEA investigated the company’s (DEA), 28 CFR 0.100(b). Authority to Laboratories, Inc. registration as an
maintenance of effective controls exercise all necessary functions with importer of those controlled substances.
against diversion by inspecting and respect to the promulgation and
implementation of 21 CFR part 1301, SUPPLEMENTARY INFORMATION: By notice
testing the company’s physical security
incident to the registration of dated June 12, 2015, and published in
systems, verifying the company’s
manufacturers, distributors, dispensers, the Federal Register on June 23, 2015,
compliance with state and local laws,
importers, and exporters of controlled 80 FR 35975, Wildlife Laboratories, Inc.,
and reviewing the company’s
substances (other than final orders in 1230 W. Ash Street, Suite D, Windsor,
background and history.
connection with suspension, denial, or Colorado 80550 applied to be registered
Therefore, pursuant to 21 U.S.C.
revocation of registration) has been as an importer of certain basic classes of
952(a) and 958(a), and in accordance
redelegated to the Deputy Assistant controlled substances. No comments or
with 21 CFR 1301.34, the above-named
Administrator of the DEA Office of objections were submitted for this
company is granted registration as an
Diversion Control (‘‘Deputy Assistant notice.
importer of the following basic classes
of controlled substances: Administrator’’) pursuant to section 7 of The DEA has considered the factors in
28 CFR part 0, appendix to subpart R. 21 U.S.C. 823, 952(a) and 958(a) and
Controlled substance Schedule In accordance with 21 CFR determined that the registration of
1301.33(a), this is notice that on June Wildlife Laboratories, Inc. to import the
Opium, raw (9600) ...................... II basic classes of controlled substances is
Poppy Straw Concentrate (9670) II 16, 2015, Cedarburg Pharmaceuticals,
Inc., 870 Badger Circle, Grafton, consistent with the public interest and
Wisconsin 53024 applied to be with United States obligations under
The company plans to import the international treaties, conventions, or
listed controlled substances in order to registered as a bulk manufacturer of the
following basic classes of controlled protocols in effect on May 1, 1971. The
bulk manufacture controlled substances DEA investigated the company’s
in Active Pharmaceutical Ingredient substances:
maintenance of effective controls
(API) form. The company distributes the against diversion by inspecting and
manufactured APIs in bulk to its Controlled substance Schedule
testing the company’s physical security
customers. Marihuana (7360) ......................... I systems, verifying the company’s
Dated: September 16, 2015. Tetrahydrocannabinols (7370) ..... I compliance with state and local laws,
Joseph T. Rannazzisi, 4-Anilino-N-phenethyl-4-piperidine II and reviewing the company’s
Deputy Assistant Administrator. (ANPP) (8333). background and history.
Remifentanil (9739) ...................... II
[FR Doc. 2015–24119 Filed 9–22–15; 8:45 am] Therefore, pursuant to 21 U.S.C.
Fentanyl (9801) ............................ II
BILLING CODE 4410–09–P 952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the above-named
The company plans to manufacture company is granted registration as an
DEPARTMENT OF JUSTICE the above-listed controlled substances importer of the basic classes of
in bulk for distribution to its customers. controlled substances:
Drug Enforcement Administration In reference to drug code (7360)
mstockstill on DSK4VPTVN1PROD with NOTICES
marihuana, the company plans to bulk Controlled substance Schedule
[Docket No. DEA–392] manufacture cannabidiol as a synthetic
intermediate. This controlled substance Etorphine (except HCl) (9056) ..... I
Bulk Manufacturer of Controlled will be further synthesized to bulk Etorphine HCl (9059) ................... II
Substances Application: Cedarburg manufacture synthetic
Pharmaceuticals, Inc. tetrahydrocannabinols (7370). No other The company plans to import the
activity for this drug code is authorized listed controlled substances for sale to
ACTION: Notice of application.
for this registration. its customer.
VerDate Sep<11>2014 18:00 Sep 22, 2015 Jkt 235001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\23SEN1.SGM 23SEN1](https://thefederalregister.org/doc/80_FR_57574/page/1.svg)
Document Created: 2015-12-15 09:44:36
Document Modified: 2015-12-15 09:44:36
| 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 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 in accordance with 21 CFR 1301.33(a) on or before November 23, 2015. | |
| FR Citation | 80 FR 57390 |
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