83 FR 5275 - Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 25 (February 6, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 25 (February 6, 2018)
| Page Range | 5275-5275 | |
| FR Document | 2018-02341 |
[Federal Register Volume 83, Number 25 (Tuesday, February 6, 2018)] [Notices] [Page 5275] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02341] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals 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 April 9, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 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 August 29, 2017, Cedarburg Pharmaceuticals, Inc., A Division of Albany Molecular Research Inc. (AMRI), 870 Badger Circle, Grafton, Wisconsin 53024 applied to be registered as a bulk manufacturer the following basic classes of controlled substances: ------------------------------------------------------------------------ Drug Controlled substance code Schedule ------------------------------------------------------------------------ Marihuana.............................. 7360 I Tetrahydrocannabinols.................. 7370 I Lisdexamfetamine....................... 1205 II Pentobarbital.......................... 2270 II Nabilone............................... 7379 II 4-Anilino-N-phenethyl-4-piperidine 8333 II (ANPP). 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 codes 7360 marihuana, the company plans to bulk manufacture cannabidiol as a synthetic intermediate. The company plans to manufacture bulk active pharmaceutical ingredients (API) for distribution to its customers. This controlled substance will be further synthesized to bulk manufacture a synthetic tetrahydrocannabinols 7370. No other activity for this drug code is authorized for this registration. Dated: January 30, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018-02341 Filed 2-5-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 25 / Tuesday, February 6, 2018 / Notices 5275
comments on or objections to the Drug Control Division (‘‘Assistant
Controlled substance Schedule
issuance of the proposed registration on code Administrator’’) pursuant to section 7 of
or before April 9, 2018. 28 CFR part 0, appendix to subpart R.
Noroxymorphone ............ 9668 II In accordance with 21 CFR
ADDRESSES: Written comments should
Alfentanil ......................... 9737 II 1301.33(a), this is notice that on August
be sent to: Drug Enforcement Remifentanil .................... 9739 II
Administration, Attention: DEA Federal 29, 2017, Cedarburg Pharmaceuticals,
Sufentanil ........................ 9740 II
Register Representative/DRW, 8701 Tapentadol ...................... 9780 II
Inc., A Division of Albany Molecular
Morrissette Drive, Springfield, Virginia Fentanyl .......................... 9801 II Research Inc. (AMRI), 870 Badger
22152. Circle, Grafton, Wisconsin 53024
The company plans to manufacture applied to be registered as a bulk
SUPPLEMENTARY INFORMATION: The
the listed controlled substances in bulk manufacturer the following basic classes
Attorney General has delegated his
for distribution and sale to its of controlled substances:
authority under the Controlled
Substances Act to the Administrator of customers.
In reference to drug codes 7360 Drug
the Drug Enforcement Administration Controlled substance Schedule
code
(DEA), 28 CFR 0.100(b). Authority to (marihuana) and 7370
exercise all necessary functions with (tetrahydrocannabinols), the company Marihuana ....................... 7360 I
respect to the promulgation and plans to bulk manufacture these drugs Tetrahydrocannabinols ... 7370 I
implementation of 21 CFR part 1301, as synthetic. No other activities for these Lisdexamfetamine .......... 1205 II
drug codes are authorized for this Pentobarbital .................. 2270 II
incident to the registration of Nabilone ......................... 7379 II
manufacturers, distributors, dispensers, registration.
4-Anilino-N-phenethyl-4- 8333 II
importers, and exporters of controlled Dated: January 30, 2018. piperidine (ANPP).
substances (other than final orders in Susan A. Gibson, Remifentanil .................... 9739 II
connection with suspension, denial, or Deputy Assistant Administrator. Fentanyl .......................... 9801 II
revocation of registration) has been [FR Doc. 2018–02343 Filed 2–5–18; 8:45 am]
redelegated to the Assistant The company plans to manufacture
BILLING CODE 4410–09–P
Administrator of the DEA Diversion the above listed controlled substances in
Control Division (‘‘Assistant bulk for distribution to its customers. In
Administrator’’) pursuant to section 7 of DEPARTMENT OF JUSTICE reference to drug codes 7360 marihuana,
28 CFR part 0, appendix to subpart R. the company plans to bulk manufacture
In accordance with 21 CFR Drug Enforcement Administration cannabidiol as a synthetic intermediate.
1301.33(a), this is notice that on July 21, The company plans to manufacture bulk
2017, Chattem Chemicals, Inc., 3801 St. [Docket No. DEA–392] active pharmaceutical ingredients (API)
Elmo Avenue, Chattanooga, Tennessee for distribution to its customers. This
Bulk Manufacturer of Controlled
37409 applied to be registered as a bulk controlled substance will be further
Substances Application: Cedarburg
manufacturer for the basic classes of synthesized to bulk manufacture a
Pharmaceuticals
controlled substances: synthetic tetrahydrocannabinols 7370.
ACTION: Notice of application. No other activity for this drug code is
Drug authorized for this registration.
Controlled substance Schedule
code
DATES: Registered bulk manufacturers of Dated: January 30, 2018.
Gamma Hydroxybutyric 2010 I the affected basic classes, and Susan A. Gibson,
Acid. applicants therefore, may file written Deputy Assistant Administrator.
Marihuana ....................... 7360 I comments on or objections to the [FR Doc. 2018–02341 Filed 2–5–18; 8:45 am]
Tetrahydrocannabinols ... 7370 I issuance of the proposed registration on
4-Methoxyamphetamine 7411 I BILLING CODE 4410–09–P
or before April 9, 2018.
Dihydromorphine ............ 9145 I
Amphetamine ................. 1100 II ADDRESSES: Written comments should
Methamphetamine .......... 1105 II be sent to: Drug Enforcement DEPARTMENT OF JUSTICE
Lisdexamfetamine .......... 1205 II Administration, Attention: DEA Federal
Methylphenidate ............. 1724 II Register Representative/DRW, 8701 Notice of Proposed Settlement
Pentobarbital .................. 2270 II Morrissette Drive, Springfield, Virginia Agreement and Draft Restoration Plan
Codeine .......................... 9050 II 22152. Under The Oil Pollution Act of 1990,
Dihydrocodeine ............... 9120 II and The Clean Water Act
Oxycodone ..................... 9143 II SUPPLEMENTARY INFORMATION: The
Hydromorphone .............. 9150 II Attorney General has delegated his Notice is hereby given that the United
Hydrocodone .................. 9193 II authority under the Controlled States of America, on behalf of the
Meperidine ...................... 9230 II Substances Act to the Administrator of Department of the Interior (‘‘DOI’’)
Meperidine intermediate- 9232 II
the Drug Enforcement Administration acting through the Fish and Wildlife
A.
Meperidine intermediate- 9233 II (DEA), 28 CFR 0.100(b). Authority to Service and the National Park Service,
B. exercise all necessary functions with the District of Columbia, on behalf of
Meperidine intermediate- 9234 II respect to the promulgation and the Department of Energy and
C. implementation of 21 CFR part 1301, Environment, and the Commonwealth
Methadone ...................... 9250 II incident to the registration of of Virginia, acting through the Virginia
daltland on DSKBBV9HB2PROD with NOTICES
Methadone intermediate 9254 II manufacturers, distributors, dispensers, Department of Environmental Quality
Morphine ......................... 9300 II importers, and exporters of controlled (collectively ‘‘Trustees’’), are providing
Oripavine ........................ 9330 II
Thebaine ......................... 9333 II
substances (other than final orders in an opportunity for public comment on
Opium tincture ................ 9630 II connection with suspension, denial, or a proposed Settlement Agreement
Opium, powdered ........... 9639 II revocation of registration) has been (‘‘Settlement Agreement’’) among the
Opium, granulated .......... 9640 II redelegated to the Assistant DOI, the District of Columbia, the
Oxymorphone ................. 9652 II Administrator of the DEA Diversion Commonwealth of Virginia, and
VerDate Sep<11>2014 19:02 Feb 05, 2018 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\06FEN1.SGM 06FEN1](https://thefederalregister.org/doc/83_FR_5300/page/1.svg)
Document Created: 2018-02-06 00:30:45
Document Modified: 2018-02-06 00:30:45
| 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 on or before April 9, 2018. | |
| FR Citation | 83 FR 5275 |
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