81 FR 9219 - Manufacturer of Controlled Substances Registration: Cedarburg Pharmaceuticals, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 36 (February 24, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 36 (February 24, 2016)
| Page Range | 9219-9220 | |
| FR Document | 2016-03853 |
[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)] [Notices] [Pages 9219-9220] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03853] ----------------------------------------------------------------------- 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 Drug Enforcement Administration (DEA) grants Cedarburg Pharmaceuticals, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated September 16, 2015, and published in the Federal Register on September 23, 2015, 80 FR 57390, 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 for this notice. The 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 following basic classes of controlled substances: [[Page 9220]] ------------------------------------------------------------------------ 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 a synthetic tetrahydrocannabinols (7370). No other activity for this drug code is authorized for this registration. Dated: February 16, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-03853 Filed 2-23-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices 9219
Controlled substance Schedule Dated: February 16, 2016. Controlled substance Schedule
Louis J. Milione,
2-(4-chloro-2,5-dimethoxyphenyl)- I Deputy Assistant Administrator. Tapentadol (9780) ........................ II
N-(2-methoxy- [FR Doc. 2016–03854 Filed 2–23–16; 8:45 am]
Fentanyl (9801) ............................ II
benzyl)ethanamine (25C–
BILLING CODE 4410–09–P
NBOMe) (7537). The company plans to manufacture
2-(4-iodo-2,5-dimethoxyphenyl)-N- I the above-listed controlled substances
(2-methoxybenzyl)ethanamine in bulk for distribution to its customers.
(25I–NBOMe) (7538). DEPARTMENT OF JUSTICE
Methylone (3,4-Methylenedioxy-N- I Dated: February 16, 2016.
methylcathinone) (7540). Drug Enforcement Administration Louis J. Milione,
Butylone (7541) ............................ I [Docket No. DEA–392] Deputy Assistant Administrator.
Pentylone (7542) .......................... I [FR Doc. 2016–03852 Filed 2–23–16; 8:45 am]
alpha-pyrrolidinopentiophenone I Bulk Manufacturer of Controlled BILLING CODE 4410–09–P
(a-PVP) (7545). Substances Application: Janssen
alpha-pyrrolidinobutiophenone (a- I Pharmaceutical, Inc.
PBP) (7546).
AM–694 (1-(5-Fluoropentyl)-3-(2- I DEPARTMENT OF JUSTICE
ACTION: Notice of application.
iodobenzoyl)indole) (7694).
Acetyldihydrocodeine (9051) ........ I Drug Enforcement Administration
DATES: Registered bulk manufacturers of
Benzylmorphine (9052) ................ I the affected basic classes, and [Docket No. DEA–392]
Codeine-N-oxide (9053) ............... I applicants therefore, may file written
Desomorphine (9055) ................... I Manufacturer of Controlled
comments on or objections to the
Dihydromorphine (9145) ............... I Substances Registration: Cedarburg
Heroin (9200) ............................... I issuance of the proposed registration in
accordance with 21 CFR 1301.33(a) on Pharmaceuticals, Inc.
Morphine-N-oxide (9307) ............. I
Normorphine (9313) ..................... I or before April 25, 2016
ACTION: Notice of registration.
Tilidine (9750) ............................... I ADDRESSES: Written comments should
Acetyl Fentanyl (N-(1- I be sent to: Drug Enforcement SUMMARY: Cedarburg Pharmaceuticals,
phenethylpiperidin-4-yl)-N- Administration, Attention: DEA Federal Inc. applied to be registered as a
phenylacetamide) (9821). Register Representative/ODW, 8701 manufacturer of certain basic classes of
Amphetamine (1100) .................... II Morrissette Drive, Springfield, Virginia controlled substances. The Drug
Methamphetamine (1105) ............ II 22152. Enforcement Administration (DEA)
Lisdexamfetamine (1205) ............. II
Methylphenidate (1724) ................ II SUPPLEMENTARY INFORMATION: The grants Cedarburg Pharmaceuticals, Inc.
Amobarbital (2125) ....................... II Attorney General has delegated her registration as a manufacturer of those
Pentobarbital (2270) ..................... II authority under the Controlled controlled substances.
Secobarbital (2315) ...................... II Substances Act to the Administrator of SUPPLEMENTARY INFORMATION: By notice
Phencyclidine (7471) .................... II the Drug Enforcement Administration dated September 16, 2015, and
Phenylacetone (8501) .................. II (DEA), 28 CFR 0.100(b). Authority to published in the Federal Register on
Cocaine (9041) ............................. II exercise all necessary functions with September 23, 2015, 80 FR 57390,
Codeine (9050) ............................. II respect to the promulgation and Cedarburg Pharmaceuticals, Inc., 870
Dihydrocodeine (9120) ................. II implementation of 21 CFR part 1301, Badger Circle, Grafton, Wisconsin 53024
Oxycodone (9143) ........................ II
incident to the registration of applied to be registered as a
Hydromorphone (9150) ................ II
manufacturers, distributors, dispensers, manufacturer of certain basic classes of
Ecgonine (9180) ........................... II
Ethylmorphine (9190) ................... II importers, and exporters of controlled controlled substances. No comments or
Hydrocodone (9193) ..................... II substances (other than final orders in objections were submitted for this
Levomethorphan (9210) ............... II connection with suspension, denial, or notice.
Levorphanol (9220) ...................... II revocation of registration) has been The DEA has considered the factors in
Meperidine (9230) ........................ II redelegated to the Deputy Assistant 21 U.S.C. 823(a) and determined that
Meperidine intermediate-B (9233) II Administrator of the DEA Office of the registration of Cedarburg
Methadone (9250) ........................ II Diversion Control (‘‘Deputy Assistant Pharmaceuticals, Inc. to manufacture
Dextropropoxyphene, bulk. Administrator’’) pursuant to section 7 of the basic classes of controlled
(non-dosage forms) (9273) .......... II 28 CFR part 0, appendix to subpart R. substances is consistent with the public
Morphine (9300) ........................... II In accordance with 21 CFR interest and with United States
Thebaine (9333) ........................... II 1301.33(a), this is notice that on obligations under international treaties,
Oxymorphone (9652) ................... II November 12, 2015, Janssen conventions, or protocols in effect on
Sufentanil (9740) .......................... II
Pharmaceutical, Inc., 1440 Olympic May 1, 1971. The DEA investigated the
Tapentadol (9780) ........................ II
Fentanyl (9801) ............................ II
Drive, Athens, Georgia 30601 applied to company’s maintenance of effective
be registered as a bulk manufacturer of controls against diversion by inspecting
the following basic classes of controlled and testing the company’s physical
The company plans to manufacture substances: security systems, verifying the
reference standards for distribution to company’s compliance with state and
their research and forensics customers. Controlled substance Schedule
mstockstill on DSK4VPTVN1PROD with NOTICES
local laws, and reviewing the company’s
In reference to drug codes 7360 background and history.
Methylphenidate (1724) ................ II Therefore, pursuant to 21 U.S.C.
(marihuana) and 7370
Oxycodone (9143) ........................ II
(tetrahydrocannabinols), the company Hydromorphone (9150) ................ II
823(a), and in accordance with 21 CFR
plans to bulk manufacture these drugs Hydrocodone (9193) ..................... II 1301.33, the above-named company is
as synthetic. No other activities for these Oripavine (9330) ........................... II granted registration as a bulk
drug codes are authorized for this Thebaine (9333) ........................... II manufacturer of the following basic
registration. Oxymorphone (9652) ................... II classes of controlled substances:
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![9220 Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices
Controlled substance Schedule physical security systems, verifying the SUMMARY: The Attorney General has
company’s compliance with state and delegated her authority under the
Marihuana (7360) ......................... I local laws, and reviewing the company’s Controlled Substances Act to the
Tetrahydrocannabinols (7370) ..... I background and history. Administrator of the Drug Enforcement
4-Anilino-N-phenethyl-4-piperidine II Therefore, pursuant to 21 U.S.C. Administration (DEA).
(ANPP) (8333).
Remifentanil (9739) ...................... II
823(a), and in accordance with 21 CFR
DATES: Registered bulk manufacturers of
Fentanyl (9801) ............................ II 1301.33, the above-named company is
the affected basic classes, and
granted registration as a bulk
applicants therefore, may file written
The company plans to manufacture manufacturer of the following basic
comments on or objections to the
the above-listed controlled substances classes of controlled substances:
issuance of the proposed registration in
in bulk for distribution to its customers. accordance with 21 CFR 1301.33(a) on
In reference to drug code 7360, Controlled substance Schedule
or before April 25, 2016.
marihuana, the company plans to bulk
Marihuana (7360) ......................... I
manufacture cannabidiol as a synthetic ADDRESSES: Written comments should
Amphetamine (1100) .................... II
intermediate. This controlled substance Methamphetamine (1105) ............ II be sent to: Drug Enforcement
will be further synthesized to bulk Lisdexamfetamine (1205) ............. II Administration, Attention: DEA Federal
manufacture a synthetic Methylphenidate (1724) ................ II Register Representative/ODW, 8701
tetrahydrocannabinols (7370). No other Nabilone (7379) ............................ II Morrissette Drive, Springfield, Virginia
activity for this drug code is authorized Phenylacetone (8501) .................. II 22152.
for this registration. Cocaine (9041) ............................. II
Codeine (9050) ............................. II SUPPLEMENTARY INFORMATION: The
Dated: February 16, 2016. Etorphine HCI (9059) ................... II Attorney General has delegated her
Louis J. Milione, Dihydrocodeine (9120) ................. II authority under the Controlled
Deputy Assistant Administrator. Oxycodone (9143) ........................ II Substances Act to the DEA, 28 CFR
[FR Doc. 2016–03853 Filed 2–23–16; 8:45 am] Hydromorphone (9150) ................ II 0.100(b). Authority to exercise all
Ecgonine (9180) ........................... II
BILLING CODE 4410–09–P
Ethylmorphine (9190) ................... II
necessary functions with respect to the
Hydrocodone (9193) ..................... II promulgation and implementation of 21
Levomethorphan (9210) ............... II CFR part 1301, incident to the
DEPARTMENT OF JUSTICE Levorphanol (9220) ...................... II registration of manufacturers,
Isomethadone (9226) ................... II distributors, dispensers, importers, and
Drug Enforcement Administration Meperidine (9230) ........................ II exporters of controlled substances (other
[Docket No. DEA–392] Meperidine intermediate–A (9232) II than final orders in connection with
Meperidine intermediate–B (9233) II suspension, denial, or revocation of
Manufacturer of Controlled Meperidine intermediate–C (9234) II registration) has been redelegated to the
Substances Registration: Chemtos, Methadone (9250) ........................ II
Methadone intermediate (9254) ... II
Deputy Assistant Administrator of the
LLC DEA Office of Diversion Control
Morphine (9300) ........................... II
Thebaine (9333) ........................... II (‘‘Deputy Assistant Administrator’’)
ACTION: Notice of registration.
Dihydroetorphine (9334) ............... II pursuant to section 7 of 28 CFR part 0,
SUMMARY: Chemtos, LLC applied to be Levo-alphacetylmethadol (9648) .. II appendix to subpart R.
registered as a manufacturer of certain Oxymorphone (9652) ................... II In accordance with 21 CFR
basic classes of controlled substances. Racemethorphan (9732) .............. II
Racemorphan (9733) ................... II
1301.33(a), this is notice that on
The Drug Enforcement Administration November 12, 2015, Insys Therapeutics,
(DEA) grants Chemtos, LLC registration Inc., 2700 Oakmont, Round Rock, Texas
as a manufacturer of those controlled The company plans to manufacture
small quantities of the listed controlled 78665 applied to be registered as a bulk
substances. manufacturer of the following basic
substances in bulk for distribution to its
SUPPLEMENTARY INFORMATION: By notice customers for use as reference classes of controlled substances:
dated September 16, 2015, and standards.
published in the Federal Register on Controlled substance Schedule
Dated: February 16, 2016.
September 23, 2015, 80 FR 57389,
Chemtos, LLC, 14101 W. Highway 290, Louis J. Milione, Marihuana (7360) ......................... I
Building 2000B, Austin, Texas 78737– Deputy Assistant Administrator. Tetrahydrocannabinols (7370) ..... I
9331 applied to be registered as a [FR Doc. 2016–03856 Filed 2–23–16; 8:45 am]
manufacturer of certain basic classes of BILLING CODE 4410–09–P The company plans to manufacture
controlled substances. No comments or the above-listed controlled substances
objections were submitted for this in bulk for distribution to its customers.
notice. DEPARTMENT OF JUSTICE In reference to drug codes 7360,
The DEA has considered the factors in marihuana, and 7370,
21 U.S.C. 823(a) and determined that Drug Enforcement Administration tetrahydrocannabinols, the company
the registration of Chemtos, LLC to plans to bulk manufacture both as
manufacture the basic classes of [Docket No. DEA–392] synthetic substances. No other activity
for these drug codes is authorized for
mstockstill on DSK4VPTVN1PROD with NOTICES
controlled substances is consistent with
the public interest and with United Bulk Manufacturer of Controlled this registration.
States obligations under international Substances Application: Insys
Therapeutics, Inc. Dated: February 16, 2016.
treaties, conventions, or protocols in
Louis J. Milione,
effect on May 1, 1971. The DEA AGENCY: Drug Enforcement
investigated the company’s maintenance Deputy Assistant Administrator.
Administration, Justice.
of effective controls against diversion by [FR Doc. 2016–03855 Filed 2–23–16; 8:45 am]
ACTION: Notice of application.
inspecting and testing the company’s BILLING CODE 4410–09–P
VerDate Sep<11>2014 17:59 Feb 23, 2016 Jkt 238001 PO 00000 Frm 00060 Fmt 4703 Sfmt 9990 E:\FR\FM\24FEN1.SGM 24FEN1](https://thefederalregister.org/doc/81_FR_9255/page/2.svg)
Document Created: 2016-02-23 23:55:39
Document Modified: 2016-02-23 23:55:39
| 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 | 81 FR 9219 |
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