81 FR 1209 - Manufacturer of Controlled Substances Registration: IRIX Manufacturing, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 6 (January 11, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 6 (January 11, 2016)
| Page Range | 1209-1210 | |
| FR Document | 2016-00215 |
[Federal Register Volume 81, Number 6 (Monday, January 11, 2016)] [Notices] [Pages 1209-1210] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00215] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Manufacturer of Controlled Substances Registration: IRIX Manufacturing, Inc. ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: IRIX Manufacturing, Inc. applied to be registered as a [[Page 1210]] manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants IRIX Manufacturing, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated August 10, 2015, and published in the Federal Register on August 18, 2015, 80 FR 50035, IRIX Manufacturing, Inc., 309 Delaware Street, Building 1106, Greenville, South Carolina 29605 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 IRIX Manufacturing, 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: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Marihuana (7360)........................... I Tetrahydrocannabinols (7370)............... I ------------------------------------------------------------------------ The company plans to manufacture the above-listed controlled substances synthetically as Active Pharmaceutical Ingredients (API) for clinical trials. Dated: January 4, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-00215 Filed 1-8-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 6 / Monday, January 11, 2016 / Notices 1209
Controlled substance Schedule
Bufotenine (7433) ........................................................................................................................................................................................ I
Diethyltryptamine (7434) ............................................................................................................................................................................. I
Dimethyltryptamine (7435) .......................................................................................................................................................................... I
Psilocybin (7437) ......................................................................................................................................................................................... I
Psilocyn (7438) ............................................................................................................................................................................................ I
5-Methoxy-N,N-diisopropyltryptamine (7439) .............................................................................................................................................. I
N-Ethyl-1-phenylcyclohexylamine (7455) .................................................................................................................................................... I
1-(1-Phenylcyclohexyl)pyrrolidine (7458) .................................................................................................................................................... I
1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) ............................................................................................................................................... I
2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine (2C–E) (7509) ..................................................................................................................... I
2-(2,5-Dimethoxyphenyl) ethanamine (2C–H) (7517) ................................................................................................................................. I
2-(4-Iodo-2,5-dimethoxyphenyl) ethanamine (2C–I) (7518) ........................................................................................................................ I
2-(4-Isopropylthio)-2,5-dimethoxyphenyl) ethanamine (2C–T–4) (7532) .................................................................................................... I
Dihydromorphine (9145) .............................................................................................................................................................................. I
Heroin (9200) ............................................................................................................................................................................................... I
Normorphine (9313) .................................................................................................................................................................................... I
Methamphetamine (1105) ........................................................................................................................................................................... II
1-Phenylcyclohexylamine (7460) ................................................................................................................................................................. II
Phencyclidine (7471) ................................................................................................................................................................................... II
Phenylacetone (8501) ................................................................................................................................................................................. II
1-Piperidinocyclohexanecarbonitrile (8603) ................................................................................................................................................ II
Cocaine (9041) ............................................................................................................................................................................................ II
Codeine (9050) ............................................................................................................................................................................................ II
Dihydrocodeine (9120) ................................................................................................................................................................................ II
Ecgonine (9180) .......................................................................................................................................................................................... II
Meperidine intermediate-B (9233) ............................................................................................................................................................... II
Morphine (9300) .......................................................................................................................................................................................... II
Noroxymorphone (9668) .............................................................................................................................................................................. II
The company plans to manufacture 22152. Request for hearings should be Controlled substance Schedule
high purity drug standards used for sent to: Drug Enforcement
analytical applications only in clinical, Administration, Attention: Hearing Phenylacetone (8501) .................. II
toxicological, and forensic laboratories Clerk/LJ, 8701 Morrissette Drive, Opium, raw (9600) ....................... II
and for distribution to its customers. Poppy Straw Concentrate (9670) II
Springfield, Virginia 22152. Comments
Tapentadol (9780) ........................ II
Dated: January 4, 2016. and request for hearings on applications
Louis J. Milione, to import narcotic raw material are not The company plans to import opium
Deputy Assistant Administrator. appropriate. 72 FR 3417 (January 25, raw (9600) and poppy straw concentrate
[FR Doc. 2016–00216 Filed 1–8–16; 8:45 am] 2007). (9670) to bulk manufacture other
BILLING CODE 4410–09–P controlled substances for distribution to
SUPPLEMENTARY INFORMATION: The
its customers. The company plans to
Attorney General has delegated her
import an intermediate form of
DEPARTMENT OF JUSTICE authority under the Controlled tapentadol (9780) to bulk manufacture
Substances Act to the Administrator of tapentadol (9780) for distribution to its
Drug Enforcement Administration the Drug Enforcement Administration customers. The company plans to
(DEA), 28 CFR 0.100(b). Authority to import phenylacetone (8501) in bulk for
[Docket No. DEA–392] exercise all necessary functions with the manufacture of a controlled
Importer of Controlled Substances respect to the promulgation and substance.
Application: Noramco, Inc. implementation of 21 CFR part 1301,
Dated: January 4, 2016.
incident to the registration of
Louis J. Milione,
ACTION: Notice of application. manufacturers, distributors, dispensers,
Deputy Assistant Administrator.
importers, and exporters of controlled
DATES: Registered bulk manufacturers of [FR Doc. 2016–00209 Filed 1–8–16; 8:45 am]
substances (other than final orders in
the affected basic classes, and connection with suspension, denial, or BILLING CODE 4410–09–P
applicants therefore, may file written revocation of registration) has been
comments on or objections to the redelegated to the Deputy Assistant
issuance of the proposed registration in DEPARTMENT OF JUSTICE
Administrator of the DEA Office of
accordance with 21 CFR 1301.34(a) on Diversion Control (‘‘Deputy Assistant Drug Enforcement Administration
or before February 10, 2016. Such Administrator’’) pursuant to section 7 of
persons may also file a written request [Docket No. DEA–392]
28 CFR part 0, appendix to subpart R.
for a hearing on the application
ebenthall on DSK6SPTVN1PROD with NOTICES
pursuant to 21 CFR 1301.43 on or before In accordance with 21 CFR Manufacturer of Controlled
February 10, 2016. 1301.34(a), this is notice that on August Substances Registration: IRIX
4, 2015, Noramco, Inc., 500 Swedes Manufacturing, Inc.
ADDRESSES: Written comments should
be sent to: Drug Enforcement Landing Road, Wilmington, Delaware
19801–4417, applied to be registered as ACTION: Notice of registration.
Administration, Attention: DEA Federal
Register Representative/ODW, 8701 an importer of the following basic SUMMARY: IRIX Manufacturing, Inc.
Morrissette Drive, Springfield, Virginia classes of controlled substances: applied to be registered as a
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![1210 Federal Register / Vol. 81, No. 6 / Monday, January 11, 2016 / Notices
manufacturer of certain basic classes of substances. The Drug Enforcement DEPARTMENT OF JUSTICE
controlled substances. The Drug Administration (DEA) grants Chattem
Enforcement Administration (DEA) Chemicals Inc. registration as an Drug Enforcement Administration
grants IRIX Manufacturing, Inc. importer of those controlled substances. [Docket No. DEA–392]
registration as a manufacturer of those SUPPLEMENTARY INFORMATION: By notice
controlled substances. dated September 1, 2015, and published Manufacturer of Controlled
SUPPLEMENTARY INFORMATION: By notice in the Federal Register on September 9, Substances Registration: AMPAC Fine
dated August 10, 2015, and published in 2015, 80 FR 54326, Chattem Chemicals Chemicals LLC
the Federal Register on August 18, Inc., 3801 St. Elmo Avenue,
2015, 80 FR 50035, IRIX Manufacturing, Chattanooga, Tennessee 37409 applied ACTION: Notice of registration.
Inc., 309 Delaware Street, Building to be registered as an importer of certain
1106, Greenville, South Carolina 29605 SUMMARY: AMPAC Fine Chemicals LLC
basic classes of controlled substances. applied to be registered as a
applied to be registered as a Comments and requests for hearings on
manufacturer of certain basic classes of manufacturer of certain basic classes of
applications to import narcotic raw controlled substances. The Drug
controlled substances. No comments or material are not appropriate. 72 FR 3417
objections were submitted for this Enforcement Administration (DEA)
(January 25, 2007). No comments or grants AMPAC Fine Chemicals LLC
notice. objections were submitted for this
The DEA has considered the factors in registration as a manufacturer of those
notice. controlled substances.
21 U.S.C. 823(a) and determined that The DEA has considered the factors in
the registration of IRIX Manufacturing, SUPPLEMENTARY INFORMATION: By notice
21 U.S.C. 823, 952(a) and 958(a) and
Inc. to manufacture the basic classes of dated June 25, 2015, and published in
determined that the registration of
controlled substances is consistent with the Federal Register on July 6, 2015, 80
Chattem Chemicals Inc. to import the
the public interest and with United FR 38467, AMPAC Fine Chemicals LLC,
basic classes of controlled substances is
States obligations under international Highway 50 and Hazel Avenue,
consistent with the public interest and
treaties, conventions, or protocols in Building 05001, Rancho Cordova,
with United States obligations under
effect on May 1, 1971. The DEA California 95670 applied to be registered
international treaties, conventions, or
investigated the company’s maintenance as a manufacturer of certain basic
protocols in effect on May 1, 1971. The
of effective controls against diversion by classes of controlled substances. No
DEA investigated the company’s
inspecting and testing the company’s comments or objections were submitted
maintenance of effective controls
physical security systems, verifying the for this notice.
against diversion by inspecting and
company’s compliance with state and The DEA has considered the factors in
testing the company’s physical security
local laws, and reviewing the company’s 21 U.S.C. 823(a) and determined that
systems, verifying the company’s
background and history. the registration of AMPAC Fine
compliance with state and local laws,
Therefore, pursuant to 21 U.S.C. Chemicals LLC to manufacture the basic
and reviewing the company’s
823(a), and in accordance with 21 CFR classes of controlled substances is
background and history.
1301.33, the above-named company is consistent with the public interest and
Therefore, pursuant to 21 U.S.C.
granted registration as a bulk with United States obligations under
952(a) and 958(a), and in accordance
manufacturer of the following basic international treaties, conventions, or
with 21 CFR 1301.34, the above-named
classes of controlled substances: protocols in effect on May 1, 1971. The
company is granted registration as an
DEA investigated the company’s
importer of the following basic classes
Controlled substance Schedule maintenance of effective controls
of controlled substances:
against diversion by inspecting and
Marihuana (7360) ......................... I testing the company’s physical security
Tetrahydrocannabinols (7370) ..... I Controlled substance Schedule
systems, verifying the company’s
The company plans to manufacture Methamphetamine (1105) ............ II compliance with state and local laws,
the above-listed controlled substances 4-Anilino-N-phenethyl-4-piperidine II and reviewing the company’s
synthetically as Active Pharmaceutical
(ANPP) (8333). background and history.
Phenylacetone (8501) .................. II Therefore, pursuant to 21 U.S.C.
Ingredients (API) for clinical trials. Opium, raw (9600) ....................... II 823(a), and in accordance with 21 CFR
Dated: January 4, 2016. Poppy Straw Concentrate (9670) II 1301.33, the above-named company is
Louis J. Milione, Tapentadol (9780) ........................ II
granted registration as a bulk
Deputy Assistant Administrator. manufacturer of the following basic
[FR Doc. 2016–00215 Filed 1–8–16; 8:45 am]
The company plans to import the classes of controlled substances:
listed controlled substances to bulk
BILLING CODE 4410–09–P
manufacture other controlled substances Controlled substance Schedule
for distribution to its customers. The
DEPARTMENT OF JUSTICE company plans to import an Methylphenidate (1724) ................ II
intermediate form of tapentadol (9780), Thebaine (9333) ........................... II
Drug Enforcement Administration to bulk manufacture tapentadol (9780) Poppy Straw Concentrate (9670) II
for distribution to its customers. The Tapentadol (9780) ........................ II
[Docket No. DEA–392]
company plans to import phenylacetone
The company is a contract
ebenthall on DSK6SPTVN1PROD with NOTICES
Importer of Controlled Substances (8501) in bulk for the manufacture of a
controlled substance. manufacturer. In reference to Poppy
Registration: Chattem Chemicals Inc. Straw Concentrate the company will
Dated: January 4, 2016. manufacture thebaine intermediates for
ACTION: Notice of registration. Louis J. Milione, sale to its customers for further
SUMMARY: Chattem Chemicals Inc. Deputy Assistant Administrator. manufacture. No other activity for this
applied to be registered as an importer [FR Doc. 2016–00218 Filed 1–8–16; 8:45 am] drug code is authorized for this
of certain basic classes of controlled BILLING CODE 4410–09–P registration.
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Document Created: 2016-01-16 01:05:46
Document Modified: 2016-01-16 01:05:46
| 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 1209 |
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