81 FR 1208 - Manufacturer of Controlled Substances Registration: Alltech Associates, 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 | 1208-1209 | |
| FR Document | 2016-00216 |
[Federal Register Volume 81, Number 6 (Monday, January 11, 2016)] [Notices] [Pages 1208-1209] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00216] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Manufacturer of Controlled Substances Registration: Alltech Associates, Inc. ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Alltech Associates, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Alltech Associates, 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 50041, Alltech Associates, Inc., 2051 Waukegan Road, Deerfield, Illinois 60015 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 Alltech Associates, 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 ------------------------------------------------------------------------ Methcathinone (1237)............................. I N-Ethylamphetamine (1475)........................ I N,N-Dimethylamphetamine (1480)................... I 4-Methylaminorex (cis isomer) (1590)............. I Gamma Hydroxybutyric Acid (2010)................. I Alpha-ethyltryptamine (7249)..................... I Lysergic acid diethylamide (7315)................ I 2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C- I T-7) (7348). Tetrahydrocannabinols (7370)..................... I Mescaline (7381)................................. I 4-Bromo-2,5-dimethoxyamphetamine (7391).......... I 4-Bromo-2,5-dimethoxyphenethylamine (7392)....... I 4-Methyl-2,5-dimethoxyamphetamine (7395)......... I 2,5-Dimethoxyamphetamine (7396).................. I 2,5-Dimethoxy-4-ethylamphetamine (7399).......... I 3,4-Methylenedioxyamphetamine (7400)............. I N-Hydroxy-3,4-methylenedioxyamphetamine (7402)... I 3,4-Methylenedioxy-N-ethylamphetamine (7404)..... I 3,4-Methylenedioxymethamphetamine (7405)......... I 4-Methoxyamphetamine (7411)...................... I 5-Methoxy-N-N-dimethyltryptamine (7431).......... I Alpha-methyltryptamine (7432).................... I [[Page 1209]] 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) I (7509). 2-(2,5-Dimethoxyphenyl) ethanamine (2C-H) (7517). I 2-(4-Iodo-2,5-dimethoxyphenyl) ethanamine (2C-I) I (7518). 2-(4-Isopropylthio)-2,5-dimethoxyphenyl) I ethanamine (2C-T-4) (7532). 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 high purity drug standards used for analytical applications only in clinical, toxicological, and forensic laboratories and for distribution to its customers. Dated: January 4, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-00216 Filed 1-8-16; 8:45 am] BILLING CODE 4410-09-P
![1208 Federal Register / Vol. 81, No. 6 / Monday, January 11, 2016 / Notices
DEPARTMENT OF JUSTICE Administrator of the DEA Office of SUMMARY: Alltech Associates, Inc.
Diversion Control (‘‘Deputy Assistant applied to be registered as a
Drug Enforcement Administration Administrator’’) pursuant to section 7 of manufacturer of certain basic classes of
[Docket No. DEA–392] 28 CFR part 0, appendix to subpart R. controlled substances. The Drug
In accordance with 21 CFR Enforcement Administration (DEA)
Importer of Controlled Substances 1301.34(a), this is notice that on October grants Alltech Associates, Inc.
Application: Hospira 1, 2015, Hospira, 1776 North Centennial registration as a manufacturer of those
Drive, McPherson, Kansas 67460–1247 controlled substances.
ACTION: Notice of application. applied to be registered as an importer
of remifentanil (9739), a basic class of SUPPLEMENTARY INFORMATION: By notice
DATES: Registered bulk manufacturers of controlled substance listed in schedule dated August 10, 2015, and published in
the affected basic class, and applicants II. the Federal Register on August 18,
therefore, may file written comments on The company plans to import 2015, 80 FR 50041, Alltech Associates,
or objections to the issuance of the remifentanil for use in dosage form Inc., 2051 Waukegan Road, Deerfield,
proposed registration in accordance manufacturing. Placement of this drug Illinois 60015 applied to be registered as
with 21 CFR 1301.34(a) on or before code onto the company’s registration a manufacturer of certain basic classes
February 10, 2016. Such persons may does not translate into automatic of controlled substances. No comments
also file a written request for a hearing approval of subsequent permit
on the application pursuant to 21 CFR or objections were submitted for this
applications to import controlled notice.
1301.43 on or before February 10, 2016. substances. Approval of permit
ADDRESSES: Written comments should applications will occur only when the The DEA has considered the factors in
be sent to: Drug Enforcement registrant’s business activity is 21 U.S.C. 823(a) and determined that
Administration, Attention: DEA Federal consistent with what is authorized the registration of Alltech Associates,
Register Representative/ODW, 8701 under to 21 U.S.C. 952(a)(2). Inc. to manufacture the basic classes of
Morrissette Drive, Springfield, Virginia Authorization will not extend to the controlled substances is consistent with
22152. Request for hearings should be import of FDA approved or non- the public interest and with United
sent to: Drug Enforcement approved finished dosage forms for States obligations under international
Administration, Attention: Hearing commercial sale. treaties, conventions, or protocols in
Clerk/LJ, 8701 Morrissette Drive, effect on May 1, 1971. The DEA
Dated: January 4, 2016.
Springfield, Virginia 22152. investigated the company’s maintenance
Louis J. Milione,
SUPPLEMENTARY INFORMATION: The of effective controls against diversion by
Attorney General has delegated her Deputy Assistant Administrator.
inspecting and testing the company’s
authority under the Controlled [FR Doc. 2016–00212 Filed 1–8–16; 8:45 am]
physical security systems, verifying the
Substances Act to the Administrator of BILLING CODE 4410–09–P
company’s compliance with state and
the Drug Enforcement Administration local laws, and reviewing the company’s
(DEA), 28 CFR 0.100(b). Authority to background and history.
exercise all necessary functions with DEPARTMENT OF JUSTICE
respect to the promulgation and Therefore, pursuant to 21 U.S.C.
Drug Enforcement Administration 823(a), and in accordance with 21 CFR
implementation of 21 CFR part 1301,
incident to the registration of [Docket No. DEA–392] 1301.33, the above-named company is
manufacturers, distributors, dispensers, granted registration as a bulk
importers, and exporters of controlled Manufacturer of Controlled manufacturer of the following basic
substances (other than final orders in Substances Registration: Alltech classes of controlled substances:
connection with suspension, denial, or Associates, Inc.
revocation of registration) has been
ACTION: Notice of registration.
redelegated to the Deputy Assistant
Controlled substance Schedule
Methcathinone (1237) .................................................................................................................................................................................. I
N-Ethylamphetamine (1475) ........................................................................................................................................................................ I
N,N-Dimethylamphetamine (1480) .............................................................................................................................................................. I
4-Methylaminorex (cis isomer) (1590) ......................................................................................................................................................... I
Gamma Hydroxybutyric Acid (2010) ........................................................................................................................................................... I
Alpha-ethyltryptamine (7249) ...................................................................................................................................................................... I
Lysergic acid diethylamide (7315) ............................................................................................................................................................... I
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C–T–7) (7348) ............................................................................................................... I
Tetrahydrocannabinols (7370) ..................................................................................................................................................................... I
Mescaline (7381) ......................................................................................................................................................................................... I
4-Bromo-2,5-dimethoxyamphetamine (7391) .............................................................................................................................................. I
4-Bromo-2,5-dimethoxyphenethylamine (7392) .......................................................................................................................................... I
4-Methyl-2,5-dimethoxyamphetamine (7395) .............................................................................................................................................. I
2,5-Dimethoxyamphetamine (7396) ............................................................................................................................................................ I
ebenthall on DSK6SPTVN1PROD with NOTICES
2,5-Dimethoxy-4-ethylamphetamine (7399) ................................................................................................................................................ I
3,4-Methylenedioxyamphetamine (7400) .................................................................................................................................................... I
N-Hydroxy-3,4-methylenedioxyamphetamine (7402) .................................................................................................................................. I
3,4-Methylenedioxy-N-ethylamphetamine (7404) ........................................................................................................................................ I
3,4-Methylenedioxymethamphetamine (7405) ............................................................................................................................................ I
4-Methoxyamphetamine (7411) ................................................................................................................................................................... I
5-Methoxy-N–N-dimethyltryptamine (7431) ................................................................................................................................................. I
Alpha-methyltryptamine (7432) ................................................................................................................................................................... I
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![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
VerDate Sep<11>2014 21:33 Jan 14, 2016 Jkt 238001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\11JAN1.SGM 11JAN1](https://thefederalregister.org/doc/81_FR_1214/page/2.svg)
Document Created: 2016-01-16 01:06:30
Document Modified: 2016-01-16 01:06:30
| 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 1208 |
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