81 FR 61249 - Bulk Manufacturer of Controlled Substances Application: Isosciences
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 172 (September 6, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 172 (September 6, 2016)
| Page Range | 61249-61250 | |
| FR Document | 2016-21241 |
[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)] [Notices] [Pages 61249-61250] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21241] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Isosciences 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 7, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal [[Page 61250]] Register Representative/ODW, 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 May 3, 2016, Isosciences, LLC, 1017 West Ninth Avenue, Building 10, Suite B, King of Prussia, Pennsylvania 19406 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Cathinone (1235)........................... I Methcathinone (1237)....................... I Lysergic acid diethylamide (7315).......... I 3,4-Methylenedioxyamphetamine (7400)....... I 3,4-Methylenedioxy-N-ethylamphetamine I (7404). 3,4-Methylenedioxymethamphetamine (7405)... I Amphetamine (1100)......................... II Methamphetamine (1105)..................... II Codeine (9050)............................. II Morphine (9300)............................ II ------------------------------------------------------------------------ The company plans to manufacture small quantities of the listed controlled substances to make reference standards which will be distributed to their customers. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-21241 Filed 9-2-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices 61249
comments on or objections to the commercial distribution in the United Administrator’’) pursuant to section 7 of
issuance of the proposed registration in States. 28 CFR part 0, appendix to subpart R.
accordance with 21 CFR 1301.34(a) on The company plans to import an In accordance with 21 CFR
or before October 6, 2016. Such persons intermediate form of tapentadol (9780) 1301.33(a), this is notice that on May 18,
may also file a written request for a to bulk manufacture tapentadol for 2016, Cody Laboratories, Inc., 601
hearing on the application pursuant to distribution to its customers. Placement Yellowstone Avenue, Cody, Wyoming
21 CFR 1301.43 on or before October 6, of this drug code onto the company’s 82414 applied to be registered as a bulk
2016. registration does not translate into manufacturer of the following basic
ADDRESSES: Written comments should automatic approval of subsequent classes of controlled substances:
be sent to: Drug Enforcement permit applications to import controlled
substances. Approval of permit Controlled substance Schedule
Administration, Attention: DEA Federal
Register Representative/ODW, 8701 applications will occur only when the
Dihydromorphine (9145) ............... I
Morrissette Drive, Springfield, Virginia registrant’s business activity is
Amphetamine (1100) .................... II
22152. All requests for hearing must be consistent with what is authorized Methamphetamine (1105) ............ II
sent to: Drug Enforcement under to 21 U.S.C. 952(a)(2). Lisdexamfetamine (1205) ............. II
Administration, Attn: Administrator, Authorization will not extend to the Methylphenidate (1724) ................ II
8701 Morrissette Drive, Springfield, import of FDA approved or non- Amobarbital (2125) ....................... II
Virginia 22152. All requests for hearing approved finished dosage forms for Pentobarbital (2270) ..................... II
commercial sale. Secobarbital (2315) ...................... II
should also be sent to: (1) Drug
4-Anilino-N-phenethyl-4-piperidine II
Enforcement Administration, Attn: Louis J. Milione, (ANPP) (8333).
Hearing Clerk/LJ, 8701 Morrissette Deputy Assistant Administrator. Cocaine (9041) ............................. II
Drive, Springfield, Virginia 22152; and [FR Doc. 2016–21240 Filed 9–2–16; 8:45 am] Codeine (9050) ............................. II
(2) Drug Enforcement Administration, Dihydrocodeine (9120) ................. II
BILLING CODE 4410–09–P
Attn: DEA Federal Register Oxycodone (9143) ........................ II
Representative/ODW, 8701 Morrissette Hydromorphone (9150) ................ II
Drive, Springfield, Virginia 22152. Diphenoxylate (9170) ................... II
DEPARTMENT OF JUSTICE Ecgonine (9180) ........................... II
SUPPLEMENTARY INFORMATION: Hydrocodone (9193) ..................... II
The Attorney General has delegated Drug Enforcement Administration Meperidine (9230) ........................ II
her authority under the Controlled [Docket No. DEA–392] Methadone (9250) ........................ II
Substances Act to the Administrator of Methadone intermediate (9254) ... II
the Drug Enforcement Administration Morphine (9300) ........................... II
Bulk Manufacturer of Controlled
(DEA), 28 CFR 0.100(b). Authority to Thebaine (9333) ........................... II
Substances Application: Cody Oxymorphone (9652) ................... II
exercise all necessary functions with Laboratories, Inc. Alfentanil (9737) ........................... II
respect to the promulgation and Remifentanil (9739) ...................... II
implementation of 21 CFR part 1301, ACTION: Notice of application. Sufentanil (9740) .......................... II
incident to the registration of Tapentadol (9780) ........................ II
manufacturers, distributors, dispensers, DATES: Registered bulk manufacturers of Fentanyl (9801) ............................ II
importers, and exporters of controlled the affected basic classes, and
substances (other than final orders in applicants therefore, may file written The company plans to manufacture
connection with suspension, denial, or comments on or objections to the the listed controlled substances in bulk
revocation of registration) has been issuance of the proposed registration in for distribution to its customers.
redelegated to the Deputy Assistant accordance with 21 CFR 1301.33(a) on
Louis J. Milione,
Administrator of the DEA Office of or before November 7, 2016.
Deputy Assistant Administrator.
Diversion Control (‘‘Deputy Assistant ADDRESSES: Written comments should
Administrator’’) pursuant to section 7 of [FR Doc. 2016–21238 Filed 9–2–16; 8:45 am]
be sent to: Drug Enforcement
28 CFR part 0, appendix to subpart R. Administration, Attention: DEA Federal BILLING CODE 4410–09–P
In accordance with 21 CFR Register Representative/ODW, 8701
1301.34(a), this is notice that on June Morrissette Drive, Springfield, Virginia
DEPARTMENT OF JUSTICE
17, 2016, Fisher Clinical Services, Inc., 22152.
7554 Schantz Road, Allentown, SUPPLEMENTARY INFORMATION: The Drug Enforcement Administration
Pennsylvania 18106 applied to be Attorney General has delegated her
registered as an importer of the [Docket No. DEA–392]
authority under the Controlled
following basic classes of controlled Substances Act to the Administrator of
substances: Bulk Manufacturer of Controlled
the Drug Enforcement Administration Substances Application: Isosciences
(DEA), 28 CFR 0.100(b). Authority to
Controlled substance Schedule
exercise all necessary functions with ACTION: Notice of application.
Methylphenidate (1724) ................ II respect to the promulgation and
Levorphanol (9220) ...................... II implementation of 21 CFR part 1301, DATES: Registered bulk manufacturers of
Noroxymorphone (9668) .............. II incident to the registration of the affected basic classes, and
Tapentadol (9780) ........................ II manufacturers, distributors, dispensers, applicants therefore, may file written
mstockstill on DSK3G9T082PROD with NOTICES
importers, and exporters of controlled comments on or objections to the
The company plans to import the substances (other than final orders in issuance of the proposed registration in
listed substances for analytical research, connection with suspension, denial, or accordance with 21 CFR 1301.33(a) on
testing, and clinical trials. This revocation of registration) has been or before November 7, 2016.
authorization does not extend to the redelegated to the Deputy Assistant ADDRESSES: Written comments should
import of finished FDA approved or Administrator of the DEA Office of be sent to: Drug Enforcement
non-approved dosage form for Diversion Control (‘‘Deputy Assistant Administration, Attention: DEA Federal
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![61250 Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices
Register Representative/ODW, 8701 DEPARTMENT OF JUSTICE The company plans to import the
Morrissette Drive, Springfield, Virginia listed substance solely for updated
22152. Drug Enforcement Administration analytical testing purposes for EU
[Docket No. DEA–392] customer requirements.
SUPPLEMENTARY INFORMATION: The This analysis is required to allow the
Attorney General has delegated her Importer of Controlled Substances company to export domestically-
authority under the Controlled Application: Unither Manufacturing, manufactured FDF to foreign markets.
Substances Act to the Administrator of LLC Louis J. Milione,
the Drug Enforcement Administration
ACTION: Notice of application. Deputy Assistant Administrator.
(DEA), 28 CFR 0.100(b). Authority to
[FR Doc. 2016–21239 Filed 9–2–16; 8:45 am]
exercise all necessary functions with
respect to the promulgation and DATES: Registered bulk manufacturers of BILLING CODE 4410–09–P
implementation of 21 CFR part 1301, the affected basic classes, and
incident to the registration of applicants therefore, may file written
comments on or objections to the DEPARTMENT OF JUSTICE
manufacturers, distributors, dispensers,
importers, and exporters of controlled issuance of the proposed registration in
Drug Enforcement Administration
substances (other than final orders in accordance with 21 CFR 1301.34(a) on
or before October 6, 2016. Such persons [Docket No. DEA–392]
connection with suspension, denial, or
may also file a written request for a
revocation of registration) has been Bulk Manufacturer of Controlled
hearing on the application pursuant to
redelegated to the Deputy Assistant 21 CFR 1301.43 on or before October 6, Substances Application: AMRI
Administrator of the DEA Office of 2016. Rensselaer, Inc.
Diversion Control (‘‘Deputy Assistant
ADDRESSES: Written comments should ACTION: Notice of application.
Administrator’’) pursuant to section 7 of
be sent to: Drug Enforcement
28 CFR part 0, appendix to subpart R.
Administration, Attention: DEA Federal DATES: Registered bulk manufacturers of
In accordance with 21 CFR Register Representative/ODW, 8701 the affected basic classes, and
1301.33(a), this is notice that on May 3, Morrissette Drive, Springfield, Virginia applicants therefore, may file written
2016, Isosciences, LLC, 1017 West Ninth 22152. All requests for hearing must be comments on or objections to the
Avenue, Building 10, Suite B, King of sent to: Drug Enforcement issuance of the proposed registration in
Prussia, Pennsylvania 19406 applied to Administration, Attn: Administrator, accordance with 21 CFR 1301.33(a) on
be registered as a bulk manufacturer of 8701 Morrissette Drive, Springfield, or before November 7, 2016.
the following basic classes of controlled Virginia 22152. All requests for hearing ADDRESSES: Written comments should
substances: should also be sent to: (1) Drug be sent to: Drug Enforcement
Enforcement Administration, Attn: Administration, Attention: DEA Federal
Controlled substance Schedule Hearing Clerk/LJ, 8701 Morrissette Register Representative/ODW, 8701
Drive, Springfield, Virginia 22152; and Morrissette Drive, Springfield, Virginia
Cathinone (1235) .......................... I (2) Drug Enforcement Administration, 22152.
Methcathinone (1237) .................. I Attn: DEA Federal Register
Lysergic acid diethylamide (7315) I Representative/ODW, 8701 Morrissette SUPPLEMENTARY INFORMATION:
3,4-Methylenedioxyamphetamine I Drive, Springfield, Virginia 22152. The Attorney General has delegated
(7400). her authority under the Controlled
SUPPLEMENTARY INFORMATION: The
3,4-Methylenedioxy-N- I Substances Act to the Administrator of
Attorney General has delegated her the Drug Enforcement Administration
ethylamphetamine (7404).
3,4- I
authority under the Controlled (DEA), 28 CFR 0.100(b). Authority to
Methylenedioxymethamphetam- Substances Act to the Administrator of exercise all necessary functions with
ine (7405). the Drug Enforcement Administration respect to the promulgation and
Amphetamine (1100) .................... II (DEA), 28 CFR 0.100(b). Authority to implementation of 21 CFR part 1301,
Methamphetamine (1105) ............ II exercise all necessary functions with incident to the registration of
Codeine (9050) ............................. II respect to the promulgation and manufacturers, distributors, dispensers,
Morphine (9300) ........................... II implementation of 21 CFR part 1301, importers, and exporters of controlled
incident to the registration of substances (other than final orders in
The company plans to manufacture manufacturers, distributors, dispensers connection with suspension, denial, or
importers, and exporters of controlled revocation of registration) has been
small quantities of the listed controlled
substances (other than final orders in redelegated to the Deputy Assistant
substances to make reference standards
connection with suspension, denial, or Administrator of the DEA Office of
which will be distributed to their revocation of registration) has been
customers. Diversion Control (‘‘Deputy Assistant
redelegated to the Deputy Assistant Administrator’’) pursuant to section 7 of
Louis J. Milione, Administrator of the DEA Office of 28 CFR part 0, appendix to subpart R.
Deputy Assistant Administrator. Diversion Control (‘‘Deputy Assistant In accordance with 21 CFR
Administrator’’) pursuant to section 7 of 1301.33(a), this is notice that on May 19,
[FR Doc. 2016–21241 Filed 9–2–16; 8:45 am]
28 CFR part 0, appendix to subpart R. 2016, AMRI Rensselaer, Inc., 33
BILLING CODE 4410–09–P
In accordance with 21 CFR
mstockstill on DSK3G9T082PROD with NOTICES
Riverside Avenue, Rensselaer, New
1301.34(a), this is notice that on May 6, York 12144 applied to be registered as
2016, Unither Manufacturing, LLC., 331 a bulk manufacturer of the following
Clay Road, Rochester, New York 14623 basic classes of controlled substances:
applied to be registered as an importer
of methylphenidate (1724), a basic class Controlled substance Schedule
of controlled substance listed in
schedule II. Marihuana (7360) ......................... I
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Document Created: 2018-02-09 12:04:03
Document Modified: 2018-02-09 12:04:03
| 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 7, 2016. | |
| FR Citation | 81 FR 61249 |
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