80 FR 38471 - Manufacturer of Controlled Substances Registration: Euticals, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 128 (July 6, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 128 (July 6, 2015)
| Page Range | 38471-38471 | |
| FR Document | 2015-16454 |
[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)] [Notices] [Page 38471] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16454] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Manufacturer of Controlled Substances Registration: Euticals, Inc. ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Euticals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Euticals, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated January 9, 2015, and published in the Federal Register on January 26, 2015, 80 FR 3978, Euticals, Inc., 2460 W. Bennett Street, Springfield, Missouri 65807- 1229 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted to this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Euticals, 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 basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Gamma Hydroxybutyric Acid (2010)........... I Amphetamine (1100)......................... II Lisdexamfetamine (1205).................... II Methylphenidate (1724)..................... II Phenylacetone (8501)....................... II Methadone (9250)........................... II Methadone intermediate (9254).............. II Oripavine (9330)........................... II Tapentadol (9780).......................... II ------------------------------------------------------------------------ The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers. In reference to Amphetamine (1100), the company plans to acquire the listed controlled substance in bulk from a domestic source in order to manufacture other controlled substances in bulk for distribution to its customers. Dated: June 25, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-16454 Filed 7-2-15; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices 38471
The company plans to import 1301.33, the above-named company is respect to the promulgation and
analytical reference standards for granted registration as a bulk implementation of 21 CFR part 1301,
distribution to its customers for research manufacturer of the basic classes of incident to the registration of
and analytical purposes. Placement of controlled substances: manufacturers, distributors, dispensers,
these drug codes onto the company’s importers, and exporters of controlled
registration does not translate into Controlled substance Schedule substances (other than final orders in
automatic approval of subsequent connection with suspension, denial, or
permit applications to import controlled Gamma Hydroxybutyric Acid I revocation of registration) has been
(2010).
substances. Approval of permit Amphetamine (1100) .................... II
redelegated to the Deputy Assistant
applications will occur only when the Lisdexamfetamine (1205) ............. II Administrator of the DEA Office of
registrant’s business activity is Methylphenidate (1724) ................ II Diversion Control (‘‘Deputy Assistant
consistent with what is authorized Phenylacetone (8501) .................. II Administrator’’) pursuant to section 7 of
under 21 U.S.C. 952(a)(2). Authorization Methadone (9250) ........................ II 28 CFR part 0, appendix to subpart R.
will not extend to the import of FDA Methadone intermediate (9254) ... II In accordance with 21 CFR
approved or non-approved finished Oripavine (9330) ........................... II 1301.33(a), this is notice that on
dosage forms for commercial sale. Tapentadol (9780) ........................ II February 4, 2015, Navinta, LLC, 1499
Dated: June 25, 2015. Lower Ferry Road, Ewing, New Jersey
The company plans to manufacture 08618–1414 applied to be registered as
Joseph T. Rannazzisi, the listed controlled substances in bulk a bulk manufacturer of the following
Deputy Assistant Administrator. for distribution and sale to its basic classes of controlled substances:
[FR Doc. 2015–16448 Filed 7–2–15; 8:45 am] customers.
BILLING CODE 4410–09–P In reference to Amphetamine (1100),
the company plans to acquire the listed
controlled substance in bulk from a Controlled substance Schedule
DEPARTMENT OF JUSTICE domestic source in order to manufacture
other controlled substances in bulk for 4-Anilino-N-phenethyl-4-piperidine II
Drug Enforcement Administration distribution to its customers. (ANPP) (8333).
Fentanyl (9801) ............................ II
[Docket No. DEA–392] Dated: June 25, 2015.
Joseph T. Rannazzisi, The company plans initially to
Manufacturer of Controlled
Deputy Assistant Administrator. manufacture API quantities of the listed
Substances Registration: Euticals, Inc.
[FR Doc. 2015–16454 Filed 7–2–15; 8:45 am] controlled substances for validation
ACTION: Notice of registration. BILLING CODE 4410–09–P purposes and FDA approval, then
eventually upon FDA approval to
SUMMARY: Euticals, Inc. applied to be produce commercial size batches for
registered as a manufacturer of certain DEPARTMENT OF JUSTICE distribution to dosage form
basic classes of controlled substances. manufacturers.
The Drug Enforcement Administration Drug Enforcement Administration
Dated: June 25, 2015.
(DEA) grants Euticals, Inc. registration [Docket No. DEA–392] Joseph T. Rannazzisi,
as a manufacturer of those controlled
substances. Deputy Assistant Administrator.
Bulk Manufacturer of Controlled
[FR Doc. 2015–16441 Filed 7–2–15; 8:45 am]
SUPPLEMENTARY INFORMATION: By notice Substances Application: Navinta, LLC
BILLING CODE 4410–09–P
dated January 9, 2015, and published in
the Federal Register on January 26, ACTION: Notice of application.
2015, 80 FR 3978, Euticals, Inc., 2460 DEPARTMENT OF JUSTICE
DATES: Registered bulk manufacturers of
W. Bennett Street, Springfield, Missouri
the affected basic classes, and
65807–1229 applied to be registered as Drug Enforcement Administration
applicants therefore, may file written
a manufacturer of certain basic classes
comments on or objections to the [Docket No. DEA–392]
of controlled substances. No comments
issuance of the proposed registration in
or objections were submitted to this Importer of Controlled Substances
accordance with 21 CFR 1301.33(a) on
notice. Registration: Mylan Pharmaceuticals,
The DEA has considered the factors in or before September 4, 2015.
ADDRESSES: Written comments should Inc.
21 U.S.C. 823(a) and determined that
the registration of Euticals, Inc. to be sent to: Drug Enforcement ACTION: Notice of registration.
manufacture the basic classes of Administration, Attention: DEA Federal
controlled substances is consistent with Register Representative/ODXL, 8701 SUMMARY: Mylan Pharmaceuticals, Inc.
the public interest and with United Morrissette Drive, Springfield, Virginia applied to be registered as an importer
States obligations under international 22152. Request for hearings should be of certain basic classes of controlled
treaties, conventions, or protocols in sent to: Drug Enforcement substances. The Drug Enforcement
effect on May 1, 1971. The DEA Administration, Attention: Hearing Administration (DEA) grants Mylan
investigated the company’s maintenance Clerk/LJ, 8701 Morrissette Drive, Pharmaceuticals, Inc. registration as an
of effective controls against diversion by Springfield, Virginia 22152. importer of those controlled substances.
Lhorne on DSK7TPTVN1PROD with NOTICES
inspecting and testing the company’s SUPPLEMENTARY INFORMATION: The SUPPLEMENTARY INFORMATION: By notice
physical security systems, verifying the Attorney General has delegated his dated March 20, 2015, and published in
company’s compliance with state and authority under the Controlled the Federal Register on March 27, 2015,
local laws, and reviewing the company’s Substances Act to the Administrator of 80 FR 16436, Mylan Pharmaceuticals,
background and history. the Drug Enforcement Administration Inc., 3711 Collins Ferry Road,
Therefore, pursuant to 21 U.S.C. (DEA), 28 CFR 0.100(b). Authority to Morgantown, West Virginia 26505
823(a), and in accordance with 21 CFR exercise all necessary functions with applied to be registered as an importer
VerDate Sep<11>2014 14:37 Jul 02, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\06JYN1.SGM 06JYN1](https://thefederalregister.org/doc/80_FR_38599/page/1.svg)
Document Created: 2015-12-15 13:17:23
Document Modified: 2015-12-15 13:17:23
| 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 | 80 FR 38471 |
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