80 FR 29337 - Importer of Controlled Substances Registration: Mylan Pharmaceuticals, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 98 (May 21, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 98 (May 21, 2015)
| Page Range | 29337-29337 | |
| FR Document | 2015-12327 |
[Federal Register Volume 80, Number 98 (Thursday, May 21, 2015)] [Notices] [Page 29337] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-12327] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Registration: Mylan Pharmaceuticals, Inc. ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Mylan Pharmaceuticals, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Mylan Pharmaceuticals, Inc. registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated January 9, 2015, and published in the Federal Register on January 26, 2015, 80 FR 3980, Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505 applied to be registered as an importer 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, 952(a) and 958(a) and determined that the registration of Mylan Pharmaceuticals, Inc. to import 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. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of the basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Amphetamine (1100)......................... II Methylphenidate (1724)..................... II Oxycodone (9143)........................... II Hydromorphone (9150)....................... II Methadone (9250)........................... II Morphine (9300)............................ II Fentanyl (9801)............................ II ------------------------------------------------------------------------ The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company's own domestically-manufactured FDF. This analysis is required to allow the company to export domestically-manufactured FDF to foreign markets. Dated: May 15, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-12327 Filed 5-20-15; 8:45 am] BILLING CODE P
![Federal Register / Vol. 80, No. 98 / Thursday, May 21, 2015 / Notices 29337
2015, 80 FR 7633, Myoderm, 48 East DEPARTMENT OF JUSTICE analysis is required to allow the
Main Street, Norristown, Pennsylvania company to export domestically-
19401 applied to be registered as an Drug Enforcement Administration manufactured FDF to foreign markets.
importer of certain basic classes of [Docket No. DEA–392] Dated: May 15, 2015.
controlled substances. No comments or Joseph T. Rannazzisi,
objections were submitted for this Importer of Controlled Substances Deputy Assistant Administrator.
notice. Registration: Mylan Pharmaceuticals,
[FR Doc. 2015–12327 Filed 5–20–15; 8:45 am]
Inc.
The DEA has considered the factors in BILLING CODE P
21 U.S.C. 823, 952(a) and 958(a) and ACTION: Notice of registration.
determined that the registration of
Myoderm to import the basic classes of SUMMARY: Mylan Pharmaceuticals, Inc. DEPARTMENT OF JUSTICE
controlled substances is consistent with applied to be registered as an importer
the public interest and with United of certain basic classes of controlled Drug Enforcement Administration
States obligations under international substances. The Drug Enforcement [Docket No. DEA–392]
treaties, conventions, or protocols in Administration (DEA) grants Mylan
effect on May 1, 1971. The DEA Pharmaceuticals, Inc. registration as an Importer of Controlled Substances
importer of those controlled substances. Registration: Noramco, Inc.
investigated the company’s maintenance
SUPPLEMENTARY INFORMATION: By notice
of effective controls against diversion by ACTION: Notice of registration.
inspecting and testing the company’s dated January 9, 2015, and published in
the Federal Register on January 26,
physical security systems, verifying the SUMMARY: Noramco, Inc. applied to be
2015, 80 FR 3980, Mylan
company’s compliance with state and registered as an importer of certain basic
Pharmaceuticals, Inc., 781 Chestnut
local laws, and reviewing the company’s Ridge Road, Morgantown, West Virginia classes of controlled substances. The
background and history. 26505 applied to be registered as an Drug Enforcement Administration
Therefore, pursuant to 21 U.S.C. importer of certain basic classes of (DEA) grants Noramco, Inc. registration
952(a) and 958(a), and in accordance controlled substances. No comments or as an importer of those controlled
with 21 CFR 1301.34, the above-named objections were submitted for this substances.
company is granted registration as an notice. SUPPLEMENTARY INFORMATION: By notice
importer of the basic classes controlled The DEA has considered the factors in dated January 9, 2015, and published in
substances: 21 U.S.C. 823, 952(a) and 958(a) and the Federal Register on January 26,
determined that the registration of 2015, 80 FR 3980, Noramco, Inc., 500
Controlled substance Schedule Mylan Pharmaceuticals, Inc. to import Swedes Landing Road, Wilmington,
the basic classes of controlled Delaware 19801–4417 applied to be
Amphetamine (1100) .................... II substances is consistent with the public registered as an importer of certain basic
Lisdexamfetamine (1205) ............. II interest and with United States classes of controlled substances. No
Methylphenidate (1724) ................ II obligations under international treaties, comments or objections were submitted
Pentobarbital (2270) ..................... II conventions, or protocols in effect on for this notice. Comments and request
Nabilone (7379) ............................ II May 1, 1971. The DEA investigated the for hearings on applications to import
Codeine (9050) ............................. II company’s maintenance of effective narcotic raw material are not
Oxycodone (9143) ........................ II controls against diversion by inspecting appropriate. 72 FR 3417 (January 25,
Hydromorphone (9150) ................ II and testing the company’s physical 2007).
Hydrocodone (9193) ..................... II security systems, verifying the The DEA has considered the factors in
Levomethorphan (9210) ............... II company’s compliance with state and 21 U.S.C. 823, 952(a) and 958(a) and
Meperidine (9230) ........................ II local laws, and reviewing the company’s determined that the registration of
Methadone (9250) ........................ II background and history. Noramco, Inc. to import the basic
Methadone intermediate (9254) ... II Therefore, pursuant to 21 U.S.C. classes of controlled substances is
Morphine (9300) ........................... II 952(a) and 958(a), and in accordance consistent with the public interest and
Oxymorphone (9652) ................... II with 21 CFR 1301.34, the above-named with United States obligations under
Fentanyl (9801) ............................ II company is granted registration as an international treaties, conventions, or
importer of the basic classes of protocols in effect on May 1, 1971. The
The company plans to import the controlled substances: DEA investigated the company’s
listed controlled substances in finished maintenance of effective controls
dosage form for clinical trials, and Controlled substance Schedule against diversion by inspecting and
research. testing the company’s physical security
Amphetamine (1100) .................... II
The import of the above listed basic Methylphenidate (1724) ................ II systems, verifying the company’s
classes of controlled substances will be Oxycodone (9143) ........................ II compliance with state and local laws,
granted only for analytical testing and Hydromorphone (9150) ................ II and reviewing the company’s
Methadone (9250) ........................ II background and history.
clinical trials. This authorization does Morphine (9300) ........................... II Therefore, pursuant to 21 U.S.C.
not extend to the import of a finished Fentanyl (9801) ............................ II 952(a) and 958(a), and in accordance
FDA approved or non-approved dosage
with 21 CFR 1301.34, the above-named
tkelley on DSK3SPTVN1PROD with NOTICES
form for commercial sale. The company plans to import the company is granted registration as an
Dated: May 15, 2015. listed controlled substances in finished importer of the basic classes of
dosage form (FDF) from foreign sources controlled substances:
Joseph T. Rannazzisi,
for analytical testing and clinical trials
Deputy Assistant Administrator. in which the foreign FDF will be Controlled substance Schedule
[FR Doc. 2015–12329 Filed 5–20–15; 8:45 am] compared to the company’s own
BILLING CODE 4410–09–P domestically-manufactured FDF. This Phenylacetone (8501) .................. II
VerDate Sep<11>2014 20:28 May 20, 2015 Jkt 235001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1](https://thefederalregister.org/doc/80_FR_29435/page/1.svg)
Document Created: 2018-10-24 10:26:40
Document Modified: 2018-10-24 10:26:40
| 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 29337 |
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