80 FR 42544 - Importer of Controlled Substances Registration: Meda Pharmaceuticals, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 137 (July 17, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 137 (July 17, 2015)
| Page Range | 42544-42545 | |
| FR Document | 2015-17514 |
[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)] [Notices] [Pages 42544-42545] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-17514] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Registration: Meda Pharmaceuticals, Inc. ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Meda Pharmaceuticals, Inc. applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Meda Pharmaceuticals, Inc. registration as an importer of this controlled substance. SUPPLEMENTARY INFORMATION: By notice dated March 20, 2015, and published in the Federal Register on March 27, 2015, 80 FR 16426, Meda Pharmaceuticals, Inc., 705 Eldorado Street, Decatur, Illinois 62523 applied to be registered as an importer of a certain basic class of controlled substance. 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 Meda Pharmaceuticals, Inc. to import the basic class of controlled substance 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 nabilone (7379) a basic class of controlled substance listed in schedule II. [[Page 42545]] The company plans to import the FDA approved drug product in finished dosage form for distribution to its customers. Dated: July 10, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-17514 Filed 7-16-15; 8:45 am] BILLING CODE 4410-09-P
![42544 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
Proposed 2016
Basic class quotas
(g)
Methadone (for sale) ..................................................................................................................................................................... 31,875,000
Methadone Intermediate ................................................................................................................................................................ 34,375,000
Methamphetamine ......................................................................................................................................................................... 2,061,375
[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 750,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 61,375 grams for methamphetamine (for sale)]
Methylphenidate ............................................................................................................................................................................. 87,500,000
Morphine (for conversion) .............................................................................................................................................................. 91,250,000
Morphine (for sale) ........................................................................................................................................................................ 62,500,000
Nabilone ......................................................................................................................................................................................... 18,750
Noroxymorphone (for conversion) ................................................................................................................................................. 17,500,000
Noroxymorphone (for sale) ............................................................................................................................................................ 1,475,000
Opium (powder) ............................................................................................................................................................................. 112,500
Opium (tincture) ............................................................................................................................................................................. 687,500
Oripavine ........................................................................................................................................................................................ 30,000,000
Oxycodone (for conversion) .......................................................................................................................................................... 6,250,000
Oxycodone (for sale) ..................................................................................................................................................................... 139,150,000
Oxymorphone (for conversion) ...................................................................................................................................................... 29,000,000
Oxymorphone (for sale) ................................................................................................................................................................. 7,750,000
Pentobarbital .................................................................................................................................................................................. 38,125,000
Phenazocine .................................................................................................................................................................................. 6
Phencyclidine ................................................................................................................................................................................. 50
Phenmetrazine ............................................................................................................................................................................... 3
Phenylacetone ............................................................................................................................................................................... 50
Racemethorphan ........................................................................................................................................................................... 3
Remifentanil ................................................................................................................................................................................... 3,750
Secobarbital ................................................................................................................................................................................... 215,003
Sufentanil ....................................................................................................................................................................................... 6,255
Tapentadol ..................................................................................................................................................................................... 25,500,000
Thebaine ........................................................................................................................................................................................ 125,000,000
List I Chemicals
Ephedrine (for conversion) ............................................................................................................................................................ 100,000
Ephedrine (for sale) ....................................................................................................................................................................... 4,000,000
Phenylpropanolamine (for conversion) .......................................................................................................................................... 22,400,000
Phenylpropanolamine (for sale) ..................................................................................................................................................... 8,500,000
Pseudoephedrine (for conversion) ................................................................................................................................................ 7,000
Pseudoephedrine (for sale) ........................................................................................................................................................... 224,500,000
The Administrator further proposes DEPARTMENT OF JUSTICE objections were submitted for this
that the aggregate production quotas for notice.
all other basic classes of schedule I and Drug Enforcement Administration The DEA has considered the factors in
II controlled substances included in 21 21 U.S.C. 823, 952(a) and 958(a) and
CFR 1308.11 and 1308.12 remain at [Docket No. DEA–392] determined that the registration of Meda
zero. In accordance with 21 CFR Pharmaceuticals, Inc. to import the
Importer of Controlled Substances
1303.13 and 21 CFR 1315.13, upon basic class of controlled substance is
Registration: Meda Pharmaceuticals,
consideration of the relevant factors, the consistent with the public interest and
Inc.
Administrator may adjust the 2016 with United States obligations under
aggregate production quotas and ACTION: Notice of registration. international treaties, conventions, or
assessment of annual needs as protocols in effect on May 1, 1971. The
necessary. SUMMARY: Meda Pharmaceuticals, Inc. DEA investigated the company’s
applied to be registered as an importer maintenance of effective controls
Dated: July 13, 2015.
of a certain basic class of controlled against diversion by inspecting and
Chuck Rosenberg, substance. The Drug Enforcement testing the company’s physical security
Acting Administrator. Administration (DEA) grants Meda systems, verifying the company’s
[FR Doc. 2015–17561 Filed 7–16–15; 8:45 am] Pharmaceuticals, Inc. registration as an compliance with state and local laws,
BILLING CODE P importer of this controlled substance. and reviewing the company’s
SUPPLEMENTARY INFORMATION: By notice background and history.
srobinson on DSK5SPTVN1PROD with NOTICES
dated March 20, 2015, and published in Therefore, pursuant to 21 U.S.C.
the Federal Register on March 27, 2015, 952(a) and 958(a), and in accordance
80 FR 16426, Meda Pharmaceuticals, with 21 CFR 1301.34, the above-named
Inc., 705 Eldorado Street, Decatur, company is granted registration as an
Illinois 62523 applied to be registered as importer of nabilone (7379) a basic class
an importer of a certain basic class of of controlled substance listed in
controlled substance. No comments or schedule II.
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![Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices 42545
The company plans to import the Controlled substance Schedule Controlled substance Schedule
FDA approved drug product in finished
dosage form for distribution to its Tapentadol (9780) ........................ II Remifentanil (9739) ...................... II
customers.
Dated: July 10, 2015. The company plans to manufacturer The company plans to initially
bulk active pharmaceutical ingredients manufacture API quantities of the listed
Joseph T. Rannazzisi,
(API) for distribution and product controlled substances for validation
Deputy Assistant Administrator.
development to its customers. purposes and FDA approval, and then
[FR Doc. 2015–17514 Filed 7–16–15; 8:45 am] produce commercial size batches for
Dated: July 10, 2015.
BILLING CODE 4410–09–P distribution to dosage form
Joseph T. Rannazzisi,
manufacturers upon FDA approval.
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE [FR Doc. 2015–17523 Filed 7–16–15; 8:45 am] Dated: July 10, 2015.
BILLING CODE 4410–09–P
Joseph T. Rannazzisi,
Drug Enforcement Administration Deputy Assistant Administrator.
[Docket No. DEA–392] [FR Doc. 2015–17525 Filed 7–16–15; 8:45 am]
DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P
Manufacturer of Controlled
Substances Registration: Mallinckrodt, Drug Enforcement Administration
LLC [Docket No. DEA–392] DEPARTMENT OF JUSTICE
ACTION: Notice of registration. Manufacturer of Controlled Drug Enforcement Administration
SUMMARY: Mallinckrodt, LLC applied to Substances Registration: Navinta LLC [Docket No. DEA–392]
be registered as a manufacturer of
certain basic classes of controlled ACTION: Notice of registration. Importer of Controlled Substances
substances. The Drug Enforcement Registration: Siegfried USA, LLC
SUMMARY: Navinta LLC applied to be
Administration (DEA) grants registered as a manufacturer of certain ACTION: Notice of registration.
Mallinckrodt, LLC registration as a basic classes of controlled substances.
manufacturer of those controlled The Drug Enforcement Administration SUMMARY: Siegfried USA, LLC applied to
substances. (DEA) grants Navinta LLC registration as be registered as an importer of certain
SUPPLEMENTARY INFORMATION: By notice a manufacturer of those controlled basic classes of controlled substances.
dated January 21, 2015, and published substances. The Drug Enforcement Administration
in the Federal Register on January 28, (DEA) grants Siegfried USA, LLC
SUPPLEMENTARY INFORMATION: By notice
2015, 80 FR 4592, Mallinckrodt LLC, registration as an importer of those
dated February 11, 2015, and published
3600 North Second Street, St. Louis, controlled substances.
in the Federal Register on February 19,
Missouri 63147 applied to be registered 2015, 80 FR 8901, Navinta LLC, 1499 SUPPLEMENTARY INFORMATION: By notice
as a manufacturer of certain basic Lower Ferry Road, Ewing, New Jersey dated April 14, 2015, and published in
classes of controlled substances. No 08618–1414 applied to be registered as the Federal Register on April 22, 2015,
comments or objections were submitted a manufacturer of certain basic classes 80 FR 22561, Siegfried USA, LLC, 33
to this notice. of controlled substances. No comments Industrial Park Road, Pennsville, New
The DEA has considered the factors in Jersey 08070 applied to be registered as
or objections were submitted for this
21 U.S.C. 823(a) and determined that an importer of certain basic classes of
notice.
the registration of Mallinckrodt, LLC to controlled substances. Comments and
The DEA has considered the factors in
manufacture the basic classes of requests for hearings on applications to
21 U.S.C. 823(a) and determined that
controlled substances is consistent with import narcotic raw material are not
the registration of Navinta LLC to
the public interest and with United appropriate. 72 FR 3417 (January 25,
manufacture the basic classes of
States obligations under international 2007).
controlled substances is consistent with
treaties, conventions, or protocols in The DEA has considered the factors in
the public interest and with United
effect on May 1, 1971. The DEA 21 U.S.C. 823, 952(a) and 958(a) and
States obligations under international
investigated the company’s maintenance determined that the registration of
treaties, conventions, or protocols in
of effective controls against diversion by Siegfried USA, LLC to import the basic
effect on May 1, 1971. The DEA
inspecting and testing the company’s classes of controlled substances is
investigated the company’s maintenance
physical security systems, verifying the consistent with the public interest and
of effective controls against diversion by
company’s compliance with state and with United States obligations under
inspecting and testing the company’s
local laws, and reviewing the company’s international treaties, conventions, or
physical security systems, verifying the
background and history. protocols in effect on May 1, 1971. The
Therefore, pursuant to 21 U.S.C. company’s compliance with state and
local laws, and reviewing the company’s DEA investigated the company’s
823(a), and in accordance with 21 CFR maintenance of effective controls
1301.33, the above-named company is background and history.
Therefore, pursuant to 21 U.S.C. against diversion by inspecting and
granted registration as a bulk testing the company’s physical security
manufacturer of the following basic 823(a), and in accordance with 21 CFR
systems, verifying the company’s
srobinson on DSK5SPTVN1PROD with NOTICES
classes of controlled substances: 1301.33, the above-named company is
granted registration as a bulk compliance with state and local laws,
manufacturer of the basic classes of and reviewing the company’s
Controlled substance Schedule background and history.
controlled substances listed:
Gamma Hydroxybutyric Acid I Therefore, pursuant to 21 U.S.C.
(2010). Controlled substance Schedule 952(a) and 958(a), and in accordance
Lisdexamfetamine (1205) ............. II with 21 CFR 1301.34, the above-named
Oripavine (9330) ........................... II Pentobarbital (2270) ..................... II company is granted registration as an
VerDate Sep<11>2014 20:59 Jul 16, 2015 Jkt 235001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\17JYN1.SGM 17JYN1](https://thefederalregister.org/doc/80_FR_42681/page/2.svg)
Document Created: 2018-02-23 09:21:45
Document Modified: 2018-02-23 09:21:45
| 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 42544 |
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