80 FR 46336 - Importer of Controlled Substances Registration: Meridian Medical Technologies
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 149 (August 4, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 149 (August 4, 2015)
| Page Range | 46336-46336 | |
| FR Document | 2015-19164 |
[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)] [Notices] [Page 46336] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-19164] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Registration: Meridian Medical Technologies ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Meridian Medical Technologies applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Meridian Medical Technologies registration as an importer of this controlled substance. SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22553, Meridian Medical Technologies, 2555 Hermelin Drive, St. Louis, Missouri 63144 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 Meridian Medical Technologies 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 morphine (9300), a basic class controlled substance listed in schedule II. The company manufactures a product containing morphine in the United States. The company exports this product to customers around the world. The company has been asked to ensure that its product, which is sold to European customers, meets the standards established by the European Pharmacopeia, administered by the Directorate for the Quality of Medicines (EDQM). In order to ensure that its product will meet European specifications, the company seeks to import morphine supplied by EDQM for use as reference standards. This is the sole purpose for which the company will be authorized by the DEA to import morphine. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-19164 Filed 8-3-15; 8:45 am] BILLING CODE 4410-09-P
![46336 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices
Controlled substance Schedule The company manufactures a product local laws, and reviewing the company’s
containing morphine in the United background and history.
Fentanyl (9801) ............................ II States. The company exports this Therefore, pursuant to 21 U.S.C.
product to customers around the world. 823(a), and in accordance with 21 CFR
The company plans to import small The company has been asked to ensure 1301.33, the above-named company is
quantities of the listed controlled that its product, which is sold to granted registration as a bulk
substances in dosage form to conduct European customers, meets the manufacturer of the basic classes of
clinical trials. standards established by the European controlled substances:
Dated: July 29, 2015. Pharmacopeia, administered by the
Joseph T. Rannazzisi, Directorate for the Quality of Medicines Controlled substance Schedule
Deputy Assistant Administrator. (EDQM). In order to ensure that its
product will meet European Oxymorphone (9652) ................... II
[FR Doc. 2015–19109 Filed 8–3–15; 8:45 am] Noroxymorphone (9668) .............. II
specifications, the company seeks to
BILLING CODE 4410–09–P
import morphine supplied by EDQM for
The company plans to manufacture
use as reference standards.
the listed controlled substance as an
This is the sole purpose for which the
DEPARTMENT OF JUSTICE active pharmaceutical ingredient (API)
company will be authorized by the DEA
for clinical trials.
Drug Enforcement Administration to import morphine.
Dated: July 29, 2015.
[Docket No. DEA–392] Dated: July 29, 2015.
Joseph T. Rannazzisi,
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
Importer of Controlled Substances Deputy Assistant Administrator.
[FR Doc. 2015–19099 Filed 8–3–15; 8:45 am]
Registration: Meridian Medical [FR Doc. 2015–19164 Filed 8–3–15; 8:45 am]
Technologies BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
ACTION: Notice of registration.
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
SUMMARY: Meridian Medical
Technologies applied to be registered as Drug Enforcement Administration
Drug Enforcement Administration
an importer of a certain basic class of
[Docket No. DEA–392] [Docket No. DEA–392]
controlled substance. The Drug
Enforcement Administration (DEA) Manufacturer of Controlled
grants Meridian Medical Technologies Manufacturer of Controlled
Substances Registration: Pharmacore, Substances Registration: Cambrex
registration as an importer of this Charles City
controlled substance. Inc.
SUPPLEMENTARY INFORMATION: By notice ACTION: Notice of registration. ACTION: Notice of registration.
dated April 14, 2015, and published in
the Federal Register on April 22, 2015, SUMMARY: Pharmacore, Inc. applied to SUMMARY: Cambrex Charles City applied
80 FR 22553, Meridian Medical be registered as a manufacturer of to be registered as a manufacturer of
Technologies, 2555 Hermelin Drive, St. certain basic classes of controlled certain basic classes of controlled
Louis, Missouri 63144 applied to be substances. The Drug Enforcement substances. The Drug Enforcement
registered as an importer of a certain Administration (DEA) grants Administration (DEA) grants Cambrex
basic class of controlled substance. No Pharmacore, Inc. registration as a Charles City registration as a
comments or objections were submitted manufacturer of those controlled manufacturer of those controlled
for this notice. substances. substances.
The DEA has considered the factors in SUPPLEMENTARY INFORMATION: By notice SUPPLEMENTARY INFORMATION: By notice
21 U.S.C. 823, 952(a) and 958(a) and dated April 14, 2015, and published in dated April 14, 2015, and published in
determined that the registration of the Federal Register on April 22, 2015, the Federal Register on April 22, 2015,
Meridian Medical Technologies to 80 FR 22554, Pharmacore, Inc., 4180 80 FR 22555, Cambrex Charles City,
import the basic class of controlled Mendenhall Oaks Parkway, High Point, 1205 11th Street, Charles City, Iowa
substance is consistent with the public North Carolina 27265 applied to be 50616 applied to be registered as a
interest and with United States registered as a manufacturer of certain manufacturer of certain basic classes of
obligations under international treaties, basic classes of controlled substances. controlled substances. No comments or
conventions, or protocols in effect on No comments or objections were objections were submitted for this
May 1, 1971. The DEA investigated the submitted for this notice. notice.
company’s maintenance of effective The DEA has considered the factors in The DEA has considered the factors in
controls against diversion by inspecting 21 U.S.C. 823(a) and determined that 21 U.S.C. 823(a) and determined that
and testing the company’s physical the registration of Pharmacore, Inc. to the registration of Cambrex Charles City
security systems, verifying the manufacture the basic classes of to manufacture the basic classes of
company’s compliance with state and controlled substances is consistent with controlled substances is consistent with
local laws, and reviewing the company’s the public interest and with United the public interest and with United
background and history. States obligations under international States obligations under international
tkelley on DSK3SPTVN1PROD with NOTICES
Therefore, pursuant to 21 U.S.C. treaties, conventions, or protocols in treaties, conventions, or protocols in
952(a) and 958(a), and in accordance effect on May 1, 1971. The DEA effect on May 1, 1971. The DEA
with 21 CFR 1301.34, the above-named investigated the company’s maintenance investigated the company’s maintenance
company is granted registration as an of effective controls against diversion by of effective controls against diversion by
importer of morphine (9300), a basic inspecting and testing the company’s inspecting and testing the company’s
class controlled substance listed in physical security systems, verifying the physical security systems, verifying the
schedule II. company’s compliance with state and company’s compliance with state and
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Document Created: 2015-12-18 14:51:20
Document Modified: 2015-12-18 14:51:20
| 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 46336 |
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