80 FR 46335 - Importer of Controlled Substances Registration: Actavis Laboratories FL, Inc.
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 | 46335-46335 | |
| FR Document | 2015-19162 |
[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)] [Notices] [Page 46335] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-19162] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Registration: Actavis Laboratories FL, Inc. ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Actavis Laboratories FL, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Actavis Laboratories FL, Inc., registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22554, Actavis Laboratories FL, Inc., 4955 Orange Drive, Davie, Florida 33314 applied to be registered as an importer of a 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 Actavis Laboratories FL, 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 following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Amphetamine (1100)......................... II Methylphenidate (1724)..................... II Oxycodone (9143)........................... II Hydromorphone (9150)....................... II Hydrocodone (9193)......................... II Fentanyl (9801)............................ II ------------------------------------------------------------------------ The company plans to import the above-listed controlled substances for clinical trials, research and analytical purposes. The import of the above-listed basic classes of controlled substances would be granted only for analytical testing and clinical trials. This authorization does not extend to the import of a finished Food and Drug Administration approved or non-approved dosage form for commercial distribution in the United States. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-19162 Filed 8-3-15; 8:45 am] BILLING CODE P
![Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices 46335
substances. The Drug Enforcement DEPARTMENT OF JUSTICE finished Food and Drug Administration
Administration (DEA) grants Johnson approved or non-approved dosage form
Matthey, Inc. registration as a Drug Enforcement Administration for commercial distribution in the
manufacturer of those controlled [Docket No. DEA–392] United States.
substances. Dated: July 29, 2015.
Importer of Controlled Substances Joseph T. Rannazzisi,
SUPPLEMENTARY INFORMATION: By notice Registration: Actavis Laboratories FL,
dated February 11, 2015, and published Deputy Assistant Administrator.
Inc.
in the Federal Register on February 19, [FR Doc. 2015–19162 Filed 8–3–15; 8:45 am]
2015, 80 FR 8902, Johnson Matthey, ACTION: Notice of registration. BILLING CODE P
Inc., Pharmaceuticals Materials, 900
River Road, Conshohocken, SUMMARY: Actavis Laboratories FL, Inc.
Pennsylvania 19428 applied to be applied to be registered as an importer DEPARTMENT OF JUSTICE
registered as a manufacturer of certain of certain basic classes of controlled
substances. The Drug Enforcement Drug Enforcement Administration
basic classes of controlled substances.
No comments or objections were Administration (DEA) grants Actavis [Docket No. DEA–392]
submitted to this notice. Laboratories FL, Inc., registration as an
importer of those controlled substances. Importer of Controlled Substances
The DEA has considered the factors in Registration: Almac Clinical Services
SUPPLEMENTARY INFORMATION: By notice
21 U.S.C. 823(a) and determined that Inc. (ACSI)
dated April 14, 2015, and published in
the registration of Johnson Matthey, Inc.
the Federal Register on April 22, 2015,
to manufacture the basic classes of ACTION: Notice of registration.
80 FR 22554, Actavis Laboratories FL,
controlled substances is consistent with
Inc., 4955 Orange Drive, Davie, Florida SUMMARY: Almac Clinical Services Inc.
the public interest and with United
33314 applied to be registered as an (ACSI) applied to be registered as an
States obligations under international
importer of a certain basic classes of importer of certain basic classes of
treaties, conventions, or protocols in
controlled substances. No comments or controlled substances. The Drug
effect on May 1, 1971. The DEA
objections were submitted for this Enforcement Administration (DEA)
investigated the company’s maintenance
notice. grants Almac Clinical Services Inc.
of effective controls against diversion by The DEA has considered the factors in
inspecting and testing the company’s (ACSI) registration as an importer of
21 U.S.C. 823, 952(a) and 958(a) and those controlled substances.
physical security systems, verifying the determined that the registration of
company’s compliance with state and SUPPLEMENTARY INFORMATION: By notice
Actavis Laboratories FL, Inc. to import
local laws, and reviewing the company’s dated April 14, 2015, and published in
the basic classes of controlled
background and history. the Federal Register on April 22, 2015,
substances is consistent with the public
Therefore, pursuant to 21 U.S.C. 80 FR 22556, Almac Clinical Services
interest and with United States
823(a), and in accordance with 21 CFR Inc. (ACSI), 25 Fretz Road, Souderton,
obligations under international treaties,
1301.33, the above-named company is Pennsylvania 18964 applied to be
conventions, or protocols in effect on
granted registration as a bulk registered as an importer of certain basic
May 1, 1971. The DEA investigated the
manufacturer of the basic classes of classes of controlled substances. No
company’s maintenance of effective
controlled substances listed: comments or objections were submitted
controls against diversion by inspecting
for this notice.
and testing the company’s physical The DEA has considered the factors in
Controlled substance Schedule security systems, verifying the 21 U.S.C. 823, 952(a) and 958(a) and
company’s compliance with state and determined that the registration of
Gamma Hydroxybutyric Acid I
(2010).
local laws, and reviewing the company’s Almac Clinical Services Inc. (ACSI) to
Amphetamine (1100) .................... II background and history. import the basic classes of controlled
Methylphenidate (1724) ................ II Therefore, pursuant to 21 U.S.C.
substances is consistent with the public
Codeine (9050) ............................. II 952(a) and 958(a), and in accordance
interest and with United States
Oxycodone (9143) ........................ II with 21 CFR 1301.34, the above-named
obligations under international treaties,
Diphenoxylate (9170) ................... II company is granted registration as an
conventions, or protocols in effect on
Hydrocodone (9193) ..................... II importer of the following basic classes
Meperidine (9230) ........................ II
May 1, 1971. The DEA investigated the
of controlled substances:
Methadone (9250) ........................ II company’s maintenance of effective
Methadone intermediate (9254) ... II Controlled substance Schedule controls against diversion by inspecting
Morphine (9300) ........................... II and testing the company’s physical
Thebaine (9333) ........................... II Amphetamine (1100) .................... II security systems, verifying the
Methylphenidate (1724) ................ II company’s compliance with state and
Oxycodone (9143) ........................ II local laws, and reviewing the company’s
The company plans to manufacture
Hydromorphone (9150) ................ II background and history.
the listed controlled substances in bulk Hydrocodone (9193) ..................... II
for distribution and sale to its Therefore, pursuant to 21 U.S.C.
Fentanyl (9801) ............................ II
customers. 952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the above-named
The thebaine (9333) will be used to The company plans to import the
company is granted registration as an
manufacture other controlled substances above-listed controlled substances for
importer of the following basic classes
tkelley on DSK3SPTVN1PROD with NOTICES
for sale in bulk to its customers. clinical trials, research and analytical
of controlled substances:
purposes.
Dated: July 29, 2015. The import of the above-listed basic
Joseph T. Rannazzisi, Controlled substance Schedule
classes of controlled substances would
Deputy Assistant Administrator. be granted only for analytical testing Oxycodone (9143) ........................ II
[FR Doc. 2015–19100 Filed 8–3–15; 8:45 am] and clinical trials. This authorization Hydromorphone (9150) ................ II
BILLING CODE 4410–09–P does not extend to the import of a Tapentadol (9780) ........................ II
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Document Created: 2015-12-18 14:50:56
Document Modified: 2015-12-18 14:50:56
| 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 46335 |
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