Notice of Registration - 2012
[Federal Register Volume 77, Number 226 (Friday, November 23, 2012)]
[Notices]
[Page 70188]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28496]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Registration;
Boehringer Ingelheim Chemicals, Inc.
By Notice dated July 17, 2012, and published in the Federal
Register on July 26, 2012, 77 FR 43863, Boehringer Ingelheim Chemicals,
Inc., 2820 N. Normandy Drive, Petersburg, Virginia 23805-9372, made
application by renewal to the Drug Enforcement Administration (DEA) to
be registered as a bulk manufacturer of the following basic classes of
controlled substances:
| Drug |
Schedule |
| Amphetamine (1100) |
II |
| Lisdexamfetamine (1205) |
II |
| Methylphenidate (1724) |
II |
| Methadone (9250) |
II |
| Methadone Intermediate (9254) |
II |
| Tapentadol (9780) |
II |
The company plans to manufacture the listed controlled substances
in bulk for sale to its customers for formulation into finished
pharmaceuticals. In reference to Methadone Intermediate (9254) the
company plans to produce Methadone HCL active pharmaceutical
ingredients (APIs) for sale to its customers.
No comments or objections have been received. DEA has considered
the factors in 21 U.S.C. 823(a) and determined that the registration of
Boehringer Ingelheim Chemicals, Inc., to manufacture the listed basic
classes of controlled substances is consistent with the public interest
at this time. DEA has investigated Boehringer Ingelheim Chemicals,
Inc., to ensure that the company's registration is consistent with the
public interest. The investigation has included inspection and testing
of the company's physical security systems; verification of the
company's compliance with state and local laws; and a review of 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 listed.
Dated: November 14, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2012-28496 Filed 11-21-12; 8:45 am]
BILLING CODE 4410-09-P
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