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Notice

Manufacturer of Controlled Substances Registration: Halo Pharmaceutical, Inc.

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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ACTION:

Notice of registration.

SUMMARY:

Halo Pharmaceutical, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Halo Pharmaceutical, Inc. registration as a manufacturer of those controlled substances.

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SUPPLEMENTARY INFORMATION:

By notice dated January 9, 2015, and published in the Federal Register on January 26, 2015, 80 FR 3979, Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, New Jersey 07981 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted to this notice.

The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Halo Pharmaceutical, Inc. to manufacture 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. 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:

Controlled substanceSchedule
Dihydromorphine (9145)I
Hydromorphone (9150)II

The company plans to manufacture Hydromorphone HCL for sale to other manufacturers and to manufacture other controlled substances for distribution to its customers. Dihydromorphine is an intermediate in the manufacture of Hydromorphone and is not for commercial distribution.

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Dated: June 25, 2015.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.

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[FR Doc. 2015-16456 Filed 7-2-15; 8:45 am]

BILLING CODE 4410-09-P