2014-24035. Manufacturer of Controlled Substances Registration: Siemens Healthcare Diagnostics, Inc.

ACTION:

Notice of registration.

SUMMARY:

Siemens Healthcare Diagnostics, Inc., applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Siemens Healthcare Diagnostics, Inc. registration as a manufacturer of those controlled substances.

SUPPLEMENTARY INFORMATION:

By notice dated May 2, 2014, and published in the Federal Register on May 15, 2014, 79 FR 27936, Siemens Healthcare Diagnostics, Inc., Attn: RA, 100 GBC Drive, Mailstop 514, Newark, Delaware 19702, applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted to this notice.

The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Siemens Healthcare Diagnostics, 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 listed:

Controlled substance	Schedule
Tetrahydrocannabinols (7370)	I
Ecgonine (9180)	II
Morphine (9300)	II

The company plans to produce the listed controlled substances in bulk to be used in the manufacture of reagents and drug calibrator controls which are DEA exempt products.

In reference to drug code 7370 the company plans to bulk manufacture a synthetic tetrahydrocannabinol. No other activity for this drug code is authorized for this registration.

Dated: October 1, 2014.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.