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Notice

Importer of Controlled Substances; Notice of Registration

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Information about this document as published in the Federal Register.

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By Notice dated January 11, 2006 and published in the Federal Register on January 23, 2006, (71 FR 3545), Cody Laboratories, Inc., 601 Yellowstone Avenue, Cody, Wyoming 82414-9321, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances listed in schedule II:

DrugSchedule
Raw Opium (9600)II.
Poppy Straw (9650)II.
Concentrate of Poppy Straw (9670)II.

The company plans to import narcotic raw materials for manufacturing and further distribution to its customers. The company is registered with DEA as a manufacturer of several controlled substances that are manufactured from raw opium, poppy straw, and concentrate of poppy straw.

Comments, objections, and requests for a hearing were received. However, after a thorough review of this matter DEA has concluded that, per 21 CFR 1301.34(a), the objectors are not entitled to a hearing. As explained in the Correction to Notice of Application dated January 25, 2007, pertaining to Cody Laboratories et al. (72 FR 3417), comments and requests for hearings on applications to import narcotic raw material are not appropriate.

DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of Cody Laboratories, 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. DEA investigated Cody Laboratories, Inc. to ensure that the company's registration would be consistent with the public interest. The investigation 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. After investigating these and other matters, I have concluded that registering Cody Laboratories, Inc. to import raw opium, poppy straw, and concentrate of poppy straw is consistent with the factors set forth in 21 U.S.C. 823(a)(2)-(6), as incorporated in 21 U.S.C. 958(a).

The DEA also considered whether the registration of Cody Laboratories, Inc. would be consistent with 21 U.S.C. 823(a)(1) that requires the DEA to limit the importation of certain controlled substances (including raw opium, poppy straw, and concentrate of poppy straw) “to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions* * *.” I find that the establishments currently registered with DEA to import raw opium, poppy straw, and concentrate of poppy straw provide an adequate and uninterrupted supply of those substances. The DEA found no evidence that the supply of such substances was inadequate or interrupted in supplying the needs of the United States for legitimate medical, scientific, research, and industrial purposes.

However, I find that the adequate and uninterrupted supply of these substances did not occur under adequately competitive conditions. Specifically, I find that Cody Laboratories, Inc. has demonstrated that the current importers of raw opium, poppy straw, and concentrate of poppy straw have, in some cases, refused to sell these substances to Cody Laboratories, Inc. Some of the current importers also use their position to demand restrictive contractual terms when selling narcotic raw material to Cody Laboratories, Inc. Many of the current importers also manufacture active pharmaceutical ingredients or have corporate ties to firms that manufacture active pharmaceutical ingredients from raw opium, poppy straw, and concentrate of poppy straw. These importers have a direct financial interest in refusing to sell narcotic raw material to Cody Laboratories, Inc. or in demanding significant contractual restrictions when selling narcotic raw material to Cody Laboratories, Inc.

Based on the information in the investigative file that is summarized herein, I find that the current importation of raw opium, poppy straw, and concentrate of poppy straw is not being conducted under adequately competitive conditions. Therefore, under 21 U.S.C. 823(a)(1), DEA may grant the application of Cody Laboratories, Inc. to import raw opium, poppy straw, and concentrate of poppy straw. Having already found that registering Cody Laboratories, Inc. to import raw opium, poppy straw, and concentrate of poppy straw is consistent with the factors set forth in 21 U.S.C. 823(a)(2)-(6), I find that the statutory factor set forth in 21 U.S.C. 823(a)(1) also weighs in favor of granting the application.

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 basic classes of controlled substances listed.

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Dated: July 18, 2008.

Joseph T. Rannazzisi,

Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.

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[FR Doc. E8-16906 Filed 7-23-08; 8:45 am]

BILLING CODE 4410-09-P