[Federal Register Volume 73, Number 143 (Thursday, July 24, 2008)]
[Notices]
[Page 43259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16906]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration

    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:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
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.

    Dated: July 18, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E8-16906 Filed 7-23-08; 8:45 am]
BILLING CODE 4410-09-P