[Federal Register Volume 64, Number 62 (Thursday, April 1, 1999)]
[Notices]
[Pages 15809-15810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7929]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Prodim Denial of Application

    On June 5, 1998, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA) issued an 
Order to Show Cause to Prodim (Respondent) proposing to deny its 
application for registration as an exporter of Schedule II, III and IV 
controlled substances under 21 U.S.C. 958, for reason that its 
registration would be inconsistent with the public interest pursuant to 
21 U.S.C. 823 (a) and (b).
    The Order to Show Cause was ultimately received by Randall Tetzner 
who signed the application for registration on behalf of Respondent. By 
letter dated September 4, 1998, Respondent waived its opportunity for a 
hearing and instead submitted a written statement pursuant to 21 CFR 
1301.43(c).
    Therefore, the Deputy Administrator concludes that Respondent has 
waived its opportunity for a hearing and hereby enters his final order 
in this matter based upon the investigative file and Respondent's 
written statement pursuant to 21 CFR 1301.43 (c) and (e) and 1301.46.
    The Deputy Administrator finds that Randall Tetzner, on behalf of 
Respondent, submitted an application dated October 7, 1995, for 
registration with DEA as an exporter of Schedule II, III and IV 
controlled substances. According to Mr. Tetzner, Respondent wants to be 
registered in order to send donated or purchased controlled substances 
to Honduras. In describing Respondent, Mr. Tetzner stated that ``[t]he 
organization I volunteer with and work with supplies needed medications 
to rural villages in Honduras. * * * From a base camp in La Paz, a 
worker brings replacement medications via motorcycle to the villages.''
    After numerous discussions and correspondence between DEA and Mr. 
Tetzner, an Order to Show Cause was issued on June 5, 1998, proposing 
to deny Respondent's application for registration. Specifically, the 
Order to Show Cause alleges that Respondent's registration would be 
inconsistent with

[[Page 15810]]

the public interest based upon the following:

    a. Mr. Tetzner is the sole representative of Prodim. On the 
application for DEA registration he provided as an address his 
trailer home. This location does not have secure controlled 
substance storage facilities and Prodim does not have an alternative 
location with which to securely store controlled substances, as 
required by 21 CFR Sec. 1301.72. Therefore, Mr. Tetzner has not 
demonstrated that he can maintain effective controls against the 
diversion of controlled substances as required pursuant to 21 U.S.C. 
Sec. 823(a)(1).
    b. In a letter to DEA dated February 15, 1996, Mr. Tetzner, 
informed DEA that he had never before exported controlled 
substances. Therefore, Prodim has no experience in the export of 
controlled substances. 21 U.S.C. Sec. 958(a) and Sec. 823(a)(5) and 
(d)(5).

    In his written statement dated September 4, 1998, Mr. Tetzner 
indicated that he never meant to store controlled substances at his 
home, but instead proposed that Respondent would ``give DEA at least 30 
days notice of our intent to send the medications, we purchase or 
recieve [sic] the medications at a hospital or drug company, then while 
on site we do the required paperwork and on site we ship the 
medications pursuant [sic] to DEA directives. * * * The medications 
would only go from an already registered facility, be transferred via 
paperwork, then the donating agency would then confirm the transfer and 
they would ship the drugs. In no manner shall PRODIM ever possess these 
drugs other than to count and verify on site.'' Further, Mr. Tetzner 
indicated that he has been a paramedic for a number of years and as 
such understands the importance of documenting the use of controlled 
substances.
    Pursuant to 21 U.S.C. 958 and 823, the Deputy Administrator may 
deny an application for registration as an exporter of controlled 
substances if he finds that such registration would be inconsistent 
with the public interest. In determining the public interest, the 
Deputy Administrator shall consider the factors set forth in 21 U.S.C. 
823(a) for registration to export Schedule II controlled substances and 
the factors set forth in 21 U.S.C. 823(d) for registration to export 
Schedule III and IV controlled substances. The factors in these two 
sections are essentially the same. Pursuant to 21 U.S.C. 823(d), the 
Deputy Administrator shall consider:

(1) Maintenance of effective controls against diversion of particular 
controlled substances and any controlled substances in Schedule III, 
IV, or V compounded therefrom into other than legitimate medical, 
scientific, or industrial channels;
(2) Compliance with applicable State and local law;
(3) Promotion of technical advances in the art of manufacturing these 
substances and the development of new substances;
(4) Prior conviction record of applicant under Federal or State laws 
relating to the manufacture, distribution, or dispensing of such 
substances;
(5) Past experience in the manufacture, distribution, and dispensing of 
controlled substances, and the existence in the establishment of 
effective controls against diversion; and
(6) Such other factors as may be relevant to and consistent with the 
public health and safety.

    The Deputy Administrator finds that there is no evidence in the 
record regarding factors two, three or four. Regarding factor one, 
there is very little specific evidence in the record as to the controls 
Respondent will maintain against the diversion of controlled 
substances. In its written statement, Respondent maintains that it will 
not take possession of the controlled substances; that the substances 
would be sent from a location already registered with DEA, that the 
donating agency would confirm the transfer and ship the rugs, and that 
Respondent will only count and verify the drugs on site.
    Pursuant to 21 CFR 1301.43(c), a written statement ``shall be made 
a part of the record and shall be considered in light of the lack of 
opportunity for cross-examination in determining the weight to be 
attached to matters of fact asserted therein.'' The Deputy 
Administrator finds that the assertions in Respondent's written 
statement warrant little weight. The Deputy Administrator is unable to 
determine from Respondent's written statement who would be responsible 
for the controlled substances since the controlled substances would be 
stored at the donating agency and the donating agency would confirm the 
transfer and ship the drugs. Further, the Deputy Administrator is 
unable to determine what controls against diversion would be in place 
during the shipment of any controlled substances. Of even greater 
concern is that the Deputy Administrator is unable to determine from 
Respondent's written statement the identity or location of the donating 
agency or agencies, and is therefore unable to determine whether 
effective controls are maintained to prevent the diversion of exported 
controlled substances.
    Regarding factor five while Mr. Tetzner indicates that he has 
handled controlled substances as a paramedic and a Navy corpsman, there 
is no evidence that he has any experience in exporting controlled 
substances, nor in the responsibilities of a DEA registrant in 
preventing the diversion of controlled substances.
    As to factor six, the record indicates that Respondent and Mr. 
Tetzner do not have sufficient knowledge and understanding of the 
export requirements set forth in 21 U.S.C. 953 and 21 CFR 1312.21. In 
Respondent's written statement, Mr. Tetzner states that it will ``give 
the DEA at least 30 days notice of our intent to send the medications. 
* * *'' Respondent does not discuss whether its proposed exportations 
would meet the requirements of 21 U.S.C. 953, nor does it indicate that 
it will follow the procedures set forth in 21 CFR 1312.21 regarding 
obtaining the authorization to export specific shipments. Particularly 
troubling to the Deputy Administrator is that the record indicates that 
Mr. Tetzer was advised by DEA on several occasions of these 
requirements and was told where he could obtain a copy of the 
regulations, yet he did not do so.
    The Deputy Administrator concludes that based upon the record 
currently before him Respondent's registration as an exporter of 
controlled substances would be inconsistent with the public interest. 
There is no evidence that Respondent would maintain effective controls 
against the diversion of controlled substances; that Respondent 
possesses relevant experience in the handling of controlled substances; 
and that Respondent understands the export requirements set forth in 21 
U.S.C. 953 and 21 CFR 1312.21.
    Accordingly, the Deputy Administrator of the Drug Enforcement 
Administration pursuant to the authority vested in him by 21 U.S.C. 823 
and 958 and 28 CFR 0.100(b) and 0.104, hereby orders that the 
application for registration submitted by Prodim, be, and it hereby is, 
denied. This order is effective May 3, 1999.

    Dated: March 15, 1999.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 99-7929 Filed 3-31-99; 8:45 am]
BILLING CODE 4410-09-M