[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
