[Federal Register: July 14, 2003 (Volume 68, Number 134)]
[Notices]
[Page 41662-41663]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy03-87]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Deanwood Pharmacy: Denial of Application for Registration
I. Background
On September 5, 2001, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Deanwood Pharmacy (Respondent) of Washington,
DC, notifying Respondent of an opportunity to show cause as to why DEA
should not deny its application for DEA registration as a pharmacy
pursuant to 21 U.S.C. 824(a)(2) and (3) and 823(f), on the ground that
such registration would be inconsistent with the public interest. As a
basis for revocation, the Order to Show Cause alleged that (1)
Respondent's employee, Mr. Watson, was hired in violation of 21 CFR
1301.76, since the Respondent did not seek a waiver of this provision
prior to hiring him; (2) that Mr. Watson had used Deanwood Pharmacy's
previous DEA Certificate of Registration to purchase various controlled
substances for his personal use; (3) that in April 1999, DEA
investigators performed an accountability audit of controlled
substances, resulting in a finding of overages and shortages of the
audited drugs; and (4) that an October 22, 1999, Mr. Watson was
convicted, upon entry of a guilty pleas, of an offense related to this
handling of controlled substances.
By letter filed on October 12, 2001, the Respondent's owner
requested a hearing in this matter. On November 6, 2001, Administrative
Law Judge Gail A. Randall (the ALJ) issued an Order for Prehearing
Statements. On November 15, 2001, the Government filed a Motion for
Summary Disposition (Motion).
The Government attached to its Motion an affidavit from Antoinette
J. Williams, the Chief of DEA's registration had been surrendered on
April 2, 1999, and that the Respondent had submitted a new application
for a DEA Certificate of Registration for a retail pharmacy on or
around April 12, 1999. The Government also attached a letter dated
August 1, 2001, from the Government of the District of Columbia,
Department of Health, asserting that Deanwood Pharmacy did not have a
current pharmacy license or DC Controlled Substance Registration.
Based on the attachments, the Government argued that the Respondent
did not have a valid license to operate a pharmacy or to handle
controlled substances in the jurisdiction of his requested DEA
certificate. Accordingly, the Government asserted that the Respondent's
pending DEA application must be denied.
After numerous extensions of time and motions to stay proceedings,
the ALJ issued an Order on January 30, 2002, giving the respondent
until February 22, 2002, to respond to the Government's Motion. On that
date, the Respondent filed an Opposition to Government's Motion for
Summary Disposition, asserting that the Respondent had a pending
application filed on January 11, 2002, before the Department of Health
for the District of Columbia, (Department of Health) for a controlled
substances registration. The Respondent also noted that the Government
contacted the Department of Health on or about January 18, 2002, and
provided that office the information in the show cause order in this
matter. As a result of the exchange of information, the Respondent now
believed that the Department of Health's decision regarding the
application for authority to handle controlled substances would not be
resolved for several months. Accordingly, the Respondent asked that
this matter be stayed until a decision was rendered by the Department
of Health, in order to avoid further delay in DEA's processing of
Respondent's application. The Respondent did not disagree with the
Government's assertions that the Respondent was currently not
authorized to handle controlled substances in the District of Columbia,
the business address of the Respondent-pharmacy, or that the Respondent
lacked a pharmacy license.
By order of March 7, 2002, the ALJ granted the Government's Motion,
on the ground that DEA does not have statutory authority under the
Controlled Substances Act to grant a registration if the applicant has
no state authority to dispense controlled substances.
II. Final Order
The Acting Administrator adopts the ALJ's decision granting the
Government's Motion, and all of the ALJ's prior decisions on motions in
this matter. The Acting Administrator has carefully reviewed the entire
record in this matter, as defined above, and hereby issues this final
rule and final order prescribed by 21 CFR 1316.67 and 21 CFR 1301.46,
based upon the following findings of fact and conclusions.
As stated by the ALJ in her order granting the Government's motion,
DEA has no authority to grant a registration if the registrant is
without state authority to dispense controlled substances in the state
in which the Respondent's business is located. 21 U.S.C. 823(f) and
824(a)(3): See Graham Travers Schuler, M.D., 65 FR 50,570 (DEA 2000);
see also Saihb S. Halil, M.D., 64 FR 33,319 (DEA 1999); Greenbelt
Professional Pharmacy, 57 FR 55,000 (DEA 1992).
Moreover, when there is not material questions of fact involved, or
when the facts are agreed upon, there is no need
[[Page 41663]]
for a plenary, administration hearing. Congress did not intend for
administrative agencies to perform meaningless tasks. See Michael G.
Dolin, M.D., 65 FR 5,661 (2000); see also Jesus R. Juarez, M.D., 62 FR
14,945 (1997); Philip E. Kirk, M.D., 48 FR 32,887 (1983), aff'd sub nom
Kirk v. Mullen, 749 F.2d 297 (6th Cir. 1984).
In the instate case, the documents attached to the Government's
Motion fully support the allegation that Respondent does not have state
authority to handle controlled substances. Moreover, the Respondent
does not argue that this information is incorrect. Accordingly, absent
an affirmative dispute of that fact by the Respondent, there is no need
for a hearing in this matter.
Furthermore, as the ALJ found, given DEA's lack of statutory
authority to grant the Respondent's application for a DEA registration,
due to the Respondent's lack of authority to handle controlled
substances in the District of Columbia, it is unnecessary to determine
whether the Respondent's application should be denied based upon any of
the other grounds alleged in the Order to Show Cause. See Greenbelt
Professional Pharmacy at 55,000 (respondent's lack of state
authorization to handle controlled substances makes it unnecessary to
decide the issue of whether respondent's continued registration is
consistent with the public interest.)
In conclusion, considering the Government's evidence and the
Respondent's failure to deny that is it not currently authorized to
handle controlled substances in the District of Columbia, the Acting
Administrator finds that the Respondent currently does not have
authority to handle controlled substances in the location of its place
of business on its application for a DEA registration. Accordingly, the
Government's Motion for Summary Disposition is granted, and the
Respondent's application for DEA registration is hereby denied. This
order is effective August 13, 2003.
Dated: June 23, 2003.
William B. Simpkins,
Acting Administrator.
[FR Doc. 03-17713 Filed 7-11-03; 8:45 am]
BILLING CODE 4410-09-M