[Federal Register Volume 68, Number 134 (Monday, July 14, 2003)]
[Notices]
[Pages 41662-41663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17713]


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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