[Federal Register Volume 69, Number 204 (Friday, October 22, 2004)]
[Notices]
[Pages 62093-62095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-23715]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 04-01]


RX Network of South Florida, LLC Revocation of Registration

    On October 10, 2003, the then-Acting Deputy Administrator of the 
Drug Enforcement Administration (DEA),

[[Page 62094]]

issued an Order to Show Cause and Immediate Suspension of Registration 
to RX Network of South Florida, LLC (Respondent), notifying it of an 
opportunity to show cause as to why DEA should not revoke its DEA 
Certificate of Registration, BR7139238, as a retail pharmacy, and deny 
any pending applications for renewal or modification of registration 
pursuant to 21 U.S.C. 823(f) and 824(a)(4), for reason that 
Respondent's continued registration would be inconsistent with the 
public interest. The Order to Show Cause and Immediate Suspension of 
Registration further informed Respondent of the suspension of its DEA 
Certificate of Registration, as an imminent danger to the public health 
or safety pursuant to 21 U.S.C. 824(d).
    The Order to Show Cause and Immediate Suspension of Registration 
alleged in relevant part, that Respondent, owned and operated by 
Vincent Chhabra, Sabrina Faruqui and Carleta Carolina, dispensed over 
19,300,000 various controlled substances through orders of customers 
who had accessed an Internet Web site set up by Respondent. Customers 
of Respondent would complete a questionnaire set up on the Web site, 
which solicited information about the customer, including the type of 
medication desired. After the customer's credit card was processed, the 
questionnaire was forwarded to one of several ``staff'' physicians who 
then issued prescriptions for the controlled substances being ordered. 
The prescriptions were then sent electronically to Respondent, which 
then dispensed the controlled substances to customers through the mail. 
The ``staff'' physicians, as well as Respondent's customers, were 
located in various states throughout the United States and the 
physicians had no interaction with customers before prescribing the 
controlled substances.
    The Order to Show Cause and Immediate Suspension of Registration 
also alleged that on April 21, 2001, DEA issued a policy statement, 
Dispensing and Purchasing Controlled Substances over the Internet, 66 
FR 21,181 (2001). The policy statement delineated certain circumstances 
under the which DEA deems prescribing over the Internet to be unlawful, 
including, inter alia, the circumstance when a controlled substance is 
issued or dispensed without a bona fide doctor/patient relationship. 
The policy further explained that completed questionnaires, later 
reviewed by a doctor hired by the Internet pharmacy ``could not be 
considered the basis of a doctor/patient relationship.'' Id., at 
21,182-21,183. In further support of DEA policy, the Order to Show 
Cause and Immediate Suspension of Registration cited the final order 
revoking the DEA registration of a practitioner who had participated in 
an Internet pharmacy scheme similar to that of Respondent. See Rick Joe 
Nelson, M.D. 66 FR 30,752 (2001).
    The Order to Show Cause and Immediate Suspension of Registration 
further referenced correspondence during November 2002 and February 
2003 between the United States Department of Justice and the then-
attorney of Vincent Chhabar. In those letters, Mr. Chhabra's attorney 
was reminded that his client had been notified of the foregoing DEA 
policy and requested to shut down its Internet pharmacy operation.
    The Order to Show Cause and Immediate Suspension of Registration 
further referenced an order of emergency suspension issued by the 
Florida Department of Health (the Department) against Respondent on May 
30, 2002, as well as administrative complaints issued by the 
Department's Pharmacy Board against Respondent and one of its 
pharmacists. While both actions stemmed from allegations that 
Respondent operated an Internet pharmacy, the Order to Show Cause and 
Immediate Suspension of Registration referenced the Pharmacy Board's 
March 31, 2003, assessment of a $48,000 fine as the only sanction.
    The Order to Show Cause and Immediate Suspension of Registration 
further alleged that on seven separated occasions during September and 
October 2003, DEA diversion investigators and agents from the United 
States Food and Drug Administration conducted a series of undercover 
operations with the objective of obtaining controlled substances from 
Respondent through its Internet operation. The operation resulted in 
law enforcement officers receiving quantities of Bontril (a Schedule 
III controlled substance) and phentermine (a Schedule IV controlled 
substance) from Respondent after filling out Internet questionnaires 
with fictitious names and fictitious weights. The law enforcement 
officers had no contact with the prescribing physicians, who issued 
prescriptions from locations in Florida, Missouri and Pennsylvania. 
However, there were no allegations in the Order to Show Cause and 
Immediate Suspension of Registration addressing the status of 
Respondent's authorization to handle controlled substances in the State 
of Florida.
    By letter dated November 3, 2003, Respondent, through counsel, 
requested a hearing in this matter. The request included various 
arguments challenging the basis for the Order to Show Cause and 
Immediate Suspension of Registration. On November 10, 2003, Presiding 
Administrative Law Judge Mary Ellen Bittner (Judge Bittner) issued an 
Order for Prehearing Statements.
    On November 21, 2003, in lieu of a prehearing statement, counsel 
for DEA filed Government's Motion for Summary Judgment and Motion to 
Stay the Filing of Prehearing Statements. In support of its motions, 
the Government referenced a letter dated November 20, 2003, in which 
Respondent's counsel had notified the Florida Board of Pharmacy of the 
following: ``Without the ability to dispense controlled substance[s], a 
crucial element of operating a pharmacy, [Respondent] can no longer 
remain viable, and must relinquish its pharmacy permit.'' According to 
the Government, the letter indicated Respondent no longer had a 
pharmacy license in the State of Florida and, as a result, further 
proceedings in the matter were not required. Attached to the 
Government's motion was the aforementioned letter from Respondent's 
counsel to the Florida Board of Pharmacy.
    In response to the Government's motion, Respondent argued in 
relevant part, that the Order to Show Cause and Immediate Suspension of 
Registration had not alleged that it did not have a current state 
pharmacy license. Respondent further argued that its lack of such a 
license now rendered these proceedings ``legally moot'' and that the 
Administrative Law Judge should deny the Government's Motion for 
Summary Disposition and issue an order dismissing the case as moot.
    On December 17, 2003, Judge Bittner issued her Opinion and 
Recommended Decision of the Administrative Law Judge (Opinion and 
Recommended Decision). As part of her recommended ruling, Judge Bittner 
rejected Respondent's contentions concerning the Government's failure 
to initially allege lack of state authority, holding the relevant 
question was Respondent's status to handle controlled substances at the 
time of the Opinion and Recommended Decision, not at what stage of the 
proceedings that status may have changed. She further noted Respondent 
had never surrendered its DEA Certificate of Registration and that the 
surrender of its state pharmacy license did not render this proceeding 
moot.
    Judge Bittner granted the Government's Motion for Summary 
Disposition, finding Respondent lacked authorization to handle 
controlled

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substances in Florida, the jurisdiction in which it is registered with 
DEA. In granting the Government's motion, Judge Bittner further 
recommended that Respondent's DEA registration be revoked and any 
pending applications be denied. According to the letter transmitting 
this matter to the Deputy Administrator, no exceptions were filed by 
either party to the Opinion and Recommended Decision.
    The Deputy Administrator has considered the record in its entirety 
and pursuant to 21 CFR 1316.67, hereby issues her final order based 
upon the findings of fact and conclusions of law as hereinafter set 
forth. The Deputy Administrator adopts, in full, the Opinion and 
Recommenced Decision of the Administrative Law Judge.
    The Deputy Administrator finds that Respondent currently possesses 
DEA Certificate of Registration RB7139238 and is registered to handle 
controlled substances in Florida as a retail pharmacy. The Deputy 
Administrator's review of the November 20, 2003, letter from 
Respondent's counsel to the Florida Board of Pharmacy reveals that 
after receiving the order of immediate suspension of its DEA 
registration, Respondent surrendered its pharmacy permit to the Board 
of Pharmacy. It appears from this action that Respondent surrendered 
its authority to handle controlled substances in Florida and, as a 
result, lacks a necessary prerequisite for DEA registration. There is 
no evidence before the Deputy Administrator that Respondent's pharmacy 
permit has been returned or reinstated or that Respondent is currently 
licensed in Florida as a retail pharmacy. Accordingly, it is reasonable 
to infer that Respondent is without authorization to handle controlled 
substances in that state.
    DEA does not have statutory authority under the Controlled 
Substances Act to issue or maintain a registration if the applicant or 
registrant is without state authority to handle controlled substances 
in the state in which he conducts business. See 21 U.S.C. 802(21), 
823(f) and 824(a)(3). This prerequisite has been consistently upheld. 
See Prescriptionline.com, 69 FR 5583 (2004); Graham Travers Schuler, 
M.D., 65 FR 50,570 (2000); Wingfield Drugs, Inc., 52 FR 27,070 (1987). 
The agency has also maintained this standard in matters involving the 
immediate suspension of a DEA Certificate of Registration under 21 
U.S.C. 824(d). See Chemical Dependence Associates of Houston, 58 FR 
37505 (1993).
    Here, Respondent is currently not licensed to handle controlled 
substances in Florida, the state where it maintains its registration 
with DEA. Therefore, Respondent is not entitled to maintain that 
registration. Because Respondent is not entitled to a DEA registration 
in Florida due to its lack of state authorization to handle controlled 
substances, the Deputy Administrator concludes it is unnecessary to 
address whether Respondent's registration should be revoked based upon 
the public interest grounds asserted in the Order to Show Cause and 
Immediate Suspension of Registration. See Deanwood Pharmacy, 68 FR 
41662 (2003); Nathaniel-Aikens-Afful, M.D., 62 FR 16871 (1997); 
Greenbelt Professional Pharmacy, 57 FR 55000 (1992).
    Accordingly, the Deputy Administrator of the Drug Enforcement 
Administration, pursuant to the authority vested in her by 21 U.S.C. 
823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA 
Certificate of Registration, BR7139238, issued to RX Network of South 
Florida, LLC, be, and it hereby is, revoked. The Deputy Administrator 
further orders that any pending applications for renewal or 
modification of such registration be, and they hereby are, denied. This 
order is effective November 22, 2004.

    Dated: October 5, 2004.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 04-23715 Filed 10-21-04; 8:45 am]
BILLING CODE 4410-09-M