[Federal Register Volume 69, Number 24 (Thursday, February 5, 2004)]
[Notices]
[Pages 5584-5585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2343]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


VI Pharmacy, Rushdi Z. Salem; Revocation of Registration

    On June 13, 2003, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to VI Pharmacy (VI) and Rushdi Z. Salem of St. 
Thomas, U.S. Virgin Islands, notifying VI of an opportunity to show 
cause as to why DEA should not revoke VI's DEA Certificate of 
Registration, BV5900421 under 21 U.S.C. 824(a)(1), (a)(2) and (a)(4) 
and deny any pending applications for renewal or modification of VI's 
retail pharmacy registration. As a basis for revocation, the Order to 
Show Cause alleged that VI materially falsified an application for 
registration, that Mr. Salem, the owner/operator of VI had been 
convicted of a felony related to controlled substances and that VI's 
continued registration was inconsistent with the public interest. The 
Order to Show Cause also notified VI that should no request for a 
hearing be filed within 30 days, its hearing right would be deemed 
waived.
    The Order to Show Cause was sent by certified mail to VI and Mr. 
Salem, at VI's registered location at 25 Dronings Gade Main Street, St. 
Thomas, U.S. Virgin Islands 00801. According to the return receipt, the 
Order to Show Cause was received at the registered address and 
receipted for by B. Nelthrop on or around June 23, 2003.
    DEA has not received a request for hearing or any other reply from 
VI or anyone purporting to represent it in this matter. Therefore, the 
Acting Deputy Administrator, finding that (1) 30 days have passed since 
the receipt of the Order to Show Cause, and (2) no request for a 
hearing having been received, concludes that VI is deemed to have 
waived its hearing right. See Samuel S. Jackson, D.D.S., 67 FR 65145 
(2002); David W. Linder, 67 FR 12579 (2002). After considering material 
from the investigative file, the Acting Deputy Administrator now enters 
her final order without a hearing pursuant to 21 CFR 1301.43(d) and (e) 
and 1301.46.
    Pursuant to 21 U.S.C. 824(a)(1), the Acting Deputy Administrator 
may revoke a DEA Certificate of Registration and deny any pending 
applications for such a certificate upon a finding that the registrant 
has materially falsified any DEA application for registration. Pursuant 
to 21 U.S.C. 824(a)(2), the Deputy Administrator may revoke a DEA 
Certificate of Registration and deny any pending applications for such 
a certificate upon a finding that the registrant has been convicted of 
a felony related to controlled substances under State or Federal law.
    In addition, the Acting Deputy Administrator may revoke a DEA 
Certificate of Registration and deny any pending applications for such 
certificate if she determines that the issuance of such registration 
would be inconsistent with the public interest as determined pursuant 
to 21 U.S.C. 823(a)(4) and 823(f). Section 823(f) requires the 
following factors be considered:
    (1) The recommendation of the appropriate state licensing board or 
professional disciplinary authority.
     (2) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
     (3) The applicant's conviction record under Federal or State laws 
relating to the manufacture, distribution, or dispensing of controlled 
substances.
     (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
     (5) Such other conduct which may threaten the public health or 
safety.

[[Page 5585]]

     As a threshold matter, it should be noted that the factors 
specified in section 823(f) are to be considered in the disjunctive: 
The Acting Deputy Administrator may properly rely on any one or a 
combination of the factors, and give each factor the weight she deems 
appropriate, in determining whether a registration should be revoked or 
denied. Henry J. Schwarz, Jr., M.D., 54 FR 16422 (1989)
     The Acting Deputy Administrator finds that in 1998, VI Pharmacy, 
through and by Mr. Rushdi Salem, R.Ph, submitted an Application for DEA 
Registration as a retail pharmacy. Instead of the required evidence of 
State/jurisdiction licensure for the pharmacy, Mr. Rushdi submitted a 
copy of his personal Virgin Islands Pharmacist License, No. 125. 
Despite this, VI was issued and currently possesses DEA Certificate of 
Registration BV5900421 which, after its 2001 renewal, currently expires 
on May 31, 2004.
     On April 18, 2001, Mr. Salem submitted a renewal application for 
VI's DEA Certificate of Registration, which he signed and certified as 
being true and correct. In response to question 3 of the application, 
asking if the applicant was authorized to distribute, dispense or 
otherwise handle controlled substances in the Virgin Islands, he 
checked the block ``Yes'' and represented that VI held Virgin Island 
registration number 11387. However the Virgin Island Board of Pharmacy 
indicates VI has never held any Board of Pharmacy license to operate as 
a pharmacy in its jurisdiction.
     Pursuant to 21 U.S.C. 824(a0(1), falsification of a DEA 
application constitutes independent grounds to revoke a registration. 
Past cases have established that the appropriate test for determining 
whether an applicant materially falsified any application is whether 
the applicant ``knew or should have known'' that the submitted 
application was false. See Barry H. Brooks, M.D., 66 FR 18305, 18307 
(2001); Terrance E. Murphy, M.D., 61 FR 2841, 2844 (1996); Bobby Watts, 
M.D., 58 FR 46995 (1993).
     Prior DEA cases have also held that `` `[s]ince [it] must rely on 
the truthfulness of information supplied by applicants in registering 
them to handle controlled substances, falsification cannot be 
tolerated.' '' See Terrance E. Murphy, M.D., supra, 61 FR at 2845 
(quoting Bobby Watts, M.D.., supra, 58 FR at 46995.). Further, in prior 
DEA cases the Deputy Administrator has held that the totality of the 
circumstances is to be considered in determining whether a registration 
should be revoked because of a registrant's material falsification of 
an application. See Barry H. Brooks, M.D., supra, 66 FR at 18308; 
Martha Hernandez, M.D., 62 FR 61145, 61147-48.
     After considering the totality of the circumstances, the Acting 
Deputy Administrator finds that VI, through its owner Mr. Rushdi, 
provided false information in its April 18, 2001, Application for DEA 
Registration and this misrepresentation constitutes a material 
falsification of an application warranting revocation of VI's 
certificate.
    The Acting Deputy Administrator further finds that in December 
2000, an undercover U.S. Federal agent posing as a patient contacted VI 
Pharmacy by phone requesting narcotics without a prescription. He was 
told to fax an order and credit card number. The agent later faxed a 
request for approximately 200 dosage units of Schedule II and III 
narcotic controlled substances. VI Pharmacy, by return fax, quoted a 
per-pill price for some, but not all of the drugs. In a subsequent 
phone call, Mr. Salem told the agent to come to VI in person to 
purchase the drugs. Later that month, without a prescription, the agent 
purchased 100 tablets of Vicodin, a controlled substance, from Mr. 
Salem. In February 2001, using the mail, the agent then bought another 
100 tablets of Vicodin and on two occasions in May 2001, the agent 
visited the pharmacy and purchased a total of 1,100 tablets of Vicodin. 
Finally, in June 2001, the agent purchased 1,500 tablets of Vicodin 
from Mr. Salem's brother, an employee of VI. All of these purchases 
were made without a prescription.
    On January 20, 2003, in United States v. Rushdi Z. Salem, United 
States District Court for the Virgin Islands, Criminal Case No. 2001-
235, Mr. Salem pled guilty to 21 U.S.C. 841(a)(1), knowingly and 
intentionally distributing a controlled substance. It is well settled 
that a pharmacy operates under the control of owners, stockholders, 
pharmacists, or other employees, and if any such person is convicted of 
a felony offense related to controlled substances, grounds exist to 
revoke the pharmacy's registration under 21 USC 824(a)(2). See Rick's 
Pharmacy, Inc., 62 FR 42595, 42597 (1997); Maxicare Pharmacy, 61 FR 
27368 (1996); Big-T Pharmacy, Inc., 47 FR 51830 (1982). The Acting 
Deputy Administrator finds that grounds exist to revoke VI's 
registration under 21 USC 824(a)(2) based on the controlled substance 
related felony conviction of Mr. Rushdi.
    Finally, with regard to the public interest factors of 21 U.S.C. 
823(f), the Acting Deputy Administrator considers the above facts as 
relevant and adverse to the registrant under factors two, three, four 
and five of section 823(f). She concludes that VI Pharmacy's continued 
registration is inconsistent with the public interest, as that term is 
used in 21 U.S.C. 823(f) and 824(a)(4).
    Accordingly, the Acting 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 BV5900421, issued to VI Pharmacy, be, 
and it hereby is, revoked. The Acting Deputy Administrator further 
orders that any pending applications for renewal of such registration 
be, and they hereby are, denied. This order is effective March 8, 2004.

    Dated: January 7, 2004.
Michele M. Leonhart,
Acting Deputy Administrator.
[FR Doc. 04-2343 Filed 2-4-04; 8:45 am]
BILLING CODE 4410-09-M