Your Druggist Pharmacy; Revocation of Registration, 75774-75776 [E8-29407]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 73, Number 240 (Friday, December 12, 2008)]
[Notices]
[Pages 75774-75776]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29407]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Your Druggist Pharmacy; Revocation of Registration

    On May 28, 2008, I, the Deputy Administrator of the Drug 
Enforcement Administration, issued an Order to Show Cause and Immediate 
Suspension of Registration to Your Druggist Pharmacy (Respondent), of 
Coral Springs, Florida. The Order immediately suspended Respondent's 
DEA Certificate of Registration, AY1916103, which authorizes it to 
dispense controlled substances as a retail pharmacy, on the grounds 
that Stanley Dyen, its owner and pharmacist-in-charge, as well as two 
of its employees, Ira Friedberg, a pharmacist, and Jennifer Lee-
Richards, a pharmacy technician, were diverting large quantities of 
oxycodone, a schedule II controlled substance, and that Respondent's 
continued registration during the pendency of the proceedings 
``constitutes an imminent danger to public health and safety.'' Show 
Cause Order at 1-2 (citing 21 U.S.C. 824(d) & 841(a)). The Order also 
proposed the revocation of Respondent's registration, and the denial of 
any pending applications to renew or modify its registration, on the 
ground that Respondent's ``continued registration is inconsistent with 
the public interest.'' Order at 1 (citing 21 U.S.C. 823(f)).
    More specifically, the Show Cause Order alleged that between March 
and June 2007, pharmacy technician Lee-Richards had ``diverted at least 
5,900 dosage units of oxycodone, and at least 500 dosage units of 
alprazolam.'' Id. (citing 21 U.S.C. 841(a)(1)). With respect to 
pharmacist Friedberg, the Order alleged that in February 2008, he had 
``diverted at least 7,500 dosage units of oxycodone.'' Id. (citing 21 
U.S.C. 841(a)(1)).
    As to Stanley Dyen, the Order alleged that in February 2008, he had 
``diverted at least 500 dosage units of hydrocodone and at least 500 
dosage units of alprazolam,'' and that ``[o]n February 18, 2008, [he] 
was arrested for trafficking in hydrocodone and delivery of 
alprazolam.'' Id. at 1-2. The Order further alleged that 
notwithstanding Stanley Dyen's arrest, he ``continues to serve on a 
daily basis as'' Respondent's pharmacist, and that ``[t]he majority of 
the time, [he] is the sole pharmacist * * * and operates without the 
supervision of any other pharmacist or employee.'' Id. at 2. Finally, 
the Order alleged that on March 4, 2008, Stanley Dyen had ``transferred 
ownership of [Respondent] to * * * his wife, without complying with the 
requirements of 21 CFR 1301.52.'' Id.
    On June 2, 2008, DEA Investigators went to Respondent and served 
the Order by handing it to Stanley Dyen. On June 12, 2008, Respondent 
requested a hearing on the allegations, and the matter was assigned to 
an Administrative Law Judge (ALJ), who proceeded to conduct pre-hearing 
procedures. On July 21, 2008, however, Respondent withdrew its request 
for a hearing. That same day, the ALJ issued an order terminating the 
proceeding.
    Thereafter, the case file was forwarded to me for final agency 
action pursuant to 21 CFR 1301.43(e). Based on the letter from 
Respondent's counsel withdrawing its request for a hearing, I

[[Page 75775]]

find that Respondent has waived its right to a hearing. I therefore 
issue this Decision and Final Order without a hearing based on relevant 
material contained in the investigative file, see id., and make the 
following findings.

Findings

    Respondent is the holder of DEA Certificate of Registration, 
AY1916103, which authorized it to dispense controlled substances in 
schedule II through V as a retail pharmacy at the registered location 
of 8091 West Sample Road, Coral Springs, Florida. Respondent's 
registration does not expire until May 31, 2009.
    In June 2007, a DEA Task Force Officer (TFO) received an anonymous 
complaint that Respondent was engaged in the unlawful distribution of 
controlled substances. Thereafter, investigators observed Jennifer Lee-
Richards, a pharmacy technician employed by Respondent, leave the 
pharmacy carrying a bag which contained several small containers. Local 
police stopped Lee-Richards and found that she had in her possession 
5800 tablets of oxycodone 30 mg., and 100 tablets of Oxycontin 80 mg., 
both of which are schedule II controlled substances, 21 CFR 
1308.12(b)(1), as well as 500 tablets of alprazolam 2 mg., a schedule 
IV controlled substance. Id. 1308.14(c). During an interview, Lee-
Richards admitted that she had been taking controlled substances from 
Respondent for approximately two months and was giving them to her son 
(Twane Lee), who sold them.
    In an interview, Twane Lee admitted that he was selling various 
controlled substances which he obtained from his mother. Both Lee-
Richards and Twane Lee were subsequently indicted by a Federal Grand 
Jury and charged with conspiracy to possess oxycodone with the intent 
to distribute.
    On February 8, 2008, local police observed C.P. leaving Respondent 
carrying a white plastic bag which contained several cardboard boxes. 
The police followed C.P. and initiated a traffic stop, during which 
they found that C.P. had in his possession 7500 tablets of oxycodone 30 
mg., 200 tablets of alprazolam 2 mg., and 100 tablets of oxycodone 80 
mg. C.P. told the police he had just purchased the drugs from Ira 
Friedberg, who worked as a pharmacist at Respondent. C.P. also related 
that he had paid Friedberg $8000 for the drugs.
    C.P. cooperated with the authorities and agreed to attempt to 
purchase additional drugs from Friedberg. On February 12, 2008, 
Friedberg agreed to sell C.P. 7500 tablets of oxycodone 30 mg., in 
exchange for $7,500. Friedberg gave C.P. 7500 tablets and his car keys 
and told C.P. to place $7500 in his car's center console. Friedberg 
also gave C.P. an additional 5000 tablets of oxycodone (which Friedberg 
was to deliver to L.H., a third party) and told C.P. to place it on the 
passenger side floorboard of Friedberg's car.
    Shortly thereafter, Friedberg left Respondent, entered his car, and 
drove away. The police conducted a traffic stop and recovered the 5000 
oxycodone tablets. A TFO told Friedberg that he was aware that the 
tablets were to be delivered to L.H.; Friedberg then agreed to 
cooperate and wear a recording device.
    Friedberg then met L.H. After a conversation, L.H. went back to his 
car and retrieved approximately $5000. Friedberg and L.H. then went to 
the former's car, opened the passenger-side door, and placed the money 
on the front seat. The police immediately arrested both Friedberg and 
L.H., and recovered both the drugs and the money. Thereafter, a Federal 
Grand Jury indicted both Friedberg and L.H., charging each with 
conspiracy to possess oxycodone with the intent to distribute.
    The following day, a confidential source (CS) told the 
investigators that he had previously bought hydrocodone and alprazolam 
from Stanley Dyen without a valid prescription. The CS agreed to make a 
controlled buy of 500 tablets of hydrocodone/apap (10/650 mg.) and 500 
tablets of alprazolam 2 mg. from Dyen.
    On February 18, the CS was provided $600 of marked currency and 
went to Respondent. Upon his arrival, the CS entered Respondent and 
paid the $600 to Dyen, who then gave 500 tablets of hydrocodone/apap 
(10/650 mg.) and 500 tablets of alprazolam 2 mg. to the CS.
    Thereafter, detectives observed Dyen leave Respondent and conducted 
a traffic stop. Dyen was arrested; during a search incident to his 
arrest, Dyen was found to have in his possession the $600 of marked 
currency. Dyen was subsequently charged under state law with 
trafficking in hydrocodone and delivery of alprazolam.
    On March 14, 2008, a state search warrant was executed at 
Respondent. During the search, investigators interviewed Dyen, who 
related that his wife owned the pharmacy. Investigators subsequently 
determined that following his arrest, Dyen had transferred ownership of 
Respondent to his wife, who was now listed (with the Florida Secretary 
of State) as Respondent's President.
    Investigators subsequently determined that Respondent was the 
largest purchaser of oxycodone in the State of Florida, with its 
purchases totaling nearly 754,000 tablets between January 1 and March 
22, 2008. Moreover, during the service of the Immediate Suspension 
Order, investigators received information that Respondent has a large 
number of out-of-town customers, who had typically traveled from 
Kentucky to fill prescriptions for such drugs as oxycodone, alprazolam, 
and carisoprodol.\1\ The customers would not show up until after 5 
p.m., and the pharmacy would fill the prescriptions even if its 
employees were unable to verify the prescriptions' legitimacy with the 
prescribing practitioners because their offices were closed.
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    \1\While carisoprodol is not controlled under Federal law, it is 
controlled under various state laws and is highly popular with drug 
abusers, especially when taken as part of a drug cocktail that 
includes an opiate and a benzodiazepine.
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Discussion

    Section 304(a) of the Controlled Substance Act provides that ``[a] 
registration * * * to * * * dispense a controlled substance * * * may 
be suspended or revoked by the Attorney General upon a finding that the 
registrant * * * has committed such acts as would render his 
registration under section 823 of this title inconsistent with the 
public interest as determined under such section.'' 21 U.S.C. 824(a). 
With respect to a practitioner (which includes a retail pharmacy), the 
Act directs that the Attorney General consider the following factors in 
making the public interest determination:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing * * * 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 and 
safety.

Id. Sec.  823(f).

    ``[T]hese factors are considered in the disjunctive.'' Robert A. 
Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or a 
combination of factors, and may give each factor the weight [I] deem[] 
appropriate in determining whether a registration should be revoked.'' 
Id. Moreover, I am ``not required to make findings as to all of the 
factors.'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also 
Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir.

[[Page 75776]]

2005). Finally, where the Government has made out its prima facie case, 
the burden shifts to the Respondent to show why its continued 
registration would be consistent with the public interest. See, e.g., 
Theodore Neujahr, 65 FR 5680, 5682 (2000); Service Pharmacy, Inc., 61 
FR10791, 10795 (1996).
    In this case, having considered all of the factors, I conclude that 
the evidence with respect to factors two and four establishes a prima 
facie case that Respondent's continued registration is ``inconsistent 
with the public interest.'' 21 U.S.C. 823(f). Accordingly, Respondent's 
registration will be revoked and any pending application for renewal of 
its registration will be denied.

Factors Two and Four--Respondent's Experience in Dispensing Controlled 
Substances and Its Record of Compliance With Applicable Controlled 
Substance Laws

    As found above, the evidence in this matter establishes that 
Respondent was a supply source for the illicit drug market in such 
highly abused prescription drugs as oxycodone, a schedule II controlled 
substance, and alprazolam, a schedule IV controlled substance. As the 
record shows, at least three individuals including Respondent's owner 
unlawfully distributed prescription controlled substances which had 
been obtained by the pharmacy. See 21 U.S.C. 841(a)(1).
    Even if it was the case that Lee-Richards (the pharmacy technician) 
and Friedberg (the pharmacist) had stolen the drugs they were 
distributing, the criminal acts of Stanley Dyen, Respondent's owner and 
pharmacist-in-charge, in distributing hydrocodone and alprazolam, 
provide ample support to conclude that its continued registration is 
``inconsistent with the public interest.'' See VI Pharmacy, Rushdi Z. 
Salem, 69 FR 5584, 5585 (2004) (``It is well settled that a pharmacy 
operates under the control of owners, stockholders, pharmacists, * * * 
and if any such person is convicted of a felony offense related to 
controlled substances, grounds exists to revoke the pharmacy's 
registration.''); Charles J. Gartland, R.Ph., d.b.a. Manoa Pharmacy, 48 
FR 28760, 28761 (1983) (``Pharmacies must operate through the agency of 
natural persons, owners or stockholders, or other key employees. When 
such persons misuse the pharmacy's registration by diverting controlled 
substances obtained there under, and when those individuals are 
convicted as a result of that diversion, the pharmacy's registration 
becomes subject to revocation under 21 U.S.C. 824, just as if the 
pharmacy itself had been convicted.'').
    Nor is this rule limited to those instances in which a pharmacy's 
owner or key employee has been formally convicted of a crime. As 
explained above, under Federal law, a registration is subject to 
revocation when a registrant commits acts which render its registration 
``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). Where a 
pharmacy's owner/key employee commits criminal acts, the Agency is not 
required to wait for the judicial process to work its course before 
revoking a registration. I therefore conclude that Respondent's 
continued registration ``is inconsistent with the public interest,'' 21 
U.S.C. 823(f), and that its registration should be revoked.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a)(4), as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA 
Certificate of Registration, AY1916103, issued to Your Druggist 
Pharmacy, be, and it hereby is, revoked. I further order that any 
pending applications to renew or modify the registration be, and they 
hereby are, denied. This Order is effective immediately.

    Dated: December 2, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-29407 Filed 12-11-08; 8:45 am]
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