Registrant Actions - 2008
FR Doc E8-29407[Federal Register: December 12, 2008 (Volume 73, Number 240)]
[Notices]
[Page 75774-75776]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12de08-119]
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]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
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