S & S Pharmacy, Inc., d/b/a Platinum Pharmacy & Compounding; Decision and Order, 57656-57660 [2013-22793]
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Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Notices
GEORGIA
Jones County
Shaver, Herman and Allene, House, 1421
Monticello Hwy., Wayside Community,
13000813
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Hospital Historic District, (United States
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MPS) 5000 S. 5th Ave., Hines, 13000814
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Inc, Civil Action No. 1:13-cv-01482,
with the United States District Court for
the Eastern District of California, Fresno
Division.
The proposed Consent Decree
resolves the claims of the United States
and the San Joaquin Valley Unified Air
Pollution Control District (the ‘‘Air
District’’) against Post Holdings, Inc.
and Ralcorp Holdings, Inc. for violations
of the Clean Air Act, 42 U.S.C. 7413,
and the federally enforceable California
state implementation plan. The
plaintiffs alleged that defendants’ cereal
manufacturing facility in Modesto,
California operated without the
appropriate permits and pollution
controls. Under the Consent Decree,
defendants will pay a civil penalty of
$635,000 ($317,500 shall be paid to the
United States; $317,500 shall be paid to
the Air District); shall operate and
maintain the facility’s pollution control
equipment as specified; and shall
comply with recordkeeping and
monitoring requirements.
The publication of this notice opens
a period for public comment on the
Consent Decree. Comments should be
addressed to the Assistant Attorney
General, Environment and Natural
Resources Division, and should refer to
United States and San Joaquin Valley
Unified Air Pollution Control District v.
Post Holdings, Inc. and Ralcorp
Holdings, Inc., D.J. Ref. No. 90–5–2–1–
10136. All comments must be submitted
no later than thirty (30) days after the
publication date of this notice.
Comments may be submitted either by
email or by mail:
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To submit
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Send them to:
By email ...
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usdoj.gov.
Assistant Attorney General, U.S.
DOJ—ENRD, P.O. Box 7611,
Washington, D.C. 20044–
7611.
By mail .....
Racine County
Burlington Cemetery Chapel, 701 S. Browns
Lake Dr., Burlington, 13000824
[FR Doc. 2013–22769 Filed 9–18–13; 8:45 am]
BILLING CODE 4312–51–P
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DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the Clean Air
Act
On September 13, 2013, the
Department of Justice lodged a proposed
Consent Decree in United States and
San Joaquin Valley Unified Air
Pollution Control District v. Post
Holdings, Inc. and Ralcorp Holdings,
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During the public comment period,
the Consent Decree may be examined
and downloaded at this Justice
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www.usdoj.gov/enrd/Consent_
Decrees.html. We will provide a paper
copy of the Consent Decree upon
written request and payment of
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request and payment to: Consent Decree
Library, U.S. DOJ—ENRD, P.O. Box
7611, Washington, DC 20044–7611.
Please enclose a check or money order
for $9.75 (25 cents per page
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reproduction cost) payable to the United
States Treasury.
Henry S. Friedman,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
[FR Doc. 2013–22808 Filed 9–18–13; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
S & S Pharmacy, Inc., d/b/a Platinum
Pharmacy & Compounding; Decision
and Order
On October 27, 2011, I, the
Administrator of the Drug Enforcement
Administration, issued an Order to
Show Cause and Immediate Suspension
of Registration to S & S Pharmacy, Inc.,
d/b/a Platinum Pharmacy &
Compounding (hereinafter, Registrant),
of Tampa, Florida. GX B, at 1. The Show
Cause Order proposed the revocation of
Registrant’s Certificate of Registration as
a retail pharmacy, which before it
expired, authorized it to dispense
controlled substances in schedules II
through V, as well as the denial of any
pending application to renew or modify
its registration, on the ground that its
‘‘continued registration is inconsistent
with the public interest.’’ Id.
More specifically, the Order alleged
that Registrant was ‘‘owned and
operated by Ihab S. Barsoum,’’ a
registered pharmacist and that its
registration was due to expire ‘‘on
February 12, 2012.’’ Id. The Order
further alleged that Registrant’s owner/
operator had ‘‘unlawfully distributed
oxycodone, a Schedule II narcotic
controlled substance, in exchange for
cash, based on fraudulent
prescriptions.’’ Id. at 2. The Order then
alleged that Barsoum had made the
following five unlawful distributions:
(1) on January 24, 2011, 429 dosage
units of oxycodone 30mg. and 372
dosage units of oxycodone 15mg. for
$2,500 cash;
(2) on February 2, 2011, 1,000 dosage
units of oxycodone 30mg. for $4,000
cash;
(3) on March 7, 2011, 2,000 dosage
units of oxycodone 30mg. for $8,100
cash;
(4) on April 13, 2011, 700 dosage
units of oxycodone 30mg. for $3,500
cash; and
(5) on June 23, 2011, 800 dosage units
of oxycodone 30mg. for $4,000 cash. Id.
Based on the above, I further
concluded that Registrant’s continued
registration during the pendency of the
proceedings ‘‘constitutes an imminent
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danger to the public health and safety’’
and ordered that its registration be
immediately suspended. Id. (citing 21
U.S.C. 824(d); 21 CFR 1301.36(e)).
Pursuant to my authority under section
824(d) and 21 CFR 1301.36(f), I
authorized ‘‘the Special Agents and
Diversion Investigators . . . who
serve[d]’’ the Order ‘‘to place under seal
or to remove for safekeeping all
controlled substances’’ possessed by
Registrant ‘‘pursuant to [its]
registration.’’ Id.
On October 28, 2011, the Order,
which also notified Registrant of its
right to either request a hearing on the
allegations or to submit a written
statement as to the matters of fact and
law involved in lieu of a hearing, the
procedure for electing either option, and
the consequence of failing to elect either
option, was personally served on Mr.
Barsoum. See id. (citing 21 CFR
1301.43(a), (c)–(e)); GX C. Thereafter,
neither Mr. Barsoum, nor any other
person purporting to represent
Registrant, timely requested a hearing,
or submitted a written statement.
On January 25, 2012, the Government
forwarded a Request for Final Agency
Action along with the Investigative
Record. Because more than thirty (30)
days have passed since service of the
Order to Show Cause and Immediate
Suspension of Registration, I find that
Registrant has waived its right to either
request a hearing or to submit a written
statement in lieu of a hearing. 21 CFR
1301.43(d). I therefore issue this
Decision and Order based upon the
investigative record submitted by the
Government. Id. 1301.43(e).
Findings
Registrant is a retail pharmacy, which
is owned by Mr. Ihab (Steve) Barsoum.
GX A. On October 17, 2009, Registrant
was issued DEA Certificate of
Registration FT0131386, which
authorized it to dispense controlled
substances in schedules II through V at
the registered location of Suite 204,
14937 Bruce B. Downs Blvd., Tampa,
Florida, with an expiration date of
February 29, 2012. GX A. According to
the Agency’s registration records,
Registrant neither submitted a renewal
application nor an application for a new
registration. As a consequence,
Registrant’s registration expired on
February 29, 2012, and on April 1, 2012,
the Agency retired its registration.
The Government, however,
supplemented the record with the
affidavit of a Diversion Investigator,
which established that on October 28,
2011, at which time the Order to Show
Cause and Immediate Suspension of
Registration was served on Mr. Barsoum
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and a search warrant was executed at
Registrant, ‘‘controlled substances were
seized from the pharmacy.’’ Affidavit of
DI (Feb. 2, 2012). Attached to the DI’s
affidavit was an inventory of the
controlled substances that were seized;
the inventory listed numerous
controlled substances in addition to
various dosage strengths of oxycodone.1
According to the affidavit of a DEA
Special Agent (S/A), in November 2010,
he was contacted by a source of
information who told him that he/she
had previously purchased oxycodone
from a person identified as Ihab Amir
(Steve) Barsoum. GX D, at 4. The S/A
then determined that Barsoum was a
registered pharmacist and the owner of
Registrant. Id. at 5.
At some point, the source of
information became a confidential
source (CS), and on January 24, 2011,
the CS was interviewed at the Tampa
DEA Office by the S/A and other Special
Agents regarding text messages he had
exchanged with Barsoum, in which
Barsoum stated that he had 372 dosage
units of oxycodone 15mg. and 430
dosage units of oxycodone 30mg. that he
could sell to the CS. Id. That same day,
the Agents conducted an undercover
buy operation, using the CS to purchase
oxycodone from Barsoum. Id. Prior to
the buy, the CS was searched for
contraband, with none found. Id. The
CS was then given $2,500 and a
recording device. Id.
The S/A observed the CS travel to
Registrant, enter and leave Registrant,
and travel back to a neutral location,
where upon arriving, the S/A received
from the CS a paper bag which
contained several bottles of oxycodone
tablets. Id. The S/A also retrieved the
recording device and searched the CS,
finding the CS ‘‘free of any excess
currency or contraband.’’ Id.
Upon counting the drugs, the S/A
found 372 dosage units of oxycodone
15mg. and 429 dosage units of
oxycodone 30mg. Id. The S/A also
watched the video recording of the
meeting and determined that Barsoum
was the person who had sold the
oxycodone to the CS. Id. In addition, a
transcription of the recording was made
and submitted as part of the record.
On February 2, 2011, a second
undercover buy was conducted using
the CS. Id. at 6. During the debriefing,
the CS told the Agents that Barsoum had
sent a text message stating that he had
1 In addition to oxycodone, the drugs seized
included, but are not limited to, morphine sulfate,
methadone, hydromorphone, fentanyl, codeine with
acetaminophen, hydrocodone with acetaminophen,
alprazolam, clonazepam, diazepam, lorazepam,
temazepam, phentermine, phendimetrazine,
zolpidem, and Lyrica.
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1,000 dosage units of oxycodone 30mg.
that he could sell to the CS and that
Barsoum had also asked the CS to
provide fictitious prescriptions for both
the current and previous transactions.
Id. After searching the CS and finding
him/her to not possess any contraband,
the CS was given $4,100 in currency, a
recording device, and several
incomplete prescription forms. Id. The
Agents then maintained surveillance as
the CS travelled to and entered
Registrant, as well as upon the CS’s
exiting from Registrant and travelling
back to meet the Agents. Id.
Upon meeting the CS, the S/A took
custody of a paper bag which contained
two bottles of oxycodone (which upon
counting, contained 1,000 dosage units);
retrieved the recording device and $100
of unused currency; and upon searching
the CS, found that the CS did not
possess any contraband or excess
currency. Id. at 6–7. The S/A reviewed
the recording and again observed that
Barsoum was the person who had sold
the drugs to the CS. Id. at 7. A
transcription of the recording was made
and submitted as part of the record.
On February 9, 2011, the CS contacted
the S/A and related that he/she had
been contacted by Barsoum, who told
the CS that the prescriptions the CS had
provided ‘‘were not going to work’’ and
that the CS needed to ‘‘generate new
prescription papers.’’ Id. at 7. Later that
day, the Agents met with the CS, and
upon searching the CS, determined that
he/she did not possess any contraband
or excess currency. Id. Thereafter, the
CS was given a recording device, as well
as eleven pieces of security paper, and
was observed travelling to and entering
Registrant, as well as upon exiting the
Registrant and travelling back to meet
the Agents, who again searched the CS
and found that he/she had neither
excess currency nor any contraband. Id.
During the meeting, Barsoum told the
CS to place the name of a Tampa-area
physician and the physician’s
registration number, along with a
working telephone number, on the
fictitious prescriptions. Id. at 7–8.
Barsoum then explained to the CS that
the prescriptions would provide
supporting documentation for the sale
of the oxycodone to the CS; Barsoum
also explained that the phone number
would be used to show that he had
called and verified the prescriptions. Id.
at 8.
The following day, the Agents met
with the CS, and after searching the CS,
gave the CS a recording device as well
as nine blank prescriptions; the CS
proceeded to fill out seven of the blank
prescriptions with the names of
patients, their dates of birth, and the
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quantity of controlled substances. Id.
The CS was then observed travelling to
and entering Registrant, as well as upon
exiting Registrant and returning to meet
the Agents. Id.
According to the S/A, the CS had
attempted to give all nine prescriptions
to Barsoum. Id. However, Barsoum gave
the two blank prescriptions back to the
CS. Id. The CS explained to Barsoum
that the doctor’s information including
his DEA number had been placed on the
prescriptions, and that the voice mail
for the telephone number had been
changed to ‘‘to match the new
prescriptions.’’ Id.
On March 7, 2011, the Agents again
met with the CS, who informed them
that Barsoum had texted him/her that he
had 2,000 dosage units of oxycodone
30mg. available for sale. Id. at 9. The CS
also told the Agents that he/she and
Barsoum had exchanged text messages
about providing fictitious prescriptions
and that Barsoum needed a list of the
names that were to be placed on the
prescriptions so that he could enter the
fictitious prescription data into
Registrant’s dispensing software on
different days to make it appear that the
dispensings had occurred on different
days. Id. The CS faxed the names to
Barsoum, who then sent a text to the CS
acknowledging that he had received
them. Id.
That same day, another undercover
buy was performed. Id. After searching
the CS and finding the CS to not possess
any contraband, the CS was provided
with $8,100 in cash, a recording device,
and several incomplete fictitious
prescriptions. Id. The CS was then
observed travelling to and entering
Registrant, as well as exiting Registrant
and traveling to meet the Agents. Id.
Upon meeting the CS, the S/A
received a paper bag which contained
five bottles of oxycodone, which upon
counting, totaled 2,000 dosage units of
oxycodone 30mg. Id. at 9–10. After
retrieving the recording device and
three unused prescriptions from the CS,
the CS was searched and found to not
possess any contraband and excess
currency. Id. at 10. Subsequently, the S/
A listened to the recording of the
transaction and determined that
Barsoum was the person who had sold
the oxycodone to the CS. Id. A
transcription of the visit was also made
and submitted as part of the record. Id.
On April 13, 2011, the Agents again
met with the CS who informed them
that Barsoum had texted him/her that he
had 700 dosage units of oxycodone
30mg available for sale. Id. The Agents
proceeded to conduct another
undercover buy. Id. After searching the
CS, who was found to not possess any
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contraband, the CS was given $5,000 in
cash, a recording device, and five
incomplete fictitious prescriptions. Id.
The Agents then observed the CS
travelling to and entering Registrant, as
well as upon exiting Registrant and
travelling back to meet the Agents. Id.
Upon meeting with the Agents, the CS
turned over a plastic bag which
contained one bottle of 700 oxycodone
30mg. tablets. Id. at 11. The S/A then
obtained the recording device, two
unused prescriptions, and $1,500 of
unused cash. Id. The CS was searched
again and found to not possess any
excess currency and contraband. Id.
Later, the S/A listened to the recording
and identified Barsoum as the person
who had sold the drugs to the CS. Id.
A transcription of the recording was
made and submitted for the record.
On June 23, 2011, the Agents again
met with the CS. Id. The CS reported
that Barsoum had texted him/her that he
had 1,000 dosage units of oxycodone
30mg. available for sale; however, the
CS’s texts to Barsoum had not been
returned. Id. That day, the CS placed a
phone call to Barsoum, which was
recorded and monitored by the Agents;
during the call, the CS told Barsoum
that he was on his way to Registrant. Id.
The Agents then proceeded to conduct
another undercover buy.
After searching the CS and finding the
CS to not possess any contraband, the
CS was provided with a recording
device, $5,000 cash, and eight
incomplete fictitious prescriptions. Id.
The Agents observed the CS travel to
and enter Registrant; they also observed
the CS exit Registrant, depart the
parking lot, then immediately return
and re-enter Registrant, followed by the
CS again exiting Registrant and traveling
back to meet with them. Id. at 12.
Upon meeting the Agents, the CS
turned over a paper bag, which
contained four bottles of oxycodone
30mg. tablets; subsequently, the
contents of the bottles were counted and
totaled 800 dosage units. Id. The S/A
also retrieved the recording device,
$1,000 in unused cash, and four unused
prescriptions. Id. The CS was then
searched and found to not possess any
excess currency and contraband. Id.
The S/A reviewed the recording and
again identified Barsoum as the person
who sold the oxycodone to the CS. Id.
Moreover, during the course of the
transaction, Barsoum told the CS to fill
out four prescriptions totaling 1,200
dosage units even though Barsoum was
selling only 800 dosage units to the CS.
Id.
On October 26, 2011, a federal grand
jury indicted Barsoum on six felony
counts of violating the Controlled
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Substances Act. The charges included
five counts of ‘‘knowingly and
intentionally’’ distributing oxycodone
‘‘outside the course of professional
practice,’’ in violation of 21 U.S.C.
841(a)(1) and 841(b)(1)(C). GX 6, at 2–
3. The indictment also charged Barsoum
with one count of ‘‘knowingly and
willfully conspir[ing] with other[ ]s’’ to
unlawfully dispense oxycodone, in
violation of 21 U.S.C. 841(a)(1) and
841(b)(1)(C) and 21 U.S.C. 846. Id. at 1.
Finally, the indictment sought the
forfeiture of, inter alia, ‘‘all of
[Barsoum’s] right, title and interest in’’
both ‘‘property constituting and derived
from any proceeds . . . obtained,
directly, or indirectly, as a result of such
violations,’’ as well as ‘‘property used
and intended to be used in any manner
or part to commit or to facilitate the
commission of such violations.’’ Id. at
4–5.
On July 5, 2012, a grand jury issued
a superseding indictment, which again
alleged each of the conspiracy and
unlawful distribution counts, as well as
sought the forfeiture of the above
described property. See Superseding
Indictment at 1–4, United States v. Ihab
‘‘Steve’’ Barsoum, No. 8:11–CR–548–T–
33MAP (M.D. Fla. July 2012). Barsoum
pled not guilty, went to trial, and was
convicted on all six counts. See
Judgment and Sentence at 1, United
States v. Barsoum (Feb. 5, 2013). The
District Court sentenced Barsoum to 204
months imprisonment on each count,
with the ‘‘terms to run concurrently,’’
and subsequently placed him in the
custody of the U.S. Bureau of Prisons;
the Court also imposed thirty-six
months of supervised release following
his term of imprisonment. Id. at 3–4.
The Court further ordered that Barsoum
‘‘forfeit [his] interest in the following
property to the United States: . . . any
and all assets previously identified in
the Indictment that are subject to
forfeiture,’’ and specifically identified
the property to include, but not be
‘‘limited to,’’ his DEA registration and
two BMW automobiles. Id. at 6.
Barsoum then filed a notice of appeal.
Discussion
Mootness
As found above, the registration at
issue in this proceeding was due to
expire on February 29, 2012, and in any
event, as part of its judgment, the
District Court ordered Mr. Barsoum to
forfeit Registrant’s registration.
Moreover, Mr. Barsoum did not file
either a renewal application or a new
application. Accordingly, there is
neither a registration to revoke nor an
application to act upon.
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While ordinarily these facts would
render this proceeding moot, see Ronald
J. Riegel, 63 FR 67132, 67133 (1998),
simultaneously with the issuance of the
Show Cause Order, I also ordered that
Registrant’s registration be immediately
suspended. Moreover, pursuant to my
authority under 21 U.S.C. 824(f), I
authorized the seizure or placement
under seal of the controlled substances
possessed by Registrant pursuant to its
registration. As found above, the
Government seized an extensive
inventory of controlled substances,
including numerous drugs in addition
to oxycodone.
Under section 824(f), ‘‘[u]pon a
revocation order becoming final, all
such controlled substances’’ which have
been seized or placed under seal ‘‘shall
be forfeited to the United States’’ and
‘‘[a]ll right, title, and interest in such
controlled substances shall vest in the
United States upon a revocation order
becoming final.’’ 21 U.S.C. 824(f). DEA
has previously held that a registrant,
who has been issued an immediate
suspension order, cannot defeat the
effect of this provision by allowing its
registration to expire. See Meetinghouse
Community Pharmacy, Inc., 74 FR
10073, 10074 n.5 (2009); RX Direct
Pharmacy, Inc., 72 FR 54070, 54072 n.3
(2007). Thus, this proceeding presents
the collateral consequence of who has
title to the controlled substances that
were seized and which have not been
forfeited under the District Court’s
judgment. Accordingly, I hold that this
case is not moot and proceed to the
merits.
The Merits
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Under the CSA, ‘‘[a] registration
pursuant to section 823 of this title to
manufacture, distribute, or 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 [its] registration under
section 823 of this title inconsistent
with the public interest as determined
under such section.’’ 21 U.S.C.
824(a)(4). In the case of a retail
pharmacy, which is deemed to be a
practitioner, see id. § 802(21), Congress
directed the Attorney General to
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 or conducting research with
respect to controlled substances.
(3) The applicant’s conviction record under
Federal or State laws relating to the
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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.
‘‘[T]hese factors are . . . considered
in the disjunctive.’’ Robert A. Leslie,
M.D., 68 FR 15227, 15230 (2003). It is
well settled that I ‘‘may rely on any one
or a combination of factors, and may
give each factor the weight [I] deem[ ]
appropriate in determining whether’’ to
suspend or revoke an existing
registration. Id.; see also MacKay v.
DEA, 664 F.3d 808, 816 (10th Cir. 2011);
Volkman v. DEA, 567 F.3d 215, 222 (6th
Cir. 2009); Hoxie v. DEA, 419 F.3d 477,
482 (6th Cir. 2005). Moreover, while I
am required to consider each of the
factors, I ‘‘need not make explicit
findings as to each one.’’ MacKay, 664
F.3d at 816 (quoting Volkman, 567 F.3d
at 222); see also Hoxie, 419 F.3d at 482.2
Under the Agency’s regulation, ‘‘[a]t
any hearing for the revocation or
suspension of a registration, the
Administration shall have the burden of
proving that the requirements for such
revocation or suspension pursuant to
. . . 21 U.S.C. 824(a) . . . are satisfied.’’
21 CFR 1301.44(e). In this matter, I have
considered all of the factors and find
that the Government’s evidence with
respect to factors two and four,
establishes that Registrant, through its
owner, has committed acts which
render its registration ‘‘inconsistent
with the public interest.’’ I therefore
affirm the Order of Immediate
Suspension.
Factors Two and Four—The Registrant’s
Experience in Dispensing Controlled
Controlled Substances and Compliance
With Applicable Laws Related to
Controlled Substances
‘‘Except as authorized by’’ the CSA, it
is ‘‘unlawful for any person [to]
knowingly or intentionally . . .
manufacture, distribute, or dispense, or
possess with intent to manufacture,
distribute, or dispense, a controlled
substance.’’ 21 U.S.C. 841(a)(1).
Moreover, ‘‘[p]ersons registered by the
Attorney General . . . to manufacture,
2 In short, this is not a contest in which score is
kept; the Agency is not required to mechanically
count up the factors and determine how many favor
the Government and how many favor the registrant.
Rather, it is an inquiry which focuses on protecting
the public interest; what matters is the seriousness
of the registrant’s or applicant’s misconduct. Jayam
Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly,
as the Tenth Circuit has recognized, findings under
a single factor can support the revocation of a
registration. MacKay, 664 F.3d at 821. Likewise,
findings under a single factor can support the
denial of an application.
PO 00000
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Sfmt 4703
57659
distribute, or dispense controlled
substances . . . are authorized to
possess, manufacture, distribute, or
dispense such substances . . . to the
extent authorized by their registration
and in conformity with the other
provisions of this subchapter.’’ Id.
§ 822(b). Under the Act, a pharmacy’s
registration authorizes it ‘‘to dispense,’’
id. § 823(f), which ‘‘means to deliver a
controlled substance to an ultimate user
. . . by, or pursuant to the lawful order
of, a practitioner.’’ Id. § 802(10).
Under a longstanding DEA regulation,
‘‘[a] prescription for a controlled
substance to be effective must be issued
for a legitimate medical purpose by an
individual practitioner acting in the
usual course of his professional
practice.’’ 21 CFR 1306.04(a).
Furthermore, ‘‘[a]n order purporting to
be a prescription issued not in the usual
course of professional treatment . . . is
not a prescription within the meaning
and intent of section 309 of the Act (21
U.S.C. 829) and the person knowingly
filling such a purported prescription
. . . shall be subject to the penalties
provided for violations of the provisions
of law relating to controlled
substances.’’ 3 Id.; see also 21 U.S.C.
829(a) (‘‘Except when dispensed
directly by a practitioner, other than a
pharmacist, to an ultimate user, no
controlled substance in schedule II,
which is a prescription drug as
determined under the Federal Food,
Drug, and Cosmetic Act [21 U.S.C.A.
§ 301 et seq.], may be dispensed without
the written prescription of a
practitioner, except that in emergency
situations, as prescribed . . . by
regulation . . . such drug may be
dispensed upon oral prescription in
accordance with . . . 21 U.S.C.A.
§ 353(b).’’).4
As found above, on five occasions,
Mr. Barsoum, Respondent’s owner and
pharmacist-in-charge, offered for sale,
and subsequently distributed to the CS,
large quantities of oxycodone, a
schedule II controlled substance (see 21
CFR 1308.12(b)(1)(xiii)), in exchange for
cash. Over the course of the five
transactions, Barsoum distributed a total
3 As the Supreme Court has explained, ‘‘the
prescription requirement . . . ensures patients use
controlled substances under the supervision of a
doctor so as to prevent addiction and recreational
abuse. As a corollary, the provision also bars
doctors from peddling to patients who crave the
drugs for those prohibited uses.’’ Gonzales v.
Oregon, 546 U.S. 243, 274 (2006) (citing United
States v. Moore, 423 U.S. 122, 135, 143 (1975)).
4 See also 21 CFR 1306.11(a) (‘‘A pharmacist may
dispense directly a controlled substance listed in
Schedule II that is a prescription drug as
determined under . . . 21 U.S.C. 353(b) . . . only
pursuant to a written prescription signed by the
practitioner,’’ except for in an emergency
situation.).
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57660
Federal Register / Vol. 78, No. 182 / Thursday, September 19, 2013 / Notices
of 4,929 tablets of oxycodone 30mg. and
372 tablets of oxycodone 15mg., in
exchange for $22,100 in cash. The
distributions were not dispensings
within the meaning of the CSA because
the controlled substances were not
delivered ‘‘pursuant to the lawful order
of[ ] a practitioner.’’ 21 U.S.C. 802(10).
Indeed, as the evidence shows, Barsoum
required the CS to produce fictitious
prescriptions in order to provide a paper
trail which, in the event his pharmacy
was inspected by the authorities, he
could use to justify the distributions. In
short each of the transactions was a
blatant drug deal and a distribution in
violation of the CSA. See 21 U.S.C.
841(a)(1), 21 CFR 1306.04(a).
Accordingly, I hold that the
Government has established that
Registrant, through its principal Mr.
Barsoum, committed acts which
rendered its registration ‘‘inconsistent
with the public interest,’’ 21 U.S.C.
824(a)(4), and which justified the
immediate suspension of its registration
as ‘‘an imminent danger to the public
health or safety.’’ Id. § 824(d). I therefore
affirm the immediate suspension of
Registrant’s registration, and while Mr.
Barsoum allowed Registrant’s
registration to expire, had he filed a
renewal application, I would have
revoked his pharmacy’s registration.
Pursuant to 21 U.S.C. 824(f), ‘‘[u]pon
a revocation order becoming final, all
. . . controlled substances’’ seized
pursuant to a suspension order, ‘‘shall
be forfeited to the United States’’ and
‘‘[a]ll right, title, and interest in such
controlled substances shall vest in the
United States upon a revocation order
becoming final.’’ As the Agency has
previously held, a registrant cannot
defeat the effect of this provision by
allowing its registration to expire.
Meetinghouse Community Pharmacy,
Inc., 74 FR 10073, 10074 n.5 (2009); RX
Direct Pharmacy, Inc., 72 FR 54070,
54072 n.3 (2007). Registrant had the
right to challenge the suspension order
before the Agency but chose not to.
Accordingly, I declare forfeited to the
United States all controlled substances
that were seized pursuant to the
Immediate Suspension Order, which
have not been previously declared
forfeited by the District Court in the
Judgment and Sentence in United States
v. Barsoum. I further hold that in the
event the District Court’s Judgment and
Sentence are vacated, any controlled
substances which had been previously
declared forfeited by the District Court,
shall be forfeited to the United States.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824(a) and (d), as well as
VerDate Mar<15>2010
18:22 Sep 18, 2013
Jkt 229001
28 CFR 0.100(b), I affirm the Order of
Immediate Suspension of Registration
issued to S & S Pharmacy, Inc., d/b/a
Platinum Pharmacy & Compounding.
Pursuant to the authority vested in me
by 21 U.S.C. 824(f), as well as 28 CFR
0.100(b), I further order that all
controlled substances seized pursuant to
the Order of Immediate Suspension of
Registration, which are not subject to
forfeiture pursuant to the District
Court’s Judgment and Sentence in
United States v. Ihab ‘‘Steve’’ Barsoum,
No. 8:11–CR–548–T–33MAP (M.D. Fla.
Feb. 5, 2013), be, and they hereby are,
forfeited to the United States. This order
is effective October 21, 2013.
Management and Budget, Room 10235,
725 17th Street NW., Washington, DC
20503, Fax: 202–395–6881 (this is not a
toll-free number), email: OIRA_
submission@omb.eop.gov. Commenters
are encouraged, but not required, to
send a courtesy copy of any comments
to the U.S. Department of LaborOASAM, Office of the Chief Information
Officer, Attn: Information Management
Program, Room N1301, 200 Constitution
Avenue NW., Washington, DC 20210,
email: DOL_PRA_PUBLIC@dol.gov.
FOR FURTHER INFORMATION CONTACT:
Michel Smyth by telephone at 202–693–
4129 (this is not a toll-free number) or
by email at DOL_PRA_PUBLIC@dol.gov.
Dated: September 8, 2013.
Michele M. Leonhart,
Administrator.
SUPPLEMENTARY INFORMATION:
Authority: 44 U.S.C. 3507(a)(1)(D).
[FR Doc. 2013–22793 Filed 9–18–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Office of the Secretary
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Labor
Standards for Federal Service
Contracts
ACTION:
Notice.
The Department of Labor
(DOL) is submitting the Wage and Hour
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collection request (ICR) titled, ‘‘Labor
Standards for Federal Service
Contracts,’’ to the Office of Management
and Budget (OMB) for review and
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Paperwork Reduction Act (PRA) of 1995
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DATES: Submit comments on or before
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ADDRESSES: A copy of this ICR with
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including a description of the likely
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PRAViewICR?ref_nbr=201304–1235–001
(this link will only become active on the
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or by contacting Michel Smyth by
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Submit comments about this request
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SUMMARY:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
The WHD
administers the McNamara-O’Hara
Service Contract Act (SCA), 41 U.S.C.
351 et seq. The SCA applies to every
contract entered into by the United
States or the District of Columbia, the
principal purpose of which is to furnish
services to the United States through the
use of service employees. The SCA
requires contractors and subcontractors
performing services on covered federal
or District of Columbia contracts in
excess of $2,500 to pay service
employees in various classes no less
than the monetary wage rates and to
furnish fringe benefits found prevailing
in the locality, or the rates (including
prospective increases) contained in a
predecessor contractor’s collective
bargaining agreement. Safety and health
standards also apply to such contracts.
The WHD administers and enforces SCA
compensation requirements. This ICR is
to continue PRA authorization the
following information collections: (1)
Vacation Benefit Seniority List, (2)
Conformance Record, and (3)
Submission of Collective Bargaining
Agreement. For additional substantive
information about this ICR, see the
related notice published in the Federal
Register on May 7, 2013 (78 FR 26657).
This information collection is subject
to the PRA. A Federal agency generally
cannot conduct or sponsor a collection
of information, and the public is
generally not required to respond to an
information collection, unless it is
approved by the OMB under the PRA
and displays a currently valid OMB
Control Number. In addition,
notwithstanding any other provisions of
law, no person shall generally be subject
to penalty for failing to comply with a
collection of information that does not
display a valid Control Number. See 5
CFR 1320.5(a) and 1320.6. The DOL
obtains OMB approval for this
information collection under Control
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Agencies
[Federal Register Volume 78, Number 182 (Thursday, September 19, 2013)]
[Notices]
[Pages 57656-57660]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22793]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
S & S Pharmacy, Inc., d/b/a Platinum Pharmacy & Compounding;
Decision and Order
On October 27, 2011, I, the Administrator of the Drug Enforcement
Administration, issued an Order to Show Cause and Immediate Suspension
of Registration to S & S Pharmacy, Inc., d/b/a Platinum Pharmacy &
Compounding (hereinafter, Registrant), of Tampa, Florida. GX B, at 1.
The Show Cause Order proposed the revocation of Registrant's
Certificate of Registration as a retail pharmacy, which before it
expired, authorized it to dispense controlled substances in schedules
II through V, as well as the denial of any pending application to renew
or modify its registration, on the ground that its ``continued
registration is inconsistent with the public interest.'' Id.
More specifically, the Order alleged that Registrant was ``owned
and operated by Ihab S. Barsoum,'' a registered pharmacist and that its
registration was due to expire ``on February 12, 2012.'' Id. The Order
further alleged that Registrant's owner/operator had ``unlawfully
distributed oxycodone, a Schedule II narcotic controlled substance, in
exchange for cash, based on fraudulent prescriptions.'' Id. at 2. The
Order then alleged that Barsoum had made the following five unlawful
distributions:
(1) on January 24, 2011, 429 dosage units of oxycodone 30mg. and
372 dosage units of oxycodone 15mg. for $2,500 cash;
(2) on February 2, 2011, 1,000 dosage units of oxycodone 30mg. for
$4,000 cash;
(3) on March 7, 2011, 2,000 dosage units of oxycodone 30mg. for
$8,100 cash;
(4) on April 13, 2011, 700 dosage units of oxycodone 30mg. for
$3,500 cash; and
(5) on June 23, 2011, 800 dosage units of oxycodone 30mg. for
$4,000 cash. Id.
Based on the above, I further concluded that Registrant's continued
registration during the pendency of the proceedings ``constitutes an
imminent
[[Page 57657]]
danger to the public health and safety'' and ordered that its
registration be immediately suspended. Id. (citing 21 U.S.C. 824(d); 21
CFR 1301.36(e)). Pursuant to my authority under section 824(d) and 21
CFR 1301.36(f), I authorized ``the Special Agents and Diversion
Investigators . . . who serve[d]'' the Order ``to place under seal or
to remove for safekeeping all controlled substances'' possessed by
Registrant ``pursuant to [its] registration.'' Id.
On October 28, 2011, the Order, which also notified Registrant of
its right to either request a hearing on the allegations or to submit a
written statement as to the matters of fact and law involved in lieu of
a hearing, the procedure for electing either option, and the
consequence of failing to elect either option, was personally served on
Mr. Barsoum. See id. (citing 21 CFR 1301.43(a), (c)-(e)); GX C.
Thereafter, neither Mr. Barsoum, nor any other person purporting to
represent Registrant, timely requested a hearing, or submitted a
written statement.
On January 25, 2012, the Government forwarded a Request for Final
Agency Action along with the Investigative Record. Because more than
thirty (30) days have passed since service of the Order to Show Cause
and Immediate Suspension of Registration, I find that Registrant has
waived its right to either request a hearing or to submit a written
statement in lieu of a hearing. 21 CFR 1301.43(d). I therefore issue
this Decision and Order based upon the investigative record submitted
by the Government. Id. 1301.43(e).
Findings
Registrant is a retail pharmacy, which is owned by Mr. Ihab (Steve)
Barsoum. GX A. On October 17, 2009, Registrant was issued DEA
Certificate of Registration FT0131386, which authorized it to dispense
controlled substances in schedules II through V at the registered
location of Suite 204, 14937 Bruce B. Downs Blvd., Tampa, Florida, with
an expiration date of February 29, 2012. GX A. According to the
Agency's registration records, Registrant neither submitted a renewal
application nor an application for a new registration. As a
consequence, Registrant's registration expired on February 29, 2012,
and on April 1, 2012, the Agency retired its registration.
The Government, however, supplemented the record with the affidavit
of a Diversion Investigator, which established that on October 28,
2011, at which time the Order to Show Cause and Immediate Suspension of
Registration was served on Mr. Barsoum and a search warrant was
executed at Registrant, ``controlled substances were seized from the
pharmacy.'' Affidavit of DI (Feb. 2, 2012). Attached to the DI's
affidavit was an inventory of the controlled substances that were
seized; the inventory listed numerous controlled substances in addition
to various dosage strengths of oxycodone.\1\
---------------------------------------------------------------------------
\1\ In addition to oxycodone, the drugs seized included, but are
not limited to, morphine sulfate, methadone, hydromorphone,
fentanyl, codeine with acetaminophen, hydrocodone with
acetaminophen, alprazolam, clonazepam, diazepam, lorazepam,
temazepam, phentermine, phendimetrazine, zolpidem, and Lyrica.
---------------------------------------------------------------------------
According to the affidavit of a DEA Special Agent (S/A), in
November 2010, he was contacted by a source of information who told him
that he/she had previously purchased oxycodone from a person identified
as Ihab Amir (Steve) Barsoum. GX D, at 4. The S/A then determined that
Barsoum was a registered pharmacist and the owner of Registrant. Id. at
5.
At some point, the source of information became a confidential
source (CS), and on January 24, 2011, the CS was interviewed at the
Tampa DEA Office by the S/A and other Special Agents regarding text
messages he had exchanged with Barsoum, in which Barsoum stated that he
had 372 dosage units of oxycodone 15mg. and 430 dosage units of
oxycodone 30mg. that he could sell to the CS. Id. That same day, the
Agents conducted an undercover buy operation, using the CS to purchase
oxycodone from Barsoum. Id. Prior to the buy, the CS was searched for
contraband, with none found. Id. The CS was then given $2,500 and a
recording device. Id.
The S/A observed the CS travel to Registrant, enter and leave
Registrant, and travel back to a neutral location, where upon arriving,
the S/A received from the CS a paper bag which contained several
bottles of oxycodone tablets. Id. The S/A also retrieved the recording
device and searched the CS, finding the CS ``free of any excess
currency or contraband.'' Id.
Upon counting the drugs, the S/A found 372 dosage units of
oxycodone 15mg. and 429 dosage units of oxycodone 30mg. Id. The S/A
also watched the video recording of the meeting and determined that
Barsoum was the person who had sold the oxycodone to the CS. Id. In
addition, a transcription of the recording was made and submitted as
part of the record.
On February 2, 2011, a second undercover buy was conducted using
the CS. Id. at 6. During the debriefing, the CS told the Agents that
Barsoum had sent a text message stating that he had 1,000 dosage units
of oxycodone 30mg. that he could sell to the CS and that Barsoum had
also asked the CS to provide fictitious prescriptions for both the
current and previous transactions. Id. After searching the CS and
finding him/her to not possess any contraband, the CS was given $4,100
in currency, a recording device, and several incomplete prescription
forms. Id. The Agents then maintained surveillance as the CS travelled
to and entered Registrant, as well as upon the CS's exiting from
Registrant and travelling back to meet the Agents. Id.
Upon meeting the CS, the S/A took custody of a paper bag which
contained two bottles of oxycodone (which upon counting, contained
1,000 dosage units); retrieved the recording device and $100 of unused
currency; and upon searching the CS, found that the CS did not possess
any contraband or excess currency. Id. at 6-7. The S/A reviewed the
recording and again observed that Barsoum was the person who had sold
the drugs to the CS. Id. at 7. A transcription of the recording was
made and submitted as part of the record.
On February 9, 2011, the CS contacted the S/A and related that he/
she had been contacted by Barsoum, who told the CS that the
prescriptions the CS had provided ``were not going to work'' and that
the CS needed to ``generate new prescription papers.'' Id. at 7. Later
that day, the Agents met with the CS, and upon searching the CS,
determined that he/she did not possess any contraband or excess
currency. Id. Thereafter, the CS was given a recording device, as well
as eleven pieces of security paper, and was observed travelling to and
entering Registrant, as well as upon exiting the Registrant and
travelling back to meet the Agents, who again searched the CS and found
that he/she had neither excess currency nor any contraband. Id.
During the meeting, Barsoum told the CS to place the name of a
Tampa-area physician and the physician's registration number, along
with a working telephone number, on the fictitious prescriptions. Id.
at 7-8. Barsoum then explained to the CS that the prescriptions would
provide supporting documentation for the sale of the oxycodone to the
CS; Barsoum also explained that the phone number would be used to show
that he had called and verified the prescriptions. Id. at 8.
The following day, the Agents met with the CS, and after searching
the CS, gave the CS a recording device as well as nine blank
prescriptions; the CS proceeded to fill out seven of the blank
prescriptions with the names of patients, their dates of birth, and the
[[Page 57658]]
quantity of controlled substances. Id. The CS was then observed
travelling to and entering Registrant, as well as upon exiting
Registrant and returning to meet the Agents. Id.
According to the S/A, the CS had attempted to give all nine
prescriptions to Barsoum. Id. However, Barsoum gave the two blank
prescriptions back to the CS. Id. The CS explained to Barsoum that the
doctor's information including his DEA number had been placed on the
prescriptions, and that the voice mail for the telephone number had
been changed to ``to match the new prescriptions.'' Id.
On March 7, 2011, the Agents again met with the CS, who informed
them that Barsoum had texted him/her that he had 2,000 dosage units of
oxycodone 30mg. available for sale. Id. at 9. The CS also told the
Agents that he/she and Barsoum had exchanged text messages about
providing fictitious prescriptions and that Barsoum needed a list of
the names that were to be placed on the prescriptions so that he could
enter the fictitious prescription data into Registrant's dispensing
software on different days to make it appear that the dispensings had
occurred on different days. Id. The CS faxed the names to Barsoum, who
then sent a text to the CS acknowledging that he had received them. Id.
That same day, another undercover buy was performed. Id. After
searching the CS and finding the CS to not possess any contraband, the
CS was provided with $8,100 in cash, a recording device, and several
incomplete fictitious prescriptions. Id. The CS was then observed
travelling to and entering Registrant, as well as exiting Registrant
and traveling to meet the Agents. Id.
Upon meeting the CS, the S/A received a paper bag which contained
five bottles of oxycodone, which upon counting, totaled 2,000 dosage
units of oxycodone 30mg. Id. at 9-10. After retrieving the recording
device and three unused prescriptions from the CS, the CS was searched
and found to not possess any contraband and excess currency. Id. at 10.
Subsequently, the S/A listened to the recording of the transaction and
determined that Barsoum was the person who had sold the oxycodone to
the CS. Id. A transcription of the visit was also made and submitted as
part of the record. Id.
On April 13, 2011, the Agents again met with the CS who informed
them that Barsoum had texted him/her that he had 700 dosage units of
oxycodone 30mg available for sale. Id. The Agents proceeded to conduct
another undercover buy. Id. After searching the CS, who was found to
not possess any contraband, the CS was given $5,000 in cash, a
recording device, and five incomplete fictitious prescriptions. Id. The
Agents then observed the CS travelling to and entering Registrant, as
well as upon exiting Registrant and travelling back to meet the Agents.
Id.
Upon meeting with the Agents, the CS turned over a plastic bag
which contained one bottle of 700 oxycodone 30mg. tablets. Id. at 11.
The S/A then obtained the recording device, two unused prescriptions,
and $1,500 of unused cash. Id. The CS was searched again and found to
not possess any excess currency and contraband. Id. Later, the S/A
listened to the recording and identified Barsoum as the person who had
sold the drugs to the CS. Id. A transcription of the recording was made
and submitted for the record.
On June 23, 2011, the Agents again met with the CS. Id. The CS
reported that Barsoum had texted him/her that he had 1,000 dosage units
of oxycodone 30mg. available for sale; however, the CS's texts to
Barsoum had not been returned. Id. That day, the CS placed a phone call
to Barsoum, which was recorded and monitored by the Agents; during the
call, the CS told Barsoum that he was on his way to Registrant. Id. The
Agents then proceeded to conduct another undercover buy.
After searching the CS and finding the CS to not possess any
contraband, the CS was provided with a recording device, $5,000 cash,
and eight incomplete fictitious prescriptions. Id. The Agents observed
the CS travel to and enter Registrant; they also observed the CS exit
Registrant, depart the parking lot, then immediately return and re-
enter Registrant, followed by the CS again exiting Registrant and
traveling back to meet with them. Id. at 12.
Upon meeting the Agents, the CS turned over a paper bag, which
contained four bottles of oxycodone 30mg. tablets; subsequently, the
contents of the bottles were counted and totaled 800 dosage units. Id.
The S/A also retrieved the recording device, $1,000 in unused cash, and
four unused prescriptions. Id. The CS was then searched and found to
not possess any excess currency and contraband. Id.
The S/A reviewed the recording and again identified Barsoum as the
person who sold the oxycodone to the CS. Id. Moreover, during the
course of the transaction, Barsoum told the CS to fill out four
prescriptions totaling 1,200 dosage units even though Barsoum was
selling only 800 dosage units to the CS. Id.
On October 26, 2011, a federal grand jury indicted Barsoum on six
felony counts of violating the Controlled Substances Act. The charges
included five counts of ``knowingly and intentionally'' distributing
oxycodone ``outside the course of professional practice,'' in violation
of 21 U.S.C. 841(a)(1) and 841(b)(1)(C). GX 6, at 2-3. The indictment
also charged Barsoum with one count of ``knowingly and willfully
conspir[ing] with other[ ]s'' to unlawfully dispense oxycodone, in
violation of 21 U.S.C. 841(a)(1) and 841(b)(1)(C) and 21 U.S.C. 846.
Id. at 1. Finally, the indictment sought the forfeiture of, inter alia,
``all of [Barsoum's] right, title and interest in'' both ``property
constituting and derived from any proceeds . . . obtained, directly, or
indirectly, as a result of such violations,'' as well as ``property
used and intended to be used in any manner or part to commit or to
facilitate the commission of such violations.'' Id. at 4-5.
On July 5, 2012, a grand jury issued a superseding indictment,
which again alleged each of the conspiracy and unlawful distribution
counts, as well as sought the forfeiture of the above described
property. See Superseding Indictment at 1-4, United States v. Ihab
``Steve'' Barsoum, No. 8:11-CR-548-T-33MAP (M.D. Fla. July 2012).
Barsoum pled not guilty, went to trial, and was convicted on all six
counts. See Judgment and Sentence at 1, United States v. Barsoum (Feb.
5, 2013). The District Court sentenced Barsoum to 204 months
imprisonment on each count, with the ``terms to run concurrently,'' and
subsequently placed him in the custody of the U.S. Bureau of Prisons;
the Court also imposed thirty-six months of supervised release
following his term of imprisonment. Id. at 3-4. The Court further
ordered that Barsoum ``forfeit [his] interest in the following property
to the United States: . . . any and all assets previously identified in
the Indictment that are subject to forfeiture,'' and specifically
identified the property to include, but not be ``limited to,'' his DEA
registration and two BMW automobiles. Id. at 6. Barsoum then filed a
notice of appeal.
Discussion
Mootness
As found above, the registration at issue in this proceeding was
due to expire on February 29, 2012, and in any event, as part of its
judgment, the District Court ordered Mr. Barsoum to forfeit
Registrant's registration. Moreover, Mr. Barsoum did not file either a
renewal application or a new application. Accordingly, there is neither
a registration to revoke nor an application to act upon.
[[Page 57659]]
While ordinarily these facts would render this proceeding moot, see
Ronald J. Riegel, 63 FR 67132, 67133 (1998), simultaneously with the
issuance of the Show Cause Order, I also ordered that Registrant's
registration be immediately suspended. Moreover, pursuant to my
authority under 21 U.S.C. 824(f), I authorized the seizure or placement
under seal of the controlled substances possessed by Registrant
pursuant to its registration. As found above, the Government seized an
extensive inventory of controlled substances, including numerous drugs
in addition to oxycodone.
Under section 824(f), ``[u]pon a revocation order becoming final,
all such controlled substances'' which have been seized or placed under
seal ``shall be forfeited to the United States'' and ``[a]ll right,
title, and interest in such controlled substances shall vest in the
United States upon a revocation order becoming final.'' 21 U.S.C.
824(f). DEA has previously held that a registrant, who has been issued
an immediate suspension order, cannot defeat the effect of this
provision by allowing its registration to expire. See Meetinghouse
Community Pharmacy, Inc., 74 FR 10073, 10074 n.5 (2009); RX Direct
Pharmacy, Inc., 72 FR 54070, 54072 n.3 (2007). Thus, this proceeding
presents the collateral consequence of who has title to the controlled
substances that were seized and which have not been forfeited under the
District Court's judgment. Accordingly, I hold that this case is not
moot and proceed to the merits.
The Merits
Under the CSA, ``[a] registration pursuant to section 823 of this
title to manufacture, distribute, or 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 [its]
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C.
824(a)(4). In the case of a retail pharmacy, which is deemed to be a
practitioner, see id. Sec. 802(21), Congress directed the Attorney
General to 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 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 and
safety.
Id.
``[T]hese factors are . . . considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I
``may rely on any one or a combination of factors, and may give each
factor the weight [I] deem[ ] appropriate in determining whether'' to
suspend or revoke an existing registration. Id.; see also MacKay v.
DEA, 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215,
222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005).
Moreover, while I am required to consider each of the factors, I ``need
not make explicit findings as to each one.'' MacKay, 664 F.3d at 816
(quoting Volkman, 567 F.3d at 222); see also Hoxie, 419 F.3d at 482.\2\
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\2\ In short, this is not a contest in which score is kept; the
Agency is not required to mechanically count up the factors and
determine how many favor the Government and how many favor the
registrant. Rather, it is an inquiry which focuses on protecting the
public interest; what matters is the seriousness of the registrant's
or applicant's misconduct. Jayam Krishna-Iyer, 74 FR 459, 462
(2009). Accordingly, as the Tenth Circuit has recognized, findings
under a single factor can support the revocation of a registration.
MacKay, 664 F.3d at 821. Likewise, findings under a single factor
can support the denial of an application.
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Under the Agency's regulation, ``[a]t any hearing for the
revocation or suspension of a registration, the Administration shall
have the burden of proving that the requirements for such revocation or
suspension pursuant to . . . 21 U.S.C. 824(a) . . . are satisfied.'' 21
CFR 1301.44(e). In this matter, I have considered all of the factors
and find that the Government's evidence with respect to factors two and
four, establishes that Registrant, through its owner, has committed
acts which render its registration ``inconsistent with the public
interest.'' I therefore affirm the Order of Immediate Suspension.
Factors Two and Four--The Registrant's Experience in Dispensing
Controlled Controlled Substances and Compliance With Applicable Laws
Related to Controlled Substances
``Except as authorized by'' the CSA, it is ``unlawful for any
person [to] knowingly or intentionally . . . manufacture, distribute,
or dispense, or possess with intent to manufacture, distribute, or
dispense, a controlled substance.'' 21 U.S.C. 841(a)(1). Moreover,
``[p]ersons registered by the Attorney General . . . to manufacture,
distribute, or dispense controlled substances . . . are authorized to
possess, manufacture, distribute, or dispense such substances . . . to
the extent authorized by their registration and in conformity with the
other provisions of this subchapter.'' Id. Sec. 822(b). Under the Act,
a pharmacy's registration authorizes it ``to dispense,'' id. Sec.
823(f), which ``means to deliver a controlled substance to an ultimate
user . . . by, or pursuant to the lawful order of, a practitioner.''
Id. Sec. 802(10).
Under a longstanding DEA regulation, ``[a] prescription for a
controlled substance to be effective must be issued for a legitimate
medical purpose by an individual practitioner acting in the usual
course of his professional practice.'' 21 CFR 1306.04(a). Furthermore,
``[a]n order purporting to be a prescription issued not in the usual
course of professional treatment . . . is not a prescription within the
meaning and intent of section 309 of the Act (21 U.S.C. 829) and the
person knowingly filling such a purported prescription . . . shall be
subject to the penalties provided for violations of the provisions of
law relating to controlled substances.'' \3\ Id.; see also 21 U.S.C.
829(a) (``Except when dispensed directly by a practitioner, other than
a pharmacist, to an ultimate user, no controlled substance in schedule
II, which is a prescription drug as determined under the Federal Food,
Drug, and Cosmetic Act [21 U.S.C.A. Sec. 301 et seq.], may be
dispensed without the written prescription of a practitioner, except
that in emergency situations, as prescribed . . . by regulation . . .
such drug may be dispensed upon oral prescription in accordance with .
. . 21 U.S.C.A. Sec. 353(b).'').\4\
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\3\ As the Supreme Court has explained, ``the prescription
requirement . . . ensures patients use controlled substances under
the supervision of a doctor so as to prevent addiction and
recreational abuse. As a corollary, the provision also bars doctors
from peddling to patients who crave the drugs for those prohibited
uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United
States v. Moore, 423 U.S. 122, 135, 143 (1975)).
\4\ See also 21 CFR 1306.11(a) (``A pharmacist may dispense
directly a controlled substance listed in Schedule II that is a
prescription drug as determined under . . . 21 U.S.C. 353(b) . . .
only pursuant to a written prescription signed by the
practitioner,'' except for in an emergency situation.).
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As found above, on five occasions, Mr. Barsoum, Respondent's owner
and pharmacist-in-charge, offered for sale, and subsequently
distributed to the CS, large quantities of oxycodone, a schedule II
controlled substance (see 21 CFR 1308.12(b)(1)(xiii)), in exchange for
cash. Over the course of the five transactions, Barsoum distributed a
total
[[Page 57660]]
of 4,929 tablets of oxycodone 30mg. and 372 tablets of oxycodone 15mg.,
in exchange for $22,100 in cash. The distributions were not dispensings
within the meaning of the CSA because the controlled substances were
not delivered ``pursuant to the lawful order of[ ] a practitioner.'' 21
U.S.C. 802(10). Indeed, as the evidence shows, Barsoum required the CS
to produce fictitious prescriptions in order to provide a paper trail
which, in the event his pharmacy was inspected by the authorities, he
could use to justify the distributions. In short each of the
transactions was a blatant drug deal and a distribution in violation of
the CSA. See 21 U.S.C. 841(a)(1), 21 CFR 1306.04(a).
Accordingly, I hold that the Government has established that
Registrant, through its principal Mr. Barsoum, committed acts which
rendered its registration ``inconsistent with the public interest,'' 21
U.S.C. 824(a)(4), and which justified the immediate suspension of its
registration as ``an imminent danger to the public health or safety.''
Id. Sec. 824(d). I therefore affirm the immediate suspension of
Registrant's registration, and while Mr. Barsoum allowed Registrant's
registration to expire, had he filed a renewal application, I would
have revoked his pharmacy's registration.
Pursuant to 21 U.S.C. 824(f), ``[u]pon a revocation order becoming
final, all . . . controlled substances'' seized pursuant to a
suspension order, ``shall be forfeited to the United States'' and
``[a]ll right, title, and interest in such controlled substances shall
vest in the United States upon a revocation order becoming final.'' As
the Agency has previously held, a registrant cannot defeat the effect
of this provision by allowing its registration to expire. Meetinghouse
Community Pharmacy, Inc., 74 FR 10073, 10074 n.5 (2009); RX Direct
Pharmacy, Inc., 72 FR 54070, 54072 n.3 (2007). Registrant had the right
to challenge the suspension order before the Agency but chose not to.
Accordingly, I declare forfeited to the United States all
controlled substances that were seized pursuant to the Immediate
Suspension Order, which have not been previously declared forfeited by
the District Court in the Judgment and Sentence in United States v.
Barsoum. I further hold that in the event the District Court's Judgment
and Sentence are vacated, any controlled substances which had been
previously declared forfeited by the District Court, shall be forfeited
to the United States.
Order
Pursuant to the authority vested in me by 21 U.S.C. 824(a) and (d),
as well as 28 CFR 0.100(b), I affirm the Order of Immediate Suspension
of Registration issued to S & S Pharmacy, Inc., d/b/a Platinum Pharmacy
& Compounding. Pursuant to the authority vested in me by 21 U.S.C.
824(f), as well as 28 CFR 0.100(b), I further order that all controlled
substances seized pursuant to the Order of Immediate Suspension of
Registration, which are not subject to forfeiture pursuant to the
District Court's Judgment and Sentence in United States v. Ihab
``Steve'' Barsoum, No. 8:11-CR-548-T-33MAP (M.D. Fla. Feb. 5, 2013),
be, and they hereby are, forfeited to the United States. This order is
effective October 21, 2013.
Dated: September 8, 2013.
Michele M. Leonhart,
Administrator.
[FR Doc. 2013-22793 Filed 9-18-13; 8:45 am]
BILLING CODE 4410-09-P