Ideal Pharmacy Care, Inc., D/B/A Esplanade Pharmacy; Revocation of Registration, 51415-51417 [2011-21060]
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Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices
the Darvocet?’’ The Agent answered
‘‘yes,’’ but Registrant did not even ask
her if she had pain, let alone ask her any
questions regarding the nature and
intensity of the pain, whether the
Darvocet was helping to alleviate her
pain, or how the pain was affecting her
physical and psychological function.
Accordingly, with respect to the Agent’s
second visit, I again conclude that
Registrant failed to establish a doctorpatient relationship with her. I also
conclude that Registrant lacked a
legitimate medical purpose and acted
outside of the usual course of
professional practice in prescribing
Xanax and Darvocet-N to her and
violated Federal law. See 21 CFR
1306.04(a); 21 U.S.C. 841(a)(1).
As the forgoing demonstrates,
Registrant has committed acts which
‘‘render his registration * * *
inconsistent with the public interest.’’
21 U.S.C. 824(a)(4). I will therefore
order that his registration be revoked
and that any pending applications be
denied.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a), as well
as by 28 CFR 0.100(b), I hereby order
that DEA Certificate of Registration,
BF7430781, issued to Joe C. Fermo,
M.D., be, and it hereby is, revoked. I
further order that any pending
application of Joe C. Fermo, M.D., to
renew or modify his registration be, and
it hereby is, denied. This Order is
effective September 19, 2011.
Dated: August 5, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–21061 Filed 8–17–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
Ideal Pharmacy Care, Inc., D/B/A
Esplanade Pharmacy; Revocation of
Registration
On November 12, 2010, I, the then
Deputy Administrator of the Drug
Enforcement Administration, issued an
Order to Show Cause and Immediate
Suspension of Registration to Ideal
Pharmacy Care, Inc., d/b/a Esplanade
Pharmacy (Registrant), of New Orleans,
Louisiana. The Show Cause Order
proposed the revocation of Registrant’s
DEA Certificate of Registration
FF1125651, which authorizes it to
dispense controlled substances in
schedules II through V as a retail
pharmacy, on the ground that it has
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committed acts which render its
registration ‘‘inconsistent with the
public interest.’’ Show Cause Order at 1
(citing 21 U.S.C. 824(a)(4)). The Show
Cause Order also proposed the denial of
any pending applications to renew or
modify Registrant’s registration. Id.
The Show Cause Order specifically
alleged that on October 14, 2010,
investigators conducted an
accountability audit of Registrant and
found that it had ‘‘significant shortages’’
of various controlled substances. Id. The
Order alleged that these included
shortages of: (1) 3,891 dosage units of
hydrocodone 7.5/650 mg, 78 percent of
the accountable total; (2) 27,179 dosage
units of hydrocodone 7.5/750 mg, 59
percent of the accountable total; (3)
5,514 dosage units of hydrocodone 10/
500 mg, 48 percent of the accountable
total; (4) 114,826 dosage units of
hydrocodone 10/650 mg, 96 percent of
the accountable total; (5) 83,254 dosage
units of alprazolam 2 mg, 96 percent of
the accountable total; and (6) 1,616,420
ml of promethazine with codeine, 99
percent of the accountable total. Id. at
1–2. Based on the audit results, the
Order alleged that the Registrant had
violated 21 U.S.C. 827(a)(3) and
842(a)(5), as well as 21 CFR 1304.03,
1304.04, and 1304.21. Id. at 2.
Next, the Show Cause Order alleged
that various distributors make deliveries
of controlled substances to Registrant
when it ‘‘is closed,’’ and that the
‘‘deliveries are received and signed for
by’’ non-employees who work ‘‘at the
grocery store in which [it] is located,’’
and that the deliveries are then
‘‘diverted in violation of 21 U.S.C.
843(a)(3).’’ Id. The Order thus alleged
that Registrant ‘‘has failed to provide
effective controls’’ against theft and
diversion of controlled substances. Id.
(citing 21 CFR 1301.71).
The Show Cause Order also alleged
that Registrant had violated a
Memorandum of Agreement (MOA) it
entered into with DEA. Id. The Order
alleged that in the MOA, Registrant
agreed that it would not employ its
former owners ‘‘in any capacity relating
to [its] business,’’ and that it would not
permit its former owners to have
‘‘access to any area of [it] where
controlled substances are kept, stored,
or maintained.’’ Id. The Order alleged
that Registrant ‘‘has permitted [its
former owners] to enter the pharmacy
where controlled substances are present
in violation of’’ the MOA and 21 CFR
1301.72(d). Id.
Based on the matters set forth above,
I concluded that Registrant’s continued
registration during the pendency of the
proceeding would constitute ‘‘an
imminent danger to public health and
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51415
safety.’’ Id. (citing 21 U.S.C. 824(d)). I,
therefore, ordered the immediate
suspension of Registrant’s registration.
Id.
On November 17, 2010, the Order to
Show Cause and Immediate Suspension
of Registration, which also notified
Registrant of its right to request a
hearing on the allegations or to submit
a written statement in lieu of a hearing,
the procedures for doing either, and the
consequences for failing to do either, id.
at 3 (citing 21 CFR 1301.43(a) & (c)), was
personally served on Registrant’s
Pharmacist-in-Charge. GX 2. Since the
date of service of the Order, more than
thirty days have now passed, and
neither Registrant, nor anyone
purporting to represent it, has requested
a hearing or submitted a written
statement. Accordingly, I find that
Registrant has waived its right to a
hearing or to submit a written statement
in lieu of a hearing. 21 CFR 1301.43(a),
(c) & (d). I, therefore, issue this Decision
and Final Order based on relevant
material contained in the record
submitted by the Government. 21 CFR
1301.43(e).
Findings
Registrant is the holder of DEA
Certificate of Registration FI1125651,
which authorizes it to dispense
controlled substances in schedules II
through V as a retail pharmacy, at the
registered address of 1400 Esplanade
Ave., New Orleans, Louisiana.
Registrant’s registration does not expire
until November 30, 2011. Registrant is
apparently located in a building which
also contains a grocery store. Affidavit
of DI, at 8 (GX 22).
On October 14, 2010, DEA
Investigators conducted an audit of
Registrant’s handling of controlled
substances. Id. at 9. The audit covered
the period of October 22, 2008, on
which date Registrant had no controlled
substances on hand, through the
beginning of business on October 14,
2010, at which time the closing
inventory for the audit was taken. Id.
According to the DI, she obtained
invoices provided by Registrant’s
suppliers to determine the total amount
of the controlled substances it had
purchased during the audit period and
was accountable for; the DI also
obtained Registrant’s records (including
the prescriptions on file), as well as data
from the state’s prescription monitoring
program showing the pharmacy’s
dispensings, and added the amount of
its dispensings to the closing inventory
to determine the total amount of each
drug which it could account for. Id.
Upon comparing the two amounts, the
DI found that Registrant had large
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shortages of six different drugs. These
included:
1. A shortage of 3,891 dosage units of
hydrocodone/apap 7.5/650 mg, which
was 78 percent of the total amount for
which it was accountable;
2. A shortage of 27,179 dosage units
of hydrocodone/apap 7.5/750 mg, which
was 59 percent of the total amount for
which it was accountable;
3. A shortage of 5,514 dosage units of
hydrocodone/apap 10/500 mg, which
was 48 percent of the total amount for
which it was accountable;
4. A shortage of 114,826 dosage units
of hydrocodone/apap 10/650 mg. which
was 96 percent of the total amount for
which it was accountable;
5. A shortage of 83,254 dosage units
of alprazolam 2 mg., which was also 96
percent of the total amount for which it
was accountable; and
6. A shortage of 1,616,420 ml of
promethazine with codeine, a shortage
of 99 percent of the total amount for
which it was accountable.
Id. at 9.
While pharmacy employees told the
DI that they were the only persons who
accepted controlled substance
deliveries, based on the records
obtained from one of Registrant’s
distributors, the DI determined that
many of the shipments had been
delivered on Saturdays, a day when the
pharmacy was closed, and that a
number of the shipments were signed
for by non-pharmacy employees who
worked in the grocery store. Id. at 7–8,
10. Moreover, while Registrant’s
employees had told the DI that
McKesson was the only distributor it
purchased controlled substances from,
Registrant was also purchasing from
ANDA and Smith Drug Company. Id. at
7–8.
Discussion
Section 304(a) of the Controlled
Substances Act (CSA) 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
[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 making
the public interest determination, the
CSA requires that the following factors
be considered:
(1) The recommendation of the appropriate
state licensing board or professional
disciplinary authority.
(2) The applicant’s experience in
dispensing * * * 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.
21 U.S.C. 823(f).
These 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
I may give each factor the weight I deem
appropriate in determining whether to
revoke an existing registration. Id.
Moreover, I am ‘‘not required to make
findings as to all 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. 2005). The
Government bears the burden of proof.
21 CFR 1316.56.
Having considered all of the factors, I
conclude that the evidence pertinent to
Registrant’s compliance with applicable
laws related to controlled substances
(factor four) is dispositive and supports
a finding that it has committed acts
which render its registration
‘‘inconsistent with the public interest.’’
21 U.S.C. 824(a)(4).
As found above, DIs conducted an
audit of Registrant’s handling of various
controlled substances and found that it
could not account for extraordinary
quantities of four different formulations
of hydrocodone, a schedule III
controlled substance, and alprazolam 2
mg (generic for Xanax), a schedule IV
controlled substance; both of these
drugs are highly popular with drug
abusers. See 21 CFR 1308.13(e);
13018.14(c). More specifically,
approximately 150,000 dosage units of
various hydrocodone drugs and 83,000
dosage units of alprazolam (96% of the
amount purchased) were purchased by
Registrant and could not be accounted
for. In addition, 1.6 million mls of
promethazine with codeine (99% of the
amount purchased), another highlyabused controlled substance, was
purchased by Registrant and could not
be accounted for.
Pursuant to DEA regulations, all
‘‘registrants shall provide effective
controls and procedures to guard against
theft and diversion of controlled
substances.’’ 21 CFR 1301.71(a). Among
the factors DEA considers in assessing
whether a registrant maintains effective
controls against theft and diversion, is
‘‘[t]he adequacy of the registrant’s * * *
system for monitoring the receipt * * *
distribution, and disposition of
controlled substances in its operations.’’
Id. 1301.71(b)(14).
Moreover, under Federal law and
DEA regulations, ‘‘every registrant
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under this subchapter * * *
distributing, or dispensing a controlled
substance or substances shall maintain,
on a current basis, a complete and
accurate record of each such substance
* * * received, sold, delivered, or
otherwise disposed of by [it].’’ 21 U.S.C.
827(a)(3). See also 21 CFR 1304.03;
1304.04, 1304.21, 1304.22(c). A
registrant is required to maintain these
records for at least two years. Id.
§ 827(b) (‘‘every inventory or other
record required under this section
* * * shall be kept and be available, for
at least two years, for inspection and
copying’’). See also 21 CFR 1304.03
(‘‘Each registrant shall maintain the
records and inventories and shall file
the reports required by this part, except
as exempted by this section.’’); id.
§ 1304.04 (mandating that records be
maintained for at least two years and be
available for inspection and copying).
See also Paul H. Volkman, 73 FR 30630,
30644 (2008) (‘‘Recordkeeping is one of
the CSA’s central features; a registrant’s
accurate and diligent adherence to this
obligation is absolutely essential to
protect against the diversion of
controlled substances.’’).
Whether the shortages are attributable
to outright diversion by either pharmacy
or store employees, theft, or the failure
to maintain accurate records, does not
matter. What is clear is that Registrant
purchased several hundred thousand
dosage units of highly abused controlled
substances which cannot be accounted
for and that it has committed acts which
render its registration ‘‘inconsistent
with the public interest.’’ 21 U.S.C.
824(a)(4). Accordingly, I will order that
Registrant’s registration be revoked and
that any pending application be
denied.1
1 On November 17, 2010, the Louisiana Board of
Pharmacy issued an Active Suspension Notice to
Registrant, which placed its Louisiana Pharmacy
Permit in active suspension pending further
proceedings. Thus, Registrant also no longer meets
the CSA’s requirement for holding a registration
that it be ‘‘authorized to dispense * * * controlled
substances under the laws of the State in which [it]
practices.’’ 21 U.S.C. 823(f); see also id. § 824(a)(3)
(authorizing revocation where registrant’s ‘‘[s]tate
license or registration [has been] suspended * * *
by competent State authority and [registrant] is no
longer authorized by State law to engage in the
* * * dispensing of controlled substances’’); id. §
802(21) (defining ‘‘[t]he term ‘practitioner’ [to]
mean[] a * * * pharmacy * * * licensed,
registered, or otherwise permitted, by the United
States or the jurisdiction in which [it] practices
* * * to dispense * * * a controlled substance in
the course of professional practice’’).
Registrant’s loss of state authority thus provides
an additional ground to revoke its registration. See
Bourne Pharmacy, Inc., 72 FR 18273, 18274 (2007).
However, the State’s suspension was not cited as a
basis for Agency action in the Order to Show Cause
(as it occurred five days after the latter was issued)
and there are no pleadings establishing that the
Agency subsequently gave notice of its intent to rely
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Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) & 824(a), as well as
28 CFR 0.100(b), I order that DEA
Certificate of Registration FI1125651,
issued to Ideal Pharmacy Care, Inc.,
d/b/a/Esplanade Pharmacy, be, and it
hereby is, revoked.
I further order that any pending
application to renew or modify this
registration, be, and it hereby is, denied.
Dated: August 5, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–21060 Filed 8–17–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10–2]
mstockstill on DSK4VPTVN1PROD with NOTICES
Surinder Dang, M.D.; Revocation of
Registration
On August 31, 2009, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Surinder Singh Dang,
M.D. (‘‘Respondent’’), of Fountain
Valley, California. The Order proposed
the revocation of Respondent’s DEA
Certificate of Registration, AD6122143,
as a practitioner, as well as the denial
of any pending applications to renew or
modify his registration ‘‘for reason that
[Respondent’s] continued registration[]
would be inconsistent with the public
interest, as that term is used in 21 U.S.C.
823(f) and 824(a)(4).’’ ALJ Ex.1, at 1.
The Order specifically alleged that
between January 2004 and July 2007,
Respondent and his wife, Dr. Satinder
Dang, ‘‘who also possesses a DEA
registration and shares [Respondent’s]
registered location,’’ ordered ‘‘more than
5,000,000 dosage units of hydrocodone’’
and that Respondent ‘‘failed to properly
account for, secure, and otherwise
handle these controlled substances.’’ Id.
The Order alleged that on January 17,
2006, one of Respondent’s ‘‘employees
removed 30,000 dosage units of
controlled substances’’ from his
registered location and ‘‘attempted to
take them to her residence.’’ Id. The
Order further alleged that on the same
day, ‘‘DEA Special Agents seized
another 10,000 dosage units of
controlled substances from this
employee’s residence.’’ Id. at 1–2.
Continuing, the Order alleged that on
March 16, 2006, ‘‘DEA Special Agents
on the State’s suspension. See 5 U.S.C. 554(b). I
therefore do not rely on it.
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seized 50,000 dosage units more from
this employee’s residence.’’ Id. at 2.
Next, the Order alleged that on March
16, 2006, DEA conducted an
accountability audit of Respondent’s
handling of hydrocodone and that
Respondent ‘‘could not account for
more than 3,500,000 dosage units’’ that
Respondent and his wife ‘‘had ordered,’’
and that Respondent ‘‘failed to keep
accurate and complete records of each
controlled substance received, sold,
delivered, or otherwise disposed of as
required by 21 U.S.C. 827(c) and 21 CFR
1304.01 et seq.’’ Id. Finally, the Order
alleged that when Respondent ‘‘made
dispensing records,’’ he ‘‘frequently
failed to indicate whether’’ he or his
wife ‘‘actually dispensed the controlled
substances as required by 21 CFR
1304.03(b).’’ 1 Id.
By letter of October 2, 2009,
Respondent, through his counsel,
requested a hearing on the allegations.
ALJ Ex. 2. The matter was then assigned
to an Administrative Law Judge (ALJ),
who conducted a hearing on March 3,
2010, in Santa Ana, California.
At the hearing, the Government called
one witness to testify and introduced
documentary evidence. Respondent did
not call any witnesses and introduced a
single exhibit, this being a letter from
the counsel for Respondent’s employee
R.K. stating that she intended to assert
her Fifth Amendment privilege if called
to testify. See RX 1. Following the
hearing, both parties submitted briefs
containing their proposed findings of
fact, conclusions of law and argument.
On May 19, 2010, the ALJ issued her
Recommended Decision (also ALJ).
Therein, the ALJ considered the five
public interest factors, see 21 U.S.C.
823(f), and concluded that Respondent’s
continued registration would be
inconsistent with the public interest and
recommended that his registration be
revoked. ALJ at 26, 30–31.
As to the first factor—the
recommendation of the appropriate
State licensing board or professional
disciplinary authority—the ALJ found
that the California Medical Board ‘‘has
not taken any formal action to limit
Respondent’s right to practice medicine
nor has it recommended limiting his
ability to prescribe controlled
substances.’’ Id. at 23. However, the ALJ
recognized that under Agency precedent
‘‘the fact that the Medical Board of
California has currently authorized
* * * Respondent to practice medicine
is not dispositive in this administrative
determination as to whether
continuation of a registration is
consistent with the public interest.’’ ALJ
at 22–23 (citing Patrick W. Stodola, 74
FR 20727, 20730 (2009); Jayam Krishna-
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51417
Iyer, 74 FR 459, 461 (2009)). The ALJ
thus concluded that ‘‘this factor does
not fall in favor of revocation.’’ Id. at 23.
Likewise, with respect to factor three—
Respondent’s record of convictions for
offenses relating to the manufacture,
distribution, or dispensing of controlled
substances—the ALJ found that
Respondent has not been convicted of
such an offense and that this factor also
did not ‘‘fall in favor of revocation.’’ Id.
The ALJ then considered factors two
and four—Respondent’s experience in
dispensing controlled substances and
his compliance with Federal, State, and
local laws relating to controlled
substances—together. Id. at 23–26. The
ALJ specifically found that: (1)
‘‘Respondent authorized’’ his employee
R.K. ‘‘to purchase large amounts of
hydrocodone using his DEA registration
and that of his wife’’; (2) another
physician who practiced at
Respondent’s clinic had ‘‘stated that the
patient load’’ at the clinic ‘‘would not
justify such large purchases of
controlled substances’’; (3) R.K.
remained in Respondent’s employ even
after ‘‘drugs were discovered in [her]
personal vehicle by the California
Highway Patrol’’; (4) ‘‘[l]arge bundles of
cash, controlled substances, and other
* * * evidence, such as receipts and
money order stubs were discovered at
[her] home’’; and (5) ‘‘[a]fter being
questioned, [R.K.] stated that she was
ordering and transporting controlled
substances all at the direction of the
Respondent.’’ Id. at 24. Based on these
findings, the ALJ concluded that ‘‘either
[Respondent] is personally involved in
hydrocodone diversion or he is
facilitating such diversion on the part of
his employee.’’ Id.
The ALJ further found that
Respondent ‘‘prescribed Vicodin,’’ a
schedule III controlled substance, to
patient B.R. ‘‘on many occasions
without a thorough examination.’’ Id.
Based on Cal. Bus. & Prof. Code
§ 2242(a), which provides that it is
‘‘unprofessional conduct’’ to
‘‘[p]rescrib[e], dispens[e] or furnish[ ]
dangerous drugs as defined in Section
4022 without an appropriate prior
examination and a medical indication,’’
the ALJ concluded that Respondent
prescribed Vicodin to B.R. without an
‘‘appropriate prior examination.’’ Id. at
25. The ALJ thus concluded that
Respondent ‘‘prescribed controlled
substances without establishing a bonafide patient relationship’’ and violated
both Federal and state law. Id. at 24–25.
Next, the ALJ found that Respondent
did not have any inventories for the
controlled substances his clinic
dispensed, that he ‘‘failed to maintain
accurate records of the controlled
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[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51415-51417]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21060]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Ideal Pharmacy Care, Inc., D/B/A Esplanade Pharmacy; Revocation
of Registration
On November 12, 2010, I, the then Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and Immediate
Suspension of Registration to Ideal Pharmacy Care, Inc., d/b/a
Esplanade Pharmacy (Registrant), of New Orleans, Louisiana. The Show
Cause Order proposed the revocation of Registrant's DEA Certificate of
Registration FF1125651, which authorizes it to dispense controlled
substances in schedules II through V as a retail pharmacy, on the
ground that it has committed acts which render its registration
``inconsistent with the public interest.'' Show Cause Order at 1
(citing 21 U.S.C. 824(a)(4)). The Show Cause Order also proposed the
denial of any pending applications to renew or modify Registrant's
registration. Id.
The Show Cause Order specifically alleged that on October 14, 2010,
investigators conducted an accountability audit of Registrant and found
that it had ``significant shortages'' of various controlled substances.
Id. The Order alleged that these included shortages of: (1) 3,891
dosage units of hydrocodone 7.5/650 mg, 78 percent of the accountable
total; (2) 27,179 dosage units of hydrocodone 7.5/750 mg, 59 percent of
the accountable total; (3) 5,514 dosage units of hydrocodone 10/500 mg,
48 percent of the accountable total; (4) 114,826 dosage units of
hydrocodone 10/650 mg, 96 percent of the accountable total; (5) 83,254
dosage units of alprazolam 2 mg, 96 percent of the accountable total;
and (6) 1,616,420 ml of promethazine with codeine, 99 percent of the
accountable total. Id. at 1-2. Based on the audit results, the Order
alleged that the Registrant had violated 21 U.S.C. 827(a)(3) and
842(a)(5), as well as 21 CFR 1304.03, 1304.04, and 1304.21. Id. at 2.
Next, the Show Cause Order alleged that various distributors make
deliveries of controlled substances to Registrant when it ``is
closed,'' and that the ``deliveries are received and signed for by''
non-employees who work ``at the grocery store in which [it] is
located,'' and that the deliveries are then ``diverted in violation of
21 U.S.C. 843(a)(3).'' Id. The Order thus alleged that Registrant ``has
failed to provide effective controls'' against theft and diversion of
controlled substances. Id. (citing 21 CFR 1301.71).
The Show Cause Order also alleged that Registrant had violated a
Memorandum of Agreement (MOA) it entered into with DEA. Id. The Order
alleged that in the MOA, Registrant agreed that it would not employ its
former owners ``in any capacity relating to [its] business,'' and that
it would not permit its former owners to have ``access to any area of
[it] where controlled substances are kept, stored, or maintained.'' Id.
The Order alleged that Registrant ``has permitted [its former owners]
to enter the pharmacy where controlled substances are present in
violation of'' the MOA and 21 CFR 1301.72(d). Id.
Based on the matters set forth above, I concluded that Registrant's
continued registration during the pendency of the proceeding would
constitute ``an imminent danger to public health and safety.'' Id.
(citing 21 U.S.C. 824(d)). I, therefore, ordered the immediate
suspension of Registrant's registration. Id.
On November 17, 2010, the Order to Show Cause and Immediate
Suspension of Registration, which also notified Registrant of its right
to request a hearing on the allegations or to submit a written
statement in lieu of a hearing, the procedures for doing either, and
the consequences for failing to do either, id. at 3 (citing 21 CFR
1301.43(a) & (c)), was personally served on Registrant's Pharmacist-in-
Charge. GX 2. Since the date of service of the Order, more than thirty
days have now passed, and neither Registrant, nor anyone purporting to
represent it, has requested a hearing or submitted a written statement.
Accordingly, I find that Registrant has waived its right to a hearing
or to submit a written statement in lieu of a hearing. 21 CFR
1301.43(a), (c) & (d). I, therefore, issue this Decision and Final
Order based on relevant material contained in the record submitted by
the Government. 21 CFR 1301.43(e).
Findings
Registrant is the holder of DEA Certificate of Registration
FI1125651, which authorizes it to dispense controlled substances in
schedules II through V as a retail pharmacy, at the registered address
of 1400 Esplanade Ave., New Orleans, Louisiana. Registrant's
registration does not expire until November 30, 2011. Registrant is
apparently located in a building which also contains a grocery store.
Affidavit of DI, at 8 (GX 22).
On October 14, 2010, DEA Investigators conducted an audit of
Registrant's handling of controlled substances. Id. at 9. The audit
covered the period of October 22, 2008, on which date Registrant had no
controlled substances on hand, through the beginning of business on
October 14, 2010, at which time the closing inventory for the audit was
taken. Id. According to the DI, she obtained invoices provided by
Registrant's suppliers to determine the total amount of the controlled
substances it had purchased during the audit period and was accountable
for; the DI also obtained Registrant's records (including the
prescriptions on file), as well as data from the state's prescription
monitoring program showing the pharmacy's dispensings, and added the
amount of its dispensings to the closing inventory to determine the
total amount of each drug which it could account for. Id. Upon
comparing the two amounts, the DI found that Registrant had large
[[Page 51416]]
shortages of six different drugs. These included:
1. A shortage of 3,891 dosage units of hydrocodone/apap 7.5/650 mg,
which was 78 percent of the total amount for which it was accountable;
2. A shortage of 27,179 dosage units of hydrocodone/apap 7.5/750
mg, which was 59 percent of the total amount for which it was
accountable;
3. A shortage of 5,514 dosage units of hydrocodone/apap 10/500 mg,
which was 48 percent of the total amount for which it was accountable;
4. A shortage of 114,826 dosage units of hydrocodone/apap 10/650
mg. which was 96 percent of the total amount for which it was
accountable;
5. A shortage of 83,254 dosage units of alprazolam 2 mg., which was
also 96 percent of the total amount for which it was accountable; and
6. A shortage of 1,616,420 ml of promethazine with codeine, a
shortage of 99 percent of the total amount for which it was
accountable.
Id. at 9.
While pharmacy employees told the DI that they were the only
persons who accepted controlled substance deliveries, based on the
records obtained from one of Registrant's distributors, the DI
determined that many of the shipments had been delivered on Saturdays,
a day when the pharmacy was closed, and that a number of the shipments
were signed for by non-pharmacy employees who worked in the grocery
store. Id. at 7-8, 10. Moreover, while Registrant's employees had told
the DI that McKesson was the only distributor it purchased controlled
substances from, Registrant was also purchasing from ANDA and Smith
Drug Company. Id. at 7-8.
Discussion
Section 304(a) of the Controlled Substances Act (CSA) 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 [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 making the public interest determination, the CSA
requires that the following factors be considered:
(1) The recommendation of the appropriate state licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * 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.
21 U.S.C. 823(f).
These 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 I may give each factor the weight I deem appropriate in
determining whether to revoke an existing registration. Id. Moreover, I
am ``not required to make findings as to all 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. 2005). The Government bears the burden of
proof. 21 CFR 1316.56.
Having considered all of the factors, I conclude that the evidence
pertinent to Registrant's compliance with applicable laws related to
controlled substances (factor four) is dispositive and supports a
finding that it has committed acts which render its registration
``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4).
As found above, DIs conducted an audit of Registrant's handling of
various controlled substances and found that it could not account for
extraordinary quantities of four different formulations of hydrocodone,
a schedule III controlled substance, and alprazolam 2 mg (generic for
Xanax), a schedule IV controlled substance; both of these drugs are
highly popular with drug abusers. See 21 CFR 1308.13(e); 13018.14(c).
More specifically, approximately 150,000 dosage units of various
hydrocodone drugs and 83,000 dosage units of alprazolam (96% of the
amount purchased) were purchased by Registrant and could not be
accounted for. In addition, 1.6 million mls of promethazine with
codeine (99% of the amount purchased), another highly-abused controlled
substance, was purchased by Registrant and could not be accounted for.
Pursuant to DEA regulations, all ``registrants shall provide
effective controls and procedures to guard against theft and diversion
of controlled substances.'' 21 CFR 1301.71(a). Among the factors DEA
considers in assessing whether a registrant maintains effective
controls against theft and diversion, is ``[t]he adequacy of the
registrant's * * * system for monitoring the receipt * * *
distribution, and disposition of controlled substances in its
operations.'' Id. 1301.71(b)(14).
Moreover, under Federal law and DEA regulations, ``every registrant
under this subchapter * * * distributing, or dispensing a controlled
substance or substances shall maintain, on a current basis, a complete
and accurate record of each such substance * * * received, sold,
delivered, or otherwise disposed of by [it].'' 21 U.S.C. 827(a)(3). See
also 21 CFR 1304.03; 1304.04, 1304.21, 1304.22(c). A registrant is
required to maintain these records for at least two years. Id. Sec.
827(b) (``every inventory or other record required under this section *
* * shall be kept and be available, for at least two years, for
inspection and copying''). See also 21 CFR 1304.03 (``Each registrant
shall maintain the records and inventories and shall file the reports
required by this part, except as exempted by this section.''); id.
Sec. 1304.04 (mandating that records be maintained for at least two
years and be available for inspection and copying). See also Paul H.
Volkman, 73 FR 30630, 30644 (2008) (``Recordkeeping is one of the CSA's
central features; a registrant's accurate and diligent adherence to
this obligation is absolutely essential to protect against the
diversion of controlled substances.'').
Whether the shortages are attributable to outright diversion by
either pharmacy or store employees, theft, or the failure to maintain
accurate records, does not matter. What is clear is that Registrant
purchased several hundred thousand dosage units of highly abused
controlled substances which cannot be accounted for and that it has
committed acts which render its registration ``inconsistent with the
public interest.'' 21 U.S.C. 824(a)(4). Accordingly, I will order that
Registrant's registration be revoked and that any pending application
be denied.\1\
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\1\ On November 17, 2010, the Louisiana Board of Pharmacy issued
an Active Suspension Notice to Registrant, which placed its
Louisiana Pharmacy Permit in active suspension pending further
proceedings. Thus, Registrant also no longer meets the CSA's
requirement for holding a registration that it be ``authorized to
dispense * * * controlled substances under the laws of the State in
which [it] practices.'' 21 U.S.C. 823(f); see also id. Sec.
824(a)(3) (authorizing revocation where registrant's ``[s]tate
license or registration [has been] suspended * * * by competent
State authority and [registrant] is no longer authorized by State
law to engage in the * * * dispensing of controlled substances'');
id. Sec. 802(21) (defining ``[t]he term `practitioner' [to] mean[]
a * * * pharmacy * * * licensed, registered, or otherwise permitted,
by the United States or the jurisdiction in which [it] practices * *
* to dispense * * * a controlled substance in the course of
professional practice'').
Registrant's loss of state authority thus provides an
additional ground to revoke its registration. See Bourne Pharmacy,
Inc., 72 FR 18273, 18274 (2007). However, the State's suspension was
not cited as a basis for Agency action in the Order to Show Cause
(as it occurred five days after the latter was issued) and there are
no pleadings establishing that the Agency subsequently gave notice
of its intent to rely on the State's suspension. See 5 U.S.C.
554(b). I therefore do not rely on it.
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[[Page 51417]]
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of
Registration FI1125651, issued to Ideal Pharmacy Care, Inc., d/b/a/
Esplanade Pharmacy, be, and it hereby is, revoked.
I further order that any pending application to renew or modify
this registration, be, and it hereby is, denied.
Dated: August 5, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-21060 Filed 8-17-11; 8:45 am]
BILLING CODE 4410-09-P
