[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51415-51417]
From the Federal Register Online via the Government Publishing 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