Notice2025-01537
Xubex Community Pharmacy; Decision and Order
Primary source
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Published
January 23, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 90 Issue 14 (Thursday, January 23, 2025)</title>
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[Federal Register Volume 90, Number 14 (Thursday, January 23, 2025)]
[Notices]
[Pages 8037-8038]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-01537]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Xubex Community Pharmacy; Decision and Order
On May 29, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to Xubex Community Pharmacy of Casselberry,
Florida (Respondent). Request for Final Agency Action (RFAA), Exhibit
(RFAAX) 1, (hereinafter, OSC/ISO), at 1. The OSC/ISO informed
Respondent of the immediate suspension of its DEA registration, No.
FX3643081, pursuant to 21 U.S.C. 824(d), alleging that Respondent's
continued registration constitutes ` ``an imminent danger to the public
health or safety.' '' Id. (quoting 21 U.S.C. 824(d)). The OSC/ISO also
proposed the revocation of Respondent's registration, alleging that
Respondent's continued registration is inconsistent with the public
interest. Id. (citing 21 U.S.C. 823(g)(1), 824(a)(4)).
The OSC/ISO notified Respondent of its right to file with DEA a
written request for a hearing within 30 days after the date of receipt
of the OSC/ISO. OSC/ISO, at 4 (citing 21 CFR 1301.43(a)). The OSC/ISO
also notified Respondent that if it failed to file such a request, it
would be deemed to have waived its right to a hearing and be in
default. Id. (citing 21 CFR 1301.43(c), (d)). The OSC/ISO further
notified Respondent that ``[d]efault constitutes a waiver of
[Respondent's] right to a hearing and an admission of the factual
allegations of this [OSC/ISO].'' Id. (citing 21 CFR 1301.43(e)).
The RFAA asserts that on June 6, 2024, a DEA Diversion Investigator
personally served the OSC/ISO on ``a representative of Respondent.''
RFAA, at 1.\1\ On June 9, 2024, Mr. M.H.\2\ communicated via email to
the Government that he represented Respondent and ``[Respondent] was
taking the default.'' RFAAX 2, at 1. Accordingly, based on Respondent's
failure to request a hearing, answer, or otherwise plead or defend the
allegations delineated in the OSC/ISO, the Agency finds that Respondent
is deemed to be in default. 21 CFR 1301.43(c). ``A default, unless
excused, shall be deemed to constitute a waiver of [Respondent's] right
to a hearing and an admission of the factual allegations of the [OSC/
ISO].'' 21 CFR 1301.43(e). To date, Respondent has not filed a motion
to excuse the default with the Office of the Administrator.
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\1\ The RFAA does not include an affidavit from the DEA
Diversion Investigator or any other documentary evidence regarding
the method of service; however, the Agency can conclude based on the
email from Mr. M.H. that Respondent actually received the OSC and
therefor that service was proper.
\2\ Mr. M.H. is ``part owner of the [Xubex Community]
Pharmacy.'' RFAA, at 2.
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``In the event that a registrant . . . is deemed to be in default .
. . DEA may then file a request for final agency action with the
Administrator, along with a record to support its request. In such
circumstances, the Administrator may enter a default final order
pursuant to [21 CFR] Sec. 1316.67.'' 21 CFR 1301.43(f)(1). Here, the
Government has requested final agency action based on Respondent's
default pursuant to 21 CFR 1301.43(c), (f), because Respondent did not
request a hearing or file an answer, and it has not filed a motion with
the Administrator seeking to excuse the default. See also id. Sec.
1316.67.
I. Findings of Fact
The Agency finds that, in light of Respondent's default, the
factual allegations in the OSC/ISO are deemed to be admitted.\3\ 21 CFR
1301.43(e). Accordingly, Respondent admits and the Agency finds
substantial evidence that on two separate occasions, Respondent
dispensed Schedule II controlled substances to a confidential source
(CS) in exchange for cash without a prescription being presented for
the controlled substances. OSC/ISO, at 3. Specifically, Respondent
admits and the Agency finds substantial evidence that on November 30,
2023, it dispensed ten oxycodone \4\ tablets to CS in exchange for $260
in the absence of a prescription. Id. Additionally, Respondent admits
and the Agency finds substantial evidence that on December 19, 2023,
Respondent dispensed two hydromorphone \5\ tablets to CS in exchange
for $50 in the absence of a prescription. Id.
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\3\ The Agency need not adjudicate the criminal violations
alleged in the instant OSC/ISO. Ruan v. United States, 597 U.S. 450
(2022) (decided in the context of criminal proceedings).
\4\ Oxycodone is a schedule II opioid. OSC/ISO, at 3; see also
21 CFR 1308.12(b)(1)(xiv).
\5\ Hydromorphone is a schedule II opioid. OSC/ISO, at 3; see
also 21 CFR 1308.12(b)(1)(vii).
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II. Discussion
A. The CSA and the OSC Allegations
Pursuant to the CSA, ``[a] registration . . . to . . . 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 his registration under . . . [21
U.S.C. 823] inconsistent with the public interest as determined by such
section.'' 21 U.S.C. 824(a)(4). In the case of a ``practitioner,''
Congress directed the Attorney General to consider five factors in
making the public interest determination. 21 U.S.C. 823(g)(1)(A-E).\6\
The five factors are considered in the disjunctive. Gonzales v. Oregon,
546 U.S. 243, 292-93 (2006) (Scalia, J., dissenting) (``It is well
established that these factors are to be considered in the
disjunctive,'' (citing In
[[Page 8038]]
re Arora, 60 FR 4447, 4448 (1995))); Robert A. Leslie, M.D., 68 FR
15227, 15230 (2003). Each factor is weighed on a case-by-case basis.
Morall v. Drug Enf't Admin., 412 F.3d 165, 173-74 (D.C. Cir. 2005). Any
one factor, or combination of factors, may be decisive. Penick Corp. v.
Drug Enf't Admin., 491 F.3d 483, 490 (D.C. Cir. 2007); Morall, 412
F.3d. at n.2; David H. Gillis, M.D., 58 FR 37507, 37508 (1993).
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\6\ The five factors of 21 U.S.C. 823(g)(1)(A-E) are:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
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In this matter, while all of the 21 U.S.C. 823(g)(1) factors have
been considered, the Agency finds that the Government's evidence in
support of its prima facie public interest revocation case is confined
to factors B and D.\7\ See OSC/ISO, at 3-4.
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\7\ As already discussed, the record contains no evidence
submitted by Respondent. Supra.
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According to DEA regulations, ``[a]t any hearing for the revocation
. . . of a registration, the . . . [Government] shall have the burden
of proving that the requirements for such revocation . . . pursuant to
. . . 21 U.S.C. 824(a) . . . are satisfied.'' 21 CFR 1301.44(e); see
also Morall, 412 F.3d. at 174; 21 CFR 1301.44(d) (applying the same
standard to a ``denial of a registration'').
B. Improper Dispensing and Public Interest Analysis
In the current matter, the Government has alleged that Respondent
violated federal and Florida laws regulating controlled substances.
OSC/ISO, at 1-5. Specifically, federal law provides that ``no
controlled substance in schedule II . . . may be dispensed without the
written prescription of a practitioner.'' 21 U.S.C. 829(a); see OSC/
ISO, at 2-3. Similarly, it is unlawful in Florida for any person to ``
`sell or dispense \8\ drugs . . . without first being furnished with a
prescription.' '' OSC/ISO, at 2 (citing Fla. Stat. section
465.015(2)(c)).
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\8\ Florida law defines ``dispense'' as ``the transfer of
possession of one or more doses of a medicinal drug by a pharmacist
to the ultimate consumer.'' Fla. Stat. section 465.003(13). The CSA
defines ``dispense'' as the ``deliver[y] [of] a controlled substance
to an ultimate user or research subject by, or pursuant to the
lawful order of, a practitioner . . . .'' 21 U.S.C. 802(10). The CSA
defines ``deliver'' and ``delivery'' as ``the actual, constructive,
or attempted transfer of a controlled substance . . . .'' Id. sec.
802(8).
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Here, the Agency finds substantial record evidence that on November
30, 2023, and December 19, 2023, Respondent dispensed Schedule II
controlled substances to CS without a prescription, which is a clear
violation of Federal and Florida law. 21 U.S.C. 829(a) and
823(g)(1)(D); Fla. Stat. section 465.015(2)(c). The Agency further
finds that this misconduct demonstrates Respondent's negative
experience in dispensing controlled substances. 21 U.S.C. 823(g)(1)(B).
Accordingly, the Agency concludes that Respondent's continued
registration is inconsistent with the public interest. Id. sec.
823(g)(1).
As Respondent failed to request a hearing, he has waived the
opportunity to present evidence and, therefore, to rebut the
Government's prima facie case. The Government's prima facie case was
established by substantial record evidence. Supra Section I.
Accordingly, the Agency finds that there is substantial and
uncontroverted record evidence supporting the revocation of
Respondent's registration. 21 U.S.C. 824(a)(4).
III. Sanction
Where, as here, the Government has met its prima facie burden of
showing that Respondent's continued registration would be inconsistent
with the public interest, the burden shifts to Respondent to show why
he can be entrusted with a registration. Morall, 412 F.3d. at 174;
Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d
823, 830 (11th Cir. 2018); Garrett Howard Smith, M.D., 83 FR 18882
(2018). The issue of trust is necessarily a fact-dependent
determination based on the circumstances presented by the individual
respondent. Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also
Jones Total Health Care Pharmacy, 881 F.3d at 833. Moreover, as past
performance is the best predictor of future performance, DEA
Administrators have required that a registrant who has committed acts
inconsistent with the public interest must accept responsibility for
those acts and demonstrate that it will not engage in future
misconduct. Jones Total Health Care Pharmacy, 881 F.3d at 833; ALRA
Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995). A
registrant's acceptance of responsibility must be unequivocal. Jones
Total Health Care Pharmacy, 881 F.3d at 830-31. In addition, a
registrant's candor during the investigation and hearing has been an
important factor in determining acceptance of responsibility and the
appropriate sanction. Id. Further, the Agency has found that the
egregiousness and extent of the misconduct are significant factors in
determining the appropriate sanction. Id. at 834 and n.4. The Agency
has also considered the need to deter similar acts by the respondent
and by the community of registrants. Jeffrey Stein, M.D., 84 FR 46972
and 46973.
Regarding these matters, there is no record evidence that
Respondent takes responsibility, let alone unequivocal responsibility,
for the founded violations meaning, among other things, that it is not
reasonable to believe that Respondent's future controlled substance-
related actions will comply with legal requirements. Accordingly,
Respondent did not convince the Agency that he can be entrusted with a
registration.
Further, the interests of specific and general deterrence weigh in
favor of revocation. Given the foundational nature of Respondent's
violations, which more closely resembled drug dealing than legal
dispensing, a sanction less than revocation would send a message to the
existing and prospective registrant community that compliance with the
law is not a condition precedent to maintaining a registration.
Accordingly, I shall order revocation of Respondent's registration
as contained in the Order below.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
FX3643081 issued to Xubex Community Pharmacy. Further, pursuant to 28
CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of Xubex Community Pharmacy to
renew or modify this registration, as well as any other pending
application of Xubex Community Pharmacy for additional registration in
Florida. This Order is effective February 24, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
January 16, 2025, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-01537 Filed 1-22-25; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on January 23, 2025.
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