Xubex Community Pharmacy; Decision and Order, 8037-8038 [2025-01537]
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Federal Register / Vol. 90, No. 14 / Thursday, January 23, 2025 / Notices
Commission and served on any parties
to the investigation within two business
days of any confidential filing. All
information, including confidential
business information and documents for
which confidential treatment is properly
sought, submitted to the Commission for
purposes of this investigation may be
disclosed to and used: (i) by the
Commission, its employees and Offices,
and contract personnel (a) for
developing or maintaining the records
of this or a related proceeding, or (b) in
internal investigations, audits, reviews,
and evaluations relating to the
programs, personnel, and operations of
the Commission including under 5
U.S.C. appendix 3; or (ii) by U.S.
Government employees and contract
personnel, solely for cybersecurity
purposes. All contract personnel will
sign appropriate nondisclosure
agreements. All nonconfidential written
submissions will be available for public
inspection on EDIS.
The Commission vote for this
determination took place on January 16,
2025.
The authority for the Commission’s
determination is contained in section
337 of the Tariff Act of 1930, as
amended (19 U.S.C. 1337), and in part
210 of the Commission’s Rules of
Practice and Procedure (19 CFR part
210).
By order of the Commission.
Issued: January 16, 2025.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2025–01563 Filed 1–22–25; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
ddrumheller on DSK120RN23PROD with NOTICES1
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
VerDate Sep<11>2014
17:45 Jan 22, 2025
Jkt 265001
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.
‘‘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] § 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.
§ 1316.67.
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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Frm 00032
Fmt 4703
Sfmt 4703
8037
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.
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
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).
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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8038
Federal Register / Vol. 90, No. 14 / Thursday, January 23, 2025 / Notices
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).
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.
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’’).
ddrumheller on DSK120RN23PROD with NOTICES1
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)).
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
7 As already discussed, the record contains no
evidence submitted by Respondent. Supra.
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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17:45 Jan 22, 2025
Jkt 265001
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
PO 00000
Frm 00033
Fmt 4703
Sfmt 9990
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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23JAN1
Agencies
[Federal Register Volume 90, Number 14 (Thursday, January 23, 2025)]
[Notices]
[Pages 8037-8038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
``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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\7\ As already discussed, the record contains no evidence
submitted by Respondent. Supra.
---------------------------------------------------------------------------
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)).
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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