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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 [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.
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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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