Federal Register / Vol. 90, No. 14 / Thursday, January 23, 2025 / Notices 8037 

1The 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. 

2Mr. M.H. is ‘‘part owner of the [Xubex 

Community] Pharmacy.’’ RFAA, at 2. 

3The 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). 

4Oxycodone is a schedule II opioid. OSC/ISO, at 

3; see also 21 CFR 1308.12(b)(1)(xiv). 

5Hydromorphone is a schedule II opioid. OSC/ 

ISO, at 3; see also 21 CFR 1308.12(b)(1)(vii). 

6The 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. 

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 

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. 

‘‘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. 

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 


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8038 Federal Register / Vol. 90, No. 14 / Thursday, January 23, 2025 / Notices 

7As already discussed, the record contains no 

evidence submitted by Respondent. Supra. 

8Florida 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). 

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’’). 

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 

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 


ddrumheller on DSK120RN23PROD with NOTICES1