84620 Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices 

1The record represents that this registration 

expired on November 30, 2023. RFAAX 1, at 1. The 

fact that a registrant allows its registration to expire 

during the pendency of an administrative 

enforcement proceeding does not impact the 

Agency’s jurisdiction or prerogative to adjudicate 

the OSC/ISO to finality. Jeffrey D. Olsen, M.D., 84 

FR 68474, 68479 (2019). 

2The Agency agrees with the Government and the 

Chief ALJ that the only individual with authority 

to request a hearing on Registrant’s behalf was its 

owner and PIC, Mr. Itani, as he has been 

Registrant’s only managing member and is the sole 

signatory and contact on Registrant’s registration. 

RFAAX 2, at 2–4; RFAAX 4, at 3–4; see also infra 

note 3. 

3See supra note 2. Given the Government’s 

unrefuted representations that Mr. Itani was 

unaware that a hearing had been requested and that 

he had no interest in a hearing, the Agency views 

Counsel’s extended silence in the face of multiple 

requests as sufficient evidence that the hearing 

request was not filed upon the direction of Mr. 

Itani, the only person entitled to request a hearing 

for Registrant. 

4Even if the hearing request had been valid, 

Registrant would be deemed to be in default based 

on its ‘‘fail[ure] to plead . . . or otherwise defend’’ 

itself. See 21 CFR 1301.43(c)(3) (‘‘In the event . . . 

a person who has requested a hearing fails to plead 

. . . or otherwise defend, said party shall be 

deemed to be in default and the opposing party may 

move to terminate the proceeding.’’). Here, as the 

Chief ALJ found, Registrant waived its right to a 

hearing by failing to respond to the Government’s 

motion to terminate, failing to respond to chambers 

staff at the Chief ALJ’s direction, failing to file 

exhibits, and failing to file a notarized power of 

attorney as ordered by the Chief ALJ. RFAAX 4, at 

4. 

registration, as well as any other 

pending application of BRX Pharmacy 

for additional registration in Texas. This 

Order is effective November 22, 2024. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 15, 2024, 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. 2024–24564 Filed 10–22–24; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Itani Family Pharmacy, PLC; Decision 

And Order 

On June 1, 2023, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause and Immediate Suspension of 

Registration (OSC/ISO) to Itani Family 

Pharmacy, PLC, of Titusville, Florida 

(Registrant). Request for Final Agency 

Action (RFAA), Exhibit (RFAAX) 1, 

Attachment (Attach.) A (hereinafter, 

OSC/ISO), at 1, 6. The OSC/ISO 

informed Registrant of the immediate 

suspension of its DEA registration, No. 

FI2917702,1 pursuant to 21 U.S.C. 

824(d), alleging that Registrant’s 

continued registration constitutes ‘ ‘‘an 

imminent danger to the public health or 

safety.’ ’’ Id. at 1 (quoting 21 U.S.C. 

824(d)). The OSC/ISO also proposed the 

revocation of Registrant’s registration, 

alleging that Registrant’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 Registrant of its 

right to file with DEA a written request 

for hearing within 30 days after the date 

of receipt of the OSC/ISO. OSC/ISO, at 

5–6 (citing 21 CFR 1301.43(a)). The 

OSC/ISO also notified Registrant 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)). The OSC/ISO 

further notified Registrant that 

‘‘[d]efault constitutes a waiver of 

[Registrant’s] right to a hearing and an 

admission of the factual allegations of 

this [OSC/ISO].’’ Id. (citing 21 CFR 

1301.43(e)). 

On June 19, 2023, the OSC/ISO was 

personally served on Registrant’s owner 

and pharmacist-in-charge (PIC), Mr. 

Basil Itani. RFAAX 1, at 1. On June 30, 

2023, a purported request for hearing 

was filed with the DEA Office of 

Administrative Law Judges (OALJ) and 

assigned to the Chief Administrative 

Law Judge (Chief ALJ). RFAA, at 2. A 

prehearing conference was then held on 

July 27, 2023. RFAA, at 2; RFAAX 2, at 

2; RFAAX 4, at 1–2. 

On September 22, 2023, the 

Government filed a motion to terminate 

the proceedings. RFAAX 2, at 4–5. In 

the motion, the Government represented 

that after the July 27 prehearing 

conference, ‘‘it came to DEA’s attention 

that Mr. Basil Itani was unaware of any 

administrative proceedings that had 

taken place’’ and that he had ‘‘no 

interest in proceeding forward with the 

administrative hearing.’’ Id. at 2. The 

Government further represented that 

Mr. Itani had informed DEA that he did 

not have interest in proceeding with a 

hearing, and ‘‘only his father . . . would 

possess any interest in moving forward 

with the DEA administrative hearing.’’ 

Id. After learning this information, 

Government counsel notified the 

attorney who filed the hearing request 

(hereinafter, Counsel) that the 

Government would file a motion to 

terminate the proceedings unless 

Counsel provided the Government with 

evidence ‘‘that [Counsel] represented 

[Mr. Itani] and his interests in this 

administrative hearing.’’ Id. The 

Government never received any 

response to this request and filed a 

motion to terminate, arguing that 

Registrant’s hearing request ‘‘was made 

without authority’’ because Mr. Itani— 

the only individual who had authority 

to request a hearing 2—did not ‘‘provide 

express authority to request a hearing on 

behalf of the pharmacy.’’ Id. at 3–5. 

On September 28, 2023, the Chief ALJ 

ordered Counsel to ‘‘provide . . . a 

notarized power of attorney showing the 

requisite authority to act as a 

representative [of Registrant] in these 

administrative enforcement 

proceedings.’’ RFAAX 3 (citing 21 CFR 

1316.50). Counsel never responded to 

the Government’s motion to terminate 

or the Chief ALJ’s directive, and never 

produced any evidence demonstrating 

that he had authority to represent 

Registrant. RFAAX 4, at 1, 3. Based on 

Registrant’s failure to respond, on 

October 5, 2023, the Chief ALJ granted 

the Government’s unopposed motion 

and terminated proceedings, finding 

that ‘‘there is simply no basis upon 

which to conclude that [Counsel] has 

authority to act on behalf of [Registrant], 

or that the [request for hearing] in this 

case is valid.’’ Id. at 4. 

The Agency agrees with the Chief 

ALJ. Counsel was given three 

opportunities to demonstrate that he 

was authorized to request a hearing for 

Registrant after the Government learned 

that Mr. Itani was unaware of the 

proceedings and had no interest in 

participating. In response to these 

opportunities, Counsel remained silent. 

Indeed, by the time the Chief ALJ 

terminated the case, it had been over 

two months since Counsel had 

communicated with OALJ or made any 

filings in the matter. RFAAX 4, at 2 

nn.3–4. Despite multiple requests, 

Counsel remained silent and, as the 

Chief ALJ found, failed to demonstrate 

that he had the authority to act for 

Registrant.3 RFAAX 4, at 3–4. 

Accordingly, the Agency finds that a 

valid hearing request was never filed in 

this matter and, consequently, that 

Registrant is deemed to be in default.4

21 CFR 1301.43(c)(1). ‘‘A default, unless 


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Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices 84621 

5The 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). 

6Methadone is a schedule II opioid. OSC/ISO, at 

3; see also 21 CFR 1308.12(c)(15). 

7Oxycodone is a schedule II opioid. OSC/ISO, at 

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

8Morphine is a schedule II opioid. OSC/ISO, at 

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

9Methylphenidate is a schedule II stimulant. 

OSC/ISO, at 3; see also 21 CFR 1308.12(d)(4). 

10Alprazolam is a schedule IV depressant. OSC/ 

ISO, at 3; see also 21 CFR 1308.14(c)(2). 

excused, shall be deemed to constitute 

a waiver of [Registrant’s] right to a 

hearing and an admission of the factual 

allegations of the [OSC/ISO].’’ 21 CFR 

1301.43(e). To date, Registrant 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 

Registrant’s default pursuant to 21 CFR 

1301.43(c), (f), because Registrant has 

not timely requested a hearing, nor 

timely moved to excuse the default, nor 

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 

Registrant’s default, the factual 

allegations in the OSC/ISO are deemed 

to be admitted.5 21 CFR 1301.43(e). 

Accordingly, Registrant admits that 

from January 5, 2023, to May 24, 2023, 

on nine separate occasions, Registrant 

dispensed controlled substances to a 

confidential informant (CI) in exchange 

for cash. OSC/ISO, at 2–4. On each 

occasion, Registrant admits that the CI 

did not present any prescription and 

that Registrant dispensed the controlled 

substances despite the absence of a 

prescription. Id. Registrant admits that 

the controlled substances dispensed and 

the cash received by Registrant on each 

of the nine occasions are as follows: 

Date Controlled substances Units 

(pills) Cash received 

January 5, 2023 ............................................................ Methadone 6 10 mg ...................................................... 200 $600 

January 18, 2023 .......................................................... Oxycodone 7 15 mg ...................................................... 15 1,000 

Morphine 8 15 mg ......................................................... 100 

Methadone 10 mg ........................................................ 100 

Methylphenidate 9 5 mg ................................................ 18 

Alprazolam 10 2 mg ....................................................... 100 

February 2, 2023 .......................................................... Oxycodone 5 mg .......................................................... 500 2,000 

Alprazolam 2 mg .......................................................... 99 

February 15, 2023 ........................................................ Oxycodone 5 mg .......................................................... 500 2,000 

Methadone 10 mg ........................................................ 100 

March 2, 2023 .............................................................. Oxycodone 5 mg .......................................................... 500 2,000 

Alprazolam 2 mg .......................................................... 100 

March 23, 2023 ............................................................ Oxycodone 5 mg .......................................................... 500 2,000 

Methadone 10 mg ........................................................ 100 

April 12, 2023 ............................................................... Oxycodone 5 mg .......................................................... 500 2,000 

Methadone 10 mg ........................................................ 200 

May 4, 2023 .................................................................. Oxycodone 5 mg .......................................................... 500 2,000 

Oxycodone 20 mg ........................................................ 3.5 

Methadone 10 mg ........................................................ 200 

May 24, 2023 ................................................................ Oxycodone 5 mg .......................................................... 500 2,000 

Methadone 10 mg ........................................................ 200 

Totals ..................................................................... ....................................................................................... 5,035.5 15,600 

See OSC/ISO, at 2–4. 

II. Discussion 

A. The Five Public Interest Factors 

Under the Controlled Substances Act 

(CSA), ‘‘[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 his registration 

under [21 U.S.C. 823] inconsistent with 

the public interest as determined under 

such section.’’ 21 U.S.C. 824(a). In 

making the public interest 

determination, the CSA requires 

consideration of the following factors: 

(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. 

21 U.S.C. 823(g)(1). 

When making this determination, 

DEA considers the public interest 

factors in the disjunctive. Robert A. 

Leslie, M.D., 68 FR 15,227, 15,230 

(2003). Each factor is weighed on a caseby-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. David H. Gillis, 

M.D., 58 FR 37,507, 37,508 (1993). 


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84622 Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices 

11As to factor A, the record contains no evidence 

of a recommendation from any state licensing board 

or professional disciplinary authority. 21 U.S.C. 

823(g)(1)(A). Nonetheless, an absence of such 

evidence ‘‘does not weigh for or against a 

determination as to whether continuation of the 

[Registrant’s] DEA certification is consistent with 

the public interest.’’ Roni Dreszer, M.D., 76 FR 

19,434, 19,444 (2011). As to factor C, there is no 

evidence in the record that Registrant has been 

convicted of any federal or state law offense 

‘‘relating to the manufacture, distribution, or 

dispensing of controlled substances.’’ 21 U.S.C. 

823(g)(1)(C). However, as Agency cases have noted, 

‘‘the absence of such a conviction is of considerably 

less consequence in the public interest inquiry’’ and 

is therefore not dispositive. Dewey C. MacKay, M.D., 

75 FR 49,956, 49,973 (2010). As to factor E, the 

Government’s evidence fits squarely within the 

parameters of factors B and D and does not raise 

‘‘other conduct which may threaten the public 

health and safety.’’ 21 U.S.C. 823(g)(1)(E). 

Accordingly, factor E does not weigh for or against 

Registrant. 

12Florida 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. § 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. § 802(8). 

While the Agency has considered all 

the public interest factors of 21 U.S.C. 

823(g)(1),11 the Government’s evidence 

in support of its prima facie case for 

sanction is confined to factors B and D. 

OSC/ISO, at 2. The Government has the 

burden of proof in this proceeding. 21 

CFR 1301.44. 

Here, having reviewed the record, the 

Agency finds that the Government 

satisfied its prima facie burden of 

showing that Registrant’s continued 

registration would be ‘‘inconsistent with 

the public interest.’’ 21 U.S.C. 824(a). 

1. Factors B and D 

Evidence is considered under public 

interest factors B and D when it reflects 

compliance or non-compliance with 

laws related to controlled substances 

and experience dispensing controlled 

substances. Blue Mint Pharmacy, 88 FR 

75,326, 75,329 (2023). 

In the current matter, the Government 

has alleged that Registrant violated 

federal and Florida laws regulating 

controlled substances. OSC/ISO, at 1–6. 

Specifically, federal law provides that 

‘‘no controlled substance in schedule II 

. . . may be dispensed without the 

written prescription of a practitioner.’’ 

Id. at 2–4 (citing 21 U.S.C. 829(a)). 

Similarly, it is unlawful in Florida for 

any person to ‘‘sell or dispense 12 drugs 

. . . without first being furnished with 

a prescription.’’ OSC/ISO, at 2 (citing 

Fla. Stat. § 465.015(2)(c)). Furthermore, 

Florida law provides that ‘‘dispensing, 

or distributing . . . any controlled 

substance, other than in the course of 

the professional practice of pharmacy’’ 

is ‘‘grounds for denial of a license or 

disciplinary action.’’ Id. (citing Fla. Stat. 

§ 465.016(1)(i)). 

Here, Registrant admits that from 

January 5, 2023, to May 24, 2023, it 

dispensed over 5,035 controlled 

substance pills to CI without a 

prescription, which is a clear violation 

of federal and Florida law. OSC/ISO, at 

2–4. Registrant additionally admits that 

this misconduct reflects negative 

experience in dispensing controlled 

substances. Id. at 2. 

Specifically, Registrant admits that it 

dispensed 3,518.5 pills of oxycodone, 

1,100 pills of methadone, 299 pills of 

alprazolam, 100 pills of morphine, and 

18 pills of methylphenidate (5,035.5 

pills in total) over the course of nine 

separate occasions. OSC/ISO, at 2–4. 

Among these, 4,736.5 pills were for 

controlled substances in schedule II. Id. 

Registrant further admits that no 

prescriptions were presented on any of 

the occasions when these controlled 

substances were dispensed. Id. 

Registrant also admits that it received a 

total of $15,600 in cash to dispense 

these controlled substances without a 

prescription. Id. 

Based on Registrant’s admissions, the 

Agency sustains the Government’s 

uncontroverted allegations that 

Registrant violated federal and Florida 

laws by dispensing controlled 

substances without a prescription. OSC/ 

ISO, at 2–4; 21 U.S.C. 829(a); Fla. Stat. 

§§ 465.015(2)(c), 465.016(1)(i). 

In sum, the Agency finds Registrant’s 

continued registration to be inconsistent 

with the public interest after balancing 

the factors of 21 U.S.C. 823(g)(1). The 

Agency further finds that Registrant 

failed to provide sufficient evidence to 

rebut the Government’s prima facie 

case. 

III. Sanction 

Where, as here, the Government has 

established sufficient grounds to revoke 

Registrant’s registration, the burden 

shifts to the registrant to show why it 

can be entrusted with the responsibility 

carried by a registration. Garret Howard 

Smith, M.D., 83 FR 18882, 18910 (2018). 

‘‘[T]rust is necessarily a fact-dependent 

determination based’’ on individual 

circumstances; therefore, the Agency 

looks at factors such as ‘‘the acceptance 

of responsibility and the credibility of 

that acceptance as it relates to the 

probability of repeat violations or 

behavior’’ and ‘‘the Agency’s interest in 

deterring similar acts.’’ Robert Wayne 

Locklear, M.D., 86 FR 33738, 33746 

(2021). To be effective, acceptance of 

responsibility must be unequivocal. 

Mohammed Asgar, M.D., 83 FR 29569, 

29573 (2018). When a registrant has 

committed acts inconsistent with the 

public interest, it must both accept 

responsibility and demonstrate that it 

has undertaken corrective measures. 

Holiday CVS, L.L.C., d/b/a CVS/ 

Pharmacy Nos. 219 and 5195, 77 FR 

62316, 62339 (2012); see also George D. 

Gowder, III, M.D., 89 FR 76152, 76154 

(2024); Michele L. Martinho, M.D., 86 FR 

24012, 24019 (2021). 

Here, Registrant did not request a 

hearing or otherwise avail itself of the 

opportunity to refute the Government’s 

case. RFAA, at 3; 21 CFR 1301.43(c)(1), 

(e), (f)(1). As such, the record does not 

contain any representations from 

Registrant demonstrating future 

compliance with the CSA, 

trustworthiness regarding the 

responsibilities of holding a DEA 

registration, acceptance of 

responsibility, or remedial measures. 

Accordingly, in light of Registrant’s 

default and the lack of mitigating 

evidence, the Agency will order the 

revocation of Registrant’s registration. 

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. FI2917702 issued to 

Itani Family Pharmacy, PLC. 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 Itani Family Pharmacy, 

PLC, to renew or modify this 

registration, as well as any other 

pending application of Itani Family 

Pharmacy, PLC, for additional 

registration in Florida. This Order is 

effective November 22, 2024. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 15, 2024, 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. 2024–24572 Filed 10–22–24; 8:45 am] 

BILLING CODE 4410–09–P 


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