Itani Family Pharmacy, PLC; Decision And Order, 84620-84622 [2024-24572]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 89, Number 205 (Wednesday, October 23, 2024)]
[Notices]
[Pages 84620-84622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24572]


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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)).
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    \1\ The 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).
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    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.
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    \2\ The 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.
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    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.
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    \3\ See 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.
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    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

[[Page 84621]]

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.
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    \4\ Even 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.
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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 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. Sec.  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:
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    \5\ 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).
    \6\ Methadone is a schedule II opioid. OSC/ISO, at 3; see also 
21 CFR 1308.12(c)(15).
    \7\ Oxycodone is a schedule II opioid. OSC/ISO, at 3; see also 
21 CFR 1308.12(b)(1)(xiv).
    \8\ Morphine is a schedule II opioid. OSC/ISO, at 3; see also 21 
CFR 1308.12(b)(1)(ix).
    \9\ Methylphenidate is a schedule II stimulant. OSC/ISO, at 3; 
see also 21 CFR 1308.12(d)(4).
    \10\ Alprazolam is a schedule IV depressant. OSC/ISO, at 3; see 
also 21 CFR 1308.14(c)(2).

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                     Date                             Controlled substances        Units (pills)   Cash received
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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
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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 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. David H. Gillis, 
M.D., 58 FR 37,507, 37,508 (1993).

[[Page 84622]]

    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.
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    \11\ As 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.
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    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. Sec.  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. Sec.  
465.016(1)(i)).
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    \12\ 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. Sec.  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, 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. Sec. Sec.  
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]
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