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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, 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 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).
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 —did not “provide express authority to request a hearing on behalf of the pharmacy.” Id. at 3-5.
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.
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. RFAAX 4, at 3-4.
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.
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 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. 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:
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).
Methadone is a schedule II opioid. OSC/ISO, at 3; see also21 CFR 1308.12(c)(15).
Oxycodone is a schedule II opioid. OSC/ISO, at 3; see also21 CFR 1308.12(b)(1)(xiv).
Morphine is a schedule II opioid. OSC/ISO, at 3; see also21 CFR 1308.12(b)(1)(ix).
Methylphenidate is a schedule II stimulant. OSC/ISO, at 3; see also21 CFR 1308.12(d)(4).
Alprazolam is a schedule IV depressant. OSC/ISO, at 3; see also21 CFR 1308.14(c)(2).