I. Introduction

On July 7, 2022, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Weise Prescription Shop Inc. (Respondent).^[1] OSC, at 1-4. Citing 21 U.S.C. 824(a)(2), the OSC proposes the revocation of Respondent's registration, and the denial of “any applications for renewal or modification of such registration and any applications for any other DEA registration,” “because Mr. Gilbert Weise, Jr. has been convicted of a felony offense relating to federal controlled substance laws.” ^[2] Id. at 1.

II. Summary of Proceedings

Respondent timely requested a hearing. In due course, the Government submitted a Motion for Summary Disposition (MSD). Government's Notice of Filing of Evidence and Motion for Summary Disposition (October 28, 2022) (First MSD). Respondent opposed the MSD. Respondent's Response in Opposition to Government's Motion for Summary Disposition (November 2, 2022) (Resp Opp. to First MSD). Respondent, among other things, argued that the Government's First MSD was meritless because there are “questions of fact involved,” there are “material facts in dispute,” and there is disagreement as to “material facts.” ^[3] Resp Opp. to First MSD, at 4.

The Administrative Law Judge (ALJ) issued her Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision granting the Government's First MSD on November 16, 2022 (First RD) and transmitted the record to the Office of the Administrator on December 12, 2022. Her transmittal letter states that no evidentiary hearing was held, no factual issues were involved, and neither party filed Exceptions to the First RD.^[4]

While it was appropriate for the ALJ to adjudicate the First MSD, the granting of the First MSD should not have ended the proceedings. See, e.g., Garrett Howard Smith, M.D.,83 FR 18882, 18910 (2018). Accordingly, the Agency remanded the matter for further proceedings, encouraging the ALJ to exercise her discretion and to develop the record to allow for the determination of an appropriate sanction. E.g.,21 CFR 1316.50, 1316.65.

On remand, the Government filed another MSD, a Request for Official Notice, and a Request to File a Supplemental Prehearing Statement. The basis of the Government's second MSD (Second MSD) is Respondent's lack of legal authority to operate as a pharmacy in Florida.^[5] It is Respondent's ( printed page 55071) lack of state authority that this Decision adjudicates.

Findings of Fact

The record contains uncontroverted evidence that, on February 28, 2023, Respondent's Florida pharmacy license expired. See, e.g., Second MSD, at 1. According to Florida online records, of which the Agency takes official notice, Respondent's pharmacy license is “delinquent.” ^[6] https://mqa-internet.doh.state.fl.us/​MQASearchServices/​HealthCareProviders (last visited date of signature of this Order). Respondent, therefore, “is not authorized to practice in the state of Florida.” Id.

Accordingly, the Agency finds that Respondent is currently without authority to operate as a pharmacy in Florida. See supra n.6.

Discussion

Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under 21 U.S.C. 823 “upon a finding that the registrant . . . has had his State license or registration suspended . . . [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” With respect to a practitioner, DEA has also long held that the possession of authority to dispense controlled substances under the laws of the state in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration. See, e.g., James L. Hooper, M.D.,76 FR 71371 (2011), pet. for rev. denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh Blanton, M.D.,43 FR 27616, 27617 (1978).^[7]

Here, the undisputed record evidence is that Respondent currently lacks authority to operate a pharmacy in Florida. Respondent, therefore, is not a “practitioner” under federal law. 21 U.S.C. 802(21) (“The term “practitioner” means a . . . pharmacy”). The CSA provides for the issuance of a registration to “practitioners.” 21 U.S.C. 823(g). It explicitly provides for the revocation of a registration issued to an entity whose “State license” has been “suspended, revoked, or denied by competent State authority.” 21 U.S.C. 824(a)(3). For these reasons, Respondent is not eligible under the CSA to maintain a DEA registration in Florida. Accordingly, the Agency orders that Respondent's DEA registration be revoked.

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. AW0201474 issued to Weise Pharmacy Shop Inc. 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 Weise Pharmacy Shop Inc. to renew or modify this registration, as well as any other pending application of Weise Pharmacy Shop Inc. for additional registration in Florida. This Order is effective September 13, 2023.

Signing Authority

This document of the Drug Enforcement Administration was signed on August 7, 2023, 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 .