90 FR 132 pgs. 31244-31247 - JYA LLC d/b/a Webb's Square Pharmacy; Decision and Order
Type: NOTICEVolume: 90Number: 132Pages: 31244 - 31247
Pages: 31244, 31245, 31246, 31247FR document: [FR Doc. 2025-13121 Filed 7-11-25; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
JYA LLC d/b/a Webb's Square Pharmacy; Decision and Order
I. Introduction
On November 18, 2024, the Agency issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to JYA LLC d/b/a Webb's Square Pharmacy of Davenport, Florida (Registrant). OSC/ISO, at 1. The OSC/ISO informs Registrant of the immediate suspension of its Drug Enforcement Administration (DEA or Government) Certificate of Registration, No. FJ2231570, 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. (quoting 21 U.S.C. 824(d)). The OSC/ISO also proposes the revocation of Registrant's registration, No. FJ2231570, as well as the denial of "any pending application for renewal or modification of such registration, or for additional DEA registrations, because . . . [Registrant's] continued registration is inconsistent with the public interest." Id.
More specifically, the OSC/ISO alleges that Registrant dispensed controlled substances to individuals without a valid prescription and for other than a legitimate medical purpose "between on or about July 31, 2021, until at least on or about March 28, 2024." Id. at 2.
II. Adequacy of Service and Default Finding
According to the signed DEA-12, Registrant's designated contact person received the OSC/ISO through personal delivery by a Diversion Investigator and a Task Force Officer on November 21, 2024. Request for Final Agency Action (RFAA), Exhibit (RFAAX) 2, at 1. According to the Controlled Substances Act (CSA) and its implementing regulations, Registrant had thirty days from November 21, 2024, to request a hearing. 21 U.S.C. 824(c)(2)(B); 21 CFR 1301.43(a), 21 CFR 1316.47. The Government represents in its RFAA that Registrant "fail[ed] to submit a request for a hearing and answer," and that as of February 7, 2025, Registrant "has not filed a motion showing good cause to excuse the default or to reinstate the proceedings." RFAA, at 2, 9.
Accordingly, based on the Government's representations, the Agency finds that Registrant has not filed a request for a hearing, is deemed to have waived its right to a hearing, is in default, and is deemed to admit the factual allegations of the OSC/ISO. 21 CFR 1301.43(c)(1) and (e). The Agency, therefore, issues this Decision and Order based on the record submitted by the Government, which constitutes the entire record before the Agency. 21 CFR 1301.43(e).
III. The CSA and Florida Pharmacy Standards of Practice
The main objectives of the CSA, according to the Supreme Court, are to "conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances." Gonzales v. Raich, 545 U.S. 1, at 12 (2005). Given these objectives, the Supreme Court states, particular congressional concerns included "the need to prevent the diversion of drugs from legitimate to illicit channels." Id. at 12-13. Further, according to the Supreme Court, to accomplish these goals in the CSA, "Congress devised a closed regulatory system making it unlawful to . . . dispense[?] or possess any controlled substance except in a manner authorized by" the statute. 1 Id. at 13. "Accordingly, the Supreme Court states, the "CSA and its implementing regulations set forth strict requirements regarding registration . . . ." Id. at 14.
Footnotes:
1 ?21 U.S.C. 841(a)(1) ("[I]t shall be unlawful for any person knowingly or intentionally . . . to . . . distribute[?] or dispense, or possess with intent to . . . distribute[?] or dispense, a controlled substance . . . [e]xcept as authorized by" the CSA.). The CSA defines "dispense" to include "prescribing" a controlled substance. 21 U.S.C. 802(10).
According to the CSA's implementing regulations, a lawful controlled substance order or prescription is one that is "issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice." 21 CFR 1306.04(a). As the Supreme Court explained in the context of the Act's requirement that Schedule II controlled substances may be dispensed only by written prescription, "the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse . . . [and] also bars doctors from peddling to patients who crave the drugs for those prohibited uses." Gonzales v. Oregon, 546 U.S. 243, 274 (2006), see also United States v. Hayes, 595 F.2d 258 (5th Cir. 1979), cert. denied, 444 U.S. 866 (1979).
While the "responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, . . . a corresponding responsibility rests with the pharmacist who fills the prescription." 21 CFR 1306.04(a). The regulations state the parameters of the pharmacist's corresponding responsibility.
An order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
Id. Accordingly, a pharmacy's registration authorizes it to "dispense," or "deliver a controlled substance to an ultimate user . . . by, or pursuant to the lawful order of, . . . a practitioner." 21 U.S.C. 802(10).
[top] The OSC/ISO is addressed to Registrant at its registered address in Florida. Therefore, the Agency also evaluates Registrant's actions according
Footnotes:
2 ?Although this statute was amended during the period of Registrant's alleged unlawfulness, the language in this provision did not change.
3 ?"Medicinal drug," according to Florida law in effect during the period of Registrant's alleged unlawfulness, means "those substances . . . required by federal or state law to be dispensed only on a prescription." Fla. Stat. §?465.003(15) (2025).
4 ?None of the amendments made to this Florida regulation during the period of Registrant's alleged unlawfulness is pertinent to the adjudication.
IV. The Deemed-Admitted Findings of Fact
Due to Registrant's default, the Agency finds that Registrant admits to all of the OSC/ISO's factual allegations. 21 CFR 1301.43(c)(1) and (e). The salient deemed-admitted facts are below.
Registrant is the holder of Certificate of Registration No. FJ2231570 at the registered address of 2200 South Boulevard West in Davenport, Florida 33827. OSC/ISO, at 1.
Between July 5, 2022, and March 28, 2024, Registrant's owner and Pharmacist-in-Charge (OPIC) engaged in frequent conversations with multiple individuals in which OPIC agreed to dispense controlled substances to individuals without a valid prescription and for other than a legitimate medical purpose. OSC/ISO, at 3. Between July 5, 2022, and December 12, 2023, OPIC and Dr. T.D. engaged in multiple conversations, via text message, in which OPIC agreed to dispense controlled substance prescriptions for cash to "patients" of Dr. T.D. where OPIC knew or should have known the prescriptions were issued for other than a legitimate medical purpose. Id. Specifically, on July 5, 2022, Dr. T.D. informed OPIC that he would be sending illegitimate prescriptions for nine patients who "[could not] come individually" to Registrant to fill prescriptions for promethazine with codeine (a Schedule IV opioid). 5 Id. OPIC stated that Mr. K.S. would be picking up the prescriptions. Id. On this same day, Dr. T.D. issued eight illegitimate controlled substance prescriptions, which Registrant dispensed to Mr. K.S. when, pursuant to the conversation with Dr. T.D., Registrant knew or should have known that the prescriptions were illegitimate. Id. at 3-4. Each of the eight controlled substance prescriptions were written for promethazine with codeine. Id. at 4. The eight individuals for whom Registrant dispensed a promethazine with codeine prescription are J.M., P.C., A.C., K.S., B.M., J.L., V.L., and D.R. Id.
Footnotes:
5 ?The OSC/ISO details only eight of the nine promethazine with codeine controlled substance prescriptions.
On or about January 2, 2023, after discussing with OPIC what promethazine with codeine and Tussionex Registrant had available, Dr. T.D. informed OPIC that he would be sending approximately thirteen illegitimate prescriptions for Registrant to dispense. Id. On that same day, Dr. T.D. issued fourteen controlled substance prescriptions. Id. One of the controlled substance prescriptions was for oxycodone and was issued for K.Y. Id. The other thirteen controlled substance prescriptions were for promethazine with codeine. Id. The thirteen individuals for whom Registrant issued a promethazine with codeine prescription are De.Y., Des. Y., Dei. Y., Dev. Y., Dee. Y., A.O., A.M., AL. Y., L.H., T.T., O.B., J.J., and A.B. Id. at 4-5. Registrant dispensed each of these fourteen controlled substance prescriptions when it knew or should have known that each of them was illegitimate. Id. at 4.
On or about January 9, 2023, after discussing with Registrant what was available, Dr. T.D. informed OPIC that he would be sending five illegitimate controlled substance prescriptions for promethazine with codeine. Id. at 5. On that same day, Registrant dispensed five prescriptions for promethazine with codeine that Dr. T.D. had issued when Registrant knew or should have known that each of these five controlled substance prescriptions were illegitimate. Id. The five individuals for whom Registrant dispensed promethazine with codeine are A.S., T.L., D.D., M.J., and R.J. Id.
On or about December 12, 2023, Dr. T.D. informed OPIC that he would be sending four illegitimate prescriptions for Registrant to dispense. On the same day, Registrant dispensed promethazine with codeine to four individuals, D.T., J.R., R.M., and A.C., when it knew or should have known that Dr. T.D.'s prescriptions were illegitimate. Id.
Between December 5, 2022, and August 2, 2023, OPIC and C.Y. engaged in multiple conversations via text message during which OPIC agreed to dispense controlled substance prescriptions to C.Y. for other than legitimate medical purposes. Id. Pursuant to these conversations between OPIC and C.Y., Registrant dispensed: promethazine with codeine, alprazolam (a Schedule IV benzodiazepine), and oxycodone for D.Y. on or about April 5, 2023; promethazine with codeine for C.Y. on or about August 2, 2023; and promethazine with codeine for D.Y, and for L.H., picked up by C.Y., a third party with no apparent authority or justification to do so, on or about August 2, 2023. Id. at 5-6.
[top] Between August 1, 2021, and March 28, 2024, OPIC and E.D. engaged in multiple conversations via text message during which OPIC agreed to dispense controlled substance prescriptions to E.D. for other than legitimate medical purposes. Id. at 6. Pursuant to these conversations between OPIC and E.D., Registrant dispensed approximately 276 unique controlled substance prescriptions for approximately fifty-eight individuals other than E.D. Id. The dispensed prescriptions were for promethazine with codeine, alprazolam, and oxycodone, and Registrant dispensed them "directly to E.D." Id. The deemed-admitted facts also include that Registrant dispensed illegitimate oxycodone 15 mg prescriptions for J.H., D.H., and T.M. on or about April 13 and 14, 2023. Id. E.D., a third party who shared no legitimate relationship to any of these three individuals, picked up the illegitimate oxycodone 15 mg prescriptions. Id. By way of further
In sum, the deemed-admitted facts establish that Registrant unlawfully dispensed about 312 controlled substance prescriptions between about July, 2022 and March, 2024. Id. at 3-6.
V. Allegation That Registrant Dispensed Illegitimate Controlled Substance Prescriptions
According to the OSC/ISO, Registrant "dispensed controlled substances to individuals without a valid prescription and for other than a legitimate medical purpose." OSC/ISO, at 2. The facts deemed admitted due to Registrant's default establish that Registrant violated multiple provisions of applicable federal and Florida law.
According to the deemed-admitted facts, Registrant knew or should have known that the controlled substance prescriptions listed in the OSC/ISO that it filled after text message conversations with Dr. T.D., C.Y., and E.D., were not issued for a legitimate medical purpose. Supra section IV. In sum, according to the deemed-admitted, uncontroverted facts, therefore, Registrant dispensed controlled substance prescriptions that it knew or should have known were not issued in the usual course of professional treatment, and for which it did not attempt to determine the validity of the prescription, in violation of federal and Florida law. 21 CFR 1306.04(a); Fla. Stat. §?465.016(1)(s); Fla. Admin. Code Ann. r. 64B16-27.831(1)(a), (1)(b), (2).
VI. Discussion
A. The CSA and the Public Interest Factors
Under Section 304 of 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," which is defined in 21 U.S.C. 802(21) to include a "pharmacy," 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
Footnotes:
6 ?The 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.
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 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).
The Agency "may rely on any one or a combination of factors and may give each factor the weight [it] deems appropriate. Morall, 412 F.3d at 185 n.2 ; see also Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018) ( citing Akhtar-Zaidi v. Drug Enf't Admin., 841 F.3d 707, 711 (6th Cir. 2016)); MacKay v. Drug Enf't Admin., 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. U.S. Drug Enf't Admin., 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while the Agency is required to consider each of the factors, it "need not make explicit findings as to each one." MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see also Hoxie, 419 F.3d at 482. "In short, . . . the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant's misconduct." Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has recognized, findings under a single factor can support the revocation of a registration. MacKay, 664 F.3d at 821.
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.
While the Agency considered all of the 21 U.S.C. 823(g)(1) factors in this matter, the Agency finds that the Government's prima facie case is confined to factors B and D. The Agency finds that the deemed-admitted facts with respect for Factors B and D satisfy the Government's prima facie burden of showing that Registrant's continued registration would be "inconsistent with the public interest." 21 U.S.C. 824(a)(4). 7
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7 ?The RFAA states that "the Administrator is authorized to render the Agency's final order without . . . making a finding of fact," citing 21 CFR 1301.43(c), (f), 1301.46. This statement is not supported by 21 CFR 1301.43 which states that following a default, the Government may file an RFAA and a supporting record with the Administrator. Thereafter, the Administrator "may enter a default final order pursuant to 1316.67 of this chapter." 21 CFR 1301.43. 21 CFR 1316.67 requires that the Administrator's final order "shall set forth the final rule and the findings of fact and conclusions of law upon which the rule is based." 21 CFR 1316.67.
B. Factors B and/or D-Registrant's Experience Dispensing Controlled Substances and Compliance With Applicable Laws Relating to Controlled Substances
Allegation That Registrant's Registration Is Inconsistent With the Public Interest
As detailed above, the Agency concludes, based on the deemed-admitted facts, that Registrant violated federal law and the applicable Florida Pharmacy Standards of Practice about 312 times between July, 2021 and March, 2024 by dispensing controlled substances when it knew, or should have known, that the prescriptions were invalid and were issued for other than a legitimate medical purpose. 21 CFR 1306.04(a); Fla. Stat. §?465.016(1)(s); Fla. Admin. Code Ann. r. 64B16-27.831(1)(a), (1)(b), (2); supra sections III, IV, and V. Any one of these unlawful controlled substance dispensings is sufficient for the Agency to revoke Registrant's registration.
Accordingly, the Agency finds that the Government presented a prima facie case for which the Agency may impose a sanction on Registrant, and that Registrant did not rebut the Government's prima facie case. 21 U.S.C. 824(a)(4).
VI. Sanction
[top] Where, as here, (1) Registrant is deemed to have admitted the factual allegations in the OSC/ISO, (2) the deemed-admitted facts are substantial evidence proving the legal violations alleged to support revocation based on acts inconsistent with the public
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 registrant and by the community of registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.
Regarding these matters, there is no record evidence that Registrant takes responsibility, let alone unequivocal responsibility, for the founded violations. As such, Registrant has not presented any evidence showing that it can be entrusted with a registration. Accordingly, the record supports the imposition of a sanction.
The interests of specific and general deterrence weigh in favor of revocation given the egregiousness of the founded violations, violations that go to the heart of the CSA and of this Agency's law enforcement mission. E.g., Jones Total Health Care Pharmacy, 881 F.3d at 834 and n.4; Garrett Howard Smith, M.D., 83 FR at 18910 (collecting cases), supra sections III and IV. In addition, as Registrant has not unequivocally accepted responsibility for the founded violations, it is not reasonable to believe that Registrant's future controlled substance prescription dispensing will comply with legal requirements. Supra. Further, given the foundational nature and vast number of Registrant's violations, a sanction less than revocation would send a message to the existing and prospective registrant community that compliance with the law is not essential to maintaining a registration.
Accordingly, the Agency shall 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)(4) and 21 U.S.C. 823(g)(1), I hereby revoke DEA Certificate of Registration No. FJ2231570 issued to JYA LLC d/b/a Webb's Square Pharmacy.
Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a) and 21 U.S.C. 823(g)(1), I hereby deny any pending application of JYA LLC d/b/a Webb's Square Pharmacy to renew or modify this registration, as well as any other pending application of JYA LLC d/b/a Webb's Square Pharmacy for registration in Florida.
This Order is effective August 13, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on July 8, 2025, by Acting Administrator Robert J. Murphy. 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. 2025-13121 Filed 7-11-25; 8:45 am]
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