[Federal Register Volume 90, Number 132 (Monday, July 14, 2025)]
[Notices]
[Pages 31244-31247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-13121]
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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.
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\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).
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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).
The OSC/ISO is addressed to Registrant at its registered address in
Florida. Therefore, the Agency also evaluates Registrant's actions
according
[[Page 31245]]
to Florida law, including the applicable Florida pharmacy professional
responsibilities. Gonzales v. Oregon, 546 U.S. at 269-71. According to
Florida pharmacy law, the grounds for denying a license or for
disciplinary action include ``[d]ispensing any medicinal drug based
upon a communication that purports to be a prescription . . . when the
pharmacist knows or has reason to believe that the purported
prescription is not based upon a valid practitioner-patient
relationship.'' \2\ \3\ Fla. Stat. Sec. 465.016(1)(s) (2025). Further,
according to the applicable Florida regulation, a controlled substance
prescription is valid when, among other things, it ``has been issued
for a legitimate medical purpose.'' Fla. Admin. Code Ann. r. 64B16-
27.831(1)(a) (2025).\4\ A controlled substance prescription is invalid,
according to the applicable Florida regulation, if ``the pharmacist
knows or has reason to know that the prescription was not issued for a
legitimate medical purpose.'' Id. 64B16-27.831(1)(b). Further, when a
pharmacist in Florida is presented with a prescription for a controlled
substance, ``the pharmacist shall attempt to determine the validity of
the prescription.'' Id. 64B16-27.831(2). When validating a controlled
substance prescription, ``if at any time the [Florida] pharmacist
determines that in his or her professional judgment, concerns with the
validity of the prescription cannot be resolved, the pharmacist shall
refuse to fill or dispense the [controlled substance] prescription.''
Id. 64B16-27.831(2)(c).
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\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. Sec. 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.
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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.
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\5\ The OSC/ISO details only eight of the nine promethazine with
codeine controlled substance prescriptions.
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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.
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
[[Page 31246]]
example of the deemed-admitted facts is one controlled substance
prescription for oxycodone 30 mg that Registrant dispensed for K.M. on
March 28, 2024. Id. E.D. picked up this illegitimate prescription that
he and OPIC had discussed earlier the same day. Id.
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. Sec.
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\
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\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.
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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.
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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. Sec. 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
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
[[Page 31247]]
interest, and (3) the Government has met its prima facie burden of
showing that Registrant's continued registration is inconsistent with
the public interest due to its experience dispensing controlled
substances and its numerous failures to comply with laws relating to
controlled substances, the burden shifts to Registrant to show why it
can be entrusted with a registration. Morall, 412 F.3d. at 174; Jones
Total Health Care Pharmacy, 881 F.3d at 830; Garrett Howard Smith,
M.D., 83 FR 18882 (2018). The issue of trust is necessarily a fact-
dependent determination based on the circumstances presented by the
individual registrant. Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019);
see also Jones Total Health Care Pharmacy, 881 F.3d at 833. Moreover,
as past performance is the best predictor of future performance, the
Agency has required that a registrant who has committed acts
inconsistent with the public interest must accept responsibility for
those acts and demonstrate that it will not engage in future
misconduct. Jones Total Health Care Pharmacy, 881 F.3d at 833 (citing
authority including Alra Labs., Inc. v. Drug Enf't Admin., 54 F.3d 450,
452 (7th Cir. 1995) (``An agency rationally may conclude that past
performance is the best predictor of future performance.'')), MacKay v.
Drug Enf't Admin., 664 F.3d 808, 820 (10th Cir. 2011) (``[Whether the
registrant will change its behavior in the future] is vital to whether
continued registration is in the public interest.''). A registrant's
acceptance of responsibility must be unequivocal. Jones Total Health
Care Pharmacy, 881 F.3d at 830-31.
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]
BILLING CODE 4410-09-P