Notice2025-19578
Hovic Pharmacy; Decision and Order
Primary source
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Published
October 17, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 90 Issue 199 (Friday, October 17, 2025)</title>
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[Federal Register Volume 90, Number 199 (Friday, October 17, 2025)]
[Notices]
[Pages 48346-48354]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19578]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Hovic Pharmacy; Decision and Order
I. Introduction
On October 20, 2021, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Hovic Pharmacy of
Houston, Texas (Respondent). Request for Final Agency Action (RFAA), at
1801.\1\ The OSC proposes the revocation of Respondent's DEA
registration No. FH5569112 (registration), pursuant to 21 U.S.C.
824(a)(4) ``because . . .
[[Page 48347]]
[Respondent's] continued registration is inconsistent with the public
interest, as that term is defined in 21 U.S.C. [823(g)(1)].'' \2\ Id.
According to the OSC, ``Respondent's pharmacists filled many controlled
substance prescriptions outside the usual course of pharmacy practice .
. . and in contravention of their `corresponding responsibility.' ''
Id. at 1802, citing 21 CFR 1306.06 and 1306.04(a).
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\1\ The Chief Administrative Law Judge (ALJ) granted the
Government's unopposed motion to amend the OSC by Order dated
January 10, 2022. RFAA, at 1799-1800. This Decision adjudicates the
amended OSC.
\2\ Effective December 2, 2022, the Medical Marijuana and
Cannabidiol Research Expansion Act, Public Law 117-215, 136 Stat.
2257 (2022) (Marijuana Research Amendments or MRA), amended the
Controlled Substances Act (CSA) and other statutes. Relevant to this
matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC, as
21 U.S.C. 823(g)(1). Accordingly, this Decision cites to the current
designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA
throughout.
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The OSC more specifically alleges that, according to an
``independent pharmacy expert'' retained by DEA who ``reviewed . . .
prescription data'' referenced in the OSC, the ``data present[ ]
multiple red flags that were highly indicative of abuse and
diversion.'' Id. at 1806. With respect to the ``controlled substances
purchased by and distributed to'' a recruiter (Recruiter), the expert
opined that the ``red flags inherent in those prescriptions could not
have been resolved by a pharmacist acting in the usual course of
professional practice, and, therefore, each prescription was filled
outside the standard of care of pharmacy practice in Texas.'' \3\ Id.
As for the prescriptions whose red flags ``could potentially be
resolved, the expert concluded that, based on documentation provided by
. . . [Respondent, Respondent] made no effort to resolve the red flags
and therefore, those prescriptions were also filled outside the
standard of care of pharmacy practice in Texas.'' Id.
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\3\ Recruiter pled guilty to ``conspiracy to dispense and
distribute hydrocodone,'' and executed a declaration while serving a
sentence of sixty months. RFAA, at 1806.
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Respondent initially requested a hearing, but submitted a Waiver of
Hearing on February 10, 2022, days before the hearing scheduled for
February 14 through February 17 was to begin.\4\ Id. at 1807-08; infra
section III.A. The Chief ALJ issued his Order Terminating Proceedings
on February 11, 2022. RFAA, at 1809. The Government filed its RFAA, and
served Respondent, on October 30, 2023. Id. at 21.
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\4\ It is not clear, from the record, that Respondent's emailed
hearing request was submitted timely. Given that this matter is now
before the Agency on the Government's request for final Agency
action, however, there is no need for the Agency to try to clear up
this matter.
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Having thoroughly analyzed the record and applicable law, the
Agency summarizes its findings and conclusions: (1) the OSC includes
multiple, specific allegations that Respondent violated the Controlled
Substances Act (CSA), the CSA's implementing rules, and Texas law, (2)
Respondent requested a hearing, participated during most of the pre-
hearing stage, and simply withdrew its hearing request, without
explanation or elaboration of any kind, days before the four-day
scheduled hearing was to begin, (3) the Government's RFAA presents a
prima facie case as to all but three of the apparent OSC allegations,
and (4) the record includes substantial record evidence, indeed
unequivocal and uncontroverted record evidence, that Respondent
violated federal and Texas law, thus unlawfully releasing about 13,135
controlled substance tablets, and about a 3,478 days' supply of
promethazine with codeine (Schedule V), into the community in a period
of about eighteen months.<SUP>5 6</SUP> Accordingly, the Agency will
revoke Respondent's registration. Infra, Order.
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\5\ According to the CSA, ``[f]indings of fact by the [DEA
Administrator], if supported by substantial evidence, shall be
conclusive.'' 21 U.S.C. 877. Here, as Respondent withdrew its
hearing request before the first day of the hearing, when the Agency
finds that the evidence that the Government submitted with its RFAA
constitutes substantial record evidence of an OSC allegation, that
evidence is also unequivocal and uncontroverted evidence of that OSC
allegation. Throughout this Decision, therefore, when the Agency
finds evidence to be unequivocal and uncontroverted record evidence,
the Agency is finding the evidence to be more than the ``substantial
evidence'' of 21 U.S.C. 877; it is unrebutted evidence.
\6\ The fills are alleged to have spanned the time period of
December 17, 2018, through March 15, 2021. RFAA, at 1804.
If the OSC includes an allegation based on Texas Health and
Safety Code 481.074(a)(5), ``a pharmacist may not . . . permit the
delivery of a controlled substance to any person not known to the
pharmacist . . . without first requiring identification of the
person taking possession of the controlled substance,'' except in
stated circumstances, it is not sustained because the Agency finds
unequivocal and uncontroverted record evidence that Recruiter is
``known'' to at least one of Respondent's pharmacists. Infra section
III.A.2.; RFAA, at 1803, para. 12; RFAA, at 1804, para. 15.
Further, given that the Agency finds unequivocal and
uncontroverted record evidence of multiple other OSC allegations,
each, alone, being a sufficient basis for revoking Respondent's
registration, the Agency need not, and does not, address two OSC
allegations: first, allegations concerning the use of cash and cash
equivalents to pay Respondent for filling controlled substance
prescriptions and, second, allegations concerning Respondent's
filling controlled substance prescriptions issued by a physician
assistant who, at the time, was allegedly subject to a Texas
Physician Assistant Board Order's restrictions and was allegedly not
under the supervision of a licensed physician. RFAA, at 1805-06,
paras. 16.f. and 16.g.
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II. The CSA and Texas Pharmacists' Professional Responsibility
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 the CSA's objectives,
``Congress devised a closed regulatory system making it unlawful to . .
. dispense[ ] or possess any controlled substance except in a manner
authorized by'' the statute.\7\ Id. at 13.
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\7\ 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 ``deliver[ing] a controlled
substance to an ultimate user . . . by, or pursuant to the lawful
order of, a practitioner.'' 21 U.S.C. 802(10). It defines
``distribute'' to mean ``to deliver (other than by administering or
dispensing) a controlled substance.'' Id. 802(11). Thus, according
to these CSA definitions, when a pharmacy fills an illegitimate
controlled substance prescription, it is ``distributing,'' not
``dispensing,'' controlled substances.
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According to the CSA's implementing rules, 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, ``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.'' \8\ 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) (pharmacist's failed challenge to his
federal corresponding responsibility).
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\8\ The context of this Supreme Court statement is the Act's
requirement that Schedule II controlled substances be dispensed only
by written prescription.
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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).
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
[[Page 48348]]
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 is addressed to Respondent at its registered address in
Texas. Therefore, the Agency also evaluates Respondent's actions
according to Texas law, including the applicable Texas pharmacist
professional responsibilities. Gonzales v. Oregon, 546 U.S. at 269-71.
During the period alleged in the OSC, Texas law specifically
addressed pharmacists' professional responsibilities. First, according
to Texas law, ``[a] pharmacist may not dispense . . . a controlled
substance . . . except under a valid prescription and in the course of
professional practice.'' Tex. Health & Safety Code Sec. 481.074(a)
(2017, 2019). Second, pharmacists ``shall make every reasonable effort
to ensure that any prescription drug order . . . has been issued for a
legitimate medical purpose by a practitioner in the course of medical
practice.'' 22 Tex. Admin. Code Sec. 291.29(b) (2018). Further,
according to Texas law, a ``pharmacist shall make every reasonable
effort to prevent inappropriate dispensing due to fraudulent, forged,
invalid, or medically inappropriate prescriptions in violation of a
pharmacist's corresponding responsibility.'' Id. Sec. 291.29(f). Texas
law specifically identifies ``red flag factors'' that are ``relevant to
preventing the non-therapeutic dispensing of controlled substances''
that ``shall be considered by evaluating the totality of the
circumstances rather than any single factor.'' Id. Several of those red
flag factors are relevant to the adjudication of the OSC.
According to Texas law, a ``reasonably discernible pattern of
substantially identical prescriptions for the same controlled
substances, potentially paired with other drugs, for numerous persons,
indicating a lack of individual drug therapy in prescriptions issued by
the practitioner'' is a red flag factor. Id. Sec. 291.29(f)(1).
Likewise, under Texas law, ``prescriptions by a prescriber . . . [that]
are routinely for controlled substances commonly known to be abused
drugs, including opioids, benzodiazepines, muscle relaxants,
psychostimulants containing codeine, or any combination of these
drugs'' is a red flag factor. Id. Sec. 291.29(f)(3). Another red flag
factor is ``prescriptions for controlled substances . . . [that] are
commonly for the highest strength of the drug and/or for large
quantities (e.g., monthly supply), indicating a lack of individual drug
therapy in prescriptions issued by the practitioner.'' Id. Sec.
291.29(f)(5). Two other red flag factors are ``multiple persons with
the same address [who] present substantially similar controlled
substance prescriptions from the same practitioner,'' and ``persons
[who] consistently pay for controlled substance prescriptions with cash
or cash equivalents more often than through insurance.'' Id. Sec. Sec.
291.29(f)(11) and (12).
The Texas Administrative Code clearly sets out the operational
standard for a pharmacy to follow when it is presented with a
controlled substance prescription exhibiting a ``red flag factor'':
``Prior to dispensing, any questions regarding a prescription drug
order must be resolved with the prescriber and written documentation of
these discussions made and maintained as specified in subparagraph (C)
of this paragraph.'' \9\ Id. Sec. 291.33(c)(2)(A)(iv) (2018-2023).
This Texas documentation requirement preludes a post hoc oral statement
that identification and resolution of a ``red flag factor'' actually
took place absent the existence of documentation compliant with Section
291.33(c)(2)(C).
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\9\ Subparagraph (C) states: ``Documentation of consultation.
When a pharmacist consults a prescriber as described in subparagraph
(A) of this paragraph, the pharmacist shall document on the
prescription or in the pharmacy's data processing system associated
with the prescription such occurrences and shall include the
following information: (i) date the prescriber was consulted; (ii)
name of the person communicating the prescriber's instructions;
(iii) any applicable information pertaining to the consultation; and
(iv) initials or identification code of the pharmacist performing
the consultation clearly recorded for the purpose of identifying the
pharmacist who performed the consultation.'' 22 Tex. Admin. Code
Sec. 291.33(c)(2)(C).
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III. Findings of Fact
A. The Government's Case <SUP>10</SUP>
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\10\ As already explained, Respondent waived its right to a
hearing just before the hearing was scheduled to begin and, as such,
the record before the Agency does not include evidence or legal
analysis from Respondent. RFAA, at 1807-08 (Respondent's Waiver of
Hearing); supra section I. Accordingly, this Decision contains no
material for a section, comparable to this one, about Respondent's
case.
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In sum, the Government charges Respondent with filling controlled
substance prescriptions outside the usual course of Texas pharmacy
practice in contravention of its corresponding responsibility over the
course of many years: (1) Respondent filled controlled substance
prescriptions for Recruiter and Recruiter's recruits, knowing that the
controlled substances were destined for resale on the street, a clearly
illegitimate purpose, and (2) Respondent filled controlled substance
prescriptions beneath the applicable standard of care and outside the
usual course of professional practice. RFAA, at 1802, 1804-1806.
The RFAA is more than 1,800 pages, mostly documentary evidence, and
includes three sworn, under penalty of perjury, Declarations: one by a
(now-retired) Diversion Investigator (DI), one by Recruiter, and one by
the Government's expert, Dr. Diane Ginsburg, a Registered Pharmacist.
Id. at 1810-50.
1. DI's Declaration
The DI's Declaration states that its content is based on ``personal
knowledge and/or information gained in the course of . . . official
duties.'' Id. at 1813. Its content includes background about DEA's
investigation of Respondent and others, information supporting the
OSC's allegations, and material that is consistent with portions of
Recruiter's Declaration.\11\ Id. at 1813-20. The Agency finds that DI's
Declaration is internally consistent and supports the Government's
request to revoke Respondent's registration. Id. The Agency affords
DI's Declaration full credibility, due to its internal consistency and
its having been sworn to under penalty of perjury.
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\11\ While ``consistent'' with portions of Recruiter's
Declaration, there is insufficient information in DI's Declaration
about the source(s) of all of those consistencies for the Agency to
conclude that DI's Declaration ``corroborates'' the entirety of
Recruiter's Declaration. In other words, if the source of the
consistent material in DI's Declaration is Recruiter, then DI's
Declaration simply repeats Recruiter's information, not
independently corroborates it. DI's Declaration does, however,
explicitly corroborate portions of Recruiter's Declaration. Infra.
section III.A.2.
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2. Recruiter's Declaration
Recruiter's declaration, dated February 17, 2022, is sworn to and
signed by Recruiter. Id. at 1810-12. According to the Declaration,
Recruiter is ``currently incarcerated'' in federal prison ``serving a
60-month sentence as a result of pleading guilty to the charge of
conspiracy to dispense and distribute hydrocodone.'' Id. at 1810.
Recruiter's Declaration describes a conspiracy in which Recruiter and
Recruiter's recruits unlawfully obtained controlled substance
prescriptions. Recruiter then presented the prescriptions to
Respondent, and Respondent's pharmacists filled them even though the
pharmacists knew or had reason to
[[Page 48349]]
know that the prescriptions were unlawfully obtained. Recruiter then
sold the unlawfully obtained controlled substances on the street. Id.
at 1810-12.
Based on the admissions in Recruiter's Declaration, the Agency
finds that Recruiter, ``[f]rom at least 2017 through 2020 . . .[,]
participated in a scheme to obtain prescriptions for controlled
substances from practitioners and those prescriptions were filled at .
. . [Respondent].'' \12\ Id. The Agency further finds unequivocal and
uncontroverted record evidence that Recruiter ``recruit[ed] individuals
to pose as patients (recruits) who would obtain prescriptions for
controlled substances from two different practitioners,'' that
Respondent would fill the controlled substance prescriptions, including
prescriptions for hydrocodone-acetaminophen 10-325 (Schedule II),
promethazine with codeine, carisoprodol (Schedule IV), and alprazolam
(Schedule IV), and that Recruiter ``would then purchase these
prescriptions with cash, pick up the drugs[,] and sell the drugs to
street level customers.'' \13\ Id. at 1810. In sum, given the self-
incriminating nature of Recruiter's Declaration, the corroboration of
its content by DI's Declaration, its internal consistency, and its
having been sworn to under penalty of perjury, the Agency affords
Recruiter's Declaration credibility.\14\
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\12\ In addition to the RFAA's documentary evidence that
corroborates Recruiter's Declaration, infra., DI's Declaration
references a court-authorized Title III wiretap that corroborates
Recruiter's Declaration. RFAA, at 1815 (DI Declaration stating that
Recruiter's ``role in the enterprise was confirmed by a court-
authorized Title III wiretap undertaken on phones utilized by
recruiters and clinic staff members'').
The Agency makes the decision that Recruiter's Declaration is
credible after evaluating paragraph 20 of DI's Declaration,
paragraph 14 of Recruiter's Declaration, and the report of
Respondent Pharmacist One. Id. at 1817, 1812, and 105, respectively.
According to DI's Declaration, DI ``attempted to confirm . . .
[Recruiter's] statement regarding an incident'' that Recruiter
described involving Respondent Pharmacist One's ``mistakenly''
filling a recruit's carisoprodol (Schedule IV) prescription with
hydrocodone-acetaminophen 10-325 tablets (Schedule II). Id. at 1817.
According to Recruiter, Respondent Pharmacist One contacted
Recruiter and asked Recruiter to return the mistakenly issued
hydrocodone-acetaminophen 10-325. Id. at 1812. According to the
report of Respondent Pharmacist One, he ``reached out to'' the
recruit, not Recruiter, to ``swap'' those tablets for an equal
number of carisoprodol tablets. Id. at 105. According to the report
of Respondent Pharmacist One, the ``customer'' ``would not come
around'' for such a swap. Id. at 105.
The Agency concludes that Recruiter's statement is consistent
with the report of Respondent Pharmacist One on all salient points,
and that the difference between Recruiter's recollection and the
report of Respondent Pharmacist One about whom he contacted
regarding the matter is not essential. Further, Recruiter's basis
for knowing about the incident could very well be from receiving the
request of Respondent Pharmacist One to return the hydrocodone-
acetaminophen 10-325. After all, Respondent Pharmacist Two
instructed Recruiter to transact business with Respondent alone,
without bringing the recruits. Id. at 1811. Second, had Respondent
Pharmacist One only contacted the recruit, as his report states, and
had the recruit not returned the hydrocodone-acetaminophen 10-325 as
his report also states, Recruiter would not necessarily know about
the wrongful hydrocodone-acetaminophen 10-325 dispensing. Third, it
is not realistic to expect Respondent Pharmacist One to report that
he contacted the ``patient's'' ``recruiter'' about the wrongly
issued hydrocodone-acetaminophen 10-325. Regardless, the Agency
finds that whether Respondent Pharmacist One contacted Recruiter or
the recruit is insignificant, and that this discrepancy between
Recruiter's Declaration and the report of Respondent Pharmacist One
does not impugn the credibility of Recruiter's Declaration.
\13\ The Agency notes that ``hydrocodone'' is used in the RFAA
when the actual controlled substance named in the RFAA's documentary
evidence is hydrocodone-acetaminophen 10-325. The RFAA brief does
not address this abbreviated usage of ``hydrocodone'' for
hydrocodone-acetaminophen 10-325. While the Agency prefers
precision, including explicit explanations in parties' submissions,
it also recognizes that the controlled portion of hydrocodone-
acetaminophen 10-325 is hydrocodone. The Agency further notes that
the Diversion Control Division issued a public fact sheet in 2019
titled ``Hydrocodone'' that includes Vicodin and Lortab, trade names
for hydrocodone with acetaminophen, in its subtitle. Hydrocodone
(Trade Names: Vicodin[supreg], Lortab[supreg], Lorcet-HD[supreg],
Hycodan[supreg], Vicoprofen[supreg]), <a href="https://www.deadiversion.usdoj.gov/drug_chem_info/hydrocodone.pdf">https://www.deadiversion.usdoj.gov/drug_chem_info/hydrocodone.pdf</a> (last
visited date of signature of this Order).
\14\ The Agency also finds unequivocal and uncontroverted record
evidence in the Declaration of Dr. Diane Ginsburg that further
corroborates the self-incriminating content of Recruiter's
Declaration. RFAA, at 1847-48; infra. section III.A.3. The
Declaration of Dr. Ginsburg also contains unequivocal and
uncontroverted record evidence of Respondent's unlawful controlled
substance distribution to Recruiter. Infra. section III.A.3.
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The Agency finds unequivocal and uncontroverted record evidence
that Recruiter ``developed a relationship with the employees'' of
Respondent who ``rarely questioned'' the controlled substance
prescriptions that Recruiter dropped off for about eleven individuals
approximately three times a week for several years.'' \15\ Id. at 1810-
11; see also id. at 1812 (``Though I firmly believe . . . [Respondent
Pharmacist Two] knew or had reason to know that the prescriptions I
purchased and picked up from . . . [Respondent] were not issued for a
legitimate medical purpose, . . . [Respondent Pharmacist One] was also
aware that I was regularly picking up prescriptions for controlled
substances that had been prescribed to others.'').
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\15\ Recruiter's Declaration includes the names of two such
pharmacist employees of Respondent and states that Recruiter
identified them both from photographs that DI displayed.
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The Agency also finds unequivocal and uncontroverted record
evidence that Respondent Pharmacist Two ``instructed'' Recruiter about
how to do business with Respondent. Id. at 1811. For example,
Respondent Pharmacist Two told Recruiter not to bring the recruits to
the store to pick up and purchase the controlled substances. Id.
Instead, she instructed Recruiter ``to come in and pick up the
prescriptions,'' and either to forge the recruits' names on the
signature log or to sign Recruiter's own name. Id.; id. at 31-89
(Respondent's signature logs, GX 4, that Recruiter annotated with a
circle or a circle with a check mark to signify when Recruiter forged
the recruit's name (circle only) and when Recruiter signed Recruiter's
own name (circle and check mark)); id. at 171-237 (Respondent's
Dispensed Drug Report for the Period of January 3, 2020, through March
29, 2021, GX 8, showing about twenty-seven prescription number matches
between the signature log prescription numbers that Recruiter signed,
forging the recruit's name, and controlled substances, such as
promethazine with codeine, hydrocodone-acetaminophen 10-325, and
carisoprodol 350, that Respondent filled and sold to Recruiter from
January 23, 2020, to March 23, 2020).\16\
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\16\ The Agency is considering Respondent's actions during the
time frame alleged in the OSC: December 17, 2018, through March 15,
2021. RFAA, at 1804.
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In sum, the Agency finds unequivocal and uncontroverted record
evidence that Respondent did not question, address, prevent, or
otherwise take any action when Recruiter asked for, signed the
signature log for, paid for, and left Respondent's store with filled
controlled substance prescriptions issued for persons other than
Recruiter. Id. at 1811 (``At no time did anyone at . . . [Respondent]
question the fact that I was picking up controlled substances for
others. At no time did anyone at . . . [Respondent] refuse to provide
me with a prescription that was issued to someone else even though I
signed the person's name instead of my own. I was also never asked to
provide any proof that I had authority to pick up prescriptions for
anyone other than myself.'').
Further, the Agency finds unequivocal and uncontroverted record
evidence that at least one of Respondent's pharmacists knew, and even
conversed ``often'' with Recruiter, about Recruiter's street resale of
the controlled substances that Respondent filled for Recruiter and
Recruiter's recruits. Id. at 1811-12. For example, Recruiter and at
least Respondent Pharmacist Two ``often'' discussed Recruiter's
specific controlled substance brand preferences, the brands with a
[[Page 48350]]
``higher resale value'' on the street. Id. at 1811 (Recruiter's
Declaration identifying specific brands of promethazine with codeine
and of hydrocodone products). Further, Respondent ``often required
[Recruiter] to pay more than the cash price that was listed on the
prescription itself.'' Id. at 1812. Regarding promethazine with
codeine, for example, Recruiter ``would pay approximately $240 for 8
ounces . . . [t]hough this arrangement seemed unfair, . . . [but
Recruiter] accepted it because . . . [Recruiter] was able to sell the
controlled substances on the street for more.'' \17\ Id.
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\17\ The Agency further finds unequivocal and uncontroverted
record evidence that at least Respondent Pharmacist Two helped
Recruiter buy the specific brand of a controlled substance that
brought the higher street resale value. RFAA, at 1811 (Recruiter's
Declaration stating that Respondent Pharmacist Two even suggested
that Recruiter fill a controlled substance prescription at another
pharmacy because Respondent did not have Recruiter's preferred brand
in stock).
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The Agency further finds unequivocal and uncontroverted record
evidence that Recruiter was not the only recruiter for whom Respondent
filled controlled substance prescriptions. Id. at 1811. The record
evidence is that Respondent Pharmacist Two interacted with another
recruiter, and even catered to him by instructing Recruiter to frequent
Respondent ``at approximately 4 p.m. each day to pick up prescriptions,
so . . . [Recruiter] would not be seen by'' the other recruiter who did
not want Recruiter to ``use'' Respondent ``to fill prescriptions.'' Id.
Further, the Agency finds unequivocal and uncontroverted record
evidence that one of Respondent's pharmacists even lent Recruiter money
to pay for the recruits' doctor visits with the understanding that
Recruiter would re-pay the money after selling on the street the
controlled substances that Respondent provided. Id. at 1811-12.
Further, the Agency finds undisputed record evidence that one of
Respondent's pharmacists lent Recruiter as much as $800 for this
purpose. Id. at 1812.
In sum, the Agency finds unequivocal and uncontroverted record
evidence that, ``[f]rom at least 2017 through 2020,'' Respondent, by
its pharmacists, filled controlled substance prescriptions for
Recruiter, and for at least one other recruiter, with knowledge that
those controlled substances would be diverted. E.g., id. at 1810.
3. The Declaration of the Government's Expert, Dr. Ginsburg
The Agency finds that Dr. Ginsburg qualifies as an expert in
pharmaceutical controlled substance dispensing in Texas, and accepts
her as such in this adjudication.\18\ Id. at 1725-84 (sixty-page
curriculum vitae of Dr. Ginsburg, a Texas Registered Pharmacist,
listing her accomplishments; education; publications on a broad variety
of pharmacy-related topics; invited papers and presentations on the
national, international, state, and local levels with a primary focus
on pharmacy- and pharmacist-related topics; professional affiliations;
honors and awards, and her work experience as a pharmacist and
educator). The Agency recognizes Dr. Ginsburg as an expert in
pharmaceutical controlled substance dispensing in Texas.\19\ Id. at
1725-84, 1821-50. The Agency, because Dr. Ginsberg is an expert in
pharmaceutical controlled substance dispensing in Texas, because her
Declaration accurately states Respondent's legal responsibilities
according to relevant federal and Texas law, because her Declaration is
sworn to under penalty of perjury, and because her Declaration asserts
that she reviewed Government exhibits 4 through 36, affords Dr.
Ginsburg's Declaration full credibility.\20\ Id. at 31-1724, 1822-23,
1825.
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\18\ This decision is consistent with prior Agency decisions
accepting Dr. Ginsburg as an expert. E.g., Lewisville Medical
Pharmacy, 87 FR 59456 (2022) (Texas), Medical Pharmacy, 86 FR 72030
(2021) (Louisiana).
\19\ Dr. Ginsburg's credentials also include the academic
appointment of Clinical Professor in the Division of Pharmacy
Practice in the College of Pharmacy at the University of Texas
(Austin), and multiple pharmacist positions in Texas. RFAA, at 1725-
29; see also id. at 1822 (``Based on my training and experience, I
am an expert in the practices of a pharmacist in Texas, and in
particular, the dispensing of controlled substances by Texas
pharmacists.'').
\20\ The Agency determines that the statement in paragraph 5 of
Dr. Ginsberg's Declaration, that her curriculum vitae is included in
the RFAA as GX 36, is a typographic error; it is RFAA GX 37. RFAA,
at 1821.
---------------------------------------------------------------------------
Based on Dr. Ginsburg's Declaration and the entirety of the record
evidence before the Agency, the Agency finds unequivocal and
uncontroverted record evidence that Respondent's ``pharmacists failed
to carry out their corresponding responsibility when they dispensed
controlled substances to . . . customers, in that they ignored red
flags indicating a risk of diversion and failed to ensure that the
prescriptions dispensed were issued for a legitimate medical purpose in
the usual course of professional practice.'' Id. at 1823 (Dr.
Ginsburg's Declaration is based on the record evidence she reviewed);
see also id. (Dr. Ginsburg's Declaration stating that ``all minimally
competent pharmacists can and should be able to recognize `red flags'
related to prescriptions, and they are required to do so in the usual
course of pharmacy practice in Texas.''); id. at 1823-24 (Dr.
Ginsburg's Declaration stating that ``a `red flag' is anything about a
prescription that would cause the pharmacist to be concerned that the
prescription was not issued for a legitimate medical purpose in the
usual course of professional practice.''); id. at 1824 (Dr. Ginsburg's
Declaration stating that, ``When confronted with a red flag or red
flags concerning a prescription for controlled substances, a pharmacist
must try to resolve the red flags to determine whether or not the
prescription is legitimate. A pharmacist must resolve the red flag(s)
prior to filling the prescription. Depending on the type of red flag,
there are different steps that the pharmacist can take to determine
whether or not the prescription is legitimate. These steps involve
obtaining more information from the physician or the patient, or
both.''); id. at 1825; infra (Dr. Ginsberg's Declaration explaining
``unresolvable'' red flags, offering the example of Recruiter's picking
up controlled substance prescriptions issued to others, and concluding
that both Respondent Pharmacists filled controlled substance
prescriptions in the face of unresolvable red flags).
According to the OSC's allegations, controlled substance ``cocktail
prescriptions'' are controlled substance prescriptions including
``various combinations of the highly abused hydrocodone, carisoprodol,
alprazolam . . . [,] and promethazine with codeine.'' RFAA, at 1804-05.
Based on Dr. Ginsburg's Declaration and the entirety of the record
evidence before the Agency, the Agency finds unequivocal and
uncontroverted record evidence that ``hydrocodone, promethazine with
codeine, carisoprodol, and alprazolam . . . [are] highly abused
controlled substances,'' and that these types of combination controlled
substance ``cocktail prescriptions have long been recognized as a red
flag for abuse and/or diversion in Texas and significantly increase a
patient's risk of morbidity and overdose.'' Id. at 1832; see also id.
at 1823 (Dr. Ginsburg's Declaration stating that ``[h]ydrocodone,
alprazolam, promethazine with codeine, and carisoprodol are several of
the more commonly diverted and abused drugs in Texas.''). Based on Dr.
Ginsburg's Declaration and the Agency's careful analysis of the
evidence before it, the Agency further finds that ``[t]here is nothing
in any of the [record] documents [that Dr. Ginsburg reviewed] to show
that . . . [Respondent]
[[Page 48351]]
recognized these cocktail prescriptions as a red flag for abuse and/or
diversion, and nothing to indicate that . . . [Respondent] took any
steps to resolve the red flags prior to dispensing'' them. Id. at 1832;
id. at 1825-32.
Accordingly, based on these expert-based, undisputed findings and
opinions, the Agency finds unequivocal and uncontroverted record
evidence that, from July 17, 2019, to July 10, 2020, Respondent filled
about 138 controlled substance cocktail prescriptions involving five
individuals without resolving those red flags of abuse and/or
diversion. Id. at 106-237, 425-616, 1824-32. By failing to exercise its
corresponding responsibility and filling these controlled substance
prescriptions, Respondent released into the community about 3143
hydrocodone-acetaminophen 10-325 mg tablets, about 2680 carisoprodol
350 mg tablets, about 1326 days' supply (or more than three and a half
years' supply) of promethazine with codeine, about 190 alprazolam 1 mg
tablets, and about 90 alprazolam 2 mg tablets. Id. at 106-237, 425-616.
According to the OSC's allegations, Respondent filled monthly
prescriptions for promethazine with codeine to three individuals from
March 4, 2019, to June 18, 2020. Id. at 1804. Based on Dr. Ginsburg's
Declaration and the entirety of the record evidence before the Agency,
the Agency finds unequivocal and uncontroverted record evidence that
Respondent failed to exercise its corresponding responsibility and
filled ``[r]epeated and continuous'' prescriptions for promethazine
with codeine to three individuals from March 4, 2019, to June 18, 2020,
approximately monthly.\21\ Id. at 1832 (describing the promethazine
with codeine prescriptions for the three individuals as ``monthly
prescriptions,'' ``continuous prescriptions,'' and ``continuous
prescriptions,'' respectively). Based on Dr. Ginsburg's Declaration and
the entirety of the record evidence before the Agency, the Agency finds
unequivocal and uncontroverted record evidence that promethazine with
codeine is a ``highly abused cough suppressant normally prescribed for
short term use,'' and that its ``repeated prescribing . . . has long
been recognized in Texas as a red flag for abuse and/or diversion.''
Id. at 1834; see also id. at 1824. Based on Dr. Ginsburg's Declaration
and the Agency's careful analysis of the evidence before it, the Agency
further finds that Respondent failed to exercise its corresponding
responsibility as ``[t]here is nothing . . . [in the record] to show
that . . . [Respondent] recognized these prescriptions as a red flag
for abuse and/or diversion, and nothing to indicate that . . .
[Respondent] took any steps to resolve the red flag prior to
dispensing.'' Id. at 1834.
---------------------------------------------------------------------------
\21\ The Agency finds unequivocal and uncontroverted record
evidence that, for the first individual, S.L., Respondent filled
monthly prescriptions for promethazine with codeine (240 mL) from
March 4, 2019, to December 6, 2019, and then again from March 9,
2020, to May 21, 2020; for the second individual, M.R., Respondent
filled twelve prescriptions for promethazine with codeine (180 mL)
more frequently than monthly, from March 15, 2019, to November 20,
2019, and five prescriptions, monthly, from February 7, 2020, to
June 5, 2020; and for the third individual, C.G., Respondent filled
fourteen promethazine with codeine (240 mL) prescriptions from March
29, 2019, to June 18, 2020, almost monthly.
---------------------------------------------------------------------------
Accordingly, consistent with the expert's undisputed Declaration,
the Agency finds unequivocal and uncontroverted record evidence that,
from March 4, 2019, to June 18, 2020, Respondent released about 1,089
days' (or almost 3 years') worth supply of promethazine with codeine
into the community by its ``[r]epeated and continuous'' failures to
exercise its corresponding responsibility and filling three
individuals' almost monthly illegitimate controlled substance
prescriptions. Id. at 294-324, 425-93, 1610-1714, 1832-34. Taking into
account overlap with the promethazine with codeine involved in the
cocktail calculations, Respondent, violating its corresponding
responsibility, released about an additional 285 days' worth supply of
promethazine with codeine into the community by its ``[r]epeated and
continuous'' filling of three individuals' prolonged, and almost
monthly, promethazine with codeine controlled substance prescriptions.
Id. at 294-324, 425-93, 1610-1714.
According to the OSC's allegations, ``pattern prescribing'' is
``when a practitioner prescribes the same controlled substances in
identical or substantially similar dosages and quantities, thus
indicating a lack of individualized care.'' Id. at 1805. According to
Dr. Ginsburg's Declaration, ``pattern prescribing'' is a prescriber's
employment of a `` `one size fits all' approach to prescribing
potentially dangerous narcotics, usually by prescribing the narcotics
in identical or nearly identical quantities to each patient regardless
of the patient's individualized medical condition.'' Id. at 1824. Based
on Dr. Ginsburg's Declaration and the Agency's careful analysis of the
evidence before it, the Agency finds unequivocal and uncontroverted
record evidence that two physicians engaged in ``pattern prescribing,''
that both doctors' pattern prescribing involved their issuing
controlled substance prescriptions for hydrocodone-acetaminophen 10-325
mg, carisoprodol 350 mg, and promethazine with codeine, and that they
issued these controlled substance prescriptions to at least seven
individuals. Based on Dr. Ginsburg's Declaration and the Agency's
careful analysis of the evidence before it, the Agency further finds
that ``[t]here is nothing . . . [in the record] to show that . . .
[Respondent] recognized these prescriptions as a red flag for abuse
and/or diversion, and nothing to indicate that . . . [Respondent] took
any steps to resolve the red flag prior to dispensing.'' Id. at 1843,
see also id. at 1834-43.
In sum, according to evidence that is unequivocal and
uncontroverted, from March 8, 2019, to July 3, 2020, Respondent
released about 1,456 days' (or almost a 4 years') worth supply of
promethazine with codeine 240 mL, about 303 days' (or about two months
shy of one year) worth supply of promethazine with codeine 180 mL,
about an additional 2,666 tablets of carisoprodol 350 mg, and about an
additional 3,328 tablets of hydrocodone-acetaminophen 10-325 into the
community by filling controlled substances prescriptions without
resolving the red flag of pattern prescribing.\22\ Id. at 325-424, 617-
804, 1610-1714, 1834-43.
---------------------------------------------------------------------------
\22\ The amount of promethazine with codeine 240 mL that
Respondent distributed that has not already been counted in this
Decision is about a 1,108 days' worth supply. RFAA, at 325-424,
1610-1714.
---------------------------------------------------------------------------
The OSC states that ``pharmacy shopping'' is when an individual
``fill[s] prescriptions for controlled substances at multiple
pharmacies.'' Id. at 1805. Dr. Ginsburg's Declaration states that
``pharmacy shopping'' may indicate that a customer is trying to avoid
being suspected of abuse and/or diversion while obtaining controlled
substances. Id. at 1847; see also id. at 1824, 1843-47. The Ginsburg
Declaration further states that ``[p]harmacy shopping has long been
recognized as a red flag for abuse and/or diversion in Texas because it
may indicate the customer is attempting to obtain prescriptions and
avoid suspicion.'' \23\ Id. at 1847. Based on Dr. Ginsburg's
Declaration and the entirety of the record evidence before the Agency,
the Agency finds
[[Page 48352]]
unequivocal and uncontroverted record evidence that controlled
substance prescriptions for three individuals, including for Recruiter,
were filled by ``pharmacy shopping,'' that is, by filling one of three
controlled substance prescriptions issued at, or at about, the same
time (including hydrocodone-acetaminophen 10-325 in all but one case)
at a different pharmacy from where they filled the other two, typically
at Respondent. Id. at 1843-47. Based on Dr. Ginsburg's Declaration and
the Agency's careful analysis of the evidence before it, the Agency
further finds that ``[t]here is nothing . . . [in the record evidence]
to show that . . . [Respondent] recognized these prescriptions as a red
flag for abuse and/or diversion,'' and that there is ``nothing [in the
record evidence] to indicate that . . . [Respondent] took any steps to
resolve the red flag prior to dispensing.'' Id. at 1847.
---------------------------------------------------------------------------
\23\ According to Recruiter's Declaration, Recruiter obtained
controlled substances from pharmacies other than Respondent when,
for example, Respondent Pharmacist Two ``suggested . . . [that
Recruiter] fill the hydrocodone prescription at another pharmacy''
because Respondent did not have Recruiter's ``preferred brand in
stock.'' RFAA, at 1811. Recruiter's Declaration also states that
Recruiter ``utilized'' Respondent after ``develop[ing] a
relationship with the employees'' and because the ``prescriptions
that were submitted were rarely questioned.'' Id. at 1810.
---------------------------------------------------------------------------
Accordingly, based on these expert-based, undisputed findings, the
Agency finds unequivocal and uncontroverted evidence that, from
December 17, 2018, to May 22, 2020, Respondent released about an
additional 1,038 tablets of carisoprodol 350 mg and about an additional
456 days' (or over one year's) worth supply of promethazine with
codeine 240 mL into the community by filling controlled substance
prescriptions issued to individuals who engaged in ``pharmacy
shopping'' without resolving that red flag. Id. at 1594-1609, 1843-47.
In sum, based on Dr. Ginsburg's Declaration and the entirety of the
record evidence before the Agency, the Agency finds unequivocal and
uncontroverted record evidence that Respondent's pharmacists failed to
recognize and resolve red flags of abuse and/or diversion, ``failed to
carry out their corresponding responsibility,'' and ``failed to ensure
that the dispensed prescriptions were issued for a legitimate medical
purpose in the usual course of professional practice.'' Id. at 1823.
B. The Unlawful Distribution Allegations: in 2019 and 2020,
Respondent's Employees Knowingly Participated in a Scheme To Distribute
Controlled Substances to a Known Street Dealer
As already discussed, the Agency finds that the evidence the
Government submitted with the RFAA, in conjunction with Respondent's
not having submitted any evidence, is unequivocal and uncontroverted
record evidence that Recruiter, ``[f]rom at least 2017 through 2020,''
participated in a scheme to obtain illegitimate controlled substance
prescriptions, to present them to Respondent to fill, and to sell the
Respondent-filled controlled substances on the street. Supra section
III.A.2. As already discussed, the Agency also finds unequivocal and
uncontroverted record evidence that Respondent Pharmacists One and Two
knowingly participated in the scheme by filling the illegitimate
controlled substance prescriptions without identifying, let alone
resolving, those prescriptions' red flags. Supra sections III.A.2,
III.A.3. For example, as already discussed, Respondent Pharmacist Two
instructed Recruiter on how to carry out parts of the scheme, lent
Recruiter money to enable accomplishment of the scheme's goals, and
charged inflated costs for fills. Supra section III.A.2. Accordingly,
the Agency finds unequivocal and uncontroverted record evidence that
Respondent violated federal and Texas law because, at least in 2019 and
2020, Respondent's employees knowingly participated in a scheme to
distribute controlled substances to a known street dealer. 21 CFR
1306.04(a); Tex. Health & Safety Code Sec. 481.074(a) (2017, 2019); 22
Tex. Admin. Code Sec. Sec. 291.29(b) and (f) (2018),
291.33(c)(2)(A)(iv) and (C) (2018-2023); supra section II.
C. The Unlawful Distribution Allegations: Between September 16, 2019,
and March 23, 2020, Respondent Distributed Controlled Substances to a
Recruiter Pursuant to Prescriptions Issued to Other Individuals, and
With Reason To Believe That the Recruiter Intended To Resell Them
As already discussed, the Agency finds unequivocal and
uncontroverted record evidence that Recruiter, ``[f]rom at least 2017
through 2020,'' participated in a scheme to obtain illegitimate
controlled substance prescriptions, to present them to Respondent to
fill, and to sell the Respondent-filled controlled substances on the
street. Supra section III.A.2. For example, as the Agency already
found, Respondent Pharmacist Two told Recruiter not to bring the
recruits to the store to pick up and purchase the controlled substance
prescriptions. Id. Instead, Respondent Pharmacist Two instructed
Recruiter ``to come in and pick up the prescriptions,'' and either to
forge the recruits' names on the signature log or to sign Recruiter's
own name. Id. By way of further examples, as the Agency already found,
Respondent Pharmacist Two and Recruiter ``often'' discussed Recruiter's
specific controlled substance brand preferences, the brands with a
``higher resale value'' on the street; a Respondent pharmacist helped
Recruiter buy the specific brand of a controlled substance that brought
the higher street resale value; and one of Respondent's pharmacists
even lent Recruiter money to pay for the recruits' doctor visits with
the understanding that Recruiter would re-pay the money after selling
on the street the controlled substances that Respondent provided. Id.
Accordingly, the Agency finds unequivocal and uncontroverted record
evidence that Respondent violated federal and Texas law between at
least September 16, 2019, and March 23, 2020. 21 CFR 1306.04(a); Tex.
Health & Safety Code Sec. 481.074(a) (2017, 2019); 22 Tex. Admin. Code
Sec. Sec. 291.29(b) and (f) (2018), 291.33(c)(2)(A)(iv) and (C) (2018-
2023); supra section II.
D. The Unlawful Distribution Allegations: Between March 4, 2019, and
June 18, 2020, Respondent Filled Monthly Prescriptions for Promethazine
With Codeine to Three Individuals
As already discussed, the Agency finds unequivocal and
uncontroverted record evidence that, monthly from March to December of
2019, and from February to June of 2020, Respondent filled
prescriptions for promethazine with codeine for two individuals. Supra
section III.A.3.; n.21. Accordingly, the Agency finds unequivocal and
uncontroverted record evidence that Respondent violated federal and
Texas law, monthly, as to the two individuals' monthly, or more
frequently than monthly, prescriptions for promethazine with codeine.
21 CFR 1306.04(a); Tex. Health & Safety Code Sec. 481.074 (2017,
2019); 22 Tex. Admin. Code Sec. Sec. 291.29 (2018), 291.33 (2018-
2023). Supra section II.
E. The Unlawful Distribution Allegations: Between December 27, 2019,
and July 10, 2020, Respondent Filled ``Cocktail'' Prescriptions for
Five Different Individuals Including Various Combinations of
Hydrocodone, Carisoprodol, Alprazolam, and Promethazine With Codeine
As already discussed, the Agency finds unequivocal and
uncontroverted record evidence that Respondent filled about 138
controlled substance cocktail prescriptions involving five individuals
without resolving those red flags of abuse and/or diversion from July
17, 2019, to July 10, 2020. Supra section III.A.3. Also as already
discussed, the Agency finds unequivocal and uncontroverted record
evidence that these cocktail prescriptions involved various
combinations of hydrocodone-acetaminophen 10-325 mg, carisoprodol 350
mg, alprazolam 1 mg, alprazolam 2 mg, and promethazine with codeine.
[[Page 48353]]
Supra section III.A.3. Accordingly, the Agency finds unequivocal and
uncontroverted record evidence that Respondent violated federal and
Texas law by filling controlled substance cocktail prescriptions
involving five individuals without resolving those red flags of abuse
and/or diversion from July 17, 2019, to July 10, 2020. 21 CFR
1306.04(a); Tex. Health & Safety Code Sec. 481.074 (2017, 2019); 22
Tex. Admin. Code Sec. Sec. 291.29 (2018), 291.33 (2018-2023); supra
section II.
F. The Unlawful Distribution Allegations: Between March 8, 2019, and
July 3, 2020, Respondent Distributed Controlled Substances Pursuant to
Prescriptions Issued by Practitioners Engaged in ``Pattern
Prescribing''
As already discussed, the Agency finds unequivocal and
uncontroverted record evidence that, between March 8, 2019, and July 3,
2020, Respondent filled controlled substance prescriptions issued by
two practitioners to at least seven individuals without resolving the
prescriptions' pattern prescribing red flags. Supra section III.A.3.
Accordingly, the Agency finds unequivocal and uncontroverted record
evidence that Respondent violated federal and Texas law, between March
8, 2019, and July 3, 2020, by filling controlled substance
prescriptions without identifying and resolving those prescriptions'
pattern prescribing red flags of abuse and/or diversion. 21 CFR
1306.04(a); Tex. Health & Safety Code Sec. 481.074 (2017, 2019); 22
Tex. Admin. Code Sec. Sec. 291.29 (2018), 291.33 (2018-2023); supra
section II.
G. The Unlawful Distribution Allegations: Between December 17, 2018,
and May 22, 2020, Respondent Filled Controlled Substances for Three
Individuals Despite Prescription Histories That Indicated Each Was
Engaged in ``Pharmacy Shopping,'' or Filling Prescriptions for
Controlled Substances at Multiple Pharmacies
As already discussed, the Agency finds unequivocal and
uncontroverted record evidence that Respondent filled controlled
substance prescriptions for three individuals without identifying and
resolving their pharmacy shopping red flags from December 17, 2018, to
May 22, 2020. Supra section III.A.3. Accordingly, the Agency finds
unequivocal and uncontroverted record evidence that Respondent violated
federal and Texas law. 21 CFR 1306.04(a); Tex. Health & Safety Code
Sec. 481.074 (2017, 2019); 22 Tex. Admin. Code Sec. Sec. 291.29
(2018), 291.33 (2018-2023); supra section II.
IV. 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).\24\
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\24\ 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. at 292-93 (Scalia, J., dissenting) (``It is well
established that these factors are to be considered in the
disjunctive'' (quoting In re Arora, 60 FR 4447, 4448 (1995))); Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). The Agency may give each
factor the weight it deems appropriate. Gonzales v. Oregon, 546 U.S. at
293 (Scalia, J., dissenting) (quoting In re Arora, 60 FR 4447, 4448
(1995)), e.g., Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490
(D.C. Cir. 2007) (importer); Morall v. Drug Enf't Admin., 412 F.3d 165,
174 (D.C. Cir. 2005) (practitioner), quoting Henry J. Schwarz, Jr.,
Denial of Application, 54 FR 16422, 16424 (Apr. 24, 1989).
The Agency ``may properly rely on any one or a combination of
factors.'' Gonzales v. Oregon, 546 U.S. at 293 (Scalia, J. dissenting)
(quoting In re Arora, 60 FR 4447, 4448 (1995)); Morall, 412 F.3d at 185
n.2 (Henderson, J. concurring and referring to pages 173-74 of the
majority opinion); 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)); 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 v. Drug Enf't Admin.,
664 F.3d 808, 816 (10th Cir. 2011) (the Agency ``must consider each of
these factors'' but ``need not make explicit findings as to each one'')
(quoting Volkman, quoting Hoxie, and citing Morall). ``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) (on
remand). 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.
The Government has the burden of proof in this proceeding. 21 CFR
1301.44(e); see also Morall, 412 F.3d. at 174.
B. Factors B and/or D--Respondent's Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Relating to Controlled
Substances
Allegation That Respondent's Continued Registration Would Be
Inconsistent With the Public Interest
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 Agency-found
facts regarding Respondent's conduct with respect to factors B and D,
its unlawful conduct under applicable federal and Texas law, constitute
a prima facie showing that Respondent's continued registration would be
inconsistent with the public interest. 21 CFR 1306.04(a); Tex. Health &
Safety Code Sec. 481.074(a) (2017, 2019); 22 Tex. Admin. Code
Sec. Sec. 291.29(b) and (f) (2018), 291.33(c)(2)(A)(iv) and (C) (2018-
2023); MacKay, 664 F.3d at 819; supra section II.
Accordingly, the Government has 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)(4) in
conjunction with 823(g)(1); supra sections II, III.A.1. III.A.2.,
III.A.3., III.B., III.C., III.D., III.E., III.F., III.G. Respondent,
who chose not to submit any evidence for the Agency's consideration,
also did not attempt to rebut the Government's prima facie case.
[[Page 48354]]
V. Sanction
Where, as here, the Government has met its prima facie burden of
showing that Respondent's continued registration would be inconsistent
with the public interest due to its experience dispensing controlled
substances and its failure to comply with applicable laws relating to
controlled substances, the burden shifts to Respondent to show why the
Agency should continue to entrust it 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 respondent. 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, DEA Administrators have 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.'').
``[T]hat consideration is vital to whether continued registration is in
the public interest.'' MacKay, 664 F.3d at 820. A registrant's
acceptance of responsibility must be unequivocal. Jones Total Health
Care Pharmacy, 881 F.3d at 830-31.
Further, DEA Administrators have found that the egregiousness and
extent of the misconduct are significant factors in determining the
appropriate sanction. Id. at 834 and n.4. DEA Administrators have also
considered the need to deter similar acts by the respondent and by the
community of registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.
Here, Respondent chose to withdraw its request for a hearing just
days before the hearing was scheduled to begin. Supra section I. As
such, the record includes no evidence submitted by Respondent. Nor did
Respondent attempt to convince the Agency that it understands that its
issuance of controlled substances fell short of the applicable legal
standards, and that this substandard controlled substance issuance has
serious negative ramifications for the health, safety, and medical care
of individuals who come to it with controlled substance prescriptions
to be filled. 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)
(``The egregiousness and extent of the misconduct are significant
factors in determining the appropriate sanction.''). As such, it is not
reasonable to believe that Respondent's future issuance of controlled
substances will comply with legal requirements.
The unequivocal and uncontroverted record evidence is the
Respondent's founded violations resulted in the release of about 13,135
controlled substance tablets, and about a 3478 days' supply of
promethazine with codeine into the community in a period of about
eighteen months. Supra sections I, III.A.3., III.B., III.C., III.D.,
III.E., III.F., III.G. The controlled substances unlawfully released
into the community were hydrocodone-acetaminophen 10-325 mg tablets,
carisoprodol 350 mg tablets, alprazolam tablets, and promethazine with
codeine, controlled substances known to be abused and diverted. Id.
There is no record evidence that Respondent takes responsibility,
let alone unequivocal responsibility, for the founded violations.
There is no record evidence from which the Agency may reasonably
conclude that Respondent's future controlled substance-related actions
will comply with legal requirements. Accordingly, Respondent did not
convince the Agency that it should continue to entrust Respondent with
a registration.
The interests of specific and general deterrence weigh in favor of
revocation. Further, given the foundational nature and vast number of
Respondent'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, I shall order the sanction the Government requested,
as contained in the Order below.
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. FH5569112 issued to Hovic 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 Hovic Pharmacy to renew or modify this registration, as
well as any other pending application of Hovic Pharmacy for
registration in Texas. This Order is effective November 17, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 1, 2025, by Administrator Terrance Cole. 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. 2025-19578 Filed 10-16-25; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on October 17, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.