Notice2022-21276
Lewisville Medical Pharmacy; Decision and Order
Primary source
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Published
September 30, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 87 Issue 189 (Friday, September 30, 2022)</title>
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[Federal Register Volume 87, Number 189 (Friday, September 30, 2022)]
[Notices]
[Pages 59456-59460]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21276]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 21-24]
Lewisville Medical Pharmacy; Decision and Order
I. Introduction
On June 9, 2021, the United States Department of Justice, Drug
Enforcement Administration (hereinafter, Agency) issued an Order to
Show Cause and Immediate Suspension of Registration (hereinafter
collectively, OSC) to Lewisville Medical Pharmacy (hereinafter,
Respondent) of Lewisville, Texas. OSC, at 1-2, 11. The OSC immediately
suspended, and proposed the revocation of, Respondent's Drug
Enforcement Administration (hereinafter, DEA) registration No.
FL2190332, pursuant to 21 U.S.C. 824(d) and (a)(4), respectively,
``because . . . [Respondent's] continued registration constitutes `an
imminent danger to the public health or safety' '' and ``because . . .
[Respondent's] continued registration is inconsistent with the public
interest, as that term is defined in 21 U.S.C. 823(f).'' Id. at 1. The
OSC more specifically alleged that, according to Respondent's
``dispensing information'' from at least March 2, 2018, through at
least March 20, 2021, Respondent ``repeatedly filled prescriptions for
Schedule III through V controlled substances in the face of obvious and
unresolved red flags of drug abuse and diversion [hereinafter, red
flags], and therefore, in violation of both federal and Texas law,''
including 21 CFR 1306.04(a) and Texas Health & Safety Code Sec.
481.074(a).\1\ Id. at 2. The OSC includes allegations about pattern
prescribing (which it defines as prescribing the same controlled
substance in identical or substantially similar quantities to multiple
individuals indicating a lack of individualized therapy), distance
(which it defines as traveling abnormally long distances to fill a
controlled substance prescription), cash payment (which it defines as a
common red flag of abuse and diversion as it permits an individual to
avoid scrutiny associated with the use of insurance as part of the
payment process), and shared address (which it defines as multiple
persons with the same address presenting the same or substantially
similar controlled substance prescriptions from the same practitioner)
red flags.\2\ Id. at 4-10.
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\1\ The Agency is only adjudicating controlled substance
prescriptions in the record that are dated on or after September 16,
2018. See 22 TAC Sec. 291.29 (effective September 16, 2018).
\2\ The phrase ``red flag'' is used in the record before the
Agency with varying accuracy. The testimony of the Government's
expert accurately defines the phrase and a Texas pharmacist's
obligation when presented with a controlled substance prescription,
that is, consistent with federal law. See, e.g., Tr. 555-56; infra,
section II.A. The use of the phrase in Respondent's case, on the
other hand, is not always fully accurate. Infra, section II.B. When
Respondent's case accurately acknowledges circumstances that are red
flags, it rarely states a Texas pharmacist's ensuing obligation
accurately. Id. When Respondent uses the phrase when questioning the
Government's expert, the context out of which the expert responds is
an accurate understanding of the phrase regardless of what
Respondent meant by its question.
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Respondent timely requested a hearing. Recommended Rulings,
Findings of Fact, Conclusions of Law, and Decision of the
Administrative Law
[[Page 59457]]
Judge (hereinafter, RD), at 1. DEA Administrative Law Judge Paul E.
Soeffing (hereinafter, ALJ) conducted a four-day video teleconference
hearing from November 15 through 18, 2021. Id. On April 1, 2022, the
ALJ issued his RD, recommending revocation of Respondent's
registration.\3\ Id. at 57.
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\3\ Neither party filed exceptions to the RD.
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Having thoroughly analyzed the record and applicable law, the
Agency summarizes its findings and conclusions: (1) the Diversion
Control Division (hereinafter, Government) presented a prima facie
case, (2) Respondent attempted, but failed, to rebut the Government's
prima facie case, and (3) substantial record evidence, including the
testimony of the Government's expert witness and large portions of the
testimony of Respondent's owner and Pharmacist-in-Charge (hereinafter,
PIC), shows Respondent's violations of applicable law, violations
against a foundation of the Controlled Substances Act (hereinafter,
CSA). Accordingly, the Agency will revoke Respondent's registration.
Infra, Order.
II. Findings <SUP>4</SUP>
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\4\ The Agency incorporates the parties' Stipulations and
accepts them as fact. RD, at 2-3. The first and second stipulations
address Respondent's DEA registration and its status. Id. at 2.
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A. The Government's Case
The Government's principal case presented two witness--a Diversion
Investigator and its expert, Diane Ginsburg, Ph.D., whom the ALJ
accepted, without objection, as an expert in Texas retail pharmacy
practice and Texas pharmacy practice.\5\ Tr. 21-85 (DI testimony), id.
at 85-559 (Dr. Ginsburg testimony). Having thoroughly analyzed the
record and applicable law, the Agency agrees with the RD and finds that
Dr. Ginsburg ``presented credible testimony that was internally
consistent and logically persuasive, . . . [and] an objective analysis
. . . [admitting] times where . . . she may not have identified a red
flag.'' RD, at 18. The Agency agrees with the RD and affords Dr.
Ginsburg's testimony ``significant weight'' in this adjudication. Id.
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\5\ In rebuttal, the Government presented one witness, the
undercover Task Force Officer. Tr. 850-95.
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The Agency finds that Dr. Ginsburg's testimony about the red flags
alleged in the OSC constitutes a portion of the substantial record
evidence that Respondent filled controlled substance prescriptions
exhibiting red flags without documenting the resolution of those red
flags, thereby violating applicable legal requirements.\6\ E.g., Tr.
108-120, 122-56, 169-90, 219-57, 261-72, 277-86, 506, 518, 553, 556;
accord, e.g., RD, at 8-11, 13-18, 34-37, 41-45, 47-48.
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\6\ Dr. Ginsburg testified that a ``red flag is something that
would raise suspicion or cause you concern related to a medication
and certainly there are those that have been identified, as well as
types of things that are considered red flags, federally, as well as
within our State that pharmacists are aware of'' and that the
``obligation is to verify validity and then to document the
resolution of that red flag.'' Tr. 555-56; see also RD, at 41.
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B. The Respondent's Case
Respondent's owner and PIC, whom Respondent characterized as ``an
expert on Texas pharmacy law and practice,'' was the only witness
Respondent presented.\7\ Respondent's Prehearing Statement, at 4; Tr.
561-849.\8\ Having thoroughly analyzed the record and applicable law,
the Agency finds that Respondent's owner and PIC is the witness with
the most at stake in this adjudication. The Agency finds that, while
the testimony of Respondent's owner and PIC does include reliable
statements, it also includes statements that lack credibility, are
implausible, and/or are not persuasive. The Agency finds that the
testimony of Respondent's owner and PIC must be considered with much
caution, and where his testimony conflicts with credible record
evidence or applicable law, the Agency does not credit it. Supra,
section II; infra, sections III, IV.B., and V; see also RD, at 27.
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\7\ At the hearing, however, Respondent did not proffer its
owner and PIC as an expert. Respondent's owner and PIC testified
that he is ``legally responsible'' for ensuring that Respondent, its
operations, its policies, and ``everything'' go ``according to the
rule and the law.'' Tr. 564. He also testified that he filled the
controlled substance prescriptions at issue in this adjudication.
Tr. 848.
\8\ As the parties' closing briefs do not challenge any of the
ALJ's pre-hearing or hearing rulings, and as neither party filed
exceptions, the Agency need not address, and does not address, any
of those rulings in this Decision/Order.
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The Agency finds substantial record evidence that (1) the testimony
of Respondent's owner and PIC includes his unsupported and previously
undocumented statements justifying, in retrospect, the legitimacy of
controlled substance prescriptions that Respondent filled, (2) the
testimony of Respondent's owner and PIC includes his ensuing
conclusions that there is no red flag on those controlled substance
prescriptions, (3) the testimony of Respondent's owner and PIC includes
his admissions that he did not document the existence or resolution of
any red flag on those controlled substance prescriptions since,
according to him, there were no red flags on the controlled substance
prescriptions and, when there is no red flag on a controlled substance
prescription, there is ``nothing to document,'' and (4) Respondent
filled controlled substance prescriptions without documented resolution
of the red flags on them.\9\ E.g., Tr. 654-56, 664-79, 714-32, 738-53,
758-75, 779-85; see also, e.g., Respondent's Closing Brief with
Proposed Findings of Fact and Conclusions of Law (hereinafter, Resp
Posthearing), at 1-2 (``With a few exceptions, . . . [Respondent]
denies such red flags were present for the prescriptions at issue.'');
RD, at 33 n.33, 40-51, 53-54.
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\9\ ``[A] corresponding responsibility rests with the pharmacist
who fills the prescription.'' 21 CFR 1306.04(a).
The testimony of Respondent's owner and PIC about ``red flags''
and ``potential red flags'' is not fully accurate. He testified at
length on multiple occasions about why, in his view, there is no red
flag on a given controlled substance prescription at issue in this
proceeding. E.g., infra, sections II.B., III., and IV.B. His
testimony lacks legal and factual credibility particularly because
Texas law explicitly lists and clearly articulates what red flags
are, making the identification of red flags on controlled substance
prescriptions a process largely devoid of professional analysis or
judgment, and because the applicable standard of practice requires
the resolution of those red flags and the documentation of the red
flags' resolutions before the controlled substance prescription is
filled. Supra, section II.A.; infra, sections III and IV.B.
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III. Texas Pharmacists' Professional Responsibility <SUP>10</SUP>
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\10\ See also 22 TAC Sec. 291.33 (Texas drug utilization review
requirement); RD, at 34-35.
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According to the CSA, ``Except as authorized by this subchapter, it
shall be unlawful for any person knowingly or intentionally . . . to .
. . distribute, . . . dispense, or possess with intent to . . .
distribute[ ] or dispense, a controlled substance.'' 21 U.S.C.
841(a)(1). The CSA's implementing regulations state that 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'' and that, 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 Pharmacy Place, 86 FR 21008,
21012-14, 21034-35 (2021) (requisite scienter under 21 CFR 1306.04(a)).
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
[[Page 59458]]
pharmacists' professional responsibilities.\11\
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\11\ See Gonzales v. Oregon, 546 U.S. 243, 269-71 (2006); see
also OSC, at 2-3.
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During the period alleged in the OSC, Texas law specifically
addressed pharmacists' professional responsibilities concerning red
flags. First, according to Texas law, 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 TAC Sec. 291.29(b); The Pharmacy
Place, 86 FR at 21012. 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'' and lists ``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.'' 22 TAC Sec. 291.29(f);
The Pharmacy Place, 86 FR at 21012; see also Resp Posthearing, at 2-3,
4. A pharmacy's ``dispens[ing]'' a ``reasonably discernible pattern of
substantially identical prescriptions for the same controlled substance
. . . for numerous persons, including a lack of individual drug therapy
in prescriptions issued by the practitioner'' is the first red flag
listed. 22 TAC Sec. 291.29(f)(1). Other red flags explicitly
identified in Texas law that are relevant to this proceeding 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 substances with
cash or cash equivalents more often than through insurance.'' 22 TAC
Sec. 291.29(f)(11) and (12).
Dr. Ginsburg's testimony, including her explanations of the
standard of practice of Texas pharmacies and Texas pharmacists'
professional responsibilities, is consistent with this legal analysis
and states that the applicable standard of practice is for the
resolution of red flags to be documented before the controlled
substance prescription is filled. Supra, section II.A.; e.g., Tr. 228,
506, 518, 553, 556; accord id. at 588 (Respondent's owner and PIC
testifying about the duty to document the resolution of a red flag).
IV. Discussion
A. The Controlled Substances Act
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
section 823 of this title 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(f)(1-5). The five factors are considered in the disjunctive. Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003).
According to Agency decisions, the Agency ``may rely on any one or
a combination of factors and may give each factor the weight [it] deems
appropriate in determining whether'' to revoke a registration. Id.; 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. [Sec. ] 824(a) . . . are satisfied.'' 21 CFR
1301.44(e).
In this matter, while all of the 21 U.S.C. 823(f) Factors have been
considered, the Government's evidence in support of its prima facie
case is confined to Factors Two and Four.\12\ Government's Proposed
Findings of Fact and Conclusions of Law, at 18. The Government
presented a prima facie case based on Factors Two and Four, and
portions of the testimony of Respondent's owner and PIC actually admit,
even if unintentionally, to foundational violations of federal law. 21
CFR 1306.04(a), supra, sections II.A., II.B., and III. Accordingly, the
Agency finds that Respondent's continued registration is inconsistent
with the public interest. 21 U.S.C. 824(a)(4) and 823(f)(2) and (f)(4).
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\12\ Neither Respondent nor the Government argues that it
offered evidence relevant to Factors One, Three, or Five. Although
the Agency considered Factors One, Three, and Five, it finds that
none of them is relevant to this adjudication, as the RD recommends.
RD, at 30, n.32.
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B. Factors Two and/or Four--The Respondent's Experience in Dispensing
Controlled Substances and Compliance With Applicable Laws Related to
Controlled Substances
Allegation That Respondent's Registration Is Inconsistent With the
Public Interest
According to the CSA's implementing regulations, a lawful
prescription for controlled substances 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); see
Gonzales v. Oregon, 546 U.S. 243, 274 (2006); see also Tex. Health &
Safety Code Sec. 481.074.
Respondent engaged a skillful team and defended itself against the
OSC's allegations. As already noted, the record evidence, including
testimony of Respondent's owner and PIC, contains substantial evidence
of violations of applicable law. Those violations go to the heart of
this Agency's law enforcement mission. Supra, sections II.A., II.B.,
and III; infra, sections IV.B. and V.
Having thoroughly analyzed the record and applicable law, the
Agency finds substantial record evidence, including testimony and
admissions of Respondent's owner and PIC, that (1) Respondent filled
controlled substance prescriptions containing red flags, including red
flags explicitly listed in Texas law, such as pattern prescribing, cash
payment, distance, and shared address and (2) Respondent filled these
controlled substance prescriptions without resolving, and documenting
the resolution of, the red flags on them.\13\
[[Page 59459]]
Supra, sections II.A., II.B., and III. Indeed, Respondent's owner and
PIC repeatedly denied that controlled substance prescriptions at issue
in this proceeding even included a red flag. Supra, section II.B.
Substantial record evidence of any one of the founded controlled
substance prescription violations is sufficient for the Agency to
revoke Respondent's registration.
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\13\ E.g., Government Exhibit (hereinafter, GX) 3, at 3
(customer AC, February 29, 2020, pattern prescribing); GX 3, at 6
(customer AC, October 6, 2020, pattern prescribing); GX 4, at 4
(customer AM, September 21, 2020, pattern prescribing); GX 5, at 2
(customer AR, July 8, 2020, pattern prescribing); GX 12, at 2
(customer DG, July 13, 2019, distance); GX 15, at 2 (customer FL,
June 22, 2020, pattern prescribing); GX 16, at 3 (customer FA,
August 3, 2020, pattern prescribing); GX 17, at 2 (customer GG,
August 5, 2020, pattern prescribing); GX 18, at 2 (customer IS,
March 8, 2019, pattern prescribing); GX 18, at 5 (customer IS, March
29, 2019, pattern prescribing); GX 18, at 8 (customer IS, January 6,
2020, pattern prescribing); GX 18 at 11 (customer IS, September 3,
2020, pattern prescribing); GX 19, at 2 (customer IS, October 5,
2020, pattern prescribing); GX 20, at 109 (customer IG, October 12,
2020, pattern prescribing); GX 21, at 3 (customer IG, September 22,
2020, pattern prescribing); GX 22, at 2 (customer JB, February 7,
2019, distance); GX 22, at 4 (customer JB, May 16, 2019, distance);
GX 22, at 6 (customer JB, March 20, 2020, distance); GX 23, at 2
(customer JS, July 8, 2020, pattern prescribing); GX 24, at 3
(customer JR, October 8, 2020, pattern prescribing); GX 25, at 2
(customer JC, January 23, 2020, shared address and pattern
prescribing with customer AL, January 23, 2020) alone and in
conjunction with GX 60, at 1 (shared address); GX 26, at 3 (customer
JL, July 24, 2020, pattern prescribing); GX 31, at 3 (customer LO,
October 7, 2020, pattern prescribing) alone and in conjunction with
GX 50, at 1 (cash); GX 35, at 3 (customer MO, July 8, 2020, pattern
prescribing); GX 37, at 2 (customer MN, August 26, 2020, pattern
prescribing); GX 41, at 5 (customer PG, January 4, 2020, pattern
prescribing) alone and in conjunction with GX 56, at 1 (cash); GX
41, at 8 (customer PG, March 3, 2020, pattern prescribing) alone and
in conjunction with GX 56, at 1 (cash); GX 42, at 5 (customer RT,
February 11, 2020, pattern prescribing); GX 45, at 2 (customer TS,
February 20, 2020, distance); GX 46, at 18 (customer YG, January 15,
2019, pattern prescribing) alone and in conjunction with GX 51, at 1
(cash); and GX 46, at 24 (customer YG, February 29, 2020, pattern
prescribing) alone and in conjunction with GX 51, at 1 (cash).
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Prior Agency decisions consistently find that controlled substance
prescriptions with these red flags are so suspicious as to support a
finding that the pharmacists who filled them violated their
corresponding responsibility due to actual knowledge of, or willful
blindness to, the prescriptions' illegitimacy. 21 CFR 1306.04(a); see
also, e.g., Tex. Health & Safety Code Sec. Sec. 481.074, 481.128; The
Pharmacy Place, 86 FR at 21013 (collecting Agency decisions).\14\
Indeed, the testimony of Respondent's owner and PIC, during which he
spoke at length about why red flags, that are explicitly listed in
Texas law as such, are not red flags, is record evidence that
Respondent was willfully blind to red flags on the prescriptions it
filled. Supra, section II.B. Accordingly, the Agency finds that there
is substantial record evidence of violations of applicable law and,
therefore, that it is appropriate to sanction Respondent for these
violations. Supra, sections II, III, and IV.
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\14\ Agency decisions have consistently found that prescriptions
with the same red flags at issue here were so suspicious as to
support a finding that the pharmacists who filled them violated the
Agency's corresponding responsibility rule due to actual knowledge
of, or willful blindness to, the prescriptions' illegitimacy. 21 CFR
1306.04(a); see, e.g., Morning Star Pharmacy and Medical Supply 1,
85 FR 51045, 51061 (2020) (pattern prescribing; distance; cash
payments; high doses/quantities of high-alert controlled
substances); Pharmacy Doctors Enterprises d/b/a Zion Clinic
Pharmacy, 83 FR 10876, 10898 (2018), pet. for rev. denied, 789 F.
App'x 724 (11th Cir. 2019) (long distances; pattern prescribing;
cash payments); Hills Pharmacy, 81 FR 49816, 49836-39 (2016)
(multiple customers presenting prescriptions written by the same
prescriber for the same drugs in the same quantities; customers with
the same last name and street address presenting similar
prescriptions on the same day; long distances); The Medicine Shoppe,
79 FR 59504, 59507, 59512-13 (2014) (unusually large quantity of a
controlled substance; pattern prescribing).
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Summary of Factors Two and Four
Respondent did not successfully rebut the Government's prima facie
case, established by substantial record evidence, that it violated
applicable law by filling controlled substance prescriptions without
resolving and documenting the resolution of the red flags on them. 21
CFR 1306.04(a), 22 TAC Sec. 291.29. Accordingly, the Agency finds that
Respondent violated applicable law, supporting the revocation of its
registration. 21 U.S.C. 824(a)(4).
V. Sanction
Where, as here, the Government has met its prima facie burden of
showing that Respondent's continued registration is inconsistent with
the public interest due to its numerous violations pertaining to
controlled substances, the burden shifts to the Respondent to show why
it can be entrusted with a registration. Garrett Howard Smith, M.D., 83
FR 18,882 (2018). 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. Id. A registrant's acceptance of
responsibility must be unequivocal. Id. In addition, a registrant's
candor during the investigation and hearing has been an important
factor in determining acceptance of responsibility and the appropriate
sanction. Id. In addition, DEA Administrators have found that the
egregiousness and extent of the misconduct are significant factors in
determining the appropriate sanction. Id. DEA Administrators have also
considered the need to deter similar acts by the respondent and by the
community of registrants. Id.
Regarding these matters, there is no record evidence that
Respondent, or its owner and PIC, takes responsibility, let alone
unequivocal responsibility, for the founded violations.\15\ Instead,
the testimony of Respondent's owner and PIC is replete with unsupported
and undocumented assertions about why controlled substance
prescriptions evidencing what Texas law labels as ``red flag factors''
are not red flags at all, typically then followed by the incantation
that, if there is no red flag, there is nothing to document. Supra,
sections II.B. and IV.B; see also Tr. 793 (testimony of Respondent's
owner and PIC regarding a prescription that, according to the
customer's profile, shows ``a pretty bad drug interaction,'' and his
assertion that ``you don't necessarily have to document that'' while
acknowledging that ``I know we say document, document, but a lot of
things are expected as a plan of care for patients that are very
important that are not documented'') in conjunction with 22 TAC Sec.
291.33(c)(2)(A)(ii); Tr. 805 (testimony of Respondent's owner and PIC
that ``there was really nothing to document because, typically, with
red flags, the things we want to document is if you think the
prescription is fraudulent''); id. at 815 (testimony of Respondent's
owner and PIC that a controlled substance prescription for codeine
cough syrup is medicine for a ``communicable disease, . . . I don't
think any pharmacist would really see that as a red flag'') in
conjunction with 22 TAC Sec. 291.29(f)(3) (listing prescriptions for
cough syrups containing codeine, a treatment for a communicable
disease, Tr. 823, as a ``red flag factor''). The Agency finds that most
of the testimony of Respondent's owner and PIC evidences, at best, a
deep
[[Page 59460]]
and endemic misunderstanding of Texas and federal law.
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\15\ Respondent's owner and PIC ``accept[ed] responsibility''
for putting a customer's ID address as the main address in the
patient profile instead of the customer's local, Texas, address. Tr.
763-64. While this testimony might sound like an acceptance of
responsibility, it is not the requisite acceptance of responsibility
required by past Agency decisions. The Agency interprets this
testimony as a way for Respondent's owner and PIC to minimize the
illegality of Respondent's actions by highlighting that the
particular customer was in the military and, for that reason, had
multiple addresses, and by stating his ``understanding'' that the
customer was ``living locally'' when he presented the controlled
substance prescription instead of resolving and documenting the
resolution of the red flag. Id.
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Testimony of Respondent's owner and PIC about what he is ``doing
differently regarding documentation now,'' given the OSC, may sound
like it describes Respondent's proposed remedial measures, but it does
not.\16\ Tr. 845. The testimony of Respondent's owner and PIC in
response to this question starts with his statement that he has
``changed a few things'' with ``rules to go above and beyond what is
required.'' Id. He testified that, ``in a lot of cases where patients
are coming from far,'' he ``will document more than I like to document
just so that way the situations like this is prevented,'' elaborating
that he told all of his employees that ``what we need is the local
address'' noted as the ``primary address.'' \17\ Tr. 846-47. This
testimony appears to be more indicative of an attempt to avoid law
enforcement attention in the future rather than of an accurate
understanding of Texas and federal legal requirements, to recognize,
resolve, and document the resolution of red flags, and a commitment to
comply with them.
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\16\ In any event, actual remedial measures are insufficient
without an unequivocal acceptance of responsibility. Brenton D.
Wynn, M.D., 87 FR 24,228, 24,261 (2022); see also Michael T. Harris,
M.D., 87 FR 30,276, 30,278 (2022) (collecting Agency decisions).
\17\ Respondent's owner and PIC also testified in response to
this question that he now documents the ``BMIs'' (body mass indexes)
of customers who present phentermine prescriptions to be filled,
elaborating ``just so we know on our own that the doctor's doing the
right thing and also that the patients really need the medication.''
Tr. 845. He testified that he now will also ask the doctor for the
patient's BMI and document it. Id. at 845-46. Even if this BMI-
related testimony constitutes remedial measures, which it does not,
remedial measures are insufficient without an unequivocal acceptance
of responsibility.
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In sum, the record supports the imposition of a sanction because
Respondent, through its owner and PIC, did not unequivocally accept
responsibility and because Respondent, through its owner and PIC, has
not convinced the Agency that it can be entrusted with a registration.
The interests of specific and general deterrence weigh in favor of
revocation. The testimony of Respondent's owner and PIC repeatedly
denied the existence of any legal violations, let alone accepted
unequivocal responsibility for them. See, e.g., supra, sections II.B.,
IV.B., and V. Respondent, through its owner and PIC, has not convinced
the Agency that it understands that its controlled substance
prescription filling fell short of the applicable legal standards and
that this substandard controlled substance prescription filling has
serious negative ramifications for the health, safety, and medical care
of individuals who come to it with controlled substance prescriptions.
See, e.g., Garrett Howard Smith, M.D., 83 FR 18,882, 18,910 (2018)
(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
controlled substance prescription filling and recordkeeping will comply
with legal requirements. 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 a condition precedent 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(f), I hereby revoke DEA Certificate
of Registration No. FL2190332 issued to Lewisville Medical 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(f), I hereby deny any pending
application of Lewisville Medical Pharmacy to renew or modify this
registration, as well as any other pending application of Lewisville
Medical Pharmacy for registration in Texas. This Order is effective
October 31, 2022.
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 26, 2022, by Administrator Anne Milgram. That document with
the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-21276 Filed 9-29-22; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on September 30, 2022.
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.