[Federal Register Volume 87, Number 189 (Friday, September 30, 2022)]
[Notices]
[Pages 59456-59460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21276]


-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \3\ Neither party filed exceptions to the RD.
---------------------------------------------------------------------------

    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 4
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \5\ In rebuttal, the Government presented one witness, the 
undercover Task Force Officer. Tr. 850-95.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

III. Texas Pharmacists' Professional Responsibility 10
---------------------------------------------------------------------------

    \10\ See also 22 TAC Sec.  291.33 (Texas drug utilization review 
requirement); RD, at 34-35.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \11\ See Gonzales v. Oregon, 546 U.S. 243, 269-71 (2006); see 
also OSC, at 2-3.
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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