[Federal Register Volume 86, Number 75 (Wednesday, April 21, 2021)]
[Notices]
[Pages 21008-21048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08018]



[[Page 21007]]

Vol. 86

Wednesday,

No. 75

April 21, 2021

Part III





Department of Justice





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Drug Enforcement Administration





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The Pharmacy Place Order; Notice

  Federal Register / Vol. 86, No. 75 / Wednesday, April 21, 2021 / 
Notices  

[[Page 21008]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 17-26]


The Pharmacy Place Order

    On April 3, 2017, a former Assistant Administrator of the Drug 
Enforcement Administration (hereinafter, DEA or Government), issued an 
Order to Show Cause (hereinafter, OSC) to The Pharmacy Place 
(hereinafter, Respondent) of Plano, Texas. Administrative Law Judge 
Exhibit 1 (OSC), at 1. The OSC proposed to revoke Respondent's DEA 
Certificate of Registration No. FT4134805 and deny any pending 
applications for a modified or new DEA registration pursuant to 21 
U.S.C. 823(f) because Respondent's ``continued registration is 
inconsistent with the public interest.'' Id.
    In response to the OSC, Respondent timely requested a hearing 
before an Administrative Law Judge. ALJ-5. The first two sessions of 
the hearing in the matter were held in Dallas, Texas from September 12-
13, 2017. The Respondent's expert, however, failed to appear on either 
of those days. To accommodate the Respondent, the hearing was 
continued. On November 20, 2017, the hearing reconvened. The November 
20, 2017 session of the hearing was conducted by video teleconference 
from the DEA Hearing Facility in Arlington, Virginia, with the parties 
and witnesses located at the DEA District Office in San Antonio, Texas.
    On February 13, 2018, Administrative Law Judge Charles Wm. Dorman 
(hereinafter, ALJ) issued the incorporated Recommended Rulings, 
Findings of Fact, Conclusions of Law, and Decision (hereinafter, 
Recommended Decision or RD). Respondent filed Exceptions to the 
Recommended Decision on March 5, 2018, and, with the permission of the 
ALJ, a Show to the Contrary on March 14, 2018 (hereinafter, 
collectively Respondent's Exceptions or Exceptions). The Government 
filed a Response to Respondent's Exceptions and Show to the Contrary on 
March 28, 2018 (hereinafter, Govt Response). The record was then 
forwarded to me for final agency action.

Suggestion of Mootness

    On October 18, 2018, the Government filed a Notice of Suggestion of 
Mootness (hereinafter, Suggestion of Mootness). The Government provided 
evidence that Respondent had closed and that Respondent's owner had 
transferred the inventory of controlled substances to a reverse 
distributor. Suggestion of Mootness, at 2, Exs. 1-3.\A\ DEA regulations 
promulgated pursuant to the authority delegated by the Controlled 
Substances Act (CSA) provide that ``the registration of any person . . 
. shall terminate, without any further action by the Administration, if 
and when such person . . . discontinues business or professional 
practice . . . .'' 21 CFR 1301.52. As Respondent discontinued business 
and transferred its controlled substances, pursuant to the regulation, 
its registration is terminated, and Respondent is no longer authorized 
to dispense controlled substances under federal law. Id. The Government 
argued that because Respondent no longer possesses a DEA registration, 
the case is now moot. Suggestion of Mootness, at 3 (citing Louisiana 
All Snax, Inc., 76 FR 20034 (2011); John G. Costino, D.O., 76 FR 4940 
(2011)).
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    \A\ The Government also provided electronic correspondence 
between a DEA attorney and Respondent's attorney informing 
Respondent that DEA would treat the discontinuation of business as 
``a surrender for cause and the registration history [would] be 
documented as such.'' Suggestion of Mootness, Ex. 4 (citing 21 CFR 
1301.76).
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    Since the Government filed its Suggestion of Mootness, however, the 
Agency has published two decisions that are directly applicable to the 
instant matter. The first, Jeffrey D. Olsen, M.D., in which my 
predecessor ordered the revocation of an expired registration, stated 
that ``mootness does not play the same role in administrative agency 
adjudications as it plays in Article III court proceedings'' and `` 
`[t]he agency, with like effect as in the case of other orders, and in 
its sound discretion, may issue a declaratory order to terminate a 
controversy or remove uncertainty.' '' 84 FR 68474, 68478 (2019) 
(quoting Tennessee Gas Pipeline v. Federal Power Comm'n, 606 F.2d 1373, 
1380 (D.C. Cir. 1979); 5 U.S.C. 554(e)); see also Climax Molybdenum Co. 
v. Sec'y of Labor, Mine Safety and Health Admin., 703 F.2d 447, 451 
(10th Cir. 1983) (``At the outset, we note that an administrative 
agency is not bound by the constitutional requirement of a `case or 
controversy' that limits the authority of [A]rticle III courts to rule 
on moot issues.''). Olsen concluded, therefore, that the Agency was 
free to, and would, adjudicate orders to show cause to finality in 
matters with expired registrations. Id. at 68479.
    The second, Steven M. Kotsonis, M.D., applied Olsen to matters 
where a registration is terminated pursuant to 21 CFR 1301.52 for a 
surrender for cause after an ALJ had issued a recommended decision and 
transmitted the matter to the Administrator for final decision. 85 FR 
85667, 85668 (2020). Kotsonis concluded that the termination of a DEA 
registration under 21 CFR 1301.52 does not preclude DEA from issuing a 
final decision on an order to show cause against that registration and 
stated that the Agency would assess such matters on a case-by-case 
basis to determine if a final adjudication is warranted or if the 
matter should be dismissed. Id. at 85668-69.
    In this matter, as in Kotsonis, Respondent's registration 
terminated under 21 CFR 1301.52 after the ALJ had issued a recommended 
decision on the order to show cause and had transmitted the record to 
me for final decision. Accordingly, I am declining the Government's 
Suggestion of Mootness as the matter is not mooted by the termination. 
Instead, I have evaluated the particular circumstances of this matter 
and determined that the matter should be adjudicated to finality. As my 
predecessor identified in Olsen,

[f]inal adjudications are particularly helpful in supporting the 
purposes of the CSA and my responsibilities to enforce the CSA 
because nothing in the CSA prohibits an individual or an entity from 
applying for a registration even when there is a history of being 
denied a registration, or a history of having a registration 
suspended or revoked. As such, having a final, official record of 
allegations, evidence, and the Administrator's decisions regarding 
those allegations and evidence, assists and supports future 
interactions between the Agency and the registrant or applicant.

84 FR at 68479. Absent a final adjudication, there would be no final 
record of the allegations and evidence from this matter.\B\ 
Adjudicating this matter to finality will create an official record the 
Agency can use in any future interactions with Respondent's owners, 
employees, or other persons who were associated with Respondent. As 
additionally noted in Olsen, ``a final adjudication is a public record 
of the Agency's expectations for current and prospective members of 
that community,'' and adjudications inform stakeholders, such as 
legislators and the public, about the Agency's work and allow them to 
provide feedback to the Agency, thereby helping shape how the Agency 
carries out its responsibilities under the CSA. Id. Adjudicating this 
matter to finality will create a public record to educate current and 
prospective registrants about the Agency's expectations regarding the 
responsibilities of registrant pharmacies under the CSA and allow 
stakeholders

[[Page 21009]]

to provide feedback regarding the Agency's enforcement priorities and 
practices.
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    \B\ Contrast with Kotsonis in which the plea agreement and 
judgment from the respondent's concurrent criminal case provided a 
final record on which the Agency could rely in any future 
interactions with the respondent. 85 FR at 85667.
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    Having determined that this matter should be adjudicated to 
finality and considered the record in its entirety, including the 
Respondent's Exceptions and the Govt Response, I have decided to adopt 
the ALJ's recommended rulings, findings of fact, conclusions of law, 
and proposed sanction from the Recommended Decision, with minor 
modifications, where noted herein.\C\ A discussion of Respondent's 
Exceptions follows.
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    \C\ I have made minor modifications to the Recommended Decision. 
I have substituted initials or titles for the names of witnesses and 
practitioners to protect their privacy, and I have made minor, 
nonsubstantive grammatical changes. Where I have made substantive 
changes to align the RD with my findings on Respondent's Exceptions 
or otherwise added to or modified the ALJ's decision, I have placed 
the edited text in brackets and included a specific description of 
the modification in a footnote marked with an asterisk.
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Respondent's Exceptions

    Respondent filed 49 exceptions--19 exceptions to the RD's Findings 
of Fact and 30 exceptions to the RD's Analysis and Conclusions of Law, 
the final two of which were expounded upon in greater detail in 
Respondent's Show to the Contrary.

Respondent's Exceptions to the Findings of Fact

    I find that the majority of Respondent's exceptions to the Findings 
of Fact do not actually dispute the RD's findings of fact but rather 
provide explanations, arguments, or interpretations. Consequently, I 
reject Respondent's Exceptions 1-2, 7, 9, 11-14, and 16-18. I also 
reject Respondent's Exceptions 3, 6, 8, and 19. I have reviewed the 
findings of fact to which Respondent objected in those exceptions and 
have determined that the findings are supported by the administrative 
record.
    I am partially sustaining Respondent's Exceptions 10 and 15. In 
Exception 10, Respondent objected to the ALJ's finding that ``Ms. Igwe 
is familiar with the Texas regulation that requires a pharmacist to 
document notes regarding the resolution of red flags.'' RD, at 29 
(citing Tr. 585). Respondent stated in its exceptions that

    Ms. Igwe is familiar with the Texas regulations that require a 
pharmacist to document notes, but not every red flag, or its 
resolution must be documented under Texas law. See 22 TAC Sec.  
291.33(c)(2)(A)(ii) and (iv). (ii) requires documentation when a 
clinically significant condition exists that is resolved by the 
pharmacist, and (iv) requires documentation when the pharmacist has 
a question about the drug regimen review per (A) of that 
regulation.''

Respondent's Exceptions, at 4. While I find that Respondent's 
explanation for Exception 10 provides an argument on what it believes 
to be the correct interpretation of the Texas regulation rather than 
disputing the factual finding, I am partially sustaining the exception 
because I find that the RD's characterization of Ms. Igwe's testimony 
was incomplete. When asked by the ALJ if she was familiar with ``a 
Texas regulation that requires that if you check with a doctor about a 
particular prescription, that you're supposed to document that,'' Ms. 
Igwe answered ``Yes.'' Tr. 585. However, Ms. Igwe qualified her answer 
stating ``[b]ut . . . it depends on what I check with the doctor about 
. . . so it would depend--if I'm calling the doctor and saying anything 
that isn't clinical in nature, I may not necessarily document it.'' Id. 
The RD, therefore, correctly found that Ms. Igwe was familiar with the 
regulation the ALJ was referencing in his question; however, I will add 
the clarification to the finding that Ms. Igwe did not expressly 
testify that the regulation requires a pharmacist to document notes 
regarding the resolution of red flags.
    Respondent's Exception 15 took exception to the RD's finding of 
fact that

[t]he prescription that [L.R.] wrote for [M.W.] raises the following 
red flags: No patient address; no provider DEA number; large 
quantity of high-alert controlled substance; the prescription was 
written on July 29, 2014, but not faxed to the Pharmacy until August 
1, 2014 and not picked up until August 4, 2014; and an unusual path 
and distance to obtain the prescription and get it filled.

RD, at 33-34 (citing Tr. 188-85). Respondent argues that ``[p]ursuant 
to Dr. Witte, the prescription for hydrocodone that `[M.W.]' received 
was a typical or therapeutic dosage.'' Respondent Exceptions, at 5 
(citing Tr. 176, 283, 366, 679). I have reviewed Dr. Witte's testimony 
regarding the red flags on the ``M.W.'' prescription and find that 
while Dr. Witte did testify that the prescription was for a ``large 
quantity,'' when asked if the quantity was a red flag, she stated that 
``[i]t could be.'' Tr. 189 (emphasis added). I, therefore, will 
partially sustain Respondent's Exception 15 as Dr. Witte did not 
unequivocally testify that the quantity of the controlled substance in 
the M.W. prescription was a red flag, only that such a quantity could 
be a red flag on a prescription.
    I have amended Findings of Fact 94 and 135 of the Recommended 
Decision to reflect my determinations on Respondent's Exceptions to the 
Recommended Decision's findings of fact.

Respondent's Exceptions to the ALJ's Analysis and Conclusions of Law

    Respondent filed 30 exceptions to the Recommended Decision's 
Analysis and Conclusions of Law and a Show to the Contrary that 
provided further explanation and documentation for its final two 
exceptions. I have reviewed the exceptions and find they can be grouped 
into five general exceptions:
    (1) Respondent objects to the Government's allegation that there 
was no evidence of Respondent filling prescriptions prior to July 7, 
2014; \D\
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    \D\ Exceptions, at 13, no. 38.
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    (2) Respondent objects to the ALJ's official notice of 22 Tex. 
Admin. Code Sec.  291.33(c)(7)(A); \E\
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    \E\ Exceptions, at 17, nos. 48-49; Respondent's Show to the 
Contrary.
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    (3) Respondent argues the Recommended Decision did not properly 
weigh the five factors from 21 U.S.C. 823(f); \F\
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    \F\ Exceptions, at 10; nos. 31-32.
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    (4) Respondent objects to the ALJ's determination that it violated 
various federal and state regulations when it dispensed controlled 
substance prescriptions that raised red flags without properly 
resolving the red flags and documenting the resolution; \G\ and
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    \G\ Exceptions, at 6-13, 16-17; nos. 20-30, 33-37, 39, 45-47.
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    (5) Respondent argues the recommended sanction is not supported by 
the record.\H\
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    \H\ Exceptions, at 14-16, nos. 40-44.
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1. Prescriptions Filled Prior to July 7, 2014
    Respondent filed an exception against ``[t]he Government's 
alleg[ation] that there was no evidence of prescriptions being filled 
prior to July 7, 2014 due to the lack of earlier information in the 
patient profiles.'' Exceptions, at 13 (citing Gov. Ex. 6). Respondent's 
exception, however, does not object to any of the ALJ's findings or 
conclusions from the Recommended Decision. As Respondent stated itself 
in the exception, the ALJ ``found evidence of prior filled 
prescriptions.'' Id. (citing RD, at 51 n.34 (``The Respondent did 
produce evidence of dispensing prior to July 7, 2014 . . . Those 
records, however, were not produced until long after the Pharmacy was 
required to produce them.'')). See also RD, at 24 (citing Tr. 60, 76) 
(``The dispensing records showed that the first dispensing took place 
on July 7, 2014, but the PMP showed that the Pharmacy filled 
prescriptions for hydrocodone between January and June 2014.''). 
Pursuant to

[[Page 21010]]

21 CFR 1316.66, an exception must be to ``the recommended decision, 
findings of fact and conclusions of law contained in the report'' from 
the ALJ to the Administrator. Respondent's ``exception'' is, therefore, 
invalid.
2. Official Notice of 22 Tex. Admin. Code Sec.  291.33(c)(7)(A)
    In the RD, the ALJ took official notice of 22 Tex. Admin. Code 
Sec.  291.33(c)(7)(A), which sets forth several requirements for labels 
on prescription bottles. RD, at 59 n.41. Respondent objected to the 
ALJ's notice of 22 Tex. Admin. Code Sec.  291.33(c)(7)(A), or in the 
alternative, requested an opportunity to show to the contrary pursuant 
to 21 CFR 1316.59(e). The ALJ issued an Order Granting Respondent 
Request for Opportunity to Show to the Contrary on March 6, 2018. In 
his Order, the ALJ cited two instances in the record where taking 
notice of this regulation was helpful. First, the ALJ ``looked to the 
regulation for additional support for Dr. Witte's testimony that the 
dispensing pharmacist's initials must be associated with each 
prescription and that [PIC] Igwe was the pharmacist who filled all the 
prescriptions in the Administrative Record.'' See RD, at 39; Tr. 389-
90. Second, the ALJ stated that he relied on the regulation in 
determining when a prescription was filled by Respondent, as the 
regulation requires the label to include the date the drug was 
dispensed.
    I can find no reason why Respondent objected to the ALJ's official 
notice of 22 Tex. Admin. Code Sec.  291.33(c)(7)(A) or why Respondent 
filed the Show to the Contrary with documentation of labels from the 
prescriptions at issue in this matter--all of which display the 
initials of Respondent's Pharmacist in Charge Ijeoma Igwe (hereinafter, 
PIC Igwe) and a date. Respondent asserts in the Show to the Contrary 
that the labels demonstrate that Respondent fully complied with section 
291.33(c)(7)(A), but there was never any allegation that Respondent did 
not. In the RD, the ALJ assumed that Respondent had fully complied with 
the regulation when labeling prescription bottles.
    To the extent, if any, Respondent is objecting to the ALJ's 
official notice of 22 Tex. Admin. Code Sec.  291.33(c)(7)(A), 
Respondent's objection is denied as the RD properly characterized the 
content of the regulation and Respondent acknowledges the regulation 
applied to Respondent's pharmacy practice.
3. Weighing the Factors From 21 U.S.C. 823(f)
    Respondent filed exceptions arguing that the ALJ did not properly 
weigh all five factors from 21 U.S.C. 823(f). Specifically, Respondent 
argues the ALJ did not properly consider that (1) ``there is no 
evidence that the State licensing board has taken a disciplinary action 
against [Respondent]'' or (2) Respondent's experience dispensing or 
conducting research with respect to controlled substances. Exceptions, 
at 10.
    The DEA considers the five public interest factors from 21 U.S.C. 
823(f) separately. Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). 
Each factor is weighed on a case-by-case basis. Morall v. Drug Enf't 
Admin., 412 F.3d 165, 173-74 (D.C. Cir. 2005). Any one factor, or 
combination of factors, may be decisive. David H. Gillis, M.D., 58 FR 
37507, 37508 (1993). Thus, there is no need to enter findings on each 
of the factors. Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 (6th Cir. 
2005). Furthermore, there is no requirement to consider a factor in any 
given level of detail. Trawick v. Drug Enf't Admin., 861 F.2d 72, 76-77 
(4th Cir. 1988). The balancing of the public interest factors ``is not 
a contest in which score is kept; 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 . . . .'' Jayam 
Krishna-Iyer, M.D., 74 FR 459, 462 (2009). When deciding whether 
registration is in the public interest, the DEA must consider the 
totality of the circumstances. See generally Joseph Gaudio, M.D., 74 FR 
10083, 10094-95 (2009) (basing sanction on all evidence on record).
    Having reviewed the Recommended Decision, I find that the ALJ did 
properly weigh the public interest factors. First, as stated above, the 
ALJ was not required to enter findings on each of the factors or to 
consider a factor in any given level of detail. Second, contrary to 
Respondent's assertion, the ALJ did enter findings regarding the 
recommendation of the State licensing board and concluded that Factor 
One (21 U.S.C. 823(f)(1)) does not weigh for or against revocation in 
this matter. The RD found that ``it is undisputed that the Respondent 
holds a valid state pharmacy license in Texas'' and ``[t]he record 
contains no evidence of a recommendation regarding the Respondent's 
privilege to operate as a pharmacy by a relevant state licensing board 
or professional disciplinary authority.'' RD, at 54. As accurately 
stated in the RD, ``Agency precedent establishes that where the record 
contains no evidence of a recommendation by a state licensing board, 
that absence does not weigh for or against revocation.'' Id. (citing 
Roni Dreszer, M.D., 76 FR 19434, 19444 (2011)). Accordingly, I agree 
with the ALJ's findings and conclusions regarding Factor One.
    Finally, I find that Respondent's assertion that the ALJ failed to 
adequately consider evidence of Respondent's ``experience with her 
other patients'' is without merit. Exceptions, at 10 (citing Jayam 
Krishna-Iyer, 249 F. App'x 159 (11th Cir. 2007). Respondent argued that 
Respondent ``dispensed over 900 hydrocodone/APAP prescriptions 
prescribed from the 5 or 6 clinics under investigation, and only 75 
prescriptions were submitted for adjudication for approximately 27 
patients.'' Id. Under Factor 2, 21 U.S.C. 823(f)(2), the Agency must 
consider a registrant's experience dispensing controlled substances. As 
previously stated, however, 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 v. Drug Enf't Admin., 664 F.3d 808, 821 (10th 
Cir. 2011).
    In this matter, even presuming that the hundreds of other 
prescriptions Respondent has referenced were legally dispensed, those 
prescriptions do not render Respondent's unlawful dispensing of the 
subject prescriptions any less unlawful or ``any less `acts which are 
inconsistent with the public interest.' '' Jayam Krishna-Iyer, 74 FR at 
462-463 (quoting 21 U.S.C. 823(f)). Moreover, the unlawful dispensings 
were not an isolated incident--the Government has proven by substantial 
evidence that Respondent dispensed 75 prescriptions that raised 
multiple red flags to over two dozen patients in less than a year. RD, 
at 88. The Agency has consistently taken the position that a 
registrant's positive dispensing experience under Factor 2 can be 
outweighed by acts held to be inconsistent with the public interest. 
See, e.g., Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195, 
77 FR 62316, 62340 (2012); Paul J. Cargine, Jr., 63 FR 51592, 51560 
(1998) (``[E]ven though the patients at issue are only a

[[Page 21011]]

small portion of Respondent's patient population, his prescribing of 
controlled substances to these individuals raises serious concerns 
regarding [his] ability to responsibly handle controlled substances in 
the future.''). I find that Respondent's repeated, serious violations 
of federal and state laws related to controlled substances support the 
ALJ's finding that the Government has made a prima facie case showing 
that the Respondent's registration is inconsistent with the public 
interest.
4. Unlawful Dispensing Allegations
    Respondent has filed exceptions against the ALJ's determination 
that Respondent dispensed 75 controlled substance prescriptions that 
raised red flags without resolving those red flags and documenting the 
resolution in contravention of Respondent's corresponding 
responsibility under 21 CFR 1306.04; outside the usual course of 
professional practice in violation of 21 CFR 1306.06; and in violation 
of 22 Tex. Admin. Code Sec.  291.33(c)(2).\I\ Respondent has stated in 
its Exceptions that, contrary to the ALJ's findings, the subject 
prescriptions did not display the red flags of pattern prescribing, 
distance, and cash payments, and, to the extent that there were red 
flags on the subject prescriptions, Respondent cleared the red flags 
before filling the prescriptions.
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    \I\ The Recommended Decision also found that Respondent violated 
other state laws when dispensing the subject prescriptions, but 
Respondent has not filed exceptions against those findings.
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Red Flags on the Subject Prescriptions
Pattern Prescribing
    As fully explained in the Recommended Decision, pattern prescribing 
occurs when a provider or group of providers repeatedly prescribe 
patients the same drug and the same quantity without any difference in 
treatment. RD, at 25, 60-62 (citing Tr. 171, 228-29, 232-33, 244, 250, 
264-65, 279, 289, 353, 745). The expert witnesses in this matter 
testified that pattern prescribing raises a red flag because the lack 
of individualized therapy can indicate the prescriber is not 
prescribing the controlled substances for a legitimate medical purpose. 
Tr. 171, 244, 745. See Jones Total Health Care Pharmacy, L.L.C., 81 FR 
79188, 79195 (2016) (citing E. Main St. Pharmacy, 75 FR 66149, 66163 
(2010)); 21 CFR 1306.04 (``A prescription for a controlled substance to 
be effective must be issued for a legitimate medical purpose . . .''). 
Unlike some red flags, such as distance and cash payments, pattern 
prescribing can manifest over an extended period of time and may not be 
immediately recognizable to a pharmacist. Tr. 210, 239-40, 333, 358-59. 
Both experts agreed that a pharmacist can resolve a red flag of pattern 
prescribing raised by a prescription by speaking with the prescriber 
and receiving information that satisfies the pharmacist that a 
prescription was issued for a legitimate medical purpose. Tr. 240, 332-
334, 660. The Government's expert, Dr. Witte, stated that if the 
pharmacist is not satisfied by the prescriber's responses to their 
questions, the pharmacist should refuse to fill the prescriptions. Tr. 
171, 333-34.
    In its Exceptions, Respondent objects to the ALJ's finding that 
many of the subject prescriptions exhibited the red flag of pattern 
prescribing and that Respondent filled the prescriptions without 
resolving the red flag. Exceptions, at 10-12. Respondent claims that it 
resolved the red flag of pattern prescribing in the subject 
prescriptions by calling the prescriber whenever a patient presented a 
controlled substance prescription for the first time. Id.
    Respondent claims in the Exceptions that ``[e]ach new time a new 
patients [sic] comes to [Respondent], or an existing patient received a 
change in medication, the pharmacist places a call to the practitioner 
to ensure the doctor/patient relationship, to verify the dosing and 
prescriptions, and to inquire as to the condition or illness being 
treated.'' Exceptions, at 11 (citing Tr. 477-78). Respondent's claim, 
however, is unsupported by the record evidence and misrepresents PIC 
Igwe's testimony. In the portion of PIC Igwe's testimony cited by 
Respondent, PIC Igwe said ``if I have a patient who is a controlled 
drug [sic] and they haven't been before, I would call the clinic and 
make sure that the clinic did write the prescription, and the number 
that I would use would not be--would be like a number in the--you know, 
on my--it wouldn't be what's on the prescription, in case it was no--it 
was forged, for example.'' Tr. 477-78. In other words, PIC Igwe 
testified that she called the prescriber's office to ensure the 
prescription was not forged, but she did not testify that she 
``verif[ied] the dosing'' or ``inquire[d] as to the condition or 
illness being treated'' as Respondent claims in its Exceptions.\J\ 
Checking that a prescription was, in fact, issued by a clinic would 
show that the prescription is not an outright fraud, but it would not 
ensure that the prescription was issued for a legitimate medical 
purpose. 21 CFR 1306.04(a); Pharmacy Doctors Enterprises d/b/a/Zion 
Clinic Pharmacy, 83 FR 10,876, 10,897 (2018), pet. for rev. denied, 789 
F. App'x 724 (11th Cir. 2019).
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    \J\ Compare PIC Igwe's testimony at Tr. 477-78 with Respondent's 
Exceptions at 11.
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    There is also no documentary evidence in the record that PIC Igwe 
``verif[ied] the dosing,'' ``inquire[d] as to the condition or illness 
being treated,'' or otherwise resolved the red flag of pattern 
prescribing on the subject prescriptions as Dr. Witte testified was 
required for a pharmacist following the accepted standard of practice 
of pharmacy in Texas. See, e.g., Tr. 210-211. There are no notes in any 
of Respondent's patient profiles documenting conversations with 
prescribers. Tr. 210, 244; see GX 2. And while PIC Igwe testified that 
she would sometimes mark a prescription with a ``V'' to indicate she 
had verified a prescription, Tr. 477, 482, only one of the subject 
prescriptions is marked with a ``V'' and that prescription was the 
sixth time Respondent had filled that prescription for the patient, GX 
2, at 44-46, 53-55. The credibility of Respondent's claim that PIC Igwe 
always checked with the prescriber the first time she filled a 
controlled substance prescription for a patient was also brought into 
question by her testimony that she had never had a conversation with 
Dr. C.V. regarding a patient and the only time she had spoken to him 
was when Dr. C.V. called her to ask for the pharmacy's fax number. Tr. 
561-62. Yet, Dr. C.V. prescribed 14 of the subject prescriptions for 
hydrocodone, GX 2; and Respondent's dispensing logs show that 
Respondent filled hundreds of additional hydrocodone prescriptions from 
Dr. C.V., including 8 hydrocodone prescriptions in a single day.\K\ GX 
6; RX G at 44-45; Tr. 424-25. Given the lack of documentary evidence 
and the contrary testimony from PIC Igwe, I agree with the ALJ and find 
that Respondent did not clear the red flags of pattern prescribing 
before dispensing the subject prescriptions. Accordingly, I

[[Page 21012]]

reject Respondent's exceptions to the ALJ's findings on pattern 
prescribing.\L\
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    \K\ The OSC did not allege that Respondent unlawfully dispensed 
any prescriptions prior to August 2014. Accordingly, while 
Respondent's dispensing history prior to August 2014 is relevant to 
rebutting Respondent's claim that the subject prescriptions did not 
display the red flag of pattern prescribing or that PIC Igwe had 
resolved the red flags prior to dispensing the subject 
prescriptions, any deficiencies in Respondent's prescription 
dispensing practices outside of the subject prescriptions do not 
weigh for or against Respondent retaining its registration.
    \L\ Respondent also argues that the ALJ's finding that many of 
the subject prescriptions presented the red flag of pattern 
prescribing was inappropriate because the prescribers engaged in 
``masking.'' Exceptions, at 12. Respondent's argument is contrary to 
the expert testimony presented at the hearing. Both the Government's 
expert, Dr. Witte, and Respondent's own expert, Mr. Litman, 
testified that the subject prescriptions raised the red flag of 
pattern prescribing. E.g., Tr. 745 (``Judge Dorman: `Do you consider 
pattern prescribing to be a red flag?' [Mr. Litman]: `Yes.' Judge 
Dorman: `Okay. Did you see anything in the documentation that you 
were provided that would suggest pattern prescribing?' [Mr. Litman]: 
`Yes.' '')
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Distance
    The ALJ found that the distances the patients travelled to obtain 
the subject prescriptions were a red flag that Respondent failed to 
clear before dispensing the prescriptions. RD at 63-65, 72-73, 76, and 
79. Dr. Witte credibly testified that the distance or route a patient 
travels to fill a prescription can be a red flag, Tr. 172-76; and 
Agency decisions have long found that the distance a patient is willing 
to travel to obtain a prescription is a factor a pharmacist must 
consider pursuant to their corresponding responsibility; e.g., Morning 
Star Pharmacy & Medical Supply 1, 85 FR 51045, 51052 (2020); Hills 
Pharmacy, L.L.C., 81 FR 49,815, 49841 n. 45 (2016); East Main Street 
Pharmacy, 75 FR 66149, 66165 (2010). Texas regulations also require 
pharmacists to ``exercise sound professional judgment with respect to'' 
the legitimacy of a prescription, 22 Tex. Admin. Code Sec.  291.29(a), 
and provide a non-exhaustive list of circumstances a pharmacist should 
weigh when evaluating a prescription's legitimacy, including ``the 
geographical distance between the practitioner and the patient or 
between the pharmacy and the patient.'' 22 Tex. Admin. Code Sec.  
291.29(c)(4).
    Respondent filed exceptions against the ALJ's determination that 
the distances traveled by the subject patients were a red flag. 
Exceptions, at 16-17. Respondent argues that ``various pharmacists have 
various thresholds for distances traveled,'' and that its expert, Mr. 
Litman, testified that he would only be concerned about distance if a 
patient were coming from out-of-state. Id.; Tr. 695-96, 730. Mr. 
Litman, however, was not aware of DEA cases that deal with pharmacy 
customers who had travelled long distances to obtain their 
prescriptions and have them filled. Tr. 727. He was also not admitted 
as an expert on Texas pharmacy practice or law (Mr. Litman was a 
practicing pharmacist in Florida), Tr. 624, 655-56; and while Mr. 
Litman stated that he had reviewed the Texas regulations for 
pharmacists, Tr. 657, he seemed to be unaware of the Texas regulation 
that requires pharmacists to consider the distance a customer traveled 
to fill a prescription, see Tr. 727, 739. For these reasons, I agree 
with, and will follow, the ALJ's decision to give no weight to Mr. 
Litman's testimony that the distance the patients travelled to obtain 
the subject prescriptions was not a red flag. See RD, at 65.
    In contrast to Mr. Litman, the Government's expert, Dr. Witte, 
testified that it would be outside the usual course of professional 
practice in the state of Texas for a pharmacist to dispense a 
prescription for a controlled substance without considering the 
distance the patient traveled to obtain and fill the prescription. Tr. 
171-76. The Government provided evidence that the roundtrip distance 
between the subject patients' homes, providers, and Respondent ranged 
between 55-121 miles through urban areas. Stipulations 9-45. Dr. Witte 
testified that the distances traveled by the patients were a red flag, 
noting concern about patients driving across the city of Dallas to 
Respondent in Plano to fill the prescriptions because ``more than 
likely, there are many pharmacies located between . . . where the 
patient lives and where the clinic is.'' Tr. 174-75, 189-94, 281, 321. 
I credit Dr. Witte's testimony that the distances traveled by 
Respondent's patients to obtain the subject prescriptions were a red 
flag and, accordingly, reject Respondent's exceptions.\M\
---------------------------------------------------------------------------

    \M\ As the ALJ noted in the Recommended Decision, Dr. Witte was 
accepted as an expert in the field of pharmacy in the state of 
Texas, not geography. Tr. 169; RD, at 64. Thus, I do not credit her 
testimony concerning distances and the availability of pharmacies as 
that of an expert; I do, however, credit it as a reasonable 
observation based upon common experience. As the ALJ found, common 
experience suggests that one is more likely to pass a pharmacy in an 
urban area than a rural one and that, in general, it is more time 
consuming to travel a specific distance in an urban area than a 
rural one. RD, at 64.
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Cash Payments
    The ALJ found that paying cash for a prescription can be a red flag 
and determined that cash payments, combined with other red flags, can 
be enough to find a pharmacist violated 21 CFR 1306.04. RD, at 66. This 
determination is consistent with the testimony of both the Government 
and Respondent's expert witnesses, see, e.g., Tr. 172-73; and with 
other Agency decisions, which have found that paying cash for 
controlled substances, rather than billing insurance, can be a red flag 
that the patient is seeking the substances for illicit purposes; see, 
e.g., Morning Star Pharmacy and Medical Supply 1, 85 FR 51045, 51052 
(2020), Jones Total Health Care Pharmacy, L.L.C., and SND Health Care, 
L.L.C., 81 FR 79,188, 79191 (2016); E. Main St. Pharmacy, 75 FR 66149, 
66158 (2010).
    Respondent concedes that cash payments can be a red flag. 
Exceptions, at 13. Respondent, however, argues that the cash payments 
made on the subject prescriptions were not red flags because ``many of 
[Respondent's] patrons paid in cash'' and because many of the cash 
payments for the subject prescriptions were ``just over'' $200, which 
Respondent's expert, Mr. Litman, ``gave [as] a ceiling . . . for a 
pretty reasonable average cash payment.'' Id. I am rejecting 
Respondent's exception because it is inconsistent with the testimony of 
Respondent's PIC and Mr. Litman and ignores the credible testimony of 
Dr. Witte. RD, at 7.
    Dr. Witte testified that cash payments for controlled substance 
prescriptions, such as those for the subject prescriptions, are a red 
flag. E.g., Tr. 172-73, 226, 313. The large majority of patients who 
received the subject prescriptions paid Respondent $179.99 for 90 
tablets of hydrocodone and $59.99 for 60 tablets of alprazolam. GX 2. 
When a patient purchased prescriptions for both hydrocodone and 
alprazolam at the same visit, the patient would pay $239.98. Id. 
Respondent's expert, Mr. Litman, testified that he would be concerned 
about cash payments in excess of $200. Tr. 692, 753. Mr. Litman 
downplayed the significance of cash payments as a red flag because 
``cash payments are more common these days.'' Tr. 753. PIC Igwe 
testified, however, that the majority of Respondent's customers used 
insurance to pay for their prescriptions, which brings into question 
why all of the subject patients paid with cash. Tr. 496.
    Accordingly, I reject Respondent's exceptions to the findings in 
the Recommended Decision that the cash payments for the subject 
prescriptions were a red flag.
ALJ's Determinations That Respondent Violated 21 CFR 1306.04 and 
1306.06
    In addition to arguing that the subject prescriptions did not raise 
the red flags of distance, cash payments, and pattern prescribing and/
or those red flags were resolved before Respondent filled the 
prescriptions, Respondent argues in its Exceptions that the Government 
failed to establish that PIC Igwe had the requisite degree of scienter 
to prove a violation of her corresponding responsibility under 21 CFR 
1306.04(a). Exceptions, at 7-9, 12-13. Respondent

[[Page 21013]]

also argues that the Government has not met its burden under 21 CFR 
1306.06 ``to prove the pharmacist repeatedly filled controlled 
substance prescriptions that contained multiple red flags of diversion 
and/or abuse without addressing or resolving those red flags, based on 
a lack of documentation of the resolution, or a failure of the 
corresponding responsibility.'' Id. at 6.
    According to the CSA's implementing regulations, a lawful 
controlled substance order or prescription is one that is ``issued for 
a legitimate medical purpose by an individual practitioner acting in 
the usual course of his professional practice.'' 21 CFR 1306.04(a). 
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.'' Id. The regulations establish the parameters of the 
pharmacy's corresponding responsibility.

    An order purporting to be a prescription issued not in the usual 
course of professional treatment . . . is not a prescription within 
the meaning and intent of . . . 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. ``The language in 21 CFR 1306.04 and caselaw could not be more 
explicit. A pharmacist has his own responsibility to ensure that 
controlled substances are not dispensed for non-medical reasons.'' 
Ralph J. Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55 FR 4729, 4730 
(1990) (citing United States v. Hayes, 595 F.2d 258 (5th Cir. 1979), 
cert. denied, 444 U.S. 866 (1979); United States v. Henry, 727 F.2d 
1373 (5th Cir. 1984) (reversed on other grounds)). As the Supreme Court 
explained in the context of the CSA's requirement that schedule II 
controlled substances may be dispensed only by written prescription, 
``the prescription requirement . . . ensures patients use controlled 
substances under the supervision of a doctor so as to prevent addiction 
and recreational abuse . . . [and] also bars doctors from peddling to 
patients who crave the drugs for those prohibited uses.'' Gonzales v. 
Oregon, 546 U.S. 243, 274 (2006).
    To prove a pharmacist violated her corresponding responsibility, 
the Government must show that the pharmacist acted with the requisite 
degree of scienter. See 21 CFR 1306.04(a) (``[T]he person knowingly 
filling [a prescription issued not in the usual course of professional 
treatment] . . . shall be subject to the penalties provided for 
violations of the provisions of law relating to controlled 
substances.'') (emphasis added). DEA has also consistently interpreted 
the corresponding responsibility regulation such that ``[w]hen 
prescriptions are clearly not issued for legitimate medical purposes, a 
pharmacist may not intentionally close his eyes and thereby avoid 
[actual] knowledge of the real purpose of the prescription.'' 
Bertolino, 55 FR at 4730 (citations omitted); see, also JM Pharmacy 
Group, Inc. d/b/a Pharmacia Nueva and Best Pharmacy Corp., 80 FR 28667, 
28670-72 (2015) (applying the standard of willful blindness in 
assessing whether a pharmacist acted with the requisite scienter). 
Pursuant to their corresponding responsibility, pharmacists must 
exercise ``common sense and professional judgment'' when filling a 
prescription issued by a physician. Bertolino, 55 FR at 4730. When a 
pharmacist's suspicions are aroused by a red flag, the pharmacist must 
question the prescription and, if unable to resolve the red flag, 
refuse to fill the prescription. Id.; Medicine Shoppe-Jonesborough, 300 
F. App'x 409, 412 (6th Cir. 2008) (``When pharmacists' suspicions are 
aroused as reasonable professionals, they must at least verify the 
prescription's propriety, and if not satisfied by the answer they must 
refuse to dispense.'').
    In this matter, the Government did not allege that Respondent 
dispensed the subject prescriptions having actual knowledge that the 
prescriptions lacked a legitimate medical purpose. Instead, the 
Government alleged that Respondent violated the corresponding 
responsibility regulation as evidenced by it ``repeatedly 
distribut[ing] controlled substances pursuant to prescriptions that 
contained one or more unresolved red flags for diversion.'' Govt 
Posthearing, at 29. See also OSC, at 5 (``Pharmacy Place's pharmacists 
were willfully blind to or deliberately ignorant of the high 
probability that the [subject prescriptions] lacked a legitimate 
medical purpose. Pharmacy Place pharmacists were willfully blind to the 
fact that large numbers of customers seeking controlled substance 
prescriptions, often prescription cocktails, and residing long 
distances from Pharmacy Place's location and/or their respective 
physicians created a suspicious situation requiring increased 
scrutiny.'').
    As partially discussed above, I agree with the ALJ's findings that 
the subject prescriptions presented multiple red flags including 
pattern prescribing, distance, cash payments, drug cocktails, high 
doses/quantities of high-alert controlled substances, and prescriptions 
lacking the patient's address or the prescriber's DEA number. 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 at 51061 (pattern 
prescribing; distance; cash payments; drug cocktails; high doses/
quantities of high-alert controlled substances; different doctors 
prescribing controlled substances to the same patient; prescriptions 
lacking the patient's address or the prescriber's DEA number); Pharmacy 
Doctors Enterprises d/b/a Zion Clinic Pharmacy, 83 FR at 10898 (long 
distances; pattern prescribing; drug cocktails; cash payments; early 
refills); Hills Pharmacy, 81 FR 49,816, 49,836-39 (2016) (multiple 
customers filling 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; drug cocktails); The Medicine Shoppe, 79 FR 59504, 
59507, 59512-13 (2014) (unusually large quantity of a controlled 
substance; pattern prescribing; irregular dosing instructions; drug 
cocktails); Holiday CVS, L.L.C., d/b/a CVS Pharmacy Nos. 219 and 5195, 
77 FR 62316, 62317-22 (2012) (long distances; pattern prescribing; cash 
payments); East Main Street Pharmacy, 75 FR 66149, 66,163-65 (2010) 
(long distances; pattern prescribing; drug cocktails; early fills/
refills; other pharmacies' refusals to fill the prescriptions). Dr. 
Witte credibly testified that a Texas pharmacist acting in the usual 
course of professional practice would have recognized these red flags 
and that a Texas pharmacist acting in the usual course of professional 
practice and fulfilling her corresponding responsibility will not fill 
prescriptions for controlled substances without investigating, 
documenting the investigation, and resolving any red flags. E.g., Tr. 
171-82, 195, 210-211, 216-17, 227.
    PIC Igwe also admitted during her testimony that she had actual 
knowledge of some of the red flags on the prescriptions. See, e.g., Tr. 
546-47. For example, PIC Igwe testified that she

[[Page 21014]]

was aware of, but unconcerned by, the distances the patients were 
traveling and the large number of substantially identical prescriptions 
for hydrocodone and alprazolam from the clinics that prescribed the 
subject prescriptions because she assumed the clinics were pain 
management clinics and based her dispensing decisions on that 
assumption. Tr. 516, 537-38. In the State of Texas, pain management 
clinics must be certified by the state, 22 Tex. Admin. Code Sec. Sec.  
195.1-195.44; and the Texas regulations governing the professional 
responsibilities of pharmacists state that a ``prescription drug order 
may not be dispensed or delivered if issued by a practitioner 
practicing at a pain management clinic'' that is not certified. 22 Tex. 
Admin. Code Sec.  291.29(e) (2011).\N\ Yet, PIC Igwe testified that she 
never checked if the clinics were certified as pain management clinics. 
Tr. 537-38. Moreover, Dr. Witte testified that a Texas pharmacist 
should still investigate and resolve the red flags on the subject 
prescriptions even if they were from a specialty clinic, such as a pain 
management clinic. Tr. 276-277; see also 22 Tex. Admin. Code Sec.  
291.29(d) (2011) (``A pharmacist shall ensure that prescription drug 
orders for the treatment of chronic pain have been issued in accordance 
with the guidelines set forth by the Texas Medical Board in 22 Tex. 
Admin. Code Sec.  170.3 (relating to Guidelines), prior to dispensing 
or delivering such prescriptions.'').
---------------------------------------------------------------------------

    \N\ 22 Tex. Admin Code Sec.  291.29 has subsequently been 
amended since the time frame relevant to this matter. The citations 
and quotations to the Texas Administrative Code in this decision 
reflect the law as it was at the time the subject prescriptions were 
dispensed.
---------------------------------------------------------------------------

    I have considered and reject Respondent's claim that it 
investigated and resolved the red flags on the subject prescriptions 
before they were filled and therefore complied with its corresponding 
responsibility. Exceptions, at 7-9, 11-12. In its Exceptions, 
Respondent claims that PIC Igwe testified that

when she initially gets a new customer's prescription, she calls the 
clinic and practitioner to verify the patient is being seen by the 
practitioner, the clinic is treating the patient, the condition that 
is treated, and whether the medication prescribed for the patient is 
appropriate. Upon the verification by the practitioner that the 
patient is being treated for a condition with the prescribed drugs, 
the pharmacist will discuss the prescription with the customer, as 
appropriate. If a different pharmacy is shown on the PMP, the 
pharmacist will occasionally call that pharmacy to discern that 
pharmacist's comfort with the previous prescription.

    Exceptions, at 7 (citing Tr. 477-80, 492). Respondent argues that 
through this process it resolved any red flags on the subject 
prescriptions. Id. at 9.
    Once again, however, Respondent has partially misrepresented PIC 
Igwe's testimony. PIC Igwe testified that for new patients presenting a 
controlled substance prescription, she would always ``call the clinic 
and make sure that the clinic did write the prescription.'' Tr. 477-
481. She did not testify that she asked about the condition being 
treated or whether the medication prescribed for the patient is 
appropriate. PIC Igwe did testify that she would check with the 
prescriber if she had a concern about ``the dose, the interactions or 
what not,'' but she did not testify that she did this for all patients 
presenting controlled substance prescriptions for the first time. Tr. 
481.
    Additionally, as I discussed supra, there is no documentary 
evidence in the administrative record that Respondent followed the 
protocols she described in her testimony. The Government issued a 
subpoena to Respondent requesting ``a copy of the complete patient 
profile record or any other patient record (paper or electronic) that 
your pharmacy maintained [for the subject patients], pursuant to the 
requirements of the Texas Administrative Code Title 22 Sec.  
291.33(c)(2)(A) & (C) Operational Standards'' and instructed Respondent 
to include ``the entire patient record that your pharmacy maintained 
for each individual, including, but not limited to, any and all 
Pharmacist comments relevant to the individuals drug therapy, including 
any information peculiar to the specific patient or drug as well as any 
consultation with the prescribing practitioner . . . .'' GX 9 (Sept. 6, 
2016 Subpoena) and 10 (June 14, 2017 Subpoena). There is no 
documentation in any of the records Respondent provided in response to 
the Government's subpoenas that Respondent ever contacted a 
practitioner or other pharmacy regarding the subject patients the first 
time they visited Respondent. GX 2. In fact, the only pharmacist notes 
on any of the records was a ``V'' on one prescription, which PIC Igwe 
testified meant she had verified the prescription, but the marked 
prescription was not the first time Respondent had dispensed the same 
controlled substances to the patient. Id.; GX 2, at 44-55.
    Respondent claims that PIC Igwe made notes in the ``Demographics'' 
section of the patient profiles when she had discussions with a 
prescriber regarding ``the dose, the interactions or what not.'' Tr. 
481, 546; Exceptions, at 15. PIC Igwe, however, had no explanation for 
why she did not produce this claimed documentation to the Government in 
response to the subpoenas other than to say that it ``is not typically 
printed in the patient profile sheet,'' and she had no explanation for 
why she did not provide it as an exhibit or otherwise bring it to the 
administrative hearing. Tr. 481-482, 546-47. PIC Igwe had a similar 
response when asked why she filled controlled substance prescriptions 
that lacked the prescriber's DEA number, a requirement for a valid 
prescription. Tr. 391, 412; 21 CFR 1306.05(a); Tex. Health & Safety 
Code Sec.  481.074(k). When a prescription lacks the prescriber's DEA 
number, Dr. Witte testified that the pharmacist should contact the 
prescriber and annotate the DEA number on the prescription itself or in 
the patient profile. Tr. 391. PIC Igwe stated that she would have the 
prescriber fax her a copy of his or her DEA license with the DEA 
number, but she did not produce those faxes in response to the 
Government subpoenas or bring them with her to the hearing. Tr. 535-36. 
In light of the allegations against Respondent and the explicit 
requests of the Government subpoenas, I find that it strains credulity 
that Respondent's claimed documentation exists, but that Respondent did 
not think it was necessary to provide it to the Government or at the 
hearing. I, therefore, do not credit Respondent's claims that it 
adequately investigated and resolved the red flags on the subject 
prescriptions.
    Further, this Agency has applied, and I apply here, the ``adverse 
inference rule.'' E.g., Pharmacy Doctors Enterprises d/b/a/Zion Clinic 
Pharmacy, 83 FR at 10899. As the D.C. Circuit explained, ``Simply 
stated, the rule provides that when a party has relevant evidence 
within his control which he fails to produce, that failure gives rise 
to an inference that the evidence is unfavorable to him.'' Int'l Union, 
United Auto., Aerospace & Agric. Implement Workers of Am. (UAW) v. 
Nat'l Labor Relations Bd., 459 F.2d 1329, 1336 (D.C. Cir. 1972). The 
Court reiterated this rule in Huthnance v. District of Columbia, 722 
F.3d 371, 378 (D.C. Cir. 2013). According to this legal principle, 
Respondent's decision not to provide records gives rise to an inference 
that any such evidence is unfavorable to Respondent.
    Based on Respondent's failure to adequately investigate and resolve 
the many red flags on the subject prescriptions before filling them, I 
find

[[Page 21015]]

that Respondent either knew the prescriptions were issued without a 
legitimate medical purpose or dispensed the prescriptions knowing there 
was a high probability that the prescriptions were issued without a 
legitimate medical purpose. Accordingly, I agree with the ALJ's finding 
in the Recommended Decision that the Government has proven by 
substantial evidence that Respondent filled prescriptions for 
controlled substances that it knew were not prescribed for legitimate 
medical purposes, or was willfully blind to such, in violation of its 
corresponding responsibility under 21 CFR 1306.04(a). I also agree with 
the ALJ's finding that by filling the subject prescriptions without 
resolving the red flags and documenting the resolution, Respondent 
acted outside the usual course of professional practice in violation of 
21 CFR 1306.06.
ALJ's Determination That Respondent Violated 22 Tex. Amin. Code Sec.  
291.33(c)(2)
    Respondent filed additional exceptions to the ALJ's determination 
that Respondent violated the Texas State Board of Pharmacy's 
Operational Standards for Community Pharmacies, 22 Tex. Admin. Code 
Sec.  291.33(c)(2). The Texas regulation requires that ``a pharmacist 
shall, prior to or at the time of dispensing a prescription drug order, 
review the patient's medication record. Such review shall at a minimum 
identify clinically significant: . . . reasonable dose and route of 
administration; . . . duplication of therapy; . . . and, proper 
utilization, including overutilization or underutilization.'' Id. at 
Sec.  291.33(c)(2)(A)(i). If a pharmacist identifies one of the listed 
``clinically significant conditions [or] situations . . . the 
pharmacist shall take appropriate steps to avoid or resolve the problem 
including consultation with the prescribing practitioner.'' Id. at 
Sec.  291.33(c)(2)(A)(ii). The pharmacist must also document the 
consultation with the prescriber including the date the pharmacist 
consulted with the prescriber, the name of the person with whom the 
pharmacist spoke, and any applicable information pertaining to the 
consultation. Id. at Sec.  291.33(c)(2)(C).
    The Government alleged, and the ALJ agreed, that Respondent 
violated 22 Tex. Admin. Code Sec.  291.33(c)(2) by failing to contact 
prescribers and document the conversations when presented with 
prescriptions that raised red flags. OSC, at 2-5; e.g., RD, at 77-79, 
82, 87. Respondent objects to the Government's and the ALJ's 
interpretation of the regulation as requiring a pharmacist to consult 
with prescribers and document the consultation for all red flags raised 
by a prescription. Exceptions, at 9-10. Respondent argues that the 
regulation only requires a pharmacist to document the resolution of ``a 
clinically significant condition or drug regimen review related 
question'' and that not all red flags, such as geographical distance, 
are ``a clinically significant condition or drug regimen review 
question'' that require documentation under the regulation. Id. (citing 
22 Tex. Admin. Code Sec.  291.33(c)(2)(A)).
    Neither the Government nor the Respondent elicited expert testimony 
or provided other evidence of what conditions or situations qualify as 
``clinically significant'' such that a Texas pharmacist is required by 
the regulation to consult with the prescriber and document the 
consultation. During the hearing, Dr. Witte was asked by the ALJ if she 
was ``aware of whether or not Texas law requires the documentation of 
red flags'' and she replied ``No. I don't believe so. . . . I'm not 
aware if there's an actual law.'' \O\ Tr. 378. Because there is 
insufficient evidence on the record through expert testimony or other 
evidence of state law that the red flags raised by the subject 
prescriptions are ``clinically significant'' and therefore required 
documentation of their resolution under Texas regulation, I cannot 
determine, based on the record before me, that Respondent violated 22 
Tex. Admin. Code Sec.  291.33(c). Accordingly, I have edited the 
Recommended Decision, which I am adopting, to remove the findings that 
Respondent violated 22 Tex. Admin. Code Sec.  291.33(c).
---------------------------------------------------------------------------

    \O\ Dr. Witte was later asked if she was familiar with the Texas 
rule that ``mandates that, `Upon identifying any clinically 
significant conditions, situation,' the pharmacist shall take 
appropriate steps to avoid or resolve the problem, including 
consultation with the prescribing practitioner . . .'' and also 
mandates that ``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.'' 
Tr. 411-412. Dr. Witte responded that ``Yes'' the rule sounded 
familiar. Id. Dr. Witte, however, did not provide any testimony 
regarding which, if any, of the red flags raised by the subject 
prescriptions were clinically significant conditions or situations 
that required consultation and documentation under the rule.
---------------------------------------------------------------------------

    However, my determination regarding 22 Tex. Admin. Code Sec.  
291.33(c) has no effect on the ultimate outcome of this matter. The 
substantial evidence on the record demonstrates that failing to resolve 
and document the resolution of red flags falls below the minimum 
standards of practice of pharmacy in the State of Texas and is, 
therefore, a violation of 21 CFR 1306.06. See Tr. 178-82, 261-62.
5. Sanction
    In the RD, the ALJ found that Respondent had taken ``no 
responsibility for its egregious and repeated failure to fulfill its 
corresponding responsibility to ensure the proper prescribing and 
dispensing of controlled substances and other responsibilities of a 
registration'' and ``presented no evidence of mitigation or 
remediation'' RD, at 94. The ALJ, therefore, recommended that I revoke 
Respondent's registration and deny any pending application for renewal 
or modification. Id. Respondent filed exceptions to the ALJ's finding 
that Respondent did not accept responsibility for its misconduct or 
``show the requisite remorse for the wrongdoing alleged against 
[Respondent].'' Exceptions, at 14.
    Where, as here, the Government has met its prima facie burden of 
showing that the respondent's continued registration is inconsistent 
with the public interest due to its violations pertaining to controlled 
substance dispensing and recordkeeping, the burden shifts to the 
respondent to show why it can be entrusted with the responsibility 
carried by its registration. Garret Howard Smith, M.D., 83 FR 18882, 
18910 (2018) (citing Samuel S. Jackson, 72 FR 23848, 23853 (2007)). DEA 
cases have repeatedly found that when a registrant has committed acts 
inconsistent with the public interest, ``the Respondent is required not 
only to accept responsibility for [the established] misconduct, but 
also to demonstrate what corrective measures [have been] undertaken to 
prevent the reoccurrence of similar acts.'' Holiday CVS, 77 FR at 62339 
(internal quotations omitted). See, also, Hoxie v. Drug Enf't Admin., 
419 F.3d 477, 483 (6th Cir. 2005); Ronald Lynch, M.D., 75 FR 78745, 
78749, 78754 (2010) (holding that respondent's attempts to minimize 
misconduct undermined acceptance of responsibility); Medicine Shoppe-
Jonesborough, 73 FR 364, 387 (2008) (noting that the respondent did not 
acknowledge recordkeeping problems, let alone more serious violations 
of federal law, and concluding that revocation was warranted).
    I agree with the ALJ's finding that there is nothing in the 
Administrative Record that suggests Respondent has accepted 
responsibility for its actions. At the hearing, PIC Igwe was asked, 
``Do you believe you failed to ensure that the prescriptions for 
controlled substances which you dispensed were issued for a legitimate 
medical purpose?'' and PIC

[[Page 21016]]

Igwe responded, ``I don't believe that I failed.'' Tr. 567. There is 
also nothing in Respondent's Proposed Findings or Closing Brief 
accepting responsibility for the controlled substances dispensed 
outside the usual course of professional practice and in violation of 
Respondent's corresponding responsibility. Respondent argues that PIC 
Igwe took responsibility by admitting that she provided DEA 
investigators with an incomplete inventory printout during the 
Administrative Inspection. Exceptions, at 14. I acknowledge PIC Igwe's 
admission to providing inaccurate documents; however, she did not 
accept her responsibility as a registrant to have a ``readily 
retrievable'' dispensing log that met the requirements of 21 CFR 
1304.22(c)-repeatedly minimizing her conduct by blaming it on her 
computer software and failing to correct her conduct by providing DEA 
with an accurate and complete log within a reasonable time following 
the inspection.\P\ See 21 CFR 1304.04(g) (requiring registrants to 
maintain specified records such that the information is readily 
retrievable); Edmund Chein, M.D., 72 FR 6580, 6593 (2007); Pharmacy 
Doctors Enterprises d/b/a Zion Clinic Pharmacy, 83 FR at 10901, aff'd 
Pharmacy Doctors Enterprises, Inc. v. Drug Enf't Admin., 789 F. App'x 
724, 730 (2019) (finding that producing records as an exhibit for the 
hearing did not comply with the ``readily retrievable'' requirement of 
the regulation). Accordingly, I agree with the ALJ that Respondent has 
not rebutted the Government's prima facie case and has not accepted 
responsibility such that I can entrust it with a registration.
---------------------------------------------------------------------------

    \P\ Although Respondent eventually produced Respondent Exhibit 
C, which PIC Igwe testified was Respondent's complete dispensing log 
for the controlled substance audited by DEA investigators, Tr. 467-
71, the document does not comply with the requirements of 21 CFR 
1304.22(c), RD, at 85-86.
---------------------------------------------------------------------------

    Respondent further argues that the ALJ should have weighed 
sanctions other than revocation, such as temporary suspension. 
Exceptions, at 15. While the Agency possesses the discretion to order a 
sanction short of revocation, I conclude that exercising that 
discretion here would ill-serve the public interest. Respondent has not 
shown that it can be entrusted with the responsibility carried by its 
registration--having failed to accept responsibility for its conduct, I 
have no assurance that Respondent would not repeat the conduct if it 
were to retain a registration. My predecessors have also revoked the 
pharmacy registrations for conduct similar to Respondent's. See, e.g., 
Morning Star Pharmacy & Medical Supply 1, 85 FR 51045 (2020); Heavenly 
Care Pharmacy, 85 FR 53402 (2020); Pharmacy Doctors Enterprises d/b/a/
Zion Clinic Pharmacy, 83 FR 10876 (2018).
    Finally, Respondent has argued that revocation is inappropriate 
because the ``DEA investigators did not make a finding of Imminent Harm 
the day they presented the Administrative Inspection Warrant to 
[Respondent] back in June of 2015.'' Exceptions, at 14. Respondent has 
provided no citation for its argument, and I reject the claim as it 
lacks any basis in Agency statute, regulation, or prior decisions.
    For the reasons above, I reject Respondent's contention that the 
ALJ's recommendation is overly broad and adopt the ALJ's recommended 
sanction.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration 
FT4134805 issued to The Pharmacy Place. Further, pursuant to 28 CFR 
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby 
deny any pending application of The Pharmacy Place to renew or modify 
this registration. This order is effective May 21, 2021.

D. Christopher Evans,
Acting Administrator.

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision

Charles Wm. Dorman

Administrative Law Judge

February 13, 2018
Appearances:
Frank W. Mann, Esq. for the Government
Lurese A. Terrell, Esq. for the Respondent

    The Drug Enforcement Administration (``DEA'' or ``Government'') 
served The Pharmacy Place (``Pharmacy'' or ``Respondent'') with an 
Order to Show Cause (``OSC''), seeking to revoke DEA Certificate of 
Registration (``COR''), Number FT4134805. Administrative Law Judge 
Exhibit (``ALJ-'') 1. In response to the OSC, the Respondent timely 
requested a hearing before an Administrative Law Judge. ALJ-2. The 
first two sessions of the hearing in this matter were held in Dallas, 
Texas, from September 12-13, 2017. The Respondent's expert, however, 
failed to appear on either of those days. To accommodate the 
Respondent, the hearing was continued. On November 20, 2017, the 
hearing reconvened. The November 20, 2017 session of the hearing was 
conducted by video teleconference from the DEA Hearing Facility in 
Arlington, Virginia, with the parties and witnesses located at the DEA 
District Office in San Antonio, Texas.
    At the conclusion of the hearing on November 20, 2017, the Parties 
were directed to submit their post-hearing briefs no later than January 
10, 2018. Tr. 767. On January 8, 2018, however, the Government filed a 
Consent Motion for Enlargement of Time to File Post-Hearing Briefs, 
requesting a new filing date of January 24, 2018. ALJ-31. That motion 
was granted. ALJ-32. Then on January 19, 2018, the Respondent filed a 
similar motion, requesting an extension of time to file post-hearing 
briefs until February 7, 2018. ALJ-33. That motion was also granted. 
ALJ-34.
    The issue before the Acting Administrator is whether a 
preponderance of the evidence supports the revocation of the 
Respondent's DEA Certificate of Registration (``DEA-COR''), No. 
FT4134805, pursuant to 21 U.S.C. 824(a)(4) and 823(f), and the denial 
of any pending applications for renewal or modification of such 
registration, pursuant to 21 U.S.C. 823(f).
    This Recommended Decision is based on my consideration of the 
entire Administrative Record, including all of the testimony, admitted 
exhibits, and the oral and written arguments of counsel.

Allegations

    1. Between August 2014 and May 2015, the Pharmacy filled 75 
controlled substance prescriptions outside the usual course of pharmacy 
practice, in violation of 21 CFR 1306.06, and in contravention of the 
Pharmacy's ``corresponding responsibility'' under 21 CFR 1306.04(a). 
The Pharmacy did so by repeatedly filling controlled substance 
prescriptions that contained red flags of diversion and/or abuse 
without addressing or resolving those red flags. The Pharmacy's conduct 
in doing so violated 21 U.S.C. 823(f)(4); Tex. Health & Safety Code 
Sec.  481.070-.075; Tex. Health & Safety Code Sec.  481,128; and Tex. 
Admin. Code Sec.  291.22(c)(2). Additionally, the Pharmacy engaged in 
conduct that demonstrates negative experience in its dispensing of 
controlled substances, in violation of 21 U.S.C. 823(f)(2). ALJ-1, at 
2-3, para. 3, 6-8.
    2. Between August 2014 and May 2015, the Pharmacy's pharmacists 
filled numerous prescriptions for highly-abused controlled substances 
that contained one or more of the following red flags, without 
resolving those red

[[Page 21017]]

flags: (1) Prescriptions written to individuals traveling long and/or 
unusual distances to obtain the prescriptions and/or to fill them at 
the Pharmacy; (2) prescriptions from individuals obtaining the same or 
similar combinations of controlled substances from the same small 
number of providers; (3) prescriptions for highly-abused ``drug 
cocktails'', such as hydrocodone and alprazolam; (4) prescriptions 
containing inappropriate and/or unusual directions for use; and (5) 
prescriptions for controlled substances which the customer purchased 
with cash. The Pharmacy's practice of filling prescriptions for 
controlled substances, despite unresolved red flags, included, but was 
not limited to, the following instances:
    a. On August 1, 2014, the Pharmacy filled a prescription for 120, 
10 mg tablets of hydrocodone presented by an undercover agent. The 
agent obtained the prescription from a practitioner in a clinic in 
south Dallas, more than 30 miles from the Pharmacy, which is located 
north of Dallas. There was no legitimate medical purpose for the 
prescription and the agent's address on the prescription was 
fictitious. The agent also sought to purchase the prescription with 
cash. ALJ-1, at 3-4, para. 10(a).
    b. From August 2014 to May 2015, the Pharmacy dispensed 
prescription cocktails (hydrocodone and alprazolam) to 25 different 
individuals, all of whom traveled unusual paths and distances to obtain 
their prescriptions for these controlled substances and to have them 
filled at the Pharmacy. Six individuals, J.W., H.J., M.H., A.S., K.S., 
and M.A., traveled more than 100 miles to obtain their prescriptions, 
have them filled at the Pharmacy, and return home. Another 17 
individuals, J.S., C.J., SW, J.W.2, S.H., R.E., R.N., R.H., B.B., S.N., 
I.B., M.W.2, Y.S., R.H.2, C.D., A.K., and S.B., traveled between 70-100 
miles to obtain their prescriptions, have them filled at the Pharmacy, 
and return home. Four individuals, R.N., E.H., B.B., and T.H., traveled 
between 60-70 miles to obtain their prescriptions, have them filled at 
the Pharmacy, and return home. All of these individuals sought to 
purchase their prescriptions with cash. Additionally, the prescriptions 
issued to M.W., J.S., J.W., C.J., S.N., J.W.2, S.H., H.J., E.H., A.S., 
R.E., K.S., S.B., R.H., T.W., I.B., M.W.2, Y.S., M.A., R.H.2, B.B., 
C.D., A.K., and R.N., were facially invalid and in violation of federal 
and state law because they lacked the patient's address and the 
practitioner's DEA number. ALJ-1, at 4, para. 10(b).
    c. Many of the individuals mentioned in paragraph (b), above, 
obtained the prescriptions from physicians who were engaged in 
``pattern prescribing,'' i.e., prescribing the same controlled 
substances in identical or substantially similar quantities. For 
instance, between August 19, 2014 and October 2, 2014, C.J., SW, J.W.2, 
S.H., and H.J. all received prescriptions for hydrocodone and 
alprazolam from the same physician, I.I., and they traveled long and 
unusual paths to obtain their prescriptions and have them filled at the 
Pharmacy. Then between November 14, 2014, and May 1, 2015, the Pharmacy 
filled 12 prescriptions for hydrocodone written by C.V. for patients 
A.S., R.E., K.S., G.B., M.A., R.H.2, A.K., R.N., and M.H. All of these 
patients traveled long and unusual paths to obtain their prescriptions 
and have them filled. The Pharmacy also filled prescription cocktails 
(hydrocodone and alprazolam), written by C.V. for patients M.A., R.H.2, 
and A.K. on April 17, 21, and May 1, 2015, respectively. Additionally, 
between January 13, 2015 and May 11, 2015, the Pharmacy dispensed 
controlled substances pursuant to ``pattern-style'' prescriptions 
issued by NE On 14 different occasions, the Pharmacy dispensed 90, 10 
mg tablets of hydrocodone to 11 different customers. On 8 different 
occasions, the Pharmacy filled identical prescription cocktails written 
by NE consisting of 90, 10 mg tablets of hydrocodone and 60, 2 mg 
tablets of alprazolam. Identical prescription cocktails were dispensed 
to both I.B. and T.W. on April 10, 2015, and to B.B. and C.D. on April 
23, 2015. ALJ-1, at 4, para. 10(c).
    d. On April 17, 2015, the Pharmacy filled a prescription for 
hydrocodone to G.B., who had traveled an unusual path and distance of 
more than 75 miles to obtain her prescription and have it filled at the 
Pharmacy, and then return home. ALJ-1, at 5, para. 10(d).
    3. A DEA audit of the Pharmacy's 10 mg hydrocodone, covering the 
period of September 25, 2013 through June 18, 2015, revealed a shortage 
of 47,183 dosage units. Because the Controlled Substances Act requires 
the maintenance of ``complete and accurate'' inventories, as well as a 
``complete accurate record of each substance . . . received, sold, 
delivered or otherwise disposed of,'' this shortage violated 21 U.S.C. 
827(a). ALJ-1, at 5, para. 13.

Witnesses

I. The Government's Witnesses

    The Government presented its case through the testimony of four 
witnesses and a sworn declaration. The Government's first witness was 
retired Diversion Investigator 1 (hereinafter, DI 1). Tr. 25-146. DI 1 
served as a DI with the DEA for 14 years and was assigned to the 
Dallas, Texas office since June 2008. Tr. 26, 78. As a DI, DI 1 
conducted scheduled regulatory investigations, all of which required 
that he conduct an audit of controlled substances. Tr. 78. DI 1 
estimated that he had conducted about 70 audits in his career. Tr. 80.
    DI 1 was part of a DEA team that conducted an Administrative 
Inspection Warrant (``AIW'') of the Pharmacy on June 18, 2015. Tr. 26-
27, 60, 451. During that inspection, the DEA obtained documents from 
the Pharmacy, including: Prescriptions; copies of order forms, 
invoices, and packing forms concerning the Pharmacy's receipt of 
controlled substances; and the Pharmacy's dispensing history of 
hydrocodone. Tr. 35-36, 77-78.
    While at the Pharmacy on June 18, 2015, DI 1 conducted a closing 
inventory of the Pharmacy's hydrocodone, during which all of the 
medication in the Pharmacy was examined. Tr. 47, 130, 132. That 
inventory revealed that the Pharmacy was short more than 47,000 tablets 
of hydrocodone. Tr. 87.
    The primary purpose of DI 1's testimony was to lay the foundation 
for the introduction of Government Exhibits 1-12. During his testimony, 
all of those exhibits were admitted into evidence. Tr. 3-4. DI 1 also 
testified that he asked the Pharmacy to provide the DEA with a 
``complete history'' of its dispensing of hydrocodone, and that in 
response to that request the Pharmacy provided the DEA with Government 
Exhibit 6. Tr. 36-37.
    DI 1's testimony was presented in a professional, candid and 
straightforward manner. In addition, DI 1's testimony was sufficiently 
objective, detailed, plausible, and internally consistent. Therefore, I 
merit it as credible in this Recommended Decision.
    The Government next presented the testimony of its expert, Dr. Amy 
Witte, Pharm.D. (``Dr. Witte''). Tr. 150-345, 355-425, 763. Government 
Exhibit 13 is a copy of Dr. Witte's curriculum vitae. Tr. 153-55. Dr. 
Witte holds a Doctor of Pharmacy degree from the University of Texas at 
Austin. Tr. 152. Dr. Witte has been a licensed pharmacist in Texas 
since 2004. Tr. 152-53. Dr. Witte is currently employed with the 
University of the Incarnate Word, Feik School of Pharmacy, Department 
of Pharmacy Practice, in San Antonio, Texas, as a full professor, where 
she has taught Federal and Texas pharmacy law. Tr. 150, 157-58. She is 
currently the main professor in the endocrine module, with a

[[Page 21018]]

specialty in diabetes and thyroid disorders. Tr. 151, 163. She is also 
currently employed as a clinical pharmacist with the Texas Veterans 
Health Care System. Tr. 150, 156. Dr. Witte worked as a pharmacist for 
Walgreens from 2004 until 2011. Tr. 157. Dr. Witte testified that she 
was certified as an expert witness with the DEA in 2013. Tr. 156. After 
Respondent's counsel conducted voir dire examination of Dr. Witte, Tr. 
158-67, she objected to Dr. Witte being accepted as an expert because 
Dr. Witte's qualifications were ``all academic.'' Tr. 167-69. The 
Respondent's objection was overruled and Dr. Witte was then accepted as 
an ``[e]xpert in the field of pharmacy in the state of Texas.'' Tr. 
169.
    Dr. Witte presented testimony concerning what a pharmacist is 
required to do before filling a prescription for a controlled substance 
in Texas. Tr. 169-71, 178-80, 192, 210. In addition, she testified 
about circumstances that may give rise to a red flag, which a 
pharmacist would need to resolve before filling a prescription for a 
controlled substance. Tr. 171-74, 177-80, 189, 191-93, 244, 281, 321, 
323. She also provided testimony based upon her review of Government 
Exhibits 2, 3, and 12, and rendered her opinion as to whether filling 
various prescriptions in those exhibits fell below the minimal standard 
of the practice of pharmacy in Texas, whether filling those 
prescriptions was within the usual course of the practice of pharmacy 
in Texas, and whether the pharmacist who filled the prescriptions had 
satisfied the corresponding responsibility to ensure that only 
prescriptions issued for a legitimate medical purpose were filled. See, 
e.g., Tr. 211, 217, 227-28, 236-37, 244-45.
    Having closely listened to Dr. Witte's testimony, and having 
closely reviewed the transcript of her testimony, I find that it was 
sufficiently objective, detailed, plausible, and internally consistent 
to be considered credible in this Recommended Decision.
    The Government's third witness was DI 2. Tr. 426-440. She testified 
that she has been a DI with the DEA since 2005. Tr. 426. To become a 
DI, DI 2 received 12 weeks of training at the DEA Training Academy 
concerning, ``diversion investigations, pharmacology of drugs, 
regulatory audits, administrative inspection warrants, . . . and 
criminal cases.'' Tr. 427. DI 2 is currently assigned to DEA's tactical 
diversion squad in Dallas, Texas, where she primarily focuses on 
criminal investigations. Tr. 427. Prior to becoming a DI, DI 2 was an 
adjunct professor in NASA's aerospace education program at Oklahoma 
State University. Tr. 427.
    DI 2 provided testimony concerning her involvement of DEA's 
investigation of the Pharmacy, indicating that the Pharmacy had come to 
DEA's attention as part of a larger investigation into pill mills. Tr. 
428. DI 2 was the case agent for the larger investigation. Tr. 428. DI 
2 noted that the Pharmacy stood out to her because it was located quite 
a distance from the offices of the pill mill doctors whose 
prescriptions the Respondent was filling. Tr. 430. DI 2 participated in 
the execution of the AIW. Tr. 430.
    DI 2's testimony was presented in a professional, candid, and 
straightforward manner. In addition, DI 2's testimony was sufficiently 
objective, detailed, plausible, and internally consistent. Therefore, I 
merit it as credible in this Recommended Decision.
    Pursuant to an agreement with the Respondent, the Government did 
not call Ms. Ijeoma Igwe, the Pharmacy's manager and pharmacist-in-
charge, as a witness so long as the Respondent called her to testify. 
Thus, an assessment of her credibility is contained under the 
discussion of the Respondent's witnesses.
    The Government also presented the sworn declaration of UC 1. GE-11. 
UC 1 presented to the Pharmacy as an undercover agent using the name 
``M.W.'' Tr. 41; GE-10, at 3; GE-11, at 2. Prior to the hearing, the 
Respondent filed an objection ``to the affidavit testimony of [UC 1] 
because it deprives the Respondent of its cross examination of said 
witness.'' ALJ-15, at 2. The Respondent's objection to the use of the 
sworn declaration of UC 1 was overruled in a prehearing Order issued on 
August 29, 2017. ALJ-18, at 1-2. When the Government introduced UC 1's 
declaration at the hearing, the Respondent again objected, and again 
that objection was overruled. Tr. 31-32. In admitting the declaration, 
I noted that it was a hearsay document and Respondent's lack of 
opportunity to cross examine UC 1 would be considered in determining 
what weight to give to the Exhibit. Tr. 32; see 21 CFR 1316.58(b). 
Having examined the sworn declaration of UC 1, I find that its contents 
are consistent with other evidence of record. For example, UC 1's 
description of the operation of the Redbird Medical Clinic is 
consistent with the testimony of DI 2. Tr. 120, 428-31, 435-37. Also, 
the declaration's statements that: UC 1 received a prescription from 
Nurse L.R. at the Redbird Medical Clinic for 120 tablets of 
hydrocodone; the prescription was faxed to the Pharmacy; he was waited 
on by a female employee at the Pharmacy when he arrived; and he paid 
$150 for the hydrocodone, are consistent with the content of Government 
Exhibit 2, at 1, and the fact that the prescription was filled by Ms. 
Igwe. Tr. 577-78. Finally, none of the evidence presented by the 
Respondent contradicts the content of the sworn declaration of UC 1. 
Accordingly, I fully credit the sworn declaration of UC 1.

II. The Respondent's Witnesses

    The Respondent presented its case through the testimony of two 
witnesses. The first witness the Respondent called was Ms. Ijeoma Igwe. 
Tr. 442-607. Ms. Igwe obtained her pharmacy degree at the University of 
Liverpool in England and she worked as a clinical pharmacist in 
England. Tr. 445. Ms. Igwe immigrated to the United States in 2005. Tr. 
445, 605-06. Ms. Igwe began her pharmacy career in the United States 
serving an internship for 8 to 10 months with CVS Pharmacies in Texas. 
Tr. 445, 606. Ms. Igwe then worked as a pharmacist for Target, filling 
in where needed at different Target stores. Tr. 446. Ms. Igwe then 
became interested in compounding pharmacy, which entails making custom 
medications, and worked for a compounding pharmacy for three years 
until April 2013. Tr. 447-48. Then in September 2013, Ms. Igwe opened 
The Pharmacy Place. Tr. 448.
    Ms. Igwe presented testimony about the character and operation of 
the Pharmacy. Tr. 448-51. She also testified about being present at the 
Pharmacy when the DEA executed the AIW on June 18, 2015, and her 
interaction with the DEA investigators. Tr. 451-54, 456-58, 465-67. Ms. 
Igwe described herself as being perplexed, surprised, and shocked 
during the execution of the AIW, and that she did her best to assist 
the investigators. Tr. 452. Ms. Igwe testified that after the DEA 
investigators left the Pharmacy she discovered that she had not 
provided them a complete record of her hydrocodone dispensing history, 
attributing her error to a lack of familiarity with the software 
program. Tr. 466-67. Working with her ``software people,'' Ms. Igwe was 
able to print out another dispensing log, which she sent to her 
attorney. Tr. 467-71, 548.
    Ms. Igwe testified concerning her standard procedures she used when 
filling prescriptions. Tr. 477-81. Those procedures included calling a 
prescriber to verify a prescription for a new patient, checking the 
prescription monitoring program (``PMP''), as well as checking the 
dosing and normal things a pharmacist looks for. Tr. 477-84, 503, 517, 
586, 590, 607. She also testified

[[Page 21019]]

that she would sometimes put a ``V'' on prescriptions to indicate that 
she had verified them. Tr. 482, 557. She also testified that she would 
make notes in the ``Demographics'' section of the patient profile to 
resolve a red flag if she had a discussion with a prescriber about a 
``clinical'' matter. Tr. 481, 585.
    Ms. Igwe testified that the Pharmacy receives prescriptions from 
other providers similar to the prescriptions at issue in this case. Tr. 
518-22. She noted that there was an orthopedist downstairs from the 
Pharmacy and he prescribes hydrocodone which she fills, and that there 
is one customer who gets 150 tablets a month and another who gets 180 
tablets a month. Tr. 476-77, 518, 522. She further testified that 
because she gets other similar prescriptions she believed the 
prescriptions at issue in this case were in line with what other 
patients were receiving from other clinics. Tr. 522.
    Ms. Igwe also testified that she was not concerned about the 
distance a customer traveled if they lived in the Dallas-Fort Worth 
metroplex. Tr. 493-94. Later she testified that distance would be a 
concern if she did not know the source of the prescription. Tr. 578. 
She also testified that she did not know where Everman, Texas, was 
located, yet she filled multiple prescriptions for patient A.S., who 
lived in Everman. Tr. 579; GE-2, at 22-33. Ms. Igwe also testified that 
she would not fill a prescription if the address on the prescription 
did not match the address on the customer's driver's license. Tr. 539.
    While Ms. Igwe seemed confident while she testified, and her 
testimony appeared sincere and candid, there are several issues with 
her testimony that detract from its overall believability. First, she 
testified that she would call the prescriber the first time a patient 
presented with a prescription for a controlled substance and that she 
would sometimes mark the prescription with a ``V'' to indicate that she 
had verified the prescription. Tr. 477, 482, 557. The documentary 
evidence, however, does not support that testimony. For example, there 
are 68 prescriptions contained in Government Exhibit 2, but only one is 
marked with a ``V.'' \1\ GE-2, at 49. Furthermore, the alprazolam 
prescription marked with a ``V'' for patient K.S. is dated February 26, 
2015. Id. K.S., however, had filled prescriptions for both alprazolam, 
as well as hydrocodone, at the Pharmacy six times before Ms. Igwe 
marked the February 26, 2015 prescription with a ``V.'' GE-2, at 44-46, 
53-55. In addition, Government Exhibit 6 establishes that Dr. C.V. 
wrote many prescriptions for hydrocodone, but in spite of all those 
prescriptions, Ms. Igwe never had a conversation with Dr. C.V. about a 
patient. Tr. 561. In fact, the only time Ms. Igwe talked with Dr. C.V. 
was when he called her about a non-patient matter. Tr. 561.
---------------------------------------------------------------------------

    \1\ None of the prescriptions submitted by the Respondent in 
Respondent Exhibit H are marked with a ``V.''
---------------------------------------------------------------------------

    Second, Ms. Igwe testified that she did not find the prescriptions 
at issue in this case to be out of line with other prescriptions she 
filled. Tr. 522. She also testified that she filled prescriptions for 
an orthopedist, who performed surgery downstairs from the Pharmacy, and 
that the orthopedist prescribed hydrocodone. Tr. 476, 518. She further 
testified that she had one customer who took 150 hydrocodone tablets a 
month and another who took 180. Tr. 518, 522. While the documentary 
evidence does not necessarily contradict that testimony, the 
documentary evidence clearly does not support Ms. Igwe's testimony. For 
example, Government Exhibit 6 details 929 prescriptions that the 
Pharmacy filled for hydrocodone. All but 25 of those prescriptions were 
written by the same small group of prescribers, whose prescriptions are 
identified on the patient profiles contained in Government Exhibit 2. 
Further examination of Government Exhibit 6 fails to reveal any patient 
with a prescription for 150 or 180 tablets of hydrocodone. In addition, 
there is only one prescription written by a prescriber, Dr. V.K., with 
the same address as the Pharmacy; she wrote a prescription for 30 
tablets of hydrocodone. GE-6, at 13.
    Third, Ms. Igwe's explanation about why she was not concerned about 
the delay between the hydrocodone that was prescribed for pain and the 
date the patient picked it up with respect to Government Exhibit 2, at 
1, makes little sense. She explained that a patient with chronic pain 
might possibly have pain medicine they had received before to tide them 
over until they could pick up a new prescription. Tr. 564-65. She also 
testified that she always checked the PMP before filling prescriptions. 
Tr. 479. The prescription on page 1 of Government Exhibit 2 was for an 
undercover agent using a fake name. Had Ms. Igwe checked the PMP for 
that patient, she would not have found any prior prescriptions, 
eliminating the possibility that the patient had leftover medication to 
tide him over. Clearly, as Government counsel suggested, Ms. Igwe was 
simply speculating about reasons for the delay. Tr. 545, 565; see also 
ALJ-35, at 24.
    When initially explaining the ``Rx Date'' on the entries in 
Government Exhibit 6, Ms. Igwe testified that all of the hydrocodone 
prescriptions identified in Government Exhibit 6 were electronic 
prescriptions and the ``Rx Date'' was the date the prescriptions were 
received. Tr. 533, 560, 562. She backtracked from that position when 
confronted by the fact that the prescription at Government Exhibit 2, 
at 1, was a handwritten prescription and it was also recorded on page 8 
of Government Exhibit 6. Tr. 562, 580. Other handwritten prescriptions 
contained in Government Exhibit 2 are also recorded in Government 
Exhibit 6. Compare GE-2, at 16 with GE-6, at 28; compare GE-2, at 28 
with GE-6, at 65. At the hearing, my impression was that Ms. Igwe was 
downplaying the significance of the ``Rx Date,'' because to do so 
decreased the likelihood that she would have observed one prescription 
after another for hydrocodone coming into the Pharmacy, written by the 
same doctors and for the same strengths and normally for the same 
quantity.
    Finally, Ms. Igwe testified that when she received faxed 
prescriptions from medical clinics, the clinics also faxed additional 
information such as the patient's address and identification on 
separate pages. Tr. 488-89, 539-40. Ms. Igwe also testified that when 
she would resolve red flags concerning clinical matters about a 
prescription she would make notes in the demographics section of the 
patient profile. Tr. 481, 546. She further explained that these notes 
did not print out when she printed the patient profile. Tr. 482. When 
asked why she did not bring copies of the materials the medical clinics 
had faxed to her, or copies of her notes that showed she had resolved 
red flags, Ms. Igwe testified that she did not think she needed to or 
that she did not think it was necessary. Tr. 547. This explanation 
makes no sense in light of the allegations against her and it is not 
credible. Ms. Igwe's credibility on this issue is further undermined by 
the fact that this type of information was sought by the investigators 
during the execution of the AIW and by the September 6, 2016 subpoena. 
Tr. 78, 356-57; GE-9.
    In light of the aspects of Ms. Igwe's testimony outlined above, and 
those are but a few of the examples that could be given, I find that 
her testimony merits only limited belief. Thus, where Ms. Igwe's 
testimony conflicts with the testimony of other witnesses, or with the 
documentary evidence of record, I credit that other testimony and those 
documents over Ms. Igwe's testimony.

[[Page 21020]]

    The Respondent's second witness was Mr. Robert Litman. Tr. 623-762. 
His curriculum vitae is contained in Respondent's Exhibit B. Tr. 632. 
Mr. Litman testified concerning his background education and work 
history. Tr. 624-631, 652-655. Mr. Litman earned his pharmacy degree 
from the University of Florida in 1981 and he has worked as a 
pharmacist since then. Tr. 624. Mr. Litman has managed about a dozen 
small pharmacies over the past 36 years. Tr. 624. He is currently the 
Director of Consultant and Management Services with Ultimed Health 
Advisors, dealing with, among other things, the ``management of retail 
pharmacy operations.'' Tr. 622; RE-B, at 1. Mr. Litman is also a 
Clinical Assistant Professor of Pharmacy Practice in geriatric medicine 
at Nova Southeastern University, Ohio State University, and Palm Beach 
Atlantic University. Tr. 641, 644; RE-B, at 2. Mr. Litman has 
previously testified as an expert witness, but only in Florida. Tr. 
623, 638-39. Mr. Litman currently works a couple of days per month as a 
retail pharmacist. Tr. 650, 652. Following voir dire by Government 
counsel, Mr. Litman was accepted as an expert witness, without 
objection, in the area of ``retail pharmacy practices.'' Tr. 656.
    Mr. Litman presented his testimony in a direct, straightforward, 
and candid manner. Mr. Litman had a professional demeanor while he 
testified. During voir dire of Mr. Litman, the Government noted that 
Mr. Litman's expert testimony was evaluated by another Administrative 
Law Judge (``ALJ'') in an earlier case before the DEA. Tr. 650-52; see 
Howard N. Robinson, M.D., 79 FR 19356 (2014). While the ALJ in that 
case found some portions of a report that Mr. Litman prepared to be 
``peculiar,'' the ALJ credited his testimony, describing it as 
``sufficiently detailed, authoritative and candid.'' Tr. 652; Robinson, 
M.D., 79 FR at 19364-65. While I too find portions of Mr. Litman's 
testimony to be a bit peculiar or inconsistent, in general I find that 
he presented testimony that was ``sufficiently detailed, authoritative, 
and candid'' to be generally credited in this decision.
    Some portions of Mr. Litman's testimony that were peculiar or 
inconsistent concerned the following areas: Distance that customers 
traveled; a lack of concern for pattern prescribing; drug cocktails; 
and a delay between the date a prescription was written to treat pain 
and the date the customer picked up the prescription. Mr. Litman was 
not particularly concerned about the distance a customer traveled to 
fill a prescription. Tr. 726-30. While he did testify that as a 
pharmacist working in Miami, he would find it a little leery if a 
customer traveled from South Carolina to fill a prescription, he also 
testified that there was no problem if the customers were from in-
state. Tr. 730. Mr. Litman's approach seemingly ignores the fact that 
portions of South Carolina are closer to Miami than is, ``in-state'', 
Pensacola, Florida. Further, and of greater significance, Mr. Litman 
was not familiar with DEA case law concerning pharmacy customers 
driving long distances, or of the Texas requirement for pharmacists to 
consider distance. Tr. 727. Thus, without an understanding of the law, 
it is understandable why Mr. Litman has little concern for the distance 
a customer travels to obtain a prescription and have it filled.
    Mr. Litman also testified that he would not be concerned about 
pattern prescribing when filling 23 successive prescriptions for 
hydrocodone from the same provider. Tr. 747-49. Nevertheless, Mr. 
Litman testified that he would call the prescriber every time he was 
presented with a new prescription for hydrocodone. Tr. 747, 749. Mr. 
Litman also testified that he would not be concerned about pattern 
prescribing if he had spoken with the doctor and was comfortable that 
there was a legitimate doctor-patient relationship. Tr. 748.
    Mr. Litman's testimony concerning drug cocktails was difficult to 
follow. Mr. Litman first acknowledged that a customer presenting 
prescriptions for hydrocodone and alprazolam would be presenting 
prescriptions for a drug cocktail. Tr. 740. Mr. Litman further 
testified that he would only be concerned about filling such 
prescriptions if the customer was diverting or abusing the controlled 
substances. Tr. 741. Mr. Litman, however, could not explain how a 
pharmacist would know if the customer was diverting or abusing the 
controlled substances. Tr. 741. He later explained that the combination 
of these two drugs could be a drug cocktail depending on the reason the 
patient received the prescription. Tr. 741-42. Mr. Litman's explanation 
ignores the fact that the only way the pharmacist could make an 
informed decision as to whether the prescriptions had been issued for a 
legitimate medical purpose would be to call the prescriber. Coming full 
circle, Mr. Litman then testified that when confronted with 
prescriptions for hydrocodone and alprazolam he would call the 
prescriber to ``make sure that [the prescriber] wrote those 
prescriptions, that they were valid prescriptions for a patient, and 
there was a doctor-patient relationship.'' Tr. 743.
    Mr. Litman was also asked whether he would have any concern where a 
patient delayed picking up a prescription written for pain, and he said 
it would not concern him at all. Tr. 749-50. When asked why he would 
have no concern, not surprisingly he gave the same speculative answer 
given by Ms. Igwe--he would assume the patient had some medication left 
over from a prior prescription or the patient had obtained medication 
samples directly from the prescriber. Tr. 750-52. The answer is not 
surprising because Mr. Litman was able to read Ms. Igwe's testimony 
before he testified. Tr. 683. Although this delay would be of no 
concern to Mr. Litman, he did testify that he would call the doctor to 
``let him know that the patient hadn't filled [the prescription] for a 
week, and [ask] if there was an issue.'' Tr. 751. Mr. Litman's 
explanation suggests that he would be concerned about a delay in 
picking up a prescription for pain medication, even though he would not 
acknowledge it.
    These four examples of areas in which Mr. Litman's testimony was 
peculiar or inconsistent are not all-inclusive. Thus, while I find Mr. 
Litman's testimony to be generally worthy of belief, where it conflicts 
with Dr. Witte's testimony, or laws, regulations, or DEA precedent, I 
give greater weight to her testimony and to legal authority.

The Facts

I. Stipulations of Fact

    The parties agree to 45 stipulations (``Stip.''), which are 
accepted as facts in these proceedings:
    1. Respondent Pharmacy Place is registered with DEA as a retail 
pharmacy authorized to handle controlled substances in Schedules II-V 
under DEA COR number FT4134805 at 4031 W. Plano Parkway, Suite 211, 
Plano, Texas 75093. DEA COR FT4134805 expires on November 30, 2019.
    2. The pharmacy is owned by HOIC Enterprises, LLC, a Texas limited 
liability company, and does business as The Pharmacy Place. It is 
operated and managed by Harrison and Ijeoma Igwe.
    3. According to the Texas Office of the Comptroller, Harrison Igwe 
and Ijeoma Igwe are listed as managers of HOIC Enterprises LLC.
    4. According to the Texas Board of Pharmacy, The Pharmacy Place is 
a licensed community pharmacy in the State of Texas, license no. 28650.
    5. According to the Texas Board of Pharmacy, Ijeoma Igwe is a 
licensed pharmacist (License No. 44785) in the

[[Page 21021]]

State of Texas and is the Pharmacist-in-Charge (``PIC'') of The 
Pharmacy Place.
    6. Norco is a brand name of a combination medication containing the 
Schedule II generic drug hydrocodone.
    7. Xanax is the brand name of the Schedule IV generic drug 
alprazolam.
    8. Promethazine with codeine is a Schedule V controlled substance.
    9. Government Exhibit (``GE'') 3, pp. 1-5, is a Mapquest printout 
showing the path and distance from M.A.'s residence (as listed in 
Respondent's Patient Profile) to (1) Dr. C.V. (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) M.A.'s 
residence. (107 miles total).
    10. Government Exhibit (``GE'') 3, pp. 6-10, is a Mapquest printout 
showing the path and distance from B.B.'s residence (as listed in 
Respondent's Patient Profile) to (1) Dr. NE on 201 Billings Street in 
Arlington, Texas (as listed in Respondent's Patient Profile) to (2) 
Respondent's address to (3) B.B.'s residence. (80 miles total).
    11. Government Exhibit (``GE'') 3, pp. 11-15, is a Mapquest 
printout showing the path and distance from B.B.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. NE on 2617 Bolton Boone 
Drive in DeSoto, Texas (as listed in Respondent's Patient Profile) to 
(2) Respondent's address to (3) B.B.'s residence. (66 miles total).
    12. Government Exhibit (``GE'') 3, pp. 16-19, is a Mapquest 
printout showing the path and distance from G.B.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) G.B.'s 
residence. (55 miles total).
    13. Government Exhibit (``GE'') 3, pp. 20-24, is a Mapquest 
printout showing the path and distance from I.B.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. NE (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) I.B.'s 
residence. (79 miles total).
    14. Government Exhibit (``GE'') 3, pp. 25-29, is a Mapquest 
printout showing the path and distance from S.B.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. NE (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) S.B.'s 
residence. (79 miles total).
    15. Government Exhibit (``GE'') 3, pp. 30-34, is a Mapquest 
printout showing the path and distance from C.D.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. NE (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) C.D.'s 
residence. (81 miles total).
    16. Government Exhibit (``GE'') 3, pp. 35-39, is a Mapquest 
printout showing the path and distance from R.E.'s residence (as listed 
in Respondent's Patient Profile) to (1) C.Z., S.G., and/or L.R. (as 
listed in Respondent's Patient Profile) to (2) Respondent's address to 
(3) R.E.'s residence. (86 miles total).
    17. Government Exhibit (``GE'') 3, pp. 40-44, is a Mapquest 
printout showing the path and distance from R.E.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) R.E.'s 
residence. (94 miles total).
    18. Government Exhibit (``GE'') 3, pp. 45-48, is a Mapquest 
printout showing the path and distance from E.H's residence (as listed 
in Respondent's Patient Profile) to (1) I.I. and/or Dr. A.Q. (as listed 
in Respondent's Patient Profile) to (2) Respondent's address to (3) 
E.H's residence. (68 miles total).
    19. Government Exhibit (``GE'') 3, pp. 49-53, is a Mapquest 
printout showing the path and distance from M.H.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. NE (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) M.H.'s 
residence. (116 miles total).
    20. Government Exhibit (``GE'') 3, pp. 54-58, is a Mapquest 
printout showing the path and distance from M.H.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) M.H.'s 
residence. (121 miles total).
    21. Government Exhibit (``GE'') 3, pp. 59-63, is a Mapquest 
printout showing the path and distance from R.H.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. A.Q. (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) R.H.'s 
residence. (79 miles total).
    22. Government Exhibit (``GE'') 3, pp. 64-68, is a Mapquest 
printout showing the path and distance from R.H.'s residence (as listed 
in Respondent's Patient Profile) to (1) J.W. (as listed in Respondent's 
Patient Profile) to (2) Respondent's address to (3) R.H.'s residence. 
(76 miles total).
    23. Government Exhibit (``GE'') 3, pp. 69-73, is a Mapquest 
printout showing the path and distance from R.H.2's residence (as 
listed in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) 
R.H.2's residence. (92 miles total).
    24. Government Exhibit (``GE'') 3, pp. 74-78, is a Mapquest 
printout showing the path and distance from S.H.'s residence (as listed 
in Respondent's Patient Profile) to (1) I.I. (as listed in Respondent's 
Patient Profile) to (2) Respondent's address to (3) S.H.'s residence. 
(76 miles total).
    25. Government Exhibit (``GE'') 3, pp. 79-83, is a Mapquest 
printout showing the path and distance from C.J.'s residence (as listed 
in Respondent's Patient Profile) to (1) I.I. (as listed in Respondent's 
Patient Profile) to (2) Respondent's address to (3) C.J.'s residence. 
(81 miles total).
    26. Government Exhibit (``GE'') 3, pp. 84-88, is a Mapquest 
printout showing the path and distance from H.J.'s residence (as listed 
in Respondent's Patient Profile) to (1) I.I. (as listed in Respondent's 
Patient Profile) to (2) Respondent's address to (3) H.J.'s residence. 
(105 miles total).
    27. Government Exhibit (``GE'') 3, pp. 89-93, is a Mapquest 
printout showing the path and distance from A.K.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) A.K.'s 
residence. (81 miles total).
    28. Government Exhibit (``GE'') 3, pp. 94-98, is a Mapquest 
printout showing the path and distance from R.N.'s residence (as listed 
in Respondent's Patient Profile) to (1) the Billings Street address in 
Arlington, Texas, where C.Z., S.G., Dr. NE and/or L.R. are listed as 
practicing according to Respondent's Patient Profile) to (2) 
Respondent's address to (3) R.N.'s residence. (95 miles total).
    29. Government Exhibit (``GE'') 3, pp. 99-103, is a Mapquest 
printout showing the path and distance from R.N.'s residence (as listed 
in Respondent's Patient Profile) to (1) the Bolton Boone Drive address 
in DeSoto, Texas, where Dr. NE is listed as practicing according to 
Respondent's Patient Profile) to (2) Respondent's address to (3) R.N.'s 
residence. (78 miles total).
    30. Government Exhibit (``GE'') 3, pp. 104-108, is a Mapquest 
printout showing the path and distance from R.N.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) R.N.'s 
residence. (64 miles total).
    31. Government Exhibit (``GE'') 3, pp.109-112, is a Mapquest 
printout showing the path and distance from S.N.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. NE (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) S.N.'s 
residence. (81 miles total).
    32. Government Exhibit (``GE'') 3, pp.113-117, is a Mapquest 
printout showing the path and distance from A.S.'s residence (as listed 
in Respondent's Patient Profile) to (1) C.Z., Dr. NE, L.R., and/or S.G. 
(as listed in

[[Page 21022]]

Respondent's Patient Profile) to (2) Respondent's address to (3) A.S's 
residence. (104 miles total).
    33. Government Exhibit (``GE'') 3, pp.118-122, is a Mapquest 
printout showing the path and distance from A.S.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) A.S.'s 
residence. (111 miles total).
    34. Government Exhibit (``GE'') 3, pp.123-127, is a Mapquest 
printout showing the path and distance from J.S.'s residence (as listed 
in Respondent's Patient Profile) to (1) L.R. (as listed in Respondent's 
Patient Profile) to (2) Respondent's address to (3) J.S.'s residence. 
(80 miles total).
    35. Government Exhibit (``GE'') 3, pp.128-133, is a Mapquest 
printout showing the path and distance from K.S.'s residence (as listed 
in Respondent's Patient Profile) to (1) C.Z., Dr. NE, S.G., and/or L.R. 
(as listed in Respondent's Patient Profile) to (2) Respondent's address 
to (3) K.S.'s residence. (101 miles total).
    36. Government Exhibit (``GE'') 3, pp.134-139, is a Mapquest 
printout showing the path and distance from K.S.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. C.V. (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) K.S.'s 
residence. (109 miles total).
    37. Government Exhibit (``GE'') 3, pp.140-144, is a Mapquest 
printout showing the path and distance from Y.S.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. NE on Billings Street in 
Arlington, Texas, (as listed in Respondent's Patient Profile) to (2) 
Respondent's address to (3) Y.S.'s residence. (97 miles total).
    38. Government Exhibit (``GE'') 3, pp.145-150, is a Mapquest 
printout showing the path and distance from Y.S.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. NE on Bolton Boone Drive in 
DeSoto, Texas (as listed in Respondent's Patient Profile) to (2) 
Respondent's address to (3) Y.S.'s residence. (79 miles total).
    39. Government Exhibit (``GE'') 3, pp.151-156, is a Mapquest 
printout showing the path and distance from J.W.'s residence (as listed 
in Respondent's Patient Profile) to (1) S.G. (as listed in Respondent's 
Patient Profile) to (2) Respondent's address to (3) J.W.'s residence. 
(108 miles total).
    40. Government Exhibit (``GE'') 3, pp.157-161, is a Mapquest 
printout showing the path and distance from J.W.2's residence (as 
listed in Respondent's Patient Profile) to (1) I.I. (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) 
J.W.2's residence. (98 miles total).
    41. Government Exhibit (``GE'') 3, pp.162-166, is a Mapquest 
printout showing the path and distance from M.W.2's residence (as 
listed in Respondent's Patient Profile) to (1) L.R. (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) 
M.W.2's residence. (97 miles total).
    42. Government Exhibit (``GE'') 3, pp.167-171, is a Mapquest 
printout showing the path and distance from M.W.2's residence (as 
listed in Respondent's Patient Profile) to (1) Dr. NE (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) 
M.W.2's residence. (79 miles total).
    43. Government Exhibit (``GE'') 3, pp.172-176, is a Mapquest 
printout showing the path and distance from SW's residence (as listed 
in Respondent's Patient Profile) to (1) I.I. (as listed in Respondent's 
Patient Profile) to (2) Respondent's address to (3) SW2's residence. 
(99 miles total).
    44. Government Exhibit (``GE'') 3, pp.177-181, is a Mapquest 
printout showing the path and distance from T.W.'s residence (as listed 
in Respondent's Patient Profile) to (1) Dr. NE (as listed in 
Respondent's Patient Profile) to (2) Respondent's address to (3) T.W.'s 
residence. (66 miles total).
    45. Government Exhibit (``GE'') 12, pp.1-5, is a Mapquest printout 
showing the path and distance from 5944 Callaston Lane, Ft. Worth, 
Texas to (1) Redbird Medical Clinic (3107 Camp Wisdom Road, Dallas, 
Texas) to (2) Respondent's location to (3) 5944 Callaston Lane, Ft. 
Worth, Texas.

II. Findings of Fact

    The factual findings below are based on a preponderance of the 
evidence, including the detailed, credible, and competent testimony of 
the aforementioned witnesses, the exhibits entered into evidence, and 
the record before me.

The Pharmacy

    1. Ms. Ijeoma Igwe (``Ms. Igwe'') graduated from pharmacy school at 
the University of Liverpool in England in 1989. Tr. 445, 605-06. After 
graduating, she worked as a clinical pharmacist in England until she 
relocated to the United States in 2005. Id. at 445.
    2. Ms. Igwe began practicing pharmacy in Texas in 2006 by working 
as a pharmacy intern with CVS for 8-10 months. Id. at 445-46, 606. She 
then worked as a full-time floater pharmacist at various Target stores. 
Id. at 446-47. She eventually left Target and worked for a 
rehabilitation hospital for three months. Id. at 447. She then worked 
as a pharmacist at Albertson's. Id. at 447.
    3. Ms. Igwe is a licensed Texas pharmacist. Id. at 516.
    4. While working at Albertson's, Ms. Igwe developed an interest in 
compounding pharmacy. Tr. 447. She then worked at a compounding 
pharmacy for approximately three years until April 2013. Id. at 447.
    5. Ms. Igwe opened the Pharmacy in September 2013. Id. at 448.
    6. The Pharmacy is owned by HOIC Enterprises, LLC, and Ms. Igwe is 
the pharmacist-in-charge of the Pharmacy. Id. at 35.
    7. The Pharmacy is a small pharmacy. Id. at 433, 449. When the DEA 
inspected the Pharmacy, the Pharmacy was filling approximately 60-100 
prescriptions a day. Id. at 474, 696-97.
    8. Ms. Igwe is the only pharmacist who works at the Pharmacy. Id. 
at 449, 481-82, 577.
    9. Because Ms. Igwe is the only pharmacist at the Pharmacy, she 
filled all the prescriptions in Government Exhibit 2. Id. at 577-78.
    10. Most of the Pharmacy's prescriptions are electronically 
received through ``e-script.'' Id. at 487-88. Some prescriptions are 
sent by fax. Id. at 488.
    11. The Pharmacy began seeing prescriptions from Redbird Medical 
Clinic, and other clinics under investigation, around January or 
February 2014. Id. at 475.

The Inspection

    12. The Pharmacy came to DEA's attention during a larger 
investigation of ``pill mill'' clinics in the Dallas area in 2013. Id. 
at 428. The DEA went to the Pharmacy because it had been identified as 
a pharmacy that was filling prescriptions issued by ``pill mill'' 
clinics. Id. at 63-64, 430.
    13. The DEA suspected that some prescriptions the Pharmacy filled 
were not issued for legitimate medical purposes because they were 
issued from a ``pill mill'' clinic. Id. at 120. The suspected ``pill 
mill'' clinic had a security guard in the parking lot who ushered 
people into the clinic. Id. at 120.
    14. At least two doctors and four nurse practitioners involved in 
the DEA's investigation of Dallas-area pill mills were indicted. Id. at 
437-38. One of the doctors pled guilty and was sentenced. Id. at 437. 
Additionally, two pharmacists were indicted, pled guilty, and 
sentenced. Id. at 438.
    15. On June 18, 2015, Diversion Investigators, DI 1and DI 2 were 
part of the DEA investigative team that executed an Administrative 
Inspection

[[Page 21023]]

Warrant (``AIW'' or ``Inspection'') at the Pharmacy. Id. at 27, 60, 
431, 451.
    16. During the inspection, Ms. Igwe was the only employee working 
at the Pharmacy. Id. at 141-42.
    17. During the inspection, DEA investigators discussed their 
concerns about the Pharmacy with Ms. Igwe. Id. at 431-32.
    18. During the inspection, DEA asked Ms. Igwe for any documentation 
she had to show that the Pharmacy had verified the prescriptions it had 
filled. Id. at 78, 431-32.
    19. DEA investigators also requested that the Pharmacy turn over 
all of the notes it had concerning the resolution of red flags. Id. at 
356-57, 431-32; GE-9.
    20. Ms. Igwe told investigators that she did not verify the 
legitimacy of every prescription the Pharmacy filled. Tr. 432.
    21. During the inspection, DI 1 and DI 2 asked Ms. Igwe if she 
believed the prescriptions were genuine, and Ms. Igwe stated that she 
believed they were. Id. at 457.
    22. The Pharmacy was asked to provide DEA with a complete history 
of its dispensing of hydrocodone \2\ from the date the Pharmacy opened 
to the date of the inspection, June 18, 2015. Id. at 36, 431-32.
---------------------------------------------------------------------------

    \2\ All of the hydrocodone dispensed by the Pharmacy in this 
case was hydrocodone/APAP 10/325 mg. This Recommended Decision will 
simply refer to it as ``hydrocodone.'' ``APAP'' is the abbreviation 
for acetaminophen. Tr. 398.
---------------------------------------------------------------------------

    23. During the inspection, when DEA investigators asked Ms. Igwe 
for documentation concerning the Pharmacy, Ms. Igwe pointed to where 
the documentation was located. Id. at 66, 431-32. At the time of the 
inspection, the Pharmacy was in disarray. Id. at 66. Investigators also 
seized invoices, 222 Forms, hard-copy prescriptions, and the Pharmacy's 
dispensing history for hydrocodone. Id. at 35-36, 77-78, 434, 456.
    24. Government Exhibit 6 is the hydrocodone dispensing log Ms. Igwe 
printed from the Pharmacy's computer and provided to DI 2 and DI 1 when 
they executed the AIW at the Pharmacy. Id. at 37, 67, 135, 456, 553.
    25. The date range printed at the top of Government Exhibit 6 runs 
from October 23, 2013, to June 18, 2015. Id. at 553.
    26. Ms. Igwe later realized that the dispensing log she gave to the 
investigators was incomplete. Id. at 466. She had never printed an 
inventory report before. Id. at 466.
    27. Sometime after the inspection, Ms. Igwe contacted the 
manufacturer of the software the Pharmacy used, and the manufacturer 
showed her how to run the complete hydrocodone dispensing report. Id. 
at 467. She then gave this report, contained in Respondent Exhibit C, 
to an attorney to forward to the DEA. Id. at 468-69, 470-71, 549.
    28. There are no dates or date range on any of the documents in 
Respondent Exhibit C. Id. at 551.
    29. Pages 5-133 of Government Exhibit 2 contain prescriptions 
obtained from the Pharmacy during the administrative inspection on June 
18, 2015, and patient profiles the Pharmacy provided to the DEA in 
response to an administrative subpoena. Id. at 44-45; GE-2.
    30. The Pharmacy's computer system automatically assigns a date, 
time, and prescription number to the prescription when it is received. 
Tr. 533-34, 562, 580.
    31. Government Exhibit 8 contains invoices showing the quantity of 
hydrocodone shipped to the Pharmacy. Id. at 49-50. The invoices in 
Government Exhibit 8 are some of the invoice documents DI 1 reviewed in 
conducting an audit of the Pharmacy's hydrocodone during the 
inspection. Id. at 52-54. DI 1 conducted the inspection at DI 2's 
direction. Id. at 64-65.
    32. During the inspection, Ms. Igwe informed DEA investigators that 
they had all the documentation they had requested. Id. at 77.
    33. During the inspection, Ms. Igwe was ``pretty upset'' and ``a 
little freaked out.'' Id. at 95, 97, 452.
    34. During the inspection, Ms. Igwe had no response when asked if 
she found it suspicious that customers were traveling from a clinic 30 
miles away to get their prescriptions filled at the Pharmacy. Id. at 
76-77, 101-02.
    35. During the inspection, Ms. Igwe told DEA investigators that she 
had spoken to one of the prescribers, Dr. C.V., on one occasion. Id. at 
106.
    36. After the administrative inspection, DI 1 conducted an audit of 
the Pharmacy's inventory of hydrocodone 10/325 mg. Id. at 45-46.
    37. In conducting the audit, the Pharmacy's initial inventory 
showed zero hydrocodone. Id. at 46-47. DI 1 reviewed the Pharmacy's 
receiving documents for controlled substances and he took a closing 
inventory for hydrocodone on June 18, 2015. Id. at 47. The audit 
revealed that the Pharmacy was short 47,183 tablets of hydrocodone 10/
325 mg. Id. at 56-58; GE-7.
    38. DI 1 looked at all medications in the Pharmacy when he 
conducted the closing inventory of hydrocodone on June 18, 2015. Tr. 
130, 132.
    39. During the inspection, Ms. Igwe signed the closing inventory. 
Id. at 141.
    40. In all of the audits that DI 1 has conducted in his career, he 
has never identified a shortage as large as the shortage he identified 
at the Pharmacy. Id. at 90. Even a shortage of 2500 tablets of 
hydrocodone is a substantial shortage. Id. at 88-89.
    41. The Texas Prescription Monitoring Program (``PMP'') did not 
match up with the Pharmacy's dispensing records. Id. at 60. The 
dispensing records showed that the first dispensing took place on July 
7, 2014, but the PMP showed that the Pharmacy filled prescriptions for 
hydrocodone between January and June 2014. Id. at 60. Those 
prescriptions are not contained in the Pharmacy's dispensing record for 
hydrocodone. Id.; GE-6. The shortage that DI 1 found when auditing the 
Pharmacy's hydrocodone would be reduced if the information contained in 
the PMP concerning the prescriptions the Pharmacy filled prior to July 
7, 2014, were considered. Tr. 76.
    42. The PMP is not a Pharmacy record. Id. at 123-24.
    43. The DEA did not receive any explanation from the Pharmacy 
concerning why its distribution report, Government Exhibit 6, did not 
report a distribution of hydrocodone until July 7, 2014. Id. at 138.
    44. DI 1 was never informed that the Pharmacy had additional 
information to provide him concerning the audit he conducted. Id. at 
85.

Controlled Substances

    45. Hydrocodone has been a schedule II controlled substance since 
October 6, 2014. Id. at 132-33.
    46. The highest strength of hydrocodone is 10/325 mg. Id. at 176.
    47. A prescription for 90 tablets of hydrocodone would be a large 
quantity of tablets. Id. at 366-67, 394.
    48. Hydrocodone is usually prescribed to be taken once every 4 to 6 
hours, as needed for moderate to severe pain, not to exceed 6 tablets 
in 24 hours. Id. at 176, 283, 366, 680. Normally a patient would have 
another medication for moderate to severe pain. Id. at 176-77, 681.
    49. The highest strength for alprazolam is 2 mg. Id. at 177, 723.
    50. A prescription for 60 tablets of alprazolam would be a large 
quantity of tablets. Id. at 394-95.
    51. Prescriptions for the highest strength of a controlled 
substance raise a concern that the patient could exceed the maximum 
daily dose. Id. at 230.
    52. The maximum dose of acetaminophen is 4 grams per day. Id. at 
531, 680. A pharmacist's concern with the dose of hydrocodone would lie 
with the acetaminophen component of

[[Page 21024]]

the drug. Id. at 531, 662. Ten tablets of hydrocodone contain 3.25 
grams, which is below the maximum per day. Id. at 531, 680. According 
to the standard instruction of one tablet every four to six hours, a 
patient would take no more than six tablets of hydrocodone per day, 
which would be less than the maximum daily dose of acetaminophen. Id. 
at 531, 680.
    53. Alprazolam, hydrocodone, and promethazine with codeine are 
high-alert drugs. Id. at 269.
    54. Any combination of alprazolam, hydrocodone, promethazine with 
codeine, and carisoprodol constitutes a drug cocktail of high-alert 
drugs. Id. at 178, 270-71, 710, 740.
    55. When taken together, alprazolam and hydrocodone can produce a 
euphoric and addictive effect very similar to that of a heroin high. 
Id. at 178, 269, 711.
    56. Alprazolam and hydrocodone are among the top 10 most frequently 
prescribed controlled substances in the United States. Id. at 271, 273, 
668.

Red Flags

    57. The term ``red flag'' is not contained in any DEA regulation. 
Id. at 256, 657.
    58. Pharmacists use the term ``red flag'' to denote a potential 
issue with a prescription. Id. at 170-71, 569, 657. The minimum 
standard of the practice of pharmacy in Texas requires a pharmacist to 
look for red flags. Id. at 171.
    59. A red flag can be indicative of drug abuse or diversion. Id. at 
172, 741.
    60. Ms. Igwe did not learn the term ``red flag'' during her 
pharmacist training in England, but she now understands what it means. 
Id. at 521.
    61. Pattern prescribing is a red flag because it indicates no 
individualization of therapy. Id. at 171, 244, 745. An example of 
pattern prescribing would be multiple prescriptions from the same 
prescriber or medical group for the same medications, in the same 
quantities, dosages, and strengths, written for different patients. Id. 
at 171.
    62. When a medical provider only prescribes the maximum strength of 
a controlled substance, the prescriptions suggest that the provider is 
engaged in pattern prescribing. Id. at 231-32.
    63. The distance a person travels, or the route a person travels, 
to fill a prescription can be a red flag because it is likely there are 
multiple pharmacies along the same route. Id. at 172, 174-75.
    64. When a patient travels all over a metropolitan area to get to a 
doctor and then to a pharmacy to fill a prescription, that behavior 
raises a red flag because there would be multiple pharmacies along the 
way where the patient could fill the prescription.\3\ Id. at 281, 321, 
323.
---------------------------------------------------------------------------

    \3\ In this case, the term ``round-trip distance'' refers to the 
distance from a patient's residence to the prescriber, continuing to 
the Pharmacy, and then returning home. Tr. 176.
---------------------------------------------------------------------------

    65. Paying cash for a prescription can be a red flag. Id. at 172, 
692.
    66. Most patients have some sort of third-party payer, such as 
health insurance, to pay for their prescriptions. Id. at 358.
    67. Hydrocodone and alprazolam are normally covered by insurance. 
Id. at 399.
    68. The lack of a patient's address and/or the prescriber's DEA 
registration number on a prescription is a red flag. Id. at 179, 391, 
412, 693-94.
    69. Prescriptions for high-alert drugs such as alprazolam, 
hydrocodone, and promethazine with codeine, have the potential for 
abuse and diversion, and thus can be a red flag. Id. at 172-74, 720.
    70. A drug cocktail is a red flag. Id. at 178.
    71. Dosing instructions for hydrocodone that require the patient to 
take one tablet twice a day for moderate to severe pain would be a red 
flag, because it is less than the normal dosage for hydrocodone. Id. at 
177.
    72. Many of the prescriptions for hydrocodone contained in 
Government Exhibit 2 had dosing instructions to take one tablet every 
four to six hours, which is the normal dosing for hydrocodone, and not 
a red flag. Id. at 343-44
    73. Dosing instructions for alprazolam that require the patient to 
take one tablet twice a day for anxiety raises a red flag because 
alprazolam is typically dosed more frequently than twice per day when 
it is prescribed for anxiety. Id. at 177.
    74. Alprazolam can be prescribed to treat pain. Id. at 665-66.
    75. A delay between the date that a prescription is written for 
moderate to severe pain and the date the prescription is filled can be 
a red flag. Id. at 396-97.

Standards of Pharmacy Practice

    76. When a customer presents a prescription to a pharmacy, the 
pharmacist should examine the prescription, looking at the date of the 
prescription, the patient's name and address, the medication and its 
strength and quantity, as well as its directions for use, and the 
signature of the provider. Id. at 169-70.
    77. If the prescription does not contain the patient's address or 
the prescriber's DEA number, the prescription is invalid and the 
pharmacist should not fill the prescription. Tr. 179, 391, 412; see 
also 21 CFR 1306.05(a); Tex. Health & Safety Code Sec.  481.074(k). 
When the prescription lacks a patient address, the pharmacist could 
resolve that red flag by speaking with the patient, checking the 
patient's driver's license, or checking the patient's profile, and then 
documenting the action the pharmacist took to resolve the red flag. Tr. 
179-80. When the prescription lacks the prescriber's DEA number, the 
pharmacist should contact the prescriber and annotate the DEA number on 
the prescription itself and in the patient profile. Id. at 391.
    78. Information contained on a cover sheet of a faxed prescription 
could resolve a red flag, but that information still must be 
documented. Id. at 302-03. That information must be documented so that 
when the customer returns with an identical prescription there would be 
no need to call the provider. Id. at 319-20. The Respondent has 
produced no cover sheets. Id. at 547.
    79. When a pharmacist is presented with a prescription that 
contains one or more red flags, the pharmacist should call the 
prescriber to try to resolve the red flag or flags and then document 
the information that resolves the red flag on the prescription itself 
or in the patient's profile. Id. at 178-79.
    80. A reasonably prudent pharmacist would investigate prescriptions 
after seeing several prescriptions written by the same doctor or 
medical practice for the same drugs and the same quantity, and with the 
same dosing instructions. Id. at 210.
    81. The first time a patient presents prescriptions for hydrocodone 
and alprazolam to a pharmacy, the pharmacist might fill the 
prescriptions. Id. at 239-40. But when the patient keeps returning with 
the same prescriptions, the pharmacist should contact the provider. Id. 
at 239-40.
    82. When presented with the first prescription of the day for 
hydrocodone and alprazolam, a pharmacist might not think much about 
filling the prescription, but after seeing a handful of prescriptions 
written for the same drug, the same dose, the same strength, and by the 
same providers, the pharmacist should identify and resolve those red 
flags. Id. at 333.
    83. Evidence of pattern prescribing raises the concern of diversion 
and/or the abuse of high-alert drugs. Id. at 257.
    84. After seeing a handful of prescriptions for the same controlled 
substances with the same strengths and instructions for use, the 
prescriptions become suspicious. Id. at 358-59.

[[Page 21025]]

    85. A pharmacist concerned about pattern prescribing should call 
the prescriber to ask about the medical purpose and dosing, and then 
document the discussion the pharmacist had with the prescriber. Id. at 
261.
    86. A pharmacist cannot resolve problems concerning the medication, 
directions for use, or medical purpose by talking to the patient. Id. 
at 179.
    87. The patient profile should contain the correct address for the 
prescriber. Id. at 361-62.
    88. A prudent pharmacist would question the distance a patient 
traveled if a patient lives in Fort Worth but sees a doctor in Dallas. 
Id. at 192.
    89. A pharmacist could resolve a red flag concerning the distance a 
patient traveled by talking with the patient and documenting the 
conversation. Id. at 402-05.
    90. The failure to document the resolution of a red flag is below 
the minimum standard of the practice of pharmacy in Texas. Id. at 180.
    91. A pharmacist can use the PMP to determine whether a patient is 
filling prescriptions at another pharmacy. Id. at 398. Most pharmacies 
have access to the PMP. Id. at 398.
    92. The PMP shows the names of the doctors and pharmacies a patient 
has been using. Id. at 479-82.
    93. Information regarding a patient is only in the PMP if a 
pharmacy inputs the information into the system. Id. at 484.

The Pharmacy's Practices

    94. Ms. Igwe is familiar with a Texas regulation that [she 
testified requires a pharmacist to document conversations with 
practitioners regarding clinical matters about a particular 
prescription.] \*A\ Id. at 585.
---------------------------------------------------------------------------

    \*A\ Text adjusted in response to Respondent's Exceptions.
---------------------------------------------------------------------------

    95. There are no pharmacist notes in the record that resolve the 
red flags in Government Exhibit 2. Id. at 566-67.
    96. Sometimes Ms. Igwe would write a ``V'' indicating ``verified'' 
on the hard-copy prescription, but she did not do this for every 
prescription. Id. at 482, 557.
    97. Ms. Igwe testified that when she verified a prescription, she 
would make a note on the ``demographics'' page of the patient's profile 
that the provider confirmed the prescription. Tr. 481, 585. This 
information does not print out along with the patient profile. Id. at 
482.
    98. When a customer came to the Pharmacy for the first time to fill 
a prescription for a controlled substance, she would call the 
prescriber's office to confirm that the doctor wrote the prescription 
and that the patient was actually seen at the clinic. Id. at 477-78, 
503, 517, 586, 590, 607.
    99. Ms. Igwe has never verified whether Redbird, AC Medical, or 
Arlington Oaks was registered with the State of Texas as a pain 
management clinic. Id. at 537-38.
    100. There were no notes in the Pharmacy's records concerning 
specialty clinics or other pharmacies refusing to fill prescriptions 
filled by the Pharmacy. Id. at 360-61.
    101. If the doctor confirmed that he or she wrote the prescription, 
Ms. Igwe would look up the patient in the PMP to make sure the patient 
was not doctor or pharmacy shopping. Id. at 478, 484, 573.
    102. Ms. Igwe does not consider it doctor shopping if a patient 
obtains prescriptions from multiple providers in the same practice. Id. 
at 556. She only considers it doctor shopping if the patient obtains 
prescriptions from ``totally different'' clinics with which she was 
unfamiliar. Id. at 556.
    103. Ms. Igwe testified that before filling a prescription for a 
controlled substance, she would search the patient's name in the PMP, 
verify the dosage was correct, and check for any potential drug 
interactions. Id. at 478, 554.
    104. Ms. Igwe testified that if she received multiple prescriptions 
from the same provider, she would not check with the provider for 
subsequent prescriptions because she did not ``see the point of doing 
it'' again when she already contacted the provider about the first 
prescription the patient presented to the Pharmacy. Id. at 478-79, 517. 
She would only contact the provider again if the prescription changed. 
Id. at 482.
    105. Ms. Igwe testified that she checked the PMP each time a 
customer came back to the Pharmacy to make sure that customer had not 
been obtaining controlled substances from other doctors. Id. at 479, 
504, 517.
    106. Ms. Igwe testified that the first page of a faxed prescription 
would be a cover sheet with the patient's identification (typically a 
driver's license) and home address. Id. at 489.
    107. Ms. Igwe testified that when a patient picked up a controlled 
substance at the Pharmacy, she would ask the patient for his or her 
driver's license and check it against the copy of the driver's license 
faxed by the provider. Id. at 490. She would then scan the patient's 
identification card into the Pharmacy's computer database. Id. at 490.
    108. Ms. Igwe testified that if the identification card presented 
by the patient at the Pharmacy did not match the information faxed with 
the prescription, then she would not fill the prescription. Id. at 491, 
539.
    109. There were no notes in the Pharmacy's records concerning the 
distances customers traveled to get their prescriptions filled at the 
Pharmacy. Id. at 360-61.
    110. The Pharmacy's records do not make a distinction between cash 
payments and insurance payments. Id. at 522. Ms. Igwe testified that 
approximately half of the prescriptions the Pharmacy fills are paid for 
using insurance. Id. at 496-97, 522. The remaining prescriptions are 
paid for in cash. Id. at 497.
    111. The ``co-pay'' information on the Pharmacy's fill stickers 
indicates the amount the customer paid for the prescription. Id. at 
499-500. On Government Exhibit 6, the information under ``billed'' is 
the amount the Pharmacy billed to the customer or insurance. Id. at 
498. On Government Exhibit 6, ``margin'' represents the Pharmacy's 
profit on a particular sale. Id.
    112. On the Pharmacy's fill stickers, the number underneath the 
patient's name is the prescription, or ``Rx'', number, which is 
assigned when the prescription is entered into the pharmacy's computer 
system. Id. at 184-85, 583; GE-2, at 1. The Rx numbers are assigned 
sequentially; the higher the number the more recent the prescription 
was filled. Id. at 185-86. For example, the Rx number ending in 6330 
would have been filled prior to Rx number 6331. Id. at 185-86.
    113. The fill sticker also shows the date the prescription was 
filled, but not the date it was written. Id. at 186. The date the 
prescription was written is recorded on the prescription itself. Id.
    114. On the fill stickers, the abbreviation ``Cpy'' stands for 
copay. Id. at 499.
    115. Ms. Igwe spoke to Dr. C.V. on only one occasion. Id. at 500, 
561, 587. Dr. C.V. called the Pharmacy to ask for the Pharmacy's fax 
number to send a statement that he was leaving Redbird Clinic. Id. at 
500, 561. During that phone call, Ms. Igwe did not talk to Dr. C.V. 
about any prescriptions. Id. at 561-62.
    116. Ms. Igwe would sometimes ask her customers if the medications 
they were prescribed were still working for them. Id. at 527.
    117. Ms. Igwe did not always fill a bottle with medication on the 
same day that she printed its label. Id. at 560, 575.

[[Page 21026]]

The Prescribers \4\
---------------------------------------------------------------------------

    \4\ The medical professionals mentioned in Findings of Fact 118-
121, and 155, when referred to as a group, will be referred to as 
``the Prescribers'' in this Recommended Decision. This group is 
comprised of C.V., L.R., I.I., L.O., A.Q., J.W., S.G., C.Z., and NE
---------------------------------------------------------------------------

    118. The prescription pad for Redbird Medical clinic (``Redbird'') 
contains the names of the following medical providers: C.V., M.D.; 
L.R., ACNS-BC; I.I., DNP-FNP; L.O., FNP-C; and J.W., ANP-BC, with an 
address on West Camp Wisdom Road in Dallas, Texas. Id. at 207-08; GE-2, 
at 12, 67. Although a prescriber identified as Dr. A.Q. was not listed 
on the prescription pad for Redbird, he had the same address on West 
Camp Wisdom Road. GE-2, at 70.
    119. On October 2, 2014, the prescription pad for AC Medical clinic 
(``AC Medical'') contained the names of the following medical 
providers: C.V., M.D.; I.I., DNP-FMP; L.R., ACNS-BC; S.G., FNP; and 
C.Z., PA, with an address on Billing Street in Arlington, Texas. GE-2, 
at 16.
    120. On January 13, 2015, the prescription pad for AC Medical 
contained the names of the following medical providers: C.V., M.D.; NE, 
M.D.; L.R., ACNS-BC; S.G., FNP; and C.Z., PA, with an address on East 
Arkansas Lane in Arlington, Texas. Tr. 207; GE-2, at 132.
    121. The prescription pad for Arlington Oaks medical clinic 
(``Arlington Oaks'') contains the names of the following medical 
providers: C.V., M.D.; S.G., FNP; L.R., ACNS-BC; and C.Z., PA, with an 
address on Billing Street in Arlington, Texas. Tr. 206; GE-2, at 5.
    The M.W. Prescription
    122. DI 1 identified Government Exhibit 11 as the declaration of UC 
1, an agent of the Texas Department of Public Safety. Tr. 30. In the 
declaration, UC 1 describes an undercover operation in which he 
obtained a prescription from the Redbird Clinic and filled the 
prescription at the Pharmacy. Id. at 30.
    123. DI 1 knew UC 1 from his work on the investigation of the 
Pharmacy, but he did not know that UC 1 was going undercover. Id. at 
68-69, 140. DI 1 reviewed UC 1's declaration and discussed it with him. 
Id. at 31-32.
    124. During the undercover operation, UC 1 used the name M.W., and 
he used a driver's license with that name. Tr. 41; GE-10, at 3. The 
driver's license had a fictitious Fort Worth address. Tr. 189, 541; GE-
11, at 2. The Pharmacy maintained a copy of the prescription it filled 
for M.W. and a copy of M.W.'s patient profile. Tr. 41; GE-10, at 4-
5.\5\
---------------------------------------------------------------------------

    \5\ Government Exhibit 2, page 1, is another copy of the 
prescription issued to ``M.W.'' Tr. 40. Government Exhibit 2, page 
2, is a photo of the prescription bottle of hydrocodone filled by 
the Pharmacy for ``M.W.'' Tr. 43.
---------------------------------------------------------------------------

    125. At 6:55 a.m. on July 29, 2014, undercover agent UC 1 was in a 
car in the Redbird parking lot. GE-11, at 2. There were about 15 other 
occupied vehicles in the parking lot at that time. Id. An individual 
came out of the clinic and asked the drivers to inform him how many 
people were in each vehicle, and the drivers indicated between two and 
five persons were in each car. Id. The individual then began directing 
traffic and controlling the flow of traffic into the clinic. Id.
    126. When UC 1 entered the Redbird clinic he was searched by an 
armed security guard and was seated in the order that he had entered 
the clinic. GE-11, at 2. When called to the receptionist's counter, UC 
1 paid a fee of $170.00, and filled out a questionnaire, using the 
``M.W.'' alias. Id. He provided the fictitious address of 5944 
Callaston Lane, Fort Worth, Texas.\6\ Id. UC 1 indicated that he was 
experiencing back pain due to sleeping on an old mattress. GE-11, at 3.
---------------------------------------------------------------------------

    \6\ I find that the fact that M.W. used a fictitious address to 
be irrelevant. See Tr. 191; infra note 40.
---------------------------------------------------------------------------

    127. At 10:40 a.m. UC 1 met with L.R., ACNS-BC, who checked his 
heart, looked at his back, and an old scar on his knee. GE-11, at 3. 
L.R. then issued ``M.W.'' three prescriptions, to include 120 tablets 
of hydrocodone 10 mg. Id. Redbird informed ``M.W.'' that the 
prescription would be sent to the Pharmacy and UC 1 confirmed that the 
Pharmacy received it on August 1, 2014. Id.; Tr. 190.
    128. The M.W. prescription was written on July 29, 2014, and 
received by the Pharmacy on August 1, 2014. Tr. 543, 562-63; GE-2, at 
1; GE-11, at 3; RE-G, at 8.
    129. The M.W. prescription was written to treat pain. Tr. 543; GE-
2, at 1.
    130. The M.W. prescription was faxed by Redbird to the Pharmacy. 
Tr. 192, 430, 571-72, 592; GE-2, at 1; GE-11, at 3; RE-G, at 8.
    131. A copy of the prescription that undercover agent UC 1 received 
from Redbird, under the name of ``M.W.,'' as well as the Pharmacy's 
fill sticker for that prescription, are both contained on page 1 of 
Government Exhibit 2. Tr. 183-84.
    132. On August 4, UC 1 presented to the Pharmacy as ``M.W.,'' and 
purchased the prescriptions, paying $150.00 for the hydrocodone. Tr. 
576, 591; GE-2, at 1; GE-11, at 3.
    133. The fact that the M.W. prescription was written on July 29, 
2014, and not picked up until August 4, 2014, did not cause Ms. Igwe 
any concern. Tr. 577.
    134. Ms. Igwe did not look up the address on M.W.'s driver's 
license to verify whether it was a real or fictitious address. Tr. 541; 
GE-11, at 3.
    135. The prescription that L.R. wrote for M.W. raises the following 
red flags: No patient address; no provider DEA number; [ ] \*B\ the 
prescription was written on July 29, 2014, but not faxed to the 
Pharmacy until August 1, 2014, and not picked up until August 4, 2014; 
and an unusual path and distance to obtain the prescription and get it 
filled.\7\ Tr. 188-94.
---------------------------------------------------------------------------

    \*B\ Text adjusted in response to Respondent's Exceptions.
    \7\ Dr. Witte testified that the delay in picking up this 
prescription raises the question of whether the patient actually 
needed the prescription for pain and whether the prescription was 
written for a legitimate medical purpose. Tr. 193. That concern is 
exacerbated by the fact that the patient waited an additional three 
days to pick up the prescription after Redbird faxed it to the 
Pharmacy. Tr. 193; GE-2, at 1; GE-11, at 3. [Dr. Witte also 
testified that M.W. received a ``large quantity'' of a high-alert 
drug, which could be a red flag. Tr. 189.]*
---------------------------------------------------------------------------

    136. There are no notes on the M.W. prescription or in the 
Pharmacy's patient profile for M.W. indicating that any of the red 
flags were resolved prior to filling the prescription. Tr. 194-95; GE-
2, at 1; GE-10, at 4-5.
    137. Based on the information provided to the Pharmacy, M.W., more 
likely than not, would have passed many pharmacies as he traveled the 
99 miles from his purported residence in Fort Worth, to Redbird south 
of Dallas, to the Pharmacy, north of Dallas, and then return to his 
purported Fort Worth home. Tr. 193-94, 364-65; GE-12.
    138. Ms. Igwe had no concern about the distance between M.W.'s 
fictitious address in Fort Worth and the Pharmacy in Plano. Tr. 542-43.
    139. There is transmission data printed along the top of the page 
that contains the M.W. prescription and fill sticker indicating that 
the page was ``4 of 4'' of the pages Redbird faxed to the Pharmacy. GE-
2, at 1. Dr. Witte was not provided pages one through three to review, 
nor are those pages contained in the Administrative Record. Tr. 255; 
GE-2, at 1.

The Other Prescriptions

    140. Government Exhibit 2 contains 77 prescriptions for 27 of the 
Pharmacy's customers. Tr. 254; GE-2. Government Exhibit 2 also contains 
patient profiles for 26 of the Pharmacy's customers. GE-2. Several of 
the patient profiles contained in Government Exhibit 2 reveal 
prescriptions the Pharmacy filled for hydrocodone and

[[Page 21027]]

alprazolam prior to August 2014, for which the actual prescriptions are 
not contained in the Administrative Record. Id. at 32-33, 42-43, 54-55, 
82.
    141. On several occasions, prescription cocktails of hydrocodone 
and alprazolam, contained in Government Exhibit 2, were written or 
filled on different days. Tr. 311; GE-2, at 28-30, 34-36, 50-52, 94-96, 
109-11, 117-19.
    142. The patient profile for A.S. raises a red flag of pattern 
prescribing: The same controlled substances; the same strength and 
dosages (90 hydrocodone 10/325 mg, 60 alprazolam 2 mg); the same small 
group of providers; and cash payments. Tr. 241, 408-09; GE-2, at 22-33. 
Between February 24, 2014 and March 30, 2015, A.S. filled six 
prescriptions for hydrocodone and six prescriptions for alprazolam at 
the Pharmacy. GE-2, at 31-33. On February 24, 2014, the Pharmacy filled 
prescriptions of 120, 10 mg tablets of hydrocodone and 60 tablets of 
alprazolam for A.S., written by S.G., a family nurse practitioner at AC 
Medical and Arlington Oaks. Id. at 32-33; see also id. at 5, 16 
(displaying S.G.'s name on prescription pads of those two practices). 
On May 1, 2014, the Pharmacy filled prescriptions of 90, 10 mg tablets 
of hydrocodone and 60 tablets of alprazolam for A.S., written by S.G. 
Id. at 32. The round-trip distance \8\ for A.S. to obtain her 
prescriptions and have them filled at the Pharmacy was 104 miles. Stip. 
32.
---------------------------------------------------------------------------

    \8\ The ``round-trip distance'' is the distance, as measured by 
MapQuest, from the patient's address as recorded in the Pharmacy's 
records, to the prescriber's office, as reflected in the patient's 
profile maintained by the Pharmacy, then to the Pharmacy, and 
returning to the patient's home. See, e.g., GE-3, at 1-5. There is 
no evidence that any patient traveled this round-trip distance, as a 
continuous or single trip, upon leaving the patient's home. 
Nevertheless, the three addresses used to calculate the distances 
are taken from the Pharmacy's records.
---------------------------------------------------------------------------

    143. The patient profile for R.E. raises a red flag of pattern 
prescribing: The same controlled substances; the same strength and 
dosages (90 hydrocodone 10/325 mg, 60 alprazolam 2 mg); the same small 
group of providers; and cash payments. Tr. 237-39; GE-2, at 34-43. 
Between April 3, 2014 and March 23, 2015, R.E. filled five 
prescriptions for hydrocodone and five prescriptions for alprazolam at 
the Pharmacy. GE-2, at 42-43. On April 3, 2014, the Pharmacy filled 
prescriptions of 90, 10 mg tablets of hydrocodone and 60 tablets of 
alprazolam for R.E., written by S.G. Id. at 43. On May 30, 2014, the 
Pharmacy filled prescriptions of 90, 10 mg tablets of hydrocodone and 
60 tablets of alprazolam for R.E., written by C.Z., a physician's 
assistant at AC Medical and Arlington Oaks. Id. at 42-43; see also Id. 
at 5, 16 (displaying C.Z.'s name on prescription pads of those two 
practices). The round-trip distance for R.E. to obtain his 
prescriptions and have them filled at the Pharmacy was 86 miles. GE-3, 
at 35-40.
    144. On March 18, 2014, the Pharmacy filled prescriptions of 120, 
10 mg tablets of hydrocodone and 60 tablets of alprazolam for K.S., 
written by L.R., a nurse practitioner at Redbird, AC Medical, and 
Arlington Oaks. GE-2, at 55; see also id. at 5, 12, 16 (displaying 
L.R.'s name on prescription pads of those three practices). On April 
15, 2014, the Pharmacy filled prescriptions of 90, 10 mg tablets of 
hydrocodone and 60 tablets of Alprazolam for K.S., written by S.G. Id. 
at 55. On May 27, 2014, the Pharmacy filled prescriptions of 90, 10 mg 
tablets of hydrocodone and 60 tablets of alprazolam for K.S., written 
by S.G. Id. at 54-55. Then on June 26, 2014, the Pharmacy filled 
prescriptions of 120, 10 mg tablets of hydrocodone and 60 tablets of 
alprazolam for K.S., written by S.G. Id. at 54. The round-trip distance 
for K.S. to obtain her prescriptions and have them filled at the 
Pharmacy was 101 miles. Stip. 35
    145. On June 19, 2014, the Pharmacy filled prescriptions of 120, 10 
mg tablets of hydrocodone and 60 tablets of alprazolam for M.W.2, 
written by L.R. Id. at 82. The round-trip distance for M.W.2 to obtain 
her prescriptions and have them filled at the Pharmacy was 97 miles. 
Stip. 41.
    146. The patient profile for R.N. raises a red flag of pattern 
prescribing: The same controlled substances; the same strength and 
dosages (90 hydrocodone 10/325 mg, 60 alprazolam 2 mg); the same small 
group of providers; and cash payments. Tr. 239-41; GE-2, at 117-29. 
Between November 17, 2014 and May 11, 2015, R.N. filled five 
prescriptions for hydrocodone and five prescriptions for alprazolam at 
the Pharmacy. GE-2, at 128-29.
    147. On August 6, 2014, L.R. wrote prescriptions for 120 tablets of 
hydrocodone and 60 tablets of alprazolam for patient J.S. GE-2, at 3-4. 
The prescriptions were filled the same day at the Pharmacy where the 
customer paid $59.99 for the alprazolam and $150.00 for the 
hydrocodone. Id. at 3. To obtain the prescription and have it filled, 
J.S. would have traveled 80 miles. Stip. 34.
    148. On August 8, 2014, S.G. wrote prescriptions for a drug 
cocktail of 90 hydrocodone and 60 alprazolam for patient J.W. Tr. 197-
98, 399; GE-2, at 5. The prescriptions were filled at the Pharmacy on 
August 11, 2014, where the customer paid $59.99 for the alprazolam and 
$125.00 for the hydrocodone. GE-2, at 5. To obtain the prescription and 
have it filled, J.W. would have traveled 108 miles. Stip. 39.
    149. On August 29, 2014, S.G. wrote prescriptions for 120 
hydrocodone and 60 alprazolam for patient J.W. GE-2, at 6. The 
prescriptions were filled at the Pharmacy on September 12, 2014, where 
the customer paid $59.99 for the alprazolam and $160.00 for the 
hydrocodone. Id. To obtain the prescription and have it filled, J.W. 
would have traveled 108 miles. Stip. 39. The patient picked up the 
prescription at the Pharmacy 14 days after the prescription was 
written. GE-2, at 6. Neither the prescriptions for J.W. nor his patient 
profile, maintained by the Pharmacy, contain any notes resolving the 
red flags presented by these prescriptions. Tr. 208-10.
    150. The January 16, 2015 prescription for R.H. for alprazolam 
raises a red flag. Tr. 242. The prescription indicates that the 
alprazolam was to be taken once every eight hours, but the prescription 
label has instructions indicating that it was to be taken one tablet 
twice per day.\9\ Tr. 242, 753-54; GE-2, at 66.
---------------------------------------------------------------------------

    \9\ Litman testified that a pharmacist should document in the 
pharmacy's computer system if he or she was dispensing a medication 
with dosing instructions different than prescribed. Tr. 753-54. 
There is no such documentation in this Administrative Record.
---------------------------------------------------------------------------

    151. The January 16, 2015 prescription for R.H. for hydrocodone 
raises several red flags. Tr. 242. The prescription indicates that the 
hydrocodone was to be taken once every 8 to 12 hours for moderate to 
severe pain. Id. at 396; GE-2, at 64-65. If the patient had moderate to 
severe pain, the patient would be taking the medication once every four 
to six hours. Tr. 396, 681, 686. In addition, while the prescription 
was written for moderate to severe pain on January 16, 2015, the 
prescription was not filled until January 20, 2015. Tr. 396; GE-2, at 
64-65. Filling a prescription for moderate to severe pain four days 
after it was written raises a red flag. Tr. 193, 396-97. Further, R.H. 
paid cash for his hydrocodone and alprazolam prescriptions, paying a 
total of $212.98 on January 20, 2015. GE-2, at 65-66. Finally, to 
obtain his prescriptions and have them filled, R.H. would have traveled 
more than 75 miles. Stips. 21, 22.
    152. The April 6, 2015 prescription for R.H. for hydrocodone 
indicates that it was to be taken 1 to 2 tablets every 8 to 12 hours 
for moderate to severe pain. Tr. 241; GE-2 at 68. These dosing

[[Page 21028]]

instructions are a red flag because for moderate to severe pain the 
patient should be taking the medication more frequently. Tr. 241, 395-
96; GE-2, at 64-65, 68-69.
    153. R.H. was receiving two different controlled substances from 
two different doctors, hydrocodone from Dr. A.Q. and promethazine with 
codeine from Nurse J.W. Tr. 242-43, 341; GE-2, at 70. Dr. A.Q. and 
Nurse J.W. had different addresses. Tr. 243, 362-64; GE-2, at 70. A 
pharmacist would want to determine why a patient was obtaining 
controlled substances from two different doctors from different 
locations. Tr. 243, 362-64.
    154. There are no pharmacist's notes or remarks written on R.H's 
prescriptions or in his patient profile that resolves the red flags 
raised by his controlled substance prescriptions. Tr. 243.
    155. Government Exhibit 6 contains the Pharmacy's hydrocodone 
dispensing history between July 7, 2014 and May 21, 2015. Tr. 37, 138, 
168; GE-6, at 1, 85. Government Exhibit 6 documents 927 prescriptions 
that the Pharmacy filled for hydrocodone. GE-6. All but 25 of those 
prescriptions were written by the same small group of prescribers, who 
wrote the prescriptions identified on the patient profiles contained in 
Government Exhibit 2: Dr. C.V., Dr. NE, ANP J.W., Dr. A.Q., PA C.Z., NP 
L.O., DNP I.I., NP S.G., and ACNS L.R.\10\ The Pharmacy filled 104 
prescriptions for hydrocodone before it filled the hydrocodone 
prescription for J.S. on August 6, 2014. GE-2, at 3; GE-6, at 1-10.
---------------------------------------------------------------------------

    \10\ See GE-6, at 13, 17, 41, 43, 47, 53, 56, 58, 64, 65, and 85 
for prescriptions written by eight other prescribers.
---------------------------------------------------------------------------

    156. Between October 10-23, 2014, the Pharmacy received 26 
consecutive prescriptions for 90 tablets of hydrocodone written by Dr. 
C.V. GE-6, at 29-31. Between November 7-12, 2014, the Pharmacy filled 
17 consecutive prescriptions for 90 tablets of hydrocodone written by 
Dr. C.V. GE-6, at 33-35.
    157. Between November 12-20, 2014, the Pharmacy received 20 
consecutive prescriptions for hydrocodone written by Dr. C.V., all but 
one of which were for 90 tablets. GE-6, at 35-37.
    158. The Pharmacy received 9 prescriptions for 90 tablets of 
hydrocodone 10/325 mg on December 31, 2014. Tr. 424-25, 560; RE-G, at 
44-45; GE-6, at 44-45. Eight of the nine prescriptions were written by 
Dr. C.V. Tr. 424-25; RE-G, at 44-45; GE-6, at 44-45. Receiving these 
nine prescriptions on the same date did not cause Ms. Igwe any concern. 
Tr. 561.
    159. Between April 9 and May 8, 2015, the Pharmacy received 105 
consecutive prescriptions for hydrocodone written by either Dr. C.V. or 
Dr. NE, all but six of which were for 90 tablets. GE-6, at 69-79. 
Finally, between May 18-21, 2015, the Pharmacy filled 23 consecutive 
prescriptions for hydrocodone 10/325 mg written by Dr. NE, all but one 
of which were for 90 tablets. Tr. 594-95; GE-6, at 83-85.
    160. The prescriptions identified in Findings of Fact 155-159 are 
examples of pattern prescribing. Tr. 171, 231, 388.
    161. All the prescriptions in Government Exhibit 6 were filled by 
Ms. Igwe. Tr. 390; see also 22 Tex. Admin. Code Sec.  
291.33(c)(7)(A)(iv) (requiring the dispensing pharmacist to write his 
or her initials on the prescription label).
    162. Prescriptions Written by Nurse Practitioner I.I.:

----------------------------------------------------------------------------------------------------------------
                                                Controlled      Round-trip
        Patient          Date prescription    substance(s);      distance          Cost         Record citations
                          written; filled        quantity        (miles)
----------------------------------------------------------------------------------------------------------------
J.W.2..................  8/18/14; 8/20/14.  Hydrocodone                 98  $150.00; $59.99..  Tr. 234; GE-2, at
                                             (120);                                             12; Stip. 40.
                                             Alprazolam (60).
C.J....................  8/18/14; 8/19/14.  Hydrocodone (90);           81  $125.00; $59.99..  Tr. 233; GE-2, at
                                             Alprazolam (60).                                   8; Stip. 25.
S.W....................  8/19/14; 8/19/14.  Hydrocodone                 99  $150.00; $59.99..  Tr. 234; GE-2, at
                                             (120);                                             10; Stip. 43.
                                             Alprazolam (60).
S.H....................  9/4/14; 9/4/14...  Hydrocodone (90);           76  $120.00; $59.99..  Tr. 234-35; GE-2,
                                             Alprazolam (60).                                   at 14; Stip. 24.
H.J....................  10/2/14; 10/2/14.  Hydrocodone                105  $160.00; $59.99..  Tr. 235; GE-2, at
                                             (120);                                             16; Stip. 26.
                                             Alprazolam (60).
----------------------------------------------------------------------------------------------------------------


[[Page 21029]]

    163. These prescriptions written by Nurse Practitioner I.I. are 
indicative of pattern prescribing: Same controlled substances; same 
quantity; same dosages; same prescriber; same drug cocktails. Tr. 236. 
This pattern indicates a lack of individualization of therapy. Id. at 
209. In addition, these patients took unusual paths and distances to 
obtain and fill their prescriptions. Id. at 236. The similarities would 
make a pharmacist wonder why multiple patients from this medical 
provider were being prescribed the same quantity of hydrocodone, and in 
the same strength and dosing. Id. at 258.
    164. The unusual path and distance that I.I.'s patients traveled to 
obtain their prescriptions and get them filled is a red flag. Id. at 
236.
    165. The fill stickers for all of I.I.'s patients indicate that 
they paid $120 to $160 for their prescriptions for hydrocodone, which 
is much higher than the usual cost of hydrocodone. Id. at 222-23. The 
cash price for 90 tablets of hydrocodone is about $70, and the cash 
price for 60 tablets of alprazolam is about $35. Id. at 223.
    166. There are no notes on I.I.'s prescriptions or the patient 
profiles documenting the Pharmacy's resolution of any red flag or 
consultation with I.I. regarding the red flags. Id. at 236; GE-2, at 4, 
7, 9, 11, 13, 15, 17, 21, 31-33, 42-43, 53-55, 59, 63, 70, 74, 78, 82, 
85, 92-93, 97, 102, 104-05, 107-08, 112, 116, 128-29, 133.
    167. Prescriptions Written by Dr. C.V.:

----------------------------------------------------------------------------------------------------------------
                                                Controlled      Round-trip
        Patient          Date prescription    substance(s);      distance          Cost         Record citations
                          written; filled        quantity        (miles)
----------------------------------------------------------------------------------------------------------------
R.E....................  11/14/14; 11/14/   Hydrocodone (90)            94  $180.............  Tr. 218, 226, 238-
                          14.                \11\.                                              39; GE-2, at 35-
                                                                                                36; Stip. 17.
R.N....................  11/15/2014; 11/17/ Hydrocodone (90)            64  $180.............  Tr. 221, 226; GE-
                          2014.              \12\.                                              2, at 117-118;
                                                                                                Stip. 30.
R.N....................  Filled: 12/19/14.  Hydrocodone (90)            64  Unknown..........  Tr. 222; GE-2, at
                                             \13\.                                              129; Stip. 30.
A.S....................  Filled: 12/22/14.  Hydrocodone (90)           111  Unknown..........  Tr. 217-18, 226,
                                             \14\.                                              241; GE-2, at
                                                                                                32; Stip. 33.
M.H....................  1/13/15; 1/13/15.  Hydrocodone (90)           121  $179.99..........  Tr. 222, 226; GE-
                                             \15\.                                              2, at 130-31;
                                                                                                Stip. 20.
K.S....................  1/27/15; 1/27/15.  Hydrocodone (90)           109  $179.99; $59.99..  Tr. 204, 219,
                                             \16\.                                              226; GE-2, at 44-
                                                                                                46; Stip. 36.
K.S....................  2/26/15; 2/26/15.  Hydrocodone (90)           109  $179.99..........  Tr. 205, 219,
                                             \17\.                                              226; GE-2, at 47-
                                                                                                48; Stip. 36.
R.E....................  3/23/15; 3/23/15.  Hydrocodone (90)            94  $179.99; $59.99..  Tr. 218, 226; GE-
                                             \18\.                                              2, at 39-42;
                                                                                                Stip. 17.
K.S....................  3/26/15; 3/26/15.  Hydrocodone (90)           109  $179.99..........  GE-2, at 50-52;
                                             \19\.                                              Stip. 36.
A.S....................  3/28/15; 3/30/15.  Hydrocodone (90)           111  $179.99..........  Tr. 217, 226; GE-
                                             \20\.                                              2, at 28-30;
                                                                                                Stip. 33.
G.B....................  4/16/15; 4/17/15.  Hydrocodone (90).           55  $179.99..........  Tr. 219-20, 226;
                                                                                                GE-2, at 83-84;
                                                                                                Stip. 12.
M.A....................  4/17/15; 4/17/15.  Hydrocodone (90)           107  $179.99..........  Tr. 205-06, 220,
                                             \21\.                                              226; GE-2, at 94-
                                                                                                95; Stip. 9.
R.H.2..................  4/20/15; 4/21/15.  Hydrocodone (90)            92  $179.99 $59.99...  Tr. 220, 226; GE-
                                             \22\.                                              2, at 98-100;
                                                                                                Stip. 23.
A.K....................  5/1/15; 5/1/15...  Hydrocodone (90)            81  $179.99 $59.99...  Tr. 221, 226; GE-
                                             \23\.                                              2, at 113-115;
                                                                                                Stip. 27.
----------------------------------------------------------------------------------------------------------------


[[Page 21030]]

    168. The prescription that Dr. C.V. wrote for G.B. on April 16, 
2015, contained unusual dosing instructions for hydrocodone, of one 
tablet three times per day. Tr. 383; GE-2, at 83. Faced with these 
dosing instructions, the pharmacist should have called the prescriber 
to confirm the dosing instructions before filling the prescription. Tr. 
383.
---------------------------------------------------------------------------

    \11\ The day before Dr. C.V. wrote R.E. a prescription for 
hydrocodone, S.G. FNP, of the same medical practice as Dr. C.V., 
wrote R.E. a prescription for 60 tablets of alprazolam 2 mg. The 
Pharmacy filled this prescription the same day it was written, 
November 13, 2014. GE-2, at 34-36. Although Dr. C.V. and FNP S.G. 
were with the same medical practice, the patient profile shows Dr. 
C.V. being located at 916 Wynnewood Shopping Center, Dallas, Texas, 
and FNP S.G. being located at 201 Billings Street, Arlington, Texas. 
GE-2, at 42.
    \12\ The day before Dr. C.V. wrote R.N. a prescription for 
hydrocodone, L.R., ACNS-BC, of the same medical practice as Dr. 
C.V., wrote R.N. a prescription for 60 tablets of alprazolam 2 mg. 
GE-2, at 119. The Pharmacy filled both prescriptions the same day, 
November 17, 2014. GE-2, at 117-19. Although Dr. C.V. and ACNS L.R. 
were with the same medical practice, the patient profile shows Dr. 
C.V. being located at 916 Wynnewood Shopping Center, Dallas, Texas, 
and ACNS L.R. being located at 202 Billings Street, Arlington, 
Texas. GE-2, at 119, 129.
    \13\ The same day the Pharmacy filled the prescription for 
hydrocodone, written by Dr. C.V. for R.N., it also filled a 
prescription for 60 tablets of alprazolam 2 mg, written by L.R., 
ACNS-BC, for R.N. GE-2, at 129. Although Dr. C.V. and ACNS L.R. were 
with the same medical practice, the patient profile shows Dr. C.V. 
being located at 916 Wynnewood Shopping Center, Dallas, Texas, and 
ACNS L.R. being located at 202 Billings Street, Arlington, Texas. 
GE-2, at 119, 129.
    \14\ The same day the Pharmacy filled the prescription for 
hydrocodone, written by Dr. C.V., for A.S., it also filled a 
prescription for 60 tablets of alprazolam 2 mg, written by L.R., 
ACNS-BC, for A.S. GE-2, at 32. Although Dr. C.V. and ACNS L.R. were 
with the same medical practice, the patient profile shows Dr. C.V. 
being located at 916 Wynnewood Shopping Center, Dallas, Texas, and 
ACNS L.R. being located at 202 Billings Street, Arlington, Texas. 
GE-2, at 30, 32.
    \15\ On the same day that Dr. C.V. wrote M.H. a prescription for 
hydrocodone, Dr. NE, of the same medical practice as Dr. C.V., wrote 
M.H. a prescription for 60 tablets of alprazolam 2 mg. Both 
prescriptions were filled by the Pharmacy on the same day, January 
13, 2015. GE-2, at 130-32. Although Dr. C.V. and Dr. NE were with 
the same medical practice, the patient profile shows Dr. C.V. being 
located at 916 Wynnewood Shopping Center, Dallas, Texas, and Dr. NE 
being located at 201 Billings Street, Arlington, Texas. GE-2, at 
132-33. Further, the address for Dr. NE in the patient profile is 
different from her address listed on the prescription, 2596 East 
Arkansas Lane, Arlington, Texas. Id.
    \16\ On the same day that Dr. C.V. wrote K.S. a prescription for 
hydrocodone, C.Z., PA, of the same medical practice as Dr. C.V., 
wrote K.S. a prescription for 60 tablets of alprazolam 2 mg. Cf. GE-
2, at 46. Both prescriptions were filled by the Pharmacy on the same 
day, January 27, 2015. GE-2, at 44-46. The Pharmacy fill sticker for 
the alprazolam prescription inaccurately lists Dr. C.V. as the 
prescriber. Compare GE-2, at 46 with known signatures of C.Z. at GE-
2, at 30, 52, 122-23. Although Dr. C.V. and C.Z. were with the same 
medical practice, the patient profile shows Dr. C.V. being located 
at 916 Wynnewood Shopping Center, Dallas, Texas, and C.Z. being 
located at 201 Billings Street, Arlington, Texas. GE-2, at 53. 
Further, the address for C.Z. in the patient profile is different 
from his address listed on the prescription for alprazolam, 2596 
East Arkansas Lane, Arlington, Texas. Compare GE-2, at 46 with GE-2, 
at 53.
    \17\ On the same day that Dr. C.V. wrote K.S. a prescription for 
hydrocodone, Dr. NE, of the same medical practice as Dr. C.V., wrote 
K.S. a prescription for 60 alprazolam 2 mg. GE-2, at 49. Both 
prescriptions were filled by the Pharmacy on the same day, February 
26, 2015. GE-2, at 47-49. Although Dr. C.V. and Dr. NE were with the 
same medical practice, the patient profile shows Dr. C.V. being 
located at 916 Wynnewood Shopping Center, Dallas, and Dr. NE being 
located at 201 Billings Street, Arlington, Texas. GE-2, at 49, 53. 
Further, the address for Dr. NE in the patient profile is different 
from her address listed on the prescription, 2596 East Arkansas 
Lane, Arlington, Texas. Id.
    \18\ Two days before Dr. C.V. wrote R.E. a prescription for 
hydrocodone, C.Z., PA, of the same medical practice as Dr. C.V., 
wrote R.E. a prescription for 60 tablets of alprazolam 2 mg. GE-2, 
at 41. Both prescriptions were filled by the Pharmacy on the same 
day, March 23, 2015. GE-2, at 39-41. The Pharmacy fill sticker for 
the prescription for alprazolam inaccurately lists Dr. C.V. as the 
prescriber. Compare GE-2, at 41 with known signatures of C.Z. at GE-
2, at 30, 52, 122-23. Although Dr. C.V. and C.Z. were with the same 
medical practice, the patient profile shows Dr. C.V. being located 
at 916 Wynnewood Shopping Center, Dallas, Texas, and C.Z. being 
located at 201 Billings Street, Arlington, Texas. GE-2, at 42. 
Further, the address for C.Z. in the patient profile is different 
from his address listed on the prescription for alprazolam, 2596 
East Arkansas Lane, Arlington, Texas. Compare GE-2, at 41 with GE-2, 
at 42.
    \19\ The day before Dr. C.V. wrote K.S. a prescription for 
hydrocodone, C.Z., PA, of the same medical practice as Dr. C.V., 
wrote K.S. a prescription for 60 tablets of alprazolam 2 mg. GE-2, 
at 52. Both prescriptions were filled by the Pharmacy the next day, 
March 26, 2015. GE-2, at 50-52. Although Dr. C.V. and PA C.Z. were 
with the same medical practice, the patient profile shows Dr. C.V. 
being located at 916 Wynnewood Shopping Center, Dallas, and PA C.Z. 
being located at 201 Billings Street, Arlington, Texas. GE-2, at 49, 
53. Further, the address for PA C.Z. in the patient profile is 
different from his address listed on the prescription, 2596 East 
Arkansas Lane, Arlington, Texas. Id.
    \20\ The day after Dr. C.V. wrote A.S. a prescription for 
hydrocodone, C.Z., PA, of the same medical practice as Dr. C.V., 
wrote A.S. a prescription for 60 tablets of alprazolam 2 mg. GE-2, 
at 30. Both prescriptions were filled by the Pharmacy the next day, 
March 30, 2015. GE-2, at 28-30. Although Dr. C.V. and PA C.Z. were 
with the same medical practice, the patient profile shows Dr. C.V. 
being located at 916 Wynnewood Shopping Center, Dallas, Texas, and 
PA C.Z. being located at 201 Billings Street, Arlington, Texas. GE-
2, at 30-31. Further, the address for Dr. C.V. in the patient 
profile is different from his address listed on the prescription, 
8222 Douglas Avenue, Dallas, Texas, and the address for PA C.Z. in 
the patient profile is different from his address listed on the 
prescription, 2596 East Arkansas Lane, Arlington, Texas. GE-2, at 
28, 30-31.
    \21\ The day before Dr. C.V. wrote M.A. a prescription for 
hydrocodone, L.R., ACNS-BC, of the same medical practice as Dr. 
C.V., wrote M.A. a prescription for 60 tablets of alprazolam 2 mg. 
GE-2, at 96. Both prescriptions were filled by the Pharmacy the next 
day, April 17, 2015. GE-2, at 94-96. Although Dr. C.V. and ACNS L.R. 
were with the same medical practice, Dr. C.V.'s prescription lists 
an address of 201 Billing Street, Arlington, Texas, and the 
prescription that L.R. wrote shows her address as being, 2596 East 
Arkansas Lane, Arlington, Texas. GE-2, at 94, 96. In addition, while 
the prescription for alprazolam clearly bears the signature of ACNS 
L.R., the fill sticker indicates that Dr. C.V. wrote the 
prescription. GE-2, at 96.
---------------------------------------------------------------------------

    169. The prescriptions written by Dr. C.V. are indicative of 
pattern prescribing: Same controlled substances; same quantity; same 
dosages; same prescriber; same drug cocktails. Id. at 215. This pattern 
indicates a lack of individualization of therapy. Id. at 209. In 
addition, these patients took unusual paths and distances to obtain and 
fill their prescriptions. Id. at 226-27. The similarities would make a 
pharmacist wonder why multiple patients from this doctor/medical 
practice were being prescribed the same quantity of hydrocodone, and in 
the same strength and dosing. Id. at 258.
---------------------------------------------------------------------------

    \22\ Three days before Dr. C.V. wrote R.H.2 a prescription for 
hydrocodone, C.Z., PA, of the same medical practice as Dr. C.V., 
wrote R.H.2 a prescription for 60 tablets of alprazolam 2 mg. GE-2, 
at 100. Both prescriptions were filled by the Pharmacy on April 21, 
2015. GE-2, at 98-100. The Pharmacy fill sticker for the 
prescription for alprazolam inaccurately lists Dr. C.V. as the 
prescriber. Compare GE-2, at 100 with known signatures of C.Z. at 
GE-2, at 30, 52, 122-23. Although Dr. C.V. and C.Z. were with the 
same medical practice, the patient profile shows Dr. C.V. being 
located at 916 Wynnewood Shopping Center, Dallas, Texas, yet the 
prescription for hydrocodone lists his address as 201 Billings 
Street, Arlington, Texas. GE-2, at 101. The prescription pad that 
C.Z. used to write the prescription for alprazolam lists his address 
as 2596 East Arkansas Lane, Arlington, Texas. GE-2, at 100.
    \23\ On the same day that Dr. C.V. wrote A.K. a prescription for 
hydrocodone, C.Z. wrote A.K. a prescription for 60 tablets of 
alprazolam 2 mg. GE-2, at 115. Both prescriptions were filled by the 
Pharmacy on the same day, May 1, 2015. GE-2, at 113-15. The Pharmacy 
fill sticker for the prescription for alprazolam inaccurately lists 
Dr. C.V. as the prescriber. Compare GE-2, at 115 with known 
signatures of C.Z. at GE-2, at 30, 52, 122-23. Although Dr. C.V. and 
C.Z. were with the same medical practice, the patient profile shows 
Dr. C.V. being located at 916 Wynnewood Shopping Center, Dallas, 
Texas, yet the prescription for hydrocodone lists his address as 201 
Billings Street, Arlington, Texas. GE-2, at 113. The prescription 
pad that C.Z. used to write the prescription for alprazolam lists 
his address as 2596 East Arkansas Lane, Arlington, Texas. GE-2, at 
115.
---------------------------------------------------------------------------

    170. The unusual path and distance that Dr. C.V.'s patients 
traveled to obtain their prescriptions and get them filled is a red 
flag. Id. at 236.
    171. The fill stickers for all of these patients indicate that they 
paid $179.99 for their prescriptions for hydrocodone, which is much 
higher than the usual cost of 90 tablets of hydrocodone. Id. at 222-23. 
The cash price for 90 tablets of hydrocodone is about $70, and the cash 
price for 60 tablets of alprazolam is about $35. Id. at 223.
    172. There are no notes on Dr. C.V.'s prescriptions or the patient 
profiles documenting that the Pharmacy resolved any red flag or 
consulted with Dr. C.V., or other prescribers. Tr. 227,

[[Page 21031]]

404-05; GE-2, at 4, 7, 9, 11, 13, 15, 17, 21, 31-33, 42-43, 53-55, 59, 
63, 70, 74, 78, 82, 85, 92-93, 97, 102, 104-05, 107-08, 112, 116, 128-
29, 133.
    173. Prescriptions written by Dr. NE:

----------------------------------------------------------------------------------------------------------------
                                                Controlled      Round-trip
        Patient          Date prescription    substance(s);      distance          Cost         Record citations
                          written; filled        quantity        (miles)
----------------------------------------------------------------------------------------------------------------
A.S....................  1/24/15;.........  Hydrocodone (90)           104  $179.99..........  Tr. 200-01; GE-2,
                         1/26/15..........   \24\.                                              at 22-23; Stip.
                                                                                                32.
R.N....................  2/2/2015; 2/3/     Hydrocodone (90)            95  $179.99..........  Tr. 239-41; GE-2,
                          2015.              \25\.                                              at 120-21; Stip.
                                                                                                28.
R.E....................  2/2/2015; 2/2/     Hydrocodone (90)            86  $179.99..........  GE-2, at 38, 42;
                          2015.              \26\.                                              GE-3, at 35-40.
A.S....................  2/27/2015; 2/27/   Hydrocodone                104  $179.99..........  GE-2, at 26-27,
                          2015.              (90)\27\.                                          31; Stip. 32.
B.B....................  3/20/2015; 3/20/   Hydrocodone (90);           80  $179.99; $59.99..  Tr. 214; GE-2, at
                          2015.              Alprazolam (60).                                   102-04; Stip.
                                                                                                10.
S.B....................  3/26/2015; 3/27/   Hydrocodone (90);           79  $179.99; $59.99..  Tr. 212; GE-2, at
                          2015.              Alprazolam (60).                                   56-58; Stip. 14.
S.N....................  4/2/2015; 4/2/     Hydrocodone (90);           81  $179.99; $59.99..  Tr. 214, 214-15;
                          2015.              Alprazolam (60).                                   GE-2, at 60-62;
                                                                                                Stip. 31.
T.W....................  4/10/2015; 4/10/   Hydrocodone (90);           66  $179.99; $59.99..  Tr. 212-13, 215;
                          2015.              Alprazolam (60).                                   GE-2, at 71-73;
                                                                                                Stip. 44.
I.B....................  4/10/2015; 4/10/   Hydrocodone (90)            79  $179.99; $59.99..  Tr. 213, 215; GE-
                          2015.              \28\.                                              2, at 75-77;
                                                                                                Stip. 13.
M.W.2..................  4/13/2015; 4/13/   Hydrocodone (90)            79  $179.99; $59.99..  Tr. 214, 215; GE-
                          2015.              \29\.                                              2, at 79-81;
                                                                                                Stip. 42.
Y.S....................  4/17/2015; 4/17/   Hydrocodone (90);           78  $179.99; $59.99..  Tr. 214-15; GE-2,
                          2015.              Alprazolam (60).                                   at 86-88; Stip.
                                                                                                38.
B.B....................  4/22/2015; 4/23/   Hydrocodone (90);           66  $179.99; $59.99..  GE-2, at 105-107;
                          2015.              Alprazolam (60).                                   Stip. 11.
C.D....................  4/23/2015; 4/23/   Hydrocodone (90)            81  $179.99; $59.99..  Tr. 214-15; GE-2,
                          2015.              \30\.                                              at 109-111;
                                                                                                Stip. 15.
R.N....................  5/11/2015; 5/11/   Hydrocodone (90);           78  $179.99; $59.99..  Tr. 214-15; GE-2,
                          2015.              Alprazolam (60).                                   at 125-27; Stip.
                                                                                                29.
Y.S....................  5/18/2015; 5/18/   Hydrocodone (90)            78  $179.99; $59.99..  GE-2, at 89-91.
                          2015.              \31\.
----------------------------------------------------------------------------------------------------------------

    174. The prescriptions written by Dr. NE are indicative of pattern 
prescribing: same controlled substances; same quantity; same dosages; 
same prescriber; same drug cocktails. Tr. 215. This pattern indicates a 
lack of individualization of therapy. Id. at 209. In addition, these 
patients took unusual paths and distances to obtain and fill their 
prescriptions. Id. at 215-16.
---------------------------------------------------------------------------

    \24\ The day before Dr. NE wrote A.S. a prescription for 
hydrocodone, L.R., ACNS-BC, also with the AC Medical practice, wrote 
A.S. a prescription for 60 tablets of alprazolam 2 mg. GE-2, at 24. 
Both prescriptions were filled by the Pharmacy on January 26, 2015. 
GE-2, at 22-24. The fill sticker, however, erroneously lists Dr. NE 
as the prescriber. The prescription pad for AC Medical shows an 
address on East Arkansas Lane, but Dr. NE's electronic prescription 
for A.C. shows an address of 201 Billings Street, and the patient 
profile for A.S. shows L.R's address as 202 Billing Street. Id. at 
22, 31.
    \25\ On the same day that Dr. NE wrote R.N. a prescription for 
hydrocodone, C.Z., PA, of the same medical practice as Dr. NE, wrote 
R.N. a prescription for 60 tablets of alprazolam 2 mg. GE-2, at 122-
23. Both prescriptions were filled by the Pharmacy on the following 
day, February 3, 2015. Id. at 120-23.
    \26\ The Administrative Record contains the Pharmacy's fill 
sticker for this prescription, but not the actual prescription. GE-
2, at 38, 42. On the same day that the Pharmacy filled this 
prescription it also filled a prescription for 60, 2 mg tablets of 
alprazolam, which was written by L.R., ACNS-BC, on the same day. GE-
2, at 37. Dr. NE's address is listed on R.E.'s patient profile as 
being at Billings Street in Arlington, Texas, while the office 
address on the prescription pad that L.R. used to write the 
prescription for alprazolam is East Arkansas Lane, Arlington, Texas. 
Id. at 37, 42.
    \27\ The day before Dr. NE wrote A.S. a prescription for 
hydrocodone, C.Z., PA, also with the AC Medical practice, wrote A.S. 
a prescription for 60, 2 mg tablets of alprazolam. GE-2, at 25. The 
Pharmacy also filled that prescription for alprazolam the day before 
it filled the prescription that Dr. NE wrote for hydrocodone. Id. at 
25. The prescription pad for AC Medical shows an address on East 
Arkansas Lane for both Dr. NE, and C.Z., but Dr. NE's electronic 
prescription for A.C. shows an address of 201 Billings Street, 
Arlington, Texas. Id. at 22-26.
    \28\ On the same day that Dr. NE wrote I.B. a prescription for 
hydrocodone, S.G., FNP, of the same medical practice as Dr. NE, 
wrote I.B. a prescription for 60 tablets of alprazolam 2 mg. GE-2, 
at 77. Both prescriptions were filled by the Pharmacy on the same 
day, April 10, 2015. Id. at 75-77. The fill sticker for the 
alprazolam, however, erroneously lists Dr. NE as the prescriber. Id. 
at 77.
    \29\ On the same day that Dr. NE wrote M.W.2 a prescription for 
hydrocodone, S.G., FNP, of the same medical practice as Dr. NE, 
wrote M.W.2 a prescription for 60 tablets of alprazolam 2 mg. GE-2, 
at 81. Both prescriptions were filled by the Pharmacy on the same 
day, April 13, 2015. Id. at 79-81. The fill sticker for the 
alprazolam, however, erroneously lists Dr. NE as the prescriber. Id. 
at 81.
    \30\ The day before Dr. NE wrote C.D. a prescription for 
hydrocodone, S.G., FNP, of the same medical practice as Dr. NE, 
wrote C.D. a prescription for 60 tablets of alprazolam 2 mg. GE-2, 
at 111. Both prescriptions were filled by the Pharmacy on April 23, 
2015. Id. at 109-11. The fill sticker for the alprazolam, however, 
erroneously lists Dr. NE as the prescriber. Id. at 111.
    \31\ On the same day that Dr. NE wrote Y.S. a prescription for 
hydrocodone, S.G., FNP, of the same medical practice as Dr. NE, 
wrote Y.S. a prescription for 60 tablets of alprazolam 2 mg. GE-2, 
at 91. Both prescriptions were filled by the Pharmacy on the same 
day, May 18, 2015. Id. at 89-91. The fill sticker for the 
alprazolam, however, erroneously lists Dr. NE as the prescriber. Id. 
at 91.
---------------------------------------------------------------------------

    175. The unusual paths and distances that Dr. NE's patients 
traveled to obtain their prescriptions and get them filled is a red 
flag. Id.
    176. The fill stickers for all of Dr. NE's patients indicate that 
they paid $179.99 for their prescriptions for hydrocodone, which is 
much higher than the usual cost of 90 tablets of hydrocodone. Id. at 
222-23. The average cash price at other pharmacies for 90 tablets of 
hydrocodone is about $70, and the cash price for 60 tablets of 
alprazolam is about $35. Id. at 223.
    177. There are no notes on the hard-copies of Dr. NE's 
prescriptions or the patient profiles documenting that the Pharmacy 
resolved any of the red flags, or consulted with Dr. NE or any other 
prescriber regarding the red flags. Id. at 216-17; GE-2, at 4, 7, 9, 
11, 13, 15, 17, 21, 31-33, 42-43, 53-55, 59, 63, 70, 74, 78, 82, 85, 
92-93, 97, 102, 104-05, 107-08, 112, 116, 128-29, 133.
    Additional facts required to resolve the issues in this case are 
included in the Analysis section of this Recommended Decision.

[[Page 21032]]

Analysis

    To revoke a respondent's registration, the Government must prove, 
by a preponderance of the evidence, that the regulatory requirements 
for revocation are satisfied. Steadman v. SEC, 450 U.S. 91, 100-02 
(1981); 21 CFR 1301.44(e). Under 21 U.S.C. 824(a)(4), the DEA may 
revoke a registrant's COR if the registrant acted in a way that renders 
continued registration ``inconsistent with the public interest.'' The 
DEA considers the following five factors to determine whether continued 
registration is in the public interest:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The [registrant's] experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The [registrant's] conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.\32\
---------------------------------------------------------------------------

    \32\ The Government has not made any Factor Five allegations 
against the Respondent. ALJ-35, at 27.

21 U.S.C. 823(f).
    These public interest factors are considered separately. See Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor is weighed on a 
case-by-case basis. Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 2005). 
Any one factor, or combination of factors, may be decisive. David H. 
Gillis, M.D., 58 FR 37507, 37508 (1993). Thus, there is no need to 
enter findings on each of the factors. Hoxie v. DEA, 419 F.3d 477, 482 
(6th Cir. 2005). Further, there is no requirement to consider a factor 
in any given level of detail. Trawick v. DEA, 861 F.2d 72, 76-77 (4th 
Cir. 1988). When deciding whether registration is in the public 
interest, the totality of the circumstances must be considered. See 
generally Joseph Gaudio, M.D., 74 FR 10083, 10094-95 (2009).
    The Government bears the initial burden of proof, and must justify 
revocation by a preponderance of the evidence. Steadman, 450 U.S. at 
100-03. If the Government makes a prima facie case for revocation, the 
burden of proof shifts to the registrant to show that revocation would 
be inappropriate. Med. Shoppe--Jonesborough, 73 FR 364, 387 (2008). A 
registrant may prevail by successfully attacking the veracity of the 
Government's allegations or evidence. Alternatively, a registrant may 
rebut the Government's prima facie case for revocation by accepting 
responsibility for wrongful behavior and by taking remedial measures to 
``prevent the re-occurrence of similar acts.'' Jeri Hassman, M.D., 75 
FR 8194, 8236 (2010) (citations omitted). In addition, when assessing 
the appropriateness and extent of sanctioning, the DEA considers the 
egregiousness of the offenses and the DEA's interest in specific and 
general deterrence. David A. Ruben, M.D., 78 FR 38363, 38385 (2013).
    Here, the Government's allegations focus on the manner in which the 
Pharmacy, through its agents, dispensed controlled substances. In 
addition, the Government has alleged recordkeeping violations.

I. The Government's Position

    The Government submitted its Proposed Findings of Fact, Conclusions 
of Law, and Argument (``Government's Brief'') on February 7, 2018.\33\ 
In its brief, the Government addressed: Numerous instances of the 
Pharmacy dispensing controlled substances in violation of its 
corresponding responsibility to ensure that the prescribing and 
dispensing of controlled substances was done only for legitimate 
medical purposes. ALJ-35, at 9-21. The Government also addressed the 
Pharmacy's recordkeeping violations, and as a result of those 
recordkeeping violations, the Pharmacy's inability to account for over 
47,000 tablets of hydrocodone. ALJ-35, at 21.
---------------------------------------------------------------------------

    \33\ The Government's Brief has been marked as ALJ-35.
---------------------------------------------------------------------------

    With respect to the Pharmacy dispensing in violation of its 
corresponding responsibility, the Government pointed out the testimony 
of its expert witness, Dr. Witte. ALJ-35, at 6-21. Dr. Witte's 
testimony touched upon virtually each prescription contained in 
Government Exhibit 2. ALJ-35, at 9-21. The Government noted that Dr. 
Witte identified numerous red flags concerning the prescriptions the 
Pharmacy filled, to include: Pattern prescribing; long and unusual 
distances traveled to obtain and fill prescriptions; delay in filling 
prescriptions; cash payments for prescriptions; prescriptions for high-
alert drugs, such as hydrocodone, alprazolam, and promethazine with 
codeine; prescriptions for high dosage strengths of the controlled 
substance; prescription cocktails, such as hydrocodone and alprazolam 
prescribed together; and prescriptions containing atypical directions 
for use. ALJ-35, at 7-9. In addition, Dr. Witte testified that to 
resolve a red flag, a pharmacist in Texas should call the prescriber 
and then document the prescriber's explanation either on the 
prescription itself, or in the patient's profile maintained by the 
pharmacy. ALJ-35, at 8. Failing to document the resolution of a red 
flag falls below the minimum standards of the practice of pharmacy in 
Texas. Id.
    With respect to recordkeeping violations, the Government's Brief 
detailed that during execution of the Administrative Inspection Warrant 
in June 2015, the Pharmacy was asked for its inventories and its 
dispensing history for hydrocodone. ALJ-35, at 21. The dispensing 
records provided by the Pharmacy did not account for any dispensing 
prior to July 7, 2014, while other non-Pharmacy records showed 
dispensing prior to that date, and the Pharmacy had opened in September 
2013. ALJ-35, at 21-22. As a result of the documentation provided by 
the Pharmacy, the Pharmacy could not account for over 47,000 tablets of 
hydrocodone. Id
    Based upon the allegation contained in the OSC, and the evidence 
produced by the Government, the Government argues that Factors 2 and 4 
of the five factors listed in 21 U.S.C. 823(f), are the relevant 
factors to consider in this case, specifically the registrant's 
experience in dispensing controlled substances and its compliance with 
applicable state, federal, or local laws relating to controlled 
substances. ALJ-35, at 27.
    The Government argues that the Pharmacy violated 21 CFR 1306.04(a) 
and 1306.06 when it failed to meet its corresponding responsibility by 
filling prescriptions outside the usual course of professional 
practice. ALJ-35, at 27-34. Specifically, the Government alleges that 
the Pharmacy ``repeatedly distributed controlled substances pursuant to 
prescriptions that contained one or more unresolved red flags for 
diversion.'' Id. at 29. The Government notes that all of the 
prescriptions in Government Exhibit 2 gave rise to one or more of the 
above mentioned red flags. Id. Significantly, the Government notes 
there is no evidence that the Pharmacy documented the resolution of any 
of the red flags concerning the prescriptions presented in this case. 
Id. at 30. The Government also notes that the Respondent was served 
with a subpoena that specifically requested any and all documentation 
concerning the resolution of red flags, yet no such documentation has 
been produced. Id.
    The Government noted that the Pharmacy also had recordkeeping 
shortcomings, and an audit revealed a substantial shortage of 
hydrocodone. Id. at 34-36. While recognizing that the Respondent 
produced records, Respondent Exhibit C, claiming they

[[Page 21033]]

represent all of the Respondent's dispensing of hydrocodone, the 
Government further argues that there is ``no record of any dispensing 
prior to July 7, 2014.'' \34\ ALJ-35, at 34. Citing Alexander Drug Co., 
66 FR 18299, 18303 (2001), the Government noted that recordkeeping 
violations alone can serve as a sufficient bases to revoke a 
registration. Id. at 35. In addition, the Government cites to Paul H. 
Volkman, 73 FR 30630, 30644 (2008), for the proposition that failing to 
maintain dispensing logs with respect to an extraordinary quantity of 
controlled substances provides sufficient reason by itself to revoke a 
registration as being inconsistent with the public interest. Id. at 35.
---------------------------------------------------------------------------

    \34\ This argument is an overstatement. The Respondent did 
produce evidence of dispensing prior to July 7, 2014, though it 
takes some digging to find it. The lowest RX number for a 
prescription for hydrocodone dispensed by the Pharmacy on July 7, 
2014, is 105254. GE-6, at 1. The Respondent demonstrated that it 
dispensed more than 300 prescriptions for hydrocodone with 
prescription numbers lower than 10525. See RE-C, at 31-42. Based on 
the RX numbers of those prescriptions, and the manner in which those 
numbers are assigned to prescriptions, those 300 prescriptions were 
filled prior to July 7, 2014. Those records, however, were not 
produced until long after the Pharmacy was required to produce them.
---------------------------------------------------------------------------

    In conclusion, the Government argued that the Pharmacy's COR should 
be revoked because a preponderance of the evidence establishes that 
allowing the Pharmacy to keep its registration would be contrary to the 
public interest. Id. at 39. In support of this argument, the Government 
noted that the Pharmacy had not accepted any responsibility for its 
actions and it had not indicated what actions it would take to ensure 
future compliance with laws and regulations governing the handling of 
controlled substances. Id.

II. The Respondent's Position

    The Respondent submitted its Proposed Findings of Fact and 
Conclusions of Law (``Respondent's Proposed Findings'') on February 7, 
2018.\35\ The Respondent also submitted the Respondent's Closing Brief 
(``Respondent's Brief'') on February 7, 2018.\36\ I have read and 
considered both documents in preparing this Recommended Decision.
---------------------------------------------------------------------------

    \35\ The Respondent's Proposed Findings has been marked as ALJ-
36.
    \36\ The Respondent's Brief has been marked as ALJ-37.
---------------------------------------------------------------------------

    In the Respondent's Proposed Findings, the Respondent highlighted 
the policies and procedures the Pharmacy has in place to confirm the 
legitimacy of new prescriptions for controlled substances. ALJ-36, at 
4-7. Some of those policies and procedures include: verifying a 
prescriber's authorization to prescribe; checking the PMP for doctor 
shopping; entering prescription and patient information into the 
Pharmacy's computer system; contacting the prescriber's office when new 
patients present to the Pharmacy to ensure there is a doctor-patient 
relationship; questioning the patient about the need for the 
medication; and marking prescriptions with a ``V'' once the 
prescription has been verified.\37\ Id. at 5-7. The Respondent also 
highlights testimony suggesting that it saw nothing unusual with the 
prescriptions contained in Government Exhibit 2. Id. at 8. For example, 
the Respondent notes that: It considered the prescriptions to be 
therapeutic and commonly prescribed; other physicians prescribe in 
similar patterns; the Prescribers only wrote 10% of the prescriptions 
the Pharmacy filled; the patients were not filling their prescriptions 
early or doctor shopping; and the patients did not show up in groups. 
Id. at 8.
---------------------------------------------------------------------------

    \37\ There is only one prescription in Government Exhibit 2 that 
is marked with a ``V''. See GE-2, at 49.
---------------------------------------------------------------------------

    Based upon the Respondent's proposed findings of fact,\38\ the 
Respondent also offers several conclusions of law. Significantly, the 
Respondent concludes that the Government failed to meet its burden of 
proof to show that the Pharmacy had filled prescriptions for controlled 
substances that contained red flags without resolving those red flags. 
Id. at 15. The Respondent also concludes that the Pharmacy was never 
asked to provide the DEA with evidence of its documentation.\39\ Id. at 
15-16. Citing Superior Pharmacy I & Superior Pharmacy II, 81 FR 31310, 
31335 (2016), the Respondent also concludes that the Government 
presented no proof of willful indifference, and that ``a reasonable 
suspicion is not enough to establish that a pharmacist acted with the 
requisite scienter.'' Id. at 15. Further, citing JM Pharmacy Group, 
Inc., d/b/a Farmacia Nueva and Best Pharma Corp., 80 FR 28667, 28667 
n.2 (2015), the Respondent concludes that there is no evidence of 
willful blindness. Id. at 16.
---------------------------------------------------------------------------

    \38\ Some of the Respondent's Proposed Findings of Fact 
(``PFF'') are not supported by the Administrative Record. 
Representative examples follow. In PFF 7 the Respondent states that 
the Pharmacy was under visual surveillance by DEA. ALJ-36, at 3. At 
best the Administrative Record would support a finding that DI 1 
thinks that the ``tactical diversion squad was going out there and 
watching it.'' Tr. 93. This ``fact,'' whether accurate or not, is 
not relevant to the issues in this case. In PFF 38 the Respondent 
cites Government Exhibit 6 for its position that not more than 10% 
of the prescriptions issued each day were issued by one of the 
medical clinics under investigation. ALJ-36, at 7. Government 
Exhibit 7, however, only concerns hydrocodone. The Administrative 
Record makes abundantly clear that the ``Prescribers wrote far more 
prescriptions than just hydrocodone.'' PFF 32 has little resemblance 
to the actual testimony cited in support of the PFF. ALJ-36, at 6. 
In PFF 44 the Respondent states that distance and route traveled by 
the patients who obtained prescriptions from one of the Prescribers 
``was often based on convenience to work, or proximity to the clinic 
rather than convenience to home.'' ALJ-36, at 8. There is no 
evidence to support this assertion. Rather, the citation to the 
record provided by the Respondent of Tr. 494-95, provides more 
reasonable support for the conclusion that Ms. Igwe did not find it 
uncommon for patients to be coming from different locations around 
the Dallas-Fort Worth area, and because it was not uncommon she did 
not question it. Further, the investigation of the Pharmacy began 
because the ``Pharmacy Place was so far from these clinics.'' Tr. 
430. The Respondent also states that Mr. Litman testified that the 
only way to determine a physician was prescribing non-controlled 
substances to mask the illegitimate prescribing of controlled 
substances was to find another red flag in the prescription. See PFF 
77, ALJ-36, at 13. That, however, is not Mr. Litman's testimony. He 
begins his answer by saying, ``the only thing to do is call the 
physician . . . .'' Tr. 683.
    \39\ This conclusion seemingly ignores Government Exhibit 9. See 
also Tr. 357.
---------------------------------------------------------------------------

    In the Respondent's Brief, the Respondent minimally summarizes some 
of the testimony.\40\ The Respondent then sets out the standards that 
must be met to prove that a Pharmacy violated its corresponding 
responsibility, once again relying on Superior Pharmacy I & Superior 
Pharmacy II, 81 FR at 31335 and JM Pharmacy, 80 FR at 28667 n.2. In 
conclusion, the Respondent argues:
---------------------------------------------------------------------------

    \40\ On at least two instances, the Respondent significantly 
mischaracterizes the testimony. The Respondent states that the ``DEA 
undercover agent did not divert the drugs . . . . nor was the 
Pharmacy Place related to any diversion activity by the Agent.'' 
ALJ-37, at 3. This statement reflects a total misunderstanding of 
diversion by the Respondent. Diversion occurs whenever anyone 
received a controlled substance they should not have received. Then 
the Respondent states that Dr. Witte testified ``she would probably 
not check the distance travelled by the customer.'' ALJ-37, at 5. 
Actually when the transcript is examined, what Dr. Witte said was 
that she would ``probably not'' check to see if an address was 
legitimate. Tr. 191. This issue is also not relevant to the issues 
in this case. What is relevant is the fact that the Pharmacy's own 
records indicate the patient in question traveled from Fort Worth to 
a clinic south of Dallas, then to the Pharmacy north of Dallas, and 
then back to Fort Worth in order to obtain a prescription and have 
it filled, yet the Pharmacy asked no questions about that distance 
the patient traveled or the unusual route the patient would have 
taken.

    Taking the admitted evidence and testimony as a whole, there is 
no evidence the pharmacist isn't completely committed to her duties 
as a pharmacist. She verifies early and checks the PMP every 
prescription. There was no evidence of diversion based on the 
surveillance by the DEA, and the 47000 doses of hydrocodone is 
probably wrong pursuant to the testimony of the man who wrote the 
report. Further, there is no evidence of willful blindness or 
willful indifference by the pharmacist. The

[[Page 21034]]

pharmacy is a neighborhood pharmacy that compounds medication and 
caters to children . . . . The Pharmacy Place is minority owned and 
operated by the owner. It compounds medications. Based on the 
pharmacist (sic) testimony in the trial, pharmacists' (sic) differ 
in approach and protocol based on experience, knowledge and 
background. The continued operation of the pharmacy is consistent 
---------------------------------------------------------------------------
with the public interest.

ALJ-37, at 7.

Factor One & Three: The Recommendation of the Appropriate State 
Licensing Board or Professional Disciplinary Authority, and Conviction 
Record Under Federal or State Laws Relating to the Manufacture, 
Distribution, or Dispensing of Controlled Substances

    In this case, it is undisputed that the Respondent holds a valid 
state pharmacy license in Texas. The record contains no evidence of a 
recommendation regarding the Respondent's privilege to operate as a 
pharmacy by a relevant state licensing board or professional 
disciplinary authority. However, possession of a state license does not 
entitle a holder of that license to a DEA registration. Mark De La 
Lama, P.A., 76 FR 20011, 20018 (2011). It is well established that a 
``state license is a necessary, but not a sufficient condition for 
registration.'' Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). 
The ultimate responsibility to determine whether a DEA registration is 
consistent with the public interest has been delegated exclusively to 
the DEA, not to entities within state government. Edmund Chein, M.D., 
72 FR 6580, 6590 (2007), aff'd Chein v. DEA, 533 F.3d 828 (D.C. Cir. 
2008).
    Agency precedent establishes that where the record contains no 
evidence of a recommendation by a state licensing board, that absence 
does not weigh for or against revocation. See Roni Dreszer, M.D., 76 FR 
19434, 19444 (2011) (``The fact that the record contains no evidence of 
a recommendation by a state licensing board does not weigh for or 
against a determination as to whether continuation of the Respondent's 
DEA certification is consistent with the public interest.'') 
Accordingly, Factor One does not weigh for or against revocation in 
this matter.
    As to Factor Three, there is no evidence that Respondent, or any of 
its agents, have been convicted of an offense under either federal or 
Texas law ``relating to the manufacture, distribution, or dispensing of 
controlled substances.'' 21 U.S.C. 823(f)(3). However, there are a 
number of reasons why even a person who has engaged in criminal 
misconduct may never have been convicted of an offense or even 
prosecuted for one. Dewey C. MacKay, M.D., 75 FR 49956, 49973 (2010), 
pet. for rev. denied, MacKay v. DEA, 664 F.3d 808, 822 (10th Cir. 
2011). Therefore, the DEA has held that ``the absence of such a 
conviction is of considerably less consequence in the public interest 
inquiry'' and is not dispositive. Id. Accordingly, Factor Three weighs 
neither for nor against revocation in this case.

Factors Two and Four: The Respondent's Experience in Dispensing 
Controlled Substances and Compliance With Applicable State, Federal, or 
Local Laws Relating to Controlled Substances

    Factors Two and Four are often analyzed together. See, e.g., Fred 
Samimi, M.D., 79 FR 18698, 18709 (2014); John V. Scalera, M.D., 78 FR 
12092, 12098 (2013). Under Factor Two, the DEA analyzes a registrant's 
``experience in dispensing . . . controlled substances.'' 21 U.S.C. 
823(f)(2). Factor Two analysis focuses on a registrant's acts that are 
inconsistent with the public interest, rather than on a registrant's 
neutral or positive acts and experience. Randall L. Wolff, M.D., 77 FR 
5106, 5121 n.25 (2012) (explaining that ``every registrant can 
undoubtedly point to an extensive body of legitimate [dispensing] over 
the course of [the registrant's] professional career'') (quoting Jayam 
Krishna-Iyer, M.D., 74 FR 459, 463 (2009)). Similarly, under Factor 
Four, the DEA analyzes an applicant's compliance with federal and state 
laws concerning controlled substances. 21 U.S.C. 823(f)(4). Factor Four 
analysis also focuses on violations of state and federal regulations. 
Volkman v. DEA, 567 F.3d 215, 223-24 (6th Cir. 2009) (citing Gonzales 
v. Oregon, 546 U.S. 243, 272, 274 (2006)); see Joseph Gaudio, M.D., 74 
FR 10083, 10090-91 (2009).
    [According to the CSA's implementing regulations, a lawful 
controlled substance order or prescription is one that is ``issued for 
a legitimate medical purpose by an individual practitioner acting in 
the usual course of his professional practice.'' 21 CFR 1306.04(a). 
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.'' Id. The regulations establish the parameters of the 
pharmacy's corresponding responsibility.

    An order purporting to be a prescription issued not in the usual 
course of professional treatment . . . is not a prescription within 
the meaning and intent of . . . 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. ``The language in 21 CFR 1306.04 and caselaw could not be more 
explicit. A pharmacist has his own responsibility to ensure that 
controlled substances are not dispensed for non-medical reasons.'' 
Ralph J. Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55 FR 4729, 4730 
(1990) (citing United States v. Hayes, 595 F.2d 258 (5th Cir. 1979), 
cert. denied, 444 U.S. 866 (1979); United States v. Henry, 727 F.2d 
1373 (5th Cir. 1984) (reversed on other grounds)). As the Supreme Court 
explained in the context of the CSA's requirement that schedule II 
controlled substances may be dispensed only by written prescription, 
``the prescription requirement . . . ensures patients use controlled 
substances under the supervision of a doctor so as to prevent addiction 
and recreational abuse . . . [and] also bars doctors from peddling to 
patients who crave the drugs for those prohibited uses.'' Gonzales v. 
Oregon, 546 U.S. 243, 274 (2006).
    To prove a pharmacist violated her corresponding responsibility, 
the Government must show that the pharmacist acted with the requisite 
degree of scienter. See 21 CFR 1306.04(a) (``[T]he person knowingly 
filling [a prescription issued not in the usual course of professional 
treatment] . . . shall be subject to the penalties provided for 
violations of the provisions of law relating to controlled 
substances.'') (emphasis added). DEA has also consistently interpreted 
the corresponding responsibility regulation such that ``[w]hen 
prescriptions are clearly not issued for legitimate medical purposes, a 
pharmacist may not intentionally close his eyes and thereby avoid 
[actual] knowledge of the real purpose of the prescription.'' 
Bertolino, 55 FR at 4730 (citations omitted); see also JM Pharmacy 
Group, Inc. d/b/a Pharmacia Nueva and Best Pharmacy Corp., 80 FR 28667, 
28670-72 (2015) (applying the standard of willful blindness in 
assessing whether a pharmacist acted with the requisite scienter). 
Pursuant to their corresponding responsibility, pharmacists must 
exercise ``common sense and professional judgment'' when filling a 
prescription issued by a physician. Bertolino, 55 FR at 4730. When a 
pharmacist's suspicions are

[[Page 21035]]

aroused by a red flag, the pharmacist must question the prescription 
and, if unable to resolve the red flag, refuse to fill the 
prescription. Id.; Medicine Shoppe-Jonesborough, 300 F. App'x 409, 412 
(6th Cir. 2008) (``When pharmacists' suspicions are aroused as 
reasonable professionals, they must at least verify the prescription's 
propriety, and if not satisfied by the answer they must refuse to 
dispense.'').
    In this matter, the Government did not allege that Respondent 
dispensed the subject prescriptions having actual knowledge that the 
prescriptions lacked a legitimate medical purpose. Instead, the 
Government alleged that Respondent violated the corresponding 
responsibility regulation as evidenced by it ``repeatedly 
distribut[ing] controlled substances pursuant to prescriptions that 
contained one or more unresolved red flags for diversion.'' Govt 
Posthearing, at 29. See also OSC, at 5 (``Pharmacy Place's pharmacists 
were willfully blind to or deliberately ignorant of the high 
probability that the [subject prescriptions] lacked a legitimate 
medical purpose. Pharmacy Place pharmacists were willfully blind to the 
fact that large numbers of customers seeking controlled substance 
prescriptions, often prescription cocktails, and residing long 
distances from Pharmacy Place's location and/or their respective 
physicians created a suspicious situation requiring increased 
scrutiny.'').] \*C\
---------------------------------------------------------------------------

    \*C\ I am omitting some language from the RD and adding the 
above to clarify the analysis of a pharmacist's corresponding 
responsibility under 21 CFR 1306.04(a).
---------------------------------------------------------------------------

    Because the Pharmacy is located in Texas, it is important to review 
the requirements of Texas law as it relates to pharmacists. To begin, 
Texas law provides that ``[a] pharmacist may not: (1) dispense . . . a 
controlled substance . . . except under a valid prescription and in the 
course of professional practice.'' Tex. Health & Safety Code Sec.  
481.074(a)(1). Texas law further provides that ``[a] pharmacist may 
not: (2) dispense a controlled substance if the pharmacist knows or 
should have known that the prescription was issued without a valid 
patient-practitioner relationship.'' Id. at Sec.  481.074(a)(2). It is 
also unlawful in Texas for any ``registrant or dispenser'' to deliver a 
controlled substance in violation of section 481.074 of the Texas 
Health and Safety Code. Id. at Sec.  481.128. Additionally, the Texas 
Health and Safety Code mandates that a ``prescription for a controlled 
substance'' must show ``the name, address, and date of birth or age of 
the patient'' as well as the ``Federal Drug Enforcement Administration 
number'' of the practitioner issuing the prescription. Id. at Sec.  
481.074(k)(3), (7).
    In addition to Texas statutes, the Texas State Board of Pharmacy 
has issued rules for the operational standards that Texas pharmacists 
are expected to follow when filling a new or refill prescription. Those 
operational standards dictate that

[f]or the purpose of promoting therapeutic appropriateness, a 
pharmacist shall, prior to or at the time of dispensing a 
prescription drug order, review the patient's medication record. 
Such review shall at a minimum identify clinically significant: . . 
. (III) reasonable dose and route of administration; (IV) reasonable 
directions for use; (V) duplication of therapy; (VI) drug-drug 
interactions; . . . [and] (X) proper utilization, including 
overutilization or underutilization.

See 22 Tex. Admin. Code Sec.  291.33(c)(2)(A)(i).
    The operational standards also mandate that ``[u]pon identifying 
any clinically significant conditions, [or] situations . . . the 
pharmacist shall take appropriate steps to avoid or resolve the problem 
including consultation with the prescribing practitioner.'' Id. at 
Sec.  291.33(c)(2)(A)(ii). Furthermore, ``[p]rior to dispensing, any 
questions regarding a prescription drug order must be resolved with the 
prescriber and written documentation of these discussions made and 
maintained.'' Id. at Sec.  291.33(c)(2)(A)(iv). [ ]\*D\ Texas 
operational standards require at a minimum that such documentation be

on the prescription or in the pharmacy's data processing system 
associated with the prescription . . . and shall include . . . (1) 
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 for 
the purpose of identifying the pharmacist who performed the 
consultation.
---------------------------------------------------------------------------

    \*D\ Text adjusted in response to Respondent's Exceptions.

Id. at Sec.  291.33(c)(2)(C). [ ]\*E\
---------------------------------------------------------------------------

    \*E\ Text removed in response to Respondent's Exceptions.
---------------------------------------------------------------------------

    The Texas State Board of Pharmacy has also issued rules concerning 
the labels that a pharmacist puts on the bottles of controlled 
substances being dispensed by a pharmacy. Those standards require that

[a]t the time of delivery of the drug, the dispensing container 
shall bear a label in plain language and printed in an easily 
readable font size, unless otherwise specified, with at least the 
following information: (i) name, address and phone number of the 
pharmacy; (ii) unique identification number of the prescription that 
is printed in an easily readable font size comparable to but no 
smaller than ten-point Times Roman; (iii) date the prescription is 
dispensed; (iv) initials or an identification code of the dispensing 
pharmacist; (v) name of the prescribing practitioner; . . .

Id. at Sec.  291.33(c)(7)(A). While this particular section of the 
operational standards was not cited in the OSC, it is relevant in this 
case because the Pharmacy should have been following these requirements 
when filling prescriptions.\41\
---------------------------------------------------------------------------

    \41\ [The ALJ used this footnote to take official notice under 
the Administrative Procedure Act of 22 Tex. Admin. Code Sec.  
291.33(c)(7)(A). In the section on Respondent's Exceptions, supra, I 
addressed Respondent's response and found that the ALJ properly 
applied the regulation.]*
---------------------------------------------------------------------------

    Finally, ``[t]he corresponding responsibility to ensure the 
dispensing of valid prescriptions extends to the pharmacy itself.'' 
Holiday CVS, 77 FR at 62341 (citing Med. Shoppe--Jonesborough, 73 FR at 
384; United Prescription Servs., Inc., 72 FR 50397, 50407-08 (2007); 
EZRX, L.L.C., 69 FR 63178, 63181 (2004); Role of Authorized Agents in 
Communicating Controlled Substance Prescriptions to Pharmacies, 75 FR 
61613, 61617 (2010); Issuance of Multiple Prescriptions for Schedule II 
Controlled Substances, 72 FR 64921, 64924 (2007) (other citations 
omitted)). The DEA has consistently held that the registration of a 
pharmacy may be revoked as the result of the unlawful activity of the 
pharmacy's owners, majority shareholders, officers, managing 
pharmacist, or other key employee. EZRX, L.L.C., 69 FR at 63,181; Plaza 
Pharmacy, 53 FR 36,910, 36,911 (1988). Similarly, ``[k]nowledge 
obtained by the pharmacists and other employees acting within the scope 
of their employment may be imputed to the pharmacy itself.'' Holiday 
CVS, 77 FR at 62341.
    In support of its allegations that the Pharmacy violated its 
corresponding responsibility, the Government convincingly argues that 
the Pharmacy filled prescriptions to customers without documenting the 
resolution of numerous red flags. Regarding the documentation of red 
flags in Texas, [Dr. Witte credibly testified that it would be below 
the minimum standards of practice and outside the usual course of 
professional practice for a Texas pharmacist to fail to document the 
resolution of red flags on a prescription before dispensing it. Tr. 
178-82, 209-211 244-47]; \*F\ see also The Medicine Shoppe, 79 FR 
59,504, 59,509 n.14, 59,516 (2014) (concluding a Texas pharmacy 
violated its corresponding

[[Page 21036]]

duty by failing to document the resolution of red flags on hard-copy 
prescriptions and that the record as a whole lacked evidence that red 
flags were resolved).
---------------------------------------------------------------------------

    \*F\ Text adjusted to add reference and citation to Dr. Witte's 
testimony.
---------------------------------------------------------------------------

Pattern Prescribing
    [Both expert witnesses in this matter testified that pattern 
prescribing is a red flag that can be indicative of drug abuse or 
diversion. FF 58-59, 61; Tr. 171-72.] \*G\ `` `Pattern prescribing' 
occurs when a physician prescribes the same drug and the same dosage to 
every patient the physician sees.'' The Medicine Shoppe, 79 FR 59504, 
59512 (2014); see also Jones Total Health Care Pharmacy, L.L.C., & SND 
Health Care, L.L.C., 81 FR 79188, 79215 (2016) (noting expert's 
definition of pattern prescribing as `` `patients going to the same 
doctor for the same ailments, receiving the same prescriptions in the 
same quantity without any difference in the treatment.' ''). Pattern 
prescribing raises a red flag because a ``prescription should be 
tailored to each patient's individual needs based on their chronic 
conditions.'' The Medicine Shoppe, 79 FR at 59,512; see also United 
States v. Hammond, 781 F.2d 1536, 1538 (11th Cir. 1986) (accepting 
expert testimony that ``the lack of individualized dosing'' is 
indicative of diversion). When a doctor prescribes the same controlled 
substances to different patients with similar doses for everybody, it 
suggests the doctor is simply churning out controlled substance 
prescriptions indiscriminately rather than conducting legitimate 
medical treatment. [See FF 61;] \*H\ Jones Total Health Care Pharmacy, 
L.L.C., & SND Health Care, L.L.C., 81 FR at 79195; 21 CFR 1306.04(a) 
(requiring controlled substances to be prescribed only for ``legitimate 
medical purpose[s]''). Ultimately, the concern with pattern prescribing 
is that it indicates a lack of individualization of therapy. [FF 61.] 
\*I\
---------------------------------------------------------------------------

    \*G\ Text and citations added for clarity.
    \*H\ Citation added.
    \*I\ Citation replaced and text removed for brevity.
---------------------------------------------------------------------------

    Agency [cases involving similar factual scenarios and credible 
expert testimony] \*J\ demonstrate that pattern prescribing manifests 
itself in one of two forms. One form of pattern prescribing occurs 
where one physician or clinic prescribes the same controlled substances 
to different patients over an extended time period. See Holiday CVS, 
L.L.C., 77 FR 62316, 62323 (2012) (determining that a doctor was 
clearly ``engaged in pattern prescribing'' where the doctor repeatedly 
prescribed ``oxycodone and alprazolam based on nearly uniform 
diagnoses'' over the course of six months). Another form of pattern 
prescribing occurs where one doctor or clinic writes the same 
prescription to different patients on the same day. See Superior 
Pharmacy I & Superior Pharmacy II, 81 FR 31310, 31322 (2016) 
(describing instance where various doctors of same clinic wrote 16 
prescriptions for oxycodone 30 mg on the same date to different 
patients). The Respondent's expert witness, Mr. Litman, however, was 
only concerned about the second category of pattern prescribing--seeing 
the same prescription 20 times in one day. Tr. 659-60.
---------------------------------------------------------------------------

    \*J\ Text adjusted for clarity.
---------------------------------------------------------------------------

    Some red flags, such as prescription cocktails, suboptimal dosing, 
and cash payment, should capture a pharmacist's attention early on, if 
not immediately. In contrast, with respect to the first variety of 
pattern prescribing--and to a lesser extent the second variety--the 
problem manifests itself over an extended period of time and is not 
immediately recognizable. FF 67, 92. Quite literally, pattern 
prescribing occurs when a single provider's or group of providers' 
prescriptions all share common characteristics and over time create a 
pattern of the same substances, doses, and strengths. Tr. 228-29, 232-
33, 250, 264-65, 279, 289, 353.
    In East Main Street Pharmacy, the respondent repeatedly dispensed 
similar prescription cocktails to different patients that were written 
by the same provider. 75 FR at 66163. The Deputy Administrator's 
decision in East Main Street Pharmacy observed that the prescriptions 
for hydrocodone and alprazolam were always prescribed at the maximum 
strength, and that the cocktails always contained some combination of 
the same substances. Id. Examples can be found in this case with the 
prescriptions issued to J.W., H.J., M.H., A.S., K.S., and M.A., where 
each patient received prescriptions for 90 to 120 tablets of 10 mg 
hydrocodone and 60 tablets of 2 mg alprazolam. Tr. 208-09. Dr. Witte 
noted that these prescriptions constituted a drug cocktail, and were 
indicative of pattern prescribing, with the ``same medications, the 
same directions, [and] the same quantity for different patients.'' Id. 
at 209. Dr. Witte further testified that upon receipt of such 
prescriptions ``a reasonably prudent pharmacist'' should investigate 
the red flag presented by the prescriptions. Id. at 210. [She further 
testified that a pharmacist acting in the usual course of professional 
practice and following the minimum standard of practice in Texas would 
not fill the prescriptions without resolving the red flag and 
documenting the resolution. Tr. 210-211.] \*K\ There is no 
documentation in the Administrative Record, however, showing that the 
Pharmacy resolved any of the red flags. Id. at 210. Additional examples 
of unresolved pattern prescribing can also be seen in the prescriptions 
issued by I.I., C.V., and NE See FF 163, 169, 174.
---------------------------------------------------------------------------

    \*K\ Text added for clarity.
---------------------------------------------------------------------------

    Repeat prescriptions for the same handful of drug cocktails issued 
by the same providers for different patients should ``create[ ] an 
obvious and compelling level of suspicion that the prescriptions lacked 
a legitimate medical purpose.'' Jones Total Health Care Pharmacy, 
L.L.C., 81 FR at 79199. Such is the case with the prescriptions filled 
by the Pharmacy. FF 162-177. Based upon her review of Government 
Exhibit 2, Dr. Witte credibly testified that while the prescriptions 
presented numerous red flags, the issue of pattern prescribing stood 
out and was suspicious. Tr. 171, 244, 296, 335, 358-59.
    Varying the substances and doses, however, would weigh against a 
finding of pattern prescribing. In Hills Pharmacy, for example, the 
Administrator rejected the Government's claim of pattern prescribing 
because the dosages ranged from 140 to 240 tablets. 81 FR at 49841 
n.46. Additionally, out of a set of 20 prescriptions provided by the 
Government, there were 3 different controlled substances prescribed in 
various strengths. Id.
    In this case, Dr. Witte identified pattern prescribing as a 
recurring issue with the prescriptions she reviewed that had been 
filled by the Pharmacy [and testified that a pharmacist dispensing 
prescriptions within the minimum standard of practice in Texas would 
have recognized the pattern prescribing in the subject prescriptions as 
a red flag].\*L\ Tr. 171, 244, 296, 335, 358-59; FF 61-62. Her 
testimony and analysis concerning those prescriptions is consistent 
with the DEA cases discussed above. FF 61-62. Furthermore, when 
examining the prescriptions filled by the Pharmacy beginning in August 
2014 and running through May 2015, the pattern prescribing becomes more 
and more apparent with each prescription filled. Because Ms. Igwe 
filled all of these prescriptions, the pattern should have become 
obvious to her. Tr. 578.
---------------------------------------------------------------------------

    \*L\ Text adjusted for clarity.
---------------------------------------------------------------------------

Distance
    The distance a patient is willing to travel to obtain a 
prescription and fill it is one factor a pharmacist must consider when 
discharging his or her

[[Page 21037]]

corresponding responsibility. [Tr. 172;] \*M\ see also Hills Pharmacy, 
L.L.C., 81 FR at 49841 n.45; Samuel Mintlow, M.D., 80 FR 3630, 3650 
(2015) (applying the distance factor to a physician case and reasoning 
that a doctor should be suspicious when a patient travels a long 
distance and ``bypass[es] numerous other potential treating 
physicians''). This is not a new consideration. Medical and pharmacy 
experts have testified in DEA cases for at least the past eight years 
that traveling long distances to obtain or fill controlled substance 
prescriptions is a red flag indicative of diversion and abuse.\42\ 
Although there is no ``categorical rule'' dictating the precise number 
of miles that raise a red flag, a pharmacist must nevertheless take the 
distance traveled into account when deciding whether to dispense 
controlled substances. Hills Pharmacy, 81 FR at 49841 n.45. [ ] \*N\
---------------------------------------------------------------------------

    \*M\ Citation added.
    \42\ Marcia L. Sills, M.D., 82 FR 36423, 36434 (2017); Jones 
Total Health Care Pharmacy, L.L.C., 81 FR 79188, 79188 (2016); Edge 
Pharmacy, 81 FR 72092, 72103 (2016); Hills Pharmacy, L.L.C., 81 FR 
49816, 49820, 49822 (2016); Superior Pharmacy I & Superior Pharmacy 
II, 81 FR 31310, 31323 (2016); Grider Drug #1 & Grider Drug #2, 77 
FR 44070, 44083 (2012), Holiday CVS, L.L.C., 77 FR 62316, 62319 
(2012); Jacobo Dreszer, M.D., 76 FR 19836, 19393 (2011); E. Main St. 
Pharmacy, 75 FR 66149, 66150 (2010); George C. Aycock, M.D., 71 FR 
17529, 17539 (2009).
    \*N\ Text removed for brevity.
---------------------------------------------------------------------------

    Additionally, Texas regulations include the distance a patient 
traveled as one factor pharmacists should be aware of before dispensing 
a controlled substance. The Texas State Board of Pharmacy, echoing the 
federal standard, requires pharmacists to ``exercise sound professional 
judgment with respect to'' the legitimacy of a prescription. 22 Tex. 
Admin. Code Sec.  291.29(a); see also 21 CFR 1306.04(a), 1306.06. The 
Board then goes on to provide a non-exhaustive list of circumstances a 
pharmacist should weigh when evaluating a prescription's legitimacy, 
including ``the geographical distance between the practitioner and the 
patient or between the pharmacy and the patient.'' 22 Tex. Admin. Code 
Sec.  291.29(c)(4).
    As Dr. Witte noted, seeing a doctor in south Dallas and filling a 
prescription in Plano (north of Dallas) when the patient lives in Fort 
Worth raises a concern Tr. 189-93, 281, 321. While testifying, Dr. 
Witte asked an appropriate rhetorical question, ``Why did these 
patients feel the need to drive clear across Dallas, all the way up to 
Plano, north of the city, to fill these prescriptions?'' Id. at 281. 
Nothing in the Administrative Record provides an answer to that 
question. Dr. Witte further opined that, ``more than likely, there are 
many pharmacies located between . . . where the patient lives and where 
the clinic is.'' \43\ Id. at 263; see also id. at 323. Certainly there 
could have been valid reasons for the distances and routes traveled, 
but the minimum standards in Texas obligate a pharmacist to at least 
raise this concern with the provider to determine the prescription's 
legitimacy, and then document the explanation. [FF 63-64, 79, 90].\*O\ 
This was not done here. FF 79, 88, 90; GE-2; RE-E. Dr. Witte's 
testimony is consistent with DEA precedent and Texas law. Further, 
while Ms. Igwe did not seem to have the slightest concern about the 
distance her customers were traveling to obtain their prescriptions and 
get them filled, she also apparently had not the slightest curiosity as 
to why this small group of prescribers had referred so many patients to 
her relatively small and out of the way Pharmacy. While nothing in the 
Administrative Record directly answers that question, that facts alone 
should have raised a question about the legitimacy of the 
prescriptions.
---------------------------------------------------------------------------

    \43\ Dr. Witte was accepted as an expert in the field of 
pharmacy in the state of Texas, not geography. Tr. 169. Thus, I do 
not credit her testimony concerning distances, routes, and general 
availability of pharmacies as that of an expert. I do credit it, 
however, as a reasonable observation based upon common experience. 
Certainly one is more likely to pass by a location to fill 
prescriptions in an urban area than a rural one. Common experience 
also suggests that, in general, it is more time consuming to travel 
even a short distance in an urban area than a rural one.
    \*O\ Text removed and citation corrected.
---------------------------------------------------------------------------

    The Respondent's expert witness, Mr. Litman, however, minimized the 
significance of distance, noting that we live ``in a very mobile 
society now, and people are on the go all the time.'' Tr. 730. Mr. 
Litman added that on some days he commutes 80 miles. Id. As a 
pharmacist, who at times works in a retail pharmacy in Miami, Florida, 
Mr. Litman would be concerned with a patient traveling from South 
Carolina to fill a prescription. Id. at 695. Mr. Litman, however, was 
not aware of DEA cases that deal with pharmacy customers who had driven 
long distances to obtain their prescriptions and have them filled. Id. 
at 727. And as previously noted, the DEA has considered distance to be 
a red flag of diversion for at least the past 8 years. See supra note 
42 and accompanying text. Further, Mr. Litman was apparently unaware of 
the Texas requirement to at least consider the distance a customer has 
traveled to fill a prescription. Tr. 739; see 22 Tex. Admin. Code Sec.  
291.29(c)(4). [His testimony concerning distance contradicts cases 
based on credible expert testimony that distance is a red flag under 
the usual course of professional practice of pharmacy. Morning Star 
Pharmacy and Medical Supply 1, 85 FR at 51052; Hills Pharmacy, L.L.C., 
81 FR at 49841 n.45 (2016); Jones Total Health Care Pharmacy, L.L.C. & 
SND Healthcare, L.L.C., 81 FR at 79194-95; 21 CFR 1306.04(a) (creating 
the pharmacist's corresponding responsibility). It also contradicts Dr. 
Witte's credible testimony that the distances the patients traveled to 
fill the subject prescriptions were red flags that a pharmacist 
following the minimum standards of practice in Texas should have 
investigated, resolved, and documented before filling the 
prescriptions. E.g., Tr. 401-404.] \*P\ Accordingly, I give no weight 
to Mr. Litman's testimony that distance is not a red flag. Tr. 726-27.
---------------------------------------------------------------------------

    \*P\ Text adjusted for clarity and additional citations.
---------------------------------------------------------------------------

Cash Payments
    Dr. Witte testified that paying cash for prescriptions was a red 
flag. See, e.g., Tr. 172-73, 229-30, 263. She also testified that the 
average cash price for 90 tablets of hydrocodone was about $70.00 and 
the average price for 60 tablets of alprazolam was about $35.00 Id. at 
223, 229. Here, the Pharmacy's customers were routinely paying $179.99 
and $59.99, respectively. FF 167, 173. When a customer purchased 
prescriptions for both hydrocodone and alprazolam at the same visit to 
the Pharmacy, the customer would pay $239.98. Id. Even Mr. Litman 
expressed concern for cash payments in excess of $200.00. Tr. 692, 753. 
Mr. Litman also downplayed the significance of cash payments because 
many individuals do not have medical insurance and ``cash payments are 
much more common these days.'' Id. Ms. Igwe testified, however, that a 
majority of customers used insurance to pay for their prescriptions. 
Id. at 496. If that is the case, it is more concerning that all of the 
customers from Government Exhibit 2 paid cash when filling 
prescriptions for hydrocodone and/or alprazolam. FF 111, 165, 171, 176.
    Paying cash for controlled substances, rather than billing 
insurance, is a red flag that the patient is seeking the substances for 
illicit purposes. ``` [A]ny reasonable pharmacist knows that a patient 
that (sic) wants to pay cash for a large quantity of controlled 
substances is immediately suspect.' '' Jones Total Health Care 
Pharmacy, 81 FR at 79194 (quoting E. Main St. Pharmacy, 75 FR at 
66158). Paying for a prescription in cash is ``the preferred payment 
method for

[[Page 21038]]

illegitimate prescriptions,'' because it is not traceable. Masters 
Pharmaceutical, Inc. v. DEA, 861 F.3d 206, 220 (DC Cir. 2017). Like all 
red flags, paying in cash for controlled substances, or cash 
equivalent, such as credit card or check, is viewed in combination with 
other evidence of diversion. See Edge Pharmacy, L.L.C., 81 FR 72092, 
72103, 72111-12 (2016) (concluding substantial distances, large 
quantities of highly-abused controlled substances, and cash payments 
indicated the prescriptions lacked a legitimate medical purpose).
    In the absence of other signs of diversion, prices in the range of 
$25 to $220 may be insufficient to prove that a pharmacist violated his 
or her corresponding responsibility. Hills Pharmacy, L.L.C., 81 FR at 
49839 n.39. DEA cases relying on expert testimony instruct, however, 
that not all red flags ``have the same hue.'' Superior Pharmacy I & 
Superior Pharmacy II, 81 FR at 31335 n.54. ``[W]here there are multiple 
red flags, none of which alone would establish the requisite scienter, 
the combination of red flags may well create a subjective belief that 
there is a high probability that a prescription lacks a legitimate 
medical purpose.'' Id. Thus, as in this case, cash payments, combined 
with other red flags, can be enough to find a pharmacist violated 21 
CFR 1306.04(a). Edge Pharmacy, L.L.C., 81 FR at 72111-12; Superior 
Pharmacy I & Superior Pharmacy II, 81 FR at 31335 n.54.

The Allegations

The Prescriptions

    1. Initially, the Government alleged that between August 2014 and 
May 2015 the Pharmacy filled 75 controlled substance prescriptions 
outside the usual course of pharmacy practice, in violation of 21 CFR 
1306.06, and in contravention of the Pharmacy's ``corresponding 
responsibility'' under 21 CFR 1306.04(a). ALJ-1, at 2, para. 3. The 
Pharmacy did so by repeatedly filling controlled substance 
prescriptions that contained red flags of diversion and/or abuse 
without addressing or resolving those red flags. The Pharmacy's conduct 
in doing so violated 21 U.S.C. 823(f)(4); Tex. Health & Safety Code 
Sec.  481.070-.075; Tex. Health & Safety Code Sec.  481.128; 22 Tex. 
Admin. Code Sec.  291.22(c)(2); and 22 Tex. Admin. Code Sec.  291.33. 
Additionally, the Pharmacy engaged in conduct that demonstrated 
negative experience in its dispensing of controlled substances, in 
violation of 21 U.S.C. 823(f)(2). ALJ-1, at 2-3, para. 3, 6-8.
    The regulation concerning the usual course of pharmacy practice 
provides that, ``[a] prescription for a controlled substance may only 
be filled by a pharmacist, acting in the usual course of his 
professional practice . . . .'' 21 CFR 1306.06. The DEA has also 
promulgated regulations concerning a pharmacist's corresponding 
responsibility. That regulation provides:

    A prescription for a controlled substance to be effective must 
be issued for a legitimate medical purpose by an individual 
practitioner acting in the usual course of his professional 
practice. The responsibility for the proper prescribing and 
dispensing of controlled substances is upon the prescribing 
practitioner, but a corresponding responsibility rests with the 
pharmacist who fills the prescription. An order purporting to be a 
prescription issued not in the usual course of professional 
treatment . . . is not a prescription within the meaning of section 
309 of the [Controlled Substances] Act (21 U.S.C. 829) and the 
person knowingly filling such 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.

21 CFR 1306.04(a). Texas regulations require that ``[u]pon identifying 
any clinically significant conditions, [or] situations . . . the 
pharmacist shall take appropriate steps to avoid or resolve the problem 
including consultation with the prescribing practitioner.'' 22 Tex. 
Admin. Code Sec.  291.33(c)(2)(A)(ii). That resolution must be 
documented [on the prescription itself or ``in the pharmacy's data 
processing system associated with the prescription.'' Id. at Sec. Sec.  
291.33(c)(2)(A)(iv) and 291.33(c)(2)(C). The minimum documentation 
requirements include] \*Q\ recording the date the pharmacist discussed 
the matter with the prescriber, recording the name of the person with 
whom the pharmacist discussed the matter, and any applicable 
information pertaining to the discussion. Id. [ ] \*R\
---------------------------------------------------------------------------

    \*Q\ Text adjusted in response to Respondent's Exceptions.
    \*R\ Text removed in response to Respondent's Exceptions.
---------------------------------------------------------------------------

    The Government's first allegation asserts that the Pharmacy 
violated its corresponding responsibility in filling the prescriptions 
contained in Government Exhibit 2, which were all filled between August 
2014 and May 2015. ALJ-1, at 2, para. 3. The testimony of Dr. Witte, 
supported by DEA cases, makes clear that pattern prescribing cannot be 
established by only a few prescriptions. Tr. 332-33. At first blush, 
the allegation seems inconsistent with DEA precedent and Dr. Witte's 
testimony that pattern prescribing cannot be established by only a few 
prescriptions.\44\ The Pharmacy, however, did not start filling 
prescriptions for the ``Prescribers'' in August 2014.
---------------------------------------------------------------------------

    \44\ The inconsistency results because the number of 
prescriptions issued by each individual prescriber in Government 
Exhibit 2 might be insufficient by itself to establish a pattern 
that the Pharmacy should have been reasonably expected to notice. 
Looking solely at the hard-copy prescriptions in Government Exhibit 
2, and not the patient profiles, reveals the following breakdown of 
the number of prescriptions issued by each practitioner. Nurse J.W. 
issued 1 prescription. GE-2, at 67. Dr. A.Q. issued 5 prescriptions. 
Id. at 18, 20, 64, 66, 68. Nurse L.R. issued 7 prescriptions. Id. at 
1, 3, 24, 37, 96, 119. Nurse Practitioner I.I. issued 10 
prescriptions. Id. at 8, 10, 12, 14, 16. Nurse S.G. issued 10 
prescriptions. Id. at 5, 6, 34, 77, 81, 91, 111, 124. C.Z., PA, 
issued 8 prescriptions. Id. at 25, 30, 41, 46, 52, 100, 115, 122. 
Dr. C.V. issued 12 prescriptions. Id. at 28, 35, 39, 44, 47, 50, 83, 
94, 98, 113, 117, 130. Dr. NE issued 23 prescriptions. Id. at 22, 
26, 49, 56, 58, 60, 62, 71, 73, 75, 79, 86, 88, 89, 102, 104, 105, 
107, 109, 120, 125, 127, 132. When written over the course of 10 
months, from August 2014 to May 2015, the volume of prescriptions 
issued by each practitioner might not be suspicious. Thus, in 
determining whether the Pharmacy filled pattern-style prescriptions, 
consideration is also given to additional documentary evidence in 
the Administrative Record beyond the 10 month period in the 
allegation. For example, consideration has been given to Government 
Exhibit 6 and Respondent Exhibit C. Consideration is also given to 
the fact that all the prescribers were associated with the same 
medical clinics.
---------------------------------------------------------------------------

    The Pharmacy started receiving prescriptions from Redbird in 
January or February 2014. FF 11; Tr. 475. In fact, prior to filling the 
cocktail prescriptions for J.S. on August 6, 2014, the Pharmacy had 
filled at least 104 prescriptions for hydrocodone written by the same 
small group of prescribers.\45\ FF 155. In addition, the Pharmacy had 
filled at least 11 prescriptions written by this small group of 
prescribers for cocktails of hydrocodone and alprazolam prior to August 
2014, for patients who had to travel a significant distance to fill 
those prescriptions. FF 140, 142-45. In each case the prescriptions 
raised numerous red flags: The patient was receiving a large quantity 
of controlled substances; the controlled substances constituted a drug 
cocktail; the prescription was written by one of a small number of 
prescribers of hydrocodone and alprazolam whose prescriptions the 
Pharmacy filled for those controlled

[[Page 21039]]

substances; the prescriber was located a significant distance from the 
Pharmacy; and the round-trip distance for the patient to obtain the 
prescription and have it filled at the Pharmacy was also significant. 
Id.\*S\
---------------------------------------------------------------------------

    \45\ Actually, if Respondent's Exhibit C is taken into 
consideration, the Pharmacy filled far more than 104 prescriptions 
for hydrocodone written by the same small group of Prescribers prior 
to filling the hydrocodone prescription for J.S. in August 2014. The 
104 figure only takes into account those prescriptions documented by 
Government Exhibit 6. A review of Respondent's Exhibit C, which the 
Pharmacy claims to be its complete dispensing history of hydrocodone 
from the date the Pharmacy opened until the date of the DEA 
inspection, Tr. 470-71, reveals that the overwhelming majority of 
prescriptions the Pharmacy filled for hydrocodone were written by 
one of the Prescribers identified in Findings of Fact 118-121, 155.
    \*S\ The OSC did not allege that Respondent unlawfully dispensed 
any prescriptions prior to August 2014. Accordingly, while 
Respondent's dispensing history prior to August 2014 is relevant to 
establishing patterns in the subject prescriptions, any deficiencies 
in Respondent's prescription dispensing practices outside of the 
subject prescriptions do not weigh for or against Respondent 
retaining its registration.
---------------------------------------------------------------------------

    Here, Government Exhibit 2 documents that the Pharmacy filled more 
than 75 controlled substance prescriptions between August 2014 and May 
2015 for 27 different customers. FF 140. Those prescriptions contain 
many of the same red flags as are contained in the prescriptions the 
Pharmacy filled prior to August 2014 that were written by the same 
small group of Prescribers.\46\ Furthermore, there is no credible 
evidence that the Pharmacy ever took any steps to resolve any of these 
red flags, either before or after August 2014. Tr. 216-17, 227, 236.
---------------------------------------------------------------------------

    \46\ Government Exhibit 6 is the Pharmacy's dispensing log for 
hydrocodone. FF 24. The stated date range on Government Exhibit 6 is 
October 23, 2013 to June 18, 2015. FF 25. The earliest date recorded 
on Government Exhibit 6, however, is July 7, 2014. GE-6, at 1. The 
actual hard-copy prescriptions for most of the prescriptions 
recorded on the dispensing log are not contained in the 
Administrative Record. Nevertheless, the dispensing log identifies 
the prescriber, the prescriber's address, the patient, the patient's 
address, the quantity of hydrocodone tablets dispensed, and amount 
the customer paid for the prescription. Thus, Government Exhibit 6 
documents that most of the prescriptions would have contained the 
following red flags: Pattern prescribing; a highly abused controlled 
substance; unusual routes of travel and/or long distances to obtain 
the prescriptions and have them filled at the Pharmacy; and cash 
payments.
---------------------------------------------------------------------------

    Accordingly, the allegations contained in paragraphs [3, 6, and 8] 
\*T\ of the OSC asserting that between August 2014 and May 2015 the 
Pharmacy filled 75 controlled substance prescriptions outside the usual 
course of pharmacy practice, in violation of 21 CFR 1306.06, and in 
contravention of the Pharmacy's ``corresponding responsibility'' under 
21 CFR 1306.04(a), as well as 21 U.S.C.Sec.  823(f)(2) and (4); Tex. 
Health & Safety Code Sec.  481.070-.075; Tex. Health & Safety Code 
Sec.  481.128; 22 Tex. Admin. Code Sec.  291.22(c)(2) [ ],\*U\ are 
sustained, and weigh in favor of revoking the Pharmacy's DEA 
registration.
---------------------------------------------------------------------------

    \*T\ Text adjusted in response to Respondent's Exceptions.
    \*U\ Text adjusted in response to Respondent's Exceptions.
---------------------------------------------------------------------------

    2. The Government next alleged four situations in which the 
Pharmacy filled prescriptions that contained one or more red flags that 
the Pharmacy did not resolve prior to filling the prescriptions. The 
Government listed the following as examples of red flags the Pharmacy 
did not resolve: (a) Prescriptions for highly-abused controlled 
substances such as hydrocodone, alprazolam, and promethazine with 
codeine; (b) prescriptions written to individuals traveling long and/or 
unusual distances to obtain their prescriptions and/or fill their 
prescriptions at the Pharmacy; (c) prescriptions for individuals 
obtaining the same or similar combinations of controlled substances 
from the same small number of providers; (d) prescriptions for highly-
abused drug cocktails, such as hydrocodone and alprazolam; (e) 
prescriptions containing inappropriate and/or unusual directions for 
use; and (f) prescriptions for controlled substances purchased with 
cash. ALJ-1, at 3-5, paras. 10, 10(a)-(d).
    Ms. Igwe testified that she did not see any red flags in the 
prescriptions introduced by the Government because they came from 
clinics with which she was familiar.\47\ Tr. 512-13. Also, the types of 
controlled substances in these prescriptions were consistent with the 
clinics' specialty, chronic pain management. Id. at 512. Additionally, 
some of the controlled substances were prescribed with appropriate non-
controlled substances. Id. at 514, 663-65. For example, some of the 
prescriptions, such as the M.W. prescription, contained Mobic, an anti-
inflammatory that can reduce the need for an opioid. Id. at 513, 663-
64; GE-2, at 1. Some prescriptions, as in the case of M.W. 
prescription, also contained Robaxin, which is a muscle relaxant. Tr. 
513, 664-65; GE-2, at 1. Mobic and Robaxin are relevant treatment 
options involving non-scheduled drugs for a patient suffering from 
chronic pain. Tr. 513, 663-65. Ms. Igwe found it common that different 
doctors practicing in the same specialty prescribed the same or similar 
types of controlled substances. Id. at 519; see also id. at 658.
---------------------------------------------------------------------------

    \47\ A former Administrator overruled a similar argument in the 
past. See Ralph J. Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55 
FR 4729, 4729-4730 (1990) (deciding that the ``sheer quantity and 
frequency of [Preludin] prescriptions'' should have tipped off the 
pharmacy that the prescriptions lacked a legitimate medical purpose 
even though the pharmacy argued that the prescriptions were ``not 
surprising'' given the provider's medical specialty).
---------------------------------------------------------------------------

    Ms. Igwe also testified that customers would come into the Pharmacy 
wearing braces or other ``mobilization'' (sic) devices, consistent with 
the patient needing a controlled substance to treat pain. Id. at 516. 
Sometimes a customer would say something that indicated to Ms. Igwe the 
customer needed the medications to treat pain. Id. at 516.
    In addition, Ms. Igwe was not concerned with patients coming from 
Fort Worth. FF 138. Ms. Igwe testified that it was not unusual to see 
patients with a Fort Worth address.\48\ Id. at 494. The Pharmacy had 
patients from towns surrounding the Plano area, such as Lavon, 
Princeton, Farmersville, Gladewater, DeSoto, and Lancaster. Id. at 494, 
584. The Pharmacy had patients who came from throughout the Dallas-Fort 
Worth metroplex. Id. at 495, 584.
---------------------------------------------------------------------------

    \48\ In fact, there are numerous Fort Worth addresses for the 
Pharmacy's customers listed in Government Exhibit 6. Most of those 
customers, however, also received their prescriptions for 
hydrocodone from the same small group of Prescribers.
---------------------------------------------------------------------------

    Although Ms. Igwe testified that she was not concerned about red 
flags, in part, because she was familiar with the clinics the customers 
were coming from, Ms. Igwe also testified that she never checked to see 
if the Prescribers' clinics were registered with the State of Texas as 
pain management clinics. FF 99. Thus, her belief that she was receiving 
prescriptions from pain management specialists was, at best, 
uninformed. While it is true that many of the prescriptions in 
Government Exhibit 6 also included non-controlled substances that could 
also be used to treat pain symptoms, it is possible that the 
Prescribers were simply ``masking'' the fact that they were issuing 
prescriptions for illegitimate reasons. Even the Respondent's own 
expert, Mr. Litman, concluded that he thought the Prescribers were 
engaged in masking. Tr. 713. Mr. Litman further testified that the only 
way to sniff out masking, or at least to ``reduce the suspicions,'' is 
to ``call the physician.'' Id. at 687, 727. The Administrative Record 
contains no evidence documenting such calls being made to the 
Prescribers.
    With respect to distance, Ms. Igwe, as well as Mr. Litman, 
apparently had no concerns about the distances the Pharmacy's customers 
were driving to obtain their prescriptions and have them filled at the 
Pharmacy. Id. at 492-95, 542-43, 695-96, 727. Contributing to Ms. 
Igwe's lack of concern about distance was the fact that she believed 
the customers were coming from pain management clinics. Id. at 512-13. 
Further, both Ms. Igwe and Mr. Litman seemed oblivious to the Texas 
requirement that a pharmacist should consider ``the geographical 
distance between the practitioner and the patient or between the 
pharmacy and the patient'' when evaluating a

[[Page 21040]]

prescription's legitimacy. 22 Tex. Admin. Code Sec.  291.29(c)(4).
    Finally, there is no documentation in the Administrative Record of 
the Pharmacy ever: Resolving any red flags; consulting with providers 
about red flags; checking the Texas PMP; or having discussions with 
customers to resolve missing addresses on prescriptions. Tr. 216-17, 
227, 236. In fact, although Ms. Igwe testified that she had such 
documentation, she did not believe she needed to present it.\49\ Id. at 
547. This belief is unreasonable given the allegations contained in the 
OSC and because Ms. Igwe was asked to produce any notes she had 
concerning the resolution of red flags during the AIW. FF 18-19.
---------------------------------------------------------------------------

    \49\ In this regard the Respondent is like the student who 
neglected to turn in his homework. They both get no credit.
---------------------------------------------------------------------------

A. The M.W. Prescription
    The Government alleged that on August 1, 2014, the Pharmacy filled 
a prescription for 120, 10 mg tablets of hydrocodone presented by an 
undercover agent without resolving the red flags presented by the 
prescription. The agent obtained the prescription from a practitioner 
in a clinic in south Dallas, more than 30 miles from the Pharmacy, 
which is located north of Dallas. There was no legitimate medical 
purpose for the prescription and the agent used a fictitious address. 
The agent also sought to purchase the prescription with cash. ALJ-1, at 
3-4, paras. 10, 10(a).
    The basic facts that support this allegation are contained in the 
sworn declaration of the undercover investigator, UC 1. GE-11. During 
his undercover investigation, UC 1 used the name M.W. FF 124. On July 
29, 2014, M.W. went to the Redbird Medical Clinic, where Nurse 
Practitioner L.R. conducted a cursory examination. FF 126-27. L.R. then 
issued M.W. a prescription for 120, 10 mg tablets of hydrocodone, as 
well as prescriptions for Robaxin (methocarbamol) and Mobic 
(meloxicam). FF 127; GE-2, at 1; GE-10, at 5. Instead of simply giving 
M.W. his prescription so that he could have it filled at the pharmacy 
of his choice, Redbird informed M.W. that they were sending his 
prescription to the Pharmacy. FF 127. The Pharmacy, however, did not 
receive the prescription until August 1, 2014. FF 129. In spite of the 
fact that the prescription was written for pain, M.W. did not pick up 
his prescriptions until August 4, 2014. FF 132. Based on the addresses 
contained in the Pharmacy's records, M.W. would have needed to travel 
almost 100 miles to obtain his prescriptions from Redbird, have them 
filled at the Pharmacy, and return to his recorded, though fictitious, 
address. GE-12. M.W. paid the Pharmacy $206.00 for his three 
prescriptions, to include $150.00 for the hydrocodone. GE-2, at 1; GE-
11, at 3.
    In the three weeks before the Pharmacy filled M.W.'s prescription 
for hydrocodone on August 1, 2014,\50\ the Pharmacy had already filled 
83 prescriptions for hydrocodone, and L.R. had written 27 of those 
prescriptions. GE-6, at 1-8. In addition, every one of those 
prescriptions had been written by one of the Prescribers. Id., see also 
FF 118-21.
---------------------------------------------------------------------------

    \50\ The allegation alleges that this prescription was filled on 
August 1, 2014, which corresponds to the date on the fill sticker. 
See GE-2, at 1. Ms. Igwe acknowledged that the date on the fill 
sticker is not necessarily the date the customer picked up his or 
her prescription. FF 117. Ms. Igwe also testified that she had no 
reason to dispute that M.W. prescription was picked up on August 4, 
2014. Tr. 576.
---------------------------------------------------------------------------

    The prescription that L.R. wrote for M.W. raises the following red 
flags: No patient address; no provider DEA number; [ ] \*V\ the 
prescription was written on July 29, 2014, but not faxed to the 
Pharmacy until August 1, 2014, and not picked up until August 4, 2014; 
\51\ and an unusual path and distance to obtain the prescription and 
get it filled. FF 47, 63, 69, 75, 135. In addition, M.W. paid over $200 
cash to pick up his three prescriptions.\52\ FF 65; GE-2, at 1; GE-11, 
at 3.
---------------------------------------------------------------------------

    \*V\ Text adjusted in response to Respondent's Exceptions.
    \51\ While Ms. Igwe was not concerned about the delay between 
the date M.W.'s prescription was written for pain and when it was 
picked up six days later, her reasoning was based on pure 
speculation that M.W. could have had other medication left over. Tr. 
564-65. Had Ms. Igwe checked the PMP she would have learned that not 
to be the case. Further, Dr. Witte credibly testified that such a 
delay would call into question whether the patient needed pain 
medication and whether the prescription was for a legitimate medical 
purpose. Id. 192-93, 397.
    \52\ Even the Respondent's expert expressed some concern for 
cash payments in excess of $200. Tr. 692, 753.
---------------------------------------------------------------------------

    There are no notations on the M.W. prescription or on M.W.'s 
patient profile, maintained by the Pharmacy, to suggest that any of the 
above noted red flags were resolved either before or after Ms. Igwe 
filled the prescription for hydrocodone. Tr. 194-95; GE-2, at 1; GE-10, 
at 4-5. Accordingly, the M.W. prescription for hydrocodone was not 
dispensed in the usual course of pharmacy practice. Tr. 195. In 
addition, the pharmacist who filled these prescriptions did not follow 
the minimum standard of the practice of pharmacy in the State of Texas, 
and did not satisfy the pharmacist's corresponding responsibility to 
ensure that prescriptions are issued for legitimate medical purposes. 
Id.
    The allegation concerning the M.W. prescription is also included in 
the allegation contained in paragraphs 3-7 of the OSC that between 
August 2014 and May 2015 the Pharmacy filled 75 controlled substance 
prescriptions outside the usual course of pharmacy practice and in 
contravention of the Pharmacy's corresponding responsibility to ensure 
that prescriptions are dispensed for legitimate medical purposes. ALJ-
1, at 2-3, paras. 3-7. The Government has not advanced any theory as to 
why this same allegation should be considered twice. See ALJ-35. 
Therefore, the allegations contained in paragraphs 10 and 10(a) of the 
OSC, that the Pharmacy filled the M.W. prescription for 120, 10 mg 
tablets of hydrocodone on August 1, 2014, without resolving red flags 
presented by the prescription, are sustained, and weighs in favor of 
revoking the Respondent's DEA registration. The substance of these 
allegations, however, will only be considered once.
B. Prescription Cocktails, Distance, Cash Payments, and Facially 
Invalid Prescriptions
    (i.) Next, the Government alleged that from August 2014 to May 
2015, the Pharmacy dispensed prescription cocktails (hydrocodone and 
alprazolam) to 25 different individuals, all of whom traveled unusual 
paths and distances to obtain their prescriptions for these controlled 
substances and to have them filled at the Pharmacy. ALJ-1, at 3-4, 
paras. 10, 10(b).
    Government Exhibit 2 reveals that between August 8, 2014, and May 
18, 2015, the Pharmacy filled prescriptions for hydrocodone and 
alprazolam on the same day for 25 different customers. GE-2, at 3-81, 
86-132. Of the 27 customers identified in Government Exhibit 2, only 
patients M.W. and G.B. did not have prescriptions for both hydrocodone 
and alprazolam filled by the Pharmacy on the same day. See id. at 1, 
and 83-84.
    (ii.) The Government also alleged that six individuals, J.W., H.J., 
M.H., A.S., K.S., and M.A., traveled more than 100 miles to obtain 
their prescriptions, have them filled at the Pharmacy, and return home. 
ALJ-1, at 3-4, para. 10, 10(b).
    Based upon round-trip distance calculations, each of these Pharmacy 
customers, J.W., H.J., M.H., A.S., K.S., and M.A., traveled more than 
100 miles to obtain their prescriptions and have them filled at the 
Pharmacy. FF 162, 167, 173. Of these six customers, K.S.

[[Page 21041]]

had the shortest round trip of 101 miles, which would have taken 1 hour 
and 51 minutes to travel during light traffic. GE-3, at 128. Customer 
M.H. had the longest round-trip distance of 121 miles, which would have 
taken 2 hours and 19 minutes to travel with heavy traffic. GE-3, at 54.
    (iii.) The Government next alleged that 17 individuals, J.S., C.J., 
SW, J.W.2, S.H., R.E., R.N., R.H., B.B., S.N., I.B., M.W.2, Y.S., 
R.H.2, C.D., A.K., and S.B., traveled between 70-100 miles to obtain 
their prescriptions, have them filled at the Pharmacy, and return home. 
ALJ-1, at 3-4, para. 10, 10(b).
    Based upon round-trip distance calculations, each of these Pharmacy 
customers, J.S., C.J., SW, J.W.2, S.H., R.E., R.N., R.H., B.B., S.N., 
I.B., M.W.2, Y.S., R.H.2, C.D., A.K., and S.B., traveled between 70 to 
100 miles to obtain their prescriptions and have them filled at the 
Pharmacy. FF 47, 151, 162, 167, 173. Of these 17 customers, K.S. had 
the shortest round trip of 76.6 miles, which would have taken 1 hour 
and 27 minutes to travel during light traffic. GE-3, at 74. Customer SW 
had the longest round-trip distance of 99.7 miles, which would have 
taken 1 hour and 54 minutes to travel in moderate traffic. GE-3, at 
167.
    (iv.) The Government alleged that four individuals, R.N., E.H., 
B.B., and T.H.,\53\ traveled between 60-70 miles to obtain their 
prescriptions, have them filled at the Pharmacy, and return home. ALJ-
1, at 3-4, para 10, 10(b).
---------------------------------------------------------------------------

    \53\ The OSC alleged that ``T.H.'' had a round-trip distance of 
between 60-70 miles. ALJ-1, at 4, para. 10(b). There is no patient 
T.H. in Government Exhibit 2. There is, however, a patient T.W. 
addressed in Government Exhibit 2. GE-2, at 71-74. The round-trip 
distance for T.W. was 66.9 miles. GE-3, at 177.
---------------------------------------------------------------------------

    Based upon round-trip distance calculations for Pharmacy customers 
R.N., E.H., B.B., and T.W., they each traveled between 60 to 70 miles 
to obtain their prescriptions and have them filled at the Pharmacy. FF 
167, 173; GE-2, at 71-73; GE-3, at 45-48, 177-181. Of these four 
customers, R.N. had the shortest round trip of 64.8 miles, which would 
have taken 1 hour and 33 minutes to travel during heavy traffic. GE-3, 
at 104. Customer E.H. had the longest round-trip distance of 68.1 
miles, which would have taken 1 hour and 22 minutes to travel in 
moderate traffic. GE-3, at 45.
    (v.) Next, the Government alleged that all of the above customers 
sought to purchase their prescriptions with cash. ALJ-1, at 3-4, para. 
10, 10(b).
    Each of the Pharmacy's fill stickers shows a dollar amount preceded 
by the abbreviation ``Cpy''. See, e.g., GE-2, at 1. That dollar amount 
is the amount the customer paid the Pharmacy for the prescription. FF 
111. Thus, each prescription in Government Exhibit 2 was purchased with 
cash. In addition, when prescriptions of hydrocodone and alprazolam 
were purchased on the same day, as they frequently were, a customer 
would normally pay $179.99 for the hydrocodone and $59.99 for the 
alprazolam, for a total of $239.98 for the two prescriptions. FF 167, 
173, 176; see, e.g., GE-2, at 80-81.
    (vi.) The Government also alleged that the prescriptions issued to 
M.W., J.S., J.W., C.J., S.N., J.W.2, S.H., H.J., E.H., A.S., R.E., 
K.S., S.B., R.H., T.W., I.B., M.W.2, Y.S., M.A., R.H.2, B.B., C.D., 
A.K., and R.N., were facially invalid and in violation of federal and 
state law because they lacked the patient's address and the 
practitioner's DEA number. ALJ-1, at 3-4, para. 10, 10(b).
    Federal regulations require that, among other information, a 
prescription must contain the patient's address and the registration 
number of the prescriber. FF 68, 77; 21 CFR 1306.05(a). Texas law also 
requires that prescriptions contain the patient's address and the 
prescriber's DEA number. FF 68, 77; Tex. Health & Safety Code Sec.  
481.074(k). The prescriptions issued to M.W., J.S., J.W., C.J., S.N., 
J.W.2, S.H., H.J., E.H., A.S., R.E., K.S., S.B., R.H., T.W., I.B., 
M.W.2, Y.S., M.A., R.H.2, B.B., C.D., A.K., and R.N., did not contain 
the patient's address. GE-2, at 1, 3, 5, 6, 8, 12, 14, 16, 20, 24, 25, 
30, 34, 37, 41, 46, 49, 52, 58, 62, 66, 67, 73, 77, 81, 88, 91, 96, 
100, 104, 107, 111, 115, 119, 122, 124, 127. In addition, all of these 
prescriptions, except those issued to S.N. and S.B., and one of the 
prescriptions issued to B.B., did not contain the prescriber's DEA 
registration number. See GE-2, at 58, 62, 104. Therefore, all of these 
prescriptions were facially invalid under federal and Texas law.
    It is also noted that Nurse Practitioner S.G. wrote cocktail 
prescriptions of hydrocodone and alprazolam for J.W. on August 29, 
2014. Id. at 6. The prescription for alprazolam indicated that J.W. was 
to take one tablet twice a day. Id. Alprazolam, however, is normally 
taken more frequently than twice a day. Tr. 177. In addition, J.W. 
waited 14 days before filling these prescriptions. GE-2, at 6. Such a 
delay raises a question of whether the prescription is legitimate. Tr. 
193. In addition to these two red flags, the two prescriptions combined 
constituted a drug cocktail. FF 54. The prescription was also written 
by one of the Prescribers, calling into question pattern prescribing, 
and J.W. paid $219.99 for the two prescriptions. GE-2, at 6. The 
Administrative Record does not document that Ms. Igwe resolved any of 
these issues before filling these two prescriptions for J.W. on 
September 12, 2014. FF 177.
    The allegations addressed in subparagraphs (i.)-(vi.), discussed 
above, concern: Dispensing drug cocktails; the long and unusual routes 
that the Pharmacy customers traveled to obtain their prescriptions and 
have them filled; paying cash for prescriptions; and prescriptions that 
were facially invalid. Each of these concerns is a red flag. FF 63, 65, 
68, 69, 70, 77; Tr. 391-92. When a prescription presents a red flag, a 
Texas pharmacist must resolve that red flag [and document the 
resolution] \*W\ prior to filling the prescription. FF 77, 79. [ ] \*X\ 
Neither the hard-copy prescriptions nor the patient profiles maintained 
by the Pharmacy contain any documentation showing that the Pharmacy 
resolved the above-noted red flags. GE-2; see also Tr. 216-17, 227, 
236. Accordingly, the prescriptions addressed in subparagraph (i.)-
(vi.) above were not dispensed in the usual course of the professional 
practice of pharmacy in the State of Texas. Id. at 217, 227, 236. 
Furthermore, the pharmacist who filled these prescriptions did not 
follow the minimum standard of the practice of pharmacy in the State of 
Texas, and did not satisfy the pharmacist's corresponding 
responsibility to ensure that prescriptions are issued for legitimate 
medical purposes. Tr. 217, 227-28, 236-37; see 21 CFR 1306.04(a).
---------------------------------------------------------------------------

    \*W\ Text adjusted in response to Respondent's Exceptions.
    \*X\ Text removed in response to Respondent's Exceptions.
---------------------------------------------------------------------------

    The allegations contained in paragraphs 10 and 10(b) of the OSC are 
also included in the allegation that between August 2014 and May 2015 
the Pharmacy filled 75 controlled substance prescriptions outside the 
usual course of pharmacy practice and in contravention of the 
pharmacist's corresponding responsibility to ensure that prescriptions 
are dispensed for legitimate medical purposes. ALJ-1, at 2-3, paras. 3-
7. The Government has not advanced any theory as to why this same 
allegation should be considered twice. See ALJ-35. Therefore, the 
allegations contained in paragraphs 10 and 10(b) of the OSC, that the 
Pharmacy filled numerous prescriptions without resolving red flags 
concerning drug cocktails, distance traveled, cash payments, and 
facially invalid prescriptions, are sustained, and weigh in favor of 
revoking the Respondent's

[[Page 21042]]

registration. The substance of these allegations, however, will only be 
considered once.
C. Pattern Prescribing
    The Government next alleged that many of the individuals mentioned 
in paragraph B, above, obtained their prescriptions from physicians who 
were engaged in pattern prescribing. ALJ-1, at 3-4, paras. 10, 10(c).
    (i.) The Government alleged that between August 19, 2014 \54\ and 
October 2, 2014, patients C.J., SW, J.W.2, S.H., and H.J. all received 
prescriptions for hydrocodone and alprazolam from Nurse Practitioner 
I.I., and they traveled long and unusual paths to obtain their 
prescriptions and have them filled at the Pharmacy. ALJ-1, at 3-4, 
paras. 10, 10(c).
---------------------------------------------------------------------------

    \54\ The first two prescriptions written by Nurse Practitioner 
I.I. were written on August 18, 2014, rather than August 19. GE-2, 
at 8, 12.
---------------------------------------------------------------------------

    In the month and a half between August 19, 2014, and October 2, 
2014, the Pharmacy filled five identical cocktail prescriptions for 
customers, C.J., SW, J.W.2, S.H., and H.J. FF 162. The Pharmacy 
provided each of these customers with 90, 10 mg tablets of hydrocodone, 
and 60, 2 mg tablets of alprazolam based upon prescriptions they had 
received from I.I. FF 162. Of the 5 customers, S.H. traveled the 
shortest round-trip distance of 76 miles, taking 1 hour and 27 minutes 
in light traffic. GE-3, at 74. H.J. had the longest round trip of 105 
miles, taking 1 hour and 56 minutes in light traffic. GE-3, at 84.
    Further, by the time the Pharmacy filled the first of I.I.'s 
prescriptions for hydrocodone for 1 of these 5 customers, the Pharmacy 
had already filled 149 prescriptions for hydrocodone since July 7, 
2014, and I.I. had written 43 of those prescriptions. GE-6, at 1-14. In 
addition, every one of those prescriptions had been written by one of 
the Prescribers. Id.; see also FF 118-21. Thus, by the time Ms. Igwe 
filled the prescription for hydrocodone for C.J. on August 19, 2014, a 
prescription written by I.I., Ms. Igwe would have had ample time to 
have identified the pattern of I.I.'s prescribing, and that of I.I.'s 
fellow Prescribers. FF 80-82, 84. Pattern prescribing is a red flag. FF 
61. When presented with evidence of pattern prescribing, a Texas 
pharmacist should contact the prescriber, ask about the prescription's 
medical purpose, and then document that discussion. FF 80, 85 [ ].\*Y\ 
While Ms. Igwe testified that she had discussions with providers 
whenever a new patient presented a prescription, those discussions are 
not documented as required by [the minimum standards of professional 
practice in Texas].\*Z\
---------------------------------------------------------------------------

    \*Y\ Text removed in response to Respondent's Exceptions.
    \*Z\ Text adjusted in response to Respondent's Exceptions.
---------------------------------------------------------------------------

    In addition, prescribing hydrocodone and alprazolam together 
constitutes a cocktail of high-alert drugs. FF 55. When taken together, 
these two controlled substances can create a euphoric and addictive 
effect similar to a heroin high. FF 55. A drug cocktail is a red flag. 
FF 70. Here, on August 19, 2014, the Pharmacy was filling drug cocktail 
prescriptions written by I.I., but as noted earlier in this Recommended 
Decision, the Pharmacy had already been filling drug cocktails of 
hydrocodone and alprazolam, written by the same small group of 
Prescribers to which I.I. belonged. See FF 130, 140, 142-45, 155.
    This allegation is also included in the allegation that between 
August 2014 and May 2015, the Pharmacy filled prescription cocktails of 
hydrocodone and alprazolam to 25 different individuals. ALJ-1, at 4, 
para. 10(b). The Government has not advanced any theory as to why this 
same allegation should be considered twice. See ALJ-35. Thus, while 
this allegation is sustained, and weighs in favor of revoking the 
Respondent's registration, its substance will only be considered once.
    (ii.) The Government alleged that between November 14, 2014, and 
May 1, 2015, the Pharmacy filled 12 prescriptions for hydrocodone 
written by Dr. C.V. for patients A.S., R.E., K.S., G.B., R.H.2, A.K., 
R.N., and M.H.\55\ All of these patients traveled long and unusual 
paths to obtain their prescriptions and have them filled. ALJ-1, at 3-
4, paras. 10, 10(c).
---------------------------------------------------------------------------

    \55\ Actually, the Pharmacy filled 13 prescriptions for these 8 
customers, plus a prescription for an additional customer, M.A., all 
of which were written by Dr. C.V. FF 167.
---------------------------------------------------------------------------

    The Pharmacy filled prescriptions for customers A.S., R.E., K.S., 
G.B., R.H.2, A.K., R.N., and M.H., all written by Dr. C.V. for 90, 10 
mg tablets of hydrocodone. FF 167. Significantly, at the same time the 
Pharmacy filled these prescriptions, it also filled a prescription for 
60, 2 mg tablets of alprazolam for each of these customers, written by 
one of the Prescribers other than Dr. C.V. FF 167. Of these 8 
customers, G.B. traveled the shortest round-trip distance of 55.8 
miles, taking 1 hour and 31 minutes in heavy traffic. GE-3, at 16. A.S. 
had the longest round trip of 111 miles, taking 2 hours in light 
traffic. GE-3, at 118.
    Further, by the time the Pharmacy filled the first of Dr. C.V.'s 
prescriptions for hydrocodone for 1 of these 8 customers on November 
14, 2014, the Pharmacy had already filled 379 prescriptions for 
hydrocodone since July 7, 2014, and Dr. C.V. had written 60 of those 
prescriptions. GE-6, at 1-14. Of the prescriptions Dr. C.V. wrote, the 
Pharmacy received 28 consecutive prescriptions from Dr. C.V. for 
hydrocodone between October 9 and October 23, 2014, and it had received 
19 in the week before it received the prescription for patient R.E. on 
November 14, 2014. GE-6, at 29-31, 33-35. In addition, all but 11 of 
the 379 prescriptions had been written by one of the Prescribers. GE-6, 
at 1-35; see also FF 118-21. Thus, by the time Ms. Igwe filled the 
prescription for hydrocodone for R.E. on November 14, 2014, a 
prescription written by Dr. C.V., Ms. Igwe would have had ample time to 
identify the pattern of Dr. C.V.'s prescribing, and that of his fellow 
Prescribers. FF 80-82, 84. Pattern prescribing is a red flag. FF 61. 
When presented with evidence of pattern prescribing, a Texas pharmacist 
should contact the prescriber, ask about the prescription's medical 
purpose, and then document that discussion. FF 80, 85. While Ms. Igwe 
testified that she had discussions with providers whenever a new 
patient presented a prescription, those discussions are not documented 
as required by [the minimum standards of practice in Texas].\*AA\
---------------------------------------------------------------------------

    \*AA\ Text adjusted in response to Respondent's Exceptions.
---------------------------------------------------------------------------

    With the exception of G.B.'s hydrocodone prescription,\56\ filled 
by the Pharmacy on April 17, 2015, this allegation is included in the 
allegation that between August 2014 and May 2015 the Pharmacy filled 
prescription cocktails of hydrocodone and alprazolam to 25 different 
individuals who had to travel long and/or unusual routes to obtain and 
fill their prescriptions. ALJ-1, at 4, para. 10(b). It is also included 
in the allegation that the Pharmacy filled 75 controlled substance 
prescriptions outside the usual course of pharmacy practice, in 
violation of 21 CFR 1306.06, and in contravention of the Pharmacy's 
``corresponding responsibility'' under 21 CFR 1306.04(a). ALJ-1, at 2, 
para. 3. The Government has not advanced any theory as to why this same 
allegation should be considered three times. See ALJ-35. Thus, while 
this allegation is sustained, and weighs in favor of

[[Page 21043]]

revoking the Respondent's registration, its substance will only be 
considered once. The portion of this allegation that alleges that the 
Pharmacy filled a hydrocodone prescription for G.B., written by Dr. 
C.V., is included in the allegation that the Pharmacy filled 75 
controlled substance prescriptions outside the usual course of pharmacy 
practice, in violation of 21 CFR 1306.06, and in contravention of the 
Pharmacy's ``corresponding responsibility'' under 21 CFR 1306.04(a). 
ALJ-1, at 2, para. 3. The Government has not advanced any theory as to 
why this same allegation should be considered twice. See ALJ-35. Thus, 
while the allegation concerning the hydrocodone prescription for G.B. 
is sustained, and weighs in favor of revoking the Respondent's 
registration, its substance will only be considered once.
---------------------------------------------------------------------------

    \56\ G.B. is not mentioned in paragraph 10(b) of the OSC. ALJ-1, 
at 4.
---------------------------------------------------------------------------

    (iii.) Next, the Government alleged that the Pharmacy also filled 
prescription cocktails (hydrocodone and alprazolam), written by Dr. 
C.V., for patients M.A., R.H.2, and A.K. on April 17, 2015, and May 1, 
2015, respectively. ALJ-1, at 3-4, paras. 10, 10(c).
    As noted above, Dr. C.V. wrote prescriptions for 90, 10 mg tablets 
of hydrocodone for M.A., R.H.2, and A.K. FF 167. The Pharmacy also 
filled prescriptions of 60, 2 mg tablets of alprazolam for these three 
customers. See supra notes 21-23. Dr. C.V., however, did not write 
prescriptions for alprazolam for those three customers. While the 
Pharmacy's fill stickers for the alprazolam that those three customers 
received indicates that Dr. C.V. was the prescribing doctor, the 
prescriptions themselves clearly show that Dr. C.V. did not write those 
prescriptions. FF 167; see supra notes 21-23; GE-2, at 96, 100, 115. 
Nurse Practitioner L.R. wrote the prescription for alprazolam for M.A. 
GE-2, at 96. Physician's Assistant C.Z. wrote the prescriptions for 
alprazolam for R.H.2 and A.K.\57\
---------------------------------------------------------------------------

    \57\ Compare known C.Z. signatures at GE-2, at 52, 122-23, with 
signatures on the R.H.2 and A.K. prescriptions at GE-2, at 100, 115.
---------------------------------------------------------------------------

    The significance of the alprazolam prescriptions, however, does not 
depend on the prescriber. Rather, the significance is that the Pharmacy 
filled the alprazolam prescriptions for M.A., R.H.2, and A.K., as well 
as for all the other customers who received prescriptions for 
hydrocodone from Dr. C.V., at the same time that it also filled 
hydrocodone prescriptions for them. In addition, the Pharmacy filled 
all of these prescriptions even though the customers presented 
prescriptions for hydrocodone written by Dr. C.V. at the same time that 
they presented prescriptions for alprazolam written by another one of 
the other Prescribers. FF 167.
    This allegation is included in the allegation that between August 
2014 and May 2015, the Pharmacy filled prescription cocktails of 
hydrocodone and alprazolam to 25 different individuals. ALJ-1, at 4, 
para. 10(b). The Government has not advanced any theory as to why this 
same allegation should be considered twice. See ALJ-35. Thus, to the 
extent that this allegation asserts that the Pharmacy filled 
prescription cocktails for these three identified patients, though the 
hydrocodone was written by Dr. C.V. and the alprazolam was written by 
another Prescriber, it is sustained, and weighs in favor of revoking 
the Respondent's registration. The allegation's substance, however, 
will only be considered once.
    (iv.) The Government alleged that between January 13, 2015, and May 
11, 2015, the Pharmacy dispensed controlled substances pursuant to 
``pattern-style'' prescriptions issued by Dr. NE On 14 different 
occasions, the Pharmacy dispensed 90, 10 mg tablets of hydrocodone to 
11 different customers. ALJ-1, at 3-4, para 10, 10(c).
    The Pharmacy filled 15 prescriptions for 11 customers, A.S., R.N., 
R.E., B.B., S.B., S.N., T.W., I.B., M.W.2, Y.S., and C.D., between 
January 24, 2015 and May 18, 2015. FF 173; GE-2, at 22-23, 89-90. These 
prescriptions were written by Dr. NE for 90, 10 mg tablets of 
hydrocodone. FF 173. Significantly, at the same time the Pharmacy 
filled these prescriptions, it also filled a prescription for 60, 2 mg 
tablets of alprazolam for each of these customers, written by either 
Dr. NE or one of the other Prescribers. FF 173. Of the 11 customers, 
T.W. traveled the shortest round-trip distance of 66.9 miles, taking 1 
hour and 23 minutes in moderate traffic. GE-3, at 177. A.S. had the 
longest round trip of 104 miles, taking 1 hour and 54 minutes in light 
traffic. GE-3, at 113. Every prescription was purchased with cash. FF 
173. The price for hydrocodone and alprazolam together totaled $239.98. 
Id.
    Further, by the time the Pharmacy filled the first of Dr. NE's 
prescriptions for hydrocodone for 1 of these 11 customers, which was 
A.S. on January 26, 2015, GE-6, at 52, the Pharmacy had already filled 
563 prescriptions for hydrocodone since July 7, 2014, and Dr. NE had 
written 60 of those prescriptions. GE-6, at 1-52. Of the prescriptions 
Dr. NE wrote, the Pharmacy received seven consecutive prescriptions 
from Dr. NE for hydrocodone on November 5, 2014, four consecutive 
prescriptions from Dr. NE for hydrocodone on November 23, 2014, and six 
consecutive prescriptions from Dr. NE for hydrocodone on December 30, 
2014. GE-6, at 32-33, 37, 44. In addition, all but 18 of the 563 
prescriptions had been written by one of the Prescribers. GE-6, at 1-
52; see also FF 118-21. Thus, by the time Ms. Igwe filled the 
prescription for hydrocodone for A.S. on January 26, 2015, a 
prescription written by Dr. NE, Ms. Igwe would have had ample time to 
identify the pattern of Dr. NE's prescribing, and that of her fellow 
Prescribers. FF 80-82, 84. Pattern prescribing is a red flag. FF 61. 
When presented with evidence of pattern prescribing, a Texas pharmacist 
should contact the prescriber, ask about the prescription's medical 
purpose, and then document that discussion. FF 80, 85. While Ms. Igwe 
testified that she had discussions with providers whenever a new 
patient presented a prescription, those discussions are not documented 
as required by [the minimum standards of practice in Texas.] \*BB\
---------------------------------------------------------------------------

    \*BB\ Text adjusted in response to Respondent's Exceptions.
---------------------------------------------------------------------------

    This allegation is included in the allegation that between August 
2014 and May 2015 the Pharmacy filled prescription cocktails of 
hydrocodone and alprazolam to 25 different individuals. ALJ-1, at 4, 
para. 10(b). The Government has not advanced any theory as to why this 
same allegation should be considered twice. See ALJ-35. Thus, while 
this allegation is sustained, and weighs in favor of revoking the 
Respondent's registration, its substance will only be considered once.
    (v.) The Government next alleged that on 8 different occasions, the 
Pharmacy filled identical prescription cocktails written by Dr. NE 
consisting of 90, 10 mg tablets of hydrocodone and 60, 2 mg tablets of 
alprazolam. Identical prescription cocktails were dispensed to both 
I.B. and T.W. on April 10, 2015, and to B.B. and C.D. on April 23, 
2015. ALJ-1, at 3-4, para. 10, 10(c).
    The Pharmacy filled drug cocktail prescriptions of 90, 10 mg 
tablets of hydrocodone and 60, 2 mg tablets of alprazolam written by 
Dr. NE seven different times. FF 173. These prescriptions were filled 
for customers B.B., S.B., S.N., T.W., Y.S., R.N., and again for B.B. FF 
173; GE-2, at 56-58, 60-62, 71-73, 86-88, 102-04, 105-07, 125-27. While 
the Pharmacy also filled identical cocktail prescriptions for I.B. and 
T.W. on April 10, 2015, and again for B.B. and C.D. on April 23, 2015, 
Dr.

[[Page 21044]]

NE did not write all of the prescriptions for alprazolam. Nurse 
Practitioner S.G. wrote the prescriptions for alprazolam for I.B. and 
C.D. GE-2, at 77, 111. The Pharmacy fill labels for those prescriptions 
improperly indicate, however, that those prescriptions were written by 
Dr. NE Id.
    As noted earlier, the significance of the Pharmacy filling 
prescriptions for alprazolam, however, does not depend on the 
prescriber. Rather, the significance is that the Pharmacy filled a 
prescription cocktail of alprazolam and hydrocodone for I.B., T.W., 
B.B., and C.D., as well as for all the other customers above who 
received prescriptions for hydrocodone from Dr. NE In addition, the 
Pharmacy filled all of these prescriptions even though the customers 
presented prescriptions for hydrocodone written by Dr. NE, while the 
prescriptions for alprazolam were written by a different one of the 
Prescribers. Further, as noted above, all of these prescriptions 
exhibited the red flags of pattern prescribing, the customers all 
traveled long or unusual routes to obtain their prescriptions and have 
them filled, and all of the prescriptions were purchased with cash.
    This allegation is included in the allegation that between August 
2014 and May 2015, the Pharmacy filled prescription cocktails of 
hydrocodone and alprazolam to 25 different individuals. ALJ-1, at 4, 
para. 10(b). The Government has not advanced any theory as to why this 
same allegation should be considered twice. See ALJ-35. Thus, to the 
extent that Dr. NE only wrote seven prescription cocktails of 
hydrocodone and alprazolam, and wrote only one such cocktail 
prescription on April 10, 2015, and one on April 23, 2015, this 
allegation is sustained, and weighs in favor of revoking the 
Respondent's registration. The substance of the allegation, however, 
will only be considered once.
    Therefore, the allegations contained in paragraphs 10 and 10(c) of 
the OSC, that the Pharmacy filled numerous prescriptions without 
resolving red flags concerning drug cocktails, distance traveled, cash 
payments, and facially invalid prescriptions, are sustained, and weigh 
in favor of revoking the Respondent's registration. With one exception, 
these sustained allegations are all included in the allegations 
contained in paragraphs 10 and 10(b) of the OSC, and with that one 
exception will not be considered as separate allegations in determining 
whether the Respondent's registration should be revoked. The portion of 
this allegation that alleged, in paragraph 10(c) of the OSC, that the 
Pharmacy filled a prescription for G.B. for hydrocodone, written by Dr. 
C.V., is sustained, but it is included in the allegation that the 
Pharmacy filled 75 controlled substance prescriptions outside the usual 
course of pharmacy practice, in violation of 21 CFR 1306.06, and in 
contravention of the Pharmacy's ``corresponding responsibility'' under 
21 CFR 1306.04(a), ALJ-1, at 2, para. 3, and it will not be considered 
twice.
    (vi.) The Government's next allegation is that on April 17, 2015, 
the Pharmacy filled a hydrocodone prescription for G.B., who had 
traveled an unusual path and distance of more than 75 miles to obtain 
her prescription and have it filled at the Pharmacy, and then return 
home. ALJ-1, at 5, para. 10, 10(d).
    Government Exhibit 2 documents that the Pharmacy filled a 
prescription for G.B. for 90, 10 mg tablets of hydrocodone on April 17, 
2015. GE-2, at 84. The prescription was written by Dr. C.V. one day 
earlier. GE-2, at 83. This allegation is included in the allegation 
that the Pharmacy filled 75 controlled substance prescriptions outside 
the usual course of pharmacy practice, in violation of 21 CFR 1306.06, 
and in contravention of the Pharmacy's ``corresponding responsibility'' 
under 21 CFR 1306.04(a). ALJ-1, at 2, para. 3. It is also included in 
the allegation that between November 14, 2014 and May 1, 2015, the 
Pharmacy filled 12 \58\ prescriptions for hydrocodone written by Dr. 
C.V. ALJ-1, at 4, para. 10(c). Again, the Government has not advanced 
any theory as to why this same allegation should be considered three 
times. See ALJ-35. Thus, while the allegation contained in paragraph 
10(d) of the OSC is sustained, and weighs in favor of revoking the 
Respondent's registration, the allegation's substance will only be 
considered once.
---------------------------------------------------------------------------

    \58\ See supra notes 45 and 56.
---------------------------------------------------------------------------

Recordkeeping Violation

    Finally, the Government alleged that a DEA audit of the Pharmacy's 
10 mg hydrocodone, covering the period of September 25, 2013, through 
June 18, 2015, revealed a shortage of 47,183 dosage units. Because the 
Controlled Substances Act requires the maintenance of ``complete and 
accurate'' inventories, as well as a ``complete accurate record of each 
substance . . . received, sold, delivered or otherwise disposed of,'' 
this shortage violated 21 U.S.C. 827(a). ALJ-1, at 5, para. 13.
    As noted above, the CSA mandates that ``[e]very registrant . . . 
shall maintain, on a current basis, a complete and accurate record of 
each [ ] substance manufactured, received, sold, delivered, or 
otherwise disposed of . . . .'' 21 U.S.C. 827(a)(3). On June 18, 2015, 
DEA investigators conducted an inspection of the Pharmacy, and asked 
Ms. Igwe to produce a copy of the Pharmacy's dispensing history of 
hydrocodone. FF 15, 23. In response, Ms. Igwe gave the inspectors a 
report of the Pharmacy's hydrocodone dispensing history, contained in 
Government Exhibit 6, with a date range of October 23, 2013 to June 18, 
2015. FF 24-25. Following the inspection, and using the report provided 
by Ms. Igwe, DI 1 conducted an audit of the Pharmacy's hydrocodone. FF 
36; Tr. 47-48. DI 1's audit revealed that the Pharmacy was short 47,183 
tablets of hydrocodone. FF 37.
    Government Exhibit 6 clearly does not report all of the hydrocodone 
that the Pharmacy dispensed. FF 41. After the inspection, Ms. Igwe 
discovered that she had not provided the DEA inspectors with a complete 
listing of the hydrocodone the Pharmacy had dispensed. FF 26-27. At the 
hearing, the Respondent produced Respondent's Exhibit C for the first 
time, which Ms. Igwe claimed is the complete dispensing report. FF 27, 
43-44. Although Ms. Igwe testified that she had provided Respondent's 
Exhibit C to an attorney so that he might provide it to the DEA, there 
is no evidence the DEA ever received it. FF 27, 43-44. At the hearing, 
both Ms. Igwe and Mr. Litman testified that if Respondent's Exhibit C 
was considered during the audits of the Pharmacy's hydrocodone, there 
would have been no shortage. Tr. 472-73, 730. Ms. Igwe, however, did 
not know if her own audit showed an overage. Id. at 605.
    The Administrative Record reveals several deficiencies concerning 
the Respondent's records. First, the Respondent's hydrocodone 
dispensing log was not ``readily retrievable'' as is required under 21 
U.S.C. 827. Second, the ``complete'' dispensing log which Ms. Igwe 
allegedly gave to DEA sometime after the inspection does not comply 
with DEA regulations. Lastly, even a manual count of the Respondent's 
``complete'' dispensing log reveals a substantial overage.
    Although the Pharmacy takes the position that it produced 
``complete and accurate'' records after the inspection, these records 
were not ``readily retrievable'' as is required by the CSA and DEA 
regulations. [The regulatory definition of ``readily retrievable'' 
calls for locating the records ``in a reasonable time.'' 21 CFR 
1300.01(b). In Edmund Chein, M.D., the Agency stated ``what

[[Page 21045]]

constitutes `a reasonable time' necessarily depends on the 
circumstances'' but that ``under normal circumstances if a practice is 
open for business, it should be capable of producing a complete set of 
records within several hours of the request.'' 72 FR 6580, 6593 (2007), 
pet. for rev. denied, Chein v. Drug Enforcement Admin., 533 F.3d 828, 
832 n.6 (D.C. Cir 2008), cert. denied, 555 U.S. 1139 (2009). During the 
hearing, Ms. Igwe was unable to specify the date on which she gave the 
``complete'' dispensing log to her then-attorney to forward to DEA, but 
it is safe to say it was at least several days after the inspection. 
See Tr. 466-69. Moreover, there is nothing in the record establishing 
that DEA ever received the log until it was exchanged in the course of 
these proceedings.\59\ Tr. 549-50. For these reasons, the Respondent 
violated its duty to maintain records that were ``readily 
retrievable.'' 21 U.S.C. 827(b); 21 CFR 1304.04(a), 1304.04(h)(1), (3); 
see Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy, 83 FR at 
10901, aff'd Pharmacy Doctors Enterprises, Inc. v. Drug Enf't Admin., 
789 F. App'x 724, 730 (2019) (finding that producing records as an 
exhibit for the hearing did not comply with the ``readily retrievable'' 
requirement of the regulation).] \*CC\
---------------------------------------------------------------------------

    \59\ See supra note 50.
    \*CC\ Text adjusted for clarity.
---------------------------------------------------------------------------

    Additionally, not only were the Pharmacy's dispensing records 
produced significantly late, but they also failed to include required 
information. This was the situation in Chein, where the registrant's 
dispensing records, produced after a delay of several hours, lacked 
information required by DEA regulations. 72 FR at 6593. The same has 
occurred here to the extent that Respondent Exhibit C, the Pharmacy's 
``complete'' hydrocodone dispensing report, is missing the patient's 
addresses and the dispensing pharmacist's initials, in violation of 21 
CFR 1304.22(c). Significantly, the dispensing log Ms. Igwe gave to 
investigators at the time of the inspection does contain this required 
information. 21 CFR 1304.22(c); GE-6; RE-G. It is also noteworthy that 
the ``complete'' dispensing log's format is strikingly different than 
the original dispensing log printed during the inspection. Compare RE-C 
with GE-6 and RE-G. Additionally, the lack of any date or date range on 
the ``complete'' dispensing log makes it difficult, if not impossible, 
to ascertain whether the document is ``complete and accurate.'' 21 
U.S.C. 827(a)(3); RE-C; Tr. 551.
    Further, a manual count of the quantities listed in the 
``complete'' dispensing log revealed an overage, itself a violation of 
the CSA and DEA regulations, albeit different than that alleged in the 
OSC. Respondent Exhibit C is broken into four sections separated by 
green pages. RE-C, at 1, 2, 3-30, 31-43; Tr. 470-71, 603; FF 27-28. The 
third section represents the same information in Government Exhibit 6 
that Ms. Igwe gave to investigators during the inspection and that DI 1 
used to conduct an audit. RE-C, at 3-30; GE-6, at 1-85; Tr. 47-48. The 
first, second, and fourth sections contain additional dispensing 
information not contained in the report that DI 1 used to conduct his 
audit. RE-C, at 1-2, 31-43. The information in the third column from 
the left is the quantity of hydrocodone dispensed. Id. A manual count 
of the quantity dispensed in the first, second, and fourth sections of 
Respondent Exhibit C revealed a total of 48,288 dosage units of 
hydrocodone. Id. The Government alleged that the Respondent's 
hydrocodone shortage was 47,183. ALJ-1, at 5, para. 13.
    Applying the 48,288 units counted in Respondent Exhibit C to DI 1's 
audit computation produces an overage of 1,105 units. GE-7, at 1. The 
computation report shows that DI 1 reached the 47,183 figure by 
subtracting ``distributions in period'' (90,209) and ``closing 
inventory'' (3,908) from ``purchases in period'' (141,300). GE-7, at 1. 
The difference between the shortage calculated by DI 1 (47,183) and the 
total derived from a count of Respondent Exhibit C (48,288) is 
+1,105.\60\ If DI 1 had the information in Respondent Exhibit C when he 
conducted the audit, he would have found an overage of hydrocodone 
instead of a shortage. Cf. Tr. 76. An overage of a thousand tablets of 
hydrocodone, however, is still sufficient circumstantial evidence that 
the Pharmacy failed to maintain complete and accurate records. See 
Superior Pharmacy I & Superior Pharmacy II, 81 FR at 31,337 (finding 
recordkeeping violation where audit revealed overage of about 4,000 
dosage units).
---------------------------------------------------------------------------

    \60\ This overage amount would be different, or reduced 
entirely, if the on-hand quantity was closer to 1,200 tablets as Ms. 
Igwe claimed at one point in the hearing. Tr. 602-03. At first, Ms. 
Igwe was unable to recall the quantity on the shelf: ``I don't 
remember what it [was] without looking.'' Tr. 602. When I asked if 
the on-hand quantity was 1,200, as stated in her Prehearing 
Statement, she agreed that was the correct figure. Tr. 602. She also 
stated early in her testimony that Respondent Exhibit C showed that 
her inventory was accurate in that all the hydrocodone she purchased 
and dispensed was accounted for. Tr. 472. When pressed further 
regarding the accuracy of her hydrocodone records, her testimony 
waivered. Tr. 605. I asked if there was an overage and she stated, 
``I can't really say yes or no to that . . . .'' Tr. 605. Overall, 
this part of Ms. Igwe's testimony created the impression that she 
was unsure about the on-hand quantity of hydrocodone on the day of 
the inspection and whether her inventory was in fact completely 
accurate. Further, Mr. Litman testified that there was no way of 
knowing whether the information contained in Respondent's Exhibit C 
was created prior to the DEA audit. Tr. 723-25. For that reason, I 
give more weight to the on-hand quantity counted on the day of the 
inspection contained in Government Exhibit 7--3,908 tablets of 
hydrocodone on-hand--than I do to Ms. Igwe's testimony that the 
Pharmacy had 1,200 hydrocodone pills on the shelves. GE-7, at 1.
---------------------------------------------------------------------------

    Accordingly, the Government's allegation contained in paragraph 13 
of the OSC that the Pharmacy failed to maintain ``complete and 
accurate'' records in violation of 21 U.S.C. 827(a)(3) is sustained, 
and weighs in favor of revoking the Pharmacy's registration.

Discussion and Conclusions of Law

    I have sustained, with minor variations, [the overwhelming 
majority]\*DD\ of the Government's allegations contained in the OSC. 
Specifically, I find that between August 2014 and May 2015, the 
Pharmacy filled 75 controlled substance prescriptions outside the usual 
course of pharmacy practice, in violation of 21 CFR 1306.06, and in 
contravention of the Pharmacy's ``corresponding responsibility'' under 
21 CFR 1306.04(a). The Pharmacy did so by repeatedly filling controlled 
substance prescriptions that contained red flags of diversion and/or 
abuse without addressing or resolving those red flags. The Pharmacy's 
conduct in doing so violated 21 U.S.C. 823(f)(4); Tex. Health & Safety 
Code Sec.  481.070-.075; and Tex. Health & Safety Code Sec.  481.128; [ 
] \*EE\. These allegations are contained in paragraphs [3 and 6] \*FF\ 
of the OSC. ALJ-1, at 2-3.\*GG\
---------------------------------------------------------------------------

    \*DD\ Text adjusted in response to Respondent's Exceptions.
    \*EE\ Text removed in response to Respondent's Exceptions.
    \*FF\ Text removed in response to Respondent's Exceptions.
    \*GG\ For the reasons given, supra, in the section on 
Respondent's Exceptions, the Government's allegation from paragraph 
7 of the OSC that Respondent violation 22 Tex. Admin. Code Sec.  
291.33(c)(2) is not sustained.
---------------------------------------------------------------------------

    I also find that all of the specific allegations contained in 
paragraphs 10 and 10(a)-(d) of the OSC are included in the general 
allegation that the Pharmacy violated 21 CFR 1306.04(a) and 21 CFR 
1306.06 when it filled 75 prescriptions between August 2014 and May 
2015. ALJ-1, at 2, para. 3. Thus, while the allegations contained in 
paragraphs 10 and 10(a)-(d) of the OSC are sustained, the substance of 
those allegations will not be considered more than once in assessing 
whether the

[[Page 21046]]

Government has presented a prima facie case for revocation of the 
Pharmacy's COR. Stated differently, the prescriptions discussed in 
paragraphs 10 and 10(a)-(d) are subsumed within the allegation in 
paragraph 3.
    Lastly, I have sustained the allegation contained in paragraph 13 
of the OSC, alleging that the Pharmacy violated 21 U.S.C. 827(a) by 
failing to maintain accurate records. The records in question in this 
case were the Pharmacy's receipt and dispensing records for 
hydrocodone. An audit of the records the Pharmacy produced in response 
to a DEA inspection warrant revealed that the Pharmacy could not 
account for a significant portion of the hydrocodone it had received 
when called upon to do so.
    The preponderance of evidence clearly establishes that the Pharmacy 
violated its corresponding responsibility by dispensing controlled 
substances outside the normal course of professional practice. 
Beginning in August 2014 and continuing into May 2015, the Pharmacy 
repeatedly filled 75 prescriptions from the Prescribers, who over and 
over again prescribed the same medications and usually in the same 
dosages, strengths, and quantities. Frequently, too, the patients would 
present with prescriptions for drug cocktails, where the hydrocodone 
prescription was written by one of the Prescribers and the alprazolam 
was written by a different Prescriber. This is a well-known behavior of 
those seeking to hide the true reason they are obtaining drug 
cocktails. Most of the prescriptions were issued in a manner that 
should have given rise to concerns of the therapeutic value of the 
prescription. [The minimum standard of the practice of pharmacy in 
Texas requires pharmacists to have consultations with prescribers when 
there are concerns about the medical legitimacy of a prescription and 
then to document that consultation. FF 90.] \*HH\ In this case there 
are no records that document any such consultations. FF 177.
---------------------------------------------------------------------------

    \*HH\ Text adjusted in response to Respondent's Exceptions.
---------------------------------------------------------------------------

    The Government's expert testified that an overriding concern she 
had concerning the prescriptions at issue in this case was that of 
pattern prescribing and the lack of individualization of treatment. Tr. 
171, 244, 260, 296, 317, 333, 335, 358-59; FF 61-62. Unquestionably, it 
is easier to identify patterns in retrospect. In addition, DEA has 
stated that ``two prescriptions do not establish pattern prescribing.'' 
Superior Pharmacy, 81 FR at 31325 n.27. But this is not a case of only 
two similar prescriptions. This is a case of the Prescribers writing 
essentially the same prescriptions to various patients who had their 
prescriptions filled by the same pharmacist, Ms. Igwe, over an extended 
period of time. In fact, apparently out of the blue, the Pharmacy, a 
small pharmacy north of Dallas, started receiving prescriptions written 
by the Prescribers at the Redbird clinic in January or February of 
2014. FF 11. The Redbird clinic was located 31 miles from the Pharmacy. 
GE-12, at 3. In addition, many of the prescriptions were sent directly 
to the Pharmacy by the Prescribers, rather than giving the patient the 
option of going to a pharmacy possibly more convenient for the patient. 
FF 10, 127.
    The Respondent has attempted to make much out of the fact that 
Government Exhibit 2 contains prescriptions of less than 30 patients, 
while the Prescribers wrote ``over a thousand scripts.'' Tr. 368; see 
also Tr. 289. While true that less than 30 patients is a small 
percentage of the prescriptions written by the Prescribers, I concur 
with Dr. Witte's assessment that ``if [she] reviewed a thousand 
[prescriptions], more than likely there would be more than 26 that had 
some of the same similarities'' based on the patterns she observed. Tr. 
370-71. Indeed, a review of Government Exhibit 6 reveals many of the 
same similarities. That exhibit shows that of the 927 prescriptions for 
hydrocodone the Pharmacy filled between July 7, 2014 and May 21, 2015, 
all but 25 were written by one of the Prescribers. Respondent Exhibit C 
reveals even more prescriptions for hydrocodone written by one of the 
Prescribers. See supra note 46. In fact, at one point Ms. Igwe filled 
28 consecutive prescriptions for hydrocodone written by Dr. C.V. and at 
another time she filled 23 consecutive prescriptions for hydrocodone 
written by Dr. NE GE-6, at 29-31, 83-85. In the face of such repetitive 
prescriptions, Ms. Igwe simply assumed ``that that's what the doctor 
preferred . . . .'' Tr. 595. While she did testify that she would call 
the prescriber the first time a patient presented with a prescription 
for a controlled substance ``if [she] was concerned,'' she provided no 
documentation of those calls. Tr. 546-47, 595; FF 177. With close to 
the thousand prescriptions, documented in Government Exhibit 6, written 
by the Prescribers, beginning in January or February 2014, and 
extending until May 2015, Ms. Igwe should have easily recognized 
pattern prescribing.\*II\ Her failure to do so, her unwillingness to 
acknowledge the pattern, [demonstrates willful blindness to the high 
probability] \*JJ\ that many of the prescriptions she filled lacked a 
legitimate medical purpose.
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    \*II\ The Government's allegations of unlawful dispensing were 
limited to the prescriptions listed in the OSC that Respondent 
dispensed between August 2014 and May 2015. Evidence of additional 
prescriptions Respondent dispensed is relevant in this matter only 
to the extent that it supports findings of violations in the subject 
prescriptions or rebuts Respondent's Exceptions. I have not 
considered the evidence of additional prescriptions from the 
Prescribers as evidence of further violations for consideration 
under Factors 2 and 4.
    \*JJ\ Text adjusted clarity.
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    Dr. Witte also addressed the red flag of cash payments with respect 
to many of the prescriptions involved in this case. See, e.g., Tr. 172, 
223, 238. Here, the Administrative Record supports a finding that most 
of the prescriptions involved a large quantity of controlled substances 
of both hydrocodone and alprazolam. FF 47, 50. A reasonable pharmacist 
should know paying cash for a large quantity of controlled substances 
raises a red flag, see Jones Total Health Care Pharmacy, 81 FR at 
79194; however, there is no evidence that the Pharmacy's customers were 
paying exorbitant prices for their prescriptions. Nevertheless, paying 
for a prescription in cash is ``the preferred payment method for 
illegitimate prescriptions,'' because it is not traceable. Masters 
Pharm., 861 F.3d at 220. DEA has noted, however, that absent other 
signs of diversion, prices in the range of $25 to $220 may be 
insufficient to prove that a pharmacist violated his or her 
corresponding responsibility. Hills Pharmacy, 81 FR at 49839 n.39.
    Here, numerous patients paid $239.98 upon picking up prescriptions 
for both alprazolam and hydrocodone at the same time. Tr. 498; FF 167, 
173. While these fees were not exorbitant, the Pharmacy made between 
$154.00 and $161.00 profit when a customer paid $179.99 for an order of 
hydrocodone. Tr. 498; GE-6, at 45, 54. Furthermore, most insurance 
plans cover hydrocodone. FF 39. Such a heavy profit margin per sale 
could certainly be an incentive to turn a blind eye to illegitimate 
prescriptions, particularly when they were so numerous. Nevertheless, 
were cash payments the only red flag involved in the prescriptions in 
this case, I would not sustain a violation of the Pharmacy's duty to 
resolve that red flag. As noted, however, cash purchases were not the 
only red flags that Ms. Igwe should have readily identified.
    Dr. Witte also testified that the distance and route that several

[[Page 21047]]

customers took to obtain and then fill their prescriptions created a 
red flag. FF 62, 63. Additionally, even Texas regulations include the 
distance a patient traveled as one factor pharmacists should be aware 
of before dispensing a controlled substance. 22 Tex. Admin. Code Sec.  
291.29(c)(4). The distances that most of the Pharmacy customers 
traveled are detailed in Government Exhibit 3, and range from 64 miles 
to 121 miles. GE-3, at 54, 104. More telling than the miles, however, 
are the routes these customers would have traveled.\61\ While Ms. Igwe 
might not have known the actual routes a customer took to arrive at the 
Pharmacy, from having been in the Dallas/Fort Worth area since at least 
2006, Tr. 445-46, she should have had an appreciation for the distances 
and traffic involved. Even a short distance, such as 30-40 miles, may 
be a concern where the route involves ``a lot of stop lights'' and 
traffic, making a relatively short distance appear suspicious given the 
added inconvenience. Hills Pharmacy, 81 FR at 49826. Given the facts in 
this case, particularly the paths the customers would have taken in a 
metropolitan environment, at a minimum, Ms. Igwe should have made 
inquiry of the six customers whose round trip distances exceeded 100 
miles, J.W., H.J., M.H., A.S., K.S., and M.A. Ms. Igwe's failure to do 
so, and her failure during these proceedings to acknowledge that she 
should have, demonstrates willful blindness to the [high probability] 
\*KK\ that many of the prescriptions she filled lacked a legitimate 
medical purpose.
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    \61\ While Respondent's counsel argued at the hearing that the 
customers might not live where the addresses on the fill stickers 
say they do, those are the addresses the Pharmacy was on notice of 
concerning where those customers lived. Tr. 377-79.
    \*KK\ Text adjusted for clarity.
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    With respect to the Pharmacy's recordkeeping violations, the 
Government has established by a preponderance of the evidence that the 
Pharmacy failed to produce a complete dispensing log for the 
hydrocodone it dispensed between the date the Pharmacy opened and June 
18, 2015. FF 22, 24-28, 44. As a result of this poor recordkeeping, 
when the DEA conducted an audit of the Pharmacy's hydrocodone, the 
Pharmacy had a shortage of over 47,000 tablets of hydrocodone. FF 37. 
Although the Respondent eventually produced Respondent Exhibit C, which 
Ms. Igwe testified was the Pharmacy's complete dispensing log, Tr. 467-
71, it does not comply with DEA's requirements for a dispensing log. 21 
CFR 1304.22(c); Chein, 72 FR at 6593. Further, even using the data 
contained in Respondent Exhibit C, the Pharmacy's inventory of 
hydrocodone does not balance out. The Pharmacy's recordkeeping 
shortcomings reinforce the DEA's position that strict adherence to 
inventory requirements is crucial so that DEA can ``closely monitor the 
flow of controlled substances'' and effectively combat diversion. 
United States v. Blanton, 730 F.2d 1425, 1428 (11th Cir. 1984).

Prima Facie Showing and Balancing

    Factors Two and Four strongly weigh in favor of revoking the 
Pharmacy's COR. Considering the public interest factors in their 
totality, I find that the Government has made a prima facie case 
showing that the Pharmacy's registration is inconsistent with the 
public interest.
    After the Government presents a prima facie case for revocation, 
the Respondent has the burden of production to present ``sufficient 
mitigating evidence'' to show why it can be entrusted with a DEA 
registration. See Medicine Shoppe--Jonesborough, 73 FR 364, 387 (2008) 
(quoting Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 (2007)). To 
rebut the Government's prima facie case, the Respondent must both 
accept responsibility for its actions and demonstrate that it will not 
engage in future misconduct. Patrick W. Stodola, M.D., 74 FR 20,727, 
20,734-35 (2009).
    The Respondent may accept responsibility by providing evidence of 
its remorse, its efforts at rehabilitation, and its recognition of the 
severity of its misconduct. See Robert A. Leslie, M.D., 68 FR 15227, 
15228 (2003). To accept responsibility, a respondent must show ``true 
remorse'' for wrongful conduct. Michael S. Moore, M.D., 76 FR 45867, 
45877 (2011). An expression of remorse includes acknowledgment of 
wrongdoing. Wesley G. Harline, M.D., 65 FR 5665, 5671 (2000). A 
respondent must express remorse for all acts of documented misconduct, 
Jeffrey Patrick Gunderson, M.D., 61 FR 26208, 26211 (1996), and may be 
required to acknowledge the scope of its misconduct. Arvinder Singh, 
M.D., 81 FR 8247, 8250-51 (2016). Acceptance of responsibility and 
remedial measures are assessed in the context of the ``egregiousness of 
the violations and the [DEA's] interest in deterring similar misconduct 
by [the] Respondent in the future as well as on the part of others.'' 
David A. Ruben, M.D., 78 FR 38,363, 38,364 (2013) (citation omitted).
    There is nothing in the Administrative Record that suggests the 
Pharmacy has accepted responsibility for its actions. During her 
testimony, Ms. Igwe took no responsibility. Tr. 567. Further, a review 
of the Respondent's Proposed Findings and the Respondent's Brief gives 
no hint of acceptance of responsibility. See ALJ-36-37.
    Because I have determined that the Government has met its prima 
facie burden, and that the Pharmacy has not accepted responsibility, I 
must next determine whether it is consistent with the public interest 
for the Pharmacy to maintain its DEA registration. When considering 
whether a registrant's continued registration is consistent with the 
public interest, the ALJ must consider both the egregiousness of the 
registrant's violations and the DEA's interest in deterring future 
misconduct by both the registrant as well as other registrants. Ruben, 
78 FR at 38364; see also Richard J. Settles, D.O., 81 FR 64940, 64,945 
n.17 (2016) (``In short, this is not a contest in which score is kept; 
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.'' (quoting Jayam Krishna-Iyer, M.D., 74 FR 459, 462 
(2009))).
    Here, I find that both aspects of the misconduct proven in the 
Administrative Record are egregious and support the revocation of the 
Pharmacy's registration. First, time and again, Ms. Igwe filled 
prescriptions that ought not have been filled without the resolution of 
red flags. Significantly, this case started with the DEA investigating 
a pill mill. Tr. 31. Over a period of eight to nine months, Ms. Igwe 
filled prescriptions for a small group of medical practitioners, who 
wrote essentially identical prescriptions, including drug cocktail 
prescriptions involving hydrocodone and alprazolam, in such a manner 
that a preponderance of evidence establishes that those practitioners 
were engaged in pattern prescribing. Such lack of individualized dosing 
of these two highly-abused controlled substances [should have indicated 
to a pharmacist following the minimum standards of practice in Texas 
that there was a high probability that the medical practitioners were 
operating a controlled substance pill mill. Tr. 258-261;] \*LL\ Jones 
Total Healthcare Pharmacy, 81 FR at 79195. This evidence of pattern 
prescribing by the Prescribers circumstantially establishes

[[Page 21048]]

that the Pharmacy knew, or should have known, that many of the 
Prescribers' prescriptions lacked a legitimate medical purpose. In 
addition to the pattern prescribing, the prescriptions raised other 
numerous red flags, to include: distance and route traveled; drug 
cocktails; multiple prescribers for controlled substances; suboptimal 
dosing; filling prescriptions on consecutive days to avoid filling drug 
cocktails on the same day; as well as some concern about cash payments.
---------------------------------------------------------------------------

    \*LL\ Text adjusted to add references and citations to Dr. 
Witte's testimony.
---------------------------------------------------------------------------

    Second, I find that the Pharmacy did not take its recordkeeping 
responsibilities seriously. The Pharmacy's failure to produce a 
complete dispensing record clearly prevented the DEA from being able to 
``closely monitor the flow of controlled substances'' flowing in and 
out of the Pharmacy and to effectively combat diversion. See United 
States v. Blanton, 730 F.2d at 1428. In response, the Pharmacy 
subsequently produced a document that did not meet the requirements of 
a dispensing log, and asserted that all was well. Such a feeble 
response exacerbates the Pharmacy's recordkeeping failure.
    I further find that the DEA's interest in deterring future 
misconduct by the Pharmacy, as well as by other pharmacies, supports 
revocation of the Pharmacy's registration.

Recommendation

    In this case, the Government has established a prima facie case for 
revocation of the Pharmacy's Certificate of Registration. It did so by 
proving by a preponderance of the evidence that the Pharmacy: 
Repeatedly violated its corresponding responsibility [and acted outside 
the usual course of professional practice between August 2014 and May 
2015 by filling 75 prescriptions that contained red flags of diversion 
and/or abuse, without addressing or resolving those red flags; and by 
failing to properly produce and maintain records of the controlled 
substances for which the Pharmacy was accountable.] \*MM\
---------------------------------------------------------------------------

    \*MM\ Text adjusted for clarity.
---------------------------------------------------------------------------

    The evidence is clear in this case that the Pharmacy has taken no 
responsibility for its egregious and repeated failure to fulfill its 
corresponding responsibility to ensure the proper prescribing and 
dispensing of controlled substances, and other responsibilities of a 
registrant. In addition, the Pharmacy presented no evidence of 
mitigation or remediation.
    Therefore, based upon my review of the entire Administrative 
Record, I recommend that the Certificate of Registration of The 
Pharmacy Place, Certificate of Registration Number FT4134805, be 
revoked. I further recommend that any pending application for renewal 
or modification of the Certificate of Registration of The Pharmacy 
Place be denied.


    Dated: February 13, 2018.

Charles Wm. Dorman,
U.S. Administrative Law Judge
[FR Doc. 2021-08018 Filed 4-20-21; 8:45 am]
BILLING CODE 4410-09-P