# The Pharmacy Place Order

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2021-08018

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** April 21, 2021
- **Citation:** 86 FR 21008

## Text

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)).

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).

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

to provide feedback regarding the Agency's enforcement priorities and practices.

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.

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.

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.

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 § 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

D
Exceptions, at 13, no. 38.

(2) Respondent objects to the ALJ's official notice of 22 Tex. Admin. Code § 291.33(c)(7)(A);
E

E
Exceptions, at 17, nos. 48-49; Respondent's Show to the Contrary.

(3) Respondent argues the Recommended Decision did not properly weigh the five factors from 21 U.S.C. 823(f);
F

F
Exceptions, at 10; nos. 31-32.

(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

G
Exceptions, at 6-13, 16-17; nos. 20-30, 33-37, 39, 45-47.

(5) Respondent argues the recommended sanction is not supported by the record.
H

H
Exceptions, at 14-16, nos. 40-44.

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

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 § 291.33(c)(7)(A)

In the RD, the ALJ took official notice of 22 Tex. Admin. Code § 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 § 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 § 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 § 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

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 § 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.

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.

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).

J

Compare
PIC Igwe's testimony at Tr. 477-78
with
Respondent's Exceptions at 11.

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

reject Respondent's exceptions to the ALJ's findings on pattern prescribing.
L

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.' ”)

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 § 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 § 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.

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

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

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 §§ 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 § 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 § 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 § 170.3 (relating to Guidelines), prior to dispensing or delivering such prescriptions.”).

N
22 Tex. Admin Code § 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 § 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 § 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

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 § 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 § 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 § 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 § 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 § 291.33(c)(2)(C).

The Government alleged, and the ALJ agreed, that Respondent violated 22 Tex. Admin. Code § 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 § 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 § 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 § 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 § 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

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 § 481.070-.075; Tex. Health & Safety Code § 481,128; and Tex. Admin. Code § 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

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

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

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.

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

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

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

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

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.

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2021-08018. Public record. Not legal advice.