The Pharmacy Place Order

Federal RegisterApr 21, 2021

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 17-26]

The Pharmacy Place Order

On April 3, 2017, a former Assistant Administrator of the Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to The Pharmacy Place (hereinafter, Respondent) of Plano, Texas. Administrative Law Judge Exhibit 1 (OSC), at 1. The OSC proposed to revoke Respondent's DEA Certificate of Registration No. FT4134805 and deny any pending applications for a modified or new DEA registration pursuant to 21 U.S.C. 823(f) because Respondent's “continued registration is inconsistent with the public interest.”

Id.

In response to the OSC, Respondent timely requested a hearing before an Administrative Law Judge. ALJ-5. The first two sessions of the hearing in the matter were held in Dallas, Texas from September 12-13, 2017. The Respondent's expert, however, failed to appear on either of those days. To accommodate the Respondent, the hearing was continued. On November 20, 2017, the hearing reconvened. The November 20, 2017 session of the hearing was conducted by video teleconference from the DEA Hearing Facility in Arlington, Virginia, with the parties and witnesses located at the DEA District Office in San Antonio, Texas.

On February 13, 2018, Administrative Law Judge Charles Wm. Dorman (hereinafter, ALJ) issued the incorporated Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision (hereinafter, Recommended Decision or RD). Respondent filed Exceptions to the Recommended Decision on March 5, 2018, and, with the permission of the ALJ, a Show to the Contrary on March 14, 2018 (hereinafter, collectively Respondent's Exceptions or Exceptions). The Government filed a Response to Respondent's Exceptions and Show to the Contrary on March 28, 2018 (hereinafter, Govt Response). The record was then forwarded to me for final agency action.

Suggestion of Mootness

On October 18, 2018, the Government filed a Notice of Suggestion of Mootness (hereinafter, Suggestion of Mootness). The Government provided evidence that Respondent had closed and that Respondent's owner had transferred the inventory of controlled substances to a reverse distributor. Suggestion of Mootness, at 2, Exs. 1-3.

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)).

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

Federal Power Comm'n,

606 F.2d 1373, 1380 (D.C. Cir. 1979); 5 U.S.C. 554(e));

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.”).

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)

Nat'l Labor Relations Bd.,

459 F.2d 1329, 1336 (D.C. Cir. 1972). The Court reiterated this rule in

Huthnance

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.”

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).

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

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.

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.

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.

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.”

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.

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

from the date the Pharmacy opened to the date of the inspection, June 18, 2015.

Id.

at 36, 431-32.

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. Any combination of alprazolam, hydrocodone, promethazine with codeine, and carisoprodol constitutes a drug cocktail of high-alert drugs.

Id.

at 178, 270-71, 710, 740.

55. When taken together, alprazolam and hydrocodone can produce a euphoric and addictive effect very similar to that of a heroin high.

Id.

at 178, 269, 711.

56. Alprazolam and hydrocodone are among the top 10 most frequently prescribed controlled substances in the United States.

Id.

at 271, 273, 668.

Red Flags

57. The term “red flag” is not contained in any DEA regulation.

Id.

at 256, 657.

58. Pharmacists use the term “red flag” to denote a potential issue with a prescription.

Id.

at 170-71, 569, 657. The minimum standard of the practice of pharmacy in Texas requires a pharmacist to look for red flags.

Id.

at 171.

59. A red flag can be indicative of drug abuse or diversion.

Id.

at 172, 741.

60. Ms. Igwe did not learn the term “red flag” during her pharmacist training in England, but she now understands what it means.

Id.

at 521.

61. Pattern prescribing is a red flag because it indicates no individualization of therapy.

Id.

at 171, 244, 745. An example of pattern prescribing would be multiple prescriptions from the same prescriber or medical group for the same medications, in the same quantities, dosages, and strengths, written for different patients.

Id.

at 171.

62. When a medical provider only prescribes the maximum strength of a controlled substance, the prescriptions suggest that the provider is engaged in pattern prescribing.

Id.

at 231-32.

63. The distance a person travels, or the route a person travels, to fill a prescription can be a red flag because it is likely there are multiple pharmacies along the same route.

Id.

at 172, 174-75.

64. When a patient travels all over a metropolitan area to get to a doctor and then to a pharmacy to fill a prescription, that behavior raises a red flag because there would be multiple pharmacies along the way where the patient could fill the prescription.

Id.

at 281, 321, 323.

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

65. Paying cash for a prescription can be a red flag.

Id.

at 172, 692.

66. Most patients have some sort of third-party payer, such as health insurance, to pay for their prescriptions.

Id.

at 358.

67. Hydrocodone and alprazolam are normally covered by insurance.

Id.

at 399.

68. The lack of a patient's address and/or the prescriber's DEA registration number on a prescription is a red flag.

Id.

at 179, 391, 412, 693-94.

69. Prescriptions for high-alert drugs such as alprazolam, hydrocodone, and promethazine with codeine, have the potential for abuse and diversion, and thus can be a red flag.

Id.

at 172-74, 720.

70. A drug cocktail is a red flag.

Id.

at 178.

71. Dosing instructions for hydrocodone that require the patient to take one tablet twice a day for moderate to severe pain would be a red flag, because it is less than the normal dosage for hydrocodone.

Id.

at 177.

72. Many of the prescriptions for hydrocodone contained in Government Exhibit 2 had dosing instructions to take one tablet every four to six hours, which is the normal dosing for hydrocodone, and not a red flag.

Id.

at 343-44

73. Dosing instructions for alprazolam that require the patient to take one tablet twice a day for anxiety raises a red flag because alprazolam is typically dosed more frequently than twice per day when it is prescribed for anxiety.

Id.

at 177.

74. Alprazolam can be prescribed to treat pain.

Id.

at 665-66.

75. A delay between the date that a prescription is written for moderate to severe pain and the date the prescription is filled can be a red flag.

Id.

at 396-97.

Standards of Pharmacy Practice

76. When a customer presents a prescription to a pharmacy, the pharmacist should examine the prescription, looking at the date of the prescription, the patient's name and address, the medication and its strength and quantity, as well as its directions for use, and the signature of the provider.

Id.

at 169-70.

77. If the prescription does not contain the patient's address or the prescriber's DEA number, the prescription is invalid and the pharmacist should not fill the prescription. Tr. 179, 391, 412;

see also

21 CFR 1306.05(a); Tex. Health & Safety Code § 481.074(k). When the prescription lacks a patient address, the pharmacist could resolve that red flag by speaking with the patient, checking the patient's driver's license, or checking the patient's profile, and then documenting the action the pharmacist took to resolve the red flag. Tr. 179-80. When the prescription lacks the prescriber's DEA number, the pharmacist should contact the prescriber and annotate the DEA number on the prescription itself and in the patient profile.

Id.

at 391.

78. Information contained on a cover sheet of a faxed prescription could resolve a red flag, but that information still must be documented.

Id.

at 302-03. That information must be documented so that when the customer returns with an identical prescription there would be no need to call the provider.

Id.

at 319-20. The Respondent has produced no cover sheets.

Id.

at 547.

79. When a pharmacist is presented with a prescription that contains one or more red flags, the pharmacist should call the prescriber to try to resolve the red flag or flags and then document the information that resolves the red flag on the prescription itself or in the patient's profile.

Id.

at 178-79.

80. A reasonably prudent pharmacist would investigate prescriptions after seeing several prescriptions written by the same doctor or medical practice for the same drugs and the same quantity, and with the same dosing instructions.

Id.

at 210.

81. The first time a patient presents prescriptions for hydrocodone and alprazolam to a pharmacy, the pharmacist might fill the prescriptions.

Id.

at 239-40. But when the patient keeps returning with the same prescriptions, the pharmacist should contact the provider.

Id.

at 239-40.

82. When presented with the first prescription of the day for hydrocodone and alprazolam, a pharmacist might not think much about filling the prescription, but after seeing a handful of prescriptions written for the same drug, the same dose, the same strength, and by the same providers, the pharmacist should identify and resolve those red flags.

Id.

at 333.

83. Evidence of pattern prescribing raises the concern of diversion and/or the abuse of high-alert drugs.

Id.

at 257.

84. After seeing a handful of prescriptions for the same controlled substances with the same strengths and instructions for use, the prescriptions become suspicious.

Id.

at 358-59.

85. A pharmacist concerned about pattern prescribing should call the prescriber to ask about the medical purpose and dosing, and then document the discussion the pharmacist had with the prescriber.

Id.

at 261.

86. A pharmacist cannot resolve problems concerning the medication, directions for use, or medical purpose by talking to the patient.

Id.

at 179.

87. The patient profile should contain the correct address for the prescriber.

Id.

at 361-62.

88. A prudent pharmacist would question the distance a patient traveled if a patient lives in Fort Worth but sees a doctor in Dallas.

Id.

at 192.

89. A pharmacist could resolve a red flag concerning the distance a patient traveled by talking with the patient and documenting the conversation.

Id.

at 402-05.

90. The failure to document the resolution of a red flag is below the minimum standard of the practice of pharmacy in Texas.

Id.

at 180.

91. A pharmacist can use the PMP to determine whether a patient is filling prescriptions at another pharmacy.

Id.

at 398. Most pharmacies have access to the PMP.

Id.

at 398.

92. The PMP shows the names of the doctors and pharmacies a patient has been using.

Id.

at 479-82.

93. Information regarding a patient is only in the PMP if a pharmacy inputs the information into the system.

Id.

at 484.

The Pharmacy's Practices

94. Ms. Igwe is familiar with a Texas regulation that [she testified requires a pharmacist to document conversations with practitioners regarding clinical matters about a particular prescription.]

Id.

at 585.

Text adjusted in response to Respondent's Exceptions.

95. There are no pharmacist notes in the record that resolve the red flags in Government Exhibit 2.

Id.

at 566-67.

96. Sometimes Ms. Igwe would write a “V” indicating “verified” on the hard-copy prescription, but she did not do this for every prescription.

Id.

at 482, 557.

97. Ms. Igwe testified that when she verified a prescription, she would make a note on the “demographics” page of the patient's profile that the provider confirmed the prescription. Tr. 481, 585. This information does not print out along with the patient profile.

Id.

at 482.

98. When a customer came to the Pharmacy for the first time to fill a prescription for a controlled substance, she would call the prescriber's office to confirm that the doctor wrote the prescription and that the patient was actually seen at the clinic.

Id.

at 477-78, 503, 517, 586, 590, 607.

99. Ms. Igwe has never verified whether Redbird, AC Medical, or Arlington Oaks was registered with the State of Texas as a pain management clinic.

Id.

at 537-38.

100. There were no notes in the Pharmacy's records concerning specialty clinics or other pharmacies refusing to fill prescriptions filled by the Pharmacy.

Id.

at 360-61.

101. If the doctor confirmed that he or she wrote the prescription, Ms. Igwe would look up the patient in the PMP to make sure the patient was not doctor or pharmacy shopping.

Id.

at 478, 484, 573.

102. Ms. Igwe does not consider it doctor shopping if a patient obtains prescriptions from multiple providers in the same practice.

Id.

at 556. She only considers it doctor shopping if the patient obtains prescriptions from “totally different” clinics with which she was unfamiliar.

Id.

at 556.

103. Ms. Igwe testified that before filling a prescription for a controlled substance, she would search the patient's name in the PMP, verify the dosage was correct, and check for any potential drug interactions.

Id.

at 478, 554.

104. Ms. Igwe testified that if she received multiple prescriptions from the same provider, she would not check with the provider for subsequent prescriptions because she did not “see the point of doing it” again when she already contacted the provider about the first prescription the patient presented to the Pharmacy.

Id.

at 478-79, 517. She would only contact the provider again if the prescription changed.

Id.

at 482.

105. Ms. Igwe testified that she checked the PMP each time a customer came back to the Pharmacy to make sure that customer had not been obtaining controlled substances from other doctors.

Id.

at 479, 504, 517.

106. Ms. Igwe testified that the first page of a faxed prescription would be a cover sheet with the patient's identification (typically a driver's license) and home address.

Id.

at 489.

107. Ms. Igwe testified that when a patient picked up a controlled substance at the Pharmacy, she would ask the patient for his or her driver's license and check it against the copy of the driver's license faxed by the provider.

Id.

at 490. She would then scan the patient's identification card into the Pharmacy's computer database.

Id.

at 490.

108. Ms. Igwe testified that if the identification card presented by the patient at the Pharmacy did not match the information faxed with the prescription, then she would not fill the prescription.

Id.

at 491, 539.

109. There were no notes in the Pharmacy's records concerning the distances customers traveled to get their prescriptions filled at the Pharmacy.

Id.

at 360-61.

110. The Pharmacy's records do not make a distinction between cash payments and insurance payments.

Id.

at 522. Ms. Igwe testified that approximately half of the prescriptions the Pharmacy fills are paid for using insurance.

Id.

at 496-97, 522. The remaining prescriptions are paid for in cash.

Id.

at 497.

111. The “co-pay” information on the Pharmacy's fill stickers indicates the amount the customer paid for the prescription.

Id.

at 499-500. On Government Exhibit 6, the information under “billed” is the amount the Pharmacy billed to the customer or insurance.

Id.

at 498. On Government Exhibit 6, “margin” represents the Pharmacy's profit on a particular sale.

Id.

112. On the Pharmacy's fill stickers, the number underneath the patient's name is the prescription, or “Rx”, number, which is assigned when the prescription is entered into the pharmacy's computer system.

Id.

at 184-85, 583; GE-2, at 1. The Rx numbers are assigned sequentially; the higher the number the more recent the prescription was filled.

Id.

at 185-86. For example, the Rx number ending in 6330 would have been filled prior to Rx number 6331.

Id.

at 185-86.

113. The fill sticker also shows the date the prescription was filled, but not the date it was written.

Id.

at 186. The date the prescription was written is recorded on the prescription itself.

Id.

114. On the fill stickers, the abbreviation “Cpy” stands for copay.

Id.

at 499.

115. Ms. Igwe spoke to Dr. C.V. on only one occasion.

Id.

at 500, 561, 587. Dr. C.V. called the Pharmacy to ask for the Pharmacy's fax number to send a statement that he was leaving Redbird Clinic.

Id.

at 500, 561. During that phone call, Ms. Igwe did not talk to Dr. C.V. about any prescriptions.

Id.

at 561-62.

116. Ms. Igwe would sometimes ask her customers if the medications they were prescribed were still working for them.

Id.

at 527.

117. Ms. Igwe did not always fill a bottle with medication on the same day that she printed its label.

Id.

at 560, 575.

The Prescribers

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

118. The prescription pad for Redbird Medical clinic (“Redbird”) contains the names of the following medical providers: C.V., M.D.; L.R., ACNS-BC; I.I., DNP-FNP; L.O., FNP-C; and J.W., ANP-BC, with an address on West Camp Wisdom Road in Dallas, Texas.

Id.

at 207-08; GE-2, at 12, 67. Although a prescriber identified as Dr. A.Q. was not listed on the prescription pad for Redbird, he had the same address on West Camp Wisdom Road. GE-2, at 70.

119. On October 2, 2014, the prescription pad for AC Medical clinic (“AC Medical”) contained the names of the following medical providers: C.V., M.D.; I.I., DNP-FMP; L.R., ACNS-BC; S.G., FNP; and C.Z., PA, with an address on Billing Street in Arlington, Texas. GE-2, at 16.

120. On January 13, 2015, the prescription pad for AC Medical contained the names of the following medical providers: C.V., M.D.; NE, M.D.; L.R., ACNS-BC; S.G., FNP; and C.Z., PA, with an address on East Arkansas Lane in Arlington, Texas. Tr. 207; GE-2, at 132.

121. The prescription pad for Arlington Oaks medical clinic (“Arlington Oaks”) contains the names of the following medical providers: C.V., M.D.; S.G., FNP; L.R., ACNS-BC; and C.Z., PA, with an address on Billing Street in Arlington, Texas. Tr. 206; GE-2, at 5.

The M.W. Prescription

122. DI 1 identified Government Exhibit 11 as the declaration of UC 1, an agent of the Texas Department of Public Safety. Tr. 30. In the declaration, UC 1 describes an undercover operation in which he obtained a prescription from the Redbird Clinic and filled the prescription at the Pharmacy.

Id.

at 30.

123. DI 1 knew UC 1 from his work on the investigation of the Pharmacy, but he did not know that UC 1 was going undercover.

Id.

at 68-69, 140. DI 1 reviewed UC 1's declaration and discussed it with him.

Id.

at 31-32.

124. During the undercover operation, UC 1 used the name M.W., and he used a driver's license with that name. Tr. 41; GE-10, at 3. The driver's license had a fictitious Fort Worth address. Tr. 189, 541; GE-11, at 2. The Pharmacy maintained a copy of the prescription it filled for M.W. and a copy of M.W.'s patient profile. Tr. 41; GE-10, at 4-5.

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

125. At 6:55 a.m. on July 29, 2014, undercover agent UC 1 was in a car in the Redbird parking lot. GE-11, at 2. There were about 15 other occupied vehicles in the parking lot at that time.

Id.

An individual came out of the clinic and asked the drivers to inform him how many people were in each vehicle, and the drivers indicated between two and five persons were in each car.

Id.

The individual then began directing traffic and controlling the flow of traffic into the clinic.

Id.

126. When UC 1 entered the Redbird clinic he was searched by an armed security guard and was seated in the order that he had entered the clinic. GE-11, at 2. When called to the receptionist's counter, UC 1 paid a fee of $170.00, and filled out a questionnaire, using the “M.W.” alias.

Id.

He provided the fictitious address of 5944 Callaston Lane, Fort Worth, Texas.

Id.

UC 1 indicated that he was experiencing back pain due to sleeping on an old mattress. GE-11, at 3.

I find that the fact that M.W. used a fictitious address to be irrelevant.

See

Tr. 191;

infra

note 40.

127. At 10:40 a.m. UC 1 met with L.R., ACNS-BC, who checked his heart, looked at his back, and an old scar on his knee. GE-11, at 3. L.R. then issued “M.W.” three prescriptions, to include 120 tablets of hydrocodone 10 mg.

Id.

Redbird informed “M.W.” that the prescription would be sent to the Pharmacy and UC 1 confirmed that the Pharmacy received it on August 1, 2014.

Id.;

Tr. 190.

128. The M.W. prescription was written on July 29, 2014, and received by the Pharmacy on August 1, 2014. Tr. 543, 562-63; GE-2, at 1; GE-11, at 3; RE-G, at 8.

129. The M.W. prescription was written to treat pain. Tr. 543; GE-2, at 1.

130. The M.W. prescription was faxed by Redbird to the Pharmacy. Tr. 192, 430, 571-72, 592; GE-2, at 1; GE-11, at 3; RE-G, at 8.

131. A copy of the prescription that undercover agent UC 1 received from Redbird, under the name of “M.W.,” as well as the Pharmacy's fill sticker for that prescription, are both contained on page 1 of Government Exhibit 2. Tr. 183-84.

132. On August 4, UC 1 presented to the Pharmacy as “M.W.,” and purchased the prescriptions, paying $150.00 for the hydrocodone. Tr. 576, 591; GE-2, at 1; GE-11, at 3.

133. The fact that the M.W. prescription was written on July 29, 2014, and not picked up until August 4, 2014, did not cause Ms. Igwe any concern. Tr. 577.

134. Ms. Igwe did not look up the address on M.W.'s driver's license to verify whether it was a real or fictitious address. Tr. 541; GE-11, at 3.

135. The prescription that L.R. wrote for M.W. raises the following red flags: No patient address; no provider DEA number; [ ]

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.

Tr. 188-94.

Text adjusted in response to Respondent's Exceptions.

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

136. There are no notes on the M.W. prescription or in the Pharmacy's patient profile for M.W. indicating that any of the red flags were resolved prior to filling the prescription. Tr. 194-95; GE-2, at 1; GE-10, at 4-5.

137. Based on the information provided to the Pharmacy, M.W., more likely than not, would have passed many pharmacies as he traveled the 99 miles from his purported residence in Fort Worth, to Redbird south of Dallas, to the Pharmacy, north of Dallas, and then return to his purported Fort Worth home. Tr. 193-94, 364-65; GE-12.

138. Ms. Igwe had no concern about the distance between M.W.'s fictitious address in Fort Worth and the Pharmacy in Plano. Tr. 542-43.

139. There is transmission data printed along the top of the page that contains the M.W. prescription and fill sticker indicating that the page was “4 of 4” of the pages Redbird faxed to the Pharmacy. GE-2, at 1. Dr. Witte was not provided pages one through three to review, nor are those pages contained in the Administrative Record. Tr. 255; GE-2, at 1.

The Other Prescriptions

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

alprazolam prior to August 2014, for which the actual prescriptions are not contained in the Administrative Record.

Id.

at 32-33, 42-43, 54-55, 82.

141. On several occasions, prescription cocktails of hydrocodone and alprazolam, contained in Government Exhibit 2, were written or filled on different days. Tr. 311; GE-2, at 28-30, 34-36, 50-52, 94-96, 109-11, 117-19.

142. The patient profile for A.S. raises a red flag of pattern prescribing: The same controlled substances; the same strength and dosages (90 hydrocodone 10/325 mg, 60 alprazolam 2 mg); the same small group of providers; and cash payments. Tr. 241, 408-09; GE-2, at 22-33. Between February 24, 2014 and March 30, 2015, A.S. filled six prescriptions for hydrocodone and six prescriptions for alprazolam at the Pharmacy. GE-2, at 31-33. On February 24, 2014, the Pharmacy filled prescriptions of 120, 10 mg tablets of hydrocodone and 60 tablets of alprazolam for A.S., written by S.G., a family nurse practitioner at AC Medical and Arlington Oaks.

Id.

at 32-33;

see also

22 Tex. Admin. Code § 291.33(c)(7)(A)(iv) (requiring the dispensing pharmacist to write his or her initials on the prescription label).

162.

Prescriptions Written by Nurse Practitioner I.I.:

Patient

Date prescription written; filled

Controlled substance(s); quantity

Round-trip distance

(miles)

Cost

Record citations

J.W.2

8/18/14; 8/20/14

Hydrocodone (120); Alprazolam (60)

$150.00; $59.99

Tr. 234; GE-2, at 12; Stip. 40.

C.J

8/18/14; 8/19/14

Hydrocodone (90); Alprazolam (60)

$125.00; $59.99

Tr. 233; GE-2, at 8; Stip. 25.

S.W

8/19/14; 8/19/14

Hydrocodone (120); Alprazolam (60)

$150.00; $59.99

Tr. 234; GE-2, at 10; Stip. 43.

S.H

9/4/14; 9/4/14

Hydrocodone (90); Alprazolam (60)

$120.00; $59.99

Tr. 234-35; GE-2, at 14; Stip. 24.

H.J

10/2/14; 10/2/14

Hydrocodone (120); Alprazolam (60)

105

$160.00; $59.99

Tr. 235; GE-2, at 16; Stip. 26.

163. These prescriptions written by Nurse Practitioner I.I. are indicative of pattern prescribing: Same controlled substances; same quantity; same dosages; same prescriber; same drug cocktails. Tr. 236. This pattern indicates a lack of individualization of therapy.

Id.

at 209. In addition, these patients took unusual paths and distances to obtain and fill their prescriptions.

Id.

at 236. The similarities would make a pharmacist wonder why multiple patients from this medical provider were being prescribed the same quantity of hydrocodone, and in the same strength and dosing.

Id.

at 258.

164. The unusual path and distance that I.I.'s patients traveled to obtain their prescriptions and get them filled is a red flag.

Id.

at 236.

165. The fill stickers for all of I.I.'s patients indicate that they paid $120 to $160 for their prescriptions for hydrocodone, which is much higher than the usual cost of hydrocodone.

Id.

at 222-23. The cash price for 90 tablets of hydrocodone is about $70, and the cash price for 60 tablets of alprazolam is about $35.

Id.

at 223.

166. There are no notes on I.I.'s prescriptions or the patient profiles documenting the Pharmacy's resolution of any red flag or consultation with I.I. regarding the red flags.

Id.

at 236; GE-2, at 4, 7, 9, 11, 13, 15, 17, 21, 31-33, 42-43, 53-55, 59, 63, 70, 74, 78, 82, 85, 92-93, 97, 102, 104-05, 107-08, 112, 116, 128-29, 133.

167.

Prescriptions Written by Dr. C.V.:

Patient

Date prescription written; filled

Controlled substance(s); quantity

Round-trip

distance

(miles)

Cost

Record citations

R.E

11/14/14; 11/14/14

Hydrocodone (90)

$180

Tr. 218, 226, 238-39; GE-2, at 35-36; Stip. 17.

R.N

11/15/2014; 11/17/2014

Hydrocodone (90)

$180

Tr. 221, 226; GE-2, at 117-118; Stip. 30.

R.N

Filled: 12/19/14

Hydrocodone (90)

Unknown

Tr. 222; GE-2, at 129; Stip. 30.

A.S

Filled: 12/22/14

Hydrocodone (90)

111

Unknown

Tr. 217-18, 226, 241; GE-2, at 32; Stip. 33.

M.H

1/13/15; 1/13/15

Hydrocodone (90)

121

$179.99

Tr. 222, 226; GE-2, at 130-31; Stip. 20.

K.S

1/27/15; 1/27/15

Hydrocodone (90)

109

$179.99; $59.99

Tr. 204, 219, 226; GE-2, at 44-46; Stip. 36.

K.S

2/26/15; 2/26/15

Hydrocodone (90)

109

$179.99

Tr. 205, 219, 226; GE-2, at 47-48; Stip. 36.

R.E

3/23/15; 3/23/15

Hydrocodone (90)

$179.99; $59.99

Tr. 218, 226; GE-2, at 39-42; Stip. 17.

K.S

3/26/15; 3/26/15

Hydrocodone (90)

109

$179.99

GE-2, at 50-52; Stip. 36.

A.S

3/28/15; 3/30/15

Hydrocodone (90)

111

$179.99

Tr. 217, 226; GE-2, at 28-30; Stip. 33.

G.B

4/16/15; 4/17/15

Hydrocodone (90)

$179.99

Tr. 219-20, 226; GE-2, at 83-84; Stip. 12.

M.A

4/17/15; 4/17/15

Hydrocodone (90)

107

$179.99

Tr. 205-06, 220, 226; GE-2, at 94-95; Stip. 9.

R.H.2

4/20/15; 4/21/15

Hydrocodone (90)

$179.99 $59.99

Tr. 220, 226; GE-2, at 98-100; Stip. 23.

A.K

5/1/15; 5/1/15

Hydrocodone (90)

$179.99 $59.99

Tr. 221, 226; GE-2, at 113-115; Stip. 27.

168. The

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

The day before Dr. C.V. wrote R.E. a prescription for hydrocodone, S.G. FNP, of the same medical practice as Dr. C.V., wrote R.E. a prescription for 60 tablets of alprazolam 2 mg. The Pharmacy filled this prescription the same day it was written, November 13, 2014. GE-2, at 34-36. Although Dr. C.V. and FNP S.G. were with the same medical practice, the patient profile shows Dr. C.V. being located at 916 Wynnewood Shopping Center, Dallas, Texas, and FNP S.G. being located at 201 Billings Street, Arlington, Texas. GE-2, at 42.

The day before Dr. C.V. wrote R.N. a prescription for hydrocodone, L.R., ACNS-BC, of the same medical practice as Dr. C.V., wrote R.N. a prescription for 60 tablets of alprazolam 2 mg. GE-2, at 119. The Pharmacy filled both prescriptions the same day, November 17, 2014. GE-2, at 117-19. Although D

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