Pharmacy 4 Less; Decision and Order

Federal RegisterOct 1, 2021

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 18-41]

Pharmacy 4 Less; Decision and Order

On July 5, 2018, a former Assistant Administrator of the Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to Pharmacy 4 Less, (hereinafter, Respondent) of Altamonte Springs, Florida. Administrative Law Judge Exhibit (hereinafter, ALJ Ex.) 1, (OSC) at 1. The OSC proposed to revoke its DEA Certificate of Registration (hereinafter, COR) No. FP5459082, and deny any pending applications for renewal or modification of such registration pursuant to 21 U.S.C. 823(f) and 824(a)(4) for the reason that 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 Ex. 2. The hearing in this matter was held in Orlando, Florida, on November 5-7, 2018, and continued in Arlington, Virginia, on February 25, 2019. On May 22, 2019, Administrative Law Judge Mark M. Dowd (hereinafter, the ALJ) issued the Recommended Rulings, Findings of Fact, Conclusions of Law and Decision (hereinafter, Recommended Decision or RD), and on June 11, 2019, the Government timely filed exceptions (hereinafter, Govt Exceptions) to the Recommended Decision. On June 23, 2019, the Respondent filed what it styled as a response to the Government's Exceptions (hereinafter, Resp Exceptions).

According to the ALJ, the Respondent Pharmacy did not request an extension of time to file exceptions, nor did it request an extension of time to file a response to the Government's Exceptions pursuant to 21 CFR 1316.66(c).

See

ALJ Transmittal Letter dated June 25, 2019. Even though Respondent did none of those things, I have decided to address the Exceptions filed by Respondent as part of my review of the record.

Having reviewed the entire record, I find the Respondent's Exceptions are without merit and I adopt the ALJ's rulings, findings of fact, as modified, conclusions of law and recommended sanction with minor modifications, where noted herein.

Despite the title, Respondent's filing appears to assert its own Exceptions to the RD rather than respond to the Government's Exceptions.

My decision to consider the Respondent's Exceptions is based on the particular circumstances of this case, including but not limited to, the withdrawal of Respondent's counsel after the conclusion of the hearing.

I have made minor modifications to the RD. I have substituted initials or titles for the names of witnesses and patients to protect their privacy, I have corrected an occasional citation, and I have made minor, non-substantive, grammatical changes. Where I have made substantive changes, omitted language for brevity or relevance, or where I have added to or modified the ALJ's opinion, I have noted the edits with an asterisk, and I have included specific descriptions of the modifications in brackets following the asterisk or in footnotes marked with an asterisk and a letter.

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 No. FP5459082 issued to Pharmacy 4 Less. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby deny the pending application for renewal or modification of this registration by Pharmacy 4 Less in Florida. This Order is effective November 1, 2021.

Anne Milgram,

Administrator.

The Government's Exceptions

The Government, though in agreement with much of the ALJ's opinion, filed exceptions to the RD on June 11, 2019. The Government described its primary concern as being delay caused by the ALJ's conditional admission of documents and proffer testimony, and asked that I “specify the manner in which the ALJ is to balance the risk of delay with the risk of being reversed, and to, where appropriate, allow only limited proffers.” Govt Exceptions, at 3. The presiding ALJ has the “duty to conduct a fair hearing, to take all necessary action to avoid delay, and to maintain order” and has the power to “[r]eceive, rule on, exclude, or limit evidence.” 21 CFR 1316.52 and (f). In other words, he possesses discretion to “regulate the course of the hearing.” 5 U.S.C. 556(c)(5) (West 2021). As such, I decline to broadly instruct ALJs in the manner requested by the Government.

Next, the Government alleged that the ALJ erroneously admitted Respondent Exhibits 18-37, which consisted of due diligence files for the patients at issue in this case which had been updated by Respondent after the dates relevant to this case (and after a Government subpoena for these same records). Govt Exceptions, at 3-6. The Government conceded that the records could have been relevant to establish remedial measures taken by Respondent Pharmacy, but argues that they would have been relevant only if Respondent Pharmacy first accepted responsibility for its actions.

Id.

The Government alleges that the ALJ's admission of RX 18-37, even conditionally, was improper without Respondent first establishing responsibility or proffering that acceptance of responsibility was forthcoming. As I have already discussed, I decline to instruct the ALJs on how to balance the risk of delay against the need to receive evidence as it lies within their discretion, because every case will be different. Here, the ALJ ultimately found that the Respondent Pharmacy did not accept responsibility for its actions, but it would have been difficult for the ALJ to have reached that conclusion at the beginning of the evidentiary hearing.

The remainder of the Government's exceptions are addressed in the relevant sections of the RD as footnoted below.

The Respondent's Exceptions

On June 23, 2019, the Respondent filed its exceptions to the Recommended Decision. Exceptions “shall include a statement of supporting reasons for such exceptions, together with evidence of record (including specific and complete citations of the pages of the transcript and exhibits) and citations of the authorities relied upon.” 21 CFR 1316.66. For the most part, the Respondent's Exceptions not only fail to comply with this regulatory requirement, but also lack evidentiary support in the Administrative Record. Some of Respondent's Exceptions

repeat facts which were already raised at the hearing in this matter and addressed by the ALJ in the adopted Recommended Decision herein.

Respondent's Exceptions ¶ 1 asserting that starting doses for opioid patients were not high and that the Pharmacy had detailed medical records; ¶ 7 regarding the initial inventory; ¶ 8 asserting the accuracy of the perpetual inventory; ¶ 12 claiming the opioid naivety red flag was resolved by checking e-FORCSE. Respondent's Exceptions, at 2-3.

Most of Respondent's Exceptions introduce evidentiary facts that Respondent Pharmacy appears to be offering to establish remedial measures.

Many of these facts are not

supported by the record and were not under oath or subject to cross examination when they were presented for the first time in Respondent's Exceptions. Moreover, where a registrant has not accepted responsibility it is not necessary to consider evidence of the registrant's remedial measures.

Jones Total Health Care Pharmacy, L.L.C. & SND Health Care, L.L.C.,

81 FR 79188, 79202-03 (2016).” As Respondent Pharmacy has failed to unequivocally accept responsibility for its actions, the purported remedial measures offered by Respondent in its Exceptions, even if they were part of the evidentiary record, would have no impact on my decision in this case.

Respondent's Exceptions ¶ 4 asserting that the pharmacy can now bill insurance companies and that 80% of the Schedule II controlled substances prescriptions it fills are through insurance now; ¶ 5 asserting the pharmacy now fills only 10% of the Schedule II controlled substances prescriptions it was filling in 2015 and 2016, admitting they filled too many Schedule II prescriptions in the past and claiming they are not “extremely due diligent in filling;” ¶ 6 asserting that the pharmacy does not fill prescriptions from a neighboring pain doctor who will not share medical records; ¶ 7 asserting that Respondent Pharmacy passed every Department of Health inspection from 2015 to 2019; ¶ 9 asserting that Patient A.R. has been discharged; ¶ 11 asserting

that Patient A.V. was successfully taken off of opioids. Resp Exceptions, at 2-3.

Similarly, the Respondent's Exceptions contained a number of factual assertions regarding Owner Richard Sprys' purported work with law enforcement bodies to report illegal pharmacy operations and provide testimony, seemingly for the DEA in one instance, to hold those pharmacies accountable.

Id.

at 3. None of these facts were given under oath and none were subject to cross-examination; therefore, they are simply not part of the evidentiary record. Even if Respondent's assertions had been appropriately submitted through testimonial evidence, they could only have been relevant in assessing whether Respondent Pharmacy could be entrusted with a registration. Here, as Respondent Pharmacy has failed to unequivocally accept responsibility for its actions, such assertions would have had no impact on my decision.

The remainder of the Respondent's Exceptions are addressed in their relevant sections of the Recommended Decision as footnoted below.

The decision below is based on my consideration of the entire administrative record, including all of the testimony, admitted exhibits, and the oral and written arguments of both parties. I adopt the ALJ's Recommended Decision with noted modifications.

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge

The Assistant Administrator, Drug Enforcement Administration (DEA), issued an Order to Show Cause,

dated July 5, 2018, seeking to deny the Respondent's Certificate of Registration, number FP5459082, on the ground that the Respondent's registration would be inconsistent with the public interest, pursuant to 21 U.S.C. 824(a)(4), and as defined in 21 U.S.C. 823(f). The Respondent requested a hearing on August 2, 2018,

and prehearing proceedings were initiated.

A hearing was conducted in this matter on November 5-7, 2018, in Orlando, Florida, and resumed on February 25, 2019, at the DEA Hearing Facility in Arlington, Virginia.

ALJ Ex. 1.

ALJ Ex. 2.

ALJ Ex. 3.

The issue ultimately to be adjudicated by the Administrator,

with the assistance of this Recommended Decision, is whether the record as a whole establishes by a preponderance of the evidence that the Respondent's subject registration with the DEA should be revoked pursuant to 21 U.S.C. 824(a)(4).

All references to “Acting Administrator” have been changed to “Administrator.”

After carefully considering the testimony elicited at the hearing, the admitted exhibits, the arguments of counsel, and the record as a whole, I have set forth my recommended findings of fact and conclusions of law below.

The Allegations

In the OSC, the Government contends that the DEA should revoke the Respondent's DEA COR because it failed to comply with 21 U.S.C. 824(a)(4) and its registration is inconsistent with the public interest,

see

21 U.S.C. 823(f). Specifically, the Government alleges the following:

1. The Respondent failed to ensure that it only filled prescriptions issued for legitimate medical purposes and repeatedly filled prescriptions in the face of obvious red flags of diversion, in violation of both federal and state law (including 21 CFR 1306.06, 1306.04(a);

Wheatland Pharmacy,

78 FR 69411, 69445 (2013); Fla. Admin. Code r. 64B16-27.810, 64B16-27.831

), specifically from at least October 27, 2015 to at least June 19, 2017, to at least ten different patients. ALJ Ex. 1 at ¶¶ 2-4.

It was noted that there was a scrivener's error by the Government citing to r. 64B16-27.821. The Government later corrected the cite to reflect the correct citation to r. 64B16-27.831.

2. The Respondent routinely filled Schedule II controlled substances without resolving the “red flag” of patients with “very high starting dosages,” both with respect to the individual dose being prescribed and with respect to the number of tablets being prescribed, which is potentially fatal for a patient. ALJ Ex. 1 at ¶ 5.

3. The Respondent routinely filled controlled substance prescriptions without resolving the “red flag” of immediate release pain medication over long periods of time. A chronic pain patient should be moved to a long acting medication. ALJ Ex. 1 at ¶ 6.

4. The Respondent routinely filled controlled substance prescriptions without resolving the “red flag” of extremely high cash prices. ALJ Ex. 1 at ¶ 7.

5. The Respondent routinely filled prescriptions without resolving the “red flag” for patients who traveled long distances to visit the Respondent's pharmacy. ALJ Ex. 1 at ¶ 8.

6. The Respondent would fill prescriptions without resolving the “red flag” for drug combinations that needed to be questioned, such as the combination of buprenorphine and oxycodone. ALJ Ex. 1 at ¶ 9.

Treatment of Patients

Patient A.E.

From November 19, 2015, to at least June 1, 2017, the Respondent filled at least 21 prescriptions for hydromorphone for A.E. outside the usual course of professional practice, in violation of 21 CFR 1306.06, and in violation of its corresponding responsibility under 21 CFR 1306.04(a). Specifically:

a. A.E.'s prescriptions were for 84 tablets of hydromorphone 8 mg, which is a large amount of tablets at the highest dosage strength.

b. A.E. filled his prescriptions for short acting hydromorphone since at least November 19, 2015, even though hydromorphone is not prescribed for long-term use or chronic conditions.

c. A.E. paid cash for his prescriptions at inflated prices, paying $500.00 for 84 tablets of hydromorphone 8 mg, approximately $5.95 per pill, at a time when legitimate pharmacies were charging approximately $1.50.

Patient A.R.

From March 17, 2016, to at least June 7, 2017, the Respondent filled at least 17 prescriptions for oxycodone for A.R. outside the usual course of professional practice, in violation of 21 CFR 1306.06, and in violation of its corresponding responsibility under 21 CFR 1306.04(a). Specifically:

a. A.R. filled his prescriptions for immediate release oxycodone since at least March 17, 2016, even though oxycodone is not prescribed for long-term use or chronic conditions.

b. A.R. drove extremely long distances to fill oxycodone prescriptions. A.R. drove approximately 37 miles southwest to visit the prescribing doctor, an additional 17.9 miles further southwest

to the Respondent's pharmacy, an additional 45.4 miles to A.R.'s home, for a total of 97.3 miles round-trip to fill the oxycodone prescriptions.

Patient A.V.

From April 12, 2016, to at least April 10, 2017, the Respondent filled at least 9 prescriptions for buprenorphine and at least 12 prescriptions for oxycodone for A.V. outside the usual course of professional practice, in violation of 21 CFR 1306.06, and in violation of its corresponding responsibility under 21 CFR 1306.04(a). Specifically:

a. A.V.'s prescriptions were for 112 tablets of oxycodone 20 mg and 60 tablets buprenorphine 8 mg, which are large amounts of tablets at a high dosage strength.

b. A.V. was filling prescriptions for opioid withdrawal at the same time he was filling a prescription for an opioid.

c. A.V. filled his prescriptions for short acting oxycodone since at least April 12, 2016, even though oxycodone was not prescribed for long-term use or chronic conditions.

Patient B.F.

From October 27, 2015, to at least May 15, 2017, the Respondent filled at least 17 prescriptions for hydromorphone and at least 5 prescriptions for oxycodone for B.F. outside the usual course of professional practice, in violation of 21 CFR 1306.06, and in violation of its corresponding responsibility under 21 CFR 1306.04(a). Specifically:

a. B.F.'s prescriptions were for 84 tablets of hydromorphone 8 mg, which is a large amount of tablets at the highest dosage strength.

b. B.F. filled his prescriptions for short acting hydromorphone since at least October 27, 2015, even though hydromorphone is not prescribed for long-term use or chronic conditions.

c. B.F. paid cash for his prescriptions at inflated prices, paying $490.00 for 84 tablets of hydromorphone 8 mg, approximately $5.93 per pill, at a time when legitimate pharmacies were charging approximately $1.50.

Patient B.N.

From January 22, 2016, to at least June 2, 2017, the Respondent filled at least 9 prescriptions for hydromorphone and at least 10 prescriptions for oxycodone for B.N. outside the usual course of professional practice, in violation of 21 CFR 1306.06, and in violation of its corresponding responsibility under 21 CFR 1306.04(a). Specifically:

a. B.N.'s prescriptions were for 100 tablets of hydromorphone 8 mg, which is a large amount of tablets at the highest dosage strength. In September 2016, B.N. switched to 120 tablets of oxycodone 30 mg, which is an even higher number of tablets at the highest dosage strength of oxycodone.

b. B.N. filled his prescriptions for immediate release oxycodone and hydromorphone since at least January 22, 2016, even though oxycodone and hydromorphone are not prescribed for long-term use or chronic conditions.

c. B.N. paid cash for his prescriptions at inflated prices, paying up to $640.00 for 100 tablets of hydromorphone 8 mg, approximately $6.40 per pill, at a time when legitimate pharmacies were charging approximately $1.50. Similarly, B.N. paid prices up to $650.00 for 120 tablets of oxycodone 30 mg, approximately $5.51 per pill, at a time when legitimate pharmacies were charging approximately $0.90 per tablet.

Patient K.Y.D.

There are two patients with the same initials, K.D. In pretrial filings, the Government and Respondent referred to these patients as K.D.1 and K.D.2. However, the Government and Respondent referred to different patients as K.D.1 and K.D.2 (

i.e.,

the Government's K.D.1 was Respondent's K.D.2). At the hearing, the parties discussed this issue and decided to refer to these two patients by the first two letters in their first name. All of the Government's pre-trial filings referring to K.D.1 are now discussed as K.Y.D. All of the Government's pre-trial findings referring to K.D.2 are now discussed as K.E.D. The opposite is true for the Respondent.

From February 4, 2016, to at least June 12, 2017, the Respondent filled at least 17 prescriptions for oxycodone and at least 17 prescriptions for morphine sulfate for K.Y.D. outside the usual course of professional practice, in violation of 21 CFR 1306.06, and in violation of its corresponding responsibility under 21 CFR 1306.04(a). Specifically:

a. K.Y.D.'s prescriptions for hydromorphone were for 84 tablets of oxycodone 30 mg, which is a large amount of tablets at the highest dosage strength.

b. K.Y.D. paid cash for his prescriptions at inflated prices, paying up to $290.00 for 84 tablets of oxycodone 30 mg, approximately $3.45 per tablet, at a time when legitimate pharmacies were charging approximately $0.90 per tablet.

Patient K.E.D.

From October 26, 2015, to at least June 7, 2017, the Respondent filled at least 20 prescriptions for oxycodone for K.E.D. outside the usual course of professional practice, in violation of 21 CFR 1306.06, and in violation of its corresponding responsibility under 21 CFR 1306.04(a). Specifically:

a. K.E.D.'s prescriptions for oxycodone were for 112 tablets of oxycodone 20 mg, which is a large amount of tablets at a high dosage strength.

b. K.E.D. filled his prescriptions for immediate release oxycodone since at least October 26, 2015, even though oxycodone is not prescribed for long-term use or chronic conditions.

c. K.E.D. paid cash for his prescriptions at inflated prices, paying up to $430.00 for 112 tablets of oxycodone, approximately $3.83 per tablet, at a time when legitimate pharmacies were charging approximately $0.90 per tablet.

Patient R.R.

From October 28, 2015, to at least May 30, 2017, the Respondent filled at least 21 prescriptions for oxycodone for R.R. outside the usual course of professional practice, in violation of 21 CFR 1306.06, and in violation of its corresponding responsibility under 21 CFR 1306.04(a). Specifically:

a. R.R.'s prescriptions for oxycodone were for 112 tablets of oxycodone 15 mg, which is a large amount of tablets at a high dosage strength.

b. R.R. filled his prescriptions for immediate release oxycodone since at least October 28, 2015, even though oxycodone is not prescribed for long-term use or chronic conditions.

Patient R.V.

From November 17, 2015, to at least June 19, 2017, the Respondent filled at least 21 prescriptions for oxycodone for R.V. outside the usual course of professional practice, in violation of 21 CFR 1306.06, and in violation of its corresponding responsibility under 21 CFR 1306.04(a). Specifically:

a. R.V.'s prescriptions for oxycodone were for 112 to 120 tablets of oxycodone 20 mg, which is a large amount of tablets at a high dosage strength.

b. R.V. filled her prescriptions for immediate release oxycodone since at least November 17, 2015, even though oxycodone is not prescribed for long-term use or chronic conditions.

Patient V.W.

From November 30, 2015, to at least May 31, 2017, the Respondent filled at least 20 prescriptions for oxycodone for V.W. outside the usual course of professional practice, in violation of 21 CFR 1306.06, and in violation of its corresponding responsibility under 21 CFR 1306.04(a). Specifically:

a. V.W.'s prescriptions for oxycodone were for 84 to 112 tablets of oxycodone 15 mg, which is a large amount of tablets at a high dosage strength.

b. V.W. filled his prescriptions for immediate release oxycodone since at least November 30, 2015, even though oxycodone is not prescribed for long-term use or chronic conditions.

c. V.W. paid cash for his prescriptions at inflated prices, paying up to $400.00 for 112 tablets of oxycodone, approximately $3.57 per tablet, at a time when legitimate pharmacies were charging approximately $0.90 per tablet.

Recordkeeping Violations

1. The Respondent did not have an initial inventory, when requested by DEA during an on-site inspection of June 6, 2017, in violation of 21 CFR 1304.11(b).

2. The Respondent's biennial inventory failed to indicate whether it was taken at the opening or closing of business as required by 21 CFR 1304.11(a).

3. The Respondent's pharmacist on duty, Amy Mincy, stated that the biennial inventory was performed over several days, in violation of 21 CFR 1304.11(a).

4. The Respondent's pharmacist on duty during the June 6, 2017 on-site inspection admitted to using the pharmacy owner's, Mr. Richard Sprys, CSOS credentials to order controlled substances in violation of 21 CFR 1311.30(a) & (c).

5. The Respondent's receiving records showed that the Respondent failed to create an electronically linked record of a quantity and date received for its controlled substances in violation of 21 CFR 1305.22(g). The Respondent also possessed 89 invoices without the date of receipt recorded in violation of 21 CFR 1304.22(c).

The Hearing

Preliminary Matters

At the outset of the hearing, the Government confirmed that it was not going forward with pursuing any independent violation against the Respondent for a delay by the Respondent in complying with the July 2018 administrative subpoena. Tr. 14-15.

This Tribunal also noticed the Government that if it intended to assert a new allegation or expand the charges, it must inform this Tribunal at the time the new matter is broached at the hearing.

Id.

at 15-16. This would also give the Respondent the opportunity to either litigate the issue by consent or to object to the new allegation.

Id.

at 15-16. No supplemental allegations were broached by the Government.

Tr.—Refers to the hearing transcript. The number(s) immediately following refer to the transcript page numbers.

The Respondent noted that they would be withdrawing their motion to suppress evidence, a motion that this tribunal had only preliminarily ruled upon.

Id.

at 17; ALJ Ex. 35. This Tribunal noted that the preliminary evidentiary rulings were for guidance and that the parties would still need to make their objections at the time of the hearing to preserve those objections. Tr. 17. The Respondent further requested that this Tribunal take official notice of 21 CFR 1304.21(a) and 21 U.S.C. 827(a)(3), to which this Tribunal acceded.

Id.

at 17-18. Next, the Respondent made preliminary objections as to authentication, failure to meet the business records exception, and improper burden shifting as to Government's Proposed Exhibits 9, 11, and 13.

Id.

at 18-19. This Tribunal carried those objections over to the hearing.

Id.

at 19. Then, the Respondent clarified that Government's Proposed Exhibit 25 had been ruled inadmissible and excluded.

Id.

at 20. The Respondent then discussed a number of other matters related to proposed exhibits, which will be later discussed.

Id.

at 20-22. Finally, the Respondent objected to Government's Proposed Exhibit 26, which objection was also carried to the hearing.

Id.

at 23.

GX 25 consisted of over 1000 pages of an Excel spreadsheet involving records of patients additional to the ten patients who are the subject of the allegations. GX 25 was ruled inadmissible as generally irrelevant. The Government was permitted to reconstitute the exhibit reflecting only the ten subject patients. The Government's substitute exhibit was introduced as GX 35.

Government's Opening Statement

In the Government's Opening Statement, it previewed that the DEA conducted an audit of Pharmacy 4 Less on June 6, 2017.

Id.

at 25. The Government intended to explain the on-site audit through the testimony of DI1, including the findings from the audit, and explain the record keeping and regulatory violations that were discovered.

Id.

at 25. The Government also intended to offer the testimony of Dr. Hamilton regarding his review of the prescriptions and due diligence files that Pharmacy 4 Less maintained and how the Respondent filled prescriptions for controlled substances without resolving red flags.

Id.

at 25. Finally, the Government argued that the Respondent had not accepted responsibility for any of the alleged violations.

Id.

at 25-26.

Respondent's Opening Statement

In the Respondent's Opening Statement, it described Pharmacy 4 Less as a small, independent pharmacy.

Id.

at 27. Pharmacy 4 Less has two pharmacists and a low volume of patients.

Id.

at 27. The Respondent contrasted it from Publix, the pharmacy where Dr. Hamilton is employed.

Id.

at 27-28. The Respondent stated that Pharmacy 4 Less cannot purchase in volume like other retail pharmacies, and cannot sell at the same prices as other larger pharmacies.

Id.

at 28.

The Respondent described Mr. Richard Sprys, the owner and operator of Pharmacy 4 Less.

Id.

at 28. The Respondent detailed Mr. Sprys' community involvement in his capacity as a pharmacist, and how he has previously testified as a witness in several cases for the Government in whistleblower cases against pharmacies.

Id.

at 28. The Respondent further asserted that Mr. Sprys has always attempted to cooperate with the Government, including the process involving the July 9, 2018 administrative subpoena.

Id.

at 28-29. The Respondent also described Ms. Amy Mincy, another pharmacist that works at Pharmacy 4 Less, including her extensive background and experience as a pharmacist.

Id.

at 30.

The Respondent described the June 6, 2017 on-site inspection of Pharmacy 4 Less.

Id.

at 29. The Respondent asserted that the DEA diversion investigators related to Ms. Mincy, the pharmacist on-site at the time of the inspection, that the inspection would only last ten to fifteen minutes when the inspection actually lasted over six hours.

Id.

at 29.

The Respondent asserted that the Government's portrayal that the Respondent has not accepted responsibility is misplaced.

Id.

at 30. The Respondent stated that they submitted a corrective action plan (which the DEA rejected), they have modified their behavior, they have reduced the number of patients they see and fill prescriptions for, and they have implemented a number of other remedial changes.

Id.

at 30.

The Respondent further described the treatment of patients when they visit Pharmacy 4 Less.

Id.

at 30-32. The Respondent asserted that each patient receives specialized attention by the pharmacists because of Pharmacy 4 Less's small size.

Id.

at 31. The Respondent also stated that not only does Pharmacy 4 Less contact patients' doctors to resolve red flags, but Pharmacy 4 Less goes beyond that of other pharmacies because they will request and keep medical records of their patients to assist in the resolution of red flags.

Id.

at 31-32.

Finally, the Respondent stressed that while Pharmacy 4 Less may not be

perfect, they keep their practice above-average.

Id.

at 32. The Respondent maintains that before and after the DEA on-site inspection, Pharmacy 4 Less has a clean record with the Florida Department of Health for their on-site inspections.

Id.

at 32.

Government's Case in Chief

The Government presented its case in chief through the testimony of two witnesses. First, the Government presented the testimony of a Diversion Investigator (hereinafter DI1). Secondly, the Government presented the testimony of its expert, Dr. Thomas D. Hamilton.

Diversion Investigator DI1

DI1 has been a Diversion Investigator for approximately seven years.

Id.

at 33. He is currently assigned to the Orlando District Office, in Orlando, Florida.

Id.

at 33. DI1 described his training and experience at the DEA Academy and in the field at the Baltimore and Orlando offices, including experience in at least 50-70 pharmacy investigations.

Id.

at 34-35.

DI1 first met with the staff at Pharmacy 4 Less on June 6, 2017.

Id.

at 37. He explained that Diversion Investigators

were doing regulatory inspections and Pharmacy 4 Less was randomly picked for a regulatory inspection.

Id.

at 37. When they arrived, the DIs showed their credentials and presented Ms. Amy Mincy, a pharmacist at Pharmacy 4 Less, with a DEA Form 82 Notice of Inspection.

Id.

at 37-38; GX 30.

The form was signed by Ms. Mincy and the DIs began their on-site inspection. Tr. 38-39.

DI1 was accompanied by Group Supervisor DI2 during the on-site inspection. Tr. 41.

A Notice of Inspection is a DEA Form evidencing a voluntary consent to search.

GX—Government's Exhibit.

The DIs began by asking questions about Pharmacy 4 Less's customer base and prescriptions, and looked at the prescriptions records, log books, and other required records.

Id.

at 39. When DI1 asked Ms. Mincy about inventories, she could not locate the initial inventory; so Mr. Richard Sprys, the owner of Pharmacy 4 Less, was contacted via speakerphone by Ms. Mincy to determine where the initial inventory could be located.

Id.

at 39-40.

DI1 asked Mr. Sprys over the phone if Pharmacy 4 Less had an initial inventory, and Mr. Sprys replied that it did not.

Id.

at 40.

Richard Sprys was not present at Pharmacy 4 Less during the on-site inspection on June 6, 2017. Tr. 40.

DI1 next inquired as to whether Pharmacy 4 Less had performed a biennial inventory.

Id.

at 40-41. Ms. Mincy provided DI1 with a document purported to be a biennial inventory.

Id.

at 41. DI1 concluded that the document did not comply with DEA regulations as the purported biennial inventory did not include a statement that it had been completed either at the opening or closing of business.

Id.

at 41-42. Further, DI1 claimed that Ms. Mincy had indicated that she had completed it over several days.

Id.

at 41. DI1 indicated that biennial inventories need to be completed either at the opening or closing of business and it needs to be notated on the biennial inventory.

Id.

at 41-42. DI1 claimed that during this exchange, Ms. Mincy said, “what was [I] supposed to do, shut down the pharmacy? ”

Id.

at 42. As part of his later audit of the pharmacy's inventories, DI1 did not use the biennial inventory because he could not verify its accuracy due to the issues he had discovered during his review.

Id.

at 56, 61, 66, 154-56.

See

21 CFR 1304.11(a).

DI1 then inquired of Ms. Mincy as to recordkeeping and CSOS records.

Id.

at 42. DI1 asked Ms. Mincy how Pharmacy 4 Less documents and records their ordering of controlled substances and validation of a prescription's legitimacy.

Id.

at 43.

When DI1 asked Ms. Mincy to produce the CSOS records (including records of receipt for Schedule 2s), he observed that Ms. Mincy proceeded to a laptop in the pharmacy to log into the CSOS system.

Id.

at 45. DI1 asked Ms. Mincy if she had her own CSOS credentials (which DI1 asserted is required for anyone accessing the CSOS system and cannot be shared with anyone else).

Id.

at 46. In response, Ms. Mincy stated she did not have her own credentials and did not have a power of attorney for anyone else's credentials.

Id.

at 46. Ms. Mincy stated to DI1 that she was using Mr. Richard Sprys credentials to log onto CSOS.

Id.

at 46.

CSOS—Controlled Substance Ordering System.

DI1 asserted during his testimony that when a pharmacy orders and receives controlled substances on-site, they are required to notate that they received them with the date and the initials of the person that received them. Tr. 44.

DI1 later contacted Mr. Chris Jewell, one of the personnel in charge of the CSOS system at DEA Headquarters, to determine which personnel at Pharmacy 4 Less had access to the CSOS system.

Id.

at 47-48. Mr. Jewell ran a report and the report stated that Ms. Mincy received her own CSOS credentials in July 2018.

Id.

at 48-49; GX 29.

The Respondent objected to admission of GX 29 on the basis of lack of authentication and not meeting the exception of a business record. Tr. 49. DI1 made it clear that he did not personally produce this record, but requested it from Mr. Jewell.

Id.

at 49-50. This Tribunal noticed that it appears to be a government record and did not appear to have any indication of inaccuracy or unreliability.

Id.

at 50. The Respondent argued that portions of the document appeared to have inaccuracies as related to Mr. Sprys, but agreed that if the Government was only offering the document as related to Ms. Mincy, it would not object if the rest of the document was blackened out to only show Ms. Mincy's records.

Id.

at 50-52. The Government agreed that it was only offering the document for Ms. Mincy's records on the top line and would not object to blackening out Mr. Spry's records.

Id.

at 51-52. This Tribunal admitted GX 29 on that basis as altered and is only considering GX 29 for the top line as related to Ms. Mincy's records.

Id.

at 51-52.

DI1 described the audit

of Pharmacy 4 Less's records and inventories.

Tr. 53-85, 919-26; GX 4, 31, 32.

DI1 conducted an audit of Pharmacy 4 Less's records and inventories at a starting date of January 1, 2017. Tr. 55-56. DI1 selected this date because Pharmacy 4 Less maintained handwritten Schedule 2 controlled substance logs, there was no initial inventory, and the investigating DIs were unsure of how accurate the biennial inventory was.

Id.

at 56, 61. For example, DI1 had used the pharmacy's handwritten perpetual inventory forms for Methadone 10 mg tablets and Oxycodone 30 mg tablets during the audit, which had been provided to DI1 by Ms. Mincy during the on-site inspection on June 6, 2017.

Id.

at 56-60; GX 31, 32.

The audit occurred both at the pharmacy and later during a review of Pharmacy 4 Less's records. Tr. 100.

DI1 was later asked about his receipt and possession of records obtained from the pharmacy during the June 6, 2017 on-site inspection. Tr. 949-54; Proposed RX 10 (not offered into evidence) (The Government also had a standing objection to this line of questioning as outside the scope of redirect examination. Tr. 951.). Proposed RX 10 was a DEA-12, a receipt of items taken by the DIs after their inspection. Tr. 951. The DEA-12 forms indicated that the DEA had taken possession of six California folders containing C-2 prescriptions, and 13 manila folders containing C-2 invoices. Tr. 951-53.

The Government initially offered GX 4 during the first portion of the hearing in Orlando, Florida. Tr. 67. The Respondent conducted voir dire and objected that it was unreliable. Tr. 68-81. This Tribunal initially admitted the exhibit. Tr. 81-85. However, this Tribunal reconsidered its ruling and found that GX 4 in its then present condition would not be helpful to the factfinder. Tr. 146. This Tribunal then afforded the Government the opportunity to resubmit GX 4 at a later time. Tr. 146-48. During the portion of the hearing in Arlington, Virginia, the Government reintroduced a corrected version of GX 4. Tr. 925. The Respondent did not object and the corrected version of GX 4 was admitted. Tr. 925-26.

For a full discussion of how DI1 conducted his audit,

see

Tr. 61-67.

DI1 explained that under DEA regulations, records need to be readily retrievable and maintained at the pharmacy. Tr. 86. It does not satisfy the regulations that records may later be retrieved.

Id.

at 86. He discovered that

Pharmacy 4 Less did not have readily retrievable records available during the June 6, 2017 on-site inspection.

Id.

at 87.

DI1 explained that “readily retrievable” means that when DIs go into a pharmacy to perform an audit or to review a record, the pharmacy should be able to provide those records within a reasonable time. Tr. 87.

Following the June 6, 2017 on-site inspection, DIs

returned to Pharmacy 4 Less again on June 21, 2017.

Id.

at 88. Ms. Mincy was again at the pharmacy, and Mr. Richard Sprys joined them later that day.

Id.

at 88. DI1 stated that he discussed his findings from the initial on-site inspection and audit (including the invoices and prescriptions) with Mr. Sprys and Ms. Mincy during this second visit.

Id.

at 88. During the discussion, DI1 asked Mr. Sprys and Ms. Mincy how they determined whether prescriptions were for a legitimate medical purpose, based on a review of the records the DIs had retrieved during the first on-site inspection.

Id.

at 89-90. The pharmacists (both Mr. Sprys and Ms. Mincy) responded that they checked E-FORCSE, the Florida prescription monitoring program website, and that they would verify prescriptions by contacting the doctor's office and/or requesting patient medical files.

Id.

at 90-91. When asked how this information is documented, one of the pharmacists (DI1 could not remember if it was Mr. Sprys or Ms. Mincy) provided a red folder that they maintained.

Id.

at 91-92. The red folder contained screenshots from the computer system, Rx30.

Tr. 92. The red folder contained information related to multiple patients. Tr. 93, 119-31; GX 5, 7, 13, 17, 21, 23. DI1 did not find any “due diligence files” for Patients A.V., B.F., K.Y.D., or R.R. in the files provided to him by Pharmacy 4 Less. Tr. 131-36.

DI1 noted that on this second visit, he was present, along with DI Debbie George, Group Supervisor Linda Stocum, and Division Program Manager of the State of Florida, Susan Langston. Tr. 88.

Rx30 is a computer software that Pharmacy 4 Less used to maintain their inventory, the dispensing of controlled substances, and as DI1 testified, patient profile screens where the pharmacist can input notes about the patient, including information about the patient, treatment, injuries, and other diagnosis notes. Tr. 92-93. The Respondent identified this as the patient record maintenance form (PRM).

Id.

at 93.

The following day on June 22, 2017, an administrative subpoena was served on Pharmacy 4 Less, requesting hard copy prescriptions for all Schedules 2-5 controlled substance prescriptions from October 2015 through June 22, 2017, all controlled substance prescription data from Rx30, and all due diligence patient files. Tr. 93-94; GX 2. Pharmacy 4 Less complied by delivering a gray tote container that contained “California” folders filled with Schedule 2 hard copy prescriptions, a thumb drive containing all Rx30 data, and the red folder seen during the June 21 on-site inspection.

Id.

at 96. The Schedules 3-5 prescriptions were delivered to the DIs by Pharmacy 4 Less at an unidentified later date.

Id.

at 97. The red folder contained screenshots from the Rx30 program.

Id.

at 96. The red folder also contained the pharmacists' notes on patients, referred to as “due diligence files.”

Id.

at 96-97. The “California” folders were organized by prescription number, which DI1 sorted through to locate prescriptions for the 10 charged patients at issue in this case. Tr. 97-111; GX 6, 8, 10, 12, 14, 16, 18, 20, 22, 24.

DI1 also discussed the Rx30 data retrieved from the thumb drive related to the 10 charged patients. Tr. 111-16; GX 35, 36.

These exhibits were admitted with the qualification that these exhibits only contained the Schedule 2 hard copy prescriptions for each of the 10 charged patients, not all of the prescriptions. Tr. 102-11. [The Government noted, that “some of the prescriptions here are not Schedule 2s, but [the Government did] not litigat[e] those prescriptions,” and they are therefore not relevant to the Government's

prima facie

case. Tr. 103.]

GX 35 is a narrowed version of Government's Proposed Exhibit 25, which was previously ruled inadmissible during prehearing proceedings. GX 35 only included information related to the 10 charged patients. Tr. 116-18.

See

ALJ Ex. 32.

Diversion Investigators (the DIs were not identified by DI1) returned to Pharmacy 4 Less during approximately February 2018. Tr. 136. During this visit, DI1 acquired copies of invoices for controlled substances. Tr. 136. DI1 noted that a few of these invoices violated DEA regulations by failing to provide a date of receipt.

25 *G

Tr. 136-39.

The Respondent conducted voir dire of DI1 on this point and argued that 21 CFR 1305 only applies to Schedule 2 controlled substances. Tr. 140-45. For further analysis,

see infra

section “Date of Receipt on Invoices.”

DI clarified his testimony to say that “only a few of them actually contained the . . . date of receipt;” specifically, there were only “four that contain[ed] the actual date of receipt,” and “eighty-five” were not properly dated. Tr. 137-38.

Another administrative subpoena was served on Pharmacy 4 Less on July 9, 2018. Tr. 95; GX 3.

DI1 was recalled during the second portion of the hearing at the DEA Hearing Facility in Arlington, Virginia. DI1 credibly explained the purpose of the corrected GX 4, and how he arrived at his results during his audit of the pharmacy's records and inventories. Tr. 919-26. DI1 also testified to GX 38—Redacted (Initial Response from Florida E-FORCSE reflecting only the 10 charged patients) and GX 40 (A declaration by DI3 as to an administrative subpoena sent to the Florida E-FORCSE for user history), which was introduced at the second portion of the hearing. Tr. 929-36.

DI3 was asked by DI1 to send an administrative subpoena to the Florida E-FORCSE program to request a user history report.

Id.

at 929-30. Based on a follow-up request by DI1, the Florida E-FORCSE personnel reviewed their system to see when Mr. Sprys and Ms. Mincy had accessed the Florida PDMP to look up patients. Tr. 931-32; GX 40, Att. C.

GX 38—Redacted was admitted and substituted in place of the original GX 38. Tr. 934. GX 40, p. 1, Att. A, and Att. C. were also admitted into evidence. Tr. 935-36.

DI1 also offered three arrest records for Patient K.Y.D. Tr. 937; GX 41-43. The arrest records were produced from “

arrest.org,

” a public website where members of the public can retrieve arrest information about individuals, which DI1 occasionally uses in the course of his employment.

Id.

at 938-39. DI1 indicated that this website is a tool that pharmacists or doctors can utilize to look up patients to see if they have ever been arrested for controlled substance violations.

Id.

at 940. According to the records, Patient K.Y.D. had previously been arrested on December 31, 2015, for possession of oxycodone with an intent to sell.

Id.

at 940; GX 43. Patient K.Y.D. had also previously been arrested on May 2, 2016, for operating with a suspended license, possession of Schedule 2 controlled substances, and possession of a Schedule 4 controlled substance. Tr. 941; GX 41. Finally, Patient K.Y.D. had also previously been arrested on February 25, 2017, for possession of a Schedule 2 controlled substance and resisting an officer without violence. Tr. 941-42; GX 42.

The Respondent objected and argued that the arrest records were unreliable and irrelevant to this matter. This Tribunal found that these records were available to the public, and not being offered for the truth of the matter of the arrests, but as a resource that an individual such as a doctor or pharmacist would be confronted with if they accessed this website. They were admitted over objection. Tr. 942-43. Reviewing such arrest websites is not required by the relevant standard of care, nor is it something that Dr. Hamilton or the other pharmacists did at Publix Pharmacies. Tr. 1022-23.

Dr. Thomas Hamilton, Pharm. D.

Dr. Hamilton received his Doctor of Pharmacy degree at Nova Southeastern University in Fort Lauderdale. Tr. 167. He has worked as a pharmacist for 18 years.

Id.

at 169; GX 27. After being licensed in 1999, he worked for a short time at a small pharmacy before beginning full-time at Publix pharmacy as a pharmacist. Tr. 172. He served in

various capacities at Publix, including Pharmacist, Assistant Manager of the Pharmacy, and Pharmacy Manager. GX 27. He also served as a “fixer,” or a temporary Pharmacy Manager, who would “clean up” pharmacies. Tr. 169. Dr. Hamilton later transitioned to a Pharmacy Supervisor, in which he oversaw up to 40-45

pharmacies, in hiring, firing and daily operations. Tr. 170. Additionally, Dr. Hamilton evaluated stand-alone, independent pharmacies for purchase by Publix Supermarkets.

Id.

at 170. This evaluation included review of the drug invoices, the filled prescriptions, and the nature of the pharmacy's overall business.

Id.

at 170-71. In order to spend more time with his young family, Dr. Hamilton decreased his responsibilities with the company, gave up his supervisory role, and now serves as a Pharmacy Manager of a single pharmacy with Publix.

Id.

at 286-87.

Amended pursuant to Tr. 170.

In connection with the investigation into Pharmacy 4 Less, Dr. Hamilton reviewed the materials sent to him by the Government, which included prescriptions (front and back), related patient medical notes, and patient addresses.

Id.

at 177, 380-81. Additionally, Dr. Hamilton reviewed prescription pricing via GoodRx.

Id.

at 177-78. Dr. Hamilton noticed “red flags” in connection with the reviewed prescriptions.

Id.

at 178. “Red flags” are concerns resulting from the review of the prescription.

Id.

at 178-79. These concerns can be resolved through some investigation by the pharmacist, such as speaking with the patient, reviewing the medical history, or checking with the prescriber.

Id.

at 179. Dr. Hamilton noted that the resolution of the “red flag” had to be documented in the file as part of the Florida Standard of Care,

noting, “[i]f it's not documented, there's no evidence that . . . it was resolved *[or a phone call was made, or an answer was given].”

Id.

at 179-81, 306, 318, 337, 1006-11, 1016.

Throughout the case, the Government's expert and all parties appear to have used the phrases “standard of care” and “corresponding responsibility” and “standard of pharmacy practice” interchangeably. The testimony regarding the requirement to resolve red flags is clearly related to Respondent Pharmacy's corresponding responsibility under 21 CFR 1306.04. The interchangeable use of this terminology does not impact my ultimate finding that Respondent Pharmacy failed to resolve red flags in contravention of Respondent's corresponding responsibility under 21 CFR 1306.04 and outside the usual course of professional practice in violation of 21 CFR 1306.06. For consistency purposes, I will use the language regarding standard of care to encompass the standard of pharmacy practice and corresponding responsibility herein.

*[Omitted for clarity. The ALJ found that the Government did not allege a separate violation regarding the documentation of the resolution of red flags, but instead chose to consider such lack of documentation as an inference supporting a finding that the red flag was not resolved. In this case, I find that the Government's expert credibly testified that documenting the resolution of red flags was required by the standard of professional practice in Florida. Furthermore, the issue of whether documentation was required by the standard of practice in Florida was thoroughly addressed by both parties at the hearing.

See id.

179-81, 434-38, 1007-08. I find that it is unimportant to find an independent violation related to the lack of documentation, because such lack of documentation already supports the overall finding that Respondent filled these alleged prescriptions in violation of its corresponding responsibility and outside the usual course of professional practice in Florida.]

Dr. Hamilton indicated the source of pharmacy standards in Florida included “Florida Regulation 64B,”

and guidance from the National Board of Pharmacy Association.

Id.

at 180, 351-58. Dr. Hamilton noted these standards are enforced by the Board of Pharmacy in Florida.

Id.

at 180.

See

West's Florida Administrative Code, Title 64. Department of Health, Subtitle 64b16, Chapter 64B16-27—Pharmacy Practice.

Dr. Hamilton explained that if the prescription involved a controlled substance, that in itself was a red flag.

Id.

at 182. The strength of medication and the duration of the medication therapy was a concern, which needed to be addressed.

Id.

The pricing structure of the controlled substance represented a concern, as well as the distance of travel.

Id.

at 182, 360-61.

Dr. Hamilton noted “red flags” in a prescription to Patient A.E., for 84 tablets of 8 mg. of hydromorphone.

Id.

at 183-84; GX. 6, pp. 1-2, GX. 5; RX 18, pp. 1-2, RX 19.

Dr. Hamilton noted that 8 mg was the highest dosage made of hydromorphone, a Schedule 2 controlled substance. Tr. 184. Further, the number of dosage units prescribed, 84, was also concerning.

Id.

at 184. Dr. Hamilton noted that, based on the records, the first “red flag” involving a dangerously high dosage level, had not been resolved.

Id.

at 186. Dr. Hamilton noted the absence of any information relating to the patient's prescribing history suggesting the patient was acclimated to this significant dosage, and not “opiate naïve” to this dosage.

Id.

at 188-90, 316-17. Dr. Hamilton indicated the Florida standard of care required the starting date of the prescribed medication to be disclosed on the face of the prescription or in a note readily available to the pharmacist.

Id.

at 186-87, 350-51, 392-94. Dr. Hamilton acknowledged that a pharmacist had access to the Florida PDMP, or “E-FORCSE” database, which contained prescribing history.

Id.

at 348-49.

Dr. Hamilton compared GX 5 with RX 18.

Dr. Hamilton noted that an identical prescription for hydromorphone was issued to A.E. for two more consecutive months. Tr. 191-92; GX 6, pp. 3-6. Dr. Hamilton noted the Florida standard of care regarding “individualization” required that the pharmacist consider whether an extended high dosage of controlled medication should be continued or should be reduced. Tr. 192-93. Dr. Hamilton expected to see a reduction in dosage over time, or an explanation by the pharmacist for continuing to dispense the same high dosage.

Id.

at 1013-14. Dr. Hamilton noted there was no evidence that any reevaluation of the patient's continued need for this strong medication had been made.

Id.

at 193. The fact that the patient was on immediate release tablets further heightened the “red flag.” GX 28, p. 6. Dr. Hamilton explained that immediate release tablets typically addressed acute versus chronic or long-term conditions, as suggested here by ongoing prescriptions for hydromorphone. Tr. 193-94, 1013-14. This “red flag” was not resolved on the face of the prescription, or in the medical notes. Tr. 194; GX 5, GX 6, pp. 5-6. Dr. Hamilton was also concerned by the cash purchase of the prescription and the “extremely high prices” paid, of $5.95 per pill. Tr. 194, 199; GX, 28, p. 6.

Dr. Hamilton explained that medications are typically priced at the “average wholesale price” plus 20%. Tr. 195. Dr. Hamilton explained that the appropriate price

of 8 mg. of hydromorphone was $1.50 per tablet. He cautioned that this was an approximation by reviewing pharmacy prices in his area, both of big chain pharmacies as well as independents.

Id.

at 195, 326, 330-31. Dr. Hamilton opined that prices per pill from wholesalers would be fairly consistent across the state.

Id.

at 195, 1011-13. However, he noted that, at the retail level, the purchase of just a few pills could result in an extremely high price per pill versus the purchase of a large number of pills. Tr. 198.

Dr. Hamilton referred to it as “the market retail price.” Tr. 195.

On rebuttal, Dr. Hamilton compared versions of the same medical records as to A.E.

See

GX 5 and RX 18, 19. After pointing out differences in the two versions, and granting the reliability of the Respondent's versions, Dr. Hamilton opined that considering the GX 18, 19 version, his previous opinions as to A.E.'s dispensing remained the same. Tr. 957-65. As related to the differences

between the Government and Respondent versions of the same records, Dr. Hamilton conceded that the Respondent versions could be updated versions of the Government versions.

Id.

at 1019-20. Dr. Hamilton observed that updating medical records was required by the standard of care.

Id.

at 1020.

Turning to patient A.R., Dr. Hamilton noted a prescription for 112 tablets of 15 mg of oxycodone represented several “red flags”, citing significant dosage, high quantity, frequency of prescribed usage (4 times daily), and high price.

Id.

at 204-05, 329; GX 8, pp. 1-2; RX 20. Dr. Hamilton was unable to find that these “red flags” were resolved on the face of the prescription or on the “information sheet” within the patient record. Tr. 205-06; GX 7. Dr. Hamilton explained that, although the patient's “information sheet” contained information relating to diagnoses and medical conditions, it did not include information justifying the long-term use of the subject oxycodone prescription. Tr. 206, 329-30; GX 28, pp. 12-14. As relates to price per pill, Dr. Hamilton estimated the retail price to be approximately 90 cents. Tr. 330-31. The next prescription for A.R. also involved 15 mg of oxycodone, but for 140 tablets at a directed frequency of 5 times per day at a price of $350. Tr. 207-08; GX 8, pp. 3-4. Dr. Hamilton noted the distance between A.R.'s residence and the prescribing doctor's office and Pharmacy 4 Less. Tr. 208. Dr. Hamilton estimated A.R. lived approximately 40 miles from the prescribing doctor, and another 13 miles further to the subject pharmacy.

Id.

at 209. Dr. Hamilton indicated this distance represented a “red flag,” which went unresolved within the subject records. Tr. 209-10, 332-37; GX 7, GX 8, p. 3.

Patient A.R. paid $280 for 112 pills of oxycodone in connection with this prescription, or $2.50 per pill. *[Later, Patient A.R. paid between $340 and $350 for 140 pills of oxycodone, or approximately $2.43-$2.50 per pill. GX 8, at 3-6, 33-34.]

The next two prescriptions for A.R., which Dr. Hamilton indicated disclosed the same “red flags” were identical prescriptions for 15 mg of oxycodone, for 140 tablets, but at a price of $340. Tr. 212-14; GX 8, pp. 5-6, 33-34. *[Omitted based on further review of the record]. Dr. Hamilton opined the subject oxycodone prescriptions for A.R. remained unresolved within the records reviewed, and were thus below the standard of care in Florida. Tr. 215-16; GX 7.

On rebuttal, Dr. Hamilton compared versions of the same medical records as to A.R.

See

GX 7 and RX 20, 21. After pointing out differences in the two versions, and granting the reliability of the Respondent's versions, Dr. Hamilton opined that considering the GX 20 and 21 version, his previous opinions as to A.R.'s dispensing remained the same. Tr. 965-69.

As to Patient B.F., Dr. Hamilton reviewed a series of prescriptions for hydromorphone 8 mg, 84 count, 3 times daily. Tr. 216-22; GX 12, pp. 13-14, 17-18, 21-22, 25-26; RX 24. The “red flags” revealed included the controlled substance itself, the dosage at the highest available, the high quantity (84 tablets), the immediate release, the ongoing length of time it is being prescribed, and the high price ($490).

Tr. 216-22.

Eighty-four tablets at $490 equals $5.83 per tablet. *[The ALJ then found that Dr. Hamilton estimated the expected retail price to be $0.90 per pill citing to Tr. 218-22 and GX 28, p. 11, but the record does not support this finding. Dr. Hamilton originally testified that hydromorphone had an estimated retail price of $0.90, Tr. 218; however, after he refreshed his recollection with his expert report he stated, “I might have misspoke at $0.90. It's a little bit more expensive for [D]ilaudid, or [h]ydromorphone . . . .” Tr. 222. Dr. Hamilton's export report stated that the estimated retail price of hydromorphone was approximately $1.50 per pill. GX 28, at 11. Dr. Hamilton also testified elsewhere in the record that the market retail price for hydromorphone was $1.50 per pill.

See e.g.

Tr. 195-97. Moreover, albeit in a different context, Dr. Hamilton testified that to the extent numbers appearing in his expert report differed from numbers to which he was testifying based on his recollection, the numbers in the expert report would be “[m]ore accurate.” Tr. 209. Based on the entirety of the record, I find that Dr. Hamilton estimated the expected retail price of hydromorphone to be $1.50 per pill.]

On rebuttal, Dr. Hamilton evaluated the Respondent's sponsored versions of medical records as to B.F., RX 24, 25. Dr. Hamilton noted references to a discharge date of May 15, 2017, a reference to liver cancer, stage 3, and the last fill of the subject prescription on May 15, 2017. Tr. 976-77. Even granting the reliability of the records, Dr. Hamilton stuck with his original opinions as to B.F.'s dispensing.

Id.

at 975-80.

As to Patient B.N., Dr. Hamilton identified “red flags” related to a series of prescriptions for hydromorphone.

Id.

at 223. The first was of 8 mg, 90 count, priced at $580. Tr. 222-23; GX 14, pp. 1-2; GX 13; RX 26. Dr. Hamilton reiterated the hydromorphone itself represented an unresolved “red flag,” as well as the dosage, quantity and cost. Tr. 223, 226. The second and third prescriptions for hydromorphone, again with the same unresolved a “red flags,” involved 8 mg, 100 count, priced at $640. Tr. 224-28; GX 14, pp. 3-6; GX 13. The fourth hydrocodone prescription, again with the same unresolved “red flags,” involved 8 mg, 100 count, priced at $600. Tr. 229-30; GX 14, pp. 15-16. This prescription prompted an additional “red flag” as it represented ongoing prescribing of hydromorphone without demonstrated justification. Tr. 230. Dr. Hamilton reviewed a prescription for oxycodone, 30 mg (the highest dosage available), 120 count, priced at $600.

Id.

at 231-32. Dr. Hamilton opined the medication itself represented a “red flag,” as well as the dosage, the quantity and the cost.

Id.;

GX 14, pp. 19-20, GX 13. Additionally, transitioning from hydromorphone to oxycodone required an explanation, which was not contained within the records reviewed by Dr. Hamilton. Tr. 232. A second prescription for oxycodone for B.N., for 30 mg, quantity 40, had the same unresolved “red flags.” Tr. 233; GX 14, pp. 21-22. As this represented the second consecutive prescription for oxycodone, an additional “red flag” was raised regarding the ongoing unjustified prescribing. Tr. 233-34. The next two oxycodone prescription for B.N. involving the same unresolved “red flags,” involved 30 mg, 120 count, priced at $600.

Tr. 234-36; GX 13; GX 14, pp. 23-24, 37-38.

Dr. Hamilton also testified that additional prescriptions falling between the November 11, 2016, and June 2, 2017, prescriptions had the same unresolved “red flags.” Tr. 236.

On rebuttal, Dr. Hamilton compared versions of the same medical records as to B.N., GX 13 and RX 26, 27. After pointing out differences in the two versions, and granting the reliability of the Respondent's versions, Dr. Hamilton opined that considering the RX 26 and 27 version, his previous opinions as to B.N.'s dispensing remained the same. Tr. 980-85.

As to patient K.Y.D., Dr. Hamilton identified a series of oxycodone prescriptions with unresolved “red flags.” Tr. 237; GX16, pp. 1-2, 5-6, 9-10, 63-64; RX 30, 31, pp. 2-4. The first three involved a dosage of 30 mg, quantity 84, price $290. Tr. 237-39 *[For these prescriptions, Dr. Hamilton testified that the red flags included the highest strength dosage, high quantity, frequency of prescribed usage (3 times daily), and high price.] By the third prescription, it also triggered an additional “red flag” involving the ongoing unjustified prescribing of oxycodone. Tr. 239. The fourth example for the identical prescription triggered the same unresolved “red flags.”

Id.

at 240.

Dr. Hamilton also testified that additional prescriptions issued between March 31, 2016, and June 12, 2017, had the same unresolved “red flags.” Tr. 241.

On rebuttal, Dr. Hamilton evaluated the Respondent's sponsored versions of medical records as to K.Y.D., RX 30, 31. Dr. Hamilton noted references to a discharge date of June 12, 2017. Tr. 990-91. Even granting the reliability of the records, Dr. Hamilton stuck with his original opinions as to K.Y.D.'s dispensing. Tr. 990-94.

As to Patient K.E.D., Dr. Hamilton determined there were unresolved “red flags” involved in a series of oxycodone prescriptions. The first was for 20.5 mg, quantity 112, for $430. Tr. 241-45; GX 17, GX 18, pp. 1-2, 3-4, 5-6, 41-42; RX 28, RX 29, p. 2. For the first, the dosage of 20.5 mg represents a dosage outside common dosage units, and would have been a compounded dosage, a “red flag” in itself. Tr. 242. *[Additionally, Dr. Hamilton noted that the quantity, and price were unresolved red flags for this prescription.

Id.

] The second and third oxycodone prescription noted were for 20 mg, 112 quantity, priced at $430. Tr. 244-45. Again, the medication itself represented a “red flag,” as well as the dosage, quantity and price. Tr. 245. The fourth oxycodone prescription was identical to the second and third, except that the price was $400. Tr. 245-46. *[In addition to the “red flags” identified with the prior two prescriptions,] the fourth prescription triggered the “red flag” of an extended prescription without apparent justification.

Id.

at 246.

Dr. Hamilton testified collectively regarding the remaining prescriptions in GX 18 issued between December 21, 2015, and June 7, 2017, and opined that there were similar red flags for all of those prescriptions and that none of those red flags were resolved. Tr. 246.

On rebuttal, Dr. Hamilton compared versions of the same medical records as to K.E.D.

See

GX 17; RX 28, 29. After pointing out differences in the two versions, and granting the reliability of the Respondent's versions, Dr. Hamilton opined that considering the RX 28 and 29 version, his previous opinions as to K.E.D.'s dispensing remained the same. Tr. 986-90.

As to Patient R.R., Dr. Hamilton identified a series of oxycodone prescriptions, each which involved unresolved “red flags.” Tr. 247-50; GX 20, pp. 1-6, 41-42; RX 32, p. 1; RX 33, p. 5. The first prescription was of 18 mg, 112 quantity, priced at $250. Tr. 247. The first “red flag” is that the dosage has been compounded, without explanation.

Id.

The high quantity is a “red flag,” as well as the high price paid.

Id.

The second and third prescriptions involved 15 mg, quantity of 112, priced at $270. Tr. 248. The fourth prescription is identical to the second and third, except for the price was $260. Tr. 249-50. The third and fourth prescriptions *[had the same unresolved red flags as the earlier prescriptions, and] additionally triggered a “red flag” as extended prescriptions without apparent justification.

Id.

Dr. Hamilton testified collectively regarding the remaining prescriptions in GX 20 issued between December 21, 2015, and May 30, 2017, and opined that there were similar red flags for all of those prescriptions and that none of those red flags were resolved. Tr. 250.

On rebuttal, Dr. Hamilton evaluated the Respondent's sponsored versions of medical records as to R.R.

See

RX 32, 33. Dr. Hamilton noted references to a discharge date of May 2, 2017, yet another prescription fill on May 30, 2017. Tr. 994-95. Even granting the reliability of the records, Dr. Hamilton stuck with his original opinions as to R.R.'s dispensing.

Id.

at 994-97.

As to Patient R.V., Dr. Hamilton identified a series of oxycodone prescriptions, each which involved unresolved “red flags.” Tr. 251-56; GX 21; GX 22, pp. 27-28, 31-32, 34-35, 78-79; RX 34, p. 1; RX 35. The first prescription was for 20 mg, 112 quantity, priced at $340. Tr. 251; GX 28. The first “red flag” was the high dosage. Tr. 251. The next “red flag” was the quantity.

Id.

And the third was the high price paid.

Id.

*[Dr. Hamilton testified that there was no evidence on either the face of the prescription or in the patient record for R.V. that these “red flags” were resolved.

Id.

at 251-52.] The second prescription was identical to the first *[and had the same unresolved “red flags.”].

Id.

at 253. The third was identical to the first two, except that it was priced at $310.

Id.

The third prescription *[had the same unresolved red flags as the earlier prescriptions, and] had the additional “red flag” as an extended prescription without apparent justification.

Id.

The fourth prescription for oxycodone was of 20 mg, quantity 120, priced at $340 *[and had the same unresolved red flags as the third].

Id.

at 254-55.

Dr. Hamilton testified collectively regarding the remaining prescriptions in GX 22 issued between January 11, 2016, and June 19, 2017, and opined that there were similar red flags for all of those prescriptions and that none of those red flags were resolved. Tr. 255.

On rebuttal, Dr. Hamilton compared versions of the same medical records as to R.V.

See

GX 21 and RX 34, 35. After pointing out differences in the two versions, and granting the reliability of the Respondent's versions, Dr. Hamilton opined that considering the RX 34 and 35 version, his previous opinions as to R.V.'s dispensing remained the same. Tr. 997-1001.

As to Patient V.W., Dr. Hamilton identified a series of oxycodone prescriptions, each which involved unresolved “red flags.” Tr. 256-60; GX 23, GX 24, pp. 1-2, 3-4, 5-6, 41-42; RX 36. The first prescription was for 15 mg, quantity of 84, priced at $300. Tr. 256. The first “red flag” was the relatively high dosage. Tr. 256. The next “red flag” was the quantity.

Id.

And the third was the high price paid.

Id.

The second prescription involved 15 mg, quantity 112, priced at $400. Tr. 257. The third prescription was identical to the second, but was priced at $350. Tr. 258. The third prescription had *[the same unresolved “red flags” as prior prescriptions based on the dose and quantity] and additional [unresolved] “red flags” *[because the prescription was written for four times a day and filled for only three times a day and] as an extended prescription without apparent justification.

Id.

The fourth prescription was identical to the third, except priced at $285.

Id.

at 259. *[The fourth prescription shared the “red flags” arising based on the dose, quantity, price, and “length of time for immediate-release medication.”

Id.

at 259-60.

Dr. Hamilton testified collectively regarding the remaining prescriptions in GX 24 issued between January 25, 2016, and May 21, 2017, and opined that each had the same red flags as the fourth prescription discussed herein and that none of those red flags were resolved. Tr. 260.

On rebuttal, Dr. Hamilton compared versions of the same medical records as to V.W.

See

GX 23 and RX 36, 37. After pointing out differences in the two versions, and granting the reliability of the Respondent's versions, Dr. Hamilton opined that considering the RX 36 and 37 version, his previous opinions as to R.V.'s dispensing remained the same. Tr. 1001-04.

As to Patient A.V., Dr. Hamilton discovered a series of controlled substance prescriptions that were filled by Pharmacy 4 Less despite unresolved “red flags.” Tr. 261-67; GX 10, pp. 1-2, 3-4, 5-6, 9-10, 15-16, 37-38, 41-42, 43-44, 45-46, 47-48, 59-60; RX 22. The first such prescription involved 29 tablets of 8 mg of buprenorphine. Tr. 261-62. The second prescription, filled 9 days after the buprenorphine was filled, involved 112 tablets of oxycodone, 20 mg each, priced at $290. Tr. 262. The oxycodone prescription itself presented “red flags,” which needed to be resolved, as discussed earlier, including the drug itself, the large quantity, the relatively high dosage, and the price.

Id.

Additionally, Dr. Hamilton observed the 20 mg oxycodone was being prescribed in conjunction with the buprenorphine.

Id.

at 263. Buprenorphine is used to wean someone off of an opiate, such as oxycodone.

Id.

The prescribing of buprenorphine along with an opioid prescription creates a “red flag,” which needs to be resolved.

Id.

at 262-63. The acceptable protocol would be to introduce the buprenorphine as the dosage of oxycodone is reduced, until the oxycodone is completely replaced by the buprenorphine.

Id.

at 262-65. Here, the buprenorphine is introduced, yet nine days later the 20 mg of oxycodone was filled, which is inconsistent with the typical detoxification protocol, and can present some contraindication issues.

Id.

at 266-67. Additionally, detoxification would require physician monitoring.

Id.

at 265. Dr. Hamilton noted there was no indication in the reviewed records

*[that the “red flag” was resolved].

Id.

at 265-66. Another 8 mg buprenorphine prescription of 60 tablets was filled almost two months after the first buprenorphine prescription.

Id.

at 267-68. On the same day, a second identical prescription for 20 mg of oxycodone was filled, triggering the same set of “red flags” as previously described *[and, according to Dr. Hamilton, there was no documentation that those “red flags” were resolved].

Id.

at 268-69. This second prescription for oxycodone,

*[according to Dr. Hamilton, raised the same unresolved “red flags” as the first one, and an additional unresolved “red flag” because the medication dosage and frequency remained unchanged and “[y]ou would see a de-escalation of medication with a patient going through detox.”

Id.

at 268-69. The next month saw a repeat of an 8 mg buprenorphine prescription *[for 60 tablets], along with a 20 mg prescription for oxycodone, thus repeating the same unresolved “red flags.”

Id.

at 271-72. Less than one month later, dual prescriptions for 8 mg of buprenorphine and 20 mg of oxycodone were filled, repeating the same unresolved “red flags” as described earlier.

Id.

at 271-73. Additionally, as to the oxycodone, the repeated prescribing created the unresolved “red flag” related to *[the length of time] without a reduction in dosage.

Id.

at 273-74. Dr. Hamilton addressed another set of dual prescriptions for 8 mg of buprenorphine and 20 mg of oxycodone, thus repeating the same unresolved “red flags” discussed earlier.

Id.

at 274-77.

The ALJ found that “Dr. Hamilton noted that there was no indication in the reviewed records that the physician was monitoring any attempted detoxification.” I have omitted the finding because I do not see support for it in the record and find it to be irrelevant. The record is clear that Dr. Hamilton did not see any documentation of resolution of the “red flag,” which is ultimately the fact at issue in this case.

The ALJ found that the second prescription “highlighted the `red flag' relating to the absence of any evaluation as to the reduction in the dosage or frequency of the oxycodone.” I have revised this finding to quote Dr. Hamilton.

Dr. Hamilton testified collectively regarding the remaining prescriptions for buprenorphine and oxycodone in GX 10 issued between August 2, 2016, and February 13, 2017, and opined that each oxycodone prescription had the same red flags as the other oxycodone prescriptions discussed herein and that there was no documentation that these red flags were resolved. Tr. 276.

On rebuttal, Dr. Hamilton evaluated the Respondent's sponsored versions of medical records as to A.V.

See

RX 22, 23. Dr. Hamilton noted references to a consultation with Dr. Seaford, to “tapering” and to “detox.” Tr. 970-72. Even granting the reliability of the records, Dr. Hamilton stuck with his original opinions as to A.V.'s dispensing.

Id.

at 970-75.

Again on rebuttal, Dr. Hamilton confirmed that nothing in the testimony of Mr. Parrado or Ms. Mincy has caused Dr. Hamilton to change his previously offered opinions in this case.

Id.

at 1004-05. Dr. Hamilton did agree with Mr. Parrado's observation that it was proper to fill a pain prescription up to a month after the patient was released from the hospital.

Id.

at 1017. Dr. Hamilton further commended the Respondent's practices of maintaining medical records within their pharmacy files.

Id.

at 1015-16.

Respondent's Case in Chief

The Respondent presented its case through the testimony of two witnesses. First, the Respondent presented the testimony of Ms. Amy Mincy (Ms. Mincy). Second, the Respondent presented the testimony of its expert, Robert M. Parrado (Mr. Parrado).

Ms. Amy Mincy, R.Ph.

Ms. Mincy testified the entire day of November 7, 2018. She was recalled to the stand during the second portion of the hearing at the DEA Hearing Facility in Arlington, Virginia on February 25, 2019, for the remainder of her testimony.

Ms. Mincy testified to the following. Several of Ms. Mincy's claims were contested by the government and will be discussed later. As background, Ms. Mincy graduated from Mercer University in Atlanta, Georgia, and has been a pharmacist since 1983. Tr. 569. She is licensed in the State of Florida and has inactive licenses in Tennessee and Virginia.

Id.

She has worked for a number of pharmacies for varying lengths of time, including independent pharmacies, as a relief pharmacist, and as a pharmacy consultant, over the course of her career.

Id.

at 569-76, 579-83; RX 1.

She has also previously been disciplined by the Florida Board of Pharmacy for filling a prescription for her mother, was placed on probation, and successfully completed the terms of her probation in 1998.

Id.

at 579-82. She began working as a pharmacist at Pharmacy 4 Less in January 2016.

Id.

at 576-77. She is one of two pharmacists that works at Pharmacy 4 Less, along with Mr. Sprys.

Id.

at 577. She works at Pharmacy 4 Less four days per week, Monday through Thursday, with Mr. Sprys working on Friday.

Id.

at 822.

Ms. Mincy's CV was admitted over objection with the corrections noted through Ms. Mincy's testimony. Tr. 584.

Ms. Mincy was working as the pharmacist on duty at Pharmacy 4 Less on June 6, 2017, when the DEA conducted its on-site inspection at the pharmacy.

Id.

at 584. She testified that DI1 and another Diversion Investigator (hereinafter DI2) arrived at the pharmacy sometime between 10:00 a.m.-12:00 p.m. that day.

Id.

at 585. She did not know the DEA was planning to conduct the on-site inspection that day.

Id.

at 585-86. She was told that the inspection would take between 20-30 minutes or up to an hour.

Id.

at 586.

She related that Mr. Sprys' son, William Sprys, was also in the pharmacy.

Id.

587. William Sprys acts as the administrator for the pharmacy, but is not a registered pharmacist, so he primarily handles clerical administrative duties.

Id.

at 587-88.

When asked, Ms. Mincy said that it was primarily DI1 that spoke to her and asked her questions during the inspection. Tr. 586. She stated that DI2 was primarily observing. Tr. 587.

During the inspection, Ms. Mincy was handed a DEA Form 82, Notice of Inspection. Tr. 589; GX 30. She was uneasy about consenting to an inspection because she only works as an independent contractor at Pharmacy 4 Less, not as a regular employee. Tr. 590-91. She asked to contact Mr. Richard Sprys to ask about the form and whether she should consent and sign the form.

Id.

at 591-92. She had William Sprys contact Mr. Richard Sprys on the telephone because Richard was out of the country at the time of the inspection.

Id.

at 592. The DIs were also present during the telephone call.

Id.

She spoke to Mr. Richard Sprys on speakerphone about the DEA inspection and the DIs request to inspect the pharmacy.

Id.

Mr. Sprys then gave permission and directed Ms. Mincy to sign the form.

Id.

at 592-93. Ms. Mincy then signed the Form 82. Tr. 594.

After signing the form, Ms. Mincy was taken into a separate room in the pharmacy.

Id.

at 596. DI1 asked to see the pharmacy's perpetual inventory.

Id.

at 598. DI1 proceeded to count pills of controlled substances contained in the pharmacy.

Id.

DI1 asked for the perpetual inventory pages for January 1, 2017, through June 6, 2017. Tr. 604-05. The perpetual inventory was handwritten and was designed to keep track of the pharmacy's prescription inventory. Tr. 630-31; RX 31 (Methadone), 32 (Oxycodone).

He then requested the pharmacy's biennial inventory. Tr. 605-06, 773-74; GX 37; RX 38.

The pharmacy keeps its inventories in a binder that is located inside the locked medication room. Tr. 607. The Respondent's version of the biennial inventory indicated that it was completed on April 26, 2017, at 8:00 a.m. by Ms. Mincy and Mr. Sprys.

Id.

at 617-18, 767-73; RX. 38, pp. 1, 2, 3, 8-16. The inventory was completed by entering the drug room, verifying the number of pills, scanning the prescription bottles, and verifying their entry into the pharmacy's computer system. Tr. 626-27. Ms. Mincy testified she completed the biennial inventory in about three hours.

Id.

at 628. Ms. Mincy indicated her understanding that the biennial inventory must be completed either in the morning before the start of business or at the end of the day at the close of business, and that it was completed before the opening of business.

Id.

at 620-21, 817-19. The biennial inventory was kept inside a binder with the C-2 perpetual inventory.

Id.

at 622. The biennial inventory was later sent by the pharmacy to DI1 after he left it at the pharmacy following the inspection.

Id.

at 638-42; 782-88. She indicated she was not aware that a biennial inventory containing Schedule 2 prescriptions needed to be separate from an inventory containing Schedules 3 through 5 prescriptions.

Id.

at 818. To complete the biennial inventory, she would open the narcotic cabinet and would hand-count the Schedule 2 pills inside.

Id.

at 820-21.

Each version was admitted following the Government's voir dire and request to admit GX 37 if this Tribunal were to admit RX 38. The Government agreed to redact the pricing information contained at the Respondent's request. Tr. 775-82. However, the Government later requested to withdraw the original GX 37 and offer an alternative version of GX 37, with only pages 1-7 considered for record. Tr. 912-17.

For the inventories in the pharmacy, Ms. Mincy would keep a perpetual inventory of the prescriptions that had been filled.

Id.

at 628-34; GX 31, 32. The perpetual inventories were usually filled out by Ms. Mincy, but were sometimes updated by Mr. Sprys. Tr. 628-29. Every time a prescription was filled, it would be noted by either Mr. Sprys or Ms. Mincy so that they could keep up with their inventory that was on hand.

Id.

at 631. These were provided by Ms. Mincy to DI1 when he asked to see the pharmacy's inventory to determine if it was correct.

Id.

at 634-35. Ms. Mincy explained from the perpetual inventories how it can be determined how many pills were currently in the inventory.

Id.

at 635.

DI1 also asked to see the pharmacy's computer software, including print-outs and reports.

Id.

at 609-11. DI1 then requested to inspect the pharmacy's CSOS system.

Id.

at 612-13. CSOS is the pharmacy's electronic controlled substance ordering system.

Id.

at 611, 865-66. The pharmacy uses the CSOS system sourced through AmerisourceBergen.

Id.

at 612. Ms. Mincy showed DI1 the steps to order, but could not order because she did not have CSOS credentials at the time of the inspection.

Id.

at 613, 839-40, 867. Each authorized user receives an individual code that must be kept confidential to that user.

Id.

at 613. When showing the program to DI1, Ms. Mincy stated she did not put in any credentials because she did not have any at the time.

Id.

at 615, 867-68. DI1 then accused her of ordering with Mr. Richard Spry's credentials, which she promptly denied.

Id.

at 615. DI1 then proceeded to take all the original copies of the pharmacy's Schedule 2 prescriptions and some of the Schedules 3-5 prescriptions from January 1, 2017, to June 6, 2017.

Id.

at 615-17, 891-93, 894-96; RX 59, 60.

Ms. Mincy could not explain how there were differences between the original copy of RX 59 she had maintained at the pharmacy and the version that the Government had introduced into evidence, as the version the Government had seized on June 6, 2017. Tr. 901-903;

compare

GX 26, pg. 50

with

RX 59.

Testimony related to RX 59 and 60 were objected to by the Government for lack of notice and being beyond the scope of cross-examination that was conducted on November 7, 2018. This Tribunal permitted the Respondent to make a record of the testimony for the Administrator's consideration, but sustained the Government's objection as to being beyond the scope of cross examination. Tr. 885-91, 893, 896-900.

Ms. Mincy would use the Florida E-FORCSE system as part of her resolution of red flags. Tr. 642-43. It is used to assist medical personnel in keeping track of medications individuals are taking.

Id.

at 642, 870-71. It contains a log of a patient's controlled substances that are disbursed from a prescription written by a doctor and filled by a pharmacist.

Id.

Pharmacies upload prescriptions daily into the E-FORCSE system.

Id.

at 643. E-FORCSE contains prescriptions for Schedules 2-4 controlled substances.

Id.

Ms. Mincy would use it daily and prior to every fill of a new prescription for clients.

Id.

at 643. E-FORCSE allows a pharmacist to immediately access a patient's name, date of birth, address, and the aforementioned prescriptions.

Id.

at 645. It also allows a pharmacist to see which pharmacies a patient goes to, or if the patient is doctor shopping or trying to fill prescriptions early. Tr. 645.

At the pharmacy each morning, either Mr. Sprys or Ms. Mincy would log on to the E-FORCSE system and it would be left open on the computer to be accessed.

Id.

at 871. Ms. Mincy understood that when E-FORCSE started, it was permissible to use another person's login since the pharmacy manager or pharmacist would log in first thing in the morning and it could be used throughout the day under that person's login information.

Id.

at 903-908.

The login systems for CSOS and E-FORCSE are two separate systems.

Id.

at 872. CSOS is regulated directly by the DEA and individual authorization and access has to be

granted by the DEA.

Id.

at 872. Ms. Mincy had a key and certificate specific to her that had to be used to access the CSOS system.

Id.

at 872. On the other hand, E-FORCSE could be properly accessed by either Mr. Sprys or Ms. Mincy and could be left open on the computer for either person to access.

Id.

at 872.

Ms. Mincy explained that this is why sometimes another person's E-FORCSE number would appear on the search records when she had actually done the search. Tr. 908-09. There was further testimony about the pharmacy's use of E-FORCSE and Ms. Mincy's understanding of its use, along with discussion about proposed RX 57. Tr. 903-09. However, proposed RX 57 was later withdrawn by the Respondent and GX 38 (redacted) was used instead after its introduction during DI1's rebuttal testimony. Tr. 927-34; 1024-25.

Ms. Mincy would turn away patients if she found discrepancies on the E-FORCSE, and did so, up to 10 to 12 times per month.

Id.

at 646. She would turn them away if she suspected their ID was not legitimate, if they were also filling their prescriptions somewhere else, if it appeared they were doctor shopping, or if there were signs of diversion or abuse.

Id.

at 647. She would also call the patient's doctor and discuss the patient's medical needs and the prescriptions that had been provided to her.

Id.

at 648. She would send patients away if there were discrepancies between the identification provided and the information provided on the prescription.

Id.

at 648. She would also look to see if any of the patients had overdosed, which would help her determine whether to fill a prescription.

Id.

at 841. She would also investigate whether there was any indication that any of the patients were selling their prescribed medications.

Id.

at 841-45.

She would then place a sticker on the prescription to signify that she had resolved any potential red flags for the prescription.

Id.

at 648-49, 827-28.

The Government confronted Ms. Mincy with arrest records of Patient K.Y.D. during its cross-examination. She was surprised to hear that he had been arrested on December 31, 2015, for possession of oxycodone with intent to sell, and later arrested on February 25, 2017, for possession of a Schedule 2 controlled substance. She said he had later been discharged as a patient and that he was unruly. Tr. 845-84; GX 41-43.

Ms. Mincy was familiar with each of the 10 charged patients in this matter.

Id.

at 649. She has filled prescriptions for controlled substances for each of the 10 subject patients.

Id.

at 830. She would try to resolve red flags for each of the 10 subject patients by using the previously discussed methods, including determining whether any of them were opiate naïve.

Id.

at 813-14. One way she would do so was by accessing E-FORCSE.

Id.

at 814, 831.

Her E-FORCSE number is *[redacted].

Id.

at 831. She conceded there was no documentary evidence that indicated that any of the subject ten patients started at lower doses of opioids, including oxycodone and hydromorphone, and worked their way up because they become opioid tolerant.

Id.

at 815-16. She had medical release forms for Patient K.Y.D., but not for the other 9 charged patients.

Id.

at 828-29. Ms. Mincy confirmed she had previously reviewed E-FORCSE in relation to the 10 charged patients.

Id.

at 875-79. Ms. Mincy indicated that while the policy at the pharmacy was presently (at the time of the hearing) to run each controlled substance patient through E-FORCSE, it had previously been only to run each Schedule 2 prescription.

Id.

at 880-81.

Ms. Mincy, responded “No” to the question “Did you ever fill any prescription the first time for a patient where it was contra-indicated for the amount because a patient might have been opiate naïve?” Tr. 649-50.

When asked, Ms. Mincy stated that she had not printed out any documents from E-FORCSE that would show she had looked at the 10 charged patients. Tr. 814-15.

The pharmacy used the Rx30 computer software to fill prescriptions.

Id.

at 650. This was an internal system the pharmacy used to collect information, such as patient's names, addresses, phone numbers, allergies, and diagnostic codes.

Id.

at 650-51, 687-90;

see, e.g.,

GX 5; RX 18, p. 1; RX 19. It is also used to input information related to the patient's doctor, prescriptions, directions for the prescriptions, and number of days for the supply. Tr. 652. Each prescription was entered into the program one at a time, even if the doctor had put multiple substances on a single prescription form.

Id.

at 652-53. The Rx30 program would flash red with an alert if there was a contra-indication that something in the prescription did not match with the information on file to let Ms. Mincy know that some follow up was necessary.

Id.

at 652-54.

The pharmacy maintained patient record maintenance files through their internal system.

Id.

at 687-90, 706-09, 713-16, 722-31, 733-67; RX 18-37. These records were also used to maintain due diligence on the pharmacy's patients and resolve red flags as they arose.

Id.

at 707-08, 840-41.

Ms. Mincy had been present at Pharmacy 4 Less during inspections by the Florida Department of Health, including on February 28, 2017.

Id.

at 657-58. Ms. Mincy assisted the DOH inspector throughout the state inspections.

Id.

at 659-60. There were no deficiencies found during the February 28, 2017 inspection.

Id.

at 662; RX 15. She was also present during an inspection of the pharmacy on September 5, 2017. Tr. 669, 674. This inspection was done by the Board of Pharmacy.

Id.

at 667, 671-72. Ms. Mincy was given an inspection report at the end of that inspection, although the inspection report appeared to be incomplete. Tr. 675-81; RX 14.

At the end of the DEA inspection, DI1 took ten “California folder” files of Schedule 2 prescriptions dated between January 1, 2017, through June 6, 2017. Tr. 799-801. A “California file” consists of bundles of prescriptions that the pharmacy keeps for its records.

Id.

at 801. DI1 later requested twenty-four additional “California files” from Mr. Sprys.

Id.

at 801-02. The pharmacy kept a receipt that documented originals of the Schedule 2 prescriptions in the pharmacy. Tr. 802-03; RX 12.

Ms. Mincy was present during the inventory taken by DI1 on June 6, 2017. Tr. 835. She signed a DEA closing inventory sheet, confirming that the drug counts were correct. Tr. 835-37; GX 39.

While she could not recall signing the inventory sheet, she stated that it was her signature on the document. Tr. 837.

Mr. Robert M. Parrado, BPharm., R.Ph.

Robert Parrado graduated from the University of Florida in 1970 with a B.S. in Pharmacy. Tr. 401. Mr. Parrado has been licensed in Florida as a Pharmacist since 1971.

Id.;

RX 5, at 1. He was formerly licensed as a Consulting Pharmacist by the State of Florida up until 1989, which involved work with institutional facilities. Tr. 401; RX5, at 1. Mr. Parrado has received several awards over the years: The R.Q. Richards Award from the Florida Pharmacy Association for pharmaceutical public relations, and the Generation Rx Award in the field of prescription drug abuse and drug diversion from Cardinal Health. Tr. 402. He is presently President and CEO of Parrado Pharmacy Consultants, Inc., which involves pharmacy consulting with pharmacies, pharmacists, and with government agencies.

Id.

at 402-03; RX 5. Mr. Parrado previously worked for CVS Pharmacy from 2000 to 2009 as a Pharmacist. Tr. 403. For nine months in 2007, Mr. Parrado was a Regional Acquisition Specialist, involved in acquiring independent pharmacies by CVS.

Id.

Prior to working for CVS, Mr. Parrado worked for approximately three years for Eckerd Drugs and Albertson's.

Id.

at 404. Previously, Mr. Parrado worked for St. Joseph's Hospital as an Inpatient Staff Pharmacist, during which time he consulted with physicians on a daily basis.

Id.

Prior to St. Joseph's, Mr. Parrado was the Director of Pharmacy at Centro Hispano Hospital in Tampa.

Id.

at 404-05. Prior to that, for a few months, Mr. Parrado worked as a Pharmacist at SupeRx Drugs.

Id.

at 405.

From 2001 to 2004, Mr. Parrado was a member of the Florida Board of

Pharmacy.

Id.

at 406. From 2003 to 2009, he was on the Board's Accreditation Council on Pharmacy Education.

Id.

As such, Mr. Parrado was involved in the accreditation of Florida schools of pharmacy.

Id.

While on the Board, Mr. Parrado was on the Rules Committee.

Id.

at 407. He also served on the Legislative Affairs Committee, which wrote proposed legislation for presentation to the Florida Department of Health, and for consideration by the Florida legislature.

Id.

During 2004, Mr. Parrado was Chairman of the Florida Board of Pharmacy.

Id.

at 408. Since 2001, Mr. Parrado has been a perpetual member of the National Association of Boards of Pharmacy.

Id.

Mr. Parrado was a member of the National “Rules Committee,” which developed “model rules” for consideration by individual states.

Id.

at 408-09. For 18 months, ending in 2001, Mr. Parrado was President-elect of the Florida Pharmacy Association.

Id.

at 409. Later, Mr. Parrado served as Speaker of the House of Delegates for the Association.

Id.

at 410. Since 2014, Mr. Parrado has been guest lecturer on pharmacy law at the University of South Florida College of Pharmacy.

Id.

As part of a recurring continuing education course, Mr. Parrado taught “Resolving Red Flags, Allowing Patients to Legally Obtain Their Lawful Medical Prescriptions.”

Id.

at 411. He has taught this course at universities, to county and state pharmacy associations, and other professional organizations.

Id.

at 411-12. He has presented to various professional organizations a course on “Identifying Drug Diversion.”

Id.

at 412. Mr. Parrado has testified as an expert witness previously, including an estimated eight or nine times as an expert called by DEA.

Id.

at 414-16.

Mr. Parrado had last prescribed a controlled substance approximately three or four years prior to the instant hearing when working as a substitute pharmacist at Genoa Healthcare.

Id.

at 418. Regarding his most recent dispensing of opioids on a regular basis, Mr. Parrado estimated it to be 2011.

Id.

at 419. Mr. Parrado was certified as a pharmacy expert.

Id.

at 431.

As relates to opioid naïve patients, Mr. Parrado described various scenarios in which a patient, even one who has been dispensed opioids in the past but who has been deprived of opioids for a month or two, can become dangerously opioid naïve.

Id.

at 433. To ensure a patient prescribed opioids is not opioid naïve, Mr. Parrado described several tools available to the pharmacist.

Id.

at 433-34. The pharmacist should ask a number of questions to alleviate concerns.

Id.

at 434. He can also reference the E-FORCSE database.

Id.

Mr. Parrado was critical of the limited records Dr. Hamilton reviewed to form his opinion in this case.

Id.

at 434. Mr. Parrado suggested he would have asked the DEA to share more documentation with him than was shared with Dr. Hamilton.

Id.

at 443.

As related to resolving red flags, Mr. Parrado opined that in addition to consulting the E-FORCSE database, a pharmacist may obtain medical records directly from the physician, or access the “patient record maintenance” from the Rx30 computer program.

Id.

at 435-36. As to Dr. Hamilton's opinion that the resolution of “red flags” had to be documented under Florida law, either on the prescription or somewhere else readily available to the pharmacist, Mr. Parrado disagreed, claiming there was no such requirement under Florida law.

Id.

at 434, 438. Mr. Parrado conceded documenting the resolution of “red flags” may represent the “best practice.”

Id.

at 434. As to the subject documentation, Mr. Parrado observed that most pharmacists do “document somewhat.”

Id.

at 435. Most document on the back of the prescription.

Id.

However, if that wasn't possible, Mr. Parrado opined that it was acceptable to “document” in a card file system, or in the “note” field on your computer system.

Id.

Mr. Parrado also noted he created a computer program, called “Red Flag Resolver,” which would preserve such documentation on the computer server.

Id.

Mr. Parrado suggested diagnostic codes could be used on the prescription to demonstrate the medication was justified on the basis of the medical condition.

Id.

Mr. Parrado testified that there is “no regulation that says you have to document . . . It may be a best practice to do that. But it [does not] say you have to.” Tr. 434. When asked by the ALJ whether “documenting the resolution of this red flag issue might be the best practice,” Mr. Parrado testified “It might be, [it is] a good, I do it.”

Id.

at 436. Later, Mr. Parrado testified that, “[y]ou have to resolve the flag . . . . Does it say anywhere that you have to document it? No. Should you? Of course. How are you going to remember; how is your partner coming going to know, because there [are] many pharmacists coming in and out of the pharmacy.”

Id.

at 438.

Mr. Parrado explained that to resolve any red flag regarding “immediate release” medication, the physician can be consulted.

Id.

at 447-48. Mr. Parrado noted that “immediate release” medications are cheaper than the extended release versions, and that the insurance company may not pay for extended release.

Id.

at 448.

Mr. Parrado also disagreed with Dr. Hamilton's estimated price for each pill of oxycodone at .90 cents.

Id.

at 449. Mr. Parrado suggested the price of Schedule 2 controlled substances are often inflated to accommodate the added expenses inherent in dispensing them, such as additionally scrutiny, legwork, record-keeping, and inventories.

Id.

Mr. Parrado conceded that pharmacy pricing was very competitive.

Id.

at 449-50. Mr. Parrado explained that insurance issues can explain why a pharmacy may only accept cash payments

*[omitted].

Id.

at 450-51. Mr. Parrado explained that “cash” in the pharmacy business may include by credit card or even by check.

Id.

at 460.

The ALJ further found that the insurance issues can explain why a customer would pay cash. That portion of the finding is neither relevant to the alleged conduct nor did I find support for it in the record. Tr. 450-51.

The only explanations Mr. Parrado could give for a pharmacy charging different prices for the same medication was a potential higher cost from a different wholesaler, the use of discount coupons, or indigent pricing programs.

Id.

at 451-52.

Regarding inordinate travel to fill a prescription, Mr. Parrado agreed it was a red flag, which needed to be resolved.

Id.

at 453. *[But Mr. Parrado did not go on to opine as to whether or not the red flag was resolved with regard to the patient file for A.R. at issue in this case.

Id.

] As to the 8.5 mg prescription for hydromorphone, Mr. Parrado did not recognize it as requiring any investigation.

Id.

at 454. Prescriptions for compounded medications are a normal part of pharmacy work.

Id.

at 453-54; GX 12, p. 17-18.

Mr. Parrado did not testify in the positive or the negative regarding the need for an investigation, and he was never asked whether an 8.5 mg prescription for hydromorphone raised a red flag that needed to be resolved. Tr. 454.

As to Patient B.F., who was apparently suffering from stage 3 hepatic cancer, Mr. Parrado opined that absent an inconsistent physical presentation by the patient at the pharmacy, the diagnosis itself resolved any “red flag” created by the large amount of opioids prescribed.

Id.

at 455-56.

Mr. Parrado disagreed with Dr. Hamilton's concept of the “minimum standard of care,” which Dr. Hamilton attributed to both the Florida Administrative Code, specifically “Florida Regulation 64B,”

and guidelines from the National Board of Pharmacy Association.

Id.

at 180, 351-58. Mr. Parrado understood the “minimum standard of care” as a violation of a law or rule of the Pharmacy Act, or of the Florida

Administrative Code.

Id.

at 456. Mr. Parrado did not recognize any violation of the Florida minimum standard of care by Pharmacy 4 Less in the documents he reviewed and interviewing the two pharmacists involved.

Id.

at 456-58. Mr. Parrado reviewed favorable Florida Department of Health Inspection Reports dated February 28, 2017, September 5, 2017.

Id.

at 475-80, 546; RX 14, 15, 16, 17. One of the documents Mr. Parrado reviewed at Pharmacy 4 Less was their biennial inventory completed April 26, 2017. Tr. 489.

See

West's Florida Administrative Code, Title 64. Department of Health, Subtitle 64b16, Chapter 64B16-27—Pharmacy Practice.

Mr. Parrado disagreed with Dr. Hamilton's opinion that 84 or 112 opioid tablets, *[for 30 mg of oxycodone,] represented “red flags,” which needed to be resolved.

Id.

at 461-63. He did not consider these to be inordinate amounts.

Id.

at 463.

Mr. Parrado agreed that the simultaneous prescribing of oxycodone and buprenorphine to Patient A.V. represented a “red flag” which needed to be resolved.

Id.

at 463. Mr. Parrado was able to resolve it by reviewing the PRM records.

Id.

at 464. It revealed the pharmacy had contacted the physician, who advised he was attempting to wean the patient off of the oxycodone.

Id.

at 463-65.

In reviewing the PRM for each of the ten subject patients, Mr. Parrado found evidence that Pharmacy 4 Less contacted or attempted to contact the physician in each of ten cases to resolve red flags, and that each ”red flag” described by Dr. Hamilton was properly resolved.

Id.

at 490-92.

Mr. Parrado found none of the dosage units inordinately high, not even the 8 mg of hydromorphone.

Id.

at 491. He actually deemed 15 to 20 mg of oxycodone a “very low dose,” in contrast to Dr. Hamilton's assertion that those doses were relatively high.

Id.

at 510. As to the high prices charged, Mr. Parrado disagreed that the subject prices were suspiciously high.

Id.

at 492-93, 534. Mr. Parrado explained that following the crackdown on “pill mills” in Florida, opioids became more difficult for patients to obtain.

Id.

at 457, 539. They may have to travel to multiple pharmacies to even find the medication, so they would be willing to pay higher prices for them.

Id.

at 457, 539.

Mr. Parrado did not address the “red flag” described by Dr. Hamilton for the ongoing opioid prescriptions without considering a reduction in dosage, “individualization.”

Id.

at 492.

Though Mr. Parrado did not specifically address this red flag, he did testify generally that assuming there were red flags with every one of the patients, those red flags “seemed to be” resolved in every case and that he “saw documentation where they had written down the resolutions.” Tr. 492.

On cross-examination, Mr. Parrado was confronted with Florida Administrative Code Section 64(B)16-27.800, requiring pharmacies to maintain patient records.

Id.

at 495-96. It specifically requires the pharmacy to “provide for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drugs at the time a new or refill prescription is presented for dispensing,” *[and requires that a “reasonable effort is made to obtain, record and maintain . . . pharmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug.” Tr. 496.]

Mr. Parrado indicated the “red flag” identified by Dr. Hamilton regarding whether patients could be opioid naïve had been resolved by the subject pharmacists.

Id.

at 497. Mr. Parrado learned this by interviewing the pharmacists, and being satisfied with the steps they *[told Mr. Parrado that they generally] took, including checking with the PDMP.

Id.

at 496-99.

Mr. Parrado did not observe the ten patients increasing their dosage above the norm.

Id.

at 511. Most appeared to remain at “maintenance levels.”

Id.

at 511-12.

As to Patient R.V., who, according to the pharmacy notes, was suffering from a neoplasm, Mr. Parrado was not “concerned” by a medical record from the pain doctor, which described her condition as cervicalgia resulting from a “fender bender.”

Id.

at 516-22, 549; RX 34, p. 1, RX 35, p. 2.

As to Patient B.F., who Mr. Parrado testified was suffering from liver cancer, however, Mr. Parrado was unable to identify the cancer diagnosis by virtue of the diagnostic codes contained in the records.

Id.

at 514. However, he recalled seeing the cancer diagnosis in a medical note.

Id.

at 513-16.

Regarding RX 22, pp. 2-3; GX 10, Mr. Parrado discovered the pharmacists resolved the red flag by speaking with the subject pharmacists, who advised they confirmed they contacted the physician, who advised he was weaning the patient off of oxycodone with buprenorphine. Tr. 522-25. However, in GX 10, it appears the buprenorphine was prescribed for sciatica pain.

Id.

at 524-25. Mr. Parrado dismissed the medical codes as likely erroneous, choosing to rely on the conversation between the pharmacist and the physician.

Id.

at 525-26. As to the nearly one year period of *[unchanged strength] oxycodone prescriptions from April 12, 2016 to April 10, 2017, in conjunction with the buprenorphine intervention, Mr. Parrado recognized it to be a red flag, which would require the pharmacist to investigate by contacting the physician, pursuant to Fla. Admin. Code § 16-27.810. Tr. 526-27. *[Mr. Parrado did not testify specifically as to whether or not this “red flag” was in fact resolved with a call to the physician. Tr. 527.]

As to Patient R.R., who apparently suffered a “broken back” and fractured tibia from a car accident, Mr. Parrado was not concerned that the patient was discharged from the hospital on May 2, 2017, yet the final prescription was issued on May 30, 2017.

Id.

at 527-28, 551; RX 32, pp. 1-2. Mr. Parrado did not consider a prescription issued a month after discharge unusual, and assumed the patient had not yet found another doctor. Tr. 528. Mr. Parrado was not concerned by the medical report denying any surgical history for R.R., as it was not contradictory of the above pharmacy notes, explaining a broken tibia does not necessarily require surgery. Tr. 529.

As to Patient A.E., although Mr. Parrado reviewed the relevant medical records, which contained some obvious contradictions, including the patient claiming a pain level of 10 of 10, yet the physical examination by the physician showed no physical restrictions.

Id.

at 532. Mr. Parrado did not appear to have evaluated the substance of the medical records, but only the fact that the pharmacist had obtained the records and verified the patient was being treated for pain.

Tr. 529-32; RX 18, RX 19, pp. 2, 3.

Mr. Parrado testified, that he was not considering the medical records with specificity for their content, but “was looking to see that they had gotten something from the doctor to help them resolve [red flags]. . . . [he] considered the fact that they had [the medical record], and that the doctor was treating pain and that they had gotten that.” Tr. 532.

As to Patient K.E.D., who was reportedly suffering from “chronic pain” as the result of a “severe auto accident,” yet the medical records deny past hospitalization, Mr. Parrado focused on the key findings of “chronic pain” and “auto accident” and not on contradictions in the medical records. Tr. 532-33, 552; RX 28, 29, p. 3.

As to Patient A.R., who apparently drove 45.4 miles *[one way] to see his physician and to obtain his medications at Pharmacy 4 Less, Mr. Parrado did not find that distance unusual, citing the difficulty in locating pharmacies which carried opioids. Tr. 539. Mr. Parrado conceded he has testified in other cases that driving 40 miles was a red flag.

Id.

at 541-42. Mr. Parrado distinguished his prior testimony as the distance was also part of a suspicious pattern.

Id.

at 542.

Mr. Parrado conceded that dual prescriptions for hydromorphone and methadone represented a red flag, but one which could be resolved by contacting the physician.

Id.

at 542-43. As to Patient B.F., Mr. Parrado did not consider multiple different opioid prescriptions concerning, explaining that physicians often try different medications to find an effective treatment.

Id.

at 543-44; RX 24, pp. 2-3. Further, Mr. Parrado did not view the simultaneous prescription of methadone and hydromorphone concerning, as methadone could be used as an extended release reliever, while the hydromorphone was an immediate release.

Id.

at 544. Mr. Parrado conceded he had testified previously that that combination was a red flag, but a resolvable red flag.

Id.

As to Patient A.V., the prescription bore a code for sciatica.

Id.

at 545. Mr. Parrado

*[testified that the diagnostic code for sciatica was inherently reliable because it was handwritten as opposed to created by a computer.]

Id.

at 545-46, 551; GX 10, p. 15.

The ALJ found that Mr. Parrado was not concerned by the sciatica code, as errors happen. I understand, and have edited this finding accordingly, Mr. Parrado's testimony to be that here the sciatica code was inherently reliable because it was handwritten rather than generated by a computer error, which he previously testified occurs frequently. Tr. 545.

Mr. Parrado testified that “due diligence files” in a pharmacy would include all information used by the pharmacists to resolve red flags. Tr. 546.

Mr. Parrado's Sur-Rebuttal Testimony

During the second part of the hearing, the Respondent recalled Mr. Parrado to give sur-rebuttal testimony to the Government's rebuttal case. The Government objected to the testimony by Mr. Parrado and argued that sur-rebuttal testimony was not permitted by the rules.

Id.

at 1027. This Tribunal sustained the government's objection, but permitted the Respondent to continue questioning Mr. Parrado to make his record for the Administrator's consideration should the Administrator find this Tribunal's evidentiary ruling in error.

Id.

at 1028-29.

This Tribunal instructed the parties to brief the issue as to the propriety of sur-rebuttal testimony. In their Posthearing Brief, the Government concedes that there is no express prohibition of sur-rebuttal testimony, however, the regulations provide that unduly repetitious testimony will not be admitted. Govt Posthearing Brief at 46-47; 21 CFR 1316.59(a). The Government argues that the Respondent did not identify what was being proffered and the additional testimony “was doing nothing more than seeking to bolster [the Respondent's] case.” Govt Posthearing Brief at 46.

Upon a review of the Government's brief and the transcript of the proceedings, I find that sustaining the Government's objection to sur-rebuttal testimony was ill-advised. Although there is no relevant regulation or rule authorizing sur-rebuttal, neither is there a regulation or rule authorizing rebuttal testimony.

However, the Attorney General's Manual on the APA finds in Presentation of Evidence, Section 7 (c) that “[e]very party shall have the right to present his case or defense by oral or documentary evidence, to submit rebuttal evidence, and to conduct such cross-examination as may be required for a full and true disclosure of the facts.” Accordingly, this Tribunal recommends that the Administrator find the subject ruling in error and fully consider Mr. Parrado's sur-rebuttal testimony as direct evidence, to the extent it does not exceed the scope of rebuttal evidence.

The Agency has permitted and considered surrebuttal evidence in the past.

Flavio D. Gentile,

M.D.; 55 FR 3113 (1990).

Sur-rebuttal evidence is permitted to confront the opposing party's rebuttal evidence.

On sur-rebuttal, in explaining the differences between the Government's and the Respondent's versions of the medical record exhibits, Mr. Parrado affirmed the propriety of updating pharmacy records as relevant information is learned.

Id.

at 1029-30. Mr. Parrado further affirmed the propriety of including Schedules 3-5 prescriptions within the pharmacy records to reflect the totality of the dispensing, and not just the Schedule 2 prescriptions.

*AA

Id.

at 1033-34.

*AA

Mr. Parrado testified that when considering the “total profile” of all prescriptions for these patients, “the patients were getting all their medications there . . . . [that is] what you want. . . . You [do not] want him just buying controls from you because now you [do not] know what else is going on with that patient. . . . It essentially resolved that red flag” meaning the person is not “just trying to obtain narcotics from [the pharmacy].” Tr. 1033-34.

Mr. Parrado further opined that many of the medical conditions and diagnoses noted in Pharmacy 4 Less files, “chronic pain, cancer, neoplasms, broken backs” are conditions which cannot be treated by surgery, but rather by opioid therapy.

Id.

at 1029-31. The dosage and frequency of such opioid therapy is designed to permit the patient to operate at a normal level.

Id.

at 1032. As to Dr. Hamilton's expectation of the tapering down of opioid doses, Mr. Parrado noted tapering in chronic pain patients was often difficult and ineffective.

Id.

at 1036. Finally, Mr. Parrado offered that the Respondent issued a below average number of oxycodone tablets as compared to other Florida pharmacies during the relevant period.

Id.

at 1037-40. Mr. Parrado conceded there were no pharmacy records explaining that the long distances traveled by customers of the Respondent was due to pharmacies going out of business.

Id.

at 1041. Nor did Mr. Parrado observe records in this case suggesting patients could not afford extended release medications.

Id.

at 1041.

The Facts

Stipulations of Fact

The Government and the Respondent, through counsel, have agreed to thirteen stipulations, which I recommend be accepted as fact in these proceedings:

1. Pharmacy 4 Less, LLC, is registered with the DEA to handle controlled substances under Schedules II to V under DEA COR No. FP5459082. Its registered address is: 805 Douglas Avenue, Suite 159, Altamonte Springs, Florida 32714.

2. Pharmacy 4 Less's COR was issued on February 2, 2018.

3. Richard Sprys, R.Ph., C.Ph., is the owner and manager of Pharmacy 4 Less.

4. Amy Mincy, R.Ph., is a pharmacist at Pharmacy 4 Less.

5. On June 6, 2017, DEA conducted an audit of Pharmacy 4 Less.

6. Proposed Government's Exhibit 2 is a true and correct copy of the June 22, 2017 Administrative Subpoena served upon Pharmacy 4 Less.

7. Pharmacy 4 Less completed its compliance with the administrative subpoena on July 11, 2017.

8. DEA served Pharmacy 4 Less with an Order to Show Cause on July 5, 2018.

9. Pharmacy 4 Less submitted a Corrective Action Plan to John J. Martin, Assistant Administrator for the Diversion Control Division of DEA, on July 31, 2018.

10. Pharmacy 4 Less submitted a Request for Hearing to the Office of the Administrative Law Judges at DEA Headquarters on August 1, 2018.

11. On August 8, 2018, Mr. Martin denied Respondent's request to discontinue or defer administrative proceedings.

12. Ms. Amy Mincy signed the DEA Form 82, Notice of Inspection of Controlled Premises on behalf of Pharmacy 4 Less during the June 6, 2017 on-site inspection. Tr. 38.

13. RX 19, 21, 23, 25, 27, 29, 31, 33, 35, 37 were supplied to the DEA in response to the July 9, 2018 administrative subpoena. Tr. 812-13.

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.

1. The Respondent currently holds active COR FP5459082. ALJ Ex. 1.

2. DI1 conducted an on-site inspection of Pharmacy 4 Less on June 6, 2017. Tr. 37.

3. Pharmacy 4 Less was randomly picked for regulatory inspection by the DEA. Tr. 37.

4. Ms. Amy Mincy signed the Notice of Inspection presented to her by DI1. Tr. 38-39; GX 30.

5. Ms. Mincy could not locate an initial inventory, and Mr. Richard Sprys confirmed via speakerphone with DI1 that Pharmacy 4 Less did not have an initial inventory. Tr. 39-40.

6. Ms. Mincy provided DI1 with a purported biennial inventory, but, *[according to DI1,] it did not indicate whether it had been completed either at the opening or closing of business. Tr. 41-42; GX 37.

7. When asked about the pharmacy's CSOS system, Ms. Mincy demonstrated to DI1 how the pharmacy ordered controlled substances on the system. Tr. 43-45.

8. DI1 contacted Mr. Chris Jewell, one of the personnel in charge of the CSOS system at DEA Headquarters. Mr. Jewell ran a report which stated that Ms. Mincy received her own CSOS credentials in July 2018. Tr. 47-49; GX 29.

9. DI1 conducted an audit of Pharmacy 4 Less's records and inventories. Tr. 53-93, 919-26; GX 4, 31, 32. DI1 selected a starting date of January 1, 2017, due to discrepancies in the biennial inventory, the lack of an initial inventory, and Pharmacy 4 Less maintained handwritten Schedule 2 controlled substance logs. Tr. 56, 61.

10. DI1 and other personnel returned to Pharmacy 4 Less on June 21, 2017. Both Ms. Mincy and Mr. Sprys were present. Tr. 88-89.

11. DI1 asked Ms. Mincy and Mr. Sprys how they determined whether prescriptions were for a legitimate medical purpose. Both pharmacists responded they would check E-FORCSE and that they would verify prescriptions by contacting the patients' doctors. The DIs were provided with a red folder that contained screenshots from the pharmacy's computer system, Rx30. Tr. 89-92. The red folder contained screenshots from the Rx30 program.

Id.

at 96. The red folder also contained the pharmacists' notes on patients, referred to as “due diligence files.”

Id.

at 97.

12. On June 22, 2017, an administrative subpoena was issued to Pharmacy 4 Less, requesting hard copy prescriptions for all Schedules 2-5 controlled substance prescriptions from October 2015 through June 22, 2017, all controlled substance prescription data from Rx30, and all due diligence patient files.

Id.

at 93-94; GX 2. Pharmacy 4 Less complied by delivering a gray tote container that contained “California” folders filled with Schedule 2 hard copy prescriptions, a thumb drive containing all Rx30 data, and the red folder seen during the June 21 on-site inspection.

Id.

at 96. The Schedules 3-5 prescriptions were delivered to the DIs by Pharmacy 4 Less at an unidentified later date.

Id.

at 97.

Treatment of Patient A.E.

13. Pharmacy 4 Less dispensed hydromorphone 8 mg to Patient A.E. on 21 occasions between November 19, 2015, and June 1, 2017. GX 6.

14. On November 19, 2015, Pharmacy 4 Less dispensed Patient A.E. 84 tablets of hydromorphone 8 mg without determining whether Patient A.E. was opioid naïve. Tr. 183-86; GX 28, p. 6; GX 37, p. 11.

15. Between November 19, 2015, and June 1, 2017, Pharmacy 4 Less, on 21 separate occasions, dispensed hydromorphone 8 mg tablets to Patient A.E. at a price of approximately $5.95 per tablet, even though other retail pharmacies were selling hydromorphone 8 mg at approximately $1.50 per tablet. Tr. 195-99; 200-03; GX 28, pp. 6-7.

16. Between December 17, 2015, and June 1, 2017, Pharmacy 4 Less, on 20 separate occasions, dispensed hydromorphone to Patient A.E. without determining why hydromorphone was being prescribed on a long-term basis without the presence of a long-acting pain medication. Tr. 192-95; 200-03; GX 28, p. 6.

Treatment of Patient A.R.

17. Pharmacy 4 Less dispensed oxycodone 15 mg to Patient A.R. on 17 occasions between March 17, 2016, and June 7, 2017; GX 8.

18. On March 17, 2016, Pharmacy 4 Less dispensed Patient A.R. 112 tablets of oxycodone 15 mg without determining whether Patient A.R. was opioid naïve. Tr. 205-07; GX 28, p. 12.

19. Between March 17, 2016, and June 7, 2017, Pharmacy 4 Less, on 17 separate occasions, dispensed oxycodone 15 mg tablets to Patient A.R. at a price of approximately $2.23 to $2.50 per tablet, even though other retail pharmacies were selling oxycodone 15 mg at approximately $0.90 per tablet at the time. Tr. 205-07, 212-14; GX 28, pp. 12-13.

20. Between May 11, 2016, and June 7, 2017, Pharmacy 4 Less, on 15 separate occasions, dispensed oxycodone 15 mg to Patient A.R. without determining why oxycodone was being prescribed on a long-term basis without the presence of a long-acting pain medication. Tr. 212-14, GX 28 p. 12.

21. Between March 17, 2016, and June 7, 2017, Pharmacy 4 Less, on 17 separate occasions, dispensed oxycodone 15 mg tablets to Patient A.R., even though Pharmacy 4 Less's records do not show that Pharmacy 4 Less ever addressed why Patient A.R. traveled southwest approximately 37 miles from his house in Daytona Beach, Florida to his doctor's office in Sanford, Florida; traveled approximately 15 miles further southwest to buy his controlled substances from Pharmacy 4 Less, and then returned approximately 45 miles northeast to his home in Daytona Beach, Florida. Tr. 207-14, 334-35, GX 28, p. 13.

Treatment of Patient A.V.

22. Pharmacy 4 Less dispensed buprenorphine and/or oxycodone to Patient A.V. on 14 occasions between April 12, 2016, and April 10, 2017. GX 10.

23. On March 17, 2016, Pharmacy 4 Less dispensed Patient A.V. 112 tablets of oxycodone 20 mg without determining whether Patient A.V. was opioid naïve. Tr. at 262, 267-68; GX 28, p. 8.

24. Between April 12, 2016, and February 13, 2017, on 8 separate occasions, Pharmacy 4 Less filled prescriptions for Patient A.V. for 112 tablets of oxycodone 20 mg, an opioid, within nine days of filling a prescription for 29-60 tablets of buprenorphine 8 mg, a controlled substance used to treat opioid addiction. Seven of the eight fills took place on the same day. Tr. at 261-76; GX 28, p. 8.

25. Between April 21, 2016, and April 10, 2017, Pharmacy 4 Less, on 12 separate occasions, dispensed oxycodone 20 mg tablets to Patient A.V. at a price of approximately $2.59 per tablet, even though other retail pharmacies were selling oxycodone 20 mg at approximately $1.25 per tablet at the time. Tr. at 262-76; GX 28, pp. 8-9.

26. Between July 5, 2016, and April 10, 2017, Pharmacy 4 Less, on 10 separate occasions, dispensed oxycodone to Patient A.V. without determining why oxycodone was being

prescribed on a long-term basis without the presence of a long-acting pain medication. Tr. at 268-76; GX 28, p. 8.

Treatment of Patient B.F.

27. Pharmacy 4 Less dispensed hydromorphone to Patient B.F. on 17 occasions between October 27, 2015, and May 15, 2017. GX 12.

28. On October 27, 2015, Pharmacy 4 Less dispensed Patient B.F. 64 tablets of hydromorphone 8 mg without determining whether Patient B.F. was opioid naïve. Tr. at 217-18; GX 28, p. 10; GX 38, p. 5.

29. Between November 24, 2015, and May 15, 2017, Pharmacy 4 Less, on 16 separate occasions, dispensed hydromorphone 8 mg tablets to Patient B.F. at a price of approximately $5.70 to $5.83 per tablet, even though other retail pharmacies were selling hydromorphone 8 mg at approximately $1.50 per tablet at the time. Tr. at 218-22; GX 28, p. 11.

30. Between December 30, 2015, and May 15, 2017, Pharmacy 4 Less, on 15 separate occasions, dispensed hydromorphone to Patient B.F. without determining why hydromorphone was being prescribed on a long-term basis without the presence of a long-acting pain medication. Tr. 219-22; GX 28, p. 10.

Treatment of Patient B.N.

31. Pharmacy 4 Less dispensed either hydromorphone or oxycodone to Patient B.N. on 19 occasions between January 22, 2016, and June 2, 2017. GX 14.

32. On January 22, 2016, Pharmacy 4 Less dispensed to Patient B.N. 90 tablets of hydromorphone 8 mg without determining whether Patient B.F. was opioid naïve. Tr. 222-27; GX 28, p. 14.

33. Between January 22, 2016, and August 15, 2016, Pharmacy 4 Less, on nine separate occasions, dispensed hydromorphone 8 mg tablets to Patient B.N. at a price of approximately $5.95 to $6.45 per tablet, even though other retail pharmacies were selling hydromorphone 8 mg at approximately $1.50 per tablet at the time. Tr. 222-35; GX 28, p. 15.

34. Between September 9, 2016, and June 2, 2017, Pharmacy 4 Less, on ten separate occasions, dispensed oxycodone 30 mg tablets to Patient B.N. at a price of approximately $5.00 per tablet, even though other retail pharmacies were selling oxycodone 30 mg tablets at approximately $0.90 per tablet at the time; Tr. 232-35; GX 28, p. 15.

35. Between March 15, 2016, and June 2, 2017, Pharmacy 4 Less, on 17 separate occasions, dispensed hydromorphone and oxycodone to Patient B.N. without determining why hydromorphone and oxycodone were being prescribed on a long-term basis without the presence of a long-acting pain medication. Tr. 222-35; GX 28, pp. 14-15.

Treatment of Patient K.E.D.

36. Pharmacy 4 Less dispensed oxycodone to Patient K.E.D. on 21 occasions between October 26, 2015, and June 7, 2017. GX 18.

37. On October 26, 2015, Pharmacy 4 Less dispensed to Patient K.E.D. 112 tablets of oxycodone 20.5 mg without determining whether Patient K.E.D. was opioid naïve. Tr. 241-44; GX 28, p. 16; GX 38, p. 7.

38. Between October 26, 2015, and June 7, 2017, Pharmacy 4 Less, on 21 separate occasions, dispensed oxycodone 20 mg tablets to Patient K.E.D. at a price of approximately $3.57 to $3.84 per tablet, even though other retail pharmacies were selling oxycodone 20 mg at approximately $0.90 per tablet at the time. Tr. 241-47; GX 28, p. 17.

39. Between December 21, 2015, and June 7, 2017, Pharmacy 4 Less, on 19 separate occasions, dispensed oxycodone to Patient K.E.D. without determining why oxycodone was being prescribed on a long-term basis without the presence of a long-acting pain medication. Tr. 244-47; GX 28, pp. 16-17.

Treatment of Patient K.Y.D.

40. Pharmacy 4 Less dispensed oxycodone to Patient K.Y.D. on 17 occasions between February 4, 2016, and June 12, 2017. GX 16.

41. On February 4, 2016, Pharmacy 4 Less dispensed to Patient K.Y.D. 84 tablets of oxycodone 30 mg without determining whether Patient K.Y.D. was opioid naïve. Tr. 237-38; GX 28, p. 20.

42. Between February 4, 2016, and June 12, 2017, Pharmacy 4 Less, on 17 separate occasions, dispensed oxycodone 30 mg tablets to Patient K.Y.D. at a price of approximately $3.45 per tablet, even though other retail pharmacies were selling oxycodone 30 mg at approximately $0.90 per tablet at the time. Tr. 237-41; GX 28, pp. 20-21.

43. Between March 31, 2016, and June 12, 2017, Pharmacy 4 Less, on 15 separate occasions, dispensed oxycodone to Patient K.Y.D. without determining why oxycodone was being prescribed on a long-term basis without the presence of a long-acting pain medication. Tr. 237-41; GX, p. 20.

Treatment of Patient R.R.

44. Pharmacy 4 Less dispensed oxycodone to Patient R.R. on 21 occasions between October 28, 2015, and May 30, 2017. GX 20.

45. On October 28, 2015, Pharmacy 4 Less dispensed to Patient R.R. 112 tablets of oxycodone 18 mg without determining whether Patient R.R. was opioid naïve. Tr. 247-50; GX 28, p. 18; GX 38, p. 8.

46. Between November 23, 2015, and May 30, 2017, Pharmacy 4 Less, on 20 separate occasions, dispensed oxycodone 15 mg tablets

*BB

to Patient R.R. at a price of approximately $2.28 to $2.41 per tablet, even though other retail pharmacies were selling oxycodone 15 mg at approximately $0.90 per tablet at the time. Tr. 247-50; GX 28, p. 19.

*BB

Additionally, on October 28, 2015, Pharmacy 4 Less, dispensed oxycodone 18 mg tablets to Patient R.R. at a price of approximately $2.23.

47. Between December 21, 2015, and May 30, 2017, Pharmacy 4 Less, on 19 separate occasions, dispensed oxycodone to Patient R.R. without determining why oxycodone was being prescribed on a long-term basis without the presence of a long-acting pain medication. Tr. 248-50; GX 28, pp. 18-19.

Treatment of Patient R.V.

48. Pharmacy 4 Less dispensed oxycodone to Patient R.V. on 22 occasions between November 17, 2015, and June 19, 2017. GX 22.

49. On November 17, 2015, Pharmacy 4 Less dispensed to Patient R.V. 112 tablets of oxycodone 20 mg without determining whether Patient R.V. was opioid naïve. Tr. 251-53; GX 28, p. 22; GX 38, p. 7.

50. Between November 17, 2015, and June 19, 2017, Pharmacy 4 Less, on 21 separate occasions,

dispensed oxycodone 20 mg tablets

*CC

to Patient R.V. at a price of approximately $2.23 to $3.04 per tablet, even though other retail pharmacies were selling oxycodone 20 mg at approximately $0.90 per tablet at the time. Tr. 251-55; GX 28, pp. 22-23.

The Government is not alleging that the price charged on March 27, 2017 was unreasonable.

*CC

Except for on April 22, 2017, when Oxycodone 15 mg was dispensed at a price of $2.23 per tablet. GX 22, p. 71.

51. Between January 11, 2016, and June 19, 2017, Pharmacy 4 Less, on 20 separate occasions, dispensed oxycodone to Patient R.V. without determining why oxycodone was being prescribed on a long-term basis without the presence of a long-acting pain medication. Tr. 252-55; GX 28, p. 22.

Treatment of Patient V.W.

52. Pharmacy 4 Less dispensed oxycodone to Patient V.W. on 21 occasions between November 30, 2015, and May 31, 2017. GX 24.

53. On November 30, 2015, Pharmacy 4 Less dispensed to Patient V.W. 84 tablets of oxycodone 15 mg without determining whether Patient V.W. was opioid naïve. Tr. 256-57; GX 28, p. 24; GX 38, p. 9.

54. Between November 30, 2015, and May 31, 2017, Pharmacy 4 Less, on 21 separate occasions, dispensed oxycodone 15 mg tablets to Patient V.W. at a price of approximately $2.54 to $3.57 per tablet, even though other retail pharmacies were selling oxycodone 15 mg at approximately $0.90 per tablet at the time. Tr. 256-60; GX 28, pp. 24-25.

55. Between January 25, 2016, and May 31, 2017, Pharmacy 4 Less, on 19 separate occasions, dispensed oxycodone to Patient V.W. without determining why oxycodone was being prescribed on a long-term basis without the presence of a long-acting pain medication. Tr. 258-60; GX 28, pp. 24.

Recordkeeping

56. Pharmacy 4 Less did not have an initial inventory readily available during DI1's on-site inspection. Tr. 39-40.

57. [According to DI1, the copy of Pharmacy 4 Less's biennial inventory that he viewed in-person during the inspection on June 6, 2017, did not notate whether the inventory was completed at the opening or closing of business. Tr. 41-42.]

*DD

Finding of fact modified for clarity.

58. Pharmacy 4 Less's biennial inventory (apparently revised sometime after June 6, 2017) did not indicate whether it was conducted at the “close” or “opening of business,” instead listing the time that it was completed.

Compare

GX 37, p. 2

with

RX 38, p. 1. *[Specifically, the content appeared on a blank document that Ms. Mincy described as a cover page with handwriting stating “Biennial Inventory; Completed April 26, 2017; 8AM” and with signatures by both pharmacists.

Id.

The cover page was included in a fax to DI1 from Respondent pharmacy on June 7, 2017.]

*EE

There is insufficient information in the record for me to conclusively determine whether or not the cover page was attached to the biennial inventory at the time of DEA's inspection. On the one hand, I fully credit DI1's testimony that the biennial inventory did not notate whether the inventory was “completed at either the opening or closing of business.” Tr. 41-42. However, I cannot tell whether DI was testifying that the specific words “opening or closing of business” did not appear on the biennial inventory (which I agree is true) or if he was testifying that the cover page at GX 37, p. 2 was not included on the biennial inventory that DI1 was handed on the date of the inspection. If DI1's testimony meant the latter, it was unclear, and unfortunately, the biennial inventory was not seized during the inspection. Instead, the biennial inventory was faxed to DI1 the following day and the cover page was included. Notably, Mr. Sprys was out of the country at the time of the inspection and subsequent fax. As Mr. Spry's signature appears on the biennial inventory cover page that was faxed, it does not seem implausible to conclude that the cover page existed prior to Mr. Sprys leaving the country and prior to the inspection. Therefore, I cannot find substantial evidence to support the Government's allegation that the biennial inventory lacked the notation regarding whether it was conducted at the opening or closing of business.

59. Pharmacy 4 Less's records were inaccurate, and included shortages and overages. GX 4. Specifically, the shortages and overages are as follows

a. Oxycodone 15 mg: Shortage of 73 tablets

b. Oxycodone 20 mg: Shortage of 212 tablets

c. Oxycodone 30 mg: Shortage of 731 tablets

d. Hydromorphone 8 mg: Shortage of 149 tablets

e. Methadone 10 mg: Overage of 1,488 tablets

f. Suboxone 8 mg/2 mg: Overage of 224 tablets

g. Carisoprodol 350 mg: Shortage of 526 tablets

60. Pharmacy 4 Less's [invoices]

*FF

did not include the date the order was received for 84 invoices. Tr. 137-38; GX 26.

*FF

Modified because he ALJ referred to these documents as “222 Forms,” but I find that they are more accurately described as “invoices.”

Analysis

Credibility Analysis of Fact Witnesses

Ability To Recall Events

DI1

Generally speaking, individuals experiencing an event out of the ordinary, such as an on-site inspection as occurred here, are likely to have a better memory of those events than the Government Diversion Investigator, who performs similar inspections on any number of clinics. It seems to me, all other factors being equal, it would be easier for a DI to forget or confuse events than the person inspected. However, in this matter, DI1 presented an overall clear description of events surrounding the June 6, 2017, and June 21, 2017 on-site inspections of Pharmacy 4 Less.

DI1 occasionally had difficulty recalling the specific individual who responded to his questions.

See, e.g.,

Tr. 90-91. This cuts slightly against his reliability. However, he was generally able to recall the key events as to what had occurred during the on-site inspections and the substance of the relevant conversations. His testimony is also generally corroborated by the documentary evidence.

Further, DI1 demonstrated a basic understanding of the relevant DEA regulations as provided in the Code of Federal Regulations in order to properly perform his duties.

He had some difficulty citing specific relevant provisions of the CFR when asked, which is quite understandable. However, part of DI1's testimony involved an issue contested by the Respondent regarding the necessity of the date of receipt on invoices maintained by the pharmacy, which this Tribunal finds necessary to separately analyze and discuss.

Tr. 136-39.

While this Tribunal heard testimony from DI1 about the regulations, it does not rely on DI1's understanding of the regulations in this Recommended Decision.

See infra

at section “Date of Receipt on Invoices.”

Based on a complete review of DI1's presentation of testimony, ability to recall events, and comparison with the other evidence, I find his testimony to be credible and should be afforded considerable weight.

Ms. Amy Mincy

Ms. Amy Mincy's credibility presents more of a challenge for this Tribunal to address. During the first portion of the hearing in Orlando, Florida, Ms. Mincy appeared on the stand for the entire duration of the third day of testimony. At the beginning of her testimony, Respondent's counsel attempted to cover Ms. Mincy's professional background and C.V. Ms. Mincy struggled greatly remembering details about pharmacies where she had previously worked, and other details about her own professional background. While the transcript does not fully capture Ms. Mincy's difficulties in discussing her background, there are indications within the transcript that demonstrate these issues.

“MR. INDEST: And since she's having a little bit of difficulty remembering some of these, I'd like the clerk to give her the hearing book and let her, if she needs to refer to the CV.

THE WITNESS: I'm good.

MR. INDEST: No, let's have it in front of you so we've got the dates right and everything, okay?” Tr. 571.

“Q Okay, but where did you work next after that? Where did you work next? If you're having trouble remembering, if you need to refresh your recollection, please look at the CV because you're taking a long, long pause before you answer my questions. This might help speed things up.” Tr. 572-73.

“Q Okay, and did you work as a pharmacy consultant after that?

A For some places, yes.

Q According to your CV, Ms. Mincy, listen, these are simple straightforward questions, and if you can't remember the answers.” Tr. 573.

“MR. INDEST: Your Honor, I'd like the record to reflect I'm asking the questions and she's taking a long, long pause.” Tr. 574.

Following the testimony of Ms. Mincy's background, Respondent's counsel moved on to the facts of this matter. Throughout her testimony, Ms. Mincy appeared to encounter great difficulty in remembering details of the June 6, 2017 on-site inspection. While Ms. Mincy appeared to remember some details, her presentation and delivery of those details appeared sometimes confused and disoriented. Throughout the direct examination, I noticed that Respondent's counsel had trouble eliciting answers from Ms. Mincy about the June 6, 2017 on-site inspection.

Further, Respondent's counsel made a number of statements on the record that demonstrated his difficulty in eliciting testimony from Ms. Mincy, leading to a number of objections by Government counsel for leading the witness.

While understandable that a lay witness may have some difficulties due to being nervous or anxious about her time on the witness stand, Ms. Mincy's inability to answer questions posed by her own attorney suggest issues with Ms. Mincy's ability to reliably recall events one would expect to be otherwise fairly memorable. Her presentation in Orlando clearly diminishes her reliability as a witness, especially as relates to her Orlando testimony.

“ADMIN. LAW JUDGE DOWD: And I know you're having some difficulty with Ms. Mincy, but try not to lead, Mr. Indest.” Tr. 588.

“MR. MANN: She needs to answer his questions and not listen to him repeat the answers to her.

MR. INDEST: Your Honor, she's having a very difficult time answering these questions.

ADMIN. LAW JUDGE DOWD: It is what it is. But I'm going to sustain the objection as to leading.

MR. INDEST: And, Your Honor, with that understanding, a witness that is hard to answer the questions should be given some, the counsel should be given some leeway to at least get the basic information.

ADMIN. LAW JUDGE DOWD: I think I've given you leeway, Mr. Indest.

MR. INDEST: Okay, thank you.

ADMIN. LAW JUDGE DOWD: We have to have the testimony come from the witness.

MR. INDEST: Okay, we'll try.” Tr. 595-96.

During the second portion of the hearing in Arlington, Virginia, Ms. Mincy appeared to be more relaxed on the stand, which appeared to increase her ability to recall and to reliably convey her perception of the relevant events.

Overall, I find that the reliability of her testimony was significantly diminished by her inability to recall details about both her own personal history and those surrounding the events of the on-site inspections at Pharmacy 4 Less.

In its Posthearing Brief, the Government argues that Ms. Mincy's false testimony should not be credited. Govt Posthearing Brief at 33-36. The Government argues that she “lied” about checking E-FORCSE every time before she filled a prescription. I will not go to the extreme the Government suggests, especially in light of Ms. Mincy's demonstrated memory deficits. *[However, I do find that when comparing the testimony to GX 38, Ms. Mincy overstated her use of E-FORCSE and that her credibility on the subject is diminished. Remainder of footnote omitted for brevity.]

The parties only presented one fact witness each as to the events surrounding the on-site inspections at Pharmacy 4 Less. It will therefore be necessary for me to compare and weigh the testimony of DI1 and Ms. Mincy regarding the factual circumstances surrounding the on-site inspections of Pharmacy 4 Less and the subsequent investigation.

Physical evidence is more corroborative of DI1's testimony than that of Ms. Mincy's. When their testimony is in conflict, I find that it is proper to give greater weight to the testimony of DI1 over that of Ms. Mincy.

As to the lack of corroboration of portions of Ms. Mincy's testimony, the owner of Pharmacy 4 Less and the only other pharmacist at the pharmacy, Mr. Richard Sprys, had the ability to corroborate crucial details about the pharmacy Ms. Mincy's testimony about the pharmacy's operations, details regarding the June 6, 2017 phone call, and the June 21, 2017 on-site inspection. However, neither the Government nor the Respondent decided to call Mr. Sprys as a witness during the hearing. This Tribunal will not question either parties' trial strategy or determination of which witnesses to call, and notes that neither party has suggested any inference should be drawn regarding the failure to present evidence through Mr. Sprys. As such, we are without the benefit of Mr. Sprys testimony and are left only with the testimony evidence of DI1 and Ms. Mincy.

Motivation to Color Testimony

DI1, as a public servant, typically has no personal stake in the outcome of the instant inspection or in the revocation of the Respondent's Registration. The instant investigation was initiated at random. I noted no animus on his part as to the Respondent, its owner, or employees. Although he may be viewed as being part of the prosecution team, I saw no indication from his testimony that any partiality interfered with his reliable testimony.

On the other hand, Ms. Mincy appeared to be very defensive of Pharmacy 4 Less and the pharmacy's practices. As one of the two pharmacists on staff at the pharmacy, the investigation directly implicates her practices and her employment at the pharmacy. I suspect that she would be more likely to color her testimony than would DI1.

Ms. Mincy made statements during her testimony that make her motivation to color her testimony more likely. When confronted about the testimony of DI1, recalling statements made by Ms. Mincy during the June 6, 2017 on-site inspection, Ms. Mincy seemed to personalize the conflict. Ms. Mincy claimed that DI1 would have been “lying,” or that “he was confused.” Tr. 823-25. Ms. Mincy said that DI1 “was like a kid in a candy store.”

Id.

at 824-25. She said that “the longer he was there and the more he got access to, the wilder and crazier he got.”

Id.

at 825. Ms. Mincy described her interactions with DI1 as “tormenting” and “almost, like, harassment” of the Respondent.

Id.

at 825-26. While Ms. Mincy may have been testifying as to how she felt during the surprise on-site inspection with DI1, this colorful language, along with her description and characterization of the inspection, makes her testimony suspect as a possible attempt to improperly discredit DI1's testimony and his characterization of the on-site inspection.

In combination with the previous discussion of Ms. Mincy's ability to recall events, I find that Ms. Mincy has more motivation to color her testimony than DI1.

In its Posthearing Brief, the Government asserts that Ms. Mincy's testimony should be discredited when it is contradicted by DI1. Govt Posthearing Brief at 37. While I cannot reach the Government's assertion that Ms. Mincy is “lying,” I have already found that greater weight will be given to DI1's testimony whenever there is conflict between DI1 and Ms. Mincy's testimony.

Credibility Analysis of Expert Witnesses and Opinions

The relevant standard of care may be established by an expert witness through his experience in the field, and through his reliance upon and application of state and federal professional standards. *[Omitted for brevity.]

Dr. Thomas Hamilton, Pharm.D.

Dr. Hamilton testified as the Government's expert witness in this matter. Dr. Hamilton was offered and was qualified as an expert in the practice of pharmacy in Florida. Tr. 174. Dr. Hamilton has worked as a pharmacist for 18 years.

Id.

at 167-69. His experience includes time at a small pharmacy before moving to work full-time as a pharmacist for Publix, where he has served in a variety of roles, including as a Pharmacist, the Assistant Manager of the Pharmacy, and as the Pharmacy Supervisor. He has served as a “fixer” or temporary Pharmacy Manager in order to “clean up” pharmacies.

Id.

at 169. In his role as Pharmacy Supervisor, he was in charge of overseeing up to 60 pharmacies, and his duties included the hiring and firing of employees, and overseeing daily operations.

Id.

at 170. Additionally, Dr. Hamilton evaluated stand-alone, independent pharmacies for purchase

by Publix. This evaluation included review of the drug invoices, filled prescriptions and the nature of each pharmacy's overall business.

Id.

at 286-87.

During the hearing in this matter, Dr. Hamilton reviewed a number of materials provided to him by the DEA, including prescriptions (front and back), related patient medical notes, and patient addresses.

Id.

at 177, 380-81. Additionally, Dr. Hamilton reviewed prescription pricing via GoodRX.

Id.

at 177-78. Dr. Hamilton also prepared an expert report in this matter based on the information and materials provided to him. GX 28.

In general, Dr. Hamilton provided detailed assessments of each of the 10 charged patients in this matter. He detailed his review of the prescriptions provided for each of the 10 charged patients and any “red flags” that he noticed through his review. His explanation that “red flags” can be resolved through a review of the prescription and some investigation, including speaking with the patient, reviewing medical history, or speaking with the prescriber, were all consistent with his ultimate opinions in this matter. His opinions in this matter were bolstered by his knowledge and experience in this field, as well as his knowledge of “Florida regulation 64B” and guidance provided by the National Board of Pharmacy Association, which provide the source of pharmacy standards of care in Florida.

Id.

at 180, 351-58.

On cross-examination, Dr. Hamilton's credibility was bolstered by his willingness to provide straightforward answers that were consistent with those opinions he had provided on direct examination. Dr. Hamilton conceded that he only reviewed the documents provided to him by the Government, but he was present throughout the hearing and was present to observe the testimony from the Respondent's witnesses. He indicated, when recalled during the Government's rebuttal case, that even after hearing the testimony and opinions from the Respondent's witnesses, his opinions in this matter had not changed. Tr. 1005. Further, Dr. Hamilton demonstrated objectivity. While Dr. Hamilton had differing opinions from Mr. Parrado in a variety of subjects, he was willing to concede areas in which he agreed with Mr. Parrado and did not appear to form opinions solely to favor the Government.

Overall, I find Dr. Hamilton's testimony and opinions in this matter to be credible and reliable.

Mr. Robert Parrado, BPharm., R.Ph.

Mr. Parrado testified as the Respondent's expert witness in this matter. Mr. Parrado was offered and qualified as a pharmacy expert.

Id.

at 431. Mr. Parrado has an extensive history in the pharmacy field. He appears to be approaching legend status in the field in Florida. He has been a licensed pharmacist in Florida since 1971. He was formerly licensed as a Consulting Pharmacist by the State of Florida until 1989. He has received numerous awards during his career. He is currently President and CEO of Parrado Pharmacy Consultants, Inc., which involves consulting with pharmacies, pharmacists, and with government agencies.

Id.

at 399-402; RX 5. He has previously worked at several pharmacies.

From 2001 to 2004, Mr. Parrado was a member of the Florida Board of Pharmacy. From 2003 to 2009, he was on the Board's Accreditation Council in Pharmacy Education. While on the Board, Mr. Parrado also served on the Rules Committee and the Legislative Affairs Committee. During 2004, Mr. Parrado was Chairman of the Florida Board of Pharmacy. Since 2001, Mr. Parrado has been a perpetual member of the National Association of Boards of Pharmacy. Mr. Parrado was a member of the National “Rules Committee” which developed “model rules” for consideration by individual states.

Id.

at 409. For 18 months, ending in 2001, Mr. Parrado was President-elect of the Florida Pharmacy Association. Later, Mr. Parrado served as Speaker of the House of Delegates for the Association.

Since 2014, Mr. Parrado has been guest lecturer on pharmacy law at the University of Florida College of Pharmacy.

Id.

at 410. As part of a recurring continuing education course, Mr. Parrado taught “Resolving Red Flags, Allowing Patients to Legally Obtain Their Lawful Medical Prescriptions.”

Id.

at 411. He has also presented to various professional organizations a course on “Identifying Drug Diversion.”

Id.

at 412. Mr. Parrado has testified as an expert witness previously, including an estimated eight or nine times as an expert called by DEA in these administrative proceedings.

Id.

at 414-16.

It is undisputed that Mr. Parrado has an extensive and impressive background in the pharmacy field. In particular, Mr. Parrado has a vast amount of experience in the practice of pharmacy within the state of Florida. His experience as a member of the Board of Pharmacy, including as a member of the Rules and Legislative Affairs Committees and as the Chairman of the Board, are highly instructive as to the Florida standard of care and those regulations governing Florida pharmacists. Mr. Parrado even noted that he was a co-author of Rule 64B16-27.831, which is the Florida state requirement that pharmacists question prescriptions that may not be valid and only fill the prescriptions if the pharmacist is able to validate the prescription.

Id.

at 420.

As it has been noted, Mr. Parrado has previously testified in similar DEA administrative proceedings. In

Superior Pharmacy I and II,

the Agency found that the ALJ in that matter properly qualified Mr. Parrado as an expert witness in that proceeding given his extensive experience in the pharmacy field.

See Superior Pharmacy I and II,

81 FR 31,309, 31,322 n.16 (2016). Mr. Parrado was also previously certified as an expert in community pharmacy practice.

Hills Pharmacy, LLC,

81 FR 49,815, 49,820 (2016). The Agency also gave credit to Mr. Parrado's expertise in

Edge Pharmacy,

81 FR 72,092 (2016). As such, I further find that Mr. Parrado's background and expertise is more than sufficient to lend weight towards his testimony in this matter.

In this matter, Mr. Parrado provided generally reliable statements as to his review of the materials and his ultimate opinions. He testified that he had reviewed not only the Respondent's exhibits, but also was provided and reviewed the DEA's exhibits. Tr. 432. Mr. Parrado suggested that if he were in Dr. Hamilton's position, he would have asked the Government to provide more documentation.

As to ultimate opinions, while Dr. Hamilton generally provided specific answers to the questions posed by the parties, Mr.

Parrado would occasionally provide more summary or conclusory opinions to the questions posed to him. For example, Mr. Parrado gave the blanket conclusory opinion that based on the discussions between Mr. Parrado and Mr. Sprys and Ms. Mincy, of which there was no record or report, Mr. Parrado opined that in every instance of a red flag, they properly resolved the red flag prior to dispensing the subject controlled substance.

There was a question as to what requirement, if any, an expert witness has in requesting additional documents. Mr. Parrado indicated that it was his experience from

Superior Pharmacy I and II

that he should request more documents. Respondent's counsel argued that

Superior Pharmacy I and II

holds that if information to resolve red flags is not documented in materials provided to the expert, the additional documentation should be requested and provided to the expert if it exists. Tr. 444-45. The Government's objection to the question was sustained and the parties were invited to brief this issue in their Posthearing Brief. The Government argues in its Posthearing Brief that

Superior Pharmacy I and II

do not stand for the argument that the Respondent asserted. Govt Posthearing Brief at 42-43. Upon a review of

Superior Pharmacy I and II,

this Tribunal agrees with that assessment. It was not established that

Superior Pharmacy I and II

have created such an obligation on the part of an expert witness to request additional documentation.

There were also a number of disagreements between Dr. Hamilton and Mr. Parrado in a number of areas, which will be discussed

infra.

However, Mr. Parrado's testimony was diminished by his failure to include important details as to the bases of his opinions in this matter. First, Mr. Parrado failed to disclose that he interviewed Mr. Sprys and Ms. Mincy in forming his opinions in this matter. Tr. 497-500, 504-06. As bases for his opinions and having testified as an expert in a number of these proceedings, Ms. Parrado should be well aware of his obligations and the necessity to disclose the bases of his opinions, particularly if interviewing witnesses in this matter formed the bases of his opinions. My Order for Prehearing Statements specifically requires witnesses who rely on hearsay statements to identify those individuals in the prehearing statement. ALJ Ex. 3. Mr. Parrado's opinions were further diminished by the fact that Mr. Sprys did not testify, so he could not be subject to cross-examination on this issue. Therefore, Mr. Parrado's subject opinions are based on hearsay statements that were not subject to cross-examination. The Government was given an opportunity to cross examine Ms. Mincy. Additionally, Mr. Parrado testified that Ms. Mincy and Mr. Sprys confirmed to him that checking the E-FORCSE database was instrumental in their resolving certain red flags. As GX 38 reveals, Mr. Sprys and Ms. Mincy's access of the E-FORCSE was not as diligent as claimed.

See infra

section “Opioid Tolerance High Starting Dosages.” This suggests that Mr. Parrado's opinions in this regard are diminished by less than reliable claims made to him by Mr. Sprys and Ms. Mincy. Additionally, as there was little or no documentary support for Mr. Sprys and Ms. Mincy's claims to Mr. Parrado that they appropriately resolved each of the subject red flags, one would have to credit them with extraordinary memory, based on specific events over a few year period which the record does not establish.

Secondly, when cross-examined about his conclusions regarding the distance traveled by Patient A.R., Mr. Parrado was asked why he did not provide certain details about his opinions in his expert report. Tr. 540-41. When asked why he didn't put anything in his report about the pharmacist's relationship with Patient A.R., he stated “I didn't see cause for that. My eloquence is not that great.” These statements further diminish Mr. Parrado's bases for his opinions in this matter. Further, there was an inconsistency in Mr. Parrado's evaluation. In defending the Respondent's resolution of red flags, Mr. Parrado often relied on the PRM records maintained in the pharmacy file to justify the resolution. However, in instances where the PRM did not establish justification of the red flag, Mr. Parrado dismissed this fact and credited the Respondent's resolution by virtue of the mere effort of contacting the physician. This is contrary to the pharmacist's corresponding responsibility. The pharmacist must resolve red flags. An unsuccessful attempt to resolve red flags is insufficient.

However, overall, I do not find that Mr. Parrado was disingenuous or lacking candor in his testimony, even when he occasionally failed to answer questions in a direct manner or to provide notice of all facts and materials upon which he relied in making his opinions. I do find his testimony to be generally credible and reliable, to the extent the information upon which he relied was accurate.

As to both experts in this matter, I consider their opinions and the merit

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