Pronto Pharmacy, LLC; Decision and Order

Federal RegisterNov 18, 2021

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 19-42]

Pronto Pharmacy, LLC; Decision and Order

On August 23, 2019, a former Acting Administrator of the Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause and Immediate Suspension of Registration (hereinafter, OSC) to Pronto Pharmacy, LLC (hereinafter, Respondent). Administrative Law Judge Exhibit (hereinafter, ALJ Ex.) 1, (OSC) at 1.

The OSC informed Respondent of the immediate suspension of its DEA Certificate of Registration Number FP2302076 (hereinafter, registration or COR) and proposed its revocation, the denial of any pending applications for renewal or modification of such registration, and the denial of any pending applications for additional DEA registrations pursuant to 21 U.S.C. 824(a)(4) and 823(f), because Respondent's “continued registration is inconsistent with the public interest.”

Id.

(citing 21 U.S.C. 824(a)(4) and 823(f)).

According to Agency records, DEA removed all controlled substances from Respondent's possession on August 29, 2019, when the OSC was served, pursuant to the Immediate Suspension Order.

In response to the OSC, Respondent timely requested a hearing before an Administrative Law Judge. ALJ Ex. 3. The hearing in this matter was conducted from January 28-29, 2020, in Tampa, Florida. On May 5, 2020, Administrative Law Judge Mark M. Dowd (hereinafter, ALJ) issued his Recommended Rulings, Findings of Fact, Conclusions of Law and Decision (hereinafter, Recommended Decision or RD). On May 26, 2020, the Government and Respondent filed exceptions to the Recommended Decision (hereinafter, Gov Exceptions and Resp Exceptions, respectively). Having reviewed the entire record, I find Respondent's Exceptions without merit and I adopt the ALJ's Recommended Decision with minor modifications, as noted herein.

I have addressed each of Respondent's Exceptions and I issue my final Order in this case following the Recommended Decision.

I have made minor, nonsubstantive, grammatical changes to the RD and nonsubstantive conforming edits. 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 in brackets, and I have included specific descriptions of the modifications in brackets or in footnotes marked with an asterisk and a letter. Within those brackets and footnotes, the use of the personal pronoun “I” refers to myself—the Administrator.

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

*C 1 2 3

I have omitted the RD's discussion of the procedural history to avoid repetition with my introduction.

[Footnote omitted,

see supra

n.*C.]

[Footnote omitted,

see supra

n.*C.]

[Footnote omitted,

see supra

n.*C.]

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 DEA Certificate of Registration, No. FP2302076, issued to the Respondent should be revoked, and any pending applications for modification or renewal of the existing registration be denied, and any applications for additional registrations be denied, because its continued registration would be inconsistent with the public interest under 21 U.S.C. 823(f) and 824(a)(4).

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

1. The Respondent repeatedly issued prescriptions in violation of the minimum practice standards that govern the practice of pharmacy in Florida. ALJ Ex. 1 at ¶ 4. Specifically, from at least January 2018 through at least May 2019, the Respondent repeatedly filled prescriptions for Schedule II narcotics in the face of obvious red flags of drug abuse and diversion.

Id.

Filling these prescriptions violated federal and Florida law, including 21 CFR 1306.04(a) and 1306.06, and Fla. Admin. Code r. 64B16-27.810.

2. In addition, the Respondent engaged in the “manufacture” of controlled substances, as the Controlled Substances Act defines that term. ALJ Ex. 1 at ¶ 5. The Respondent is not registered with the DEA as a manufacturer.

Id.

Manufacturing controlled substances without the appropriate registration is a violation of federal law, including 21 U.S.C. 841(a)(1) and 21 CFR 1301.13(e).

Id.

Improper Dispensing

Between January 9, 2018, and May 7, 2019, the Respondent repeatedly issued prescriptions in violation of the minimum practice standards that govern the practice of pharmacy in Florida. ALJ Ex. 1 at ¶ 11. These prescriptions presented numerous red flags of drug abuse and diversion, including drug cocktails, early refills, excessive dispensing of high-strength controlled substances, travelling long distances, and cash payments.

Id.

at ¶¶ 12-15, 18-19. Filling these prescriptions violated federal and state law, including 21 U.S.C. 842(a)(1), 21 CFR 1306.04(a), and Florida Administrative Code r. 64B16-27.810.

Id.

at ¶ 19. The OSC/ISO provided the following specific examples of prescriptions that raised these red flags:

Drug Cocktails

3. Patient A.G.: On at least nine occasions between January 25, 2018, and April 12, 2019, the Respondent filled prescriptions issued by the same prescriber for patient A.G. for alprazolam and oxycodone or hydromorphone on the same date. ALJ Ex. 1, ¶ 12(a). Specifically, the Respondent filled prescriptions for hydromorphone and alprazolam for A.G. on the following four occasions: January 25, 2018; March 1, 2018; April 12, 2018; and May 8, 2018.

Id.

The Respondent filled prescriptions for oxycodone and alprazolam for A.G. on the following five occasions: December 20, 2018; January 17, 2019; February 14, 2019; March 20, 2019; and April 12, 2019.

Id.

4. Patient B.S.: On at least five occasions between January 29, 2018, and April 22, 2019, the Respondent filled prescriptions issued by the same prescriber for patient B.S. for alprazolam and oxycodone or hydromorphone on the same date. ALJ Ex. 1, ¶ 12(b). Specifically, the Respondent filled prescriptions for hydromorphone and alprazolam for B.S. on the following two occasions: January 29, 2018, and May 22, 2018.

Id.

The Respondent filled prescriptions for oxycodone and alprazolam for B.S. on the following three occasions: December 20, 2018; February 28, 2019; and March 26, 2019.

Id.

5. Patient N.B.: On at least three occasions between September 14, 2018, and January 16, 2019, the Respondent filled prescriptions issued by the same prescriber for patient N.B. for alprazolam and oxycodone or hydromorphone on the same date. ALJ Ex. 1, ¶ 12(c). Specifically, the Respondent filled prescriptions for hydromorphone and alprazolam for N.B. on September 14, 2018.

Id.

The Respondent filled prescriptions for oxycodone and alprazolam for N.B. on the following two occasions: December 20, 2018, and January 16, 2019.

Id.

6. Patient C.R.: On at least three occasions between March 6, 2018, and July 12, 2018, the Respondent filled prescriptions issued by the same prescriber for patient C.R. for alprazolam and oxycodone on the same date. ALJ. Ex. at ¶ 12(d). Specifically, the Respondent filled prescriptions for oxycodone and alprazolam for C.R. on March 6, 2018; April, 19, 2018; and July 12, 2018.

Id.

7. Patient J.M.: On at least five occasions between January 25, 2018, and May 16, 2018, the Respondent filled prescriptions issued by the same prescriber for patient J.M. for alprazolam and oxycodone on the same date.

Id.

Specifically, the Respondent filled prescriptions for oxycodone and alprazolam for J.M. on January 25, 2018; March 1, 2018; April 4, 2018; April 19, 2018; and May 16, 2018.

Id.

Early Refills

8. Patient A.H.: On January 22, 2019, the Respondent filled a prescription for patient A.H. for a 30-day supply of hydromorphone 8 mg tablets. ALJ Ex. 1, ¶ 13(a). The Respondent filled additional prescriptions for A.H. for 30-day supplies of hydromorphone 8 mg tablets on February 15, 2019 (six days early); February 27, 2019 (18 days early); and March 14, 2019 (15 days early).

Id.

9. Patient M.M.: On January 3, 2019, the Respondent filled a prescription for patient M.M. for a 28-day supply of hydromorphone 8 mg tablets. ALJ Ex. 1, ¶ 13(b). The Respondent filled additional prescriptions for M.M. for 30-day supplies of hydromorphone 8 mg tablets on January 24, 2019 (seven days early); February 19, 2019 (four days early); and a 28-day supply on March 15, 2019 (six days early).

Id.

10. Patient J.D.: On May 10, 2018, the Respondent filled a prescription for patient J.D. for a 30-day supply of hydromorphone HCL powder. ALJ Ex. 1, ¶ 13(c). The Respondent filled additional prescriptions for J.D. for 30-day supplies of hydromorphone HCL powder on May 30, 2018 (10 days early); June 15, 2018 (14 days early); and June 30, 2018 (15 days early).

Id.

11. Patient R.G.: On January 29, 2018, the Respondent filled prescriptions for patient R.G. for a 30-day supply of oxycodone HCL powder and a 30-day supply of alprazolam 2 mg tablets. ALJ Ex. 1, ¶ 13(d). The Respondent filled additional prescriptions for 30-day supplies of oxycodone HCL powder and alprazolam 2 mg tablets for R.G. on February 21, 2018 (seven days early); March 19, 2018 (four days early); April 17, 2018 (one day early); and May 8, 2018 (nine days early).

Id.

12. Patient R.L.: On February 1, 2018, the Respondent filled a prescription for patient R.L. for a 30-day supply of hydromorphone HCL powder. ALJ Ex. 1, ¶ 13(e). The Respondent filled additional prescriptions for 30-day supplies of hydromorphone HCL powder for R.L. on February 26, 2018 (five days early); a 29-day supply on March 22, 2018 (six days early); a 30-day supply on April 17, 2018 (three days early); and a 30-day supply on May 11, 2018 (six days early).

Id.

High-Strength Controlled Substances

13. During the relevant time period, virtually all of the prescriptions for oxycodone and hydrocodone that the Respondent “compounded” were for oxycodone 30 mg immediate release and hydromorphone 8 mg immediate release, the highest strengths of these controlled substances. ALJ Ex. 1, ¶ 14. Furthermore, between January 11, 2018, and July 17, 2018, 100 percent of the oxycodone tablet prescriptions and 87 percent of the hydromorphone tablet prescriptions (approximately 44 prescriptions total) issued by a particular prescriber were for the highest strength available for those controlled substances.

Id.

Long Distances

14. Between September 10, 2018, and May 6, 2019, the Respondent filled:

a. 86 prescriptions for patients with addresses in Cape Coral, Florida, which is approximately 140 miles from the Respondent;

b. 145 prescriptions for patients with addresses in Fort Myers, Florida, which is approximately 130 miles from the Respondent;

c. 41 prescriptions for patients with addresses in Lehigh Acres, Florida, which is approximately 140 miles from the Respondent;

d. 15 prescriptions for patients with addresses in Immokalee, Florida, which is approximately 150 miles from the Respondent;

e. 15 prescriptions for patients with addresses in Naples, Florida, which is approximately 170 miles from the Respondent;

f. 11 prescriptions for patients with addresses in Opa-locka, Florida, which is approximately 270 miles from the Respondent. ALJ Ex. 1, ¶¶ 15(a)-(f).

15. In addition, between September 10, 2018, and May 6, 2019, over 75 percent of the prescriptions for controlled substances filled by the Respondent were issued by prescribers whose medical practices are located more than 150 miles away from the Respondent. ALJ Ex. 1, ¶ 16.

Cash Payments

16. During the relevant time period, over 90 percent of the prescriptions for oxycodone 30 mg and hydromorphone 8 mg filled by the Respondent were paid for with cash. ALJ Ex. 1, ¶ 18. In contrast, in 2018 “approximately 11 percent of all prescriptions filled by independently owned pharmacies . . . were paid for with cash.”

Id.

Illegal Manufacturing

17. Between January 2018 and May 2019, the Respondent was engaged in manufacturing controlled substances, as that term is defined in the CSA, without a separate DEA registration authorizing it to manufacture controlled substances, in violation of 21 U.S.C. 841(a)(1) and 21 CFR 1301.13(e). ALJ Ex. 1, ¶ 20-28.

The Hearing

Government's Opening Statement

In its Opening Statement, Tr. 14-17, the Government stated that through its investigation of the Respondent, the DEA obtained the Respondent's dispensing records and patient profiles, a pharmacy expert reviewed those records, and that review revealed suspicious patterns. Tr. 14. Those suspicious patterns included the fact that 99 percent of the Respondent's prescriptions were paid for in cash; over 90 percent of the Respondent's patients travelled more than 100 miles to fill their prescriptions; and that the Respondent dispensed a disproportionately high volume of opioids.

Id.

The DEA's expert reviewed the Respondent's records related to 11 specific patients and found that the prescriptions filled by these patients presented numerous red flags that could not have been resolved by a pharmacist acting in the usual course of professional practice. Tr. 14-15. The expert further opined that based on his review of the Respondent's records, the Respondent made no attempt to resolve the red flags presented by these prescriptions.

Id.

In addition, the Government previewed that its evidence would show that the Respondent unlawfully manufactured controlled substances, specifically oxycodone and hydromorphone, without a manufacturer's registration. Tr. 15-17. To support this allegation, the Government intended to show that in May 2012 the Respondent's owner, Mr. Norman J. Clement, Sr., told DEA investigators that he compounded oxycodone and hydromorphone because it was cheaper than obtaining them from distributors. Tr. 14-15. In conclusion,

the Government requested that the Respondent's registration be revoked and any pending applications be denied because its continued registration presents a threat to the public. Tr. 17.

Respondent's Opening Statement

In the Respondent's opening statement, Tr. 503-06, the Respondent stated that the DEA initiated this case without objectively evaluating the evidence. Tr. 503. The DEA did not interview any patients identified in the OSC/ISO or the doctors who issued the prescriptions involved in this case.

Id.

The DEA also did not subpoena the medical records of the patients at issue.

Id.

The Respondent argued that the Government's evidence would fail to show that any patients involved in this case suffered adverse consequences from the prescriptions filled by the Respondent. Tr. 504. Furthermore, the Respondent argued that the Government's evidence would fail to meet its burden to revoke the Respondent's registration.

Id.

In the Respondent's view, the Government's case is based on the faulty assumption that the patients must have been drug abusers because they received treatment for chronic pain.

Id.

The Respondent characterized this assumption as “inherently unfair and inappropriate.”

Id.

The Respondent argued that the Government's assumption ignores the Respondent's combined 90-years of pharmacy experience possessed by the Respondent's pharmacists, as well as their professional education and training. Tr. 505. The Respondent's evidence is expected to prove that its pharmacists exercised appropriate professional judgment and resolved red flags.

Id.

The Respondent highlighted that the Government's evidence on red flags comes from a witness who has never practiced in Florida.

Id.

Furthermore, the Respondent argued that its evidence will show that its pharmacists' professional judgment complied with the Florida standard of care, and that the Florida standard of care is established by state statutes rather than an “ivory tower aspirational goal.”

Id.

Government's Case-in-Chief

The Government presented its case-in-chief through the testimony of three witnesses. First, the Government presented the testimony of Diversion Investigator Richard Albert. Tr. 24-180. Second, the Government presented the testimony of Task Force Officer Jeffrey Shearer. Tr. 181-94. Finally, the Government presented the testimony of its expert, Dr. Donald Sullivan. Tr. 195-502.

Diversion Investigator (DI) Richard J. Albert, Jr.

DI Albert has been a Diversion Investigator for more than seven years. Tr. 24-25. He is currently stationed in Tampa, Florida. Previously, he was stationed in Nashville, Tennessee. Tr. 24. To become a Diversion Investigator, DI Albert received training at the 12-week basic diversion school in Quantico, Virginia.

Tr. 25.

DI Albert became involved in the investigation of the Respondent in May 2017, when he received a call from the Department of Health regarding a pharmacy that was compounding hydromorphone and oxycodone. Tr. 26. DI Albert and his supervisor then met with the Health Department investigator at Respondent.

Id.

The Respondent's owner, Mr. Norman J. Clement, Sr., was not present at the pharmacy, but his daughter and wife were present. Tr. 26-27. The investigators presented a Notice of Inspection to Mr. Clement, Sr.'s, daughter, who allowed the investigators to inspect the pharmacy.

Id.

Approximately 15-minutes into the inspection, Mrs. Clement asked the investigators to leave.

Id.

The investigators complied. Tr. 27.

In September 2017, the DEA served a subpoena on the Respondent requesting Schedule II controlled substance prescriptions, receiving records, and batch records. Tr. 27. Government Exhibit 2 is a receiving record sent from Auburn Pharmaceutical to the Respondent. Tr. 28; GX 2. The DEA received this document in response to the September 2017 subpoena.

Id.

Government Exhibit 3 is a receiving record for hydromorphone

sent from B&B Pharmaceuticals to the Respondent. Tr. 29; GX 3. The DEA received this document in response to the September 2017 subpoena.

Id.

Hydromorphone is a Schedule II controlled substance. Tr. 29.

Government Exhibit 4 is a receiving record for oxycodone sent from Fagron, Inc., to the Respondent. Tr. 31; GX 4. The DEA received this document in response to the September 2017 subpoena. Tr. 32.

Government Exhibit 5 contains batch records for hydromorphone 8 mg. Tr. 32-33; GX 5. A batch record documents the production of a controlled substance and lists the ingredients in the controlled substance. Tr. 33. The batch record is created by the person who makes the substance.

Id.

The batch records indicate how many capsules were used in the production of a particular batch. Tr. 38, 40-41. Government Exhibit 5 documents the production of hydromorphone 8 mg. Tr. 33. The initials “N.C.,” who DI Albert presumed to be the Respondent's owner, Norman J. Clement, Sr., appear in the columns labelled “Manufactured By,” “Checked By,” and “Final Product Checked By.”

Tr. 35-37; GX 5.

During cross-examination, the Respondent's counsel directed DI Albert's attention to page 7 and 11 of Government Exhibit 6, which shows illegible initials in the “Manufactured By” column (page 7) and the “Checked By” column (page 11). Tr. 150; GX 6, pp. 7, 11. DI Albert was also unable to identify the signature on page 13 of Government Exhibit 6. Tr. 151; GX 6, p. 13.

Government Exhibit 6 contains batch records for oxycodone 30 mg. Tr. 38-39; GX 6. The DEA received this document in response to the September 2017 subpoena. Tr. 39.

Upon reviewing the batch records received in response to the September 2017 subpoena, DI Albert noticed that the records listed lactose as the only non-controlled substance ingredient. Tr. 42-43. When he reviewed the prescriptions received in response to the subpoena, he noticed that patients were travelling long distances to the pharmacy. Tr. 43, 129-30.

Government Exhibit 10 is a printout of the prescription drug monitoring program (“PDMP”) for the Respondent's dispensing from September 2016 to June 2018. Tr. 46, 159, 162; GX 10, pp. 1, 20. This document represents the total number of controlled substance prescriptions that the Respondent dispensed during that 21-month time period. Tr. 162-63. The document lists 2,360 prescriptions. Tr. 162-63. DI Albert reviewed the Respondent's PDMP records during his investigation. Tr. 43-44. Government Exhibits 8 and 9 also contain PDMP printouts of the Respondent's dispensing. Tr. 49-52; GX 8-9.

DI Albert returned to Respondent in September 2018 to serve an administrative inspection warrant (“AIW”) and subpoena. Tr. 52. Government Exhibit 67 is the subpoena, dated September 5, 2018, that DI Albert served on the Respondent's counsel at the time of executing the AIW. Tr. 52-53; GX 67. The second page of the subpoena is a list of patient names. Tr. 53; GX 67, p. 2. DI Albert did not speak with any patients who presented at the pharmacy while the AIW was being executed. Tr. 168. He also did not speak with any of the Respondent's staff, including Mr. Norman J. Clement, Sr., who was instructed by counsel to not answer any questions. Tr. 168, 173, 177.

During service of the AIW, digital forensic specialists captured mirror

images of the Respondent's computer system. Tr. 54, 62, 91, 93, 134. The Respondent used Rx30 pharmacy software. Tr. 135. DI Albert received the information that was captured from the Respondent's system in Excel format, but he did not know the process that the digital forensic team used to convert that information into the format he received. Tr. 136. DI Albert was unable to determine whether errors were made in converting the captured images of the Respondent's system into Excel. Tr. 136-37.

During execution of the AIW, DI Albert observed Mr. Clement, Sr., conduct a closing inventory of the controlled substances that the Respondent had on-hand at the time. Tr. 54, 56, 165-66. Mr. Clement, Sr., signed the closing inventory. Tr. 56, 58; GX 7. The closing inventory lists 470 tablets of hydromorphone 8mg, 3,546 capsules of hydromorphone 8 mg, hydromorphone powder, 204 tablets of oxycodone 30 mg, 574 capsules of oxycodone 30 mg, and oxycodone powder. Tr. 59, 61; GX 7. Medications from distributors are in the form of tablets. When medications are compounded from powder in batch at a pharmacy, the dosage units are contained in capsules. Tr. 60.

Government Exhibit 11 is saved on a DVD. Tr. 63-64; GX 11. Government Exhibit 11 contains records electronically downloaded from the Respondent's computer system during execution of the AIW. Tr. 63.

Government Exhibit 12 is a report of the Respondent's dispensing over a three-month period from November 2015 through January 2016. Tr. 68; GX 12. This document was obtained electronically during execution of the AIW in September 2018. Tr. 69. Government Exhibit 13 was also obtained during service of the AIW. Tr. 70; GX 13.

Government Exhibit 14 is a PDMP dispensing record for patient A.G. Tr. 71-72; GX 14. Government Exhibit 15 is a record kept by the Respondent for patient A.G. with information about the patient as well as notes. Tr. 73-74; GX 15. It was electronically downloaded from the Respondent's computer system during the AIW search. Tr. 75. The DEA also obtained Government Exhibits 16 and 17 during the AIW search. Tr. 76-81, 140; GX 16-17. Government Exhibits 16 and 17 are dispensing records for patient A.G. maintained by the Respondent and obtained from the pharmacy.

Id.

Government Exhibit 19 is a PDMP dispensing record for patient A.H. Tr. 81-82; GX 19. The Government moved for the admission of Exhibits 19 through 43 and 46 through 52 as a group. Tr. 85-87. These exhibits were either obtained from the Respondent during the AIW search in September 2018 or printed from the PDMP.

Id.

They relate to the specific patients identified in the OSC/ISO.

Id.

After executing the AIW at the pharmacy in September 2018, DI Albert sent the records he obtained to a pharmacy expert, Dr. Donald Sullivan, for review. Tr. 88. DI Albert served another subpoena on the Respondent in May 2019. Tr. 88-89; GX 68. Attached to the subpoena is a list of seven patients. Tr. 89; GX 68, p. 2. This subpoena requested that the Respondent produce five categories of documents, to include (1) patient profiles for the patients identified in the attachment; (2) other records documenting the steps taken to avoid or resolve any issues or red flags with prescriptions; (3) original prescriptions and fill stickers of all prescriptions filled for patients listed in the attachment from September 10, 2018, to May 10, 2019; (4) any pharmacist notes evaluating potential red flags with prescriptions; (5) and any other documentation related to the specific patients identified, such as dispensing records, billing records, PDMP records, and medical records. Tr. 89-90; GX 68.

DI Albert received additional documents from the Respondent in response to the May 2019 subpoena. Tr. 94. The documents that DI Albert received related to patients A.G. and R.B. are contained in Government Exhibits 18 and 44. Tr. 94-98; GX 18, 44. DI Albert sent the documents that he received in response to the May 2019 subpoena to the expert witness for review. Tr. 118. He then began preparing the OSC/ISO. Tr. 118-19.

In his investigation of the Respondent, DI Albert calculated the approximate distances from the cities where patients lived to the Respondent pharmacy. Tr. 99-105, 130. DI Albert made these calculations by using Google Maps to determine the distance from the cities of residence to the Respondent's address. Tr. 99-101. The approximate distances on Google Maps are contained in Government Exhibit 54.

Tr. 99; GX 54.

Although Google Maps includes estimated travel times as well as mileage, due to the high variability of travel times, only the mileage is being considered herein.

DI Albert also searched for specific addresses in Google Maps. Tr. 105-12. Each of the specific addresses that DI Albert searched relate to a specific patient. Tr. 106, 108-09, 111-12. The one-way distances from those addresses to the Respondent are in Government Exhibits 55 through 60 and 62 through 65. Tr. 105-12; GX 55-60, 62-65.

Government Exhibit 55 shows a distance of 131 miles.

Tr. 106; GX 55, p. 1. Government Exhibit 56 shows a distance of 132 miles. Tr. 109; GX 56, p. 1. Government Exhibit 57 shows a distance of 148 miles. Tr. 110; GX 57, p. 1. Government Exhibit 58 shows a distance of 134 miles. GX 58, p. 1. Government Exhibit 59 shows a distance of 130 miles. GX 59, p. 1. Government Exhibit 60 shows a distance of 144 miles. GX 60, p. 1.

The Google Maps printouts list three routes with different distances and travel times. When speaking of the distances between patients' homes and the Respondent, I will refer to the route with the shortest mileage.

Government Exhibit 62 shows a distance of 137 miles. GX 62, p. 1. Government Exhibit 63 shows a distance of 138 miles. GX 63, p. 1. Government Exhibit 64 shows a distance of 131 miles. GX 64, p. 1. Government Exhibit 65 shows a distance of 138 miles. GX 65, p. 1.

Government Exhibit 61 shows the roundtrip distance from patient M.M.'s home, to the doctor's office, to the Respondent, and then back home. Tr. 112-18, 131, 172; GX 61. The total roundtrip distance from M.M.'s home to the doctor's office and the Respondent, and then back home, is 327 miles. Tr. 117, 131; GX 61, p. 1. Although DI Albert searched for the roundtrip distance between M.M.'s home, doctor's office, and the Respondent, he did not check to see whether M.M. filled any prescriptions at the Respondent in Tampa on the same day that he obtained them from the doctor in Fort Myers. Tr. 133, 171. DI Albert is therefore not sure whether M.M. ever made the roundtrip drive that is depicted in Government Exhibit 61.

Id.

If M.M. had travelled from her home to the doctor's office and the Respondent on separate days, however, the total travel distance would be similar to the roundtrip distance travelled on one day.

Tr. 173.

The distance from M.M.'s home to her doctor's office is 134 miles. GX 61, p. 3. Thus, the total distance travelled if M.M. went to the doctor and returned home on the same day would be 268 miles. The distance from M.M.'s home to the Respondent is 38 miles. Tr. 134; GX 61, p. 6. Thus, the total distance travelled if M.M. went to the Respondent and returned home on the same day would be 76 miles. Added together, these distances total 344 miles. Thus, if M.M. travelled to her doctor's office to obtain a prescription on one day and returned home, and then travelled to the Respondent on another day to fill the prescription and returned home, the total distance travelled to obtain and fill that prescription would be slightly higher (344 miles) than if she had made the roundtrip drive from home, to the doctor's office, to the pharmacy, and back home, all in one day (327 miles). However, during the hearing, counsel

for the Government conceded, and Dr. Sullivan confirmed, it was the distance from the patient's home to her physician's office which represented the red flag of long distance. Tr. 294.

DI Albert was candid in conceding there were matters and facts of which he was unaware. For example, during his investigation, DI Albert readily conceded he did not talk to any of the 11 patients named in the OSC/ISO. Tr. 123-24, 155. He also conceded that he did not contact the subject prescribing doctors. Tr. 125-26, 128, 173-74, 178-80. DI Albert also conceded that he was unfamiliar with the FDA guidelines on compounding and that he did not receive training on compounding during DI training. Tr. 152. He also admitted that he did not familiarize himself with the Florida laws governing pharmacies, and that he only applied federal law in his investigation. Tr. 152-53. DI Albert also candidly acknowledged that he did not know the significance of the citations to Florida law in the subpoenas that he served. Tr. 153-54. In addition, DI Albert acknowledged that he had not done a comparison of the Respondent's daily, weekly, and monthly dispensing volume to other nearby pharmacies. Tr. 167-68.

DI Albert's willingness to concede these points, excepting in these areas, bolsters his credibility. DI Albert's testimony focused primarily on identifying exhibits and describing his investigation. Based on my close observation of DI Albert at the hearing, my careful review of his testimony in the transcript, and in conjunction with other credible evidence, I find DI Albert to be a credible witness. DI Albert presented as an impartial investigator with no direct stake in the outcome of the case, and his testimony was straightforward, professional, and candid. Furthermore, his testimony was also detailed and internally consistent. For these reasons, I fully credit DI Albert's testimony and find that his testimony merits considerable weight in this Recommended Decision.

Task Force Officer (TFO) Jeffrey Shearer

TFO Shearer has been running a private investigation business for the past five years. Tr. 182. Before that, he was a police officer with the Tampa Police Department for 16 years.

Id.

He spent the last five-and-a-half years of his career with the Tampa Police Department as a task force officer working out of the DEA's Tampa District Office. Tr. 182-83. As a TFO, Mr. Shearer worked with the DEA in the Tactical Diversion Squad on investigations related to the diversion of controlled substances. Tr. 182.

TFO Shearer worked on an investigation of the Respondent. Tr. 183. In May 2012, during execution of an AIW at the Respondent pharmacy, TFO Shearer interviewed Mr. Clement, Sr., the Respondent's owner.

Id.

Mr. Clement, Sr., was cooperative during execution of the AIW. Tr. 192. Mr. Clement, Sr., was not in custody at the time and was free to leave. Tr. 183. In the interview, Mr. Clement, Sr., told TFO Shearer about his process for manufacturing oxycodone and hydromorphone in capsules. Tr. 183-84. Mr. Clement, Sr., told TFO Shearer that he could buy a 100 gram bottle of oxycodone powder for $1,100, enough to manufacture about 6,000 dosage units. Tr. 185. Tablets of oxycodone purchased from commercial distributors cost roughly $2-$10 per pill.

Id.

Mr. Clement, Sr., told TFO Shearer that he manufactured thousands of capsules per batch because it was cost effective.

Tr. 184-85. The batch records that TFO Shearer reviewed in 2012 documented that Mr. Clement, Sr., produced thousands of pills in each batch.

Id.

Mr. Clement, Sr., was not charged with a crime. Tr. 190.

[Footnote omitted for relevance.]

Based on listening to him testify at the hearing, and reviewing the transcript of his testimony, I find TFO Shearer to be a credible witness who testified in a candid, professional, and straightforward manner. TFO Shearer testified regarding events that had occurred approximately seven years prior to the hearing. He seemed fully capable of recalling the majority of those events with ease, but it is not surprising that some of his answers lacked detail. Any lack of detail, however, did not detract from his credibility or the usefulness of his testimony. He was honest about what he could not recall and he presented as an impartial individual without a direct stake in the outcome of the case. For these reasons, TFO Shearer's testimony is credible and merits significant weight in this Recommended Decision.

Dr. Donald L. Sullivan

[I agree with the ALJ's discretionary decision to allow the Government to ask leading questions of its expert witness, over objection by Respondent's counsel.

See

RD, at n.10.]

Dr. Sullivan is presently employed as a professor of Clinical Pharmacy at Ohio State University College of Pharmacy, and has been for five years. Tr. 196-97.

See

GX 53. Previously, he was employed at Ohio Northern University for 17 years. Tr. 197. He obtained his Bachelor's degree in 1990. Tr. 198. In 1991, he obtained his Master's in pharmacy administration, and his doctorate in pharmacy administration in 1996. Tr. 198. At Ohio State, in addition to performing research, he teaches pharmacy practice law to all four years of students. He teaches two courses on pharmacy operations, financial analysis, marketing, and human resource issues. Tr. 197. His courses cover professional standards for pharmacy personnel, including: Dispensing; record keeping; documentation; drug utilization review; patient education and counseling; compounding from a pharmacy practice perspective, as well as state and federal statutes governing the practice of pharmacy. The study of federal law comprises about 50-percent of the legal curriculum. Tr. 197-98, 203.

He has lectured to independent pharmacies on behalf of wholesalers, including Cardinal Health, AmerisourceBergen, HD Smith, as well as several pharmacy organizations. Tr. 199. For the past four years, he has presented a two-hour Continuing Education program to Florida pharmacists on controlled substance dispensing. Tr. 199. Within the past two-to-three years, Florida has increased the professional requirements for pharmacists, to include validating controlled substance prescriptions, understanding different types of diversion, red flags for diversion, how to resolve red flags, naloxone availability, and state and federal laws governing dispensing controlled substances and related record keeping. Tr. 200. Dr. Sullivan has authored five publications, consumer drug reference books, as well as several peer-reviewed publications. Tr. 200. He has completed a research study into community pharmacists, the resources they use in identifying red flags, and their willingness to identify red flags of diversion. Tr. 202. He presents training for government investigators and attorneys. Tr. 203. He has been qualified as an expert in a California criminal trial and in four DEA show cause hearings similar to the instant hearing. Tr. 201, 354-55, 359.

He is a registered pharmacist in Ohio and in Florida. Tr. 198. He has worked as a pharmacist in Ohio, but not in Florida. Tr. 198. However, he has not worked in retail pharmacy for 20 years. Tr. 414. His background is primarily in community pharmacy, which relates to typical private pharmacies and chain pharmacies. Tr. 199. He has also had experience at a pharmacy located within a mental health clinic, and in a mail order pharmacy.

Id.

Dr. Sullivan described a recent problematic trend in medication reimbursement in which the pharmacies are sometimes being reimbursed less than their actual costs to purchase the

medications. Tr. 430-31. This trend has caused small independent pharmacies to seek niche markets. Tr. 431.

Through his education, training, and experience, Dr. Sullivan is familiar with compounding in retail pharmacy, as well as issues related to abuse and diversion of controlled substances, and with the responsibilities of a retail pharmacist in the detection and prevention of such abuse and diversion. Tr. 203. Dr. Sullivan is also familiar with a pharmacist's corresponding responsibility under federal law, and the standard of care and professional obligations of a pharmacist in the state of Florida. Tr. 204. Dr. Sullivan was qualified as an expert in the field of pharmacy and the standard of care for the practice of pharmacy in the state of Florida. Tr. 204-05, 490.*

Throughout the case, the Government's expert and all parties appear to have used the phrases “standard of care,” “corresponding responsibility,” and “usual course of professional practice” interchangeably. Dr. Sullivan testified that in the practice of pharmacy the phrases “standard of care” and “usual course of professional practice” are the same. Tr. 321-22. Dr. Sullivan's testimony regarding the requirement to resolve red flags clearly related to Respondent's corresponding responsibility under 21 CFR 1306.04. The interchangeable use of this terminology does not impact my ultimate finding that Respondent 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 corresponding responsibility herein.

Dr. Sullivan described the duties of a pharmacist in filling a controlled substance prescription. Tr. 206. First, the pharmacist must ensure the prescription is a “valid prescription for a legitimate medical purpose.”

Id.

That is, the pharmacist must determine if it is issued “in the normal course of professional practice,” that the pharmacist believes the patient can safely take it, that the medication is for an actual medical purpose, and is not being abused, misused, or diverted.

Id.

These requirements are codified in both federal and Florida law. Fla. Admin. Code r. 64B16-27.800, .810, and .831.

In reviewing a prescription, a pharmacist must first determine if the prescription appears legal on its face; that all the information necessary appears on the face of the prescription. Tr. 208. Then, applying clinical expertise, the pharmacist must consider possible over-utilization and under-utilization, where the patient is taking more or less medication than prescribed; consider possible abuse or misuse; whether it is serving a legitimate medical purpose; and whether it exposes the patient to potential undue risk of side-effects, adverse effects, or overdose. Tr. 208-09. The Florida standard of care requires pharmacists to document their resolution of any potential issues discovered in the pharmacist's review of a prescription. Tr. 210, 437, 489.

Dr. Sullivan was unaware that Florida had codified a definition of “standard of care” for healthcare workers. Tr. 438; Fla. Stat 766.102.

He was unaware of the Florida Patient Bill of Rights. Tr. 462. Dr. Sullivan initially conceded there was no federal or Florida regulation mandating where or how the resolution of red flags must be documented. Tr. 435-37. In particular, Dr. Sullivan agreed that Florida Administrative Code r. 64B16-27.831, Standards of Practice for the Filling of Controlled Substance Prescriptions, subpart three, is silent as to whether a pharmacist must document the steps a pharmacist takes to validate a prescription. Tr. 449-50, 453-54. [However, Florida Administrative Code r. 64B16-27.831 requires pharmacists to record “[p]harmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug,” which Dr. Sullivan agreed would generally include the information that is needed to resolve red flags. Tr. 488-89.]

The “prevailing professional standard of care,” is defined under Florida law as “that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar heath care providers.” Fla. Stat. § 766.102.

In conjunction with the precautionary evaluation described, the pharmacist is required to maintain a “patient profile” for each patient, which includes: The patient's full name, address and telephone number, age or date of birth, gender, a list of all new and refilled prescriptions obtained by the patient at the pharmacy, and any notes or comments by the pharmacist particular to that patient, such as drug allergies or contraindications. Tr. 209-10.

Dr. Sullivan explained that under federal law, the pharmacist has a corresponding responsibility, an equal responsibility with the prescribing physician, to determine if a prescription has been written for a legitimate medical purpose. Tr. 210-11. That a prescription is written by a physician does not absolve the pharmacist from ensuring that it is for a legitimate medical purpose. Tr. 211. Common potential concerns for a pharmacist are referred to as “red flags.” Red flags include potential for diversion or abuse, patients traveling long distances to see their physicians, or to the pharmacy

12 13

“drug cocktails commonly abused, large dosage units, payment in cash for all or part of a patient's prescriptions,

over-prescribing of immediate release pain killers, and patients traveling in groups. Tr. 213-15, 240-41

, 473-76. Traveling long distances to a pharmacy creates the suspicion that pharmacies closer to the patient have declined to fill that particular prescription. Tr. 220. Drug cocktails, or drug combinations known for abuse, such as the combination opioid/benzodiazepine, represent a “red flag.” Tr. 220-21; GX 66. Indeed, the FDA issued a “black box” warning in August 2016, highlighting the potential danger to the patient of this combination of medications. Tr. 221-23. Cash payment for medications is a red flag as medications are typically expensive and normally patients will defer those costs to their health insurance. Tr. 224-25. Dr. Sullivan testified that “[t]he theory behind [cash payments] is that patients are selling [the drugs] and that's where they're getting all the cash from.”

Id.

at 225. Early refills, or early fills of new prescriptions, are suspicious as they may suggest the patient is not taking the medication as prescribed. Tr. 224-25. Florida initiated annual CME four years previously involving “validation and appropriate use of controlled substances.” Tr. 235. Florida pharmacists are taught to identify the

above red flags, to resolve them, and to document the resolution. Tr. 235-36.

Dr. Sullivan noted 90% of prescriptions filled at the Respondent involved patients living more than 100 miles from the pharmacy. Tr. 235.

Dr. Sullivan conceded that he was not aware of any federal or Florida regulation limiting the distance traveled to fill a prescription. Tr. 462.

Dr. Sullivan conceded that he was not aware of any federal or Florida laws that prohibit pharmacies from accepting cash as payment for prescriptions. Tr. 444.

The Government offered various statistical evidence regarding average national prices for controlled substances, average miles driven to the pharmacy by patients nationally, a high percentage of Respondent's patients traveling long distances to the Respondent's pharmacy, the relatively high percentage of the Respondent's patients paying by cash, the high percentage of the Respondent's controlled substance dispensations versus non-controlled, the extremely high percentage of compounded hydromorphone 8 mg dispensed versus the commercially available hydromorphone 8 mg tablet dispensed by the Respondent, the extremely high percentage of oxycodone 30 mg, and Alprazolam 2 mg (the highest dosage units commercially produced) prescriptions issued as compared with lower dosage units dispensed, that the Respondent dispensed almost twice as many oxycodone 30 mg capsules as tablets. Tr. 235-38, 241, 244-46, 250-51. This evidence was admitted as it related to the prompting and evaluation of various red flags. It was not admitted, and will not be considered, as probative evidence that specific prescriptions were filled contrary to the standard of care in Florida, which determination requires individualized proof and individualized analysis.

To resolve red flags, a pharmacist should discuss the matter with the patient, and attempt to get to know each patient. Tr. 239, 445-49;

see

Fla. Admin. Code r. 64B16-27.831. The pharmacist should also discuss the matter with the prescribing physician, which would provide another source of input for the pharmacist. Tr. 229. However, the prescribing physician can never be the only source of information obtained. Tr. 229. Next, the pharmacist would review the patient's drug record, the PDMP, to determine other medications and the strengths of those medications, and conduct a “prospective drug utilization review,” to make an independent clinical evaluation whether the subject prescription was written for a legitimate medical purpose. Tr. 211, 227. Once the pharmacist makes his independent clinical evaluation, the standard of care requires the pharmacist to document his evaluation. Tr. at 210, 228, 488-89;

see also

Tr. 236.

If a pharmacist is unable to resolve the red flags he should decline to fill the prescription. Tr. 228, 488. *[Omitted for relevance.]

*[Dr. Sullivan testified that a pharmacist does not look at individual red flags in isolation; rather, he looks at them “as a collective whole based on what's going on with that prescription at that time.” Tr. 482, 498. When asked whether you can evaluate a prescription based on isolated red flags alone, Dr. Sullivan testified that “[i]t's like pieces in a puzzle, you look at everything related to that prescription and patient.” Tr. 498.

Dr. Sullivan testified that there are some red flags that, “when taken as a collective whole[,] . . . cannot be resolved.” Tr. 481. Dr. Sullivan testified that in these circumstances, “no matter what the patient tells me, what the doctor tells me, any of that, I'm still not filling the prescription.” Tr. 282. Dr. Sullivan testified that an individual red flag (such as long distances traveled or cash payments) may become unresolvable if it is combined with multiple additional red flags. Tr. 473 (testifying that there is nothing that the patients could have told Respondent to resolve the distance red flag in conjunction with the other red flags); Tr. 475 (testifying that Respondent's lack of contracts for commercial insurance does not resolve the red flag of cash payment “when taken into account with the other red flags on these prescriptions”);

see also

Tr. 409-11 (testifying that when there are “so many [red flags],” a pharmacist can make the decision not to fill a prescription without calling the prescribing physician).]

Dr. Sullivan testified that [it is often difficult to determine whether any individual red flag is unresolvable, because] red flags should be evaluated in combination. Tr. 480-86, 498. However, he testified that a single red flag could be so egregious that it was unresolvable. Tr. 497-99.

Dr. Sullivan explained compounding, in which a pharmacist “makes a drug . . . from scratch . . . to meet the unique therapeutic needs of a patient.” Tr. 230. Typical justification for compounding may include a patient's allergies to certain ingredients within commercially manufactured medications, or the unavailability of a particular medication, or strength of medication required for treatment among commercially available medications. Tr. 230-32, 336-38. Both oxycodone 30 mg, and hydromorphone 8 mg, are commercially available. Tr. 232. [Dr. Sullivan testified that compounding would typically be a “very very small” percentage of a pharmacy's business because it is “very time and labor intensive. Tr. 232.]

Dr. Sullivan reviewed materials sent to him by DI Albert related to Respondent's dispensing. Tr. 233, 349, 405-06. These materials included the Respondent's pharmacy prescription log covering approximately three months [GX 11], PDMP data over an eighteen-month period [GX 8-10], and the Respondent's Prehearing Statement, which included witness summaries. Tr. 341-43, 347-48. Dr. Sullivan did not speak with the pharmacy customers at issue. Tr. 407, 416-18. Dr. Sullivan did not review copies of the actual prescriptions. Tr. 348, 416, 500. Dr. Sullivan agreed that the average 4-5 prescriptions filled at the Respondent's pharmacy per day were much fewer than the average community pharmacy of 190 prescriptions. Tr. 420.

Dr. Sullivan reviewed a list of prescriptions issued by Dr. L. Tr. 251; ALJ Ex. 42

, p. 8. Dr. L.'s prescriptions for the highest strength available opioid was a potential red flag for diversion or abuse. Tr. 251-52. As to Dr. P., whose prescribing history revealed he prescribed 65,000 doses of hydromorphone 8 mg to only 135 doses of hydromorphone 4mg, Dr. Sullivan opined that a prudent pharmacist would not fill Dr. P.'s prescriptions for the highest dosage of hydromorphone. Tr. 253, 496. Similarly, Dr. Sullivan opined a reasonable pharmacist would not fill Dr. P.'s prescriptions for oxycodone 30 mg, as Dr. P. prescribed over 24,000 dosage units of oxycodone 30 mg, to only 200 of the lower dosage units. Tr. 253-54.

The Government's demonstrative exhibit will be marked as ALJ Exhibit 42.

Turning to specific patients, Dr. Sullivan opined the distance traveled by Patient A.G. from his home to the Respondent's pharmacy was a red flag. Tr. 254; GX 55; ALJ Ex. 42, p. 10. In reviewing A.G.'s prescription history, he was always prescribed the highest dose of hydromorphone and of oxycodone, and except for one instance, the highest dose of alprazolam. Tr. 254-55; GX 17; ALJ Ex. 42, p. 11. The combination of opioid and benzodiazepine, coming even after the FDA's black box warning, is a well-known red flag of diversion and abuse. Tr. 255-56. A review of the PDMP report revealed the dangerous combination of the highest dosage unit of opioid along with a benzodiazepine, in addition to early fills on April 12, 2019, representing unresolvable red flags. Tr. 256-57, 267; GX 14; ALJ Ex. 42, p. 12.

A review of Patient A.G.'s patient profile in RX30, and of the prescriptions and fill stickers, failed to resolve the red flags noted or to justify the compounding done. Tr. 259, 267; GX 17; ALJ Ex. 42, p. 11. In the patient memo, it simply stated, “Doctor OK to receive medication in compound capsule form,” which Dr. Sullivan testified is insufficient to justify compounding that medication, which requires an individualized therapeutic need. Tr. 257-59; GX 15; ALJ Ex. 42, p. 13.

See

21 U.S.C. 802(10), (15). In addition, Dr. Sullivan noted that A.G. was prescribed both capsules and tablets of oxycodone 30 mg between November 8, 2017, and January 25, 2018, demonstrating there was no therapeutic need for compounding the oxycodone 30 mg. Tr. 256.

Dr. Sullivan was suspicious of the patient questionnaire used by Respondent. Tr. 259-60; GX 18. The questionnaire questioned whether the patient lived more than 100 miles from the pharmacy. Dr. Sullivan interpreted the questionnaire as cover for filling prescriptions for distant patients, rather than an effort to disclose or resolve red flags. Tr. 259-61; GX 18. A follow-up question to the distant traveling patients asked, “why do you travel this distance,” and in this case, the patient responded, “quick and good service.” Tr. 262. Dr. Sullivan opined that this reason was insufficient to resolve the red flags. The questionnaire contained a certification to be made by the patient, certifying that “I am taking all of my medication prescribed.” Tr. 262. Dr. Sullivan deemed this certification ineffectual in resolving the red flags of

early fills and of diversion. A further statement by the patient that, “I am not selling any of my medication,” did not alleviate any concerns that the patient may have been diverting his medication. Tr. 262. Indeed, Dr. Sullivan suspected the question exposed a subterfuge by the pharmacy, revealing the pharmacy believed patients were selling their medications, and the question was designed to relieve the pharmacy of any liability. Tr. 263. If a pharmacist believes a patient is selling his medications, the pharmacist should not fill any further prescriptions of that patient. Tr. 264.

Dr. Sullivan was directed to the “Pharmacy Comment” at the bottom of the prescriptions for A.G. Tr. 265-66; GX 18, p. 6. The notation, “non acute pain Uninsured Patient” suggested to Dr. Sullivan that whoever made the notations was trying to signal that this medication therapy was ongoing and to provide some justification for cash payment. Tr. 266.

Dr. Sullivan also questioned the prescribing protocol for A.G., in that he was prescribed alternate monthly doses of 30 mg oxycodone and 10 mg of oxycodone. Tr. 264; GX 18, p. 6. However, I believe Dr. Sullivan misread the 30 mg oxycodone prescription of October 30, 2018, as a 10 mg dosage due to a poor copy. So, his conclusions in this regard will not be considered.

As to Patient A.H., Dr. Sullivan opined the 132 miles from A.H.'s home to the Respondent pharmacy represented a red flag. Tr. 268; GX 56; ALJ Ex. 42, p. 14. The prescriptions from January to August, 2018 contained several red flags including, highest dosage of short acting pain-relievers, hydromorphone 8 mg and oxycodone 30 mg, and of alprazolam 2 mg; capsules of hydromorphone being dispensed without required therapeutic justification; and the combination of short-acting opioids with a benzodiazepine. Dr. Sullivan deemed these unresolvable red flags. Tr. 269. Later prescriptions for A.H. revealed significantly early fill dates for four consecutive months. Tr. 269-71; GX 19; ALJ Ex. 42, p. 16. Dr. Sullivan viewed this pattern of early fills as evidence of diversion or abuse, warranting action by the pharmacist such as refusing to fill these prescriptions. Tr. 271-72. The fact that the prescribing physician wrote the prescriptions early does not relieve the pharmacist's responsibility to resolve the red flag of early fills. Tr. 272. A review of this patient's file received by Dr. Sullivan failed to reveal any effort by the Respondent to resolve the red flags relating to Patient A.H. Tr. 272-73. Dr. Sullivan opined that, for the reasons discussed above, the relevant standard of care would have caused a reasonable pharmacist operating within the usual course of professional practice to decline filling the prescriptions for A.H. Tr. 272-73; GX 19, 21; ALJ Ex. 42, p. 15-16.

As to Patient B.S., Dr. Sullivan opined the 132 mile distance from B.S.'s home to Respondent represented a red flag. Tr. 273; GX 57; ALJ Ex. 42, p. 18. The prescriptions from August 2017 to August 2018 contained several red flags including, highest dosage of short-acting pain-relievers, hydromorphone 8 mg and oxycodone 30 mg, and of alprazolam 2 mg; capsules of hydromorphone being dispensed without required therapeutic justification; and the combination of short-acting opioids with a benzodiazepine. Dr. Sullivan deemed these unresolvable red flags. Tr. 274, 276. Dr. Sullivan noted the anti-inflammatory ibuprofen 400 mg prescription, which he found inconsistent in combination with the high dose of pain medication. He opined that a once a day ibuprofen dose would have no effect in combination with such a high dose of pain medication. Dr. Sullivan interpreted the ibuprofen as an attempt to demonstrate that the doctor was trying an alternate therapy as opposed to prescribing controlled substances without a legitimate medical purpose, which Dr. Sullivan viewed as a red flag. Tr. 275. Later prescriptions for B.S. revealed significantly early fill dates. Tr. 275-76; GX 22; ALJ Ex. 42, p. 20. Dr. Sullivan viewed this pattern of early fills as evidence of diversion or abuse, warranting action by the pharmacist such as refusing to fill these prescriptions. Tr. 276-78. A review of this patient's file received by Dr. Sullivan failed to reveal any effort by the Respondent to resolve the red flags relating to patient B.S. Tr. 277. Dr. Sullivan opined that, for the reasons discussed above, he relevant standard of care would have caused a reasonable pharmacist operating within the usual course of professional practice would have declined to fill the prescriptions for B.S. GX 22, 24; ALJ Ex. 42, p. 19-20.

As to Patient C.R., Dr. Sullivan opined the 134 miles from C.R.'s home to Respondent represented a red flag. Tr. 279; GX 58; ALJ Ex. 42, p. 22. The prescriptions from July 2017 to August 2018 contained several red flags including, highest dosage of short-acting pain-reliever, oxycodone 30 mg, capsules of oxycodone 30 mg being dispensed without required therapeutic justification; and the combination of short-acting opioids with a benzodiazepine, and the muscle relaxant tizanidine. A July 12, 2018 prescription for morphine sulphate 60 mg per day further heightened the danger to the patient. Tr. 280. Dr. Sullivan deemed these unresolvable red flags. Tr. 279-82; GX 27; ALJ Ex. 42, p. 23. A review of this patient's profile by Dr. Sullivan failed to reveal any effort by the Respondent to resolve the red flags relating to patient C.R. Tr. 281. Dr. Sullivan opined that, for the reasons discussed above, the relevant standard of care would have caused a reasonable pharmacist operating within the usual course of professional practice to decline filling the prescriptions for C.R. Tr. 281-83; GX 27; ALJ Ex. 42, p. 23.

As to Patient J.D., Dr. Sullivan opined that the 130 miles from J.D.'s home to the Respondent pharmacy represented a red flag. Tr. 283; GX 59; ALJ Ex. 42, p. 23. The prescriptions from January 2018 to September 2019 contained several red flags including, highest dosage of short-acting pain-reliever, hydromorphone 8 mg, capsules of hydromorphone 8 mg being dispensed without required therapeutic justification; and the combination of two short-acting pain-relievers, hydromorphone and methadone 10 mg, resulting in an “extreme risk of overdose.” Tr. 283-84, 468; GX 30; ALJ Ex. 42, p. 26. Dr. Sullivan deemed these red flags unresolvable and testified that a reasonable pharmacist operating within the usual course of professional practice would not have filled these prescriptions. Tr. 284, 288-89. Several prescriptions filled in mid-2018 revealed unjustified early fills. Tr. 284-87; GX 30; ALJ Ex. 42, p. 27. The pharmacist noted in J.D.'s patient profile, “NEXT FILL DATE 7/5/18!!! WATCH FILL DATES!!!!!!,” demonstrating the Respondent knew of J.D.'s issues with early fills. Such note is insufficient to justify filling J.D.'s prescriptions early. Tr. 287-88; GX 29; ALJ Ex. 42, p. 28.

As to Patient J.M., Dr. Sullivan opined that the 144 miles from J.M.'s home to Respondent represented a red flag. Tr. 289; GX 60; ALJ Ex. 42, p. 29. The prescriptions from June 2017 to September 2018 contained several red flags including, highest dosage of short-acting pain-relievers, hydromorphone 8 mg and oxycodone 30 mg, and of alprazolam 2 mg; capsules of oxycodone and hydromorphone being dispensed without required therapeutic justification; and the combination of short-acting opioids with a benzodiazepine, and a muscle relaxer. Dr. Sullivan deemed these unresolvable red flags. Tr. 290-91. Dr. Sullivan noted that J.M. was prescribed both capsules and tablets of oxycodone 30 mg between April 2018 and May 2018 demonstrating

there was no therapeutic need for compounding the oxycodone 30 mg. Tr. 290. A review of this patient's file received by Dr. Sullivan failed to reveal any effort by the Respondent to resolve the red flags relating to patient J.M.

Id.

Dr. Sullivan opined that, for the reasons discussed above, the relevant standard of care would have caused a reasonable pharmacist acting within the usual course of professional practice to decline to fill the prescriptions for J.M. Tr. 291; GX 33; ALJ Ex. 42, p. 30.

As to Patient M.M., Dr. Sullivan opined the distance between M.M.'s home and the prescribing physician's office, south of Ft. Myers, Florida, represented a red flag. Tr. 294; ALJ Ex. 42, p. 32. In reviewing M.M.'s dispensing log, Dr. Sullivan identified many of the same red flags as revealed by the other patient's records: high-strength hydromorphone prescribed and dispensed; and capsules of hydromorphone dispensed without individualized therapeutic justification. Tr. 295; GX 36; ALJ Ex. 42, p. 33. Dr. Sullivan was also suspicious of the .4 mg of folic acid, which he suspected was intended to mask the opioid prescriptions. Tr. 295-96. In reviewing the prescriptions filled from January 2019 to April 2019, Dr. Sullivan noted that the Respondent filled both capsules and tablets of hydromorphone, thus negating any prospect that the patient had an individualized therapeutic need for compounded medication. Tr. 297-98; GX 34; ALJ Ex. 42, p. 34. Dr. Sullivan was also concerned regarding a significant break in therapy, from July 18, 2018, and January 3, 2019. Tr. 297. Despite an almost six-month lapse in opioid therapy, the Respondent filled a prescription for hydromorphone 8 mg, the highest commercially available dosage. Tr. 298. If the patient had become opioid naïve during this lapse, there is a heightened risk of overdose. Tr. 298. Dr. Sullivan also recognized some red flags in the form of early fills. Tr. 299; GX 34; ALJ Ex. 42, p. 34. Dr. Sullivan deemed the above red flags unresolvable, and testified that no reasonable pharmacist acting within the usual course of professional practice would have filled the subject prescriptions. Tr. 299-301.

As to Patient N.B., Dr. Sullivan opined the 137 miles from N.B.'s home to the Respondent pharmacy represented a red flag. Tr. 301; GX 62; ALJ Ex. 42, p. 36. The prescriptions from June 2017 to August 2018 contained several red flags, including highest dosage of short-acting pain-reliever, hydromorphone 8 mg, capsules of hydromorphone 8 mg being dispensed without required therapeutic justification; two separate prescriptions for alprazolam with two separate dosage units; and the combination of an opioid and benzodiazepine. Dr. Sullivan noted the anti-inflammatory ibuprofen 400 mg prescription, which he found inconsistent in combination with the high dose of pain medication. A once a day low ibuprofen dose would have no effect in combination with such a high dose of pain medication. Dr. Sullivan found these red flags unresolvable. Tr. 302-03, 305-06; GX 39; ALJ Ex. 42, p. 37. The PDMP data revealed several prescriptions filled unjustifiably early. Tr. 303-04; GX 37; ALJ Ex. 42, p. 38. Dr. Sullivan found no evidence of an attempt to resolve these red flags. Tr. 306-07; GX 37, 39; ALJ Ex. 42, pp. 38-39. Dr. Sullivan was concerned by the two-month gap in opioid treatment from September 14, 2018, and December 20, 2018, potentially producing opioid naïveté in the patient. Tr. 304. In the patient memo, it simply stated, “Doctor ok patient to receive medication in compound capsule form,” which, according to Dr. Sullivan, is insufficient to justify compounding that medication, which requires an individualized therapeutic need. Tr. 306, 471; GX 38; ALJ Ex. 42, p. 39.

As to Patient R.B., Dr. Sullivan opined the 138 miles from R.B.'s home to Respondent represented a red flag. Tr. 307; GX 63; ALJ Ex. 42, p. 40. Dr. Sullivan further asserted that the number of patients traveling from the Ft. Myers area to Respondent represented a red flag itself. Tr. 308. The coincidence of patients traveling over 100 miles to the Respondent's pharmacy from the same proximate area represents a pattern that the standard of care would require a pharmacist to notice and to investigate. Tr. 309-10.

The prescriptions from June 2017 to August 2018 contained several red flags, including highest dosage of short-acting pain-reliever, hydromorphone 8 mg, capsules of hydromorphone 8 mg being dispensed without required therapeutic justification; prescriptions for alprazolam at the highest dosage strength; and the combination of an opioid and benzodiazepine. Dr. Sullivan found these red flags were not resolvable according to the standard of care in Florida. Tr. 311, 313, 321; GX 43; ALJ Ex. 42, p. 41. The PDMP data revealed several prescriptions filled unjustifiably early. Tr. 311-12; GX 40; ALJ Ex. 42, p. 42. Dr. Sullivan was concerned by the two-month gap in opioid treatment from September 12, 2018, to January 22, 2019, potentially producing opioid naïveté in the patient. Tr. 312, 471. Dr. Sullivan found no evidence of an attempt to resolve these red flags. Tr. 313; GX 41; ALJ Ex. 42, p. 41. In R.B.'s Patient Questionnaire, R.B. gave conflicting information as to the year of her injury. Tr. 313-14. Furthermore, R.B.'s justification for traveling more than 100 miles to the Respondent's pharmacy, “it's cheaper and they're good people,” does not resolve the red flag of long-distance travel. Tr. 315; GX 44. Nor does R.B.'s declaration that she is not selling her medications resolve concerns of diversion. Tr. 315. Patient R.B.'s PDMP report reveals she filled prescriptions at five different pharmacies, including the Respondent's pharmacy. Tr. 316-17; GX 44, p. 5. Dr. Sullivan views this as clear evidence of pharmacy shopping. Another suspicious entry in the PDMP record is the payment source for an April 6, 2016 prescription for oxycodone acetaminophen, and two August 22, 2017 prescriptions for hydrocodone, which were paid for using commercial insurance. Tr. 317-18; GX 44, p. 4. A patient alternately paying cash and using commercial insurance is a red flag of diversion or abuse. Tr. 318-19.

Dr. Sullivan noted prescriptions for R.B. in which it appeared the pharmacist, by permission of the prescribing physician, changed the prescribed “tablet” form of medication to compounded capsule. Tr. 319-20; GX 44, pp. 6, 8. As the “tablet” form was initially prescribed, changing to compounded capsule does not appear to have been done on the basis of an individualized therapeutic purpose. Tr. 321.

As to Patient R.G., Dr. Sullivan opined the 131 miles from R.G.'s home to the Respondent pharmacy represented a red flag. Tr. 322; GX 64; ALJ Ex. 42, p. 44. The prescriptions from June 2017 to September 2018 contained several red flags, including highest dosage of short-acting pain-reliever, capsules of oxycodone 30 mg being dispensed without required therapeutic justification; the highest strength for alprazolam; and the combination of an opioid and benzodiazepine. Dr. Sullivan noted the ongoing prescribing at the highest opioid dosage suggested a red flag for the lack of individualized treatment, with patients consistently receiving the highest dosage. Tr. 322-24, 329-30. A further indication that there was no therapeutic justification for the compounded capsules of oxycodone 30 mg was the two fills on August 10, 2018, for oxycodone. Tr. 324; GX 49; ALJ Ex. 42, p. 45. R.G. was dispensed 68 tablets and 70 capsules on that same day. Tr. 324-26. Dr. Sullivan found these red flags unresolvable. Tr. 322-23, 326,

328-29; GX 49; ALJ Ex. 42, p. 45. The PDMP data revealed several prescriptions filled unjustifiably early. Tr. 326-28; GX 49; ALJ Ex. 42, p. 46. The pharmacist noted in R.G.'s patient profile, “WATCH FILL DATES!!!!!!,” demonstrating the Respondent knew of R.G.'s issues with early fills. Such note is insufficient to justify filling R.G.'s prescriptions early. Tr. 328; GX 47; ALJ Ex. 42, p. 47. Dr. Sullivan found no evidence of the resolution of these red flags. Tr. 329; GX 49; ALJ Ex. 42, p. 45.

As to Patient R.L., Dr. Sullivan opined the 138 miles from R.L.'s home to the Respondent pharmacy represented a red flag. Tr. 330; GX 65; ALJ Ex. 42, p. 48. The prescriptions from June 2017 to September 2018 contained several red flags, including highest dosage of short-acting pain-relievers, hydrocodone 8 mg and oxycodone 30 mg; capsules of hydromorphone 8 mg being dispensed without required therapeutic justification; the highest strength of alprazolam; and the combination of an opioid and benzodiazepine. Dr. Sullivan was concerned by the promethazine 25 mg prescription, as it acts as a muscle relaxant with sedative qualities, thus increasing potential side effects in combination with the opioid and benzodiazepine medications. Dr. Sullivan noted the ongoing prescribing at the highest opioid dosage suggested a red flag for the lack of individualized treatment, with patients consistently receiving the highest dosage. Tr. 331-32, 329-30. Dr. Sullivan found these red flags unresolvable. Tr. 332; GX 52; ALJ Ex. 42, p. 49.

The PDMP data revealed several prescriptions filled unjustifiably early. Tr. 333-35; GX 52; ALJ Ex. 42, p. 51. The pharmacist noted in R.L.'s patient profile, “NEXT FILL 6/10/18-10 DAYS EARLY MARCH & APRIL-TOLD HIM THIS 5/11/18GD,” demonstrating the Respondent knew of R.L.'s issues with early fills. Such note is insufficient to justify filling R.L.'s prescriptions early. Tr. 334-35; GX 51; ALJ Ex. 42, p. 52. Dr. Sullivan found no evidence of the resolution of these red flags. Tr. 335-36; GX 50, 52; ALJ Ex. 42, pp. 49-52.

Finally, Dr. Sullivan opined that the compounding done in this case was not legitimate, as it was outside the standard of practice. Tr. 336-38. Dr. Sullivan explained that the FDA wants pharmacists to have the ability to compound to address the rare cases of patients with special needs, such as allergies. Tr. 337-38. If a patient had an allergy that required compounding, Dr. Sullivan would expect that to be documented in the patient profile. Tr. 339. However, compounding is also the subject of licensing and regulation. Tr. 339-40.

See

21 U.S.C. 353a; Fla. Admin. Code r. 64B16-27.700, .797. Manufacturing is not permitted under a standard community retail pharmacy license. Tr. 340. It requires specific licensing.

Id.

Dr. Sullivan noted that 95 or 96 percent of the subject hydromorphone medication was compounded. Dr. Sullivan concluded the extreme volume alone as proof positive that the Respondent's compounding was not limited to patients with individualized therapeutic needs. Tr. 337. Although the Patient Profiles reviewed contained a category for “allergy,” no allergies were documented, either within the Patient Profiles or in any of the other records reviewed. Tr. 339;

see

Fla. Admin. Code r. 64B16-27.800(2). Dr. Sullivan found no evidence that any of the subject patients receiving compounded medications were subject to medication allergies. Tr. 339.

Expert Opinion

[Omitted for brevity.]

Dr. Sullivan was qualified as an expert in the field of pharmacy and the standard of care for the practice of pharmacy in the State of Florida. He gave his opinion regarding the relevant standards of care in Florida for the practice of pharmacy, including the existence of red flags, or generally suspicious circumstances. He also gave his opinion regarding the parameters of lawful pharmacy compounding in light of federal statutes and regulations governing compounding and manufacturing. 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. Sullivan demonstrated a commanding grasp of pharmacy practice and of the distinctions between pharmacy compounding and manufacturing. However, there were several matters for which he had diminished credibility. For one, he was unaware that Florida had codified the standard of care for medical personnel. Although I later determined the statute in question did not apply to pharmacists, it was somewhat surprising he was unaware of it, as he teaches Florida pharmacy law.

[Text omitted.] *

E 19

However, under Florida Statute 766.102, pharmacists are not considered “healthcare providers.” This Florida law defines “healthcare providers” as:

. . . any hospital or ambulatory surgical center as defined and licensed under chapter 395; a birth center licensed under chapter 383; any person licensed under chapter 458, chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, part I of chapter 464, chapter 466, chapter 467, part XIV of chapter 468, or chapter 486; a health maintenance organization certificated under part I of chapter 641; a blood bank; a plasma center; an industrial clinic; a renal dialysis facility; or a professional association partnership, corporation, joint venture, or other association for professional activity by health care providers.

Fla. Stat. 766.202(4). Pharmacists are administered under chapter 465.

I have omitted the RD's statement that Dr. Sullivan agreed that this statute (which does not apply to pharmacists) was consistent with his understanding of the Florida standard of care for pharmacists. RD, at 39. I have also deleted the RD's statement that Dr. Sullivan “arguably conceded an alternate generalized standard of care for pharmacists in Florida, which is not consistent with Florida law or regulation.”

Id.

at 39-40. When Respondent's counsel asked Dr. Sullivan whether he was aware of the statute, and whether he agreed with the definition of the standard of care outlined in the statute, Dr. Sullivan replied, “Is that out of the pharmacy statutes? I'm not familiar with that.” Tr. 438. Respondent's counsel stated that the definition comes from Florida statute 766.102, and it applies to healthcare providers.

Id.

Dr. Sullivan replied, “I'll take your word for it that that's what it says.”

Id.

Their exchange continued:

Q: Okay. Do you agree that, that's the definition—the appropriate definition of the standard of care in Florida?

A: In a broad sense, yes.

Q: Okay. And it talks about reasonably prudent healthcare providers, correct?

A: Can you read that statement in there where it says that again, please?

Q: Sure, I would be happy to. I'll read you the whole thing just to make sure you have it all. “The prevailing professional standard of care for a given healthcare provider shall be that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar healthcare providers.

A: And what was the question again, please?

Q: Do you agree that that's an accurate statement of the standard of care that applies in Florida?

A: If that's what the statute says, yes.

Tr. 438-39. During this exchange, Dr. Sullivan did not testify that this statute outlines the standard of care for pharmacists. Dr. Sullivan agreed—when asked whether the statute outlined “the appropriate definition of the standard of care in Florida”—that it captured the standard of care in a “[i]n a broad sense.”

Id.

Dr. Sullivan repeated several times that he was not aware of this statute, but he would “take [counsel's] word for it” that he was accurately reciting the definition from the statute.

Id.

I do not find that this testimony diminishes Dr. Sullivan's credibility as an expert in the standard of care for Florida pharmacists.

[Text omitted where footnote was included.]

[Text omitted.] *

I have omitted the RD's assertion that Dr. Sullivan offered inconsistent testimony regarding unresolvable red flags. RD, at 40. I find that Dr. Sullivan's testimony on this issue was consistent, reliable, and supported by prior Agency Decisions. The RD found that Dr. Sullivan's testimony was

inconsistent because he “described several red flags as unresolvable,” but later “conceded that those same red flags could be resolved.

Id.

Additionally, the RD states that Dr. Sullivan “at one point suggested no single red flag was unresolvable, rather it was the combination of red flags which made them unresolvable.”

Id.

The RD does not cite to specific portions of the record here, but an earlier section of the RD discusses portions of Dr. Sullivan's testimony that the ALJ found confusing. RD, at 24.

The ALJ primarily seemed to be concerned with Dr. Sullivan's testimony about prescribing two immediate-release opioids concurrently. The ALJ asked Dr. Sullivan for an example of an unresolvable combination of red flags, and Dr. Sullivan testified that it would be unresolvable if a patient “brought in a prescription for two immediate release narcotic pain killers

in very high doses.”

Tr. 228 (emphasis added). The following day, the ALJ said to Dr. Sullivan, “Yesterday you testified that the prescribing of two fast-acting opioids can never be permitted,” and Dr. Sullivan replied, “I'm sorry, Your Honor. If I said that, I misspoke.” Tr. 481. Dr. Sullivan's testimony, however, had been that the prescribing of two immediate-release opioids

in very high doses

was unresolvable.

Id.

at 228. Dr. Sullivan clarified that there were instances were two immediate-release opioids could be used together. Tr. 481. Dr. Sullivan also testified that this red flag “didn't apply to this case here.”

Id.

at 482. I do not find that Dr. Sullivan's testimony about immediate-release opioids undermines his testimony about unresolvable red flags. Throughout the hearing, Dr. Sullivan consistently testified that a pharmacist should analyze all of the red flags with a prescription as a “collective whole,” rather than analyzing each red flag in isolation, and that certain combinations of red flags may not be resolvable “when taken as a collective whole.” Tr. 282, 409-11, 473, 475, 481-82, 498. Dr. Sullivan further testified that the red flags presented by each prescription in this case were unresolvable. As discussed in more detail below, Dr. Sullivan's testimony finds support in prior Agency decisions, which have consistently held—based on the credible testimony of pharmacy experts—that prescriptions may raise red flags that are so strongly indicative of diversion that they cannot be resolved by a pharmacist acting within the usual course of professional practice.

Dr. Sullivan deemed the questionnaire used by the Respondent as essentially a subterfuge, designed not to reveal red flags and enable the Respondent to assess them, but as cover for red flags already known to exist by the Respondent. This conclusion was developed on the basis of Dr. Sullivan's experience in reviewing pharmacies, which were found to be operating in violation of pharmacy standards. It seemed more in the nature of an observation of coincident patterns. This conclusion assumes the questionnaires were never intended to assist the Respondent in assessing red flags versus being a good faith effort to identify red flags, which was never fulfilled. If the questionnaires were designed to provide cover to the Respondent's illegal behavior, they fail to do so. I did not see the questionnaires as providing any cover to the Respondent's improper filling of prescriptions. If anything, the completed questionnaires highlighted and documented red flags of long-distance travel. The completed questionnaires are damning, not exculpatory. Although not dispositive of this issue, the Government has not alleged intentional diversion. I find Dr. Sullivan's subject conclusion more in the nature of speculation. I don't believe the record provides sufficient factual foundation to support this expert opinion.

I also find it inconsistent with the facts of the case. Accordingly, on the basis of the instant record, I find Dr. Sullivan's subject conclusion unjustified.

[Omitted for clarity.]

Dr. Sullivan made a similar conclusion regarding the prescribing of non-controlled substances and of controlled substances not subject to abuse or diversion. Again, he deemed such prescriptions as an apparent subterfuge on the part of the prescriber, designed to mask the improper prescribing of controlled substances highly subject to abuse and diversion, and creating a red flag, which went unaddressed by the Respondent. I question the sufficiency of the factual foundation for Dr. Sullivan's expert opinion that the above prescriptions were an apparent attempt to mask scores of improper opioid prescriptions. [Omitted for brevity].

*G 21

This finding does not affect the probity of Dr. Sullivan's opinions as to the therapeutic effect of the subject medications, their contraindication with other prescribed medications, or the justification of their prescription.

I agree with the ALJ's conclusions about Dr. Sullivan's testimony regarding the physicians' motivations for prescribing non-controlled substances, so I am disregarding this testimony.

[Omitted for clarity.]

The Respondent made the point that Dr. Sullivan did not confer with the subject patients or with their prescribing physicians. Dr. Sullivan conceded that a diligent pharmacist would, as circumstances require, attempt to resolve any red flags by discussing them with the patient and with the prescribing physician. The Respondent argues that the fact Dr. Sullivan did not discuss any red flags with the patients or with the prescribers renders Dr. Sullivan's conclusions regarding red flags questionable as Dr. Sullivan did not attempt to resolve the subject red flags.

Although certainly the extent of Dr. Sullivan's review of relevant material is critical to the conclusions he draws, the focus of Dr. Sullivan's opinions relate to whether the Respondent complied with his corresponding responsibility to resolve red flags prior to dispensing the subject medications, and to documenting any resolution within the file. It is neither here nor there that Dr. Sullivan could have resolved his own concerns regarding the subject red flags by speaking to the patients and prescribers years later. Nor is it dispositive that Dr. Sullivan could have determined that the subject red flags were resolvable at the time they were dispensed, if the Respondent failed to satisfy his corresponding responsibility to resolve them. So, with the exception of his opinion regarding the apparent red flag created by the prescribing of non-controlled substances (discussed immediately above), I don't view the fact that Dr. Sullivan did not speak with the subject patients or prescribers as diminishing the probity of his relevant opinions as to the Respondent's acts or omissions at all.

The Respondent makes the similar point regarding the fact that Dr. Sullivan did not review copies of the physical prescriptions, as there is evidence Respondent may have made notations relevant to resolving red flags directly onto the prescriptions. Dr. Sullivan freely conceded he had not been provided with copies of the prescriptions to review. [Omitted for Relevance.] [However, because Dr. Sullivan credibly testified that the red flags for each patient could not have been resolved by a pharmacist acting within the usual course of professional practice, it was unnecessary for Dr. Sullivan to review the prescriptions.] Here, Dr. Sullivan was provided sufficient materials to develop his opinions, which assist the factfinder to understand or to determine facts in issue. [Citation omitted.]

[The RD does not make an explicit credibility finding on Dr. Sullivan's testimony, aside from stating that Dr. Sullivan was provided sufficient materials to develop his opinions and that he demonstrated a commanding grasp of pharmacy practice and the distinctions between pharmacy compounding and manufacturing. Based on these statements, and based on the controlling weight that the ALJ accorded Dr. Sullivan's unrebutted expert testimony in his legal analysis, it is evident that the ALJ found Dr. Sullivan's opinions to be generally consistent, reliable, and credible. I agree with that conclusion.]

Respondent's Case-in-Chief

The Respondent presented its case-in-chief through the testimony of a single witness, Norman L. Clement, Jr. Tr. 506-57.

Norman L. Clement, Jr.

Mr. Clement, Jr., is the son of Mr. Norman Clement, Sr., the Respondent's

owner. Tr. 506-07. Mr. Clement, Jr., has held a pharmacy tech license in Florida since 2014. Tr. 507. He has worked for the Respondent since 2014. Tr. 507, 521. Mr. Clement, Jr., reported the Respondent employs approximately four pharmacists-in-charge.

Id.

He described the Respondent as a family operation.

Id.

The Respondent gets few patient customers per day. Tr. 508. Typically, the pharmacy would only see two to three patients a day, sometimes none.

Id.

Four patients in one day would make for a busy day at the pharmacy.

Id.

The fact that the Respondent only saw a few patients per day meant that the staff could spend more time talking with the patients and getting to know them.

Id.

Mr. Clement, Jr., testified that the Respondent's staff always recorded the information it collected from the patients. Tr. 509, 543. The types of information the Respondent collected from patients included “personal life information,” how treatment was progressing, and dietary information. Tr. 509. The Respondent recorded this information in the patient's profile. Tr. 543. Sometimes it recorded the information on the hard-copy prescriptions.

Id.

When a new patient presents at the pharmacy, the Respondent gathers information about the patient to assist the pharmacist in making a decision about whether to dispense to that patient. Tr. 509, 537-38, 540. The Respondent charges new patients $25 for an initial consultation. Tr. 542. As part of this information-gathering process, the Respondent asks patients to complete a questionnaire. Tr. 511, 537-38, 542. The questionnaire solicits information regarding the reason the patient is visiting the Respondent, how the patient feels, and what caused the patient's ailment or injury. Tr. 511-12, 538, 540. Sometimes a patient has been rejected by three to six other pharmacies before visiting the Respondent. Tr. 538. The Respondent creates a patient profile for all new patients and places a copy of the questionnaire in the profile. Tr. 546-48. Notes regarding the resolution of red flags would be contained in the patient's profile. Tr. 553. Mr. Clement, Jr., testified that the Respondent “look[ed] at every aspect” of a prescription before filling it, and that if “everything checks out,” the patient is cleared to fill the prescription. Tr. 540-41. The Respondent places a check mark on a prescription to verify it is cleared for dispensing. Tr. 554-55.

Mr. Clement, Jr., testified that the questionnaire asks the patients to provide details about their injury; simply claiming that “my back pain hurts” will not suffice. Tr. 512. The Respondent also makes a copy of the patient's driver's license. Tr. 513, 538. Mr. Clement, Jr., testified that the pharmacy checked the medical legitimacy of prescriptions

and called the prescribing doctor for all controlled substance prescriptions. Tr. 538-40, 542-43, 545. Initially, Mr. Clement, Jr., testified that the Respondent would write down what the doctor says in the patient's profile. Tr. 543-44. Government counsel later asked if the lack of notes about calling the doctor meant the doctor was never called. Tr. 550. Mr. Clement, Jr., responded, “Not necessarily,” and explained that sometimes the Respondent would write those notes on the hard-copy prescription. Tr. 550-51. The Respondent would write, “M.D. okay” on the prescription to verify the doctor had been called. Tr. 550-52.

[Omitted for clarity.]

After reviewing the questionnaire, a staff member searches for the patient in the PDMP to see if the patient is visiting other pharmacies. Tr. 512-13, 538. Typically, the Respondent attaches a copy of the PDMP reports to the patient's file. Tr. 513. The software system that the Respondent used also produced a “Narx” score that informed the pharmacy about a patient's risk of addiction. Tr. 518-19. The Respondent and its staff used the “Narx” score feature when deciding whether to fill prescriptions.

Id.

Sometimes after conducting this process the Respondent has turned patients away. Tr. 512, 538, 542.

Mr. Clement, Jr.'s, primary duties at the Respondent are working with the computer system and records. Tr. 515, 522. The Respondent uses Rx30 software. Tr. 514. When the DEA served the OSC/ISO on the Respondent in August 2019, it also executed a search warrant and seized two of the Respondent's computers. Tr. 514-15, 530-31. The Respondent also kept files on a back-up system, which was also seized by the DEA. Tr. 534-35. When the computers were eventually returned, they did not work and the scanned copies of prescriptions had been erased.

Tr. 514-15, 530-31. Mr. Clement, Jr., worked with an IT consultant and Rx30's technical support to try to recover the prescription image files from the computers seized by DEA. Tr. 517-18. Those recovery efforts were unsuccessful.

Id.

Although Mr. Clement, Jr.'s, testimony about how files were backed-up was sometimes difficult to follow, Tr. 531-36, he seemed to indicate that the Respondent had the capability of retrieving lost files from Rx30's system. Tr. 535-36.

The DEA also seized a touch-screen computer monitor. Tr. 516. When DEA returned the monitor, the screen had been shattered and it no longer worked.

Tr. 516-17, 531. The DEA also seized most of the hard-copy prescriptions that were kept at the pharmacy.

Tr. 516.

[I have omitted, for brevity and relevance, the RD's discussion of unfair, unequal, or uneven treatment. Respondent did not raise any claims of unfair treatment in its Posthearing brief, and I do not find sufficient evidence on the record to suggest that Respondent was treated unfairly. Respondent raised concerns prehearing that it had not received access to all of the evidence that DEA had seized when it executed the OSC on August 29, 2019. However, those concerns appear to have been addressed before the hearing. Respondent also raised concerns that certain equipment that was seized by DEA had been damaged. However, the evidence on the record provides no indication of any sort of unequal treatment, or any improper motive in commencing the investigation. In fact, the evidence demonstrates that such an investigation was routine. DEA began investigating Respondent after receiving a tip from the Florida Department of Health in May 2017.]

Mr. Clement, Jr., testified that the Respondent has not received back the hard-copy prescriptions seized by the DEA. Tr. 520. After testifying to this, the Respondent's counsel informed the Tribunal, on the record, that the DEA had provided copies of the prescriptions to counsel's office.

Id.

In general, I found Mr. Clement, Jr.'s, testimony to be somewhat subjective. As essentially a party to the litigation, he had a clear personal and family interest in the outcome. The Respondent's position that the Agency has treated the Respondent unfairly was reflected in Mr. Clement, Jr.'s, testimony. His emotional description of the manner of the seizure of Respondent's equipment and records, and their destruction and loss in the hands of the Agency, manifests his partiality in this matter. However, having a personal interest in the litigation, or manifesting an emotional commitment to your cause, are not bars to credibility. They are simply factors to be considered. I had some concerns with aspects of his testimony, however, which detracted from his credibility on certain topics. For the most part, these concerns were situations where Mr. Clement, Jr., provided conclusory testimony, and then followed-up with more detail when pressed by counsel.

There were also instances of inconsistency. For example, Mr. Clement, Jr., initially testified that the Respondent's computer system worked normally after the DEA made mirror images of the Respondent's computer hard-drive. Tr. 522, 525. He then clarified that the Respondent's computers did not work normally. Tr. 525-26. The computer system started working normally again about 3-4 months after the DEA made mirror images of it. Tr. 527.

Another example concerns the Respondent's efforts to call patients' past pharmacies. At the beginning of direct examination, Mr. Clement, Jr., testified that as part of its intake process for new patients, the Respondent would call a new patient's past pharmacy only if the Respondent had questions of that pharmacy. Tr. 512. Government counsel later asked, “Sometimes you call their past pharmacist?” Tr. 546. He answered, “Yes.”

Id.

Just moments later, Mr. Clement, Jr., testified that the Respondent always called pharmacies for every new patient. Tr. 547, 549. This testimony paints an unclear picture of whether the Respondent always called a patient's previous pharmacy or whether it only called in certain situations.

Another example concerned the extent to which the Respondent verified prescriptions' medical legitimacy. Mr. Clement, Jr., explained that neither he nor the Respondent's pharmacists were qualified to read an MRI report (or any other laboratory test). Tr. 539-40.

He said that some patients would provide a copy of their MRI report, but “no pharmacist needs to look at an MRI.”

Id.

This testimony seems to conflict with his testimony that the Respondent got to know its new patients by looking into their history, background, “pain ailments, what they're going through, [and] sometimes treatment plans.” Tr. 508. If the Respondent checked a patient's background, and confirmed medical legitimacy of the prescription, then it seems that the Respondent merely took the patient (and his or her doctor) at their word, since checking commonly-procured objective medical findings, such as an MRI report, was outside the Respondent's scope of review. The fact that the Respondent may have merely taken doctors, patients, and pharmacies at their word is supported by Mr. Clement, Jr.'s, later testimony that a patient is cleared to receive controlled substances if the doctor says “yes” and the patient's previous pharmacy says the patient is “okay.” Tr. 542.

Mr. Clement, Jr's., testimony would make sense if he was referring to the actual x-ray or MRI, which require special training to interpret, such as that of a radiologist, who reduces his findings to a written report, which might then be appropriate for a pharmacist to review.

There was another instance where Mr. Clement, Jr., came across as more of an advocate for the Respondent rather than an objective witness. In this instance, the Respondent's counsel asked Mr. Clement, Jr., whether the Respondent had developed a niche business in the types of patients it sees. Tr. 509-10. This seemed to be a straightforward, unambiguous question. Mr. Clement, Jr., responded, however, by describing, at length, the process of checking the patient's identification, and checking the PDMP and NarcFacts. Tr. 510-11. The Respondent's counsel then followed-up with a leading question, asking Mr. Clement, Jr., whether the Respondent “dispense[d] primarily to patients who are suffering from chronic non-malignant pain?” Tr. 511. Mr. Clement, Jr., answered in the affirmative.

Id.

Mr. Clement, Jr.'s, non-responsive answer demonstrated an eagerness to advocate the Respondent's safety measures for screening patients and preventing diversion, rather than answering the question about what types of clients the Respondent serviced.

Having listened to Mr. Clement, Jr.'s, testimony at the hearing, and having closely reviewed the transcript of his testimony, I find him to be generally credible, with the few exceptions noted above. He generally presented as a professional, knowledgeable, and honest witness. I will give his testimony weight to the extent it is internally consistent, and to the extent it is consistent with other evidence and testimony of record.

The Government's Rebuttal Case

After each party presented its case-in-chief, the Government presented the rebuttal testimony of DI Albert. Tr. 557-68.

DI Albert

The Government introduced DI Albert's rebuttal testimony to rebut Mr. Clement, Jr.'s, testimony about the resolution of red flags. Tr. 559-60, 563-64. DI Albert testified about a blog post authored by Mr. Clement, Sr.

Tr. 559, 561. DI Albert downloaded this blog post from the internet. Tr. 562. The blog post identifies its author as “Norman J. Clement, R.Ph, DDS.” Tr. 563. DI Albert also downloaded an attachment from the blog post. Tr. 564-65. The attachment is a copy of the Government's prehearing statement in this case. Tr. 565. There are notes written on the prehearing statement, to include the following note on page 23:

Although the Government offered the title of the blog post, “DEA's Kourt of the Kangaroo,” the title was only admitted for authentication purposes.

The question of the red flag issue is not an issue to [me] because I don't challenge the physician for diagnosing and writing prescriptions for the patients because I'm not authorized or qualified to challenge a physician's diagnosis and treatment of his or her patients. Therefore, on the red flag issues, the question is, are they challenging me for filling the prescription or are they challenging the physician who wrote the prescription?

Tr. 566. Neither the hard-copied blog post nor attachment were admitted into evidence; only the oral testimony of DI Albert reading the above-quoted paragraph. Tr. 567.

During this brief rebuttal testimony, DI Albert presented, as he did in the Government's case-in-chief, as an honest, professional, and impartial investigator who had no stake in the case's outcome. DI Albert presented his rebuttal testimony in a credible and reliable manner. Although I fully credit DI Albert's rebuttal testimony, I will only consider his rebuttal testimony to the extent that the paragraph he read into the record rebuts Mr. Clement, Jr.'s, testimony that the Respondent resolved red flags.

The Facts

Stipulations of Fact

The Government and the Respondent did not agree to any stipulations of fact.

Findings of Fact

The factual findings below are based on a preponderance of the evidence, including the detailed, credible, and competent testimony of the aforementioned witnesses, the exhibits entered into evidence, and the record before me. The findings of fact are based primarily on those proposed by the Government in its post-hearing brief. I have also considered the findings of fact proposed by the Respondent and found that many of those proposed findings related to matters proposed by the Government or related to matters addressed elsewhere in this Recommended Decision. If a proposed finding of fact is not included in this section and is also not addressed elsewhere in this Decision, it is because that proposed finding was not relevant to deciding this case.

1. Respondent is registered with the DEA to handle controlled substances in Schedules II through V under Certificate of Registration No. FP2302076. Respondent's registered address is 1461 West Busch Boulevard, Tampa, Florida 33612. Respondent's DEA Certificate of Registration expires by its own terms on March 31, 2022. GX 1.

2. Oxycodone is a Schedule II controlled substance. 21 CFR 1308.12(b)(1).

3. Hydromorphone is a Schedule II controlled substance. 21 CFR 1308.12(b)(1).

4. Alprazolam is a Schedule IV controlled substance. 21 CFR 1308.14(c).

5. Morphine Sulfate is a Schedule II controlled substance. 21 CFR 1308.12(b)(1).

6. Methadone is a Schedule II controlled substance. 21 CFR 1308.12(c).

7. Hydromorphone 8 mg is a commercially available drug. Tr. 232. Hydromorphone 8 mg is the highest strength of hydromorphone that is commercially available. Tr. 248.

8. Oxycodone 30 mg is a commercially available drug. Tr. 232.

DEA's Investigation

9. After receiving a tip from the Florida Department of Health in May 2017, DEA investigators traveled to Respondent's registered address and presented a Notice of Inspection to the pharmacist present, who consented to the inspection. Approximately ten to fifteen minutes later, Respondent's owner, Norman Clement, Sr., indirectly asked the DEA investigators to leave, which they did. Tr. 26-27.

10. In September 2017, DEA investigators served an administrative subpoena on Respondent seeking, among other things, original Schedule II controlled substances prescriptions, receiving records, and “batch records.” Tr. 27. Government Exhibits 2 through 6 were produced by Respondent to DEA in response to the September 2017 subpoena and were admitted into evidence in this matter. Tr. at 27-34.

11. On September 10, 2018, DEA investigators executed an Administrative Inspection Warrant (“AIW”) at Respondent's registered address. Tr. 52.

12. DI Albert and Respondent's owner conducted an inventory of the Schedule II controlled substances contained in the safe located at Respondent's address. Tr. 56. On September 10, 2018, there were 3,546 compounded capsules of hydromorphone 8 mg; 470 commercially-produced tablets of hydromorphone 8 mg; 574 compounded capsules of oxycodone 30 mg; and 204 commercially-produced oxycodone 30 mg tablets in the safe. GX 7. There were also 155.2 grams of hydromorphone powder and 26 grams of oxycodone powder.

Id.

There were no other Schedule II controlled substances contained in the safe. Tr. 59.

13. During the AIW, DEA investigators attempted to inspect and copy certain records. Tr. 56. At the time, Respondent's owner was not able to tell the investigators where these records were located. Tr. 56-57. As a result, one of Respondent's owner's sons (Norman Clement, Jr.) was reached by video-teleconference on a series of mobile devices and was able to direct the investigators to the location of various records. Tr. 61-62;

see also

Tr. 521-23.

14. During the execution of the AIW, DEA investigators also served an administrative subpoena, seeking complete copies of the “patient record system” for certain specific patients. Tr. 53; GX 67.

15. During the execution of the AIW, a technician from DEA's Digital Evidence Laboratory (SFL-9) was able to obtain copies of electronic records from Respondent's system by “mirroring” the hard drive. Tr. 62. The records obtained by the SFL-9 investigator included information relating to patients not involved in this proceeding.

Tr. 90-93. The SFL-9 provided DI Albert with electronic copies of the records obtained during the execution of the AIW. Tr. 62-63, 94.

I do not agree that DI Albert's testimony supports a finding that the SFL-9 investigator obtained a complete copy of the Respondent's electronic records, as the Government proposed in its post-hearing brief. Gov't PHB, p. 4, ¶ 16 (citing Tr. 90-93). DI Albert's testimony supports a finding that the information “mirrored” from the hard-drive included patients other than the eleven involved here, but his testimony does not support the conclusion that the information obtained was a “complete copy” of all of the Respondent's records. Tr. 90-93.

16. Government Exhibit 11 is a complete and accurate copy of Respondent's dispensing log for June 1, 2017, to September 7, 2018, which was obtained during the execution of the AIW in September 2018. Tr. 63-66. Government Exhibits 12-13; 15-17; 20-21; 23-24; 26-27; 29-30; 32-33; 35-36; 38-39; 41-43; 47-49, and 51 are correct and accurate copies of documents that were obtained from Respondent's electronic record system by the SFL-9 technician during the execution of the AIW. Tr. 68-86.

17. During the course of the investigation, DI Albert queried the Florida Prescription Drug Monitoring Database (E-FORCSE or PDMP) and obtained information regarding Respondent's dispensing of controlled substance as it was reported to the State of Florida. Tr. 44. Government Exhibits 8-10 are accurate copies of the data obtained from the E-FORSCE database for the dates listed. Tr. 48-51. Government Exhibits 14, 19, 22, 25, 28, 31, 34, 37, 40, 46, and 50 are complete and accurate copies of E-FORSCE information for certain specific enumerated patients. Tr. 68-86. There is no evidence in the record to indicate that the information reported by Respondent to the E-FORSCE database is inaccurate or unreliable.

18. In May 2018, DI Albert served an additional subpoena on Respondent seeking the complete patient record system maintained by Respondent for certain specific patients, as well as any “other documentation kept by [Respondent] in connection with the filling of prescriptions . . . for these individuals.” Tr. 88-89; GX 68.

19. Government Exhibit 18 includes all documents and information produced in response to the May 2018 subpoena regarding Patient A.G. Tr. 96; GX 18. Government Exhibit 44 includes all documents and information produced in response to the May 2018 subpoena regarding Patient R.B. Tr. 97-98; GX 44.

20. The Respondent dispensed four to five prescriptions per day on average. Tr. 419.

The Standard of Professional Pharmacy Practice in Florida

21. Dr. Sullivan testified that the standard of professional practice in Florida requires that a pharmacist make sure each prescription is valid and has been issued for a legitimate medical purpose prior to dispensing controlled substances. Tr. 206. As part of this evaluation, Dr. Sullivan testified that a pharmacist must first determine whether the prescription is facially legitimate—whether it includes all of the required information.

Id.

at 208. Then, Dr. Sullivan testified that the pharmacist must attempt to determine whether there is over-utilization or under-utilization; clinical abuse or misuse going on; whether the prescription was issued for a legitimate medical purpose; and whether the prescription puts the patient at “any potential undue risk of side effects, adverse effects, and/or potentially overdose situations.”

Id.

at 207-08;

see also

Fla. Admin. Code r. 64B16-27.810 (stating that “a pharmacist shall review the patient record and each new and refill prescription” to identify potential concerns such as “[o]ver-utilization or under-utilization,” and “take appropriate steps to avoid or resolve the potential problems”); Fla. Admin. Code r. 64B16-27.831(2)(c) (“When validating a prescription, if at any time the pharmacist determines that in his or her professional judgment, concerns with the validity of the prescription cannot be resolved, the pharmacist shall refuse to fill or dispense the prescription.”)

22. [Omitted Florida law regarding the maintenance of a patient profile, because I do not think it is relevant to the facts in this case.]

23. Dr. Sullivan testified that a “red flag” is a “warning sign” that “there's something potentially wrong with the prescription.” Tr. 211. Specifically, it is a sign that “the patient may be either abusing or diverting it.”

Id.

at 212. Dr. Sullivan testified that these “red flags” are well-documented in the pharmacy

community and are known to pharmacists in the State of Florida.

Id.

at 211-14; 235-36.

24. Dr. Sullivan testified that some of these red flags include (1) patients travelling long distances to the pharmacy; (2) certain drug cocktails; (3) high dosages of immediate release pain killers; and (4) cash-paying customers.

Id.

at 214.

25. Dr. Sullivan testified that the prescribing of an opioid pain reliever and benzodiazepine at the same time is a significant red flag.

Id.

at 220-21. Dr. Sullivan noted that the FDA had issued a warning in 2016 regarding the serious health risks posed by the combination of those two medications.

Id.

at 220-21; GX 66. Dr. Sullivan testified that a reasonable pharmacist acting within the usual course of professional practice in Florida would be “very very reluctant to dispense that combination of drugs” after the FDA safety warning. Tr. 223.

26. Dr. Sullivan testified that filling a controlled substance prescription early is a red flag.

Id.

at 225-27. He testified that the standard of care required a pharmacist not to fill a Schedule II controlled substance prescription until “the day of or day before the medication from a previous prescription is supposed to run out.” Tr. 270-71. While there may be legitimate reasons for a particular prescription to be filled early in “extreme” and “unusual” cases, there is no legitimate reason for a pharmacist to fill a Schedule II controlled substance prescription early in multiple consecutive months. Tr. 270-71.

27. When a pharmacist identifies one or more red flags, he must undertake an investigation into the prescription before he can fill it. Tr. 227. This may include speaking with the patient and/or speaking with the prescriber. A pharmacist would also be expected to look at the patient profile as well as apply his clinical expertise to the drug, quantity, and strength prescribed.

Id.

The standard of care requires that the pharmacist document these conversations and analyses.

Tr. 227-28. [Dr. Sullivan testified that a pharmacist does not look at individual red flags in isolation; rather, he looks at them “as a collective whole based on what's going on with that prescription at that time.” Tr. 482, 498. Dr. Sullivan testified that there are some red flags that, “when taken as a collective whole[,] . . . cannot be resolved.” Tr. 481. Dr. Sullivan testified that in these circumstances, “no matter what the patient tells me, what the doctor tells me, any of that, I'm still not filling the prescription.” Tr. 282. Dr. Sullivan testified that an individual red flag (such as long distances traveled or cash payments) may become unresolvable if it is combined with multiple additional red flags.

Id.

at 473, 475;