[Federal Register Volume 86, Number 220 (Thursday, November 18, 2021)]
[Notices]
[Pages 64714-64746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25133]



[[Page 64713]]

Vol. 86

Thursday,

No. 220

November 18, 2021

Part IV





Department of Justice





-----------------------------------------------------------------------





Drug Enforcement Administration





-----------------------------------------------------------------------





Pronto Pharmacy, LLC; Decision and Order; Notice

  Federal Register / Vol. 86 , No. 220 / Thursday, November 18, 2021 / 
Notices  

[[Page 64714]]


-----------------------------------------------------------------------

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.\*A\ 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)).
---------------------------------------------------------------------------

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

    \*B\ 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
---------------------------------------------------------------------------

    \*C\ I have omitted the RD's discussion of the procedural 
history to avoid repetition with my introduction.
    \1\ [Footnote omitted, see supra n.*C.]
    \2\ [Footnote omitted, see supra n.*C.]
    \3\ [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.

[[Page 64715]]

    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,

[[Page 64716]]

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 \4\ 
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.
---------------------------------------------------------------------------

    \4\ 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.'' \5\ Tr. 35-37; 
GX 5.
---------------------------------------------------------------------------

    \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

[[Page 64717]]

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.\6\ Tr. 
99; GX 54.
---------------------------------------------------------------------------

    \6\ 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.\7\ 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.
---------------------------------------------------------------------------

    \7\ 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.\8\ Tr. 173.
---------------------------------------------------------------------------

    \8\ 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.

---------------------------------------------------------------------------

[[Page 64718]]

    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.\9\ 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.
---------------------------------------------------------------------------

    \9\ [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 10
---------------------------------------------------------------------------

    \10\ [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

[[Page 64719]]

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.*\D\
---------------------------------------------------------------------------

    *\D\ 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.\11\ 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.]
---------------------------------------------------------------------------

    \11\ 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. Sec.  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,\14\ over-prescribing of 
immediate release pain killers, and patients traveling in groups. Tr. 
213-15, 240-41 \15\, 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

[[Page 64720]]

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

    \12\ Dr. Sullivan noted 90% of prescriptions filled at the 
Respondent involved patients living more than 100 miles from the 
pharmacy. Tr. 235.
    \13\ Dr. Sullivan conceded that he was not aware of any federal 
or Florida regulation limiting the distance traveled to fill a 
prescription. Tr. 462.
    \14\ 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.
    \15\ 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 \16\, 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.
---------------------------------------------------------------------------

    \16\ 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

[[Page 64721]]

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.\17\ 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.
---------------------------------------------------------------------------

    \17\ 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

[[Page 64722]]

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 na[iuml]ve 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 na[iuml]vet[eacute] 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 na[iuml]vet[eacute] 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,

[[Page 64723]]

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.\18\ [Text omitted.] *E 19
---------------------------------------------------------------------------

    \18\ 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.
    *\E\ 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.
    \19\ [Text omitted where footnote was included.]
---------------------------------------------------------------------------

    [Text omitted.] *\F\
---------------------------------------------------------------------------

    *\F\ 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.

---------------------------------------------------------------------------

[[Page 64724]]

    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.\20\ 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.
---------------------------------------------------------------------------

    \20\ [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.
---------------------------------------------------------------------------

    \*G\ 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.
    \21\ [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

[[Page 64725]]

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 \22\ 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.
---------------------------------------------------------------------------

    \22\ [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.\23\ 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.
---------------------------------------------------------------------------

    \23\ 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.\24\ Tr. 516-17, 531. The DEA also seized most of the 
hard-copy prescriptions that were kept at the pharmacy.\25\ Tr. 516.
---------------------------------------------------------------------------

    \24\ [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.]
    \25\ 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.

[[Page 64726]]

    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.\26\ 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.
---------------------------------------------------------------------------

    \26\ 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.\27\ 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:
---------------------------------------------------------------------------

    \27\ 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).

[[Page 64727]]

    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.\28\ 
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.
---------------------------------------------------------------------------

    \28\ 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

[[Page 64728]]

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.\29\ 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; see also 
id. at 409-11.]
---------------------------------------------------------------------------

    \29\ [Footnote omitted.]
---------------------------------------------------------------------------

Respondent's Dispensing
Patient A.G.
    28. At all times relevant to this matter, Patient A.G. resided at 
411 NE 25th Ave., Cape Coral, Florida 33909. GX 15. Patient A.G.'s 
residence is approximately 130 miles (one-way) from Respondent's 
registered address. GX 55.
    29. All of the prescriptions filled by Patient A.G. at Respondent 
were paid for in cash. GX 14, 17.
    30. Dr. Sullivan examined the dispensing data and the patient 
profile for Patient A.G. and identified multiple ``red flags.'' 
Specifically, Dr. Sullivan concluded that the distance travelled by 
Patient A.G. was a ``red flag,'' as was the fact that Patient A.G. was 
prescribed a ``cocktail of benzodiazepine and opioid'' at the highest 
strengths of both medications. Tr. 254-55. Dr. Sullivan also observed 
that Patient A.G. filled multiple prescriptions early. Tr. 257-59.
    31. Between June 26, 2017, and August 30, 2018, Respondent filled 
30 prescriptions for controlled substances for Patient A.G., including 
10 prescriptions for hydromorphone 8 mg; 10 prescriptions for oxycodone 
30 mg; 9 prescriptions for alprazolam 2 mg; and 1 prescription for 
alprazolam 1 mg. Information regarding the controlled substances 
dispensed to Patient A.G. is accurately set forth in Government Exhibit 
17.
    32. Between December 20, 2018, and April 12, 2019, Respondent 
filled 10 prescriptions for controlled substances for Patient A.G., 
including 5 prescriptions for oxycodone 30 mg and 5 prescriptions for 
alprazolam 1 mg. Information regarding the controlled substances 
dispensed to Patient A.G. is accurately set forth in Government Exhibit 
14.
    33. Respondent maintained a patient profile for Patient A.G. The 
only pharmacist note in the profile for Patient A.G. stated: ``Doctor 
OK to Receive Medication in Compound Capsule Form.'' Govt. Ex. 15.
    34. Dr. Sullivan testified that the notes contained the Patient 
A.G.'s patient profile were insufficient to resolve (or to suggest an 
attempt to resolve) any of the red flags that he identified.*\H\ Tr. 
258.
---------------------------------------------------------------------------

    \*H\ The Findings of Fact Section discusses Respondent's efforts 
to document the resolution of red flags. This discussion has minimal 
relevance to my Decision, because I have concluded that the 
combination of red flags presented by each prescription in this case 
could not have been resolved by a pharmacist operating within the 
usual course of professional practice based on the credible and 
unrebutted testimony of the Government's expert. However, I have 
retained this discussion to provide context for Respondent's 
dispensing to each patient.
---------------------------------------------------------------------------

    35. Dr. Sullivan further testified that the answers provided on the 
Medical Questionnaire were not sufficient to resolve any of the 
specific red flags that he identified. Tr. 260-63. [Dr. Sullivan 
testified that the red flags raised by Patient A.G.'s prescriptions 
were not resolvable, and that a pharmacist operating in the usual 
course of professional practice would not have filled them. Tr. 256-57, 
267-68.]
Patient A.H.
    36. At all times relevant to this matter, Patient A.H. resided at 
1001 NE 6th Place, Cape Coral, Florida 33909. GX 20. Patient A.H.'s 
residence is approximately 130 miles (one-way) from Respondent's 
registered address. GX 56.
    37. All of the prescriptions filled by Patient A.H. at Respondent 
were paid for in cash. GX 19, 21.
    38. Dr. Sullivan examined the dispensing data and the patient 
profile for Patient A.H. and identified multiple ``red flags.'' 
Specifically, Dr. Sullivan concluded that the distance travelled by 
Patient was a ``red flag,'' as was the fact that Patient A.G. was 
prescribed a ``cocktail of benzodiazepine and opioid'' at the highest 
strengths of both medications. Tr. 268-69.
    39. Between January 4, 2018, and August 16, 2018, Respondent filled 
11 prescriptions for controlled substances for Patient A.H., including 
six prescriptions for hydromorphone 8 mg and five prescriptions for 
alprazolam 2 mg. Information regarding the controlled substances 
dispensed to Patient A.H. is accurately set forth in Government Exhibit 
21.
    40. Between September 11, 2018, and April 18, 2019, Respondent 
filled at least seven prescriptions for controlled substances for 
Patient A.H., including seven prescriptions for hydromorphone 8 mg. 
Information regarding the controlled substances dispensed to Patient 
A.H. is accurately set forth in Government Exhibit 19.
    41. Respondent maintained a patient profile for Patient A.H. The 
patient profile for Patient A.H. contained no pharmacist notes or 
comments. GX 20. In Dr. Sullivan's opinion, Patient A.H.'s patient 
profile was insufficient to resolve any of the red flags that he 
identified. Tr. 272. [Dr. Sullivan testified that the red flags raised 
by Patient A.H.'s prescriptions were not

[[Page 64729]]

resolvable, and that a pharmacist operating in the usual course of 
professional practice would not have filled them. Tr. 269, 273.]
Patient B.S.
    42. At all times relevant to this matter, Patient B.S. resided at 
117 Zobora Circle, Fort Myers, Florida 33913. GX 23. Patient B.S.'s 
residence is approximately 150 miles (one-way) from Respondent's 
registered address. GX 57.
    43. All of the prescriptions filled by Patient B.S. at Respondent 
were paid for in cash. GX 22, 24.
    44. Dr. Sullivan examined the dispensing data and the patient 
profile for Patient B.S. and identified multiple ``red flags.'' 
Specifically, Dr. Sullivan concluded that the distance travelled by 
Patient B.S. was a ``red flag,'' as was the fact that Patient B.S. was 
prescribed a cocktail of benzodiazepine and opioid at the highest 
strengths of both medications. Tr. 274-75.
    45. Between August 22, 2017, and August 23, 2018, Respondent filled 
19 prescriptions for controlled substances for Patient B.S., including 
12 prescriptions for hydromorphone 8 mg; six prescriptions for 
alprazolam 2 mg; and one prescription for alprazolam 1 mg. Information 
regarding the controlled substances dispensed to Patient B.S. is 
accurately set forth in Government Exhibit 24.
    46. Between December 20, 2018, and April 22, 2019, Respondent 
filled at least nine prescriptions for controlled substances for 
Patient B.S., including two prescriptions for hydromorphone 8 mg, four 
prescriptions for oxycodone 30 mg, and three prescriptions for 
alprazolam 1 mg. Information regarding the controlled substances 
dispensed to Patient B.S. is accurately set forth in Government Exhibit 
22.
    47. Respondent maintained a patient profile for Patient B.S. The 
patient profile for Patient B.S. contained no pharmacist notes or 
comments. GX 23.
    48. Dr. Sullivan testified that the notes contained in Patient 
B.S.'s patient profile were insufficient to resolve (or to suggest an 
attempt to resolve) any of the red flags that he identified. Tr. 277. 
[Dr. Sullivan testified that the red flags raised by Patient B.S.'s 
prescriptions were not resolvable, and that a pharmacist operating in 
the usual course of professional practice would not have filled them. 
Tr. 274, 276-77.]
Patient C.R.
    49. At all times relevant to this matter, Patient C.R. resided at 
2907 Jackson Street, Fort Myers, Florida 33901. GX 26. Patient C.R.'s 
residence is approximately 130 miles (one-way) from Respondent's 
registered address. GX 58.
    50. All of the prescriptions filled by Patient C.R. at Respondent 
were paid for in cash. GX 25, 27.
    51. Dr. Sullivan examined the dispensing data and the patient 
profile for Patient C.R. and identified multiple ``red flags.'' 
Specifically, Dr. Sullivan concluded that the distance travelled by 
Patient C.R. was a ``red flag,'' as was the fact that Patient C.R. was 
prescribed a cocktail of benzodiazepine and opioid with the opioid 
prescribed at the highest strength. Tr. 279-80.
    52. Between July 19, 2017, and August 30, 2018, Respondent filled 
13 prescriptions for controlled substances for Patient C.R., including 
six prescriptions for oxycodone 30 mg, six prescriptions for alprazolam 
1 mg, and one prescription for morphine sulfate 30 mg. Information 
regarding the controlled substances dispensed to Patient C.R. is 
accurately set forth in Government Exhibit 27.
    53. Respondent maintained a patient profile for Patient C.R. The 
only pharmacist note in the profile for Patient C.R. stated: ``Script 
has wrong birthdate on it. Dr[.] has now update[.]'' GX 26.
    54. Dr. Sullivan testified that the notes contained the Patient 
C.R.'s patient profile were insufficient to resolve (or to suggest an 
attempt to resolve) any of the red flags that he identified. Tr. at 
281.
Patient J.D.
    55. At all times relevant to this matter, Patient J.D. resided at 
229 NW 15th Place, Cape Coral, Florida 33993. GX 29. Patient J.D.'s 
residence is approximately 130 miles (one-way) from Respondent's 
registered address. GX 59.
    56. All of the prescriptions filled by Patient J.D. at Respondent 
were paid for in cash. GX 28, 30.
    57. Dr. Sullivan examined the dispensing data and the patient 
profile for Patient A.H. and identified multiple ``red flags.'' 
Specifically, Dr. Sullivan concluded that the distance travelled by 
Patient A.H. was a ``red flag,'' as was the fact that Patient A.G. was 
prescribed the highest strengths of hydromorphone. Tr. 283.
    58. Between January 15, 2018, and September 4, 2018, Respondent 
filled ten prescriptions for controlled substances for Patient J.D., 
including nine prescriptions for hydromorphone 8 mg and one 
prescription for methadone 10 mg. Information regarding the controlled 
substances dispensed to Patient J.D. is accurately set forth in 
Government Exhibit 30.
    59. In addition, Dr. Sullivan noted that Respondent dispensed two 
immediate release narcotic pain relievers (hydromorphone 8 mg and 
methadone 10 mg) to Patient J.D. on March 24, 2018. Dr. Sullivan 
testified that dispensing two immediate release narcotic pain relievers 
on the same day was ``a red flag in and of itself.'' Tr. 283-84.
    60. Respondent maintained a patient profile for Patient J.D. The 
only pharmacist note in the profile for Patient J.D. stated: ``Next 
Fill 7/5/18!!! Watch fill dates!!!!!!'' GX 29.
    61. Dr. Sullivan testified that the notes contained in Patient 
J.D.'s patient profile were insufficient to resolve (or to suggest an 
attempt to resolve) any of the red flags that he identified. Tr. 287-
88. [Dr. Sullivan testified that the red flags raised by Patient J.D.'s 
prescriptions were not resolvable, and that a pharmacist operating in 
the usual course of professional practice would not have filled them. 
Tr. 284, 288-89.]
Patient J.M.
    62. At all times relevant to this matter, Patient J.M. resided at 
3004 30th Street SW, Lehigh Acres, Florida 22976. GX 32. Patient J.M.'s 
residence is approximately 140 miles (one-way) from Respondent's 
registered address. GX 60.
    63. All of the prescriptions filled by Patient J.M. at Respondent 
were paid for in cash. GX 31, 33.
    64. Dr. Sullivan examined the dispensing data and the patient 
profile for Patient J.M. and identified multiple ``red flags.'' 
Specifically, Dr. Sullivan concluded that the distance travelled by 
Patient J.M. was a ``red flag,'' as was the fact that Patient J.M. was 
prescribed a cocktail of benzodiazepine and opioid with the opioid 
prescribed at the highest strength. Tr. 289-90.
    65. Between June 22, 2017, and September 7, 2018, Respondent filled 
23 prescriptions for controlled substances for Patient J.M., including 
eight prescriptions for oxycodone 30 mg; six prescriptions for 
hydromorphone 8 mg; and nine prescriptions for alprazolam 2 mg. 
Information regarding the controlled substances dispensed to Patient 
J.M. is accurately set forth in Government Exhibit 33.
    66. Respondent maintained a patient profile for Patient J.M. The 
patient profile for Patient J.M. contained no pharmacist notes or 
comments. GX 32.
    67. Dr. Sullivan testified that the notes contained the Patient 
J.M.'s patient profile were insufficient to resolve (or to suggest an 
attempt to resolve) any of the red flags that he identified. Tr. 290. 
[Dr. Sullivan testified that the red flags raised by

[[Page 64730]]

Patient J.M.'s prescriptions were not resolvable, and that a pharmacist 
operating in the usual course of professional practice would not have 
filled them. Tr. 290-91.]
Patient M.M.
    68. At all times relevant to this matter, Patient M.M. resided at 
1145 W Walnut Street, Lakeland, Florida 22815. GX 35. The prescriptions 
that Patient M.M. filled at Respondent were issued by a practitioner 
located at 1670 San Carlos Blvd., Fort Myers Beach, Florida 22931. GX 
36.
    69. Patient M.M.'s residence is approximately 130 miles (one-way) 
from the prescriber's location. GX 61. All of the prescriptions filled 
by Patient M.M. at Respondent were paid for in cash. GX 34, 36.
    70. Between June 6, 2017, and August 16, 2018, Respondent filled 14 
prescriptions for controlled substances for Patient M.M., including 14 
prescriptions for hydromorphone 8 mg. Information regarding the 
controlled substances dispensed to Patient M.M. is accurately set forth 
in Government Exhibit 36.
    71. Between January 3, 2019, and April 16, 2019, Respondent filled 
at least 5 prescriptions for controlled substances for Patient M.M., 
including 5 prescriptions for hydromorphone 8 mg. Information regarding 
the controlled substances dispensed to Patient M.M. is accurately set 
forth in Government Exhibit 34.
    72. Dr. Sullivan examined the dispensing data and the patient 
profile for Patient M.M. and identified multiple ``red flags.'' 
Specifically, Dr. Sullivan concluded that the distance travelled by 
Patient M.M. from her home to her physician was a ``red flag,'' as was 
the fact that Patient M.M. was prescribed the highest available 
strength of hydromorphone.\30\ Tr. 292-95.
---------------------------------------------------------------------------

    \30\ For reasons explained later in this Recommended Decision, I 
am not accepting Dr. Sullivan's opinion that the roundtrip distance 
from M.M.'s home to the prescriber's office, to the Respondent, and 
back home, is a red flag, as proposed by the Government. Gov't PHB, 
pp. 20-21, ] 101.
---------------------------------------------------------------------------

    73. Respondent maintained a patient profile for Patient M.M. The 
patient profile for Patient M.M. contained no pharmacist notes or 
comments. GX 35.
    74. Dr. Sullivan testified that the notes contained in Patient 
M.M.'s patient profile were insufficient to resolve (or to suggest an 
attempt to resolve) any of the red flags that he identified. Tr. 300. 
[Dr. Sullivan testified that the red flags raised by Patient M.M.'s 
prescriptions were not resolvable, and that a pharmacist operating in 
the usual course of professional practice would not have filled them. 
Tr. 299-300.]
Patient N.B.
    75. At all times relevant to this matter, Patient N.B. resided at 
2132 SE 5th Place, Cape Coral, Florida 33990. GX 38. Patient N.B.'s 
residence is approximately 135 miles (one-way) from Respondent's 
registered address. GX 62.
    76. All of the prescriptions filled by Patient N.B. at Respondent 
were paid for in cash. GX 37, 39.
    77. Between June 21, 2017, and August 14, 2018, Respondent filled 
19 prescriptions for controlled substances for Patient N.B., including 
12 prescriptions for hydromorphone 8 mg, four prescriptions for 
alprazolam 2 mg, and three prescriptions for alprazolam 1 mg. 
Information regarding the controlled substances dispensed to Patient 
N.B. is accurately set forth in Government Exhibit 39.
    78. Between September 14, 2018, and April 10, 2019, Respondent 
filled at least nine prescriptions for controlled substances for 
Patient N.B., including five prescriptions for oxycodone 30 mg, three 
prescriptions for alprazolam 1 mg, and one prescription for 
hydromorphone 8 mg. Information regarding the controlled substances 
dispensed to Patient N.B. is accurately set forth in Government Exhibit 
37.
    79. Dr. Sullivan examined the dispensing data and the patient 
profile for Patient N.B. and identified multiple ``red flags.'' 
Specifically, Dr. Sullivan concluded that the distance travelled by 
Patient N.B. was a ``red flag,'' as was the fact that Patient N.B. was 
prescribed a cocktail of benzodiazepine and opioid at the highest 
strengths of both medications. Tr. 301-02, 305.
    80. Respondent maintained a patient profile for Patient N.B. The 
only pharmacist note in the profile for Patient N.B. stated: ``Doctor 
OK Patient to Receive Medication in Compound Capsule Form.'' GX 38.
    81. Dr. Sullivan testified that the notes contained in Patient 
N.B.'s patient profile were insufficient to resolve (or to suggest an 
attempt to resolve) any of the red flags that he identified. Tr. 306. 
[Dr. Sullivan testified that the red flags raised by Patient N.B.'s 
prescriptions were not resolvable, and that a pharmacist operating in 
the usual course of professional practice would not have filled them. 
Tr. 302-07.]
Patient R.B.
    82. At all times relevant to this matter, Patient R.B. resided at 
2512 Pauldo Street, Fort Myers, Florida 33916. GX 41. Patient R.B.'s 
residence is approximately 140 miles (one-way) from Respondent's 
registered address. GX 63.
    83. All of the prescriptions filled by Patient R.B. at Respondent 
were paid for in cash. GX 40, 43.
    84. Between June 28, 2017, and August 16, 2018, Respondent filled 
24 prescriptions for controlled substances for Patient R.B., including 
12 prescriptions for hydromorphone 8 mg, 11 prescriptions for 
alprazolam 2 mg, and one prescription for alprazolam 1 mg. Information 
regarding the controlled substances dispensed to Patient R.B. is 
accurately set forth in Government Exhibit 43.
    85. Between September 12, 2018, and April 15, 2019, Respondent 
filled at least 10 prescriptions for controlled substances for Patient 
R.B., including five prescriptions for hydromorphone 8 mg and five 
prescriptions for alprazolam 1 mg. Information regarding the controlled 
substances dispensed to Patient R.B. is accurately set forth in 
Government Exhibit 40.
    86. Respondent maintained a patient profile for Patient R.B. The 
patient profile for Patient R.B. contained no pharmacist notes or 
comments. GX 41.
    87. Dr. Sullivan examined the dispensing data and the patient 
profile for Patient R.B. and identified multiple ``red flags.'' 
Specifically, Dr. Sullivan concluded that the distance travelled by 
Patient R.B. was a ``red flag,'' as was the fact that Patient R.B. was 
prescribed a cocktail of benzodiazepine and opioid with the opioid 
prescribed at the highest strength. Tr. 310-11.
    88. Dr. Sullivan testified that the notes contained in Patient 
R.B.'s patient profile were insufficient to resolve (or to suggest an 
attempt to resolve) any of the red flags that he identified. Tr. 313. 
[Dr. Sullivan testified that the red flags raised by Patient R.B.'s 
prescriptions were not resolvable, and that a pharmacist operating in 
the usual course of professional practice would not have filled them. 
Tr. 311, 313, 321.]
Patient R.G.
    89. At all times relevant to this matter, Patient R.G. resided at 
1915 NE 5th Street, Cape Coral, Florida 33909. GX 47. Patient R.G.'s 
residence is approximately 130 miles (one-way) from Respondent's 
registered address. GX 64.
    90. All of the prescriptions filled by Patient R.G. at Respondent 
were paid for in cash. GX 46, 49.
    91. Between June 28, 2017, and September 7, 2018, Respondent filled 
29 prescriptions for controlled substances for Patient R.G., including 
17 prescriptions for oxycodone 30 mg, and 12 prescriptions for 
alprazolam 2 mg. Information regarding the controlled

[[Page 64731]]

substances dispensed to Patient R.G. is accurately set forth in 
Government Exhibit 49.
    92. Dr. Sullivan examined the dispensing data and the patient 
profile for Patient R.G. and identified multiple ``red flags.'' 
Specifically, Dr. Sullivan concluded that the distance travelled by 
Patient R.G. was a ``red flag,'' as was the fact that Patient R.G. was 
prescribed a cocktail of benzodiazepine and opioid at the highest 
strengths of both medications. Tr. 322-23.
    93. Respondent maintained a patient profile for Patient R.G. The 
only pharmacist note in the profile for Patient R.G. stated: ``Watch 
Fill Dates!!!!!!!!!!!!'' GX 47.
    94. Dr. Sullivan testified that the notes contained in Patient 
R.G.'s patient profile were insufficient to resolve (or to suggest an 
attempt to resolve) any of the red flags that he identified. Tr. 328. 
[Dr. Sullivan testified that the red flags raised by Patient R.G.'s 
prescriptions were not resolvable, and that a pharmacist operating in 
the usual course of professional practice would not have filled them. 
Tr. 322-23, 326, 328-29.]
Patient R.L.
    95. At all times relevant to this matter, Patient R.L. resided at 
135 SW 29th Terrace, Cape Coral, Florida 33914. GX 51. Patient R.L.'s 
residence is approximately 140 miles (one-way) from Respondent's 
registered address. GX 65.
    96. All of the prescriptions filled by Patient R.L. at Respondent 
were paid for in cash. GX 50, 52.
    97. Between June 21, 2017, and September 4, 2018, Respondent filled 
16 prescriptions for controlled substances for Patient R.L., including 
14 prescriptions for hydromorphone 8 mg, one prescription for oxycodone 
30 mg, and one prescription for alprazolam 2 mg. Information regarding 
the controlled substances dispensed to Patient R.L. is accurately set 
forth in Government Exhibit 52.
    98. Between December 27, 2018, and April 16, 2019, Respondent 
filled at least five prescriptions for controlled substances for 
Patient R.L., including five prescriptions for oxycodone 30 mg. 
Information regarding the controlled substances dispensed to Patient 
R.L. is accurately set forth in Government Exhibit 50.
    99. Dr. Sullivan examined the dispensing data and the patient 
profile for Patient R.L. and identified multiple ``red flags.'' 
Specifically, Dr. Sullivan concluded that the distance travelled by 
Patient R.L. was a ``red flag,'' as was the fact that Patient R.L. was 
prescribed opioids at the highest strengths available. Tr. 330-31.
    100. Respondent maintained a patient profile for Patient R.L. The 
only pharmacist note in the profile for Patient R.L. stated: ``Next 
Fill 6/10/18--10 Days Early March & April--Told Him This 5/11/18 
GD[.]'' GX 51.]
    101. Dr. Sullivan testified that the notes contained in Patient 
R.L.'s patient profile were insufficient to resolve (or to suggest an 
attempt to resolve) the red flags that he identified. Tr. 335. [Dr. 
Sullivan testified that the red flags raised by Patient R.L.'s 
prescriptions were not resolvable, and that a pharmacist operating in 
the usual course of professional practice would not have filled them. 
Tr. 332, 335-36.]
Compounding
    102. Respondent repeatedly dispensed both commercially-available 
tablet and compounded capsule forms of controlled substances to the 
same patients, indicating that those patients did not have a legitimate 
therapeutic need for the compounded form. See, e.g., Tr. 256, 290, 297, 
321, 325, 326.
    103. In May 2012, then-TFO Jeffrey Shearer conducted an interview 
with Respondent's owner regarding the compounding that he was doing at 
Respondent. Tr. 183.
    104. Respondent's owner indicated that his formulary was designed 
to ensure that the compounded product was ``essentially similar'' to 
the commercially-produced product. Respondent's owner stressed that his 
compounded product had the same ``bioavailability'' as the commercially 
available product. Tr. 184-85.
    105. TFO Shearer observed that Respondent's owner was compounding 
thousands of dosage units at one time. Respondent's owner explained 
that he did so because it was ``cost effective'' to produce large 
volumes at the same time. Tr. 185.
    106. Respondent's owner told TFO Shearer that some of his customers 
did not want the compounded capsules, but that Respondent's owner 
assured the patients that the capsules and the tablets were ``the same, 
that they would have the same effect.'' Tr. 185-86.

Analysis

Findings as to Allegations

    The Government alleges that the Respondent's COR should be revoked 
because the Respondent failed to ensure that it only filled 
prescriptions issued for legitimate medical purposes, and within the 
course of professional practice, in violation of its corresponding 
responsibility, and repeatedly filled prescriptions in the face of 
obvious [and unresolvable] red flags of diversion, and in violation of 
state law under the Florida Administrative Code, and state requirements 
for the minimum standard of care, and its registration would be 
inconsistent with the public interest, as provided in 21 U.S.C. 
824(a)(4) and 21 U.S.C. 823(f). The Government also alleges that the 
Respondent engaged in a pattern of manufacturing controlled substances 
without proper registration.
    In the adjudication of a revocation or suspension of a DEA COR, DEA 
has the burden of proving that the requirements for such revocation or 
suspension are satisfied. 21 CFR 1301.44(e). Where the Government has 
sustained its burden and made its prima facie case, a respondent must 
both accept responsibility for his actions and demonstrate that he will 
not engage in future misconduct. Patrick W. Stodola, M.D., 74 FR 
20,727, 20,734 (2009). Acceptance of responsibility and remedial 
measures are assessed in the context of the ``egregiousness of the 
violations and the [DEA's] interest in deterring similar misconduct by 
[the] Respondent in the future as well as on the part of others.'' 
David A. Ruben, M.D., 78 FR 38,363, 38,364 (2013). Where the Government 
has sustained its burden, the registrant must present sufficient 
mitigating evidence to assure the Administrator that he can be 
entrusted with the responsibility commensurate with such a 
registration. Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008).
    The Agency's conclusion that ``past performance is the best 
predictor of future performance'' has been sustained on review in the 
courts, Alra Labs., Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), as 
has the Agency's consistent policy of strongly weighing whether a 
registrant who has committed acts inconsistent with the public interest 
has accepted responsibility and demonstrated that he or she will not 
engage in future misconduct. Hoxie, 419 F.3d at 482-83; see also Ronald 
Lynch, M.D., 75 FR 78,745, 78,754 (2010) (holding that the Respondent's 
attempts to minimize misconduct undermined acceptance of 
responsibility); George C. Aycock, M.D., 74 FR 17,529, 17,543 (2009) 
(finding that much of the respondent's testimony undermined his initial 
acceptance that he was ``probably at fault'' for some misconduct); 
Krishna-Iyer, 74 FR 463 (noting, on remand, that despite the respondent 
having undertaken measures to reform her practice, revocation had been 
appropriate because the respondent had refused to acknowledge her 
responsibility under the law); Med.

[[Page 64732]]

Shoppe-Jonesborough, 73 FR 387 (noting that the respondent did not 
acknowledge recordkeeping problems, let alone more serious violations 
of federal law, and concluding that revocation was warranted).
    The burden of proof at this administrative hearing is a 
preponderance-of-the-evidence standard. Steadman v. SEC, 450 U.S. 91, 
100-01 (1981). The Administrator's factual findings will be sustained 
on review to the extent they are supported by ``substantial evidence.'' 
Hoxie, 419 F.3d at 481. The Supreme Court has defined ``substantial 
evidence'' as such relevant evidence as a reasonable mind might accept 
as adequate to support a conclusion. Consol. Edison Co. of New York v. 
NLRB, 305 U.S. 197, 229 (1938). While ``the possibility of drawing two 
inconsistent conclusions from the evidence'' does not limit the 
Administrator's ability to find facts on either side of the contested 
issues in the case, Shatz v. U.S. Dep't of Justice, 873 F.2d 1089, 1092 
(8th Cir. 1989); Trawick, 861 F.2d at 77, all ``important aspect[s] of 
the problem,'' such as a respondent's defense or explanation that runs 
counter to the Government's evidence, must be considered. Wedgewood 
Village Pharm. v. DEA, 509 F.3d 541, 549 (D.C. Cir. 2007); Humphreys v. 
DEA, 96 F.3d 658, 663 (3rd Cir. 1996). The ultimate disposition of the 
case must be in accordance with the weight of the evidence, not simply 
supported by enough evidence to justify, if the trial were to a jury, a 
refusal to direct a verdict when the conclusion sought to be drawn from 
it is one of fact for the jury. Steadman, 450 U.S. at 99 (internal 
quotation marks omitted).
    Regarding the exercise of discretionary authority, the courts have 
recognized that gross deviations from past agency precedent must be 
adequately supported, Morall, 412 F.3d at 183, but mere unevenness in 
application does not, standing alone, render a particular discretionary 
action unwarranted. Chein v. DEA, 533 F.3d 828, 835 (D.C. Cir. 2008) 
(citing Butz v. Glover Livestock Comm'n Co., 411 U.S. 182, 188 (1973)). 
It is well-settled that since the Administrative Law Judge has had the 
opportunity to observe the demeanor and conduct of hearing witnesses, 
the factual findings set forth in this Recommended Decision are 
entitled to significant deference, Universal Camera Corp. v. NLRB, 340 
U.S. 474, 496 (1951), and that this Recommended Decision constitutes an 
important part of the record that must be considered in the 
Administrator's decision. Morall, 412 F.3d at 179. However, any 
recommendations set forth herein regarding the exercise of discretion 
are by no means binding on the Administrator and do not limit the 
exercise of his discretion. 5 U.S.C. 557(b) (2006); River Forest 
Pharmacy, Inc. v. DEA, 501 F.2d 1202, 1206 (7th Cir. 1974); Attorney 
General's Manual on the Administrative Procedure Act 8 (1947).
Analysis of Dispensing Allegations
    The Government alleges that the Respondent filled numerous 
prescriptions for eleven patients that raised red flags of drug abuse 
and/or diversion, to include drug cocktails; early fills; traveling 
long distances; prescriptions for the highest strengths of oxycodone, 
hydromorphone, and alprazolam; paying in cash; and dispensing 
compounded capsules without therapeutic justification. ALJ Ex. 1, pp. 
4-7. The Government further alleges that [the red flags presented by 
these prescriptions were so strongly indicative of drug abuse and 
diversion that they could not have been resolved by a pharmacist acting 
in the usual course of professional practice.]\*I\ Id. The Government 
claims that by filling these eleven patients' controlled substance 
prescriptions, the Respondent violated its corresponding responsibility 
under 21 CFR 1306.04(a) and dispensed controlled substances outside the 
usual course of pharmacy practice in violation of 21 CFR 1306.06, in 
addition to Florida Administrative Code r. 64B16-27.831. Id. [Omitted 
for relevance.]
---------------------------------------------------------------------------

    \*I\ I have modified this paragraph to clarify that the 
Government alleged that the red flags presented by the prescriptions 
in this case could not have been resolved by a pharmacist acting 
within the usual course of professional practice. Because the 
Government presented sufficient evidence to support this allegation, 
I do not need to consider the Government's alternative claim that 
Respondent failed to take adequate steps under Florida and federal 
law to resolve the red flags.
---------------------------------------------------------------------------

    With respect to each patient, the Government presented documentary 
evidence and testimony from its pharmacy expert, Dr. Sullivan, that the 
Respondent filled numerous controlled substance prescriptions that 
raised red flags, including drug cocktails, early fills, long distance, 
highest strengths, and cash payments. The Government further presented 
evidence that [the red flags presented by these prescriptions could not 
have been resolved by a pharmacist acting in the usual course of 
professional practice.] Finally, the Government proved the Respondent 
compounded medication without therapeutic justification.
    I will now turn to the evidence the Government presented for each 
patient. After examining the evidence for each patient, I will 
determine whether the Government has presented a prima facie case that 
the Respondent filled these prescriptions in violation of federal and 
state law.
Patient A.G.
    From January 2018 to April 2019, the Respondent dispensed a drug 
cocktail of alprazolam and oxycodone to A.G. on six occasions. GX 14. 
During the same time period, the Respondent dispensed a drug cocktail 
of alprazolam and hydromorphone to A.G. on three occasions. Id.
    Dr. Sullivan testified that the Respondent filled several 
prescriptions for A.G. before his prior month's supply of medication 
ran out. Tr. 257. For example, the Respondent filled oxycodone and 
alprazolam prescriptions for A.G. on January 17, 2019, the 28th day 
after dispensing a 30-day supply of each drug to him on December 20, 
2018 (2 days early). ALJ Ex. 42,\31\ p. 12; GX 14. The Respondent 
filled an alprazolam prescription for A.G. on February 14, 2019, the 
28th day after dispensing a 30-day supply on January 17, 2019 (2 days 
early). Id. The Respondent filled another oxycodone prescription for 
A.G. on April 12, 2019, the 23rd day after dispensing a 28-day supply 
on March 20, 2019 (5 days early). Id. The Respondent also filled an 
alprazolam prescription for A.G. on April 12, 2019, the 23rd day after 
dispensing a 30-day supply on March 20, 2019 (7 days early). Id. These 
prescriptions should not have been filled early unless the Respondent 
documented a good reason for doing so. Tr. 257.
---------------------------------------------------------------------------

    \31\ Because the Government structured its direct examination of 
Dr. Sullivan by using the demonstrative exhibit for ease of 
reference, I will cite to that document as well as the Government 
Exhibit from which the information is derived. I will mark the 
demonstrative exhibit as ALJ Exhibit 42. I will treat the 
demonstrative exhibit similar to a summary of voluminous records 
under Federal Rule of Evidence 1006. The demonstrative exhibit, 
however, was never introduced into evidence, so it is being used as 
a guide or aid for review of the record. Thus, the admitted evidence 
trumps the demonstrative exhibit with respect to any inconsistency 
between the two.
---------------------------------------------------------------------------

    Patient A.G.'s home address was located about 130 miles from the 
Respondent. ALJ Ex. 42, p. 10; GX 55. Dr. Sullivan opined that this 
distance should have raised a red flag to a reasonable pharmacist.\32\ 
Tr. 254.
---------------------------------------------------------------------------

    \32\ Although we do not know if A.G., in fact, travelled 131 
miles from his home to the Respondent each time he filled a 
prescription there, the Respondent knew he lived that far away, and 
was therefore on notice of a well-established red flag of drug abuse 
and/or diversion. This is true of ten of the eleven patients. The 
fact that the patients lived over 100 miles away is a red flag even 
if the patients did not travel that distance each time they visited 
the pharmacy. The focus is on the information the Respondent knew, 
and the Respondent knew the patients lived over 100 miles away 
because it had their addresses on the prescriptions. According to 
Dr. Sullivan, this information should have aroused the Respondent's 
suspicion. The remaining patient (M.M.) lived approximately 134 
miles from his prescriber's office, which represents its own red 
flag of long distance travel to obtain the prescription. Tr. 291-94.

---------------------------------------------------------------------------

[[Page 64733]]

    From June 2017 to August 2018, the Respondent dispensed ten 
prescriptions each for oxycodone, hydromorphone, and alprazolam. ALJ 
Ex. 42, p. 11; GX 17. Each of these prescriptions, except for one 
alprazolam prescription, was written for the highest commercially 
available strength of the drug. Id.; Tr. 255. All of the oxycodone 
prescriptions dispensed during this time period were for 30 mg dosage 
units, the highest strength available of oxycodone. Id. All of the 
hydromorphone prescriptions dispensed during this time period were for 
8 mg dosage units, the highest strength available of hydromorphone. Id. 
Nine of the ten alprazolam prescriptions dispensed during this time 
period were for 2 mg dosage units, the highest strength available of 
alprazolam. Id. Dispensing these controlled substances at their highest 
strengths, especially in combination with each other, raised red flags 
that required resolution. Tr. 256.
    In addition to these red flags, patient A.G. paid for all of his 
prescriptions in cash. GX 14; GX 17. Dr. Sullivan testified that paying 
in cash is a red flag.\33\ Tr. 214.
---------------------------------------------------------------------------

    \33\ The Respondent argues that it did not view cash payments as 
suspicious because it did not accept insurance as a form of payment. 
Resp't PHB, at 19-20, 35. I am not convinced by this argument for 
two reasons. First, the Respondent did not provide any direct 
evidence that the only form of payment it accepted during the 
relevant time period was cash. Rather, it drove at this issue 
indirectly by asking hypothetical questions such as how would the 
Respondent get paid if it did not have contracts with insurance 
carriers or pharmacy benefit managers. Tr. 443-44. Second, even if 
the only form of payment that the Respondent accepted was cash, the 
fact that a patient was willing to pay in cash should still have 
aroused the Respondent's suspicion since it is a [part of the 
standard of professional practice of pharmacy as testified by Dr. 
Sullivan. Tr. 221-225.] The fact that the patients in this case were 
willing to pay in cash was even more concerning given the other red 
flags that they raised. Dr. Sullivan testified that paying in cash 
for controlled substances remains suspicious when it occurs with the 
other red flags involved here, even if the pharmacy did not take 
insurance. Tr. 475-76. [DEA has consistently relied on the testimony 
of pharmacy experts in finding that cash payments are a red flag of 
diversion or abuse. See, e.g., Edge Pharm., 81 FR 72,092, 72,103, 
72,111-12 (2016) (crediting Florida pharmacy expert's testimony that 
paying in cash or cash equivalent, such as by credit or debit card, 
creates a suspicion that a controlled substance may be abused or 
diverted).]
---------------------------------------------------------------------------

    Although patient A.G. presented prescriptions to the Respondent 
that raised multiple red flags of drug abuse and/or diversion, the 
Respondent filled each prescription. Tr. 259, 267; GX 17; ALJ Ex. 42, 
p. 11. [Omitted for relevance. Dr. Sullivan testified that the red 
flags raised by Patient A.G.'s prescriptions were not resolvable, and 
that a pharmacist operating in the usual course of professional 
practice would not have filled them. Tr. 256-57, 267-68.]
Patient A.H.
    From January 2018 to August 2018, the Respondent dispensed a drug 
cocktail of alprazolam and hydromorphone to A.H. on five occasions. ALJ 
Ex. 42, p. 15; GX 21.
    The Respondent provided three early fills of hydromorphone 
prescriptions for A.H. from February to March 2019. Tr. 270-71; ALJ Ex. 
42, p. 16; GX 19. The Respondent dispensed hydromorphone to A.H. on 
February 15, 2019, the 24th day after dispensing a 30-day supply on 
January 22, 2019 (6 days early). Id. The Respondent also dispensed 
hydromorphone to A.H. on February 27, 2019, the 12th day after 
dispensing a 30-day supply on February 15, 2019 (18 days early). Id. 
The Respondent then dispensed hydromorphone to A.H. on March 14, 2019, 
the 15th day after dispensing a 30 day-supply on February 27, 2019 (15 
days early). Id. Filling three consecutive hydromorphone prescriptions 
early is a red flag. Tr. 271. A pharmacist acting within the usual 
course of professional practice would have either refused to fill these 
prescriptions until at least the day before the prior month's supply 
would have run out or refused to fill future prescriptions of the same 
drug for the patient. Id.
    Patient A.H.'s home address was located about 130 miles from the 
Respondent. ALJ Ex. 42, p. 14; GX 56; Tr. 268. Dr. Sullivan opined that 
this distance is a red flag. Tr. 268.
    From January 2018 to August 2018, the Respondent dispensed six 
prescriptions of hydromorphone and five prescriptions of alprazolam. 
ALJ Ex. 42, p. 15; GX 21. Each of these prescriptions was written for 
the highest strength of the drug. Id.; Tr. 269. All of the 
hydromorphone prescriptions dispensed during this time period were for 
8 mg dosage units, the highest strength available of hydromorphone. Id. 
All of the alprazolam prescriptions dispensed during this time period 
were for 2 mg dosage units, the highest strength available of 
alprazolam. Id. Dispensing these controlled substances at their highest 
strengths, especially in combination with each other, raised red flags 
that required resolution. Tr. 269.
    In addition to these red flags, patient A.H. paid for all of his 
prescriptions in cash. GX 19; GX 21. Dr. Sullivan testified that paying 
in cash is a red flag. Tr. 214.
    Although patient A.H. presented prescriptions to the Respondent 
that raised multiple red flags of drug abuse and/or diversion, the 
Respondent filled each prescription. Tr. 272; GX 20; ALJ Ex. 42, p. 17. 
[Dr. Sullivan testified that the red flags raised by Patient A.H.'s 
prescriptions were not resolvable, and that a pharmacist operating in 
the usual course of professional practice would not have filled them. 
Tr. 269, 273.]
Patient B.S.
    From August 2017 to August 2018, the Respondent dispensed a drug 
cocktail of alprazolam and hydromorphone to B.S. on five occasions. ALJ 
Ex. 42, p. 19; GX 24; Tr. 274. From December 2018 to March 2019, the 
Respondent dispensed a drug cocktail of alprazolam and oxycodone to 
B.S. on three occasions. ALJ Ex. 42, p. 20; GX 22; Tr. 276-77.
    Dr. Sullivan also pointed out the duplicative therapy that the 
Respondent dispensed in January and February 2019. Tr. 276; ALJ Ex. 42, 
p. 20. After dispensing a 30-day supply of oxycodone to B.S. on January 
31, 2019, only five days later the Respondent dispensed a 28-day supply 
of hydromorphone. Id. Then only two weeks later, the Respondent 
dispensed another 30-day supply of oxycodone to B.S. Id. Oxycodone and 
hydromorphone are potent immediate-release narcotic pain killers. Tr. 
276. The fact that B.S. presented overlapping prescriptions for 
different immediate-release opioids with duplicative therapy was a red 
flag of abuse and/or diversion. Id.
    Patient B.S.'s home address was located about 148 miles from the 
Respondent. ALJ Ex. 42, p. 18; GX 57; Tr. 273-74. Dr. Sullivan opined 
that this distance is a red flag. Tr. 273-74.
    From August 2017 to August 2018, the Respondent dispensed 12 
prescriptions of hydromorphone and 7 prescriptions of alprazolam. ALJ 
Ex. 42, p. 19; GX 24; Tr. 274. All but one of these prescriptions was 
written for the highest commercially available dosage strength of the 
drug. Id. All of the hydromorphone prescriptions dispensed during this 
time period were for 8 mg dosage units, the highest strength of 
hydromorphone. Id. All but one of the alprazolam prescriptions 
dispensed during this time period were for 2 mg dosage units, the 
highest strength of alprazolam. Id. From December 2018 to April 2019, 
the Respondent dispensed four

[[Page 64734]]

prescriptions of oxycodone and one prescription of hydromorphone. ALJ 
Ex. 42, p. 20; GX 22; Tr. 276. All four of the oxycodone prescriptions 
were written for 30 mg, the highest strength of oxycodone. Id. The 
hydromorphone prescription was written for 8 mg, the highest strength 
of hydromorphone. Id. Dispensing these controlled substances at their 
highest strengths, especially in combination with each other, raised 
red flags that required resolution. Tr. 274, 276-77.
    [Text omitted.] * J 34 Id.
---------------------------------------------------------------------------

    *\J\ As referenced herein, the ALJ did not find that Dr. 
Sullivan's testimony regarding the ibuprofen prescriptions was 
factually supported. I find it unnecessary given the strength of the 
other evidence in this case to reach this issue, and therefore, I am 
omitting the references to this testimony as irrelevant.
    \34\ [Texted omitted where footnote was included.]
---------------------------------------------------------------------------

    In addition to these red flags, patient B.S. paid for all of his 
prescriptions in cash. GX 22; GX 24. Dr. Sullivan testified that paying 
in cash is a red flag. Tr. 214.
    Although patient B.S. presented prescriptions to the Respondent 
that raised multiple red flags of drug abuse and/or diversion, the 
Respondent filled each prescription. Tr. 277-78; GX 23; ALJ Ex. 42, p. 
21. [Dr. Sullivan testified that the red flags raised by Patient B.S.'s 
prescriptions were not resolvable, and that a pharmacist operating in 
the usual course of professional practice would not have filled them. 
Tr. 274, 276-77.]
Patient C.R.
    From July 2017 to August 2018, the Respondent dispensed a drug 
cocktail of alprazolam and oxycodone to C.R. on five occasions. ALJ Ex. 
42, p. 23; GX 27; Tr. 280. On one of these occasions, the Respondent 
dispensed morphine tablets in addition to oxycodone and alprazolam. Id.
    Patient C.R.'s home address was located about 134 miles from the 
Respondent. ALJ Ex. 42, p. 22; GX 58; Tr. 279. Dr. Sullivan opined that 
this distance is a red flag. Tr. 279.
    From July 2017 to August 2018, the Respondent dispensed six 
prescriptions of oxycodone. ALJ Ex. 42, p. 23; GX 27; Tr. 279-80. Each 
of these six oxycodone prescriptions were for 30 mg dosage units, the 
highest strength available of oxycodone. Id.
    In addition to these red flags, patient C.R. paid for all of her 
prescriptions in cash. GX 25; GX 27. Dr. Sullivan testified that paying 
in cash is a red flag. Tr. 214.
    Although patient C.R. presented prescriptions to the Respondent 
that raised multiple red flags of drug abuse and/or diversion, the 
Respondent filled each prescription. Tr. 281-82; GX 24; ALJ Ex. 42, p. 
23. [Omitted for relevance. Dr. Sullivan testified that the red flags 
raised by Patient C.R.'s prescriptions were not resolvable, and that a 
pharmacist operating in the usual course of professional practice would 
not have filled them. Tr. 279-83.]
Patient J.D.
    On one occasion the Respondent dispensed a drug cocktail of 
hydromorphone and methadone to J.D. Tr. 283-84; ALJ Ex. 42, p. 26; GX 
30. Dr. Sullivan testified that taking these two immediate-release 
narcotic pain killers at the same time put J.D. ``at extreme risk of 
overdose.'' Tr. 284.
    The Respondent provided three early fills of hydromorphone 
prescriptions for J.D. from May to June 2018. Tr. 284-87; ALJ Ex. 42, 
p. 27; GX 30. The Respondent dispensed hydromorphone to J.D. on May 30, 
2018, the 20th day after dispensing a 30-day supply on May 10, 2018 (10 
days early). Id. The Respondent also dispensed hydromorphone to J.D. on 
June 15, 2018, the 16th day after dispensing a 30-day supply on May 30, 
2018 (14 days early). Id. The Respondent then dispensed hydromorphone 
to J.D. on June 30, 2018, the 15th day after dispensing a 30 day-supply 
on June 15, 2018 (15 days early). Id. Dr. Sullivan testified that 
filling three consecutive hydromorphone prescriptions early is a red 
flag. Tr. 285. He testified that a pharmacist acting within the usual 
course of professional practice would have either refused to fill these 
prescriptions until at least the day before the prior month's supply 
would have run out or refused to fill future prescriptions of the same 
drug for the patient. Tr. 271.
    Patient J.D.'s home address was located about 130 miles from the 
Respondent. ALJ Ex. 42, p. 25; GX 59; Tr. 283. Dr. Sullivan opined that 
this distance is a red flag. Tr. 283.
    From January 2018 to September 2018, the Respondent dispensed nine 
prescriptions of hydromorphone. ALJ Ex. 42, p. 26; GX 30; Tr. 283-84. 
Each of these nine hydromorphone prescriptions were for 8 mg dosage 
units, the highest strength available of hydromorphone. Id.
    In addition to these red flags, patient J.D. paid for all of her 
prescriptions in cash. GX 28; GX 30. Dr. Sullivan testified that paying 
in cash is a red flag. Tr. 214.
    Although patient J.D. presented prescriptions to the Respondent 
that raised multiple red flags of drug abuse and/or diversion, the 
Respondent filled each prescription. Tr. 287-88; GX 29; ALJ Ex. 42, p. 
28. [Omitted for relevance. Dr. Sullivan testified that the red flags 
raised by Patient J.D.'s prescriptions were not resolvable, and that a 
pharmacist operating in the usual course of professional practice would 
not have filled them. Tr. 284, 288-89.]
Patient J.M.
    From June 2017 to September 2018, the Respondent dispensed a drug 
cocktail of alprazolam and oxycodone to J.M. on five occasions. ALJ Ex. 
42, p. 30; GX 33; Tr. 289-90. During the same time period, the 
Respondent dispensed a drug cocktail of alprazolam and hydromorphone to 
J.M. on three occasions. Id.
    Patient J.M.'s home address was located about 144 miles from the 
Respondent. ALJ Ex. 42, p. 29; GX 60; Tr. 289. Dr. Sullivan opined that 
this distance is a red flag. Tr. 289.
    From June 2017 to September 2018, the Respondent dispensed nine 
prescriptions of alprazolam, eight prescriptions of oxycodone, and six 
prescriptions of hydromorphone. ALJ Ex. 42, p. 30; GX 33; Tr. 289-90. 
All of these prescriptions were for the highest strength available of 
the drug. All of the nine alprazolam prescriptions were for 2 mg dosage 
units, the highest strength of alprazolam. Id. All of the eight 
oxycodone prescriptions were for 30 mg dosage units, the highest 
strength of oxycodone. Id. All of the six hydromorphone prescriptions 
were for 8 mg dosage units, the highest strength of hydromorphone. Id.
    In addition to these red flags, patient J.M. paid for all of her 
prescriptions in cash. GX 31; GX 33. Dr. Sullivan testified that paying 
in cash is a red flag. Tr. 214.
    Although patient J.M. presented prescriptions to the Respondent 
that raised multiple red flags of drug abuse and/or diversion, the 
Respondent filled each prescription. Tr. 290; GX 32; ALJ Ex. 42, p. 31. 
[Dr. Sullivan testified that the red flags raised by Patient J.M.'s 
prescriptions were not resolvable, and that a pharmacist operating in 
the usual course of professional practice would not have filled them. 
Tr. 290-91.]
Patient M.M.
    The Respondent provided three early fills of hydromorphone 
prescriptions for M.M. from January to March 2019. Tr. 299-300; ALJ Ex. 
42, p. 34; GX 34. The Respondent dispensed hydromorphone to M.M. on 
January 24, 2019, the 21st day after dispensing a 28-day supply on 
January 3, 2019 (7 days early). Id. The Respondent also dispensed 
hydromorphone to J.D. on February 19, 2019, the 26th day after 
dispensing a 30-

[[Page 64735]]

day supply on January 24, 2019 (4 days early). Id. The Respondent then 
dispensed hydromorphone to J.D. on March 15, 2019, the 24th day after 
dispensing a 30-day supply on February 19, 2019 (6 days early). Id. Dr. 
Sullivan testified that filling three consecutive hydromorphone 
prescriptions early is a red flag. Tr. 285, 300. He testified that a 
pharmacist acting within the usual course of professional practice 
would have either refused to fill these prescriptions until at least 
the day before the prior month's supply would have run out or refused 
to fill future prescriptions of the same drug for the patient. Tr. 271, 
300.
    Patient M.M.'s home address was located about 38 miles from the 
Respondent. GX 60, pp. 5-6; Tr. 292-93. The concern about the distance 
M.M. would have had to travel, however, was the distance from his home 
to the prescribing doctor's office. Tr. 293-94. Patient M.M.'s home was 
located about 134 miles from the office of the doctor who issued him 
controlled substance prescriptions. GX 61, pp. 1-3. Dr. Sullivan opined 
that the distance from M.M.'s home to the doctor's office is a red 
flag.\35\ Tr. 292-94.
---------------------------------------------------------------------------

    \35\ I am not accepting Dr. Sullivan's testimony that the 
roundtrip distance from M.M.'s home to the doctor's office, and then 
to the Respondent, and then back home, is a red flag. Tr. 293. There 
was no evidence M.M. ever made that round trip. The 38 miles from 
M.M.'s home to the Respondent is not overly suspicious on its face. 
I believe the Government withdrew its allegation as to that 
distance. I will, however, accept Dr. Sullivan's testimony that the 
134 miles from M.M.'s home to the doctor's office is a red flag. Tr. 
294.
---------------------------------------------------------------------------

    From June 2017 to August 2018, and from January to April 2019, the 
Respondent dispensed 14 and 5, respectively, hydromorphone 
prescriptions to patient M.M. ALJ Ex. 42, p. 33-34; GX 34; GX 36; Tr. 
295. All of these 19 prescriptions were for 8 mg dosage units, the 
highest strength of hydromorphone. Id.
    Dr. Sullivan also pointed out the red flag raised by M.M.'s 
prescriptions for folic acid 0.4 mg. Tr. 295-96; ALJ Ex. 42, p. 33; GX 
36. From June 2017 to August 2018, the Respondent dispensed folic acid 
0.4 mg to M.M. on eight occasions. Id. Folic acid is a vitamin and 0.4 
mg of folic acid is a dose that could be obtained over-the-counter 
without a prescription. Tr. 295. Dr. Sullivan opined that it is common 
for doctors who unlawfully prescribe controlled substances to add low 
doses of non-controlled medication to make their controlled substance 
prescribing appear legitimate. Id. For the same reasons I gave earlier 
with respect to B.S., however, I do not accept Dr. Sullivan's testimony 
in this regard.
    Dr. Sullivan also observed a concerning lapse in M.M.'s opioid 
prescriptions from July 2018 to January 2019. Tr. 297-98; ALJ Ex. 42, 
p. 34; GX 34. After M.M. filled a hydromorphone prescription in July 
2018, M.M. did not present another prescription until January 2019, 
when she presented a prescription for 8 mg dosage units of 
hydromorphone, the highest strength of that drug. Id. The seven-month 
lapse in hydromorphone prescriptions followed by a prescription for the 
highest strength of hydromorphone should have raised a red flag because 
returning abruptly to such a high dose after not taking it for seven 
months would have put M.M. at ``heightened risk for overdose.'' Id.
    In addition to these red flags, patient M.M. paid for all of her 
prescriptions in cash. GX 34; GX 36. Dr. Sullivan testified that paying 
in cash is a red flag. Tr. 214.
    Although patient M.M. presented prescriptions to the Respondent 
that raised multiple red flags of drug abuse and/or diversion, the 
Respondent filled each prescription. Tr. 300-01; GX 35; ALJ Ex. 42, p. 
35. [Dr. Sullivan testified that the red flags raised by Patient M.M.'s 
prescriptions were not resolvable, and that a pharmacist operating in 
the usual course of professional practice would not have filled them. 
Tr. 299-300.]
Patient N.B.
    From June 2017 to August 2018, the Respondent dispensed a drug 
cocktail of alprazolam and hydromorphone to N.B. on six occasions. ALJ 
Ex. 42, p. 37; GX 39; Tr. 302. From September 2018 to January 2019, the 
Respondent dispensed a drug cocktail of alprazolam and oxycodone to 
N.B. on two occasions, and a cocktail of alprazolam and hydromorphone 
on one occasion. ALJ Ex. 42, p. 38; GX 37; Tr. 305.
    The Respondent provided two early fills of prescriptions for N.B. 
from January to March 2019. Tr. 303-04; ALJ Ex. 42, p. 38; GX 37. 
First, the Respondent dispensed oxycodone and alprazolam to N.B. on 
January 16, 2019, the 27th day after dispensing a 30-day supply of each 
drug on December 20, 2018 (3 days early). Id. Then, the Respondent 
dispensed oxycodone to N.B. on March 13, 2019, the 19th day after 
dispensing a 28-day supply on February 22, 2019 (9 days early). Id. A 
pharmacist acting within the usual course of professional practice 
would have either refused to fill these prescriptions until at least 
the day before the prior month's supply would have run out or refused 
to fill future prescriptions of the same drug for the patient. Tr. 271, 
300, 304.
    Patient N.B.'s home address was located about 137 miles from the 
Respondent. ALJ Ex. 42, p. 36; GX 62; Tr. 301. Dr. Sullivan opined that 
this distance is a red flag. Tr. 301.
    From June 2017 to August 2018, the Respondent dispensed 12 
prescriptions of hydromorphone to N.B. ALJ Ex. 42, p. 37; GX 39; Tr. 
302. All of these 12 hydromorphone prescriptions were for 8 mg dosage 
units, the highest strength of hydromorphone. Id. In addition, the 
Respondent also dispended four prescriptions of alprazolam in 2 mg 
dosage units, the highest strength of alprazolam. Id. Dr. Sullivan also 
pointed out that on one occasion the Respondent dispensed alprazolam to 
N.B. in 2 mg and 1 mg dosage units. Id. He testified that aking the 
same controlled substance in two different strengths is a red flag. Id.
    [Text omitted, see supra n.*J.]
    Dr. Sullivan also observed a concerning two-month gap in N.B.'s 
opioid prescriptions in October and November 2018. Tr. 304-05; ALJ Ex. 
42, p. 38; GX 37. N.B. presented a prescription for hydromorphone in 
September 2018 and then presented an oxycodone 30 mg prescription in 
December 2018, but did not present any opioid prescriptions to the 
Respondent in October and November. Id. Dr. Sullivan testified that not 
taking opioids for two months and then starting up again on the highest 
strength of oxycodone is concerning and puts the patient at heightened 
risk of overdose. Tr. 297-98, 304-05. This lapse in filling opioid 
prescriptions raises a red flag. Id.
    In addition to these red flags, patient N.B. paid for all of her 
prescriptions in cash. GX 37; GX 39. Dr. Sullivan testified that paying 
in cash is a red flag. Tr. 214.
    Although patient N.B. presented prescriptions to the Respondent 
that raised multiple red flags of drug abuse and/or diversion, the 
Respondent filled each prescription. Tr. 306-07; GX 38; ALJ Ex. 42, p. 
39. [Omitted for relevance. Dr. Sullivan testified that the red flags 
raised by Patient N.B.'s prescriptions were not resolvable, and that a 
pharmacist operating in the usual course of professional practice would 
not have filled them. Tr. 302-07.]
Patient R.B.
    From June 2017 to August 2018, the Respondent dispensed a drug 
cocktail of alprazolam and hydromorphone to R.B. on twelve occasions. 
ALJ Ex. 42, p. 41; GX 43; Tr. 311.
    The Respondent provided one early fill of hydromorphone to R.B. On 
February 18, 2019, the Respondent dispensed hydromorphone to R.B. on

[[Page 64736]]

February 18, 2019, the 27th day after dispensing a 31-day supply of 
hydromorphone on January 22, 2019 (4 days early). ALJ Ex. 42, p. 42; GX 
40; Tr. 312.
    Patient R.B.'s home address was located about 138 miles from the 
Respondent. ALJ Ex. 42, p. 40; GX 63; Tr. 307. Dr. Sullivan opined that 
this distance is a red flag. Tr. 307.
    From June 2017 to August 2018, the Respondent dispensed 12 
prescriptions of hydromorphone and 12 prescriptions of alprazolam to 
R.B. ALJ Ex. 42, p. 41; GX 43; Tr. 311. All of the 12 hydromorphone 
prescriptions were for 8 mg dosage units, the highest commercially 
available strength of hydromorphone. Id. Eleven of the 12 alprazolam 
prescriptions were for 2 mg dosage units, the highest strength of 
alprazolam. Id.
    As with patients M.M. and N.B., Dr. Sullivan also observed a 
concerning three-month gap in R.B.'s opioid prescriptions in October, 
November, and December 2018. Tr. 312; ALJ Ex. 42, p. 42; GX 40. R.B. 
presented a prescription for hydromorphone in September 2018 and did 
not present another hydromorphone prescription to the Respondent until 
January 2019.\36\ Id. A three-month lapse in opioid treatment renders 
the patient opioid na[iuml]ve and puts the patient at heightened risk 
of overdose upon resumption of opioid treatment. Tr. 297-98, 304-05, 
312. This lapse in filling opioid prescriptions raises a red flag. Id.
---------------------------------------------------------------------------

    \36\ Patient R.B.'s PDMP report indicates that the hydromorphone 
prescription he received from the Respondent in September 2018 was 
for a 120-day supply. GX 40; ALJ Ex. 42, p. 42. If that were true, 
the gap in opioid prescriptions from September 2018 to January 2019 
would not raise any concern because the September 2018 prescription 
would have lasted four months. That number, however, must have been 
incorrectly reported to the PDMP. In fact, the September 2018 
prescription was written for a 30-day supply, not 120-days as 
reported in the PDMP. This becomes evident by comparing the PDMP 
report to the actual prescription, which is one of the few hard-copy 
prescriptions in evidence. The PDMP report indicates that the Rx 
number for the September 2018 hydromorphone prescription (10th from 
the top) is 5011489 and was issued by Dr. L. GX 40. The 
corresponding prescription bearing the same Rx number on the fill 
sticker is located at Government Exhibit 44, pages 6-7 (prescription 
at top right corner). That prescription was written by Dr. L. for 
120 tablets of hydromorphone 8 mg, to be taken one tablet every 6 
hours (or 4 tablets per day). GX 44, p. 6. A 120-tablet prescription 
with these instructions would last one month, not four months. Thus, 
R.B.'s three month lapse in filling opioid prescriptions at the 
Respondent remains a concern that the Respondent should have 
addressed.
---------------------------------------------------------------------------

    Dr. Sullivan also observed that R.B.'s PDMP report revealed 
evidence of pharmacy shopping, which Dr. Sullivan considered 
significant. Tr. 316-17. The PDMP report showed that R.B. filled 
controlled substance prescriptions at five different pharmacies, to 
include the Respondent. Tr. 316-17; GX 44, p. 5.
    In addition to these red flags, patient R.B. paid for all of her 
prescriptions that were filled by the Respondent in cash. GX 40; GX 43. 
Dr. Sullivan testified that paying in cash is a red flag. Tr. 214. 
Although R.B. always paid in cash at the Respondent, she used insurance 
to purchase controlled substance prescriptions at other pharmacies on 
three occasions. GX 44, pp. 4-5; Tr. 317-19. Dr. Sullivan noted that a 
patient does not break the law by alternating between paying in cash 
and using insurance. Tr. 319. It is, however, another red flag that a 
pharmacist should resolve. Tr. 318-19. When a pharmacist evaluates the 
red flag raised by a patient paying in cash for controlled substances, 
it would be relevant to consider the fact that the patient was using 
insurance to fill prescriptions at another location. Tr. 318.
    Although patient R.B. presented prescriptions to the Respondent 
that raised multiple red flags of drug abuse and/or diversion, the 
Respondent filled each prescription. Tr. 313; GX 41; ALJ Ex. 42, p. 43. 
[Dr. Sullivan testified that the red flags raised by Patient R.B.'s 
prescriptions were not resolvable, and that a pharmacist operating in 
the usual course of professional practice would not have filled them. 
Tr. 311, 313, 321.]
Patient R.G.
    From June 2017 to September 2018, the Respondent dispensed a drug 
cocktail of alprazolam and oxycodone to R.G. on twelve occasions. ALJ 
Ex. 42, p. 45; GX 49; Tr. 322-24.
    The Respondent provided multiple early fills of prescriptions for 
R.G. from February to May 2018. Tr. 326-28; ALJ Ex. 42, p. 46; GX 49. 
The Respondent dispensed alprazolam and oxycodone to R.G. on February 
21, 2018, the 23rd day after dispensing a 30-day supply of each drug on 
January 29, 2018 (7 days early). Id. The Respondent again dispensed 
alprazolam and oxycodone to R.G. on March 19, 2018, the 26th day after 
dispensing a 30-day supply of each drug on February 21, 2018 (4 days 
early). Id. The Respondent then dispensed alprazolam to R.G. on April 
17, 2018, even though the doctor instructed that the prescription 
should not be filled until April 20, 2018 (3 days early). Id. The 
Respondent dispensed oxycodone to R.G. on May 8, 2018, the 21st day 
after dispensing a 30-day supply of oxycodone on April 17, 2018 (9 days 
early). Id. A pharmacist acting within the usual course of professional 
practice would have either refused to fill these prescriptions until at 
least the day before the prior month's supply would have run out or 
refused to fill future prescriptions of the same drug for the patient. 
Tr. 271, 300, 304, 328.
    Patient R.G.'s home address was located about 131 miles from the 
Respondent. ALJ Ex. 42, p. 44; GX 64; Tr. 322. Dr. Sullivan opined that 
this distance is a red flag. Tr. 322.
    From June 2017 to September 2018, the Respondent dispensed 17 
prescriptions of oxycodone and 12 prescriptions of alprazolam to R.G. 
Tr. 322-24; ALJ Ex. 42, p. 45; GX 49. All of these 29 prescriptions 
were for the highest strength of the drug. Id. All of the 17 oxycodone 
prescriptions were for 30 mg dosage units, the highest strength of 
oxycodone. Id. All of the 12 alprazolam prescriptions were for 2 mg 
dosage units, the highest strength of alprazolam. Id.
    In addition to these red flags, patient R.G. paid for all of his 
prescriptions in cash. GX 46; GX 49. Dr. Sullivan testified that paying 
in cash is a red flag. Tr. 214.
    Although patient R.G. presented prescriptions to the Respondent 
that raised multiple red flags of drug abuse and/or diversion, the 
Respondent filled each prescription. Tr. 328-29; GX 47; ALJ Ex. 42, p. 
47. [Omitted for relevance. Dr. Sullivan testified that the red flags 
raised by Patient R.G.'s prescriptions were not resolvable, and that a 
pharmacist operating in the usual course of professional practice would 
not have filled them. Tr. 322-23, 326, 328-29.]
Patient R.L.
    From June 2017 to September 2018, the Respondent dispensed a drug 
cocktail of alprazolam and hydromorphone to R.L. on one occasion. ALJ 
Ex. 42, p. 49; GX 52; Tr. 331.
    The Respondent provided four early fills of hydromorphone to R.L. 
from February to May 2018. Tr. 333-34; ALJ Ex. 42, p. 51; GX 52. First, 
the Respondent dispensed hydromorphone to R.L. on February 26, 2018, 
the 25th day after dispensing a 30-day supply of hydromorphone on 
February 1, 2018 (5 days early). Id. The Respondent dispensed 
hydromorphone to R.L. again on March 22, 2018, the 24th day after 
dispensing a 30-day supply of hydromorphone on February 26, 2018 (six 
days early). Id. Then the Respondent dispensed hydromorphone to R.L. on 
April 17, 2018, the 26th day after dispensing a 30-day supply of 
hydromorphone on March 22, 2018 (4 days early). Id. The Respondent also 
dispensed hydromorphone to R.L. on May 11, 2018, the 24th day after

[[Page 64737]]

dispensing a 30-day supply of hydromorphone on April 17, 2018 (6 days 
early). Id. Filling four consecutive hydromorphone prescriptions early 
is a red flag. Tr. 271, 285, 300, 334. A pharmacist acting within the 
usual course of professional practice would have either refused to fill 
these prescriptions until at least the day before the prior month's 
supply would have run out or refused to fill future prescriptions of 
the same drug for the patient. Tr. 334.
    Patient R.L.'s home address was located about 138 miles from the 
Respondent. ALJ Ex. 42, p. 48; GX 65; Tr. 330. Dr. Sullivan opined that 
this distance is a red flag. Tr. 330.
    From June 2017 to September 2018, the Respondent dispensed 14 
prescriptions of hydromorphone, one prescription of oxycodone, and one 
prescription of alprazolam to R.L. Tr. 331-32; ALJ Ex. 42, p. 49; GX 
52. All of these 16 prescriptions were for the highest strength of the 
drug. Id. All of the 14 hydromorphone prescriptions were for 8 mg 
dosage units, the highest strength of hydromorphone. Id. The oxycodone 
prescription was for 30 mg dosage units, the highest strength of 
oxycodone. Id. The alprazolam prescription was for 2 mg dosage units, 
the highest strength of alprazolam. Id. From December 2018 to April 
2019, the Respondent dispensed five prescriptions of oxycodone to R.L. 
in 30 mg dosage units, the highest strength of oxycodone. Tr. 331-32; 
ALJ Ex. 42, p. 50; GX 50.
    In addition to these red flags, patient R.L. paid for all of his 
prescriptions in cash. GX 50; GX 52. Dr. Sullivan testified that paying 
in cash is a red flag. Tr. 214.
    Although patient R.L. presented prescriptions to the Respondent 
that raised multiple red flags of drug abuse and/or diversion, the 
Respondent filled each prescription. Tr. 334-36; GX 51; ALJ Ex. 42, p. 
52. [Omitted for relevance. Dr. Sullivan testified that the red flags 
raised by Patient R.L.'s prescriptions were not resolvable, and that a 
pharmacist operating in the usual course of professional practice would 
not have filled them. Tr. 332, 335-36.]

Analysis of Dispensing Evidence for All Eleven Patients

    [Analysis omitted for brevity and relevance.] *K \37\ 
\38\ \39\ \40\ \41\ \42\ \43\
---------------------------------------------------------------------------

    *K I disagree with the ALJ's decision not to credit 
Dr. Sullivan's testimony that the red flags in this case could not 
have been resolved by a pharmacist operating in the usual course of 
professional practice. Because the ALJ did not credit this 
testimony, his analysis centered on whether Respondent had 
adequately resolved the red flags with each prescription and whether 
Respondent had adequately documented the resolution of red flags. 
RD, at 90-100. The ALJ concluded that he was unable to determine 
that Respondent had violated its corresponding responsibility for 
the majority of the prescriptions, because Dr. Sullivan testified 
that red flags may be resolved in the patient profile or on the face 
of the prescription, and the Government did not admit copies of the 
majority of the prescriptions into evidence. Id. Instead, the ALJ 
found that Respondent had violated Florida law--which the ALJ 
interpreted as requiring pharmacists to resolve red flags in the 
patient profile--and therefore, that Respondent had dispensed 
controlled substances outside the usual course of professional 
practice, in violation of 21 CFR 1306.06. In its Exceptions, 
Respondent argued that the ALJ's interpretation of Florida law was 
incorrect, because it does not require pharmacists to document the 
resolution of red flags. Resp Exceptions, at 8-17.
    As discussed in more detail above, it is not necessary for me to 
resolve this conflict. Because Dr. Sullivan offered credible and 
unrebutted expert testimony that the prescriptions in this case 
presented unresolvable red flags of drug abuse and diversion, and 
that these prescriptions would not have been filled by a pharmacist 
acting within the usual course of professional practice, I have 
concluded that Respondent violated Florida and federal law. Thus, I 
need not determine whether Respondent made adequate attempts under 
Florida law to resolve red flags and document their resolution. 
Therefore, I have omitted the RD's discussion of Florida and federal 
law requirements for documenting the resolution of red flags. I have 
also omitted the RD's discussion of whether Respondent adequately 
documented the resolution of red flags in this case.
    This section also included a discussion of Florida requirements 
for conducting a drug utilization review of each controlled 
substance prescription. This discussion has been incorporated into 
the section below summarizing the evidence under Factors Two and 
Four of the public interest analysis.
    \37\ [Text omitted where footnote was included.]
    \38\ [Text omitted where footnote was included.]
    \39\ [Text omitted where footnote was included.]
    \40\ [Text omitted where footnote was included.]
    \41\ [Text omitted where footnote was included.]
    \42\ [Text omitted where footnote was included.]
    \43\ [Text omitted where footnote was included.]
---------------------------------------------------------------------------

    [As discussed in more detail infra, the Government's evidence 
showed that Respondent repeatedly filled controlled substances 
prescriptions for eleven patients that raised numerous red flags of 
drug abuse and diversion. These red flags included early fills, long 
distances traveled, cash payments, dangerous drug cocktails, and high-
strength narcotics. Dr. Sullivan offered credible and unrebutted expert 
testimony that, for each of these customers, these red flags could not 
have been resolved by a reasonable pharmacist acting within the usual 
course of his professional practice. Thus, by filling these 
prescriptions, Respondent violated its corresponding responsibility and 
filled prescriptions outside the usual course of professional practice, 
in violation of 21 CFR 1306.04 and 1306.06. Respondent also violated 
Florida law, which requires pharmacists to ``exercise[ ] sound 
professional judgment,'' to conduct a prospective drug use review 
before dispensing a controlled substance, and to take appropriate steps 
to avoid or resolve problems with the prescriptions. Fla. Admin. Code 
rs. 64B16-27.831, 64B16-27.810.]

Analysis of Unlawful Manufacturing Allegation

    Finally, the Government alleges that the Respondent engaged in 
``manufacturing'' controlled substances, as that term is defined in the 
CSA, without a separate DEA registration authorizing the manufacture of 
controlled substances, in violation of 21 U.S.C. 841(a)(1) and 21 CFR 
1301.13(e). ALJ Ex. 1, ] 20-28. Specifically, the Government alleges 
that the Respondent compounded oxycodone and hydromorphone capsules in 
such large quantities that this activity constituted manufacturing 
rather than permissible compounding for individual patients. Id.
    DEA regulations require registrants to obtain a separate 
registration for each regulated business activity in which they engage. 
21 CFR 1301.13(e). Section 1301.13(e) provides ten separate business 
activities, to include manufacturing and dispensing.\44\ Id. at 
(e)(1)(i), (iv). Each business activity is ``deemed to be independent 
of each other.'' 21 U.S.C. 1301.13(e). In other words, a registration 
for one activity does not authorize the registrant to engage in another 
activity. Id. To engage in both dispensing and manufacturing, a 
registrant would need to apply for and obtain separate registrations 
for each activity. No person or entity may engage in a regulated 
business activity ``until the application for registration is granted 
and a Certificate of Registration is issued by the Administrator to 
such person [or entity].'' 21 CFR 1301.13(a).
---------------------------------------------------------------------------

    \44\ Although not relevant to this case, the other business 
activities include distributing, reverse distributing, research 
(Schedule I), research (Schedules II-V), narcotic treatment 
programs, importing, exporting, and chemical analysis. 21 U.S.C. 
1301.13(e)(1).
---------------------------------------------------------------------------

    Requiring separate registrations for manufacturing and dispensing 
is more than mere formality. In fact, the CSA imposes stricter 
requirements on manufacturers than dispensers, not to mention a 
different standard for issuing a sanction. Wedgewood Village Pharm., 71 
FR 16,593, 16,594 (2006); compare 21 U.S.C. 823(a) (setting forth six 
public interest factors for manufacturers of Schedule I and II 
controlled substances), with 21 U.S.C. 823(f) (establishing five 
similar, yet different, public interest factors for practitioners, 
which includes pharmacies engaged in dispensing). Additionally, the CSA 
imposes higher

[[Page 64738]]

standards for recordkeeping, reporting, and security on manufacturing 
than it does on dispensing. 71 FR 16,594. Manufacturers are also 
required to obtain a registration annually, whereas dispensers are only 
required to obtain a registration every three years. Id. (citing 21 
U.S.C. 822(a)(1)-(2)).
    The Respondent is registered with the DEA as a ``retail pharmacy.'' 
GX 1. Pursuant to this registration, the Respondent may dispense 
controlled substances in Schedules II-V. Id.; 21 CFR 1301.13(e)(1)(iv). 
The Respondent's registration as a retail pharmacy authorizing it to 
engage in the regulated activity of dispensing does not permit the 
Respondent to manufacture controlled substances; thus, any 
manufacturing it performed would be unlawful. To prevail on its claim 
that the Respondent manufactured controlled substances, the Government 
must show by a preponderance of the evidence that the Respondent 
engaged in an activity that met the CSA's definition of 
``manufacturing.''
    Although the CSA does not define what the term ``to compound'' 
means, it does define ``manufacture.'' *L Wedgewood Village 
Pharm. v. DEA, 509 F.3d 541, 543 (D.C. Cir. 2007) (noting the CSA does 
not define ``compounding''). ``The term `manufacture' means the 
production, preparation, propagation, compounding, or processing of a 
drug or other substance, either directly or indirectly or by extraction 
from substances of natural origin, or independently by means of 
chemical synthesis or by a combination of extraction and chemical 
synthesis, and includes any packaging or repackaging of such substance 
or labeling or relabeling of its container.'' 21 U.S.C. 802(15) 
(emphasis added). Importantly, the CSA includes compounding in its 
definition of manufacturing. Id. Not all compounding, however, is 
considered to be manufacturing. The definition of manufacturing ``does 
not include the preparation, compounding, packaging, or labeling of a 
drug or other substance in conformity with applicable State or local 
law by a practitioner as an incident to his administration or 
dispensing of such drug or substance in the course of his professional 
practice.'' Id. [Omitted.] \45\ \46\
---------------------------------------------------------------------------

    *\L\ Respondent argues in its Exceptions that it was permitted 
to compound under the definition of ``dispense'' in the CSA. Resp 
Exceptions, at 17-22. However, as the ALJ stated,
    [u]nder the CSA, ``dispense'' means ``to deliver a controlled 
substance to an ultimate user or research subject by, or pursuant to 
the lawful order of, a practitioner, including the prescribing and 
administering of a controlled substance and the packaging, labeling 
or compounding necessary to prepare the substance for such 
delivery.'' 21 U.S.C. 802(10) (emphases added).
    RD, at 105. Respondent has not demonstrated that there was a 
lawful order of a practitioner to prepare the substance for such 
delivery to fall under the definition of ``dispense.''
    \45\ [Text omitted where footnote was included.]
    \46\ [Text omitted where footnote was included.]
---------------------------------------------------------------------------

    *\M\ The thrust of the Respondent's argument is that because the 
CSA does not define compounding, the appropriate question is whether 
the Respondent complied with Florida law and other federal laws. Resp't 
PHB, at 37-38. The Respondent argues that it engaged in anticipatory 
compounding (i.e., compounding before receiving a prescription), which 
is permissible under Florida law and the Food, Drug, and Cosmetic Act 
(hereinafter, FDCA).*\N\ Id. at 37-41. Florida law provides that lawful 
compounding includes ``[t]he preparation of drugs or devices in 
anticipation of prescriptions based on routine, regularly observed 
prescribing patterns.'' Fla. Admin. Code r. 64B16-27.700(1)(a).*\O\ 
[However, as explained herein, the facts on the record do not support a 
finding that Respondent was compounding in this manner, nor do they 
support a finding that Respondent was compounding within the usual 
course of the professional practice of pharmacy in order to meet the 
CSA's manufacturing exemption.] [Text omitted.] \47\
---------------------------------------------------------------------------

    *\M\ RD's discussion was relocated.
    *\N\ The RD contained an analysis of the FDCA requirements in 
rebuttal of Respondent's assertion, but declined to make a finding 
as to whether Respondent was in compliance. RD, at 107-09. As the RD 
noted, the FDCA does not have a direct impact on DEA's 
interpretation of the CSA manufacturing provision. Id.
    *\O\ Even if Florida law were controlling in this case, there is 
no evidence that Respondent's compounding was permissible under 
Florida law. Although Florida Law permits what the Respondent 
describes as ``anticipatory compounding,'' there are plain language 
restrictions in the regulation that require the preparation to be in 
anticipation of prescriptions. As described herein, the facts of 
this case contradict the Respondent's claim that its compounding was 
in compliance with this law. Respondent also cited to Fla. Admin. 
Code r. 64B16-27.700(1)(c) that permits ``the preparation of 
commercially available products from bulk when the prescribing 
practitioner has prescribed the compounded product on a per 
prescription basis,'' but the evidence shows that Respondent 
typically contacted the physicians for permission to substitute 
compounded capsules when the prescriptions were written for tablets. 
The Respondent has presented no evidence or argument to support that 
physicians were specifically prescribing the compounded product, 
which appears to be what is required by this section of Florida 
code. Furthermore, there is no evidence that this section, or the 
other section of the Florida code, permits the Respondent to 
compound without an individualized patient need in accordance with 
the usual course of professional practice.
    \47\ [Text omitted where footnote was included.]
---------------------------------------------------------------------------

    *\P\ The clearest evidence that the Respondent manufactured, rather 
than compounded for individual patients, comes from the closing 
inventory conducted by DI Albert and Mr. Clement, Sr., in September 
2018. Tr. 52, 54, 56, 165-66; GX 7. The closing inventory documented 
the number of controlled substances the Respondent had on hand at the 
time. Id. DI Albert observed Mr. Clement, Sr., conduct the inventory 
and Mr. Clement, Sr., signed off on it. Tr. 56, 166.
---------------------------------------------------------------------------

    *\P\ RD's discussion was relocated.
---------------------------------------------------------------------------

    The closing inventory shows that on September 10, 2018, the 
Respondent had 3,546 compounded capsules of hydromorphone 8 mg on hand 
and 574 compounded capsules of oxycodone 30 mg on hand. GX 7, p. 1. 
These capsules were sitting in a safe when they were counted. Tr. 56. 
Several thousand capsules sitting in a safe is not consistent with 
compounding for an individual patient's therapeutic needs as an 
incident to dispensing [nor is it consistent with anticipated 
prescriptions based on routine prescribing patterns as described in 
Florida law]. It is consistent with manufacturing capsules in bulk and 
storing them until a prescription is presented.
    The Respondent argues that no evidence of record proves that it 
``produced significantly large quantities of any drug.'' Resp't PHB, at 
41. Whether the 4,120 capsules stored in the Respondent's safe on 
September 10, 2018, constitutes a ``significantly large'' quantity is 
beside the point. Whether the Respondent produced a large or small 
amount of compounded capsules, however, is relative, and my finding on 
this allegation has nothing to do with the amount of capsules produced. 
[Omitted.] \48\
---------------------------------------------------------------------------

    \48\ [Text omitted where footnote was included.]
---------------------------------------------------------------------------

    This is especially true when the Respondent typically filled only 
two to four prescriptions per day. Tr. 508. The rough math shows that 
four thousand compounded capsules could be enough for two weeks of 
dispensing. Considering that a month's supply of oxycodone would be 
roughly 112 tablets (GX 18, p. 6) and a month's supply of hydromorphone 
would be roughly 120 tablets (GX 44, p. 6), the Respondent had enough 
oxycodone capsules on hand to fill approximately 5 prescriptions and 
enough hydromorphone capsules on hand to fill about 29 prescriptions. 
Together, this would approximate the number of prescriptions the 
Respondent typically saw over the course of two weeks. This lends 
further support to my conclusion that the amount of compounded capsules 
the Respondent had on hand on September 10, 2018, is [more

[[Page 64739]]

consistent with manufacturing than dispensing compounding within the 
scope of the CSA.]
    In addition to the closing inventory, the Government also points to 
statements made by Mr. Clement, Sr., in 2012. Gov't PHB, at 46. In May 
2012, during execution of an administrative inspection warrant (AIW) at 
the Respondent pharmacy, TFO Shearer interviewed Mr. Clement, Sr., the 
Respondent's owner. Tr. 183. Mr. Clement, Sr., was not in custody at 
the time and was free to leave. Id. 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. In other words, $1,100 worth of powder 
could produce at least $12,000 worth of dosage units. 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., also told TFO 
Shearer that he persuaded patients to take capsules even if they did 
not want them because capsules have the same effect as tablets.\49\ Tr. 
185-86.
---------------------------------------------------------------------------

    \49\ While reliable hearsay statements may be admissible in 
these administrative proceedings, Mr. Clement, Sr.'s, statements to 
TFO Shearer in 2012 are not hearsay. They enjoy enhanced credibility 
as they would qualify as statements by a party opponent and would, 
therefore, be excluded from the definition of hearsay. Fed. R. Evid. 
801(d)(2). [Respondent argues that this conversation was six or 
seven years ago and to rely on it would be arbitrary and capricious. 
Resp't Exceptions, at 3. This conversation lends further support for 
a finding that has other support in the record. Also, I note that 
Respondent did not refute this evidence through the testimony of Mr. 
Clement, Sr.]
---------------------------------------------------------------------------

    Although these statements were made in 2012, they demonstrate that 
the Respondent had a system in place to compound thousands of capsules 
at a time. Tr. 184-85. These statements also demonstrate that the 
Respondent's motive for mass-compounding thousands of capsules per 
batch was cost effectiveness, rather than patients' unique therapeutic 
needs. Tr. 184-86. These statements provide additional support to the 
conclusion that the Respondent's compounding was cost-driven rather 
than patient-driven, and that the Respondent was, therefore, 
manufacturing and not compounding as the CSA understands those terms.
    The Government also points to the batch records obtained pursuant 
to the 2017 subpoena. Gov't PHB, at 46; Tr. 27. 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 each batch. 
Tr. 38, 40-41. The batch records in Government Exhibit 5 document the 
production of hydromorphone 8 mg. The batch records in Government 
Exhibit 6 document the production of oxycodone 30 mg. The hydromorphone 
batch records show that the Respondent ``compounded'' from 600 to 2,400 
capsules per batch, with 1,200 capsules being the most frequently 
occurring quantity. See generally GX 5. The oxycodone batch records 
show that the Respondent ``compounded'' from 600 to 1,800 capsules per 
batch, with 1,200 capsules being the most frequently occurring 
quantity. See generally GX 6. These numbers are consistent with the 
number of compounded capsules found during the 2018 closing inventory 
and with Mr. Clement, Sr.'s, statements to TFO Shearer in 2012. [When 
viewed with the other facts,] these numbers are also consistent with 
manufacturing rather than [dispensing] compounding.
    Furthermore, the Respondent's dispensing records also demonstrate 
that the patients for whom the Respondent compounded oxycodone and 
hydromorphone did not have valid therapeutic needs for compounded 
medication. Dr. Sullivan explained that the definition of compounding 
in the practice of pharmacy is to ``make[ ] a drug . . . from scratch, 
make it in a finished form from an unfinished form, to meet the 
individual, unique therapeutic needs of a patient.'' Tr. 230. 
Compounding would be necessary, he continued, if the patient had an 
allergy to the commercially available version or if the patient needed 
a unique dose or strength that was not available in the mass-produced 
product. Tr. 230-31. [Omitted. Dr. Sullivan also testified that the 
dosage units dispensed in GE-11, at 7, demonstrated that 90,179 dosage 
units of the compounded 8 milligram hydromorphone capsules. Tr. 248. He 
testified that ``[t]here cannot be that many patients that need to have 
compounded hydromorphone 8 milligram tablets to meet the unique 
therapeutic needs of the patient. In [his] opinion, that's 
manufacturing.'' Tr. 249; see also Tr. 250 (same for oxycodone).]
    Dispensing records, however, show that the Respondent dispensed 
both commercially manufactured tablets and compounded capsules to the 
same patient. The fact that the Respondent dispensed both commercially 
available tablets and compounded capsules of the same controlled 
substances to the same patients indicates that the patients lacked 
``unique therapeutic needs'' for the compounded version. Tr. 231, 256. 
For example, the Respondent dispensed seven prescriptions of oxycodone 
30 mg tablets to patient A.G. from June 2017 to August 2018. ALJ Ex. 
42, p. 11. During that same time period, the Respondent also dispensed 
to A.G. three prescriptions of oxycodone 30 mg compounded capsules. Id. 
A note dated March 13, 2017, in A.G.'s profile states that a doctor 
approved dispensing medication to A.G. in compounded capsules. GX 15, 
p. 1; ALJ Ex. 42, p. 13. After March 2017, however, the Respondent 
continued dispensing both tablets and compounded capsules to A.G. ALJ 
Ex. 42, p. 11. Thus, even if a doctor approved of A.G. taking 
compounded capsules, it was not for a therapeutic or medical reason 
because he continued to alternate between capsules and tablets. [Dr. 
Sullivan testified that nothing in the record demonstrated that there 
was a therapeutic need for the compounded medication. Tr. 258-59].
    In another example, the Respondent dispensed both tablets and 
compounded capsules to patient R.G. to fill the same oxycodone 
prescription. GX 49; Tr. 325-26. Dr. Sullivan opined that R.G. clearly 
had no valid therapeutic need for compounded capsules since he also 
took the tablet form of the same drug. Tr. 326. Patient R.G. also 
received oxycodone in capsules on 15 occasions from June 2017 to 
September 2018, and in tablets on 2 occasions during the same time 
period. ALJ Ex. 42, p. 45. As Dr. Sullivan observed, the fact that the 
Respondent dispensed oxycodone to R.G. in both capsule and tablet 
forms, and dispensed capsules and tablets together on one occasion, 
demonstrates that the Respondent was not compounding for R.G. in 
response to a unique therapeutic need for compounded capsules. Tr. 325-
26. Furthermore, no profile for any of the patients documents an 
allergy or other reason that would have necessitated compounded 
capsules. Tr. 339; GX 15, 20, 23, 26, 29, 32, 35, 38, 41, 47, 51.
    Dr. Sullivan pointed out numerous other instances where the 
Respondent's dispensing history demonstrated that patients lacked 
legitimate therapeutic justification for compounded capsules. From 
January 2018 to December 2018, the Respondent dispensed compounded 
capsules of hydromorphone 8 mg to A.H. on eight occasions: January 4;

[[Page 64740]]

February 15; March 5; April 3; May 2; August 16; September 11; and 
December 5. ALJ Ex. 42, pp. 15-16; GX 19; GX 21. The Respondent then 
dispensed tablets of hydromorphone 8 mg to A.H. on the following five 
occasions in 2019: January 22; February 15; February 27; March 14; and 
April 18. Id. The fact that the Respondent dispensed capsules of 
hydromorphone to A.H. on eight occasions in 2018 and then tablets of 
hydromorphone on five occasions in 2019 demonstrates that A.H. had no 
unique therapeutic justification that required the Respondent to 
compound hydromorphone capsules for him. Tr. 255-56, 258-59, 269.
    Dr. Sullivan noted a lack of therapeutic justification to compound 
hydromorphone for B.S. since he received hydromorphone in both tablets 
and capsules. Tr. 274. From August 2017 to August 2018, the Respondent 
filled 12 hydromorphone prescriptions with compounded capsules for 
B.S.: August 22, 2017; September 27, 2017; October 18, 2017; November 
15, 2017; December 12, 2017; January 4, 2018; January 29, 2018; 
February 28, 2018; March 26, 2018; April 23, 2018; May 22, 2018; and 
August 24, 2018. ALJ Ex. 42, p. 19; GX 24. On February 5, 2019, the 
Respondent filled a hydromorphone prescription for B.S. with tablets. 
ALJ Ex. 42, p. 20; GX 22. The fact that the Respondent dispensed 
hydromorphone tablets to B.S. in 2019 shows that B.S. had no unique 
therapeutic justification that required the Respondent to compound 
hydromorphone capsules for him on 12 occasions in 2017 and 2018. Tr. 
255-56, 258-59, 269, 274.
    The Respondent dispensed oxycodone capsules and tablets to C.R., 
indicating that there was no valid therapeutic reason for the 
Respondent to compound oxycodone capsules for her. Tr. 255-56, 258-59, 
269, 274, 279-80. On July 19, 2017, and October 26, 2017, the 
Respondent filled oxycodone prescriptions for C.R. with compounded 
capsules. ALJ Ex. 42, p. 23; GX 27. The Respondent then filled four 
oxycodone prescriptions for C.R. with tablets: March 6, 2018; April 19, 
2018; July 12, 2018; and August 28, 2018. Id.
    Dr. Sullivan observed that J.M. alternated between tablets and 
capsules of oxycodone, demonstrating that there was no valid 
therapeutic need for the Respondent to compound oxycodone capsules for 
her. Tr. 290. First, the Respondent dispensed oxycodone tablets to J.M. 
on January 25, 2018, and then filled J.M.'s next oxycodone prescription 
with compounded capsules on March 1, 2018. ALJ Ex. 42, p. 30; GX 33; 
Tr. 290. The next month the Respondent switched back to oxycodone 
tablets on April 4, 2018, followed by oxycodone capsules on April 19, 
2018, and then switched back again to tablets on May 16, 2018. Id. The 
fact that the Respondent alternated between dispensing oxycodone 
tablets and capsules to J.M. demonstrates that there was no valid 
therapeutic reason for the Respondent to compound oxycodone capsules 
for her. Tr. 255-56, 258-59, 269, 274, 279-80, 290.
    Dr. Sullivan observed that the Respondent dispensed oxycodone 
tablets and compounded capsules to M.M. Tr. 295, 297. From June 2017 to 
August 2018, the Respondent filled 14 oxycodone prescriptions for M.M. 
with compounded capsules. Tr. 295, 297; ALJ Ex. 42, pp. 33-34; GX 34; 
GX 36. From January 2019 to April 2019, the Respondent filled five 
oxycodone prescriptions for M.M. with tablets. Id. The fact that the 
Respondent dispensed compounded oxycodone capsules to M.M. for over a 
year and then switched to dispensing oxycodone tablets to her for 
several months demonstrates that there was no valid medical reason for 
the Respondent to have compounded oxycodone for her. Tr. 255-56, 258-
59, 269, 274, 279-80, 290, 295, 297.
    Dr. Sullivan observed that the Respondent compounded hydromorphone 
capsules for N.B. without any apparent therapeutic justification. Tr. 
302. From June 2017 to August 2018, the Respondent filled twelve 
hydromorphone prescriptions for N.B. with compounded capsules. ALJ Ex. 
42, p. 37; GX 39.
    Dr. Sullivan pointed out that the Respondent compounded 
hydromorphone capsules for R.B. without any apparent medical 
justification. Tr. 311, 319-20. From June 2017 to January 2019, the 
Respondent filled 14 hydromorphone prescriptions for R.B. with 
compounded capsules. GX 40; GX 43; ALJ Ex. 42, pp. 41-42. At least 
three of those prescriptions were originally written for tablets and 
were substituted for capsules by the Respondent. Tr. 319-20; GX 44, pp. 
6-7. The Respondent then dispensed hydromorphone tablets to R.B. on 
three occasions from February to April 2019. ALJ Ex. 42, p. 42; GX 40. 
The fact that the Respondent dispensed tablets and capsules of 
hydromorphone to R.B., switching prescribed tablets to capsules, 
demonstrates that there was no valid therapeutic reason for the 
Respondent to compound hydromorphone for R.B. Tr. 311, 319-21.
    Lastly, Dr. Sullivan noted that the Respondent compounded capsules 
of hydromorphone for R.L. without any apparent medical justification. 
Tr. 331; ALJ Ex. 42, p. 49; GX 52. From June 2017 to September 2018, 
the Respondent filled 14 hydromorphone prescriptions for R.L. with 
compounded capsules. Id.
    [Contrary to the Respondent's contention, due to the credible and 
unrebutted testimony of the Government's expert witness, Respondent's 
compounding cannot fall into the CSA's exception to the definition of 
manufacturing ``in conformity with applicable State or local law by a 
practitioner as an incident to his administration or dispensing of such 
drug or substance in the course of his professional practice.'' 
*Q 21 U.S.C. 802(15). Dr. Sullivan's testimony was clear 
that the compounding here was outside the course of professional 
practice, because there was no individualized therapeutic need for the 
compounded capsules, as evidenced by the quantities dispensed and the 
alternating of compounded capsules and commercially available product 
and the lack of documentation or other support demonstrating any 
individualized need. Further, as described above, Respondent's reliance 
on Florida law is unavailing for many

[[Page 64741]]

reasons. Although Florida law permits compounding based on routine, 
regularly observed prescribing patterns, there is nothing in Florida 
law to suggest that this anticipation would negate the professional 
practice of pharmacy requirement for there to be individualized 
therapeutic need, which the record has repeatedly demonstrated was 
lacking with regard to these compounded capsules.*R See Fla. 
Admin. Code r. 64B16-27.700(1)(a).]
---------------------------------------------------------------------------

    *Q In finding that Respondent engaged in 
manufacturing, the ALJ relied primarily on a statutory 
interpretation of ``incident to'' and determined that the 
compounding in this case would not be considered ``incident to'' the 
dispensing. RD, at 103-06. I find that it is unnecessary to rely on 
a statutory interpretation of ``incident to'' in this case, because 
the evidence on the record clearly establishes that this compounding 
was not in the course of professional practice, which the statute 
states plainly is required for the exception to the manufacturing 
definition to apply. In analyzing this issue, the ALJ discussed the 
Agency's decision in Wedgewood, which clarifies that to use a 
dispensing registration for compounding the important consideration 
is that the compounding is ``for a specific patient on a patient by 
patient basis.'' Id. (citing Wedgewood Village Pharm., 71 FR 16,593, 
16,595 (2006)). It is noted that Wedgewood was appealed and 
remanded, based primarily on the Agency's interpretation of 
distribution--not manufacturing, Wedgewood Village Pharmacy v. DEA, 
509 F.3d 541, 550-52 (D.C. Cir. 2007) and therefore, that the 
Agency's interpretation in Wedgewood regarding what constitutes 
manufacturing remains intact; however, I also find it unnecessary to 
rely on prior Agency interpretation in this case, because, again, 
the statute is clear regarding the requirement that such compounding 
must be in the course of professional practice. My conclusions rely 
on Dr. Sullivan's testimony that patients must have a specific need 
for compounded capsules and other support in the record that the 
usual course of professional practice requires such a need. As 
discussed in more detail herein, the record does not demonstrate 
that Respondent's customers had individualized needs. The RD also 
provided examples where courts, including the Supreme Court, have 
defined the term ``compounding'' to require individualized patient 
need. RD, at 105, n.45, and 116. Although not in the context of the 
CSA, these interpretations further support Dr. Sullivan's credible 
and unrebutted testimony regarding the course of the professional 
practice and the lack of individualized need for compounded capsules 
in this case.
    *R Although stated in a different context, there is 
further support for this finding in Department of Health, Petitioner 
v. Discovery Experimental and Development, Inc., Respondent 
Discovery Experimental and Development, Inc., Petitioner, 2003 WL 
1921003 (April 18, 2003), where a Florida Administrative Law Judge 
stated that Fla. Admin. Code r. 64B16-27.700 ``requires patient 
specific compounding of medicinal drugs, on a per prescription basis 
where there is an established patient-physician relationship, and 
the patient has been made aware that a pharmacist will prepare the 
compounded drug.'' Id. at n.14). Although the portion of the Florida 
regulation cited to by Respondent would permit advance preparation 
of compounded drugs under state law, there is no evidence that 
Florida intended it to permit a pharmacy to compound drugs without a 
specific therapeutic need. In fact, the Government's expert opined 
that such compounding is not within the course of professional 
practice of pharmacy, and in his opinion, constitutes manufacturing.
---------------------------------------------------------------------------

    In sum, the evidence paints a picture of a pharmacy mass-
compounding bulk quantities of oxycodone and hydromorphone in thousands 
of capsules per batch. The evidence further reveals the Respondent's 
motive for doing so: Profit rather than patient need. The evidence 
shows that the Respondent's ``compounding'' was not incidental to the 
act of dispensing and was not in the course of its professional 
practice. [Omitted]. Thus, the Respondent engaged in manufacturing 
thousands of controlled substance dosages over a period of several 
years without the proper registration. For these reasons, the 
Government's allegation that the Respondent illegally manufactured 
controlled substances is SUSTAINED. ALJ Ex. 1, pp. 8-10, ] 20-28. 
[Although I find that this constitutes a separate violation of federal 
law, which I consider under Factor Four below, I also find that there 
is more than enough evidence of other violations in this case to 
support a sanction of revocation, even if I had not sustained this 
allegation.]

Government's Burden of Proof and Establishment of a Prima Facie Case

    [In order to make a prima facie case that a ground for revocation 
of Respondent's registration exists, the Government must demonstrate 
that Respondent's continued registration is inconsistent with the 
public interest]. [Text omitted for clarity.].
Public Interest Determination: The Standard
    Pursuant to 21 U.S.C. 823(a)(4) (2006 & Supp. III 2010), the 
Administrator \50\ may revoke a DEA Certificate of Registration if the 
Registrant has committed such acts as would render its registration 
inconsistent with the public interest. Evaluation of the following 
factors have been mandated by Congress in determining whether 
maintaining such registration would be inconsistent with ``the public 
interest'':
---------------------------------------------------------------------------

    \50\ This authority has been delegated pursuant to 28 CFR 
0.100(b) and 0.104 (2008).

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The [registrant's] experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The [registrant's] conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

21 U.S.C. 823(f).

    ``These factors are . . . considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). Any one or a combination 
of factors may be relied upon, and when exercising authority as an 
impartial adjudicator, the Agency may properly give each factor 
whatever weight it deems appropriate in determining whether a 
registrant's registration should be revoked. Id. (citation omitted); 
David H. Gillis, M.D., 58 FR 37,507, 37,508 (1993); see also Morall v. 
DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005); Henry J. Schwarz, Jr., 
M.D., 54 FR 16,422, 16,424 (1989). Moreover, the Agency is ``not 
required to make findings as to all of the factors,'' Hoxie v. DEA, 419 
F.3d 477, 482 (6th Cir. 2005); see also Morall, 412 F.3d at 173, and is 
not required to discuss consideration of each factor in equal detail, 
or even every factor in any given level of detail. Trawick v. DEA, 861 
F.2d 72, 76 (4th Cir. 1988) (holding that the Administrator's 
obligation to explain the decision rationale may be satisfied even if 
only minimal consideration is given to the relevant factors, and that 
remand is required only when it is unclear whether the relevant factors 
were considered at all). The balancing of the public interest factors 
``is not a contest in which score is kept; the Agency is not required 
to mechanically count up the factors and determine how many favor the 
Government and how many favor the registrant. Rather, it is an inquiry 
which focuses on protecting the public interest.'' Jayam Krishna-Iyer, 
M.D., 74 FR 459, 462 (2009).

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

    The Government seeks the revocation of the Respondent's COR based 
primarily on conduct most appropriately considered under Public 
Interest Factors Two and Four.\51\ The Government has also raised one 
allegation under Factor Five.
---------------------------------------------------------------------------

    \51\ 21 U.S.C. 823(f)(2), (4). There is nothing in the record to 
suggest that a state licensing board made any recommendation 
regarding the disposition of the Respondent's DEA COR (Factor One). 
Likewise, the record contains no evidence that the Respondent has 
been convicted of (or charged with) a crime related to controlled 
substances (Factor Three).
---------------------------------------------------------------------------

    [Factors Two and Four are often analyzed together. See, e.g., Fred 
Samimi, M.D., 79 FR 18,698, 18,709 (2014); John V. Scalera, M.D., 78 FR 
12,092, 12,098 (2013). Under Factor Two, the DEA analyzes a 
registrant's ``experience in dispensing . . . controlled substances.'' 
21 U.S.C. 823(f)(2). Factor Two analysis focuses on an applicant's acts 
that are inconsistent with the public interest, rather than on an 
applicant's neutral or positive acts and experience. Randall L. Wolff, 
M.D., 77 FR 5106, 5121 n.25 (2012) (explaining that ``every registrant 
can undoubtedly point to an extensive body of legitimate prescribing 
over the course of [the registrant's] professional career'') (quoting 
Jayam Krishna-Iyer, M.D., 74 FR 459, 463 (2009)). Similarly, under 
Factor Four, the DEA analyzes an applicant's compliance with federal 
and state controlled substance laws. 21 U.S.C. 823(f)(4). Factor Four 
analysis focuses on violations of state and federal laws and 
regulations. Volkman v. DEA, 567 F.3d 215, 223-24 (6th Cir. 2009) 
(citing Gonzales v. Oregon, 546 U.S. 243, 272, 274 (2006)); see Joseph 
Gaudio, M.D., 74 FR 10,083, 10,090-91 (2009).] *S 52
---------------------------------------------------------------------------

    *S For brevity and keeping with recent cases, I have 
removed the RD's legal analysis of Factors Two and Four and replaced 
it with this text.
    \52\ [Text omitted where footnote was included.]
---------------------------------------------------------------------------

Standard of Care as to Charged Violations *T
---------------------------------------------------------------------------

    *T This section was modified to clarify the analysis 
of a pharmacist's corresponding responsibility under 21 CFR 
1306.04(a).
---------------------------------------------------------------------------

    [According to the CSA's implementing regulations, ``[a] 
prescription for a controlled substance may only be filled by a 
pharmacist, acting in the usual course of his professional practice.'' 
21 CFR 1306.06.

[[Page 64742]]

Further, a controlled substance prescription must be ``issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a). While 
the ``responsibility for the proper prescribing and dispensing of 
controlled substances is upon the prescribing practitioner . . . a 
corresponding responsibility rests with the pharmacist who fills the 
prescription.'' Id. The regulations establish the parameters of the 
---------------------------------------------------------------------------
pharmacy's corresponding responsibility.

    An order purporting to be a prescription issued not in the usual 
course of professional treatment . . . is not a prescription within 
the meaning and intent of . . . 21 U.S.C. 829 . . . and the person 
knowingly filling such a purported prescription, as well as the 
person issuing it, shall be subject to the penalties provided for 
violations of the provisions of law relating to controlled 
substances.

Id. ``The language in 21 CFR 1306.04 and caselaw could not be more 
explicit. A pharmacist has his own responsibility to ensure that 
controlled substances are not dispensed for non-medical reasons.'' 
Ralph J. Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55 FR 4729, 4730 
(1990) (citing United States v. Hayes, 595 F.2d 258 (5th Cir. 1979), 
cert. denied, 444 U.S. 866 (1979); United States v. Henry, 727 F.2d 
1373 (5th Cir. 1984) (reversed on other grounds)). As the Supreme Court 
explained in the context of the CSA's requirement that schedule II 
controlled substances may be dispensed only by written prescription, 
``the prescription requirement . . . ensures patients use controlled 
substances under the supervision of a doctor so as to prevent addiction 
and recreational abuse . . . [and] also bars doctors from peddling to 
patients who crave the drugs for those prohibited uses.'' Gonzales v. 
Oregon, 546 U.S. 243, 274 (2006).
    To prove a pharmacist violated his or her corresponding 
responsibility, the Government must show that the pharmacist acted with 
the requisite degree of scienter. See 21 CFR 1306.04(a) (``[T]he person 
knowingly filling [a prescription issued not in the usual course of 
professional treatment] . . . shall be subject to the penalties 
provided for violations of the provisions of law relating to controlled 
substances.'') (emphasis added). DEA has also consistently interpreted 
the corresponding responsibility regulation such that ``[w]hen 
prescriptions are clearly not issued for legitimate medical purposes, a 
pharmacist may not intentionally close his eyes and thereby avoid 
[actual] knowledge of the real purpose of the prescription.'' 
Bertolino, 55 FR 4730 (citations omitted); see also JM Pharmacy Group, 
Inc. d/b/a Pharmacia Nueva and Best Pharmacy Corp., 80 FR 28,667, 
28,670-72 (2015) (applying the standard of willful blindness in 
assessing whether a pharmacist acted with the requisite scienter). 
Pursuant to their corresponding responsibility, pharmacists must 
exercise ``common sense and professional judgment'' when filling a 
prescription issued by a physician. Bertolino, 55 FR 4730. When a 
pharmacist's suspicions are aroused by a red flag, the pharmacist must 
question the prescription and, if unable to resolve the red flag, 
refuse to fill the prescription. Id.; Medicine Shoppe-Jonesborough, 300 
F. App'x 409, 412 (6th Cir. 2008) (``When pharmacists' suspicions are 
aroused as reasonable professionals, they must at least verify the 
prescription's propriety, and if not satisfied by the answer they must 
refuse to dispense.'').
    Finally, ``[t]he corresponding responsibility to ensure the 
dispensing of valid prescriptions extends to the pharmacy itself.'' 
Holiday CVS, 77 FR 62,341 (citing Med. Shoppe--Jonesborough, 73 FR 384; 
United Prescription Servs., Inc., 72 FR 50,397, 50,407-08 (2007); EZRX, 
L.L.C., 69 FR 63,178, 63,181 (2004); Role of Authorized Agents in 
Communicating Controlled Substance Prescriptions to Pharmacies, 75 FR 
61,613, 61,617 (2010); Issuance of Multiple Prescriptions for Schedule 
II Controlled Substances, 72 FR 64,921, 64,924 (2007) (other citations 
omitted)). The DEA has consistently held that the registration of a 
pharmacy may be revoked as the result of the unlawful activity of the 
pharmacy's owners, majority shareholders, officers, managing 
pharmacist, or other key employee. EZRX, L.L.C., 69 FR 63,181; Plaza 
Pharmacy, 53 FR 36,910, 36,911 (1988). Similarly, ``[k]nowledge 
obtained by the pharmacists and other employees acting within the scope 
of their employment may be imputed to the pharmacy itself.'' Holiday 
CVS, 77 FR 62,341.
    In this matter, the Government did not allege that Respondent 
dispensed the prescriptions at issue having actual knowledge that the 
prescriptions lacked a legitimate medical purpose. Instead, the 
Government alleged that Respondent violated its corresponding 
responsibility by filling prescriptions that raised red flags that were 
so strongly indicative of drug abuse and diversion that they could not 
have been resolved by a pharmacist acting in the usual course of 
professional practice. ALJ Ex. 1, pp. 4-7. Agency decisions have 
consistently found that prescriptions with similar red flags were so 
suspicious as to support a finding that the pharmacists who filled them 
violated their corresponding responsibility because they had actual 
knowledge of, or were willfully blind to, the prescriptions' 
illegitimacy.*U Additionally, DEA has 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, and should not be filled.*V DEA 
has also held that a pharmacist who fills prescriptions that present 
unresolvable red flags engages in knowing diversion of controlled 
substances.*W]
---------------------------------------------------------------------------

    *U See, e.g., Pharmacy Doctors Enterprises d/b/a Zion 
Clinic Pharmacy, 83 FR 10,876, 10,898, pet. for rev. denied, 789 F. 
App'x 724 (11th Cir. 2019) (long distances; pattern prescribing; 
customers with the same street address presenting the same 
prescriptions on the same day; drug cocktails; cash payments; early 
refills); Hills Pharmacy, 81 FR 49,816, 49,836-39 (2016) (multiple 
customers presenting prescriptions written by the same prescriber 
for the same drugs in the same quantities; customers with the same 
last name and street address presenting similar prescriptions on the 
same day; long distances; drug cocktails); The Medicine Shoppe, 79 
FR 59,504, 59,507, 59,512-13 (2014) (unusually large quantity of a 
controlled substance; pattern prescribing; irregular dosing 
instructions; drug cocktails); Holiday CVS, 77 FR 62,316, 62,317-22 
(2012) (long distances; multiple customers presenting prescriptions 
written by the same prescriber for the same drugs in the same 
quantities; customers with the same last name and street address 
presenting virtually the same prescriptions within a short time 
span; payment by cash); East Main Street Pharmacy, 75 FR 66,149, 
66,163-65 (2010) (long distances; lack of individualized therapy or 
dosing; drug cocktails; early fills/refills; other pharmacies' 
refusals to fill the prescriptions).
    *V See, e.g., Pharmacy Doctors Enterprises, 83 FR 
10,286, 10,888 (2018) (crediting expert testimony that certain red 
flags were ``not resolvable''); The Medicine Shoppe, 79 FR 59,504, 
59,507-08 (2014) (same); Holiday CVS, LLC, 77 FR 62,316, 62,319 
(2012) (same); cf. Edge Pharmacy, 81 FR 72,092, 72,112 n.54 (2016) 
(noting that ``many of the prescriptions presented unresolvable red 
flags'').
    *W The Medicine Shoppe, 79 FR at n.10.
---------------------------------------------------------------------------

    [Text omitted for brevity.]*X
---------------------------------------------------------------------------

    *X I have omitted, for brevity, text regarding the 
legal standard requiring a nexus between the state laws that have 
been violated and the CSA's purpose of preventing drug abuse and 
diversion. I find that the Florida laws in this case are 
sufficiently related to controlled substances to be considered in my 
public interest analysis, and that my consideration of these state 
law violations bears a rational relationship to the core purpose of 
the CSA. See Salman Akbar, M.D., 86 FR 52,181, 52,194-95 (2021) 
(citing 21 U.S.C. 823(a)(4); Judulang v. Holder, 556 U.S. 42, 63 
(2011)).
---------------------------------------------------------------------------

    The Government has introduced a preponderance of evidence to prove 
that the Respondent dispensed numerous controlled substance 
prescriptions for at least eleven patients that raised red flags of 
drug abuse and/or diversion. These

[[Page 64743]]

red flags included early fills, long distances traveled, cash payments, 
dangerous drug cocktails, and high-strength narcotics, among others. 
[Dr. Sullivan offered credible and unrebutted testimony that these red 
flags could not have been resolved by a reasonable pharmacist acting 
within the usual course of his professional practice. Therefore, I find 
that the Respondent filled prescriptions for controlled substances that 
the pharmacists knew were not prescribed for legitimate medical 
purposes, or were willfully blind to such, in violation of their 
corresponding responsibility under 21 CFR 1306.04(a) and outside the 
usual course of professional practice in violation of 21 CFR 
1306.06.*Y
---------------------------------------------------------------------------

    *Y I have omitted the RD's discussion of Respondent's 
efforts (or lack thereof) to document a resolution of the red flags 
in this case.
---------------------------------------------------------------------------

    Further, the Government introduced evidence that Respondent 
violated Florida law by repeatedly filling prescriptions that raised 
unresolvable red flags. Florida law and the Florida standard of care 
require a pharmacist to conduct a prospective drug use review before 
dispensing a controlled substance. Tr. 211, 227-28; Fla. Admin. Code r. 
64B16-27.810. This includes ``review[ing] the patient record and each 
new and refill prescription presented for dispensing'' to identify, 
among other things, ``[o]ver-utilization or under-utilization,'' 
``[t]herapeutic duplication,'' ``drug-drug interactions,'' and 
``[c]linical abuse/misuse.'' Fla. Admin. Code r. 64B16-27.810. After 
conducting this review, the pharmacist must ``take appropriate steps to 
avoid or resolve the potential problems.'' Id. The purpose of the 
prospective drug use review is to identify red flags that require 
resolution before dispensing a controlled substance. Tr. 207-08, 211. 
Additionally, Florida law requires pharmacists to ``exercise[ ] sound 
professional judgment,'' review each prescription ``with each patient's 
unique situation in mind,'' and ``attempt to work with the patient and 
the prescriber to assist in determining the validity of the 
prescription.'' Fla. Admin. Code r. 64B16-27.831.
    Respondent violated Fla. Admin. Code rs. 64B16-27.810 and 64B16-
27.831 by repeatedly filling prescriptions that presented unresolvable 
red flags. Based on Dr. Sullivan's credible expert testimony, as 
supported by Florida law and prior Agency Decisions, a pharmacist 
acting in accordance with Florida law would have declined to fill these 
prescriptions after conducting a prospective drug use review.]
    The Respondent failed to rebut or discredit the Government's case. 
The Respondent did not introduce any documentary evidence and it only 
offered the testimony of a single witness, who failed to convincingly 
rebut the Government's evidence. In light of the record as to this 
factor, I find that the Government has overwhelmingly proven that the 
Respondent failed to comply with federal and state law with respect to 
its corresponding responsibility for the prescriptions in evidence.
    Furthermore, I find that the Government has sponsored a 
preponderance of evidence to show that the Respondent engaged in 
unlawful manufacturing of controlled substances without the proper DEA 
registration, in violation of 21 U.S.C. 841(a)(1) and 21 CFR 
1301.13(e). Thus, the Government has introduced evidence against the 
Respondent with respect to two aspects of the controlled drug supply 
chain, dispensing and manufacturing. The totality of this evidence 
demonstrates a concerning lack of compliance with applicable federal 
and state law that poses a significant risk of diversion and threatens 
public health and safety. This evidence further demonstrates a lack of 
commitment on the Respondent's part with respect to its federal and 
state controlled substance obligations. Therefore, I find that this 
factor significantly favors revoking the Respondent's 
registration.*Z
---------------------------------------------------------------------------

    *Z As found herein, there is substantial record 
evidence that Respondent dispensed controlled substances 
prescriptions outside the usual course of the professional practice 
in Florida and in violation of its corresponding responsibility and 
in violation of state law. There is also substantial record evidence 
that Respondent manufactured controlled substances outside the usual 
course of professional practice and without the proper registration. 
I, therefore, have concluded that Respondent engaged in misconduct 
that supports a determination that its registration is inconsistent 
with the public interest. See Pharmacy Doctors Enterprises d/b/a 
Zion Clinic Pharmacy, 83 FR 10,876, 10,903 (2018).
    For purposes of the imminent danger inquiry, my findings also 
lead to the conclusion that Respondent has ``fail[ed] . . . to 
maintain effective controls against diversion or otherwise comply 
with the obligations of a registrant'' under the CSA. 21 U.S.C. 
824(d)(2). At the time the Government issued the OSC, the Government 
had clear evidence that Respondent repeatedly filled prescriptions 
that presented a combination of red flags that could not have been 
resolved by a pharmacist acting in the usual course of professional 
practice, which establishes ``a substantial likelihood of an 
immediate threat that death, serious bodily harm, or abuse of a 
controlled substance . . . [would] occur in the absence of the 
immediate suspension'' of Respondent's registration. Id.
---------------------------------------------------------------------------

    [Section omitted for brevity and relevance.] *AA 53 54
---------------------------------------------------------------------------

    *AA The Government argued that I should consider 
under Factor Five that ``Respondent's business consisted almost 
entirely of dispensing controlled substances to customers who 
exhibited one or more significant red flags.'' Gov't Posthearing, at 
39-40. The ALJ declined to consider this conduct under Factor Five. 
RD, at 130-31. I find that the Government has provided substantial 
evidence related to Factors Two and Four to support my finding that 
Respondent's continued registration is inconsistent with the public 
interest and that the appropriate remedy in this case is revocation. 
Therefore, I decline to consider the Government's evidence under 
Factor Five.
    \53\ [Text omitted where footnote was included.]
    \54\ [Text omitted where footnote was included.]
---------------------------------------------------------------------------

Acceptance of Responsibility

    With the Government's prima facie burden having been met, the 
Respondent must present sufficient mitigating evidence to assure the 
Administrator that it can be entrusted with the responsibility 
incumbent with such registration. Medicine Shoppe-Jonesborough, 73 FR 
364, 387 (2008); Samuel S. Jackson, 72 FR 23,848, 23,853 (2007).*\BB\ 
As past performance is the best predictor of future performance, DEA 
has repeatedly held that where a registrant has committed acts 
inconsistent with the public interest, the registrant must accept 
responsibility for its actions and demonstrate that it will not engage 
in future misconduct. ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th 
Cir. 1995); Medicine Shoppe, 73 FR 387; see also Hoxie v. DEA, 419 F.3d 
477, 483 (6th Cir. 2005) (reasoning that ``admitting fault'' is 
``properly consider[ed]'' by DEA to be an ``important factor[]'' in the 
public interest determination). Likewise, in making the public interest 
determination, ``this Agency places great weight on a registrant's 
candor, both during an investigation and in [a] subsequent 
proceeding.'' Robert F. Hunt, 75 FR 49,995, 50,004 (2010); Hoxie, 419 
F.3d at 483.
---------------------------------------------------------------------------

    *BB This sentence was relocated for clarity, and text 
was omitted for brevity.
---------------------------------------------------------------------------

    Although correcting improper behavior and practices is very 
important to establish acceptance of responsibility, conceding 
wrongdoing is critical to reestablishing trust with the Agency. Holiday 
CVS, L.L.C., 77 FR 62,316, 62,346 (2012); Daniel A. Glick, D.D.S., 80 
FR 74,800, 74,801 (2015).
    The Respondent has not unequivocally accepted responsibility for 
the proven violations. In fact, the Respondent has not tendered any 
acceptance of responsibility at all, whether equivocal or unequivocal. 
The Respondent's owner and pharmacist-in-charge never testified at the 
hearing in order to accept responsibility. Instead, the Respondent's 
sole witness, a pharmacy tech, never admitted that the Respondent 
committed any wrongdoing. The Respondent's post-hearing brief is silent 
on this issue. Resp't PHB, p. 29, ] (i); p. 32, ] (ii); p. 36, ] (iii). 
[In its

[[Page 64744]]

opening statement, Respondent previewed its failure to accept 
responsibility]. Respondent argued that the Government had failed to 
satisfy its burden; accused the DEA of never intending to clearly or 
objectively evaluate the evidence; attacked the credentials of the 
Government's expert; claimed that the Respondent exercised appropriate 
judgment when dispensing the relevant controlled substance 
prescriptions in compliance with Florida law; and complained about the 
so-called ``ivory tower aspirational'' standard the DEA is imposing on 
its conduct. Tr. 503-05. In other words, the message from the 
Respondent's post-hearing brief and its opening statement is that it 
has done nothing wrong. These sentiments are inconsistent with a 
registrant that is remorseful for misconduct and determined to regain 
the Agency's trust. By failing to accept responsibility, the Respondent 
has failed to overcome the Government's prima facie case. In addition 
to failing to accept responsibility, the Respondent has also failed to 
offer any evidence of remediation.

Egregiousness and Deterrence

    *CC The egregiousness and extent of an applicant's 
misconduct are significant factors in determining the appropriate 
sanction. See Jacobo Dreszer, 76 FR 19,386, 19,387-88 (2011) 
(explaining that a respondent can ``argue that even though the 
Government has made out a prima facie case, his conduct was not so 
egregious as to warrant revocation''); Paul H. Volkman, 73 FR 30,630, 
30,644 (2008); see also Gregory D. Owens, 74 FR 36,751, 36,757 n.22 
(2009). [Likewise, DEA considers its interest in deterring future 
misconduct by both the registrant as well as other registrants. David 
A. Ruben, M.D., 78 FR 38363, 38364 (2013).]
---------------------------------------------------------------------------

    *CC Omitted for brevity.
---------------------------------------------------------------------------

    I find that the proven misconduct is egregious and that deterrence 
considerations weigh in favor of revocation. The proven misconduct 
involves repeated instances of dispensing high-strength schedule II 
controlled substances despite the presence of well-known signs of drug 
abuse and diversion. The proven misconduct also involves repeat 
instances of failing to follow state law and state standards of 
practice [by filling prescriptions that presented unresolvable red 
flags].*DD Respondent repeatedly dispensed high-strength 
schedule II opioids, sometimes dangerously combined with high-strength 
benzodiazepines, to patients who raised multiple red flags of 
diversion. [These red flags included paying in cash, filling 
prescriptions early, filling dangerous combinations of high-strength 
narcotics and benzodiazepines, and traveling between two and five 
hundred miles round trip to Respondent. The Government's expert 
credibly testified that the rationales that the patients offered for 
traveling such extraordinary distances should have concerned the 
pharmacists. Patient A.G. wrote on his questionnaire that he traveled 
two hundred and eighty miles roundtrip for ``quick and good service,'' 
GX 18; and Patient R.B. wrote that she traveled the same distance 
because ``[i]t's cheaper and [she has] found that they are good 
people.'' GX 44, at 1. Dr. Sullivan testified that the red flags raised 
by these prescriptions were so strongly indicative of drug abuse and 
diversion that a pharmacist acting in the usual course of professional 
practice would not have filled them. Respondent's decision to 
repeatedly turn a blind eye to these red flags] constitutes egregious 
misconduct because it allowed for the potential of unchecked diversion 
of controlled substances into illegitimate channels.
---------------------------------------------------------------------------

    *DD Paragraph modified for consistency with my 
finding that the prescriptions in this case presented a combination 
of red flags that could not have been resolved by a pharmacist 
acting in the usual course of professional practice.
---------------------------------------------------------------------------

    [Omitted for brevity.] *EE
---------------------------------------------------------------------------

    *EE I have omitted, for brevity, the RD's statements 
that revocation is the appropriate remedy notwithstanding the lack 
of evidence related to Factors One, Three, and Five. As discussed in 
more detail above, the Agency is ``not required to make findings as 
to all of the factors,'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 
2005); see also Morall, 412 F.3d at 173, and is not required to 
discuss consideration of each factor in equal detail, or even every 
factor in any given level of detail. Trawick v. DEA, 861 F.2d 72, 76 
(4th Cir. 1988).
---------------------------------------------------------------------------

    In addition to the severity of the Respondent's dispensing 
misconduct, the Respondent also unlawfully manufactured thousands of 
capsules of schedule II controlled substances without being registered 
with the DEA as a manufacturer. As noted earlier, registered 
manufacturers of controlled substances are held to higher standards 
than practitioners with respect to recordkeeping, reporting, security, 
and frequency of renewing registration. Thus, manufacturing controlled 
substances without the DEA's blessing enabled the Respondent to produce 
thousands of dosage units of controlled substances over several years 
in the absence of regulatory monitoring. As with unlawful dispensing, 
unlawful manufacturing is an egregious violation and warrants the 
revocation of registration.
    I further find that deterrence considerations weigh in favor of 
revocation. Allowing the Respondent to retain its COR despite the 
proven misconduct would send the wrong message to the regulated 
community. Imposing a sanction less than revocation would create the 
impression that registrants can maintain DEA registration despite 
repeatedly [ignoring glaring red flags of drug abuse and diversion], 
and despite engaging in a regulated activity without obtaining approval 
from the DEA to engage in that activity. Revoking the Respondent's COR 
communicates to registrants that the DEA takes all failings under the 
CSA seriously and that severe violations will result in severe 
sanctions.

Advice of Counsel

    When the DEA executed an AIW at the Respondent in September 2018, 
the Respondent's owner and pharmacist-in-charge, Mr. Clement, Sr., 
refused to speak to DI Albert upon advice of counsel to not answer any 
questions. Tr. 168, 173, 177. The Respondent has an absolute right to 
seek advice of counsel, and no adverse inference from obtaining advice 
of counsel may be drawn. It does not provide, however, any defense to 
actions taken, including failing to eventually respond to DEA inquiries 
following consultation with counsel, or lack of cooperation with the 
DEA's investigation.

Loss of Trust

    Where the Government has sustained its burden and established that 
a registrant has committed acts inconsistent with the public interest, 
that registrant must present sufficient mitigating evidence to assure 
the Administrator that he can be entrusted with the responsibility 
commensurate with such a registration. Medicine Shoppe-Jonesborough, 73 
FR 364, 387 (2008).
    There is no evidence that suggests the Respondent has learned any 
lessons from its misconduct. As just discussed, the Respondent does not 
appear to believe it has done anything wrong. [Text omitted for 
clarity.] The Respondent's failure to accept responsibly and present 
remediation evidence has convinced this Tribunal that the DEA cannot 
trust Respondent with the obligations of a DEA registration. [Omitted 
for relevance.] *FF
---------------------------------------------------------------------------

    *FF I have omitted the ALJ's discussion of 
Respondent's failure to cooperate with DEA investigators during 
inspections. Although cooperation with law enforcement can be 
relevant to sanction determinations, it is not necessary for me to 
consider this evidence in this case. I find that revocation is the 
appropriate remedy based on the egregiousness of Respondent's 
conduct and its failure to accept responsibility.

---------------------------------------------------------------------------

[[Page 64745]]

Recommendation

    Considering the entire record before me, the conduct of the 
hearing, and observation of the testimony of the witnesses presented, I 
find that the Government has met its burden of proof and has 
established a prima facie case for revocation. Furthermore, I find that 
the Respondent has not accepted responsibility, or presented sufficient 
evidence demonstrating that the Agency can entrust it with a COR.
    Therefore, I recommend that the Respondent's DEA COR No. FP2302076 
should be revoked, and that any pending applications for modification 
or renewal of the existing registration, and any applications for 
additional registrations, be denied.

    Signed: May 5, 2020.
Mark M. Dowd,
U.S. Administrative Law Judge

The Respondent's Exceptions *GG
---------------------------------------------------------------------------

    *\GG\ Jack Folson, Jr., who identifies himself as a clinical 
pharmacist in Westland, Michigan, filed a document on June 9, 2020, 
titled Amicus Brief Concerning the Standard of Practice in Pharmacy, 
Law and Decision of the Administrative Law Judge. Mr. Folson states 
that Respondent retained him to review the trial transcript and the 
RD, and he outlines his disagreements with the RD and Dr. Sullivan's 
testimony. The ALJ issued an Order Regarding Respondent's Amicus 
Brief on June 10, 2020. Order, at 1. The Order stated that 
Respondent had already filed the one set of exceptions it was 
entitled to file, and that the Amicus Brief was essentially a second 
set of exceptions that was filed after the May 26, 2020 deadline. 
Id. The ALJ also noted that the Amicus Brief repeatedly cites to 
materials outside of the record and includes unsworn expert 
testimony. Id. at 2. I agree with the RD's conclusion that the 
Amicus Brief is a set of untimely exceptions that is not permitted 
by the agency's adjudicative process. Id. at 2. Further the Brief 
presented evidence that was not on the record of the hearing, which 
I cannot consider, because doing so would, among other things, 
deprive the Government of an opportunity to address Respondent's 
representations and prevent a full credibility assessment. See Lisa 
Hamilton, 84 FR 71,465, 71,466 n.3 (2019). Therefore, I do not 
consider the Amicus Brief in my Decision.
---------------------------------------------------------------------------

    On May 26, 2020, Respondent filed its exceptions to the Recommended 
Decision. DEA regulations require that Exceptions ``include a statement 
of supporting reasons for such exceptions, together with evidence of 
record (including specific and complete citations of the pages of the 
transcript and exhibits) and citations of the authorities relied 
upon.'' 21 CFR 1316.66. For the most part, Respondent's Exceptions not 
only fail to comply with this regulatory requirement, but they also 
lack evidentiary support in the Administrative Record. Additionally, 
some of Respondent's Exceptions repeat arguments that were already 
raised in Respondent's Posthearing Brief, and were adequately addressed 
by the ALJ in the adopted Recommended Decision.
Exceptions #1 and 2
    In the first two Exceptions, Respondent argues that the ALJ erred 
in concluding that approximately thirty of the documents that the 
Government admitted into evidence were accurate and reliable. Resp 
Exceptions, at 5-8. These documents consist of: (1) Dispensing data, 
prescription records, and other patient records that DEA downloaded 
from Respondent's computers during the September 2018 AIW; and (2) 
dispensing data that DEA obtained from Florida's controlled substance 
dispensing database, E-FORSCE. Id. Because all of these records were 
generated by Respondent, and Respondent has not identified any specific 
concerns with the accuracy of these records, I find that these 
Exceptions are without merit.
    The only record evidence that Respondent identifies as potentially 
undercutting the reliability of these records is Mr. Clement, Jr.'s 
testimony that Respondent's computers were inoperable when DEA returned 
them after the search warrant was executed in August of 2019, which 
precluded Respondent from confirming the accuracy of the records that 
DEA downloaded. Resp Exceptions, at 6-7 (citing Tr. 515, 517-18). 
Respondent also argues that DEA did not present ``sufficient evidence 
to prove the accuracy or reliability of the[se] records,'' because DI--
who laid the foundation for each document--did not download the records 
from Respondent's computers himself, and therefore could not attest to 
whether any errors were made when the records were 
extracted.*HH Id. at 5-6 (citing Tr. 62-65, 134-36).
---------------------------------------------------------------------------

    *HH Respondent also argues that the Government did 
not adequately authenticate these records, but Respondent waived 
this objection by failing to raise it in writing prior to the 
hearing and failing to show good cause for not raising it prior to 
the hearing. See 21 CFR 1316.59; see also Tr. 64-68. Moreover, 
Respondent has not raised any noteworthy objections to the 
authenticity of these records.
---------------------------------------------------------------------------

    Respondent, however, has not identified any inconsistencies or 
errors in the documents that would cause me to question their 
reliability. For example, Respondent has not identified any particular 
prescriptions that it believes it did not dispense, or patients to whom 
it did not dispense.*II Moreover, Respondent has not 
identified any discrepancies between the E-FORSCE dispensing records, 
which DEA obtained directly from E-FORSCE, and the dispensing records 
that DEA downloaded from Respondent's computers. It is reasonable for 
DEA to rely on these records as evidence of Respondent's dispensing, 
because these are all records that Respondent is required to generate 
under Florida *JJ and federal law.*KK
---------------------------------------------------------------------------

    *II The one error that Respondent identifies in the 
PDMP data does little to undercut the reliability of the PDMP data, 
and in fact, it elucidates the suspicious nature of Respondent's 
dispensing. Resp Exceptions, at 7 (citing RD, at 86 n.36). The PDMP 
indicates that Respondent prescribed a 120-day supply of 
hydromorphone to Patient R.B. in September 2018, when in fact the 
prescription was for a 30-day supply. RD, at 86 n.36. This PDMP 
error highlights an unexplained lapse in Patient R.B.'s opioid 
prescriptions, because this patient did not fill another 
hydromorphone prescription for four months after receiving the 30-
day supply. Id.
    In questioning the PDMP data, Respondent also states that ``the 
Government's own expert acknowledged that there are errors in the 
PDMP data.'' Resp Exceptions, at 7. Respondent cites to Dr. 
Sullivan's testimony--in response to the question of whether he has 
``ever encountered . . . a data entry error'' in the PDMP--that he 
``know[s] that there are data entry errors in the PDMP. Potential 
errors.'' Id. This testimony is not specific enough to undermine the 
reliability of the PDMP data, especially because Respondent is 
required by state law to accurately report each controlled substance 
that it dispenses to E-FORSCE. See Fla. Stat. Sec.  893.055(3)(a) 
(2019) (requiring certain information to be reported to E-FORSCE 
each time a controlled substance is dispensed, including the date 
the prescription was filled; the patient's name and other 
identifying information; and the name, quantity, and strength of the 
controlled substance dispensed).
    *JJ See Fla. Stat. Sec.  893.055(3)(a).
    *KK See generally 21 CFR 1304.04; see also Tr. 492 
(DI's testimony that pharmacists must keep accurate dispensing 
logs).
---------------------------------------------------------------------------

Exception #3
    Respondent next argues that the RD's conclusion that Florida law 
and the Florida standard of care require pharmacists to document the 
resolution of red flags ``was based upon a clear error of law, and thus 
arbitrary and capricious.'' Resp Exceptions, at 8-17. Respondent argues 
that the RD's conclusion that Respondent violated 21 CFR 1306.04(a) and 
1306.06 was dependent on his erroneous conclusion that Florida law 
requires documentation, and therefore, Respondent argues that these 
conclusions should be overturned. Id.
    I do not need to address this Exception because I have concluded 
above, based on Dr. Sullivan's credible and unrebutted expert 
testimony, that the prescriptions that Respondent dispensed raised red 
flags that could not have been resolved by a pharmacist acting within 
the usual course of professional practice. I have also concluded that, 
by filling these prescriptions, Respondent violated its corresponding 
responsibility because the pharmacists knew these controlled substances 
were not prescribed for

[[Page 64746]]

legitimate medical purposes, or were willfully blind to such, in 
violation of their corresponding responsibility under 21 CFR 
1306.04(a), and Respondent dispensed controlled substances outside the 
usual course of professional practice, in violation of 21 CFR 
1306.04(a) and 1306.06. Because the red flags were unresolvable, I find 
that it is irrelevant whether Respondent took adequate steps under 
Florida law to document any attempts to resolve the red flags.
Exception #4
    Respondent's final Exception restates, nearly verbatim, arguments 
that it made in its Posthearing brief. Compare Resp Exceptions, at 17-
21 with Resp Posthearing, at 36-41. I find that the RD adequately 
addresses these arguments, and I agree with the RD's conclusion that 
Respondent engaged in illegal manufacturing. I therefore find that this 
Exception is without merit.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a) and 21 U.S.C. 823(f), I hereby revoke DEA Certificate of 
Registration No. FP2302076 issued to Pronto Pharmacy, LLC. Pursuant to 
28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a) and 
21 U.S.C. 823(f), I further hereby deny any pending applications for 
renewal or modification of this registration, as well as any other 
pending application of Pronto Pharmacy, LLC for registration in 
Florida. Pursuant to the authority vested in me by 21 U.S.C. 824(f), as 
well as 28 CFR 0.100(b), I further order that all controlled substances 
seized pursuant to the Order of Immediate Suspension of Registration 
are forfeited to the United States. This Order is effective December 
20, 2021.

Anne Milgram,
Administrator.
[FR Doc. 2021-25133 Filed 11-17-21; 8:45 am]
BILLING CODE 4410-09-P