[Federal Register Volume 86, Number 243 (Wednesday, December 22, 2021)]
[Notices]
[Pages 72694-72735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27718]



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Vol. 86

Wednesday,

No. 243

December 22, 2021

Part II





Department of Justice





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Drug Enforcement Administration





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Gulf Med Pharmacy; Decision and Order; Notice

  Federal Register / Vol. 86 , No. 243 / Wednesday, December 22, 2021 / 
Notices  

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 20-06]


Gulf Med Pharmacy; Decision and Order

    On November 18, 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 Gulf Med Pharmacy (hereinafter, Respondent). 
Administrative Law Judge Exhibit (hereinafter, ALJ Ex.) 1, (OSC) at 1. 
The OSC informed Respondent of the immediate suspension of its DEA 
Certificate of Registration Number FG6290061 (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)).
    In response to the OSC, Respondent timely requested a hearing 
before an Administrative Law Judge. ALJ Ex. 2. The hearing in this 
matter was conducted from July 20-23, 2020, from August 12-13, 2020, 
and on August 20, 2020, at the DEA Hearing Facility in Arlington, 
Virginia, with the parties and their witnesses participating through 
video-teleconference. On November 25, 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 December 15, 2020, Respondent filed 
exceptions to the Recommended Decision (hereinafter, Resp Exceptions), 
and on December 28, 2020, the Government filed a response to 
Respondent's exceptions (hereinafter, Gov Response). 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.*\A\ I have addressed each of Respondent's Exceptions and I 
issue my final Order in this case following the Recommended Decision.
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    *\A\ I have made minor modifications to the RD. I have 
substituted initials or titles for the names of witnesses and 
patients to protect their privacy and I have made minor, 
nonsubstantive, grammatical changes 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 with in brackets, and I have 
included specific descriptions of the modifications in the brackets 
or in footnotes marked with a letter and an asterisk. Within those 
brackets and footnotes, the use of the personal pronoun ``I'' refers 
to myself--the Administrator.
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Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge *B 1 2 3
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    *\B\ I have omitted the RD's discussion of the procedural 
history to avoid repetition with my introduction.
    \1\ [Footnote omitted, see supra n.*B.]
    \2\ [Footnote omitted, see supra n.*B.]
    \3\ [Footnote omitted, see supra n.*B.]
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    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. FG6290061, 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

    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 March 22, 2017, until at 
least August 8, 2019, Gulf Med Pharmacy repeatedly ignored obvious red 
flags of abuse or diversion and filled prescriptions without exercising 
its corresponding responsibility to ensure that they were issued for a 
legitimate medical purpose, in violation of federal and state law, 
including 21 CFR 1306.04(a) and 1306.06, and Fla. Admin. Code r. 64B16-
27.800, .810, and .831. ALJ Ex. 1.
    The Order to Show Cause also alleged the following:
    1. Gulf Med Pharmacy is registered with the DEA to handle 
controlled substances in Schedules II-V under DEA COR No. FG6290061. 
Gulf Med Pharmacy's registered address is 4106 Del Prado Boulevard 
South, Cape Coral, Florida 33904. Gulf Med Pharmacy's COR expires by 
its own terms on September 30, 2022.
    2. Gulf Med Pharmacy's DEA COR should be revoked and any pending 
application should be denied because Gulf Med Pharmacy has committed 
such acts as would render its registration inconsistent with the public 
interest under 21 U.S.C. 823(f). See 21 U.S.C. 824(a)(4). From March 
22, 2017, until at least August 8, 2019, Gulf Med Pharmacy repeatedly 
ignored obvious red flags of abuse or diversion and filled 
prescriptions without exercising its corresponding responsibility to 
ensure that they were issued for a legitimate medical purpose, in 
violation of federal and state law. Given Gulf Med Pharmacy's 
longstanding and pervasive violations of legal requirements relating to 
the practice of pharmacy, Gulf Med Pharmacy's continued registration 
constitutes an ``imminent danger'' as that term is defined by 21 U.S.C. 
824(d).

Legal Requirements

    3. 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. Pharmacists at Gulf Med Pharmacy were 
permitted to fill prescriptions ``issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of his 
professional practice.'' 21 CFR 1306.04(a). Although ``[t]he 
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. ``DEA has consistently interpreted this provision as prohibiting a 
pharmacist from filling a prescription for a controlled substance when 
[s]he either knows or has reason to know that the prescription was not 
written for a legitimate medical purpose.'' Wheatland Pharmacy, 78 FR 
69441, 69445 (2013) (internal quotation marks and citation omitted, 
alteration in original).
    4. In addition to complying with federal statutes and regulations, 
Gulf Med Pharmacy and its pharmacists also must comply with applicable 
Florida law. In particular, Florida pharmacists must ``review 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 Ann. 
r. 64B16-27.810(1). Upon recognizing any of these red flags of abuse or 
diversion, a Florida pharmacist ``shall take appropriate steps to avoid 
or resolve the potential problems which shall, if necessary, include 
consultation with the

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prescriber.'' Id. at r. 64B16-27.810(2). Florida pharmacies must also 
maintain a patient record system that documents resolution of red 
flags. See id. at r. 64B16-27.800. Finally, Florida pharmacists must 
comply with the standards for filling of controlled substance 
prescriptions. See id. at r. 64B16-27.831 (requiring pharmacists, among 
other things, to ``exercise[ ] sound professional judgment'' and 
``attempt to work with the patient and the prescriber to assist in 
determining the validity of the prescription''). A Florida pharmacy's 
failure to comply with Florida's prescription review requirements also 
constitutes a violation of the federal Controlled Substances Act. See, 
e.g., Trinity Pharmacy II, 83 FR 7304, 7329 (2018) (``Thus, [Florida] 
pharmacists violate Florida law if they fail to identify and resolve 
the red flags that are part of the prospective drug use review set 
forth in Rule 64B16-27.810. And if they knowingly fill prescriptions 
without resolving these red flags during this review, then they violate 
their corresponding responsibility under 21 CFR 1306.04(a).'').
    5. As explained in greater detail below, a Florida pharmacy expert 
retained by the DEA has reviewed numerous prescriptions filled by Gulf 
Med Pharmacy and has concluded that from March 22, 2017, until at least 
August 8, 2019, Gulf Med Pharmacy repeatedly filled prescriptions for 
controlled substances in violation of binding minimal standards that 
govern the practice of pharmacy in the State of Florida.

Cocktail Medications

    6. As discussed above, both federal and Florida law require 
pharmacists to identify and resolve red flags of abuse and diversion. 
See paragraph 4, supra. One common red flag of drug abuse or diversion 
is when a practitioner prescribes (via one or more prescriptions) 
``cocktail medications.'' Cocktail medications are combinations of 
controlled substances that are widely known to be abused or diverted, 
and when taken together, significantly increase a patient's risk of 
death or overdose. The DEA's expert reviewed numerous prescriptions 
filled by Gulf Med Pharmacy, as well as Gulf Med Pharmacy's patient 
profiles for the relevant patients, and concluded that Gulf Med 
Pharmacy regularly dispensed cocktail medications without addressing or 
resolving this red flag. For example, the DEA's expert noted that Gulf 
Med Pharmacy repeatedly dispensed high doses of opioids (in the form of 
hydromorphone, oxycodone, and morphine sulfate extended release) along 
with high doses of other central nervous system depressant medications, 
such as benzodiazepines (e.g., alprazolam, clonazepam, or diazepam) or 
muscle relaxants (e.g., carisoprodol). The DEA's expert opined that 
these controlled substances are dangerous when used in combination.
    7. Gulf Med Pharmacy repeatedly dispensed ``cocktail medications'' 
without any indication that its pharmacists addressed or resolved the 
fact that such prescriptions present a risk of abuse or diversion. 
Examples of instances when Gulf Med Pharmacy dispensed cocktail 
medications in the face of unresolved red flags include the following:
    a. On at least three occasions between May 22, 2019, and July 17, 
2019, Gulf Med Pharmacy filled prescriptions written on the same day by 
Physician R.D. for Patient A.B. for 120 units of hydromorphone 8 mg, 60 
units of morphine sulfate extended release 15 mg, and 30 units of 
diazepam 10 mg.
    b. On at least four occasions between February 9, 2018, and July 
17, 2019, Gulf Med Pharmacy filled prescriptions written on the same 
day by Physician A.N. for Patient B.Di. for 120 units of hydromorphone 
8 mg, 60 units of morphine sulfate extended release 30 mg, and 60-90 
units of alprazolam 1 mg.
    c. On at least five occasions between December 28, 2018, and August 
8, 2019, Gulf Med Pharmacy filled prescriptions written on the same day 
by Physician A.N. for Patient J.B. for 120 units of oxycodone 30 mg, 60 
units of morphine sulfate extended release 30 mg, and 90 units of 
alprazolam 1 mg.
    d. On at least four occasions between May 14, 2019, and August 6, 
2019, Gulf Med Pharmacy filled prescriptions written on the same day by 
Physician M.L. for Patient R.R. for 120 units of hydromorphone 8 mg, 60 
units of morphine sulfate extended release 60 mg, and 30 units of 
alprazolam 2 mg.
    e. On at least four occasions between May 8, 2019, and August 5, 
2019, Gulf Med Pharmacy filled prescriptions written on the same day by 
Physician M.L. for Patient B.Da. for 120 units of hydromorphone 8 mg, 
30 units of morphine sulfate extended release 30 mg, and 30 units of 
alprazolam 2 mg. On February 12, 2018, Gulf Med Pharmacy also filled 
prescriptions written on the same day by another physician in the same 
practice--Physician D.P.--for Patient B.Da. for 150 units of 
hydromorphone 8 mg, 90 units of methadone 10 mg, and 30 units of 
alprazolam 2 mg.
    8. According to the DEA's expert, the cocktail of an opioid, a 
benzodiazepine, and carisoprodol--commonly known as the ``Trinity'' 
cocktail--is a particularly serious red flag because that combination 
of controlled substances is highly dangerous and is widely known to be 
abused and/or diverted. Gulf Med Pharmacy repeatedly dispensed Trinity 
cocktail medications without any indication that its pharmacists 
addressed or resolved the fact that such prescriptions present a risk 
of abuse or diversion. Examples of instances when Gulf Med Pharmacy 
dispensed Trinity cocktail medications in the face of unresolved red 
flags include the following: Between May 30, 2019, and July 29, 2019, 
Gulf Med Pharmacy filled three sets of prescriptions from Physicians 
D.G. and F.M. for Patient J.R. for the Trinity cocktail. For each set 
of prescriptions, Physician F.M. prescribed Patient J.R. 
benzodiazepines and muscle relaxants; specifically, 30 units of 
temazepam 30 mg, 30-60 units of diazepam 5 mg, and 120 units of 
carisoprodol 350 mg. Meanwhile, Physician D.G. prescribed Patient J.R. 
opioids; specifically, 120 units of Norco (hydrocodone-acetaminophen) 
5-325 mg, 120 units of Percocet (oxycodone-acetaminophen) 5-325 mg, and 
120 units of Percocet 10-325 mg.

Improper Dosing for Pain Management

    9. As noted above, both federal and Florida law require a 
pharmacist to identify and address red flags of drug abuse or diversion 
including over-utilization and under-utilization. See 21 CFR 
1306.04(a); 21 CFR 1306.06; Fla. Admin. Code. Ann. r. 64B16-27.810. 
According to the DEA's expert, for a patient receiving treatment with 
both long-acting and short-acting opioids, the proper pharmacologic 
dosing for pain management is to use larger, scheduled doses of the 
long-acting opioid to control chronic pain with smaller, as-needed 
doses of the short-acting opioid for breakthrough pain. According to 
the DEA's expert, this method of dosing reduces the amount of the 
short-acting opioid that the patient must use in order to obtain the 
same level of pain control. In contrast, the DEA's expert opined that 
prescriptions that provide a larger daily dose of short-acting opioids, 
rather than long-acting opioids, do not make pharmacologic sense and 
thus are a red flag of drug abuse or diversion. From at least March 22, 
2017, until at least August 8, 2019, Gulf Med Pharmacy repeatedly 
filled prescriptions for patients receiving a much greater daily 
morphine milligram equivalent dosage of short-acting opioids than long-
acting opioids. The DEA's expert also noted that each of the short-
acting or immediate release opioid prescriptions was scheduled four 
times a day or every

[[Page 72696]]

six hours, even though the patient was also prescribed a scheduled, 
long-acting opioid. The DEA's expert reviewed Gulf Med Pharmacy's 
patient profiles for several of these patients. In the expert's view, 
because these prescriptions were illogical from a pharmacological 
perspective, they therefore raised a red flag. The DEA's expert further 
opined that Gulf Med Pharmacy should have attempted to address or 
resolve this red flag of drug abuse or diversion prior to filling these 
prescriptions, but, on numerous occasions, its pharmacists failed to do 
so. Examples of Gulf Med Pharmacy filling such improper prescriptions 
include the following:
    a. On at least 23 occasions between November 8, 2017, and July 17, 
2019, Gulf Med Pharmacy filled prescriptions for Patient A.B. for 120 
units of immediate release hydromorphone 8 mg (equal to 128 mg of 
morphine per day), but only 60 units of morphine sulfate extended 
release 15 mg (equal to 30 mg of morphine per day).
    b. On at least 28 occasions between April 21, 2017, and July 17, 
2019, Gulf Med Pharmacy filled prescriptions for Patient B.Di. for 120 
units of immediate release hydromorphone 8 mg (equal to 128 mg of 
morphine per day), but only 60 units of morphine sulfate extended 
release 30 mg (equal to 60 mg of morphine per day).
    c. On at least 18 occasions between January 10, 2018, and May 1, 
2019, Gulf Med Pharmacy filled prescriptions for Patient S.K. for 110 
units of immediate release hydromorphone 8 mg (equal to 125-128 mg of 
morphine per day), but only 60 units of morphine sulfate extended 
release 15 mg (equal to 30 mg of morphine per day).
    d. On at least 27 occasions between March 22, 2017, and August 8, 
2019, Gulf Med Pharmacy filled prescriptions for Patient J.B. for 108-
120 units of immediate release oxycodone 30 mg (equal to 162-180 mg of 
morphine per day), but only 60 units of morphine sulfate extended 
release 30 mg (equal to 60 mg of morphine per day).
    e. On at least eight occasions between October 2, 2018, and August 
6, 2019, Gulf Med Pharmacy filled prescriptions for Patient R.R. for 
120 units of immediate release hydromorphone 8 mg (equal to 128 mg of 
morphine per day), but only 28 units of morphine sulfate extended 
release 60 mg (equal to 60 mg of morphine per day).
    f. On at least eight occasions between January 16, 2019, and August 
5, 2019, Gulf Med Pharmacy filled prescriptions for Patient B.Da. for 
120 units of immediate release hydromorphone 8 mg (equal to 128 mg of 
morphine per day), but only 30 units of morphine sulfate extended 
release 30 mg (equal to 30 mg of morphine per day).

Long Distances

    10. Between October 25, 2017, and August 5, 2019, Gulf Med Pharmacy 
regularly filled controlled substance prescriptions for individuals who 
traveled an unusual distance to obtain their prescriptions. The DEA's 
expert opined that traveling long distances to obtain or fill a 
controlled substance is indicative of diversion and/or abuse and that 
such behavior is a red flag that must be addressed prior to dispensing. 
See 21 CFR 1306.04(a); 21 CFR 1306.06; Fla. Admin. Code. Ann. r. 64B16-
27.810. Gulf Med Pharmacy did not do so, as illustrated by the 
following examples of prescriptions that it filled:
    11. On at least 20 occasions between November 8, 2017, and July 17, 
2017, Patient A.B. traveled 45 miles round trip to obtain prescriptions 
for hydromorphone 8 mg, morphine sulfate extended release 15 mg, and 
diazepam 10 mg, which Gulf Med Pharmacy filled.
    12. On at least five occasions between October 25, 2017, and 
February 12, 2018, Patient B.Da. traveled over 48 miles round trip to 
obtain prescriptions for hydromorphone 8 mg and methadone 10 mg, which 
Gulf Med Pharmacy filled. On two of those trips--January 15, 2018, and 
February 12, 2018--Patient B.Da. also obtained prescriptions for 
alprazolam 2 mg, which Gulf Med Pharmacy also filled. Subsequently, on 
at least seven occasions between February 13, 2019, and August 5, 2019, 
Patient B.Da. traveled over 48 miles round trip to obtain prescriptions 
for hydromorphone 8 mg, morphine sulfate extended release 30 mg, and 
alprazolam 2 mg, which Gulf Med Pharmacy also filled.
    13. On at least 17 occasions between January 17, 2018, and May 8, 
2019, Patient R.D. traveled over 41 miles round trip to obtain 
prescriptions for hydromorphone 8 mg and lorazepam 2 mg, which Gulf Med 
Pharmacy filled.

Cash Payments and Price Gouging/Black Market Pricing

    14. Another common red flag of abuse or diversion that pharmacists 
must monitor is the use of cash payments for controlled substances 
instead of insurance payments. See 21 CFR 1306.04(a); 21 CFR 1306.06; 
Fla. Admin. Code. Ann. r. 64B16-27.810. According to the DEA's expert, 
when a prescription for a controlled substance is electronically 
processed through insurance, the insurance company will frequently 
reject suspicious controlled substance prescriptions that may be 
related to drug abuse or diversion, such as controlled substance 
prescriptions for the same patient filled at multiple pharmacies. 
Consequently, cash payments for controlled prescriptions are a red flag 
of abuse or diversion because some suspect patients may choose to pay 
cash in order to avoid an insurance rejection that might alert the 
pharmacist to potential drug abuse or diversion. Such cash payments are 
especially suspicious when the patient bills insurance for other 
prescriptions, but pays cash for controlled substance prescriptions.
    15. Similarly, the DEA's expert indicated that price gouging, or 
charging more than the market rate for prescriptions for a controlled 
substance, is a separate indicator of drug abuse or diversion. The 
DEA's expert explained that price gouging is a red flag because a 
legitimate patient, who could fill his or her prescription at any 
pharmacy, will switch pharmacies in order to pay the fair market price 
for that prescription. In contrast, the highly suspect patient can only 
fill prescriptions at a suspicious pharmacy and must pay whatever price 
that suspicious pharmacy sets. Consequently, patients paying inflated 
prices for controlled substance prescriptions are another red flag of 
drug abuse or diversion, especially when the price paid is 
substantially higher than the market price available from other nearby 
pharmacies. See Jones Total Health Care Pharmacy, L.L.C., 81 FR 79188, 
79191 (2016). For the same reason, filling controlled substance 
prescriptions at inflated cash prices shows that a pharmacy has 
knowledge that it is filling prescriptions that are not legitimate, as 
its inflated prices reflect a ``risk premium'' that the pharmacy 
charges to account for the risk it is taking by filling illegitimate 
prescriptions. See id. at 79,199-200 (``[E]ven granting that there are 
no prohibitions on the prices a pharmacy can charge for controlled 
substances, when those prices far exceed what other pharmacies would 
charge, the Agency may properly draw the inference that the pharmacy is 
charging those prices because it knows it is supplying persons who are 
seeking the drugs to either abuse them or divert them to others.''). To 
determine a baseline of normalcy (i.e., legitimate pricing), the DEA's 
expert contacted representative pharmacies in Cape Coral, Florida, and 
found that the price of 120-140 units of oxycodone 30 mg varied from 
about $1.59 to $1.63 per unit, while the sale price of 120-140 units of 
hydromorphone 8 mg varied from about $1.25 to $1.27 per unit.

[[Page 72697]]

    16. From March 22, 2017, until at least August 6, 2019, Gulf Med 
Pharmacy repeatedly filled prescriptions for oxycodone 30 mg and 
hydromorphone 8 mg for patients who paid for these prescriptions in 
cash at substantially inflated prices that far exceeded what other area 
pharmacies charged. The DEA's expert reviewed Gulf Med Pharmacy's 
patient profiles for several of these patients. The DEA's expert opined 
that Gulf Med Pharmacy should have attempted to address or resolve 
these red flags of drug abuse or diversion prior to filling these 
prescriptions, but failed to do so. Gulf Med Pharmacy dispensed 
controlled substances at inflated prices to individuals paying cash in 
the following instances:
    17. On at least 15 separate occasions between March 14, 2018, and 
April 10, 2019, Gulf Med Pharmacy filled prescriptions for 120 units of 
hydromorphone 8 mg for Patient R.D. On each occasion, Patient R.D. paid 
for the prescription in cash, and on all but one occasion Patient R.D. 
paid $4 per unit ($480 in total)--over three times the market rate.
    18. On at least six separate occasions between February 26, 2018, 
and April 22, 2019, Gulf Med Pharmacy filled prescriptions for 84 to 
120 units of oxycodone 30 mg for Patient T.G. On each occasion, Patient 
T.G. paid for the prescription in cash at a price of $4 per unit ($336 
to $480 in total)--over three times the market rate.
    19. On at least 16 separate occasions between March 7, 2018, and 
May 1, 2019, Gulf Med Pharmacy filled prescriptions for 108 to 110 
units of hydromorphone 8 mg for Patient S.K. On each occasion, Patient 
S.K. paid for the prescription in cash at a price ranging from $3.56 
per unit to $4 per unit ($392 to $432 in total)--in each case at least 
two-and-a-half times the market rate, and as high as over three times 
the market rate.
    20. On at least 14 separate occasions between March 20, 2018, and 
April 15, 2019, Gulf Med Pharmacy filled prescriptions for 90 to 120 
units of oxycodone 30 mg for Patient L.V. On each occasion, Patient 
L.V. paid for the prescription in cash at a price ranging from $2.50 
per unit to $3.33 per unit ($300 in total)--in each case at least one-
and-a-half times the market rate, and as high as twice the market rate. 
Further, Patient L.V. used insurance to pay for other prescriptions, 
including prescriptions for controlled substances such as alprazolam 
and zolpidem.
    21. On at least 19 separate occasions between March 22, 2017, and 
September 7, 2018, Gulf Med Pharmacy filled prescriptions for 108 to 
120 units of oxycodone 30 mg for Patient J.B. On each occasion, Patient 
J.B. paid for the prescription in cash at a price of $3.40 to $4 per 
unit ($408 to $480 in total)--in each case over twice the market rate.
    22. On at least 23 occasions between November 8, 2017, and July 17, 
2019, Gulf Med Pharmacy filled prescriptions for 120 units of 
hydromorphone 8 mg for Patient A.B. On each occasion, Patient A.B. paid 
for the prescription in cash at a price of $3.73 to $4 per unit ($448 
to $480 in total)--in each case over two-and-a-half times the market 
rate, and as high as three times the market rate.
    23. On at least five occasions between October 25, 2017, and 
February 12, 2018, Gulf Med Pharmacy filled prescriptions for 150 units 
of hydromorphone 8 mg for Patient B.Da. Subsequently, on at least six 
occasions between March 13, 2019, and August 5, 2019, Gulf Med Pharmacy 
filled prescriptions for 120 units of hydromorphone 8 mg for Patient 
B.Da. On each of these 11 occasions, Patient B.Da. paid for the 
prescription in cash at a price of $4 per unit ($480 to $600 in 
total)--over three times the market rate.
    24. On at least 28 occasions between April 21, 2017, and July 17, 
2019, Gulf Med Pharmacy filled prescriptions for 120 units of 
hydromorphone 8 mg for Patient B.Di. On each occasion, Patient B.Di. 
paid for the prescription in cash at a price of $4 per unit ($480 in 
total)--over three times the market rate.
    25. On at least 18 occasions between December 5, 2017, and least 
August 6, 2019, Gulf Med Pharmacy filled prescriptions for 120 to 168 
units of hydromorphone 8 mg for Patient R.R. On each occasion, Patient 
R.R. paid for the prescription in cash at a price ranging from $4 per 
unit to $4.60 per unit ($480 to $672 in total)--in each case over three 
times the market rate. ALJ Ex. 1.

The Hearing

Government's Opening Statement

    The Government seeks to revoke the Respondent's DEA certificate of 
registration, and deny any applications for renewal, or modification of 
that registration because the Respondent has committed acts that render 
its continued registration inconsistent with the public interest. Tr. 
14-15. The testimony and evidence will show that the Respondent 
repeatedly ignored red flags of abuse and diversion--many established 
under prior Agency decisions--and sold prescriptions for controlled 
substances without exercising their corresponding responsibility to 
ensure that those prescriptions were issued in the usual course of 
professional practice, and for a legitimate medical purpose.
    With respect to the prescriptions that the Respondent filled for 
the charged patients in this matter, the Government's expert, Dr. Tracy 
Schossow, will explain that the Respondent filled prescriptions for 
controlled substances for those patients in the face of multiple red 
flags of abuse and diversion. Tr. 15-16. The red flags that the 
Respondent ignored include filling prescriptions for patients (J.B., 
A.B., B.Da., R.D., B.Di., R.R., and L.B.) that were cocktail 
combinations of opioids and benzodiazepines that are dangerous when 
used in combination, and are widely known to be sought after for drug 
abuse and diversion.
    The Respondent also filled prescriptions for two charged patients 
(J.B. and R.R.) for the Trinity drug cocktail, which is a non-
therapeutic combination of an opiate, a benzodiazepine, and muscle 
relaxer, Carisoprodol, which is a known dangerous combination and used 
for drug abuse and diversion.
    The Respondent filled prescriptions for Patient J.R. for 
benzodiazepines, which duplicated the therapeutic effects. The 
Respondent also filled prescriptions for charged patients (J.B., A.B., 
B.Da., B.Di., S.K., and R.R.) for both long-acting and short-acting 
opioids in combinations that do not make pharmacological sense. Tr. 16-
17. The Respondent filled prescriptions for Patient R.R. for 
benzodiazepines at dosages that do not make pharmacological sense.
    The Respondent filled prescriptions for charged patients (J.B., 
A.B., B.Da., R.D., B.Di., T.G., S.K., R.R., and L.B.) despite each 
paying cash for controlled substances. The Respondent also sold 
prescriptions for charged patients (J.B., A.B., B.Da., R.D., B.Di., 
T.G., S.K., R.R., and L.B.) for opioids despite substantial mark-ups in 
price. The Respondent also filled prescriptions for charged patients 
(A.D., B.Da., and R.D.) despite these patients travelling long round-
trip distances to have the Respondent's pharmacy fill the controlled 
substance prescriptions.
    DI will explain that the DEA executed administrative inspection 
warrants and served three administrative subpoenas on the Respondent 
during the investigation. Tr. 17-18. This gave the Respondent several 
opportunities to provide the DEA with evidence that it identified and 
resolved red flags of diversion or abuse before dispensing the charged 
prescriptions. As Dr. Schossow will testify, the Respondent's records

[[Page 72698]]

indicate that it failed to address and resolve any of these red flags 
of diversion or abuse, and that it failed to exercise its corresponding 
responsibility to ensure that the prescriptions were issued for a 
legitimate medical purpose by a practitioner acting in the normal 
course of professional practice. Therefore, the Respondent violated 
federal and state law when it dispensed the charged prescriptions.

Respondent's Opening

    Gulf Med Pharmacy is a small, independent pharmacy in southeast 
Florida. Tr. 19. Respondent contended that it has been unfairly and 
inappropriately targeted by the DEA for conduct that does not violate 
any Florida state or federal statues or regulations. Respondent 
contended that this action is based upon the DEA's created idea about 
review of prescriptions retrospectively related to some opiate 
prescriptions, and combinations of those opiates and benzodiazepines. 
Respondent contested that the DEA's position is not supported by 
medical literature or by anything other than supposition and conjecture 
on the part of the DEA's expert witness.
    The Respondent will present testimony from Dr. Daniel Buffington. 
Dr. Buffington is a professor associated with the University of South 
Florida in the Departments of Medicine and Pharmacy. Tr. 19-20. He has 
extensive experience in pharmacy practice, and will describe the 
appropriateness of the Respondent's actions in filling prescriptions 
defined in the Order to Show Cause, as well as the appropriateness of 
the documentation related to those prescriptions.
    Respondent contended that what is important in this matter is there 
has been, and continues to be, a tortured and unsupportable 
interpretation of the Florida Administrative Code, as it related to the 
obligation of a pharmacist licensed by the state. Tr. 20. The State of 
Florida has the right and obligation to control the scope and the 
manner of the practice of pharmacy and medicine within the state, 
consistent with the Supreme Court of the United States' precedence.
    The Respondent's evidence will be direct and will show that the 
attempt to characterize the distance that was traveled by the charged 
patients to the Respondent's pharmacy is nothing short of manufactured. 
Tr. 20. In order to make the distances seem longer, the Government 
included round-trip travel as opposed to direct travel or the direct 
distance between the residence of the patient and the pharmacy. Tr. 20-
21. Given the distances in south Florida, since patients are coming 
from some of the barrier islands, the distance between a straight line 
and coming from the barrier islands and comparing them to facilities on 
the mainland, is a significant factor that was not considered by the 
DEA or its expert witness.
    Respondent contended that the DEA's expert witness is neither 
qualified, nor capable of, having any knowledge or information to 
justify opinions regarding the price paid for medications by the 
patients, or on the distance, travel, or mechanism of payment. Tr. 21. 
Even though it does not have any burden of proof, the Respondent will 
demonstrate the fallacies of the DEA's position. Tr. 21. It also looks 
forward to receiving a recommendation that Gulf Med Pharmacy's DEA 
registration be reinstated and continuing to operate in its usual and 
appropriate manner. Tr. 21.

Government's Case-in-Chief

Diversion Investigator (DI)

    DI has been a Diversion Investigator with the DEA for three years 
and has been assigned to the Miami Field Division, Western office for 
most of that time. Tr. 25-27. Prior to working for the DEA, DI worked 
as a transportation screening officer with the Transportation Security 
Administration. Tr. 26. As a Diversion Investigator, DI is tasked with 
enforcing the Controlled Substances Act, which regulates the 
manufacture, distribution, possession, use, and importation of 
controlled substances. Diversion Investigators also strive to prevent 
the diversion of controlled substances to the streets. DI conducts 
civil and criminal investigations, including administrative actions 
like the current matter. Tr. 26-27. DI has attended the DEA Academy at 
Quantico and has conducted approximately twelve investigations with the 
DEA. Tr. 27-28, 279-81.
    The investigation of Gulf Med Pharmacy was initiated because Gulf 
Med Pharmacy was found to be one of the top ten purchasers of 
Oxycodone, Hydromorphone, and Hydrocodone in the State of Florida. Tr. 
28-29, 362.\4\ This was the impetus for the DEA inquiry, to investigate 
why Gulf Med was a top purchaser of these controlled substances. Tr. 
30.
---------------------------------------------------------------------------

    \4\ This evidence was admitted as relevant to the allegations. 
The Respondent probed this evidence, but gave notice that he was 
delving into this issue only on the basis the evidence was ruled to 
be relevant to the existing charges, and was not consenting to 
broaden the scope of the charges. The Tribunal explained to the 
Respondent that it did not permit the Government to expand the scope 
of the charges at the hearing, without giving timely notice to the 
Respondent, so that the Respondent had an opportunity to object. Tr. 
359-61.
---------------------------------------------------------------------------

    DI became the case agent in approximately December 2018, after DI 
2, the original case agent \5\ retired. Tr. 28, 39, 315. Upon becoming 
case agent, DI reviewed the case file, which included the 
administrative inspection warrant. Tr. 40-42. DI had not reviewed the 
case file before he became the case agent or before the administrative 
inspection warrant was served. Tr. 368-70. Based solely upon DEA 
reports he later reviewed, DI confirmed that Gulf Med Pharmacy was one 
of the top purchasers in Florida of these controlled substances in 
2017. Tr. 362, 365-68. At the hearing, he could not confirm whether the 
sole supplier of these controlled substances to the Respondent was 
Cardinal. Tr. 364.
---------------------------------------------------------------------------

    \5\ [Footnote omitted.]
---------------------------------------------------------------------------

    Initially, DI's role in this matter was to assist the case agent 
with the administrative inspection warrant. Tr. 28. The administrative 
inspection warrant allows the DEA to inspect and copy records, 
information, reports, files, inventories, invoices, official order 
forms, prescriptions, and other documents required to be kept under the 
Controlled Substances Act. Tr. 302; GX 2 at 1; see, 21 U.S.C. 880. The 
warrant describes what records and information are subject to seizure, 
including all of the electronic data maintained by the Respondent 
pharmacy. Tr. 302-03; GX 2 at 2. In terms of the Respondent's 
compliance with the Controlled Substances Act and the laws applicable 
to the operation of a pharmacy, the DEA has the authority to go into 
the pharmacy and seize all of the relevant electronic data. Tr. 304-06. 
An administrative inspection warrant is used if the investigators 
suspect that the pharmacy may deny entry to investigators presenting 
with a notice of inspection. Tr. 289. When an administrative inspection 
warrant is served, DI follows the instructions of his group 
supervisors. Tr. 286. During an inspection, one or two agents conduct 
the inspection during normal business hours. Tr. 288.
    The purpose of the inspection warrant was to gather all information 
relevant to the investigation, including both inculpatory and 
exculpatory evidence. Tr. 281-85. The warrant was based upon an 
affidavit by DI 2, the original case agent. DI did not create the 
warrant and he does not know the circumstances under which it was 
issued. Tr. 36-38. DI was part of the pre-inspection briefing session, 
which was conducted by DI 2. Tr. 281. He was advised that the 
Respondent was one of the top ten

[[Page 72699]]

purchasers of oxycodone, hydromorphone, and hydrocodone in the State of 
Florida by DI 2 during the briefing before the execution of the 
warrant. Tr. 370-71.
    DEA investigators served an administrative inspection warrant on 
Gulf Med Pharmacy on February 14, 2018. Tr. 31. DI was present when the 
warrant was served on the Respondent. Tr. 33-35.\6\ The inspection of 
February 14, 2018, was performed by both diversion investigators and 
armed DEA special agents. Tr. 289-90. DI could not recall if any local 
law enforcement were present. Tr. 290. Prior to and at the point of 
service of the administrative inspection warrant, DI did not know where 
the Respondent kept its records. Tr. 387. DI knew that the employees of 
the pharmacy would know where the requested documents were located 
within the pharmacy, including the pharmacy technician and the 
Pharmacist-in-Charge. Tr. 391-92.
---------------------------------------------------------------------------

    \6\ DI identified the Respondent's DEA COR. Tr. 32-33; GX 1. He 
also identified the administrative inspection warrant, dated 
February 14, 2018. GX 2.
---------------------------------------------------------------------------

    On February 14, 2018, the DEA simultaneously served an 
administrative subpoena on the Respondent through Dr. Ricard Fertil, 
the pharmacist in charge of Gulf Med Pharmacy. Tr. 44-45, 57, 393-94; 
GX 3; see 21 U.S.C 876. DI is familiar with administrative subpoenas, 
and regularly uses them. Tr. 46. DI was present on the day it was 
served and is familiar with the document. Tr. 46-49. The Respondent 
produced documents in response to the subpoena, and the DEA seized 
those documents from the Respondent. Tr. 64. The DEA provided a receipt 
for seized documents to the Respondent through a DEA-12 form. Tr. 50-
60; GX 4. The receipt was signed by DI 2 and Mr. Ricard Fertil. DI did 
not attend the closeout meeting with the Respondent following the 
February 14, 2018 inspection. Tr. 356-57.
    Items seized, and reflected in the receipt, included patient 
profiles, reports and printouts. Tr. 61, 63-64.\7\ The investigators 
also seized the original prescriptions from the date the pharmacy 
opened until the date of the administrative inspection warrant. Tr. 
291-92. During the service of the administrative inspection warrant, 
the DEA seized all of the Respondent's prescriptions and records, 
including electronic prescriptions for controlled substances. Tr. 73-
75; GX 4 at 3-4, 6.
---------------------------------------------------------------------------

    \7\ DI identified the patient profiles for Patients J.B., T.G, 
and L.V. Tr. 65-69; GX 5. DI also identified the patient dispensing 
reports for Patient J.B., T.G., and L.V. Tr. 69-71; GX 6.
---------------------------------------------------------------------------

    DI identified the prescriptions written and filled for Patient J.B. 
that were seized. Tr. 75-76; GX 7. These were included in the 
controlled substance prescriptions that had been filled by the 
Respondent pharmacy up until the date of the inspection. Tr. 77. The 
back side of the prescriptions have a filled sticker that show that the 
prescriptions were filled by Gulf Med Pharmacy. Tr. 78-79; GX 7 at 2. 
DI identified prescriptions for Patient A.B. that were taken from Gulf 
Med Pharmacy. Tr. 80-82; GX 8. DI also identified prescriptions for 
several patients filled by Gulf Med Pharmacy: Patient B.Da. (Tr. 83-85, 
88-89; GX 9); Patient R.D. (Tr. 89-92; GX 10); Patient B.Di. (Tr. 95-
98; GX 11); Patient P.G. (Tr. 99-101; GX 12); Patient S.K. (Tr. 101-03; 
GX 13); Patient R.R. (Tr. 111-13; GX 14); and Patient L.V. (Tr. 114-16; 
GX 15).
    Once the prescriptions were seized from the Respondent pharmacy, 
they were placed into evidence and scanned. Tr. 93. The original 
prescriptions are maintained in the custody of the DEA evidence 
custodian. Tr. 94.
    Once a warrant is served, the DEA investigators ask the pharmacist-
in-charge where the prescriptions are located. Tr. 86. The 
investigators request a date range of prescriptions and seize them. 
Here, the prescriptions were in separate folders and were categorized 
by prescription number. Tr. 86-87. The folders were in various 
locations, including in drawers, cabinets, boxes, and ``just out in the 
open.'' Tr. 87.
    A DEA technology specialist retrieved dispensing reports for the 
patient profiles from the pharmacy's computer. Tr. 87-88, 292. The 
technician downloaded information from the Respondent's computer 
system, including patient profiles and dispensing reports. Tr. 292. The 
investigators did not retrieve a mirror image of the Respondent's hard 
drive. Tr. 306-07.
    On the prescription for Patient S.K., there is a fill sticker, 
which was printed out once the prescription was filled by the pharmacy. 
Tr. 103-04; GX 13 at 2. On the fill sticker, the prescription number 
was identified as N-000346, the date of the prescription, and 
``PPCash'' to identify the method of payment. This shows that the 
prescription was paid for with a method of payment other than by 
insurance, which in this instance was cash. Tr. 104-05. This 
prescription was for hydromorphone, eight milligrams. In DI's 
experience, a cash method of payment for a prescription of a controlled 
substance is significant, because it raises the question why a patient 
would pay by cash as opposed to insurance. Tr. 106-07. This was a ``red 
flag'' \8\ that the prescription may be illegitimate. Red flag methods 
of payment include cash, credit, credit card, or check. Tr. 107-08. 
There is no DEA regulation that prohibits a pharmacy from accepting 
cash as payment for a prescription. Tr. 373-74. There is no guidance 
document from the DEA that instructs pharmacists to limit the 
acceptance of cash as payment for prescriptions for controlled 
substances. Tr. 374. DI does not know whether patients can pay cash for 
prescriptions and then submit claims to their own insurance company. 
Tr. 375. He did not determine whether the charged patients had 
insurance. Tr. 375.
---------------------------------------------------------------------------

    \8\ A ``red flag'' serves as an indication that a ``prescription 
may be illegitimate.'' Tr. 107.
---------------------------------------------------------------------------

    On the prescription for Patient S.K., below the ``PPCash'' 
language, there is an indicator of the price paid for the prescription. 
Tr. 108. The price that is paid for a controlled substance is a 
significant factor because, if the price paid is two or three times 
higher than a traditional price, it is an indicator that the patient is 
willing to pay any cost in order to get the prescription filled. Tr. 
109-110. This would be an indication that the prescription may be 
illegitimate. These red flags are not only true for hydromorphone, but 
for other controlled substances as well.
    Apart from the prescriptions, patient profiles, and dispensing 
reports previously discussed, there were no other documents pertaining 
to the specific patients that either the Respondent produced pursuant 
to the administrative subpoena, or that the DEA seized pursuant to the 
administrative inspection warrant. Tr. 117-18, but see 358-59 (purchase 
orders, invoices from suppliers, were seized during the administrative 
inspection warrant).
    As the Government's investigation continued, the DEA served two 
additional administrative subpoenas. Tr. 118-19. The second 
administrative subpoena was served on the Respondent's attorney in May 
of 2019 by DI. Tr. 119-22, 350, 396; GX 16. DI was the investigator 
responsible for collecting and maintaining the evidence received from 
the Respondent. Tr. 350-51.
    Dr. Fertil completed, and DI received, a completed copy of a 
certificate of authenticity of domestic business records, along with 
the documents responsive to the second administrative subpoena. Tr. 
122-25; GX 18. In response to the May 2019 subpoena, the Respondent 
produced hard-copy prescriptions, patient profiles, and dispensing 
reports. DI did not know

[[Page 72700]]

who actually gathered the documents that were responsive to the 
subpoena. Tr. 396-97. The DEA provided a receipt for these documents. 
Tr. 125-28; GX 17. The second administrative subpoena required 
documents dated from February 15, 2018 to May 3, 2019, which begins the 
day after the end of time period of the administrative inspection 
warrant. Tr. 129, 347; GX 2.
    DI identified patient profile printouts for Patient R.D. (Tr. 129-
31; GX 19); Patient P.G. (Tr. 132-33; GX 20); Patient S.K. (Tr. 135-37; 
GX 21); and Patient L.V. (Tr. 137-39; GX 22).
    The Respondent also produced hard copy prescriptions in response to 
the second administrative subpoena. Tr. 142, 348-49. The prescriptions 
were for Schedule II to V controlled substance prescriptions. DI 
identified prescriptions and fill stickers for Patient J.V. (Tr. 143-
46; GX 23); Patient A.B. (Tr. 146-48; GX 24); Patient B.Da. (Tr. 148-
51; GX 25); Patient R.D. (Tr. 151, 156-58; GX 26); Patient B.Di. (Tr. 
158-60; GX 27); Patient P.G. (Tr. 160-62; GX 28); Patient S.K. (Tr. 
163-65; GX 29); Patient J.R. (Tr. 165-70; GX 30), which includes 
prescription drug monitoring reports (GX 30, pp. 16-17, 26); Patient 
R.R. (Tr. 170-75; GX 31), which includes an E-FORCSE PDMP reports, a 
Florida Department of Health license verification printout for Dr. 
M.L., and a DEA website printout for Dr. M.L. (GX 31, pp. 19-21, 26, 
31, 36, 39); Patient L.V. (Tr. 175-77; GX 32). No other documents were 
produced by the Respondent pursuant to the second administrative 
subpoena served in May of 2019, including dispensing reports. Tr. 178, 
349-50.
    A third administrative subpoena was served in August of 2019 by DI. 
Tr. 179-82; GX 33. DI served the administrative subpoena on 
Respondent's counsel on behalf of Gulf Med Pharmacy. Tr. 396. Ricard 
Fertil produced documents in response to the third administrative 
subpoena to DI. Tr. 183. DI did not know who actually gathered the 
documents responsive to the third subpoena. Tr. 396-97. The Respondent 
completed a certificate of authenticity of domestic business records. 
Tr. 184-85; GX 34. The documents produced include patient profiles, 
hard copy prescriptions, dispensing reports, and any notes for the 
patients. DI identified the produced records for Patient J.B. (Tr. 186-
89; GX 35); Patient A.B. (Tr. 189-92; GX 36); Patient B.Da. (Tr. 192-
94; GX 37); Patient B.Di. (Tr. 194-96; GX 38); Patient J.R. (Tr. 196-
98; GX 39); Patient R.R. (Tr. 198-201; GX 40).
    DI is familiar with the E-FORCSE program. Tr. 201-02, 206-08. E-
FORCSE is the Florida prescription drug monitoring program, which is a 
database of controlled substance prescriptions filled, as reported by 
pharmacists or pharmacies to the State of Florida. Tr. 202-03. During 
the investigation, DI obtained information from the E-FORCSE database 
about the prescriptions that were filled by the Respondent. He logged 
onto the website and set his search query. Tr. 203-04, 206-07. A 
request then generated an electronic report. The report is produced 
after the database pulls all of the requested information and it is 
approved by a PDMP administrator. Tr. 205. An E-FORCSE PDMP report was 
generated for dates between January 1, 2018 and May 16, 2019 for Gulf 
Med Pharmacy. Tr. 205-06, 208-10; GX 41. Not including the title bar, 
there are 2,566 lines of data in the spreadsheet. Tr. 383. A second E-
FORCSE PDMP report was generated for dates between February 14, 2018 
and August 27, 2019 for Gulf Med Pharmacy. Tr. 211-17; GX 42. Not 
including the title bar, there are 2,912 lines of data in the 
spreadsheet. Tr. 384. Each line of data represents a separate 
prescription. Tr. 385. DI did not compare the E-FORCSE data with the 
data provided by the Respondent. Tr. 385. He did not do any 
investigation regarding the E-FORCSE data available prior to February 
14, 2018 for the charged patients. Tr. 385-86.
    During the service of the administrative inspection warrant in 
February of 2018, electronic printouts of purchase orders, patient 
profiles, dispensing reports, and other documents related to the 
charged patients were seized from the Respondent's computers. Tr. 237. 
The computers were not seized. Tr. 237-38. Copies of the software and 
hard drives were not taken. DI was aware that the pharmacy uses the 
PioneerRx software on their computers. During the investigation, the 
DEA obtained a declaration from a representative of PioneerRx, 
concerning the function of the software. Tr. 238-48; GX 48. DI received 
it from PioneerRx's attorney. Tr. 239, 242.
    DI never spoke to Jenny Roe directly. Tr. 343. Because DI had a 
printout, he did not perform any investigation to determine what 
information was in the computer system behind the tabs of information 
on the computer program. Tr. 343-46; GX 5. The administrative subpoena 
asked for all documents maintained in patient profiles, so if the 
Respondent only provided one page, then the investigators assumed that 
is all the Respondent had. Tr. 346. The Respondent is expected to 
produce what is listed in the subpoena. Tr. 347.
    DI is familiar with the term National Average Drug Acquisition Cost 
(NADAC). Tr. 249, 255.\9\ DI first became familiar with it during the 
investigation of the Respondent. Tr. 255. It is a database monitored by 
the Center for Medicare and Medicaid Services, where a survey is sent 
out to pharmacies throughout the country. Tr. 256. The pharmacies will 
voluntarily submit acquisition costs for the drugs that they purchase 
from the manufacturers. Tr. 256, 275. The Center for Medicare and 
Medicaid Services is a government agency, whose role with respect to 
the NADAC is to determine prices to be compensated for insurance 
purposes. Tr. 256-57. The results of the survey are updated monthly and 
posted online. There is data that relates to different controlled 
substances. Tr. 257-58. DI reviewed the data for Oxycodone 30 mg and 
Hydrocodone 8 mg. Other data available include the name of the 
substance, cost per unit, NDC number, and effective date. DI identified 
the NADAC results for Hydrocodone 8 mg and Oxycodone 30 mg. Tr. 259-62; 
GX 44-45.\10\
---------------------------------------------------------------------------

    \9\ [Footnote omitted, see infra n.*P.]
    \10\ Pursuant to the Tribunal's previous ruling, Government's 
Exhibits 44 and 45 were not admitted. Tr. 262.
---------------------------------------------------------------------------

    DI found NADAC by doing a Google search. Tr. 272. He had never 
worked with it before. There is a fact sheet which explains how NADAC 
gathers their information and its use. Tr. 273. DI did not communicate 
with anyone at NADAC. For the Center for Medicare and Medicaid 
Services, the data only applies to patients whose medications are being 
paid for by Medicare or Medicaid. Tr. 273-74.
    DI does not know if any of the NADAC volunteered information is 
from independent pharmacies in the Fort Meyers or Cape Coral area, or 
any in southeast Florida. Tr. 275. He is aware that prices are 
different in terms of acquisition cost for chain pharmacies versus 
independent pharmacies. Tr. 276. He does not know whether chain 
pharmacies have a greater buying power than independent pharmacies, or 
whether there are different reimbursements that are paid by insurance 
companies compared to private pay price. Tr. 277-78. He does not know 
whether independent pharmacies are reimbursed at a lower rate than 
chain pharmacies. Tr. 357-58.
    DI became familiar with the term ``federal upper limit'' as part of 
his duties. Tr. 263. He became familiar of the term through the NADAC 
database. Federal upper limit is a multiplier that the Center for 
Medicare and Medicaid

[[Page 72701]]

Services uses from the NADAC average. Tr. 264-65.\11\ When the Center 
determines the federal upper limit, it is provided online on their 
database website. Tr. 267-68. The federal upper limit is available with 
respect to particular drugs, including controlled substances. DI 
reviewed the data for Oxycodone 30 mg and Hydrocodone 8 mg. DI 
identified the NADAC federal upper limit results for Hydrocodone 8 mg 
and Oxycodone 30 mg. Tr. 268-71; GX 46-47.\12\
---------------------------------------------------------------------------

    \11\ [Footnote omitted, see infra n.*P.]
    \12\ Pursuant to the Tribunal's previous ruling, Government's 
Exhibits 46 and 47 were not admitted. Tr. 270-71.
---------------------------------------------------------------------------

    The federal upper limit pertains to people who are not using 
insurance to pay. Tr. 274. It does not matter where a person fills 
their prescriptions if they are a Medicare patient. The same upper 
limit of what can be charged applies. Tr. 274-75.
    DI's intention through the second and third administrative 
subpoenas was to obtain the same type of information and documents that 
the DEA sought at the time of the administrative inspection warrant and 
administrative subpoena on February 14, 2018. Tr. 293-98; GX 3, 16, 33. 
DI did not draft the first administrative subpoena, but he did draft 
the second and third administrative subpoenas. Tr. 308-09. He is 
familiar with the process for the service of an administrative 
subpoena, which includes identifying a return date for the person on 
whom the subpoena is served to produce information. Tr. 310. The first 
administrative subpoena directs the person to whom that subpoena is 
served to respond to DI 2 by February 9, 2018. Tr. 310-11; GX 3 at 2. 
The return date had already passed by five days by the time the 
subpoena was served. Tr. 311. DI explained that when drafting 
administrative subpoenas, the system auto-populates the date at the 
bottom of the subpoena that is within two weeks or ten business days. 
Tr. 312. Taking into consideration travel and getting appropriate 
signatures, these subpoenas are drafted ahead of time. The date of 
issue on this subpoena is the date that the document was printed and 
submitted. Tr. 312-13.
    The return date for the third administrative subpoena was for was 
February 9, 2018. Tr. 314. The date and time for appearance auto-
populates, so it appeared that the drafter forgot to change the date, 
but DI was not sure. It would be impossible for the Respondent to 
timely respond to the subpoena as the Respondent did not receive it 
until February 14, 2018. Tr. 314-15.
    DI did not interview any of the physicians that prescribed the 
charged prescriptions. Tr. 319-20. He also did not interview any of the 
charged patients. Tr. 320. DI did not do any investigation to determine 
the distances from the charged patients' home to the pharmacy. Tr. 377-
78. DI did not have any evidence that any of the charged patients were 
abusing or diverting their medications. Tr. 321-24.\13\ He did not know 
the number of patients that had been served by the Respondent prior to 
February 14, 2018, and did not know what percentage of patients in the 
Order to Show Cause are of the Respondent's total patients. Tr. 325-26.
---------------------------------------------------------------------------

    \13\ The Tribunal sustained the Government's objection as to 
being outside the scope of the Government's direct examination and 
that this information is irrelevant. The Tribunal found that the 
Government does not require evidence of diversion or abuse to 
initiate or pursue an investigation, and they do not require 
evidence of diversion or improper behavior by the pharmacist to 
initiate an investigation. The Tribunal permitted the Respondent to 
make a proffer, but advised that the Government's theory is set out 
in the Order to Show Cause and Immediate Suspension of Registration 
and the Government's prehearing statements, which will serve as the 
focus of the hearing. Tr. 321-23.
---------------------------------------------------------------------------

    DI did not receive training at the DEA Academy regarding the 
Florida administrative code or Florida law. Tr. 327. In the 
administrative subpoenas, DI referenced Florida Administrative Rule 
64B16-27.800. Tr. 331. DI has previously read Florida Administrative 
Rule 64B16-27.800. Tr. 351. He understood that investigators were 
looking for the same types of profile information that the DEA 
technology specialist had downloaded during the administrative 
inspection warrant on February 14, 2018. Tr. 331-32.\14\
---------------------------------------------------------------------------

    \14\ The Tribunal sustained the Government's objection to 
relevancy of the underlying Government investigation. The Tribunal 
found that the focus of the hearing is not on whether there were 
mistakes or missteps in the investigation, but rather on the 
evidence that was seized and noticed with the allegations set out in 
the Order to Show Cause. Tr. 333-39.
---------------------------------------------------------------------------

    When he was assigned as the case agent, DI reviewed all of the 
information that the DEA had then collected. Tr. 339. Following the 
service of the second and third administrative subpoenas, he compared 
the patient profiles that were seized on February 14, 2018 to the 
patient profile information that was obtained in response to the second 
and third administrative subpoenas. Tr. 339-40, 342-43.
    DI transmitted the documents collected in response to the 
administrative subpoenas to Dr. Schossow. Tr. 378. The subpoenas were 
not issued at the request of the expert. Tr. 379. DI did not review any 
of the information with Dr. Schossow. Dr. Schossow provided a written 
report to DI before the OSC was issued, but he did not recall the exact 
date. Tr. 379-80.
    All of DI's interactions with Ricard Fertil and Gulf Med Pharmacy 
were both pleasant and cooperative. Tr. 399.

Dr. Tracey Schossow

    Dr. Schossow is a contracted expert with the Drug Enforcement 
Administration. Tr. 863-64. She expects to make $15,000 on the instant 
case. Tr. 879-80. She has only testified as an expert for government 
agencies. Tr. 865. Although she was not averse to defending someone 
charged by the Government, she has never been hired to defend anyone 
charged by the Government or by the State. Tr. 876-78. Dr. Schossow is 
a licensed pharmacist in the State of Florida. Tr. 404. She has a 
Bachelor's of Science Degree in Pharmacy from Florida A&M, and later 
received her Doctorate in Pharmacy from the University of Florida in 
2001. Tr. 881. Although she has written non-peer reviewed articles, she 
has not published a peer reviewed article. Tr. 939-40. She worked in 
retail pharmacy for a total of fifteen years, including time as a drug 
clerk and pharmacy tech for her father, who was a pharmacist. She 
worked as a pharmacist in retail pharmacy for approximately twelve 
years. She has also worked as a pharmacy intern, assistant manager, a 
pharmacy manager, and then as a ``floater'' for other pharmacy chains. 
Tr. 406-07, 417. She has worked in over 200 different pharmacies during 
her retail pharmacy experience, but never one in southwest Florida. Tr. 
988. However, she has not worked in a retail pharmacy since 2012. Tr. 
417, 881. Since 2012, she has only worked for pharmacy benefit 
managers. Tr. 883. Her last position in retail pharmacy was with Publix 
Pharmacies from July 2008 to October 2012. Tr. 418, 930. She last 
served a customer at a pharmacy approximately seven years ago. Tr. 880.
    She has worked for ProCare, a hospice-centered company, as a 
clinical pharmacist. Tr. 404, 418-19. In that capacity, she worked with 
patients who were dying, and managed cocktail medications for comfort 
management, while still maintaining cost effectiveness. Tr. 404-05, 
419-20. She was also part of the PNT committee, which decided which 
medications were non-formulary based on cost and efficacy. Tr. 405. She 
additionally managed a rejection queue, where claims are rejected for 
being excessively priced. Dr. Schossow offered more cost-effective 
therapies.

[[Page 72702]]

    Dr. Schossow presently works as a pharmacist at Florida Blue Cross/
Blue Shield. Tr. 403. As part of her duties, she reviews ``high-dollar 
reports'' (meaning high cost medications) and makes sure that the 
medications are being issued for a legitimate medical purpose. Tr. 403. 
If she determines they are being issued for a legitimate medical 
purpose, she works with the patient and provider to offer cost-
effective alternatives. Tr. 403-04. If, upon speaking to the pharmacy 
and patient, she determines the medications are not for a legitimate 
medical purpose, she reports those findings and opens up an 
investigation through Blue Cross's fraud, waste, and abuse department 
for further investigation. She also works on a team of ``complex 
members'' with a nursing team and reviews medications with patients. 
Blue Cross provides pharmaceutical education and offers cost-effective 
alternatives to its members.
    Blue Cross also submits test claims at different pharmacies, 
including independent pharmacies, to determine costs at different 
pharmacies in the area where patients reside. Tr. 405. Dr. Schossow did 
not actually prescribe medications in these roles, but she made 
recommendations to physicians based on the patient's symptoms. Tr. 406. 
She was a member of an interdisciplinary team, which made medication 
recommendations that the physicians generally followed. In that role, 
she served as a clinical pharmacist. Tr. 406.
    There are differences between a regional pharmacist and a clinical 
pharmacist. Tr. 407. A regional pharmacist receives the prescriptions 
from the physician. The pharmacist evaluates it, looks at the 
computerized patient profile and ensures the medication is safe for the 
patient before dispensing. A clinical pharmacist makes the 
recommendations saved on the computer patient profile. In Dr. 
Schossow's current position, she looks at all of the claims that the 
patient has, from the insurance perspective. She can review all of the 
medications the patient has received, and then she can make a 
recommendation based on the profile, and by talking to the patient and 
physician. Dr. Schossow has similar responsibilities as a regional 
pharmacist, except she does not dispense medications. Tr. 407. There is 
no difference in licensure between a clinical pharmacist and a 
community pharmacist. Tr. 419.
    Dr. Schossow has been a pharmacist for approximately twenty-six 
years. Tr. 408. All of her experience is in the state of Florida. She 
has experience filling approximately one million prescriptions. Dr. 
Schossow also holds a consultant license in the state of Florida. The 
consultant license allows her to perform additional duties, including 
nursing home inspections.
    Dr. Schossow has taught in the pharmacy field. Tr. 409. She taught 
at a pharmacy technician school, teaching subjects including diversion, 
red flags, and issues involving opioids. Tr. 409-10. She also worked at 
the Veterans Administration (VA) for six years. Tr. 412. In this role, 
she was a clinical pharmacy specialist and mentored residents and 
interns. Tr. 412. At the VA, Dr. Schossow prescribed medication. Tr. 
419. While with the VA, Dr. Schossow could prescribe medications 
because she operated under the VA regulations. Tr. 422-23. However, 
with the hospice and retail positions, she cannot prescribe medications 
and can only make recommendations. Tr. 423. She has never had the 
ability or authority to prescribe Schedule II controlled substances. 
Tr. 423. At ProCare, she was a trainer in regards to high-dollar cost 
rejections, including training pharmacists on these rejections, how to 
handle them, and how to offer cost-effective alternatives. Tr. 412, 
936-38. She also worked for Caremark, a PBM, where her role was to 
control costs for contracted healthcare plans. Tr. 972-73. Dr. Schossow 
conceded that, outside the realm of insurance subsidization, there is 
no limit on the mark up a pharmacy can charge for medications. Tr. 
1035.
    Dr. Schossow is familiar with DEA regulations with respect to 
dispensing of controlled substances. Tr. 408-09, 888-92, 927-28. She 
has previously testified as an expert witness three times in DEA 
administrative cases. Tr. 411-12, 423-24. She has been qualified each 
time she has been offered as an expert. She has only testified in 
administrative hearings, not in courts. Tr. 928. Her opinions have been 
accepted by the DEA Administrator. Through her education and 
professional experience,\15\ she is familiar with the responsibilities 
of a retail pharmacist in the detection and prevention of abuse and 
diversion of controlled substances. Tr. 414. She is familiar with the 
standard of care \16\ and professional obligations of a pharmacist in 
the state of Florida. Tr. 888-92.
---------------------------------------------------------------------------

    \15\ Dr. Schossow identified her curriculum vitae. Tr. 412-13; 
GX 43.
    \16\ The term of art, ``standard of care'' was used by the 
Tribunal, the parties and sometimes witnesses as a shorthand 
reference to a pharmacist's professional obligations, or acting 
within the ``course of professional practice of pharmacy.'' See 
Florida Statute XLVI Sec.  893.04. However, the term ``standard of 
care'' is defined in Sec.  766.102, and has a different usage and 
application. This distinction will be discussed in detail below.
---------------------------------------------------------------------------

    In the instant case, Dr. Schossow was offered as an expert in 
Florida pharmacy practice and the standard of care for the practice of 
pharmacy in Florida. Tr. 414, 416. She reviewed all of the exhibits in 
this matter, including prescriptions, patient profiles, E-FORCSE 
reports, and documents provided by Gulf Med Pharmacy. She asked the 
Government to gather information that a responsible pharmacist would 
look at before determining whether a prescription could be safely 
filled for a legitimate medical purpose. So she asked for those items 
that she would look for if she was standing in the pharmacy filling the 
prescriptions. Tr. 415-16.
    Dr. Schossow was qualified as an expert in Florida pharmacy 
practice and the standard of care for the practice of pharmacy in 
Florida.\17\ The duties of a Florida pharmacist with respect to filling 
controlled substance prescriptions include exercising a corresponding 
responsibility to make sure that medications are being issued for a 
legitimate medical purpose by the practitioner acting within their 
usual course of professional practice. Tr. 431. The pharmacist is 
responsible for evaluating prescriptions based on the manufacturer's 
guidelines and for the safety for the patient. Tr. 432. Florida 
Administrative Rule 64B16 lists responsibilities regarding what should 
be maintained in the patient record systems, including the patient's 
name address, allergies, pharmacist's comments, and a Drug Use Review 
(DUR) for each new prescription and refilled prescription. A DUR 
includes side effects, drug interactions, whether the medication is 
being clinically abused or misused, and dosages.
---------------------------------------------------------------------------

    \17\ The Respondent objected to the Government's offer of Dr. 
Schossow as a proposed expert witness and to restriction on voir 
dire as to her opinions relating to specific aspects of the standard 
of care. The Tribunal overruled the Respondent's objections and Dr. 
Schossow was qualified as offered. Tr. 424-27. The Tribunal noted 
that the burden to qualify an expert is by a preponderance of the 
evidence. Thereafter, apparent limitations to expertise will impact 
the weight given to the expert's testimony.
---------------------------------------------------------------------------

    Dr. Schossow is familiar with Florida Administrative Rules 64B16-
27.800, 27.810, and 27.831. Tr. 434-36, 891-92. These provisions inform 
the standard of care of a pharmacist working in Florida. Tr. 434-36, 
891-94, 912-16.\18\ They provide an outline of the minimal requirements 
for Florida pharmacists in regards to patient safety and continuity of 
care. Florida Administrative Rule

[[Page 72703]]

64B16-27.831 describes methods a pharmacist should use to validate a 
prescription. Tr. 897-900. This provision also requires pharmacists to 
maintain a computerized record of controlled substances dispensed, 
which the Respondent did in this case as to the charged patients. Tr. 
908-12. The Florida statutes define requirements for patient care and 
for maintaining a patient records system. Tr. 437. These statutes 
provide that the pharmacist shall ensure a reasonable effort is made to 
obtain, record, and maintain certain information, including the 
patient's full name, address, date of birth, gender, and prescription 
list, as well as the pharmacist's comments relating to allergies, drug 
interactions or any idiosyncrasies, and any conversations that the 
pharmacist had with the healthcare provider in regards to the patient's 
individual drug therapy. Tr. 438, 913-20. The Florida statutes also 
require prescription drug review, including therapeutic 
inappropriateness, which the pharmacist must address for drug therapies 
that do not fall within the guidelines of the standard of care. This 
ensures continuity of care with the next pharmacist reviewing the 
medication protocol, as well as to assure that the medication is safe 
for the patient. Tr. 927-30. These concerns include over or under-
utilization of medication, therapeutic duplications, drug interactions, 
incorrect dosage forms, drug allergy interactions, and clinical abuse. 
The pharmacist must take appropriate steps to resolve these issues and 
to record those resolutions. Tr. 438-39, 888, 918-26. Dr. Schossow 
conceded that the relevant federal regulations that she relied on to 
inform the standard of care do not specifically require documentation 
of the resolution of red flags. Tr. 927-28.
---------------------------------------------------------------------------

    \18\ Dr. Schossow testified that the pharmacist is required to 
apply the version of the regulation or statute applicable at the 
time the subject prescription is filled. Tr. 896-97, 904-05.
---------------------------------------------------------------------------

    A prospective drug use review is a checklist that a pharmacist 
should go through when reviewing each new and refilled prescription to 
ensure therapeutic appropriateness and patient safety. Tr. 439-40. 
Additional concerns include therapeutic duplication, drug interactions, 
correct dosages, clinical abuse and misuse, and drug allergy 
interactions. Prospective drug utilization review is discussed in the 
Florida Administrative Rules under section 27.810. Tr. 440-41. Upon 
recognizing any therapeutic inappropriateness, the pharmacist is 
supposed to take appropriate steps to resolve the issue and to record 
the resolution in the patient records. It is important to document the 
results of a review for continuity of care, so that when the next 
pharmacist reviews the medication protocol, he will have the 
information readily available and the prescription can be filled 
without delay. Tr. 441-42. It also represents a safety issue. In Dr. 
Schossow's opinion, the Florida standard of care requires documentation 
of the resolution of these matters. Tr. 442.
    Dr. Schossow is familiar with DEA regulations regarding a 
pharmacist's corresponding responsibility. Tr. 442. The pharmacist has 
just as much responsibility as the doctor to ensure that the medication 
is for a legitimate medical purpose and that the practitioner is acting 
in the usual course of professional practice. Tr. 442-43. It applies to 
all pharmacists. This responsibility is in addition to all of the 
requirements under the Florida rules and regulations. A pharmacist's 
corresponding responsibility is not satisfied by simply verifying that 
a doctor wrote the prescription. The pharmacist has an independent 
responsibility to evaluate each prescription. Tr. 444.
    Dr. Schossow is familiar with the phrase ``in the usual course of 
professional practice.'' Tr. 444. This means that the doctor is issuing 
prescriptions in an effective and safe manner and ``within his 
training.'' This is a requirement for a pharmacist. ``Within his 
training'' means within the scope of his practice. Tr. 444-45. 
Pharmacists are required to fill prescriptions in the usual course of 
their profession.
    Apart from the requirements for pharmacists set forth by the State 
of Florida and the DEA, Dr. Schossow testified that she believed that a 
pharmacist's standard of care is also informed by past DEA 
administrative cases.*\C\ Tr. 445-46. Pharmacists learn about the DEA 
administrative decisions through mandatory CMEs and during education 
seminars, including those required by Sec.  27.831. Tr. 457-62.
---------------------------------------------------------------------------

    *\C\ It is noted that DEA administrative cases rely on expert 
testimony to establish the standard of care.
---------------------------------------------------------------------------

    Dr. Schossow is familiar with the term ``red flag.'' Tr. 446. Red 
flags are circumstances surrounding a prescription that cause a 
pharmacist to take pause, including signs of diversion or the potential 
for patient harm. These concerns are codified under clinical abuse and 
misuse within the DUR in Florida's Administrative Rule 64B16. The 
section also talks about abuse under Chapter 893, in which abuse is 
defined. Tr. 446. Pharmacists in the State of Florida ``must learn 
three main statutes'' in order to pass the Florida Board: ``64B16, 893, 
and 465.'' Tr. 449, 1004-05, 1039-40. Pharmacy students learn these 
statutes for the Florida Board of Pharmacy. Chapter 893 informs the 
Florida standard of care for pharmacists as it defines potential for 
abuse, which relates back to 64B16. Tr. 449-50. The prospective DUR 
requires that one of the things a pharmacist must review is clinical 
abuse or misuse, so a pharmacist must understand what abuse means.
    Florida pharmacists become familiar with red flags through their 
training in pharmacy school and through their on-the-job training. Tr. 
451, 888. This training includes the opioid crisis in the United 
States, which led to mandatory continuing education in Florida for the 
validation of prescriptions for controlled substances. Tr. 451-53. This 
additional training includes, use of the PDMP, appropriate therapeutic 
values for opioids, legitimate medical purpose and the laws and rules 
around it, as well as protocol that addresses how to resolve red flags, 
and the CDC Guidelines for Prescribing Opioids for Chronic Pain, 2016. 
The CDC guidelines relating to opioid prescribing are reviewed in the 
Continuing Medical Education (CME) courses. Tr. 454. The CDC guidelines 
cover appropriate dosing, which is part of the mandatory CME that all 
Florida pharmacists must attend every other year, as well as risks of 
certain dosages of Morphine Milligram Equivalent (MME). Tr. 455. The 
training covers dosing and risks to patients, as well as combining 
central nervous system depressive medications that may lead to overdose 
and death. Tr. 456. The training also covers dosage concerns based on 
clinical studies, for which the pharmacist is responsible to know. The 
standard of care requires pharmacists to remain current as to the 
therapeutic appropriateness findings of these studies. The items 
outlined in Florida Administrative Rule 64B16-27.810 represent red 
flags. Tr. 457.
    The presence of a red flag itself does not mean that a pharmacist 
cannot fill a prescription. Tr. 462. Consistent with the standard of 
care, a red flag means that there is a potential concern with the 
prescription, which the pharmacist must address and resolve, and to 
make a record of its resolution, assuming it is resolvable. Tr. 462-63, 
906-07. If the pharmacist is unable to resolve the red flag, he should 
not fill the prescription. Tr. 907-08. This is something that a Florida 
pharmacist acting in the usual course of professional practice would do 
upon encountering one or more red flags relating to a prescription. The 
lack of documentation identifying and resolving of a red flag warrants 
the

[[Page 72704]]

conclusion under the standard of care that the prescription was treated 
as falling within the guidelines for a legitimate medical purpose and 
is safe for the patient to take. Tr. 463-66.
    Dr. Schossow was asked by the DEA to review material relating to 
Gulf Med Pharmacy. Tr. 466, 983-84. She reviewed the front and back of 
hard-copy prescriptions, the computer printouts of the patients' 
pharmacy files, which included any pharmacist comments, medical records 
from the pharmacy, dispensing reports, and patient profiles, including 
the PDMP reports for patients. Tr. 466-71. Dr. Schossow does not know 
if she received all of the relevant information from the Respondent's 
computer system used to fill the subject prescriptions. Tr. 976-78. 
Specifically, Dr. Schossow confirmed the screen shots of the patient 
profile only depicted one of five tabs. Tr. 978; GX 19. The tab opened 
in the relevant Government exhibits was the ``comment'' tab. The tab 
identified as ``profile'' was not revealed. Tr. 978-79. Similarly, the 
tab, ``RX history'' is not revealed. Tr. 979.
    Dr. Schossow is familiar with pharmacy management software, which 
maintains patient records. Tr. 471. She is familiar with how it 
generally works and has worked with different systems of pharmacy 
management software. However, she is not familiar with the Respondent's 
system, PioneerRx. Generally, when a prescription is submitted to a 
pharmacy, the technician types up the prescription, which then goes 
through the system. Tr. 472. Most pharmacies perform the DUR. It is the 
responsibility of the pharmacist to override it or to document that 
issues revealed by the DUR were addressed. Tr. 475. Not all red flags 
are flagged in the computer system, but red flags that are flagged 
include major drug interactions, including central nervous system (CNS) 
depressant medications that fall under an X interaction according to 
the DEA and the CDC, and the FDA black box warnings on things such as 
benzodiazepines combined with opioids. Tr. 476.
    After a warning appears in the electronic program, that is 
considered a DUR \19\ and the severity of the DUR should be addressed 
by the pharmacist with either the patient or the doctor to assure 
patient safety going forward and how it was resolved. There is 
generally a click-through function on the program and documentation 
must be provided. Tr. 476-77. For example, in the system at Walgreens, 
the pharmacist has to document what they did to resolve the red flag. 
If the software program does not allow the pharmacist to document in 
the computer, then the pharmacist must either document in the computer 
program under the patient notes or somewhere in the patient records 
system, or on the prescription, as to how the DUR was resolved in terms 
of patient safety, for the continuity of care for the next pharmacist. 
A click-through does not count as documentation of a red flag. Tr. 477-
78. A click-through allows the pharmacist to override a DUR. For 
example, at Publix, the pharmacist has a lanyard that the pharmacist 
clicks to override the DUR. However, a higher level DUR requires more 
documentation because of patient safety concerns. Tr. 478-79.
---------------------------------------------------------------------------

    \19\ Dr. Schossow appeared to use the term DUR in place of ``red 
flag'', as per the subject question.
---------------------------------------------------------------------------

    A pharmacist practicing in the normal course of pharmacy practice 
in Florida would record what the resolution of the red flag was for 
continuity of care and to assure patient safety. Tr. 479-80. In a 
pharmacy, the pharmacist is responsible for resolving any potential red 
flag of abuse or diversion. Tr. 480. A pharmacy technician cannot 
resolve or sign off on the resolution of a red flag.
    Dr. Schossow is familiar with a combination of controlled 
substances known as a ``trinity''. Tr. 480-81. A trinity is usually an 
opioid like Hydromorphone or Oxycodone, plus a benzodiazepine like 
Alprazolam, Temazepam, Diazepam, plus Soma or Carisoprodol, which is a 
controlled muscle relaxant. Tr. 481. It is a dangerous combination. In 
Dr. Schossow's experience and training, the trinity is commonly sought 
by drug abusers. Tr. 482-83. A trinity is a red flag.
Patient J.B.
    Dr. Schossow identified a patient medication dispensing report 
printout for Patient J.B. Tr. 483-84; GX 6. The number in the quantity 
column is the amount of dosage units dispensed by the pharmacy of the 
controlled substance. Tr. 485. On March 22, 2017, six prescriptions 
were filled. The bottom-listed controlled substance is Carisoprodol. 
Tr. 485; GX 6 at 2. The prescription immediately above is Oxycodone 30 
mg. Tr. 486. The prescription above that is another controlled 
substance, listed as Alprazolam. Two lines above Alprazolam, Morphine 
Sulfate Extended is listed. Morphine Sulfate Extended is an opioid, 
Alprazolam is a benzodiazepine, Oxycodone is an opioid, and 
Carisoprodol is a controlled substance muscle relaxant. Together, these 
controlled substances form a trinity. Dispensing these controlled 
substances on the same day represents a red flag for the pharmacy. Tr. 
486-87.
    Dr. Schossow noted prescriptions paid for in cash indicated a red 
flag.\20\ Tr. 851-53; GX 6 at 1-2; GX 23 at 61-63. There is also an 
indication of a red flag for the payment of an unusually large amount 
of cash for an opioid. Tr. 852-53, GX 6 at 2. Dr. Schossow identified 
prescriptions demonstrating a red flag for combining extended release 
and immediate release opioids. Tr. 853-57; GX 23 at 57, 61-63, 66-69, 
72-74, 77-80; GX 35 at 10, 21, 11-14, 19, 20, 24-27.
---------------------------------------------------------------------------

    \20\ Dr. Schossow conceded that she was not aware whether the 
charged patients, who paid cash for the subject controlled 
substances, later sought reimbursement from their insurance 
companies. Tr. 1036.
---------------------------------------------------------------------------

    On April 19, 2017, another series of prescriptions were filled, 
including Morphine Sulfate, Oxycodone 30 mg, 90 units of Alprazolam, 
and Carisoprodol. Tr. 487-88; GX 6. This is a trinity combination. In 
addition, the patient was also on Gabapentin and Butalbital, Aspirin, 
and Caffeine, which are also additional CNS depressants, which make 
this combination even more dangerous. These were prescription numbers 
734 through 737; GX 6 at 2. On May 19, 2017, another series of 
prescriptions were filled, including Morphine Sulfate, Oxycodone 30 mg, 
Alprazolam, and Carisoprodol. Tr. 488; GX 6 at 2. This is a trinity 
combination and a red flag. Tr. 488-89.
    On June 16, 2017, another series of prescriptions were filled, 
including Morphine Sulfate, Oxycodone 30 mg, Alprazolam, and 
Carisoprodol. Tr. 489. This is a trinity combination and a red flag. 
These included prescription numbers 1306, 1317, 1319, and 1321.
    On July 14, 2017, another series of prescriptions were filled, 
including Morphine Sulfate, Oxycodone 30 mg, Alprazolam, and 
Carisoprodol. Tr. 489-90. This is a trinity combination and a red flag. 
These included prescription numbers 1627, 1628, 1633, and 1634.
    On August 11, 2017, another series of prescriptions were filled, 
including Morphine Sulfate Extended Release, Oxycodone 30 mg, 
Alprazolam 10 mg, and Carisoprodol. Tr. 490. This is a trinity 
combination and a red flag. These included prescription numbers 1946, 
1947, 1950, and 1951.
    On September 8, 2017, another series of prescriptions were filled, 
including Morphine Sulfate, Oxycodone 30 mg, and Alprazolam 10 mg. Tr. 
491. These included prescription numbers 2250, 2251, and 2252. There 
was no Carisoprodol issued on this date. It is still a dangerous 
combination because all of those drugs suppress the central

[[Page 72705]]

nervous system and can lead to respiratory depression, overdose, and 
death.
    The records indicate which pharmacist actually filled the 
prescription. Tr. 492. At the top of the patient record, the initial 
RPH, which means registered pharmacist, lists the initials of the 
pharmacist that filled the prescription. Tr. 492; GX 6 at 1.
    On October 6, 2017, another series of prescriptions were filled, 
including Morphine Sulfate, Oxycodone 30 mg, Alprazolam, and 
Carisoprodol. Tr. 497-98; GX 6. This is a trinity combination and a red 
flag. These included prescription numbers 2603 to 2606.
    On November 3, 2017, prescriptions were filled, including Oxycodone 
30 mg and Alprazolam. On November 6, 2017, prescriptions were issued, 
including Morphine Sulfate and Carisoprodol. Tr. 498-99. This is a 
trinity combination and a red flag. These included prescription numbers 
3034, 3036, 3062, and 3064. It is a red flag as the medications were 
dispensed so close in time.
    On December 1, 2017, another series of prescriptions were filled, 
including Oxycodone 30 mg and Alprazolam. Tr. 499. These included 
prescription numbers 3474 and 3475. These prescriptions represent a red 
flag. Tr. 500. Both of these drugs depress the central nervous system 
and the Oxycodone dosage is the highest strength available, which in 
itself is a red flag. These prescriptions fall under the FDA black box 
warning and 2016 CDC guidelines that specifically recommend against 
taking benzodiazepines with opioids. Although familiar with the 2016 
CDC Guidelines, and upon which she relied in forming her opinions 
herein, Dr. Schossow was unfamiliar with the clarification issued, 
which clarified that the 2016 Guidelines did not apply to patients on 
long-term opioid treatment. Tr. 992-94. Dr. Schossow conceded that if a 
patient had been on a long-term drug regimen, that would be a 
consideration of the pharmacist in conducting the DUR analysis. Tr. 
1035. Dr. Schossow clarified that she had previously reviewed the CDC's 
clarification to the 2016 CDC Guidelines, and noted it did not change 
her opinion as it did not relate to the combination of benzodiazepines 
and opioids. Tr. 1060-64.
    On December 29, 2017, another series of prescriptions were filled, 
including Oxycodone 30 mg, Alprazolam, Morphine Sulfate, and 
Carisoprodol. Tr. 503; GX 6. These included prescription numbers 3973, 
3975, 3976, and 3979. These prescriptions represent a trinity and thus 
a red flag.
    On January 26, 2018, another series of prescriptions were filled, 
including Oxycodone 30 mg and Alprazolam. Tr. 503. These included 
prescription numbers 4549 and 4550. On January 31, 2018, Morphine 
Sulfate Extended Release was issued, which includes prescription number 
4658. Tr. 504. These prescriptions are a combination of opioid and 
benzodiazepine and thus represent a red flag.
    Dr. Schossow identified the actual prescriptions for Patient J.B. 
Tr. 504-05; GX 7. She did not see any resolution of red flags 
documented for any of the subject prescriptions that were filled. Tr. 
505-06; GX 7 at 1-69. The notation ``PDMP'' on the back of the 
prescription would mean that the pharmacist checked the PDMP before 
filling the prescription. Tr. 506; GX 7 at 18. This does not resolve 
the red flag as there are several red flags present regarding that 
prescription. Tr. 507. The red flags include the high strength of the 
Oxycodone at 30 mg. The second is that the medication is over 50 mg 
MME, which puts the patient at risk for CNS depression, overdose, and 
death. The third red flag is the scheduling of an immediate relief 
opioid. Checking the PDMP did not resolve or address any of those red 
flags, but only satisfied part of the law that requires the pharmacist 
to check the PDMP to ensure the patient is not doctor or pharmacy 
shopping and to check the total milligram of MME. Reference to the PDMP 
does not contribute to resolving any of the red flags related to the 
prescription. Tr. 507-08. Dr. Schossow identified a patient computer 
profile for Patient J.B. Tr. 529-30; GX 35.\21\ She did not see any 
documentation or resolution of the red flags previously discussed on 
the first page. Tr. 530, 857-58; GX 35, p. 1. She did not see any 
documentation of red flags, or the resolution thereof, in the patient 
profile, particularly under the critical comments section where the 
pharmacist can fill in comments. Tr. 493-96, 504, 857-58. Nor did she 
see any indication the medical records or dispensing log for J.B. 
indicated the subject red flags as to J.B. were addressed, resolved or 
documented. Tr. 858-59; GX 35 at 2-5, 8, 9.
---------------------------------------------------------------------------

    \21\ Although both parties used the term, ``patient profile'', 
Dr. Schossow confirmed the Florida subject regulations did not 
define the term. Tr. 1035.
---------------------------------------------------------------------------

    There were additional prescriptions of the same opioid and 
benzodiazepine (Oxycodone 30mg, and Xanax) that were also red flags, 
based upon the cocktail created by the controlled substances, which are 
central nervous system depressants, which can cause sedation, 
respiratory depression, overdose, coma, and death. Tr. 530-34; GX 35, 
pp. 6-7, 10, 11-16, 21. There were additional prescriptions for 
Oxycodone, Xanax, and Morphine that were red flags for the same 
reasons. Tr. 533-34; GX 35 at 17-20, 22-27. Dr. Schossow did not see 
any indication of red flags being documented or resolved on the 
prescriptions. Tr. 534, 857-58, 860; GX 35 at 2-27.
    Dr. Schossow opined that a pharmacist, acting within the relevant 
standard of care, when confronted with the red flags revealed within 
the subject records for Patient J.B., would not have filled the subject 
prescriptions without addressing, resolving, and documenting the red 
flags discussed. Tr. 859-60; GX 5 at 1.
Patient L.V.
    Dr. Schossow identified a patient medication dispensing report 
printout for Patient L.V. Tr. 510; GX 6 at 6. On March 2, 2017, 
prescriptions for Morphine Sulfate, Alprazolam, and Oxycodone were 
filled. Tr. 511. They are included as prescription numbers 308 to 310. 
Dispensing these medications on the same day causes concern and serves 
as a red flag as they each suppress the CNS and fall under the FDA 
black box warning for risk of sedation, respiratory depression, coma, 
and death.
    Oxycodone is an opioid and Xanax is a benzodiazepine. Tr. 513. 
Looking at fill stickers, these prescriptions were issued on February 
23, 2018. Tr. 513-14; GX 23 at 2, 4. These prescriptions are a red flag 
since they both depress the central nervous system and fall under the 
prospective DUR for drug interaction and side effects. Tr. 514-15. 
Viewing additional prescriptions, Oxycodone 30, Xanax 1 mg, and Soma 
were both filled on March 21, which again, represents a trinity. Tr. 
515; GX 23 at 8-10. There are two more prescriptions for Xanax and 
Oxycodone 30 mg, which indicate a red flag because an opioid and 
benzodiazepine were filled on the same day. Tr. 516; GX 23, p. 11, 14.
    A prescription for an opioid, Oxycodone 30 mg, and a 
benzodiazepine, Alprazolam 2 mg, prescriptions 5127 and 5129, are a red 
flag. Tr. 520; GX 7 at 1-4. There were additional prescriptions of the 
same opioid and a benzodiazepine (Oxycodone 30mg and Xanax) that were 
also red flags, based upon the cocktail created by the controlled 
substances, which are a central nervous system depressant, and can 
cause sedation,

[[Page 72706]]

respiratory depression, overdose, coma, and death. Tr. 521-28; GX 7 at 
8-9, 10-11, 14-17, 22-25, 26, 28-29, 31-36, 37, 40-42, 43, 46-47, 49, 
55-59, 60-65, 66-71, 72-76, 77-82. When checking both the front and 
back of the prescriptions, Dr. Schossow did not see any indications 
that any of the red flags were documented or resolved as to any of the 
subject prescriptions. Tr. 529.
    Additional red flags for cash payments were present. Tr. 758, 767-
68, 772-74, 776, 778; GX 15 at 1-6, 7-12, 13-8, 19-21, 25, 27, 31-36, 
38, 40, 43-48, 50, 52, 56, 58, 62, 64, 75-80. Red flags for the 
unusually high amount of the cash payment were also present. Tr. 758-
64, 767-68, 772, 775-78; GX 15 at 8, 16, 22, 34, 50, 58, 64, 76.
    An additional matter of suspicion arose in L.V.'s alternate use of 
insurance to pay for benzodiazepine prescriptions in lieu of the many 
cash payments for opioids, especially considering the high prices L.V. 
paid for them. Tr. 768-76, 677-78; GX 15 at 30, 31-36, 42, 48, 54, 60, 
71, 72, 75.
Patient A.B.
    Dr. Schossow identified patient computer profiles and prescriptions 
for Patient A.B. Tr. 534-35, 538; GX 8, 24. Viewing the prescriptions 
in the patient profile, she found that the listed prescriptions, which 
included combinations of a benzodiazepine and an opioid to create a 
cocktail, which are a central nervous system depressants, again were 
red flags. Tr. 535-38; GX 3 at 1-6, 7-12, 13-18, 19-24; GX 24 at 1-6, 
7-12, 13-18, 19-24, 26-31, 32, 33, 35, 38, 39, 40, 42-45. These 
prescriptions included additional controlled substances, including 
Diazepam (a benzodiazepine), Hydromorphone, OxyContin, and Valium (a 
benzodiazepine). Tr. 540-41. She did not see any of the subject red 
flags documented or resolved in the prescriptions that she reviewed. 
Tr. 539; GX 8.
Patient T.G.
    Dr. Schossow identified a patient medication dispensing report 
printout for Patient T.G. Tr. 509-10; GX 6 at 3. She also identified 
the patient profile prescriptions for Patient T.G. Tr. 556; GX 12. She 
identified ``ACQ Cost'' in the record, as referring to acquisition 
cost. Tr. 556; GX 1 at 2. Viewing the second column, she saw an 
acquisition price of $43.19. Tr. 557. Further up on the same page in 
the record, there was a ``price paid'' in the same column. The price 
paid was $480. This accounting occurred with additional groups of 
prescriptions for this patient. Tr. 563; GX 12 at 5-8, 10. In Dr. 
Schossow's opinion, the amount paid by a customer can be a red flag. 
Tr. 563-65.\22\
---------------------------------------------------------------------------

    \22\ Dr. Schossow has experience working in retail for twelve 
years in different pharmacies all over the State of Florida, but not 
including southwest Florida. Tr. 564. There are regional variations 
for the prices of medication, but the typical mark-up of medications 
is around 20 to 25 percent. Tr. 565. Dr. Schossow is familiar with 
the price of these medications during the charged period from her 
time working in hospice. Tr. 566. She worked with the rejection 
queue with high-cost medications for patients all over the State of 
Florida. Tr. 566-67. She was the lead of the team, and a trainer for 
the queue, so everyone who she trained understood normal pricing for 
Oxycodone and Hydromorphone. The mark-up is about 20 percent over 
the pharmacy's acquisition cost. There are slight variations 
regionally in different counties and different areas of Florida, but 
the typical mark-up is 20 to 25 percent over the acquisition. Tr. 
569. When Dr. Schossow sees very high prices, it is a red flag. 
Hospice also would not pay for it, so she would contact the pharmacy 
and inquire how much they paid for it. Dr. Schossow could not 
definitively quantify what the slight variations would be, but it 
would typically be around 20 percent at most. Tr. 569-70. I 
overruled the Respondent's objections to Dr. Schossow's testimony 
and allowed her to testify about the acquisition cost and how she 
determined that the price paid is much higher than what would 
normally be charged in Florida, even with slight variations in 
prices regionally. Tr. 571-72.
---------------------------------------------------------------------------

    Dr. Schossow's experience in the pricing of medications in Florida 
reflected an approximate twenty percent mark-up from acquisition cost. 
Tr. 570-72. She also did research on her own of the pricing of the 
subject medications within the subject locale. She phoned pharmacists 
at Walgreens and CVS and obtained the actual prices for the subject 
medications.\23\
---------------------------------------------------------------------------

    \23\ The Respondent objected to this hearsay evidence, and it 
was ruled inadmissible as the individuals who provided the pricing 
information were not identified in the Government's Supplemental 
Prehearing Statement, as required by the Order for Prehearing 
Statements. Tr. 572-78, 1009-10; ALJ Ex. 6.
---------------------------------------------------------------------------

    Viewing Patient T.G.'s patient profile prescriptions, the type of 
payment was an ``RX-lock'', which Dr. Schossow understood to mean a 
cash payment. Tr. 579; GX 12 at 13-16. It applied to both 
prescriptions. The method of payment and the amount paid by the 
customer are red flags. This also applied to additional prescriptions 
for Patient T.G.\24\ Tr. 580-83, 589-94; GX 12 at 17-20, 21-24, 25-28, 
29-32, 33-34, 35-38, 39-42; GX 28 at 1-4, 5-8, 9-10, 11-12, 13-14, 15-
17. There was no documentation that the red flags relating to payments 
in cash or high prices paid were flagged or addressed by the pharmacy. 
Tr. 595-96; GX 5 at 2; GX 20. A pharmacist acting in the usual course 
of professional practice would not have filled the charged 
prescriptions without addressing those red flags and documenting the 
resolution. Tr. 596-97.
---------------------------------------------------------------------------

    \24\ I sustained the Respondent's objections to Dr. Schossow 
speculating on the connection between the price paid for the 
prescription and how the drug-seeking community is taking advantage 
of using this system, including the pharmacy's reputation within the 
community as without established foundation. Tr. 583-89.
---------------------------------------------------------------------------

Patient S.K.
    Dr. Schossow identified the patient profile prescriptions for 
Patient S.K. Tr. 597; GX 13. All of the prescriptions were paid for in 
cash, which is a red flag. Tr. 597-98; GX 13, pp. 1-6. It is also a red 
flag for the high amount of cash paid by the customer. Tr. 598; GX 13 
at 2. There are additional concerns for these prescriptions. Looking at 
the first prescription, the first concern is that the doctor is writing 
for the highest dosage of immediate release Hydromorphone; the second 
is that the doctor scheduled the medication, which is usually given as 
a PRN (``take as needed'') dosing or breakthrough medication; and the 
third is that the prescription was written for an anxiety disorder, 
while Hydromorphone is not indicated for anxiety. Tr. 598-99; GX 13 at 
1.
    Another prescription written for this patient included concerns 
that the doctor wrote a prescription for Morphine ER 15 mg, one tablet, 
twice daily. Tr. 599. This prescription was concerning because the 
prescription was for an opioid. It was also concerning because the 
pharmacist did not address that the prescription was for an anxiety 
disorder, for which Morphine is not indicated. Another concern was that 
long-acting opioid prescriptions were developed by the manufacturers to 
limit the number of PRN medications the patient would have to take. In 
this case, the lowest dosage of Morphine was 15 mg twice a day, along 
with the Hydromorphone 8 mg, which is equivalent to around 32 mg of 
Morphine four times per day. It is not within the standard of care for 
a low-dose Morphine to be prescribed with the highest dose of another 
opioid. Tr. 599-600.
    In order for a pharmacist to safely dispense medication, she must 
know the dosing and how long the drug lasts in the body. Tr. 603. 
Pharmacists know that Hydromorphone lasts in the body from two to four 
hours, while a long-acting opioid like MS Contin lasts in the body 
eight to twelve hours. Long-acting opioids were meant to reduce the 
amount of immediate release opioids given. In this case, there are very 
high doses of immediate release opioids, which are usually given on an 
as-needed basis because they only last a short time. When working in 
pain management, the doctor determines the total daily dose of the MME 
and schedules that dose on the basis of the long-acting opioid; the 
doctor does not

[[Page 72707]]

give more immediate release medication than a long-acting opioid. Tr. 
1036-37. In this case, because the way the doctor wrote the 
prescription did not make pharmacological sense, the pharmacist should 
have done his due diligence to address the inappropriate dosing of the 
medications. Tr. 605. Dr. Schossow did not see any documentation on the 
resolution of these red flags, including the pharmacist contacting the 
doctor. Improper pharmacological drug dosing is discussed in ``Florida 
Rule 64B16-27.810.'' Tr. 605. The lower dose of the long-acting opioid 
with the higher doses of the short-acting opioid is a red flag. Tr. 
606. This is something the pharmacy should have addressed.
    The first two prescriptions for the patient are opioids and the 
third prescription is for Clonazepam, which is a benzodiazepine. Tr. 
606; GX 13 at 1-6. Taken together, these prescriptions represent a 
cocktail, which is a red flag. Additional prescriptions given to the 
patient indicate red flags for cash payments, the high price paid by 
the patient, the dosages of the medications, improper medications for 
listed conditions, and cocktail combinations. Tr. 606-11, 612-24, 626-
40; GX 13 at 7-12, 13-18, 19-24, 25-30, 31-36, 37-42, 43-48, 49-54, 55-
60, 61-66, 67-72, 73-78; GX 29 at 1-6, 7-12, 13-18, 19-24, 25-30, 31-
33, 34-39, 40-45, 46-49, 50-53, 54-57, 58-61, 62-65, 66-69, 70-73, 74-
79.
    A Florida pharmacist operating within the standard of care should 
have resolved the red flags and documented that resolution that were 
identified for Patient S.K. for subsequent pharmacists to assure 
continuity of care and patient safety, assuming the red flags were 
resolvable. Tr. 640-41. Looking at the patient profile, there was 
nothing in the patient profile or prescriptions for Patient S.K. to 
suggest that any sort of investigation was done or that the red flags 
were addressed, resolved, or documented. Tr. 641; GX 21. A reasonable 
pharmacist acting in the usual course of professional practice would 
not have filled these prescriptions without addressing, resolving, and 
documenting such resolution of the red flags. Tr. 641.
Patient R.R.
    Dr. Schossow identified the patient profile prescriptions for 
Patient R.R. Tr. 641-42; GX 14. The prescriptions present red flags for 
cash payment. Tr. 642; GX 14 at 1-7. They also indicate a red flag for 
high prices paid by the patient. Tr. 642; GX 14 at 2. They also 
indicate a red flag for cocktail medications. An additional 
prescription is for Alprazolam or Xanax 2 mg, which is the highest 
strength available. Tr. 643; GX 14 at 5-6. This drug is called ``Xany 
Bars'' on the street, and is a highly sought-after diverted medication. 
Although it is not usual to dose this medication to half a tablet, it 
raises a red flag with this particular drug that the instructions were 
to dispense 30, which is the entire tablet. The pharmacist should 
address why the patient is prescribed 2 mg in order to take half a 
tablet of a highly sought-after medication, when Xanax 1 mg is 
available. Tr. 643-44. Dr. Schossow has never seen Xanax directions 
like this. This prescription represents a red flag with respect to the 
nature of the dispensing order of the controlled substance. Tr. 644-45. 
The additional prescriptions issued to the patient demonstrated these 
red flags, including red flags for clinical abuse use under Florida 
Regulation 810,\25\ inappropriate clinical and therapeutic dosing, and 
extended release opioids combined with immediate release opioids. Tr. 
645-47, 648-66, 666-73; GX 14 at 8-13, 14-19; GX 31 at 1-6, 7-12, 13-
18, 22-25, 27-28, 29-30, 32-33, 34-35, 37-38, 40-41, 42-47, 48-51, 52-
55, 56-59, 60-63, 64-69, 70-75; GX 40 at 8-11, 12-13, 14-15, 16-19, 20-
23, 24-29, 30-31.
---------------------------------------------------------------------------

    \25\ Florida Administrative Rule 64B16-27.810.
---------------------------------------------------------------------------

    A Florida pharmacist operating within the standard of care should 
have acknowledged the therapeutic inappropriateness of the 
prescriptions, and should have contacted the patient or the provider 
and recorded the resolution of those red flags, if they were 
resolvable. Tr. 673. Dr. Schossow believed all red flags herein were 
resolvable. Tr. 1038, 1068. Dr. Schossow did not see any indication on 
the prescriptions for Patient R.R. that any specific red flags were 
identified or documented or resolved on any of the prescriptions. There 
is nothing in the patient profile to suggest that an investigation was 
done or that the red flags were identified, resolved or documented in 
the patient profile. Tr. 673; GX 40 at 1. The critical comments listed 
did not address or show how the red flags or DURs were resolved. Tr. 
673-74. None of the documents in the dispensing log address the red 
flags for the prescriptions. Tr. 674; GX 40 at 2-7. Based on a review 
of the prescriptions, the patient profile, or any other documents for 
Patient R.R., Dr. Schossow opined that a reasonable pharmacist acting 
in the usual course of profession practice would not have filled the 
charged prescriptions without addressing, resolving, and documenting 
the red flags for this patient. Tr. 674.
Patient R.D.
    Dr. Schossow identified the patient profile prescriptions for 
Patient R.D. Tr. 675-76; GX 10. She noted that Ativan is a 
benzodiazepine. Tr. 676. The prescriptions indicate a red flag for 
cocktail medications. Tr. 676; GX 10 at 1-4. They also indicate a red 
flag for payment of cash for controlled substance prescriptions. They 
further indicate a red flag for the high amount of cash paid for 
controlled substances. Dr. Schossow explained that one of the 
medications is Hydromorphone 8 mg, which is the highest dosage of 
medication commercially available for this medication. Tr. 677. 
Although the prescribing physician said the medication was not only for 
anxiety, but also to manage hypertension, this medication does not 
treat anxiety or hypertension. This is very dangerous because there 
were no records that the pharmacist attempted to contact the physician 
to discuss the red flag. Tr. 677.
    There was an additional red flag present with Patient R.D. Tr. 678. 
The red flag involved long distances traveled by the patient. Tr. 678-
79; GX 10 at. 1-2. Dr. Schossow looked up the address of the doctor, 
the patient, and the pharmacy, which she characterized as an abnormally 
long distance. Additionally, there were other pharmacies that were very 
close. Dr. Schossow had concerns with the patient traveling longer than 
necessary to get to the Respondent pharmacy and then paying ``double 
the amount'' for the prescription. Tr. 679. A community pharmacist 
knows her community and the area around it, so this presents a safety 
issue. Tr. 682, 1032. Dr. Schossow would defer to a local community 
pharmacist's knowledge of the subject area. Tr. 1032. For example, 
central nervous system depressant drugs suppress the central nervous 
system and cause drowsiness, dizziness, and profound sedation, 
including a warning on operating heavy machinery. If a patient can 
drive across the street to obtain her medication versus driving 
further, it is safer for the patient. Tr. 950-53.
    Dr. Schossow did not suggest that distance is a reason not to fill 
a prescription, but it is a reason to ask more questions and clear up 
concerns. Tr. 682-83, 954-58. In this case, there was no such 
documentation. Dr. Schossow mapped all of the relevant cities and 
determined the route that the patient used. The patient lived very far 
west, had to cross over three bridges to get to the prescribing 
physician, and then crossed over another bridge to get

[[Page 72708]]

to the pharmacy. These prescriptions issued to Patient R.D. thus 
presented a red flag for distance. Tr. 684; GX 10 at 1-4.
    The additional prescriptions issued to the patient demonstrated the 
previously discussed red flags. Tr. 685-701; GX 10 at 5-8, 9-12; GX 26 
at 1-4, 5-8, 9-12, 13-16, 17-20, 21-23, 24-27, 28-31, 32-35, 36-39, 40-
43, 44-47, 48-51, 52-55, 56-59.
    A Florida pharmacist operating within the standard of care must 
make a reasonable effort to address each red flag for therapeutic 
appropriateness through either the patient and/or the physician, 
document if the red flag is resolved, and maintain those records. Tr. 
701. Looking at the patient profile and prescriptions, there is nothing 
to suggest that an investigation or assessment was done of any of the 
red flags identified by Dr. Schossow. Tr. 701-02; GX 10, 19, 26. In the 
patient profile, the comments in the critical comments popup box do not 
address the red flags identified by Dr. Schossow. Tr. 702; GX 19. Based 
on her review of the prescriptions and patient profile, Dr. Schossow 
opined that a reasonable pharmacist acting in the usual course of 
professional practice would not have filled the prescriptions for 
Patient R.D. without addressing, identifying, resolving, and 
documenting the red flags observed and charged by the Government. Tr. 
702.
Patient J.R.
    Dr. Schossow identified the patient profile prescriptions for 
Patient J.R. Tr. 702-03; GX 30. The prescriptions issued to the patient 
present a red flag for cocktail combinations or a trinity. Tr. 703; GX 
30, p. 47-54. The prescriptions contain two benzodiazepines, 
Carisoprodol or Soma, and an opioid, Hydrocodone. Tr. 703-04. The 
prescriptions also indicate another red flag that falls under 
Regulation 810 \26\ of the DUR for therapeutic duplication. Tr. 704; GX 
10 at 49-50, 53-54. Therapeutic duplication means two drugs that are in 
the same class, and thus act in the same way. With Patient J.R., there 
are two medications that are benzodiazepines and they are both long-
acting benzodiazepines. They are Temazepam and Diazepam. This 
represents a dangerous combination. The two medications duplicate 
effects and are therapeutically inappropriate because they can compound 
the side effects of each other. These side effects include CNS 
depression, leading to respiratory depression, pronounced sedation, 
overdose, and death. Tr. 704-05. Additional prescriptions to Patient 
J.R. also indicated these red flags. Tr. 705-07; GX 30 at 55-60, 61-68.
---------------------------------------------------------------------------

    \26\ Florida Administrative Rule 64B16-27.810.
---------------------------------------------------------------------------

    Patient J.R. was prescribed additional trinity cocktails. Tr. 708-
09; GX 39 at 3-4, 13-14, 31-34. The patient received an opioid, the 
muscle relaxer Carisoprodol, and two long-acting benzodiazepines. Tr. 
710. The prescriptions also indicated a red flag of therapeutic 
duplication of benzodiazepines. Tr. 710; GX 39 at 31-34. Additional 
prescriptions indicated these red flags. Tr. 710-16; GX 39 at 2, 7-10, 
11-12, 15-16, 35-38.
    A Florida pharmacist operating within the standard of care should 
have made a reasonable effort to contact the patient and/or the doctor 
and inquire about the therapeutic inappropriateness of the medication, 
the risk involved in taking the medications together, and if the 
therapeutic inappropriateness was resolvable, to document the 
resolution and maintain those records. Tr. 716-17. There is nothing in 
the patient profile or prescriptions that suggests that an 
investigation was done of any of the red flags or that the red flags 
were resolved. Tr. 717; GX 39 at 1. A reasonable pharmacist acting in 
the usual course of professional practice would not have filled the 
prescriptions for Patient J.R. without addressing, resolving, and 
documenting the red flags that have been charged by the Government. Tr. 
717.
Patient B.Di.
    Dr. Schossow identified the patient profile prescriptions for 
Patient B.Di. Tr. 718-19; GX 11. Prescriptions indicated a red flag for 
cash payment for controlled substance prescriptions. Tr. 719; GX 11 at 
1-6. There is also an indication of a red flag for the payment of an 
unusually large amount of cash for an opioid. Tr. 719; GX 11 at 2. The 
prescriptions taken together represent a red flag for cocktail 
medications with respect to opioids and benzodiazepines. Finally, the 
prescriptions for Dilaudid 8mg and MS Contin 30 mg, extended release, 
indicate a red flag for opioid dosing. Tr. 719-20; GX 11 at 1, 3. 
Additional prescriptions indicated the previously discussed red flags. 
Tr. 720-43; GX 11 at 7-12, 13-18, 19-24, 25-30, 31-36, 37-42, 43-48, 
49-54, 55-60; GX 27 at 1-6, 7-12, 13-18, 19-23, 24, 26-27, 29-30, 32-
35, 36-39, 41-42, 43-44, 46-49, 50-55, 56-61, 62-67, 68-73, 74-79, 80-
83, 86-93; GX 38, pp. 5-6, 7-10, 11-14, 15-16, 17-18, 19-20, 21-22.
    A Florida pharmacist operating within the standard of care should 
have addressed each red flag of concern, documented it appropriately in 
his patient record, and maintained those records. Tr. 743-44. There is 
nothing in the patient profile or in the prescriptions to suggest that 
any sort of investigation or resolution was made or attempted or 
documented with respect to the identified red flags. Nothing in the 
patient profile indicated that any of the prescriptions were reviewed. 
A reasonable pharmacist acting in the usual course of professional 
practice would not have filled the prescriptions for Patient B.Di. 
without first addressing, resolving, and documenting the specific red 
flags identified by Dr. Schossow. Tr. 744.
Patient B.Da.
    As to Patient B.D.a., prescriptions indicated a red flag for cash 
payment for controlled substance prescriptions. Tr. 745-46; GX 9 at 1-
6. There is also an indication of a red flag for the payment of an 
unusually large amount of cash for an opioid. Tr. 745; GX 9 at 4. The 
prescriptions taken together represent a red flag for cocktail 
medications with respect to opioids and benzodiazepines. Finally, the 
prescriptions demonstrate a red flag for long distance travel, with the 
patient traveling from Bokeelia, Florida. Tr. 745-46; GX 9 at 1-6. 
Additional prescriptions indicated a red flag for cash payment for 
controlled substance prescriptions. Tr. 746; GX 9 at 7-12. The 
prescriptions taken together represent a red flag for cocktail 
medications with respect to opioids and benzodiazepines. Finally, the 
prescriptions demonstrate a red flag for long distance travel. Tr. 747; 
GX 9 at 7-12.
    Additional prescriptions indicated a red flag for cash payment for 
controlled substance prescriptions. Tr. 747; GX 9 at 13-18. There is 
also an indication of a red flag for the payment of an unusually large 
amount of cash for an opioid. Tr. 747; GX 9 at 14. The prescriptions 
taken together represent a red flag for cocktail medications with 
respect to opioids and benzodiazepines. Finally, the prescriptions 
demonstrate a red flag for long distance travel, with the patient 
traveling from Bokeelia, Florida. Tr. 748; GX 9 at 13-18.
    Additional prescriptions indicated a red flag for cash payment for 
controlled substance prescriptions. Tr. 748; GX 9 at 19-24. There is 
also an indication of a red flag for the payment of an unusually large 
amount of cash for an opioid. Tr. 749; GX 9 at 20. The prescriptions 
taken together represent a red flag for cocktail medications with 
respect to opioids and benzodiazepines. Finally, the prescriptions 
demonstrate a red flag for long distance travel, with the patient 
traveling from Bokeelia, Florida. Tr. 749; GX 9 at 19-24.
    Additional prescriptions indicated a red flag for cash payment for 
controlled

[[Page 72709]]

substance prescriptions. Tr. 749; GX 9 at 25-30. There is also an 
indication of a red flag for the payment of an unusually large amount 
of cash for an opioid. Tr. 749; GX 9 at 30. The prescriptions taken 
together represent a red flag for cocktail medications with respect to 
opioids and benzodiazepines. Tr. 749; GX 9 at 25-30. Finally, the 
prescriptions demonstrate a red flag for long distance travel, with the 
patient traveling from Bokeelia, Florida. Tr. 748.
    Additional prescriptions indicated a red flag for cash payment for 
controlled substance prescriptions. Tr. 750; GX 25 at 1-3. The 
prescriptions taken together represent a red flag for cocktail 
medications with respect to opioids and benzodiazepines. Tr. 751; GX 25 
at 1-3. The prescriptions demonstrate a red flag for combining extended 
release and immediate release opioids. Tr. 751; GX 25 at 1-3. Finally, 
the prescriptions demonstrate a red flag for long distance travel, with 
the patient traveling from Bokeelia, Florida. Tr. 748.
    Additional prescriptions indicated a red flag for cash payment for 
controlled substance prescriptions. Tr. 752; GX 25 at. 7-12. The 
prescriptions taken together represent a red flag for cocktail 
medications with respect to opioids and benzodiazepines. Tr. 752; GX 25 
at 8. The prescriptions demonstrate a red flag for combining extended 
release and immediate release opioids. Tr. 752; GX 25 at 7-12. Finally, 
the prescriptions demonstrate a red flag for long distance travel, with 
the patient traveling from Bokeelia, Florida. Tr. 748.
    Additional prescriptions indicated a red flag for cash payment for 
controlled substance prescriptions. Tr. 752; GX 25 at 13-18. The 
prescriptions taken together represent a red flag for cocktail 
medications with respect to opioids and benzodiazepines. Tr. 752; GX 25 
at 13-18. The prescriptions demonstrate a red flag for combining 
extended release and immediate release opioids. Tr. 752; GX 25 at 13-
18. Finally, the prescriptions demonstrate a red flag for long distance 
travel, with the patient traveling from Bokeelia, Florida. Tr. 748.
    Additional prescriptions indicated a red flag for cash payment for 
controlled substance prescriptions. Tr. 752; GX 25 at 19-24. There is 
also an indication of a red flag for the payment of an unusually large 
amount of cash for an opioid. Tr. 752; GX 25 at 22. The prescriptions 
taken together represent a red flag for cocktail medications with 
respect to opioids and benzodiazepines. Tr. 752; GX 25 at 19-24. The 
prescriptions demonstrate a red flag for combining extended release and 
immediate release opioids. Tr. 753; GX 25 at 19-24. Finally, the 
prescriptions demonstrate a red flag for long distance travel, with the 
patient traveling from Bokeelia, Florida. Tr. 748.
    Additional prescriptions indicated a red flag for cash payment for 
controlled substance prescriptions. Tr. 753; GX 37 at 24-25, 28-31. 
There is also an indication of a red flag for the payment of an 
unusually large amount of cash for an opioid. Tr. 753; GX 37 at 29. The 
prescriptions taken together represent a red flag for cocktail 
medications with respect to opioids and benzodiazepines. Tr. 753; GX 37 
at 28-31. The prescriptions demonstrate a red flag for combining 
extended release and immediate release opioids. Tr. 754; GX 37 at 28-
31. Finally, the prescriptions demonstrate a red flag for long distance 
travel, with the patient traveling from Bokeelia, Florida. Tr. 748.
    Additional prescriptions indicated a red flag for cash payment for 
controlled substance prescriptions. Tr. 754; GX 37 at 18-19, 22-23, 26-
27. There is also an indication of a red flag for the payment of an 
unusually large amount of cash for an opioid. Tr. 754; GX 37 at 27. The 
prescriptions taken together represent a red flag for cocktail 
medications with respect to opioids and benzodiazepines. Tr. 754; GX 37 
at 28-31. The prescriptions demonstrate a red flag for combining 
extended release and immediate release opioids. Tr. 754; GX 37 at 28-
31. Finally, the prescriptions demonstrate a red flag for long distance 
travel, with the patient traveling from Bokeelia, Florida. Tr. 748.
    Additional prescriptions indicated a red flag for cash payment for 
controlled substance prescriptions. Tr. 755; GX 37 at 8-9, 16-17, 20-
21. The prescriptions taken together represent a red flag for cocktail 
medications with respect to opioids and benzodiazepines. Tr. 755; GX 37 
at 8-9, 16-17, 20-21. The prescriptions demonstrate a red flag for 
combining extended release and immediate release opioids. Tr. 755; GX 
37, pp. 8-9, 16-17, 20-21. Finally, the prescriptions demonstrate a red 
flag for long distance travel, with the patient traveling from 
Bokeelia, Florida. Tr. 748.
    Additional prescriptions indicated a red flag for cash payment for 
controlled substance prescriptions. Tr. 755; GX 37 at 10-15. There is 
also an indication of a red flag for the payment of an unusually large 
amount of cash for an opioid. Tr. 755; GX 37 at 11. The prescriptions 
taken together represent a red flag for cocktail medications with 
respect to opioids and benzodiazepines. Tr. 756; GX 37 at 10-15. The 
prescriptions demonstrate a red flag for combining extended release and 
immediate release opioids. Tr. 756; GX 37 at 10-15. Finally, the 
prescriptions demonstrate a red flag for long distance travel, with the 
patient traveling from Bokeelia, Florida. Tr. 748.
    Dr. Schossow opined that a pharmacist, acting within the relevant 
standard of care, when confronted with the red flags revealed within 
the subject records for Patient B.D.a., would have investigated the 
therapeutic appropriateness of the subject prescriptions by contacting 
the prescribing physician or patient, document if the red flags were 
resolvable, and to maintain that documentation. Tr. 756. Nothing in the 
patient profile, prescriptions nor medical records suggest any 
investigation to identify, resolve or document the subject red flags. 
Tr. 756-57; GX 37 at 1, 4-8.
Patient L.V.
    Dr. Schossow identified prescriptions revealing the red flag for 
cocktail medications with respect to opioids and benzodiazepines. Tr. 
791, 794, 796, 797, 798-807; GX 32 at 1-8, 9-16, 25-28, 37-42, 44-51, 
53-60, 61-68, 69-74, 75-80, 83-90, 91-98, 101-08, 109-114, 117-124. 
Additional prescriptions indicated a red flag for cash payment for 
controlled substance prescriptions. Tr. 794, 796-807; GX 32 at 9-16, 
23, 24, 25-28, 37-42, 44-51, 53-60, 61-68, 69-74, 75-80, 83-90, 91-98, 
101-108, 109-114, 117-124. Dr. Schossow noted a further red flag with 
some prescriptions paid for by cash, while others were paid for by 
insurance. Tr. 792-93, 794; GX 32 at 6, 8, 9-16. There is also an 
indication of a red flag for the payment of an unusually large amount 
of cash for an opioid. Tr. 793-807; GX 32 at 2, 10, 24, 26, 37, 47, 54, 
64, 70, 75, 84, 94, 102, 110, 120.
    Dr. Schossow opined that a pharmacist, acting within the relevant 
standard of care, when confronted with the red flags revealed within 
the subject records for Patient L.V., would not have filled the subject 
prescriptions without addressing, resolving and documenting the red 
flags discussed. Tr. 812-13. Nothing in the patient profile, 
prescriptions nor medical records suggest any investigation to 
identify, resolve or document the subject red flags. Tr. 808-09, 812-
13; GX 5 at 3; GX 6 at 5-6; GX 22.
Patient A.B.
    Dr. Schossow identified prescriptions demonstrating a red flag for 
combining extended release and immediate release opioids. Tr. 813-16, 
819-823, 825, 827-28, 830, 831, 832, 833-34, 835-41, 842-43, 845-48; GX 
8 at 1-4, 7-10, 13-16, 19-22; GX 24 at 1-4, 7-10, 13-16, 26-

[[Page 72710]]

29, 32-33, 37-38, 40-41, 44-47, 50-53, 56-59, 62-63, 68-71, 74-77, 80-
83, 86-89, 92-95; GX 36 at 17-20, 21-24, 27-30. Additional 
prescriptions indicated a red flag for cash payment for controlled 
substance prescriptions. Tr. 814, 820-21, 823, 827, 828, 830, 831-34, 
836-41, 843, 845-47, 848-49; GX 8 at 1-4, 7-10, 13-16; GX 24 at 1-4, 7-
10, 26-29, 32-33, 37-38, 40-41, 44-47, 50-53, 56-59, 62-63, 68-71, 74-
77, 80-83, 86-89, 92-95; GX 36 at 17-20, 21-24, 27-30. There is also an 
indication of a red flag for the payment of an unusually large amount 
of cash for an opioid. Tr. 816-17, 820, 821-23, 825-27, 828-29, 830-32, 
833-37, 839, 841, 842-44, 845-47, 848-49; GX 8 at 2, 8, 14, 20; GX 24 
at 10, 20, 27, 32-33, 38, 47, 51, 53, 59, 63, 71, 77, 83, 87, 95; GX 36 
at 20, 24, 30. Finally, the prescriptions demonstrate a red flag for 
long distance travel, with the patient traveling from Bokeelia, 
Florida. Tr. 748, 816-17, 820-21, 822, 824, 826, 827, 829-30, 832-37, 
838-40, 841-44, 847, 848-50; GX 8 at 2, 8; GX 24, p. 4, 7-10, 13-16, 
26-29, 33, 41, 44-47, 51, 53, 59, 63, 71, 77, 83, 87, 95; GX 36 at 17-
20, 21-24, 30.
    Nothing in the patient profile, prescriptions nor medical records 
suggest any investigation to identify, resolve or document the subject 
red flags. Tr. 844-45; GX 36 at 1-12. Dr. Schossow opined that a 
pharmacist, acting within the relevant standard of care, when 
confronted with the red flags revealed within the subject records for 
Patient A.B., would not have filled the subject prescriptions without 
addressing, resolving and documenting the red flags discussed. Tr. 850-
51.\27\
---------------------------------------------------------------------------

    \27\ 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 the 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.
---------------------------------------------------------------------------

Respondent's Case-in-Chief

    The Respondent presented its defense through the testimony of five 
witnesses: Dr. Daniel Buffington, L.V., J.R., Dr. N., and Dr. Ricard 
Fertil.

J.R.\28\
---------------------------------------------------------------------------

    \28\ The testimony of patients of the Respondent was relevant as 
relates to information they shared with the Respondent prior to the 
filling of prescriptions, the protocols employed by the Respondent 
in filling prescriptions, the reasons they traveled some distance to 
fill their prescriptions, and as relates to the Respondent's 
experience in filling prescriptions under 21 U.S.C. 823(f)(2). Any 
patient testimony relating to the efficacy of their physician's 
treatment and prescribing, whether their physician performed 
consistent with professional standards, and whether the Respondent's 
professional performance was consistent to professional standards 
will not be considered herein. See ALJ Exs. 11, 14.
---------------------------------------------------------------------------

    J.R. lives in Cape Coral, Florida and is a disabled Vietnam 
veteran. Tr. 1310. He has service-connected disabilities as a result of 
back problems, including four back surgeries, eye cancer, and suffers 
from post-traumatic stress disorder. Tr. 1310-1313. Dr. D. has been his 
pain management doctor for three or four years. Tr. 1313. J.R. began 
seeing Dr. D. at his practice in Fort Myers, but Dr. D.'s practice has 
since moved to Naples, Florida. Tr. 1314. Despite Dr. D.'s relocation, 
J.R. drives to Dr. D.'s new office. Tr. 1314-15. Dr. D. has prescribed 
J.R. Oxycodone, hydrocodone, and extended-release morphine sulfate. Tr. 
1315. J.R.'s primary care doctor, Dr. M., also prescribed J.R. 
diazepam, temazepam, and carisopridol, also known as Soma. Tr. 1316.
    J.R. was a customer with Gulf Med Pharmacy for about two or three 
years. Tr. 1317. J.R. provided the pharmacy a disk with his MRI from 
the VA. Tr. 1317. Prior to becoming a customer at Gulf Med, J.R. filled 
his prescriptions with Walgreens. Tr. 1318. Walgreens failed to provide 
him with a prescription after a surgery so he went to the closest 
pharmacy that could fill his prescription, Gulf Med. Tr. 1318. Gulf Med 
is even closer than Dr. D.'s office in Naples, Florida. Tr. 1319. Gulf 
Med always answered his questions to his satisfaction and provided him 
with written or printed materials like brochures or informational 
material for his opioid prescriptions. Tr. 1319. J.R. discussed 
information regarding his medical history, treatment, and prescriptions 
with Gulf Med staff that he had previously discussed with his doctors. 
Tr. 1320. He spoke with Mr. Fertil about medication he was taking and 
the ways he could wean himself off some medications and Mr. Fertil 
appeared very knowledgeable about this. Tr. 1321. J.R. did in fact 
taper off some of his medicines.

L.V.

    L.V. lives at 1103 Northeast 32nd Terrace in Cape Coral, Florida 
and serves as a billing manager for Charlotte Compassionate Care. Tr. 
1292. She suffers from anxiety, cervical disc degeneration, 
cervicalgia, lumbar or lumbrosacral disc degeneration, lumbago, partial 
tear of a rotator cuff, chronic pain syndrome, breast cancer and was 
diagnosed with COVID-19 in July 2020. Tr. 1293-94, 1298. She is a 
patient of Dr. N. in Fort Myers, Florida. Tr. 1194. Dr. N. prescribed 
certain medications to L.V. including 30 milligrams of oxycodone and 
extended-release MS Contin 60 milligram and L.V. had previously been 
prescribed alprazolam or Xanax. Tr. 1294.\29\ L.V. was previously a 
customer of Gulf Med, but could not recall how many years she was a 
customer there. Tr. 1301. She had gone to a different pharmacy, 
Myerlee, but changed to Gulf Med because there was a delay in Myerlee 
filling her prescriptions, which caused her a lot of pain for weeks at 
a time until the prescriptions were filled. Tr. 1301-02.
---------------------------------------------------------------------------

    \29\ At this point in the testimony the Respondent's counsel 
asked L.V. if she had ever discussed the risks associated with 
taking an opioid and a benzodiazepine together. Tr. 1294. The 
Government's counsel objected based on relevance and that the 
information was not provided in the Respondent's prehearing 
statement. Tr. 1295. The Tribunal sustained the objection of 
relevance, see Tr. 1295, and after reviewing the Respondent's first 
Supplemental Prehearing Statement, overruled the Government's second 
objection about the testimony being unnoticed. Tr. 1298. The 
Respondent's counsel next asked if L.V. takes her medications as 
prescribed, the Government's counsel objected, and the Tribunal 
sustained the objection based on relevance. Tr. 1298-99.
---------------------------------------------------------------------------

    L.V. had tried using other pharmacies. Tr. 1302-03. Walgreens told 
her to never come back to the pharmacy after putting her name in the 
computer and Publix told her that it could not run the prescriptions 
through her insurance and it would not fill her prescriptions. Tr. 
1303. She then went to Gulf Med, where her prescriptions were filled in 
a timely fashion at a reasonable price. Tr. 1303. She selected Gulf Med 
over other pharmacies because it always had her medications at cheaper 
prices. Tr. 1305. Gulf Med also provided her with informational 
materials/brochures regarding the prescriptions it was dispensing to 
her, which included a CDC pamphlet about prescription opioids. Tr. 
1306. Based on discussions with her physician, Dr. N., she learned that 
Dr. N. had been in contact with Gulf Med regarding her prescriptions. 
Tr. 1307.

[[Page 72711]]

Dr. N.\30\
---------------------------------------------------------------------------

    \30\ Dr. N. is a treating physician of one of the charged 
patients. His relevant testimony is limited to his interactions with 
the Respondent prior to the filling of the subject prescriptions and 
as relates to the Respondent's experience in dispensing controlled 
substances. 21 U.S.C. 823(f)(2); ALJ Ex. 11.
---------------------------------------------------------------------------

    Dr. N. has been a licensed physician since 1979 and is licensed in 
New York, New Jersey, Massachusetts, Connecticut, and Florida. Tr. 
1324-25. He completed his residency at Mount Sinai in New York and 
currently practices in Fort Myers, Florida with a specialty in pain 
management and anesthesiology. Tr. 1325.
    Dr. N. is aware of what an FDA black box warning is.\31\ Dr. N. 
treated a patient by the name of L.V., but could not recall how long he 
treated her or what medications he prescribed her. Tr. 1327. It has 
been in Dr. N.'s practice in the past to include an ICD-10 diagnosis 
code on prescriptions he writes for his patients, which is a diagnosis 
that Dr. N. gave for the patient. Tr. 1327-28.\32\
---------------------------------------------------------------------------

    \31\ At this point in the testimony, the Respondent's counsel 
asked Dr. N. about the black box warning pertaining to the 
prescribing of a combination of drug therapies and whether Dr. N. 
prescribed certain medications. Tr. 1325-26. The Government's 
counsel objected to both questions and the Tribunal sustained both 
objections noting that the relevance of Dr. N.'s testimony was 
limited to his interaction with the pharmacy. Tr. 1326.
    \32\ After reviewing the Government's Exhibit 15, Page 1, Dr. N. 
noted that the prescription in the exhibit was for 30 milligrams of 
oxycodone and instructed the patient to take the medication up to 
four times per day only when necessary to alleviate breakthrough 
pain. Tr. 1330-31; GX 15 at 1. Government's Exhibit 15 on Page 3 is 
for MS Contin, 60 milligrams. Tr. 1331; GX 15 at 3. Page 5 of 
Exhibit 15 depicts a prescription for Xanax. Tr. 1331; GX 15 at 5. 
MS Contin and oxycodone are opiate medications and Xanax is a 
benzodiazepine. Tr. 1331.
---------------------------------------------------------------------------

    Dr. N. could not recall whether pharmacies ever contacted him or 
his office to verify prescriptions or ask questions about some of the 
drug therapies he prescribed to his patient. Tr. 1332. Dr. N. is not 
familiar with Gulf Med Pharmacy and could not recall whether he or his 
staff communicated with Gulf Med Pharmacy or its staff about verifying 
prescriptions or drug therapies. Tr. 1333.

Dr. Daniel Buffington

    Dr. Daniel Buffington is a pharmacist practicing in Tampa, Florida. 
Tr. 1081, 1087. Dr. Buffington received his PharmD degree from Mercer 
University in Atlanta, Georgia and then completed a post-doctorate 
degree residency and fellowship in clinical pharmacology at Emory 
University. Tr. 1079. He has practiced as a pharmacist for over thirty 
years. Tr. 1078, 1087.
    Dr. Buffington has training in conducting drug diversion 
investigations and has worked with attorneys general, states attorneys' 
offices, the DEA, and local law enforcement. Tr. 1159. He helped these 
agencies identify how healthcare investigations are different from 
other investigations involving drug gangs or illicit drug sales. Tr. 
1159-60. Dr. Buffington is active with the National Association of 
Investigators and Drug Diversion Investigators, which is a 
multidisciplinary organization that aids healthcare professionals in 
understanding how to conduct and design investigations and look for 
healthcare fraud, drug divergence, and substance abuse. Tr. 1160.
    Dr. Buffington currently practices as a pharmacist in Tampa, 
Florida at a practice where patients are referred who are typically 
prescribed high-risk medications. Tr. 1080-85. Dr. Buffington also 
provides consulting services to pharmacists, medical practitioners, 
healthcare facilities and organizations, and law enforcement agencies. 
Tr. 1080, 1085, 1087, 1091. This includes consulting with practices in 
both Southeast and Southwest Florida. Tr. 1097. Dr. Buffington has 
served in several capacities as a pharmacist, including direct 
dispensing roles, administrative roles, and as a medication safety and 
review officer. Tr. 1088. Although it is unclear how many prescriptions 
Dr. Buffington has dispensed in the last year or five years, he has 
experience making determinations about whether or not a particular 
prescription should be filled for a controlled substance based on the 
legitimacy or medical reason for its prescription. Tr. 1088-89.
    Dr. Buffington also serves on the faculty at the University of 
South Florida's Colleges of Medicine and Pharmacy where he teaches 
toxicology, pharmacy law, and other healthcare administration and 
practice management aspects. Tr. 1076, 1096. He has served as a guest 
lecturer or taught pharmacy law at the University of Florida, Florida 
A&M, Nova, Southeastern, Palm Beach, Mercer University, Marshall 
University, and the University of Pittsburgh. Tr. 1097. Through 
teaching these courses, Dr. Buffington must review applicable Florida 
administrative code provisions and is therefore familiar with Florida 
Administrative Rules 4B16-27.800, 64B16-27.810, and 64B16-27.831. Tr. 
1098. Dr. Buffington is also familiar with the standard of care that 
applies to pharmacists in the State of Florida as the standard of care 
relates to these administrative code provisions, and corresponding 
statutes of the federal Controlled Substances Act. Tr. 1099.\33\
---------------------------------------------------------------------------

    \33\ Dr. Buffington testified that the Federal Controlled 
Substances Act does not have jurisdiction over the practice of 
pharmacy in Florida. Tr. 1099.
---------------------------------------------------------------------------

    Dr. Buffington reported he has testified as an expert witness on 
over 300 occasions in state, federal, and administrative proceedings. 
Tr. 1077-78, 1083, 1094. Dr. Buffington reported he has previously 
testified in DEA administrative hearings before a DEA Administrative 
Law Judge, but could not recall when or the names of any participants. 
Tr. 1230. He has appeared as an expert with respect to the Florida 
standard of care in a DEA administrative proceeding, but is unsure if 
his testimony was credited by the DEA administrator in a final opinion. 
Tr. 1230-31.\34\
---------------------------------------------------------------------------

    \34\ During cross-examination, the Government questioned Dr. 
Buffington regarding his CV. Tr. 1201-1209. Dr. Buffington stated 
that he was not admonished in a district court case in Ohio and his 
testimony was not stricken for failing to include his legal 
experience as part of his CV. Tr. 1208. Instead, Dr. Buffington 
asserts that there was an issue with an Ohio court where the 
opposing counsel claimed that Dr. Buffington's CV did not follow 
Federal Rule 26 formatting and opposing counsel petitioned the court 
for more detail. This updated information for Dr. Buffington's CV 
was not provided by the deadline and therefore the testimony was 
withheld and not permitted. Tr. 1209. Unlike the Government 
counsel's assertion that the district court had found that this was 
the third time Dr. Buffington failed to disclose legal testimony, 
see Tr. 1210, 13-14, Dr. Buffington asserts that instead there was 
simply a formatting issue and the court requested for him to include 
more detail in another case with the same parties, and that the 
corrected report was done but was missing a case. Tr. 1214.
---------------------------------------------------------------------------

    In approximately February 2020, Dr. Buffington was contacted by a 
firm representing Gulf Med Pharmacy and reviewed documents in the 
instant case including copies of prescriptions, dispensing logs, and 
PDMP data that was produced by the DEA as well as all exhibits offered 
by both parties in this case. Tr. 1076-77. This included the Order to 
Show Cause, the Government's Prehearing Statements, and other documents 
such as CDC guidelines, statutes, administrative rules, and stakeholder 
challenges. Tr. 1198-99. He also reviewed different statutes and 
regulations, including Florida statute 766.102, which includes 
pharmacists in the definition of a ``healthcare practitioner.'' Tr. 
1233-34. Dr. Buffington also wrote the summaries of his testimony in 
concert with counsel. Tr. 1198. He spent approximately ten to fifteen 
hours preparing for this hearing. Tr. 1201.
    Dr. Buffington testified that the standard of care in Florida does 
not require a pharmacist to document in writing any specific resolution 
of ``red

[[Page 72712]]

flags'' \35\ and in fact, he testified that the term ``red flags'' is 
not mentioned in the Florida regulatory documents or the DEA guidance 
documents, but rather is a DEA slang term.\36\ Tr. 1100, 1124, 1145. 
Dr. Buffington testified that Florida Code 64B16-27.810 merely states 
what exercise a pharmacist is supposed to perform professionally in the 
process of evaluating the prescription, not what is required 
documentation. Tr. 1100. Dr. Buffington stated that the standard of 
care for a pharmacist in Florida is based on the level of care that a 
reasonable pharmacist would use in like circumstances and reasonable 
pharmacists could disagree about what the requirements are for 
documentation of prescriptions in the state of Florida. Tr. 1101, 1249.
---------------------------------------------------------------------------

    \35\ [Omitted for brevity.]
    \36\ Dr. Buffington noted that these items should be referred to 
as ``yellow flags'' or ``yellow lights'' as opposed to ``red flags'' 
because these are things that should be factored and considered. Tr. 
1124.
---------------------------------------------------------------------------

    Dr. Buffington testified that Florida's guidelines are clear that a 
pharmacist must exercise his or her professional judgment in evaluating 
each prescription and such judgment should have the patient's safety 
and therapeutic outcomes in mind. Tr. 1101-02, 1135.\37\ He testified 
that, based on a review of all the prescriptions identified in the 
Government's exhibits that were admitted into evidence, as well as 
Respondent's exhibits, the pharmacists at Gulf Med Pharmacy complied 
with the applicable standard of care as it relates to documentation of 
the resolution of red flags and the DEA provided no substantive 
evidence to presume otherwise. Tr. 1109, 1112. Furthermore, Dr. 
Buffington testified that Florida Administrative Rule 64B-27.810 
provides categories of elements that pharmacists would consider in 
their determination of both legally validated and clinically validated 
prescriptions based on the record they had while performing 
prescription fulfillment and dispensing, and the code does not state 
that a written report is required. Tr. 1110.
---------------------------------------------------------------------------

    \37\ Dr. Buffington's analysis was a direct contradiction to Dr. 
Schossow's testimony regarding her analysis of the guidelines for a 
pharmacist in Florida.
---------------------------------------------------------------------------

    Dr. Buffington testified that Rule 64B16-27.800 specifically 
requires that the pharmacist provide the full name, address, phone 
number, age, date of birth, gender, and the refill details as well as 
any related information provided by the healthcare professional. Tr. 
1111. Furthermore, he testified that it is in the pharmacist's 
professional judgment as to what is relevant to address and/or record 
because there is no specific Florida pharmacy law that clearly states 
what steps are required for each patient. Tr. 1111.
    Dr. Buffington reviewed Florida Administrative Rule 64B16-27.831 as 
it relates to validating a prescription in the retail setting. Tr. 
1112. He testified that the administrative code requires that there 
must be a valid or eligible prescription to move forward and that if 
the pharmacist has specific concerns (that does not necessarily mean a 
red flag), then the pharmacist could resolve any issues by speaking to 
the prescriber or the patient or taking consultation with the 
prescription drug monitoring program. Tr. 1112-13, 1122. Furthermore, 
he testified that if a pharmacist learns that a physician is writing a 
prescription for non-legitimate purpose or ill-intent by the patients, 
then the pharmacist has a duty to report this to the Florida Department 
of Public Health. Tr. 1113.
    Dr. Buffington testified that there are pharmacy software programs 
that identify potential issues through an alert system. Tr. 1113-14. He 
testified that an alert is not inherently a stop and is a pop-up 
message that prompts the pharmacist to consider something at the time, 
but the pharmacist may accept or move past the prompt. Tr. 1114. He 
testified that when a pharmacist ``clicks through'' the pop-up prompt, 
the software program records this through a ``click tracking'' program. 
Tr. 1114, 1115. He testified that this click tracking is a key way to 
track individual activity. Tr. 1114. He testified that when a person 
has a prescription for both a benzodiazepine and opiate, an alert does 
not require a stop because these prescriptions are routinely prescribed 
together. Tr. 1115-16. He testified that it routinely happens that 
different prescribers prescribe medications that interact and although 
a pharmacist with concerns should have an assessment with a patient and 
a provider, there is no requirement set forth in the Florida 
administrative code that requires such concerns be put in writing. Tr. 
1118.
    Dr. Buffington testified that as to the specific software program 
used by Gulf Med, PioneerRx, there are certain boxes that must be 
clicked, called pathways, in order to fill a prescription. Tr. 1239. He 
testified that the PioneerRx system allows someone to run a specific 
report to see how long a pharmacist spent on a particular pathway 
click. Tr. 1240. Although Dr. Buffington does not recall seeing a 
report being run, he thinks he saw a ``time change.'' He testified that 
whether a pharmacist spent ten minutes or five seconds on a particular 
box looking at a pathway, however, is irrelevant to the instant case 
given that there is not a single requirement for documentation 
formatting and the documentation may not have transpired during that 
pathway.
    Dr. Buffington testified that opiates and benzodiazepines, or Class 
II drugs in general, are routinely prescribed together and although 
such a combination is not always justified, there is no default 
presumption that the two drugs cannot be prescribed together. Tr. 1115-
16, 1241. Furthermore, he testified that even if two sets of Class II 
prescriptions are prescribed, this would not be a hard stop. Tr. 1116. 
[Omitted. See infra n.*L.]
    Dr. Buffington testified that if a pharmacist receives a 
prescription for an opiate, benzodiazepine, and a muscle relaxant, 
there must be an analysis of clinical oversight. Tr. 1118-19. In 
particular, he testified that the first analysis would be to evaluate 
for duplicity and whether other muscle relaxants have been prescribed 
and whether such an addition should be communicated with the prescriber 
or assessed with the patient based on the pharmacist's professional 
judgment. Tr. 1119-20.
    Furthermore, Dr. Buffington testified that even a black box warning 
does not serve as a stop if the pharmacist consults with the patient 
and the E-FORSCE data demonstrates that a patient has been on a certain 
treatment regimen for a significant period of time. Tr. 1118. He 
testified that if a muscle relaxant is prescribed with an opiate and 
benzodiazepine, the analysis as a clinician changes and a pharmacist 
would then need to make a professional judgment. Tr. 1119-20. Dr. 
Buffington testified that pursuant to Section 1306.04 of the Controlled 
Substances Act,\38\ the physician has certain responsibilities and 
makes decisions based on the needs of the patient and selecting a 
medication by name, product formulation, and dose. Tr. 1120. [Omitted 
discussion of confusing testimony purporting to interpret federal and 
state law.] *\D\
---------------------------------------------------------------------------

    \38\ 21 CFR 1306.04.
    *\D\ Dr. Buffington's testimony addressed the level of intent 
required for a violation of 21 CFR 1306.06, which is outside of his 
expertise as a pharmacy expert.
---------------------------------------------------------------------------

    Dr. Buffington testified that although the combination of three 
controlled substances--colloquially known as the ``holy trinity'' or 
``trinity'' \39\--heightens a risk to a patient, there is the same risk 
when combining many types of

[[Page 72713]]

medications including over-the-counter medications. Tr. 1243. He 
testified that the circumstance of prescribing this combination of 
prescriptions alone would not automatically raise a reasonable 
suspicion. Tr. 1265-68. Therefore, he testified that there is need and 
merit to evaluate and counsel the patient, but it is not necessarily 
inappropriate to prescribe three controlled substance together as it is 
commonplace for physicians to prescribe this combination. Tr. 1243-44. 
Dr. Buffington testified that it is a clinical question as to whether 
there is inappropriate use as opposed to a law enforcement question. 
Tr. 1253-54. Furthermore, he testified that although these three 
combined substances can also produce a high by illicit drug use, 
alcohol use and other base medications can have the same effect and 
this is irrelevant to the case. Tr. 1255. Furthermore, he testified 
that the practice of prescribing these three drugs together is 
declining based on the research that Carisoprodol is of less utility. 
Tr. 1255. Dr. Buffington testified that even if ``red flags'' are an 
inference to things that a pharmacist should look at and evaluate, 
these are not something that should be counted and a person is in 
trouble if his count hits a threshold. Tr. 1254. In Dr. Buffington's 
view, this would be a disingenuous attempt at an investigation.\40\
---------------------------------------------------------------------------

    \39\ According to Dr. Buffington, the slang term, ``trinity,'' 
refers to an opiate, a benzodiazepine, and Carisoprodol being 
prescribed to one patient at the same time. Tr. 1255.
    \40\ At this point in the testimony the Tribunal directed Dr. 
Buffington not to give his opinion about whether the investigation 
was appropriate as he had not been qualified to give that opinion. 
Tr. 1254. The Tribunal reiterated that this not a criminal matter, 
but rather an administrative proceeding, and directed Dr. Buffington 
to focus on his expertise as it relates to pharmacy practice and to 
pharmacy law. Tr. 1254-55.
---------------------------------------------------------------------------

    Dr. Buffington compared the Florida Administrative Codes to the 
federal regulations and the Controlled Substances Act, noting that the 
statute is very clear that the responsibility of the prescriber or the 
dispenser is to knowingly demonstrate that a prescription was written 
or dispensed for an appropriate purpose whereas the Florida law speaks 
to the duty of the pharmacist and the requirement to report. Tr. 1120. 
Furthermore, he testified that ``combination therapy'' or ``multidrug 
regimen'' \41\ are routine and the Respondent in this case had not 
failed in its responsibility nor was there evidence that the Respondent 
breached its standard of pharmacy practice with regards to such 
medications. Tr. 1121-22.
---------------------------------------------------------------------------

    \41\ Respondent's counsel referred to ``cocktail medications'' 
when questioning Dr. Buffington, however, Dr. Buffington asserted 
that this was a ``colloquial'' or ``slang'' term, and the proper 
terminology was ``combination therapy'' or ``multidrug regimen''. 
Tr. 1121, 1122.
---------------------------------------------------------------------------

    Dr. Buffington testified that the quantity of the dosage of a 
product formulation should not itself be a ``red flag'' because 
pharmacists will instruct patients to take multiples of whatever that 
formulation is at the time of dosing which makes product formulation an 
irrelevant basis of a ``red flag.'' \42\ Tr. 1124-25. He testified that 
even lower dosages carry the possibility of adverse side effects. Tr. 
1125. He testified that it is not a deviation from a Florida 
pharmacist's standard of care or corresponding responsibility to fill a 
prescription that includes a long-acting or extended release opiate 
(some of which are twelve or twenty-four hours) along with an immediate 
release for breakthrough pain. Tr. 1129-30.\43\
---------------------------------------------------------------------------

    \42\ Dr. Buffington specifically disagreed with Dr. Schossow's 
opinion that there should be an inference of an alert or caution if 
a medication is prescribed at a magnitude or dose in relation to 
product formulation that the manufacturer produces. Tr. 1123. In 
fact, Dr. Buffington described such an inference as ``preposterous'' 
and stated that it is a complete misrepresentation to make such an 
inference. However, when later prompted by the Tribunal regarding 
his critique of Dr. Schossow, Dr. Buffington declined, stating that 
he did not come to testify about Dr. Schossow's findings, but rather 
to testify about his own findings in the case. Tr. 1248.
    \43\ Dr. Buffington testified that the long-acting release are 
also supposed to provide baseline relief, not 100%. Tr. 1129. Dr. 
Buffington also described that aggravated pain could occur, which 
can be triggered by things such as a patient's lifestyle and can 
vary from patient to patient and even with one patient. Tr. 1129-30, 
1248.
---------------------------------------------------------------------------

    Dr. Buffington testified that there were no breaches of the 
pharmacist's responsibilities or that the pharmacist had breached a 
duty. Tr. 1131-32.\44\ Specifically, he testified that there was no 
evidence presented in this case that a pharmacist in the State of 
Florida at Gulf Med Pharmacy was knowingly aware. Tr. 1134. He 
testified that Gulf Med also did not ``turn a blind eye'' or ``bur[y] 
[its] head in the sand'' when Gulf Med pharmacists were presented with 
issues due to red flags because the Florida pharmacy statutes, and 
administrative rules require a pharmacist use professional judgment and 
there is no requirement that this needs to be documented. Tr. 1135.
---------------------------------------------------------------------------

    \44\ Respondent had posed a question asking whether there was 
any evidence that the Respondent pharmacist deviated or violated the 
Florida standard of care for a pharmacist as to over- or 
underutilization, therapeutic duplication, drug disease 
contraindications, drug-drug interactions, incorrect drug dosage or 
duration of drug treatment, drug allergy interactions, or clinical 
abuse or misuse. Tr. 1132
---------------------------------------------------------------------------

    Dr. Buffington testified that there is no restriction on the 
distance a patient may travel to a pharmacy and there are in fact now 
mail order pharmacists. Tr. 1136. Furthermore, he testified that a 
patient travelling a distance of thirty miles is not a reason to cause 
a pharmacist pause because many people like to stay engaged with a 
particular practitioner or the pharmacy is near their work or 
doctor.\45\ Tr. 1138-39. Furthermore, he testified that the Florida 
Administrative Code does not require a pharmacist to identify or 
document the distance a patient travelled to their doctor or the 
pharmacy. Tr. 1141.
---------------------------------------------------------------------------

    \45\ Dr. Buffington testified that it is ``particularly 
offensive to infer the opposite.'' Tr. 1139.
---------------------------------------------------------------------------

    As to payment, Dr. Buffington testified that there is nothing that 
prohibits a patient from paying in cash and even when a patient pays in 
cash, this is reported through PDMP and E-FORCSE. Tr. 1144-45. He 
testified that there is no circumventing the system when a patient pays 
in cash. Tr. 1145. He testified that E-FORCSE data includes the name of 
the prescriber, the prescriber's address, the name of the patient, the 
patient's address, the price that was paid, the date the prescription 
was issued, and the date it was filled, and the manner of payment. Tr. 
1145, 1274. He testified that a pharmacist must evaluate many other 
data elements including a patient's response to medications and medical 
history. Tr. 1145. Furthermore, he testified that a patient may pay 
with cash because there is a better pathway for their out-of-pockets 
costs, including a discount plan. Tr. 1146. He testified that even 
paying for an opioid prescription with cash would not change this 
analysis. Tr. 1151-52.
    Dr. Buffington testified that there are also many variables 
pharmacists consider when choosing how much to charge a patient.\46\ 
Tr. 1147. In Dr. Buffington's view, a pharmacy is like any other 
business and requires sufficient practice revenue and pricing tables 
evolve. Tr. 1148. He testified that cash price is usually higher 
because there is counter-contract similar to Medicaid or Medical 
programs that will contract at a reduced price.
---------------------------------------------------------------------------

    \46\ At one point Dr. Buffington stated that payment options 
were unique to each pharmacy; however, he later went on to state 
that he ``amend[ed] the comment,'' and in fact the pricing was 
``almost universal.'' Tr. 1147.
---------------------------------------------------------------------------

    Dr. Buffington testified that pharmacies must also take into 
consideration their overhead costs including rent, payroll, taxes, and 
utilities. Tr. 1149. Furthermore, he testified that whether Gulf Med 
has a debt or rent against the building is a nonissue because nothing 
regulates what a physician charges for a medical service, a surgery, a 
hospital admission,

[[Page 72714]]

or what a pharmacy charges for a particular dispensed medication. Tr. 
1151. Dr. Buffington testified that after reviewing the acquisition 
price and sales price on the pill stickers, there was no apparent 
evidence of inappropriate practice based on the fee structure for the 
cash paying patients. Tr. 1152.
    Dr. Buffington testified that the analysis would not change if a 
person paid in cash, had a combination of drugs, and drove 30 to 50 
miles. Tr. 1153. He testified that once a pharmacist finds the 
prescription to be fillable the first time based on certain factors, 
each time after that, there is no longer a red flag.\47\ Dr. Buffington 
testified that pharmacists use their professional judgment in deciding 
whether to fill it, while complying with Florida Rule 64B17-831. Tr. 
1155.
---------------------------------------------------------------------------

    \47\ Furthermore, Dr. Buffington noted that there is no evidence 
in the record providing how often a pharmacist at Gulf Med did not 
fill a particular prescription. Tr. 1154.
---------------------------------------------------------------------------

    Based on his education, training, and experience, Dr. Buffington 
reviewed the information in this case and did not see any evidence that 
would support the inferences made by the Government. He testified that 
no formal metrics were used and he felt that DEA ``attempt[ed] to 
manifest or fabricate information from pharmacy records that are 
incomplete or descriptive of things that they're trying to infer.'' Tr. 
1161. Dr. Buffington did not see any red flags, noted that there was 
other attainable information, and that all the prescriptions charged by 
the Government and issued by the Respondent are within the standard of 
care and the scope of professional practice of Florida law as to 
Florida pharmacies. Tr. 1162, 1241, 1277-78. In particular, Dr. 
Buffington noted that there were additional fields in the PioneerRx 
database referred to as Medication Therapy Management and that there 
were multiple other tabs and therefore further additional information 
that the investigator can request and consider as a factor. Tr. 1163-
64.\48\ [However, as discussed in more detail below, Respondent was 
served with three subpoenas that required the production of all 
documents that contained any discussion or resolution of red flags. 
Thus, Dr. Buffington's testimony that there might have been additional 
materials resolving red flags is not entitled to any weight. Further, 
there is no evidence that Dr. Buffington reviewed any additional tabs 
and thus his testimony as to whether there could be information on such 
other tabs is entirely speculative.] As to the legality, Dr. Buffington 
testified that there is a three-step process: (1) Presuming legality of 
a prescription absent evidence to the contrary, (2) the pharmacist 
validates that the order is valid based on data points and data 
elements, and (3) doing a Prospective Drug Review. Tr. 1278.
---------------------------------------------------------------------------

    \48\ Dr. Buffington analogized his review of the record to that 
of a puzzle and the missing tabs equated to missing pieces of the 
puzzle. Tr. 1163-64.
---------------------------------------------------------------------------

    Dr. Buffington has also worked with the Florida Department of 
Health and Board of Pharmacy in developing regulations relating to 
pharmacy practice. Tr. 1164. At one point, Dr. Buffington served on the 
national association of the American Pharmacists Board of Trustees, 
where he had a dialogue with the DEA to express that healthcare 
professionals feel like they are part of the solution and although the 
term ``red flag'' has merit, flags are not metrics and are only things 
to consider. Tr. 1164-65. According to Dr. Buffington, despite pleas 
from healthcare professionals, no guidance material has been published 
for pharmacists since the 2010 Pharmacists Manual and in fact the term 
``red flags'' is not even in the manual. 1165-66.
    Dr. Buffington testified that there is no requirement that a 
pharmacist learn about DEA administrative decisions or be familiar with 
or read the Federal Register as the DEA does not have jurisdiction over 
pharmacy practice. Tr. 1168-69. Although Dr. Buffington testified that 
the DEA administrator's findings are binding upon DEA registrants, he 
believes that this does not include every pharmacist and such findings 
would relate to criminal issues rather than the scope of practice. Tr. 
1237. Furthermore, he testified that the DEA is law enforcement and has 
jurisdiction over criminality, not medical decision-making and 
pharmacologic decision-making over the use of medications. Tr. 1245.
    Dr. Buffington testified that the second aspect of the mandatory CE 
or assessment ``b'' is using the Prescription Drug Monitoring Database, 
which Dr. Buffington incorporates into his class. Tr. 1169. Dr. 
Buffington is familiar with the types of data that E-FORCSE maintains, 
serves as a consultant with the team that manages the E-FORCSE system 
in Florida, and covers the types of data that E-FORCSE includes in his 
continuing education course. Dr. Buffington testified that the third 
assessment, ``c'', is the assessment of prescriptions for therapeutic 
value, which requires the practitioners involved in dispensing the drug 
to use their professional judgment in assessing risk and reviewing a 
patient's historical response to a medication in deciding whether a 
drug should be dispensed. Tr. 1169-71, 1175. Dr. Buffington testified 
that unless there is a known drug allergy or an actual drug 
interaction, the pharmacist does not need to document his process in 
dispensing prescriptions. Tr. 1171. Furthermore, Dr. Buffington 
testified that a pharmacist does not always have the opportunity to 
speak directly with a patient because a caregiver or family member may 
bring the prescription, the prescription is called in and the patient 
is not present, or the prescription may be mailed to a patient. Tr. 
1172. Dr. Buffington testified that in these instances, and especially 
with the current pandemic, such events do not minimize the opportunity 
to call and have a direct dialogue with a patient and practitioners 
should touch point to discuss concerns instead of just refusing a 
prescription. Tr. 1173.
    Dr. Buffington testified that pharmacists must also learn how to 
detect whether a prescription is not based on a legitimate medical 
purpose, which can be done through communicating with a prescriber, 
evaluating and having a discussion with the patient, and putting down 
the patient's diagnosis \49\ in the records. Tr. 1178. Dr. Buffington 
also noted that even if a prescription is outside of the FDA-approved 
list, pharmacologically, using such a prescription is fine as long as 
the pharmacist has supporting clinical rationale. Tr. 1174-75. Dr. 
Buffington testified that Florida Administrative Rule 64B16-27.831 is 
the law and rule related to prescribing and dispensing of controlled 
substances, which does not require that pharmacists be educated on DEA 
administrative decisions, because this would be based on criminal 
issues and not on something in terms of delivery of healthcare 
services, which is dictated on the a state level. Tr. 1176-77.\50\
---------------------------------------------------------------------------

    \49\ Dr. Buffington noted that in his review of the universe of 
prescriptions for this case, although it is not required, some of 
the prescribers routinely include diagnostic codes on the 
prescriptions. Tr. 1175-76.
    \50\ See Gonzalez v. Oregon, 546 U.S. 243, 270-72 (2006), for 
context.
---------------------------------------------------------------------------

    Dr. Buffington testified that the next section is proper patient 
storage and disposal of controlled substances which discusses how a 
patient is supposed to store and dispose of controlled substances and 
requires healthcare professionals to record the receipts, the transfer, 
and the destruction of controlled substances. Tr. 1177. Dr. Buffington 
testified that the next section of Florida Administrative Rule 64B16-
27.831 relates to protocols for addressing and resolving problems

[[Page 72715]]

recognized during the drug utilization review, including but not 
limited to, drug-drug interactions, side effects, high-dose and low-
dose guidelines, which is new to the CE as of June 2018. Tr. 1177-78. 
Dr. Buffington testified that the mere presence of a dosage range is 
not a rate limiter for dispensing a prescription, but rather a 
pharmacist must use his professional judgment. Tr. 1178. Dr. Buffington 
does not advise pharmacies to document any resolution of these DUR-
related issues because there is no requirement to do so and each 
pharmacy has a process within their own facility to convey from peer to 
peer. Tr. 1178-79.
    Dr. Buffington testified that the protocol for addressing and 
resolving issues relating to drug utilization review are limited to 
drug-drug interactions, side effects, and high-dose and low-dose 
guidelines. Tr. 1179. He testified that such issues must rise to the 
level of needing resolution in a pharmacist's professional judgment, 
not that something just occurred. Dr. Buffington testified that Section 
H requires pharmacists to be educated on the availability of NARCAN or 
naloxone for overdose treatment. He testified that Section I relates to 
pharmacists initiating counseling with patients who have opioid 
prescriptions, which makes it imperative for there to be an open 
dialogue between the pharmacist and patient. He testified that Section 
J relates to available treatment resources for opioid physical 
dependence, addiction, misuse, or abuse. Tr. 1181. Dr. Buffington 
testified that Respondent pharmacists at Gulf Med were not providing 
copies of the CDC pamphlet to patients receiving opioid prescriptions, 
but there is no legislative mandate that the pharmacists give that 
particular document to patients. Tr. 1181-82. Dr. Buffington testified 
that there was a legislative change in 2019 that requires pharmacists 
to develop and/or produce or distribute a patient education pamphlet so 
the CDC's pamphlet would be an acceptable tool to satisfy that 
requirement. Tr. 1182.
    Dr. Buffington testified that when a prescription is dispensed, a 
label is produced and given to the patient as an educational resource. 
Tr. 1182-83. He testified that this labeling is in response to an OBRA-
90 mandate that serves as an additional trigger to see if a patient has 
any questions and leaves with information that improves their health 
outcomes and safety. Tr. 1185. He testified that the software also 
generates educational information about warning signs, side effects, 
drug interactions, and how to store and protect medication. At this 
point in the testimony, the Respondent's counsel discussed that there 
is a Critical Comments box in the lower right-hand corner on page 1 of 
Government's Exhibit 39 which includes a data field for pop-ups and 
went through several patients. Tr. 1185-1192; GX 39. Dr. Buffington 
testified that for patient J.R., among the critical comments listed for 
various dates, the signature or the directions for the use of the 
prescriptions were verified by the pharmacist with the prescriber. Tr. 
1184. Dr. Buffington testified that on May 15, 2019, patient J.R. was 
also given the CDC pamphlet. On August 5, 2019, the pharmacist 
requested clarification or verification of the prescription with the 
provider. Tr. 1184-85; GX 39 at 5. Dr. Greshler prescribed Oxycodone 
acetaminophen, a combination tablet, and the pharmacist wrote a note 
saying ``per M.D. patient prior dose was ineffective. Need to start 
oxy/acet 10/325'' and ``Spoke to Rochelle. Patient was told to increase 
his dose to 10 milligrams per M.D.'' with the ten milligrams referring 
to the first active ingredient, Oxycodone. Tr. 1186; GX 39 at 5. There 
is also a prescription from Dr. Mikovic for morphine extended release, 
fifteen milligram tablet with a note saying ``new regimen is added to 
help, current therapy is not sufficient.'' Tr. 1178-92; GX at 7. Dr. 
Buffington testified that there is only a minimal requirement for a 
pharmacist so such a note would be an acceptable note. Tr. 1187; GX at 
7. Dr. Buffington testified that continuity of care information is also 
available to pharmacies even in different pharmacies for particular 
patients. Tr. 1188.
    There was also a prescription from a physician, Gilberto Acosta, 
for an Oxycodone and acetaminophen combination for five milligrams of 
Oxycodone and 325 milligrams of acetaminophen with a note that said 
``doctor wants to add long-acting MS Contin with short Percocet 5.'' 
Tr. 1190. Based on the dispensing log, the patient also received 
diazepam, a benzodiazepine typically used for management of anxiety and 
muscle spasms as well as temazepam, another benzodiazepine, which is 
used as a sleep aid. Tr. 1191. Dr. Buffington testified that such a 
prescription is not uncommon, but would necessitate counseling of the 
patient to watch for over drowsiness in the morning from the temazepam 
and to limit the diazepam used during the day. Tr. 1191-92. Based on 
Dr. Buffington's review of the universe of prescriptions that were 
provided in this case, there were no prescriptions that caused him any 
concerns. Tr. 1192.
    Dr. Buffington testified that there is nothing unusual or 
inappropriate in a patient using insurance to pay for one prescription 
and not another because the patient may have an access issue, scope of 
benefit and coverage issue, difference in out-of-pocket cost at one 
pharmacy, and other reasons. Tr. 1193. Furthermore, Dr. Buffington 
believes that the prices that Gulf Med charged for prescriptions such 
as Oxycodone or Hydromorphone were not surprising or astonishing 
numbers and even if there was a high value there would be no regulatory 
problem because that is the patient's prerogative. Tr. 1194. 
Furthermore, there was nothing that Dr. Buffington reviewed that caused 
him any concern about whether or not Gulf Med and its pharmacists were 
exercising their corresponding responsibility or violating the 
applicable standard of care based upon any of the dosing instructions 
included in any of the prescriptions. Tr. 1193-94, 1995-96.
    Dr. Buffington disagreed with Dr. Schossow's testimony regarding 
driving under the influence of a benzodiazepine and an opiate as there 
was no way to determine whether or not the patient was the person who 
was driving and that there is no clinical expectation that combining 
these two drugs would in fact impair someone's ability to drive or 
impact their cognitive status. Tr. 1194-1195. Dr. Buffington testified 
that although it is possible, it would be disingenuous to infer that 
putting the two drugs together would be an incorrect behavior. Tr. 
1195, 1241. In fact, he testified that the FDA does not say in the 
black box warning that both drugs cannot be used together and it is not 
inappropriate to prescribe them together. Tr. 1195, 1243. Dr. 
Buffington testified that once a prescription is dispensed, the 
pharmacist cannot control if a person is going to independently abuse 
something. Tr. 1277.

Dr. Ricard Fertil

    Dr. Fertil is a licensed pharmacist in Florida. Tr. 1337. He 
attended FIU for undergraduate school. He attended and received his 
doctorate of pharmacy degree from Florida A&M in 2003. Tr. 1336-37. 
During his attendance at Florida A&M, he performed internships and 
externships at area hospitals including Jackson Hospital, Texas 
Hospital and Hollywood Memorial Hospital. Tr. 1337-38. He also trained 
at CVS and Publix pharmacies in Florida. Tr. 1338. All of his training 
and experience as a pharmacist has been in Florida. Tr. 1339.

[[Page 72716]]

    Following his licensing, he worked at CVS and Publix Pharmacies, 
retail chain pharmacies. Tr. 1339. Later, he worked at independent 
pharmacies in Southwest Florida for eight or nine years. Tr. 1339-40. 
While at independent pharmacies, he was involved in setting the prices 
for medications dispensed to customers. Tr. 1340. He was also involved 
in negotiating contracts with pharmacy benefits managers in setting 
rates of reimbursement. Tr. 1341.
    Dr. Fertil is the pharmacist in charge at Gulf Med Pharmacy. Gulf 
Med operates with a single pharmacist and a pharmacy technician. Tr. 
1370-71. He was involved with software venders, and in setting up the 
PioneerRx software for Gulf Med, including setting the pricing formulas 
within the software. Tr. 1341-42.
    Dr. Fertil described the layout of Gulf Med. Located within a 
building formerly housing a bank, Gulf Med has a drive-through window 
to service customers. It also has separate rooms for compounding 
medications, and a consultation room, where HIPAA-protected matters are 
discussed with the patient in private, and where the pharmacist 
exercises his professional judgement in determining whether to fill 
each separate prescription. Tr. 1334-35, 1367-68, 1397-98. Dr. Fertil 
is unfamiliar with the term, ``red flag.'' Tr. 1395. The pharmacist 
reviews the diagnosis and medical history with the customer. Distance 
traveled by the customer would only concern Dr. Fertil if they traveled 
from outside the County, although he was unaware of any law restricting 
the filling of a prescription on the basis of distance traveled. Tr. 
1406-07. Dr. Fertil did not view payment by cash as a suspicious 
circumstance, nor would it cause him to decline filling a prescription. 
Tr. 1408-10. If the customer is opiate na[iuml]ve, as determined by a 
review of the E-FORCSE, the pharmacy has a policy not to fill the 
prescription. Tr. 1346-47. The pharmacist determines if the 
prescription contains the statutorily required components. Tr. 1351-52. 
The PioneerRx software also prompts the pharmacist as to required 
components and alerts. Tr. 1352-56; RX 13-22. Review of the E-FORCSE 
database, which the pharmacist does for every controlled substance 
prescription presented, also reveals whether the customer is doctor-
shopping. Tr. 1347-50, 1357-58; RX 1-11. When directed to review three 
controlled substance prescriptions for B.D.a., Dr. Fertil confirmed 
none contained any notations that the E-FORCSE had been referenced. Tr. 
1418-21. Dr. Fertil explained that no documentation was necessary, and 
that his signature on the prescription was proof that he checked the E-
FORCSE. When asked if he ever noted PDMP on the prescriptions, he 
confirmed that sometimes he wrote PDMP to confirm that he checked the 
PDMP, but that sometimes he simply signed the prescriptions, also 
confirming that he checked the PDMP. Tr. 1419-20. Ultimately, Dr. 
Fertil explained that there was no set way that he confirmed on the 
prescription that he checked the PDMP. Sometimes he would note 
``verified E-FORCSE'', sometimes he put a check mark or initials. Tr. 
1423. The pharmacist will also consult with the prescribing physicians 
as needed. Tr. 1349-50.
    Dr. Fertil confirmed that he discussed with the charged patients, 
J.R. and L.V. their restrictions presented for their prescriptions for 
combinations of medications of opioids, benzodiazepine and a muscle 
relaxant, the risks of this combination, including the sedative effect. 
Tr. 1360-61. Further, the patients were questioned as to whether they 
were experiencing any of the noted side effects of the drug 
combinations, and were provided written warnings, including drug 
interactions, abuse and side effects, produced by the PioneerRx 
software system and stapled to their receipts. Tr. 1361-64. Dr. Fertil 
confirmed that he used his professional judgement in resolving some of 
the alerts of the PioneerRx software and in filling the subject 
prescriptions. Tr. 1362-63. Dr. Fertil explained that Gulf Med had a 
much smaller volume of prescriptions than the large chain pharmacies, 
permitting the pharmacist to spend more time and attention with 
patients than at the chain pharmacies. Tr. 1363.
    Dr. Fertil was present when the Administrative Inspection Warrant 
was served on Gulf Med., on February 14, 2018. Tr. 1364-65, 1372. He 
also received the Administrative Subpoena requiring ``patient profile'' 
information. Tr. 1365, 1372-73. Dr. Fertil cooperated and worked with 
the DEA computer technician to retrieve the information DEA required. 
Tr. 1365, 1369, 1373-74, 1379. The DEA technician also worked with a 
representative of PioneerRx to obtain the information required. Tr. 
1365. The DEA technician operated the PioneerRx software in obtaining 
the information sought, and printed the documents in question. Tr. 
1367, 1377. The documents printed by the DEA Technician included 
``screen shots'' of the first tab of the ``patient profiles.'' Tr. 
1425-29; GX 5, 19, 20, 21, 22, 35, 36, 37, 38, 39, 40. Whereas, RX 13-
22 represents an Excel spreadsheet reflecting information from all five 
tabs of the same document. Tr. 1428-29.
    When the DEA made further requests for patient profile information, 
Dr. Fertil produced the same type of information as they retrieved 
during their first request. Tr. 1365-66, 1381-95. Dr. Fertil could not 
remember whether he read the May, 2019 subpoena, which required the 
``patient profiles'' and patient medication records for the charged 
patients, so he could not confirm that the documents he provided in 
response to the subpoena were complete. Tr. 1388-89. Dr. Fertil had 
great difficulty recalling receiving the third subpoena in August, 
2019. Tr. 1391. He could not recall reviewing the subpoena to determine 
what documents were being requested or what documents were provided in 
response to the subpoena, despite attempts to refresh his memory. Tr. 
1390-95. Although Dr. Fertil could not remember what documents he 
provided in response to the second and third subpoenas, he was adamant 
the documents provided were the same type of documents the DEA seized 
during service of the first administrative subpoena. Tr. 1392-94.

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.
I. Background
    1. Respondent is registered with the DEA to handle controlled 
substances in Schedules II through V under DEA COR No. FG6290061 at 
4106 Del Prado Boulevard, South, Cape Coral, FL 33904. DEA COR No. 
FG6290061 will expire by

[[Page 72717]]

its own terms on September 30, 2022. GX 1
    2. DEA lists Ambien (zolpidem tartrate) as a Schedule IV controlled 
substance under 21 CFR 1308.14(c)(54).
    3. DEA lists Ativan (lorazepam) as a Schedule IV controlled 
substance under 21 CFR 1308.14(c)(30).
    4. DEA lists hydromorphone as a Schedule II controlled substance 
under 21 CFR 1308.12(b)(1)(vii).
    5. DEA lists methadone as a Schedule II controlled substance under 
21 CFR 1308.12(c)(15). DEA lists MS Contin (morphine sulfate extended 
release) as a Schedule II controlled substance under 21 CFR 
1308.12(b)(1)(ix).
    6. DEA lists Klonopin (clonazepam) as a Schedule IV controlled 
substance under 21 CFR 1308.14(c)(11).
    7. DEA lists Norco (hydrocodone-acetaminophen) as a Schedule II 
controlled substance under 21 CFR 1308.12(b)(1)(vi).
    8. DEA lists oxycodone as a Schedule II controlled substance under 
21 CFR 1308.12(b)(1)(xiii).
    9. DEA lists Percocet (oxycodone-acetaminophen) as a Schedule II 
controlled substance under 21 CFR 1308.12(b)(1)(xiii).
    10. DEA lists Restoril (temazepam) as a Schedule IV controlled 
substance under 21 CFR 1308.14(c)(50).
    11. DEA lists Soma (carisoprodol) as a Schedule IV controlled 
substance under 21 CFR 1308.14(c)(6).
    12. DEA lists Valium (diazepam) as a Schedule IV controlled 
substance under 21 CFR 1308.14(c)(16).
    13. DEA lists Xanax (alprazolam) as a Schedule IV controlled 
substance under 21 CFR 1308.14(c)(2).
II. DEA's Investigation Into Respondent
    14. On February 14, 2018, DEA investigators executed an 
administrative inspection warrant (``AIW'') on the Respondent, pursuant 
to which DEA seized the hardcopies of controlled substance 
prescriptions that Respondent had dispensed from its opening through 
the date the AIW was executed. GX 2; Tr. at 34-35. On the same date, 
the DEA also served an administrative subpoena on Respondent seeking, 
(a) copies of Respondent's patient profiles for certain listed 
individuals; (b) copies of ``[a]ny and all other records . . . 
maintained pursuant to the requirements of Florida Statutes and Florida 
Administrative Code 64B16-27.800 documenting the steps taken to avoid 
or resolve any issues with the prescriptions presented by'' those same 
listed individuals; and (c) copies of ``[a]ny other documentation kept 
by'' the Respondent ``in connection with the filling of prescriptions 
or providing medical treatment'' for those named individuals, including 
dispensing logs or reports, for those listed individuals. GX. 3; Tr. at 
45. Government Exhibits 2 and 3 are true and correct copies of the AIW 
and administrative subpoena, respectively, that DEA served on 
Respondent on February 14, 2018. Tr. at 35,41-42,64-65.
    15. Government Exhibit 5 contains true and correct copies of the 
patient profiles for Patients J.B., T.G., and L.V. produced by 
Respondent pursuant to the administrative subpoena served on February 
14, 2018. Tr. at 65-69. Government Exhibit 6 contains true and correct 
copies of the dispensing logs for Patients J.B., T.G., and L.V. 
produced by Respondent pursuant to the administrative subpoena served 
on February 14, 2018. Tr. at 69-71. Government Exhibits 7-15 contain 
true and correct copies of the prescriptions Respondent dispensed to 
Patients J.B., A.B., B.Da., R.D., B.Di., T.G., S.K., R.R., and L.V., 
respectively, that the DEA seized pursuant to the AIW served on 
February 14, 2018. Tr. at 76-103, 111-16. The DEA did not seize any 
other documents pertaining to Patients J.B., A.B., B.Da., R.D., B.Di., 
T.G., S.K., R.R., and L.V. pursuant to the AIW served on February 14, 
2018, beyond those reflected in Government Exhibits 5-15; nor did 
Respondent produce any other documents pertaining to those same 
patients pursuant to the administrative subpoena served on February 14, 
2018, beyond those reflected in Government Exhibits 5-15. Tr. at 117-
18.
    16. The DEA provided Respondent a receipt for the items that were 
seized by DEA during the execution of the AIW on February 14, 2018, or 
that were produced by the Respondent pursuant to the administrative 
subpoena served that same day. Government Exhibit 4 is a true and 
correct copy of the warrant return filed pursuant to the AIW served on 
February 14, 2018, and contains as an attachment a true and accurate 
copy of the receipt provided to the Respondent. Tr. at 52-59.
    17. In May 2019, DI served a second administrative subpoena on 
Respondent seeking, inter alia, (a) hardcopies of controlled substance 
prescriptions that Respondent had dispensed from February 15, 2018, 
through May 3, 2019; (b) copies of Respondent's patient profiles for 
certain listed individuals; and (c) copies of ``[a]ny and all records . 
. . maintained pursuant to the requirements of Florida Statutes and 
Florida Administrative Code 64B16-27.800 for Patient Records, 
documenting the steps taken to avoid or resolve any issues with the 
prescriptions presented by'' those same listed individuals ``reflecting 
efforts by the pharmacist to exercise their corresponding 
responsibility to assess the validity'' of controlled substance 
prescriptions dispensed to those listed individuals. Gov't Ex. 16; Tr. 
at 119. Government Exhibit 16 is a true and correct copy of the 
administrative subpoena that DEA served on Respondent in May 2019. Tr. 
at 120-21.
    18. DI has conducted approximately twelve (12) investigations while 
employed by DEA. Tr. 27-28.
    19. With its production of documents in response to the May 2019 
administrative subpoena, the Respondent also produced a signed 
certificate of authenticity of domestic business records. Tr. at 123-
24. Government Exhibit 18 is a true and correct copy of the signed 
certificate of authenticity of domestic business records produced by 
the Respondent with its production of documents in response to the May 
2019 administrative subpoena. Tr. at 124.
    20. Government Exhibits 19-22 contain true and correct copies of 
the patient profiles for Patients R.D., T.G., S.K., and L.V., 
respectively, produced by Respondent pursuant to the administrative 
subpoena served in May 2019. Tr. at 129-38. Government Exhibits 23-32 
contain true and correct copies of the prescriptions Respondent 
dispensed to Patients J.B., A.B., B.Da., R.D., B.Di., T.G., S.K., J.R., 
R.R., and L.V., respectively, that the Respondent produced pursuant to 
the administrative subpoena served in May 2019. Tr. at 143-77. The 
Respondent did not produce any other documents pertaining to Patients 
J.B., A.B., B.Da., R.D., B.Di., T.G., S.K., J.R., R.R., or L.V., 
pursuant to the administrative subpoena served in May 2019 beyond those 
reflected in Government Exhibits 19-32. Tr. at 178.
    21. The DEA provided Respondent a receipt for the items that were 
produced by the Respondent pursuant to the administrative subpoena 
served in May 2019. Tr. at 126-27. Government Exhibit 17 is a true and 
correct copy of the receipt provided to the Respondent. Tr. at 127.
    22. In August 2019, DI served a third administrative subpoena on 
Respondent seeking, with respect to Patients J.B., A.B., B.Da., B.Di., 
J.R., and R.R., (a) hardcopies of controlled substance prescriptions 
that Respondent had dispensed to those patients from May 3, 2019, 
through August 9, 2019; (b) copies of Respondent's patient profiles for 
those patients; and (c) copies of ``[a]ny and all records . . . 
maintained pursuant to the requirements of Florida Statutes and Florida 
Administrative

[[Page 72718]]

Code 64B16-27.800 for Patient Records, documenting the steps taken to 
avoid or resolve any issues with the prescriptions presented by'' those 
patients ``reflecting efforts by the pharmacist to exercise their 
corresponding responsibility to assess the validity'' of controlled 
substance prescriptions dispensed to those patients. Gov't Ex. 33; Tr. 
at 179.
    23. Government Exhibit 33 is a true and correct copy of the 
administrative subpoena that DEA served on Respondent in August 2019. 
Tr. at 179-82.
    24. With its production of documents in response to the August 2019 
administrative subpoena, the Respondent also produced a signed 
certificate of authenticity of domestic business records. Tr. at 184. 
Government Exhibit 34 is a true and correct copy of the signed 
certificate of authenticity of domestic business records produced by 
the Respondent with its production of documents in response to the 
August 2019 administrative subpoena. Tr. at 184-85.
    25. Government Exhibits 35-40 contains true and correct copies of 
the patient profiles, prescriptions, and other responsive documents for 
Patients J.B., A.B., B.Da., B.Di., J.R., and R.R., respectively, that 
Respondent produced pursuant to the administrative subpoena served in 
August 2019. Tr. at 186-201. The Respondent did not produce any other 
documents pertaining to Patients J.B., A.B., B.Da., B.Di., J.R., or 
R.R. pursuant to the administrative subpoena served in August 2019 
beyond those reflected in Government Exhibits 35-40. Tr. at 187, 190-
91, 193, 195, 197- 98, 200-01.
    26. During the course of the investigation, DI queried the Florida 
Prescription Drug Monitoring Database (``E-FORCSE'') and obtained 
information regarding Respondent's dispensing of controlled substance 
as it was reported to the State of Florida. Tr. at 205-216. Government 
Exhibits 41-42 are true and correct copies of the data obtained from 
the E-FORSCE database for the dates listed. Id. There is no evidence in 
the record to indicate that the information reported by Respondent to 
the E-FORSCE database is inaccurate or unreliable.
    27. Subsequent to Respondent's Second Supplement Prehearing 
Statement, which concerned information retrieved from the PioneerRx 
pharmacy management software used by the Respondent, DEA obtained a 
declaration from J.R., Vice President of PioneerRx, concerning the 
functioning of that software. Tr. at 238-40. Government Exhibit 48 is a 
true and correct copy of the declaration of J.R. Tr. at 242-48.
    28. DI testified that use of cash to pay for a prescription for 
controlled substances and the willingness of a customer to pay a 
higher-than-market price to purchase said medications are ``red flags'' 
that a prescription may be illegitimate. Tr. 106-107; 109-110. However, 
he later testified that there is no DEA regulation prohibiting a 
pharmacy from accepting cash as payment for prescriptions for 
controlled substances. Tr. 373-374.
III. The Government's Expert
    29. Tracey J. Schossow, a pharmacy expert retained by DEA, is a 
clinical pharmacist at Florida Blue Cross Blue Shield. In that 
capacity, she reviews medications prescribed to Blue Cross members to 
ensure, among other things, that the medications are being issued for a 
legitimate medical purpose, and to provide cost-effective alternatives 
for prescribed medications where appropriate. Dr. Schossow holds both a 
bachelor's degree in pharmacy and a doctorate in pharmacy. She is a 
licensed pharmacist in Florida and also holds an additional Florida 
license as a consultant pharmacist. Tr. at 403-04, 408; GX 43.
    30. Dr. Schossow has 26 years of experience as a pharmacist, with 
12-years' experience as a retail pharmacist and the remainder as a 
clinical pharmacist. Immediately prior to her current role, Dr. 
Schossow was a clinical pharmacist for ProcareRx, a hospice-centered 
pharmacy benefits manager (``PBM''). While at ProcareRx, Dr. Schossow 
worked with hospice patients and managed medications for those 
patients, including opioids, benzodiazepines, and muscle relaxants. 
Additionally, Dr. Schossow served on the committee that managed which 
medications were on the ProcareRx formulary based on cost and efficacy 
considerations, and she also managed the queue for high-cost claims 
submitted by the hospices and ran test claims for the PBM to determine 
costs at different pharmacies across the State of Florida. Tr. at 404-
08; GX 43.
    31. Through her education and experience, Dr. Schossow has gained 
specialized knowledge regarding the practice of pharmacy, including the 
costs charged by pharmacies for controlled substance medications, the 
standard of care for dispensing controlled substances in the State of 
Florida, the obligations of a retail pharmacist in the detection and 
prevention of abuse and diversion of controlled substances, and a 
pharmacist's corresponding responsibility under federal law. Tr. at 
411-14.
    32. Dr. Schossow has previously been accepted by this Agency as an 
expert witness on three occasions. Tr. at 412, 423-24.
    33. Dr. Schossow was accepted by the Tribunal as an expert in in 
the field of pharmacy and the standard of care for the practice of 
pharmacy in the State of Florida. Tr. at 427.
    34. Dr. Schossow was unfamiliar with any clarification issued by 
the Center for Disease Control (``CDC'') regarding its 2016 opiate 
guidelines.*\E\ Tr. 992.
---------------------------------------------------------------------------

    *\E\ There was an attempt to clarify Dr. Schossow's testimony 
regarding the 2016 opiate guidelines, but it is difficult from the 
transcript to tell which documents are being referenced by counsel 
and the witness. Tr. 1060-1068. The RD states infra that Dr. 
Schossow clarified later that she was generally aware of the CDC's 
clarification regarding its 2016 opiate guidelines.
---------------------------------------------------------------------------

IV. The Standard of Care in the State of Florida
A. Generally
    35. Florida law, like federal law, requires that a pharmacist 
exercise his or her corresponding responsibility to ensure, prior to 
dispensing controlled substances, that each prescription is valid and 
has been issued for a legitimate medical purpose by an individual 
practitioner in the usual course of professional practice. As part of 
this evaluation, the pharmacist must perform a drug use review 
(``DUR'') on each new and refill prescription. This DUR includes 
examination of, among other things, potential side effects of the 
medication, potential drug interactions, whether the medication is 
being clinically abused or misused, and whether the medication is being 
dosed appropriately. Tr. at 431-32, 438-40. Many of these issues are 
specifically enumerated in Fla. Admin. Code r. 64B16-27.810. Tr. at 
437.
    36. Florida law also requires that a pharmacy maintain a ``patient 
profile'' for its customers that includes a variety of information, 
such as the pharmacist's comments relevant to the patient's drug 
therapy. Tr. at 437-39; see also Fla. Admin. Code r. 64B16-27.800. The 
standard of care requires a pharmacist to document the steps that he 
took to resolve any areas of concern or potential problems in the 
patient records. Tr. at 437-42.
B. Red Flags
    37. Dr. Schossow testified that a red flag is something ``about a 
prescription that causes the pharmacist to take pause'' when filling a 
prescription. Tr. at 446. Dr. Schossow testified that the red flag 
``may be signs of diversion'' or

[[Page 72719]]

signs that the prescription ``may harm the patient,'' and that the 
pharmacist's examination of red flags was part of the prospective drug 
use review with respect to issues of clinical abuse or misuse of the 
prescribed substance. Id. Dr. Schossow testified that red flags are 
well known to pharmacists in the State of Florida. Id. at 452-60.
    38. Dr. Schossow testified that the standard of care in the State 
of Florida requires a pharmacist who encounters a prescription with a 
red flag to address that red flag and to resolve it, if the red flag is 
in fact resolvable, and to record the issue by identifying the red flag 
and how the pharmacist resolved it. Id. at 462-63. Dr. Schossow further 
testified that a Florida pharmacist acting in the usual course of 
professional practice would likewise identify red flags and record the 
resolution of those red flags. Id. at 463.
    39. Dr. Schossow testified that the combination of an opioid, a 
benzodiazepine, and the muscle relaxer carisoprodol--commonly known as 
the ``Trinity'' cocktail--is a red flag because that combination of 
controlled substances is dangerous to the patient and known by 
pharmacists to be sought after by drug abusers. Id. at 480-83.
    40. Dr. Schossow testified that prescriptions for cocktail 
medications--specifically the combination of an opioid and a 
benzodiazepine--is a red flag for the pharmacist because both of those 
categories of drugs depress the patient's central nervous system. Id. 
at 499-500. Dr. Schossow testified that the CDC Guidelines for 
Prescribing Opioids for Chronic Pain and FDA black box warning for 
opioid medications both warn against the combination of opioids and 
benzodiazepines because that combination of medications, which both 
depress the patient's central nervous system, can lead to sedation, 
respiratory depression, overdose, and death. Id. at 455-56, 476, 500, 
526.
    41. Dr. Schossow testified that cash payment for controlled 
substance prescriptions is a red flag. Id. at 580-83. Dr. Schossow 
further testified that high cash payments for controlled substance 
prescriptions enhance the red flag for cash payments because ``a drug 
seeker is willing to pay more for a drug if they can get the drug'' and 
is ``willing to pay . . . whatever they need to pay to obtain the 
medication.'' Id. at 580-86.
    42. Dr. Schossow testified that prescriptions for long-acting and 
short-acting opioids in a combination that does not make 
pharmacological sense are also a red flag for pharmacists. Id. at 599-
600. Specifically, Dr. Schossow testified that long-acting opioids, 
like MS Contin, last in the body 8-to-12 hours, while a short acting 
opioid like hydromorphone lasts in the body only 2-to-4 hours, and the 
proper method of treatment for pain management was to give more of the 
patient's total daily MME dose of opioids in the form of long-acting 
opioids than short-acting opioids. Dr. Schossow testified that, in 
contrast, prescriptions that provide a patient with a greater MME of 
short-acting opioids than long-acting opioids do not make 
pharmacological sense and are a red flag. Id. at 603-06.
    43. [Omitted for brevity and relevance.]
    44. Dr. Schossow testified that abnormal travel distances on the 
part of a patient to obtain and fill controlled substance prescriptions 
are a red flag. Id. at 679. While I accept this concept, I did not find 
that the evidence supported 30-50 mile round trip distances as abnormal 
under the facts of this case.
    45. Dr. Schossow testified that therapeutic duplication--which is 
the simultaneous prescription of two medications that are in the same 
drug class and act the same way--is a red flag because prescribing two 
medications that do the same thing is not necessary and is 
therapeutically inappropriate. Id. at 704-05. Dr. Schossow testified 
that therapeutic duplication of benzodiazepines can compound the side 
effects of those drugs, which depress the patient's central nervous 
system and can cause respiratory depression, sedation, overdose, and 
death. Id. at 705.
V. Patient J.B.
    46. Between March 22, 2017, and August 8, 2019, Respondent filled 
at least 100 prescriptions for controlled substances for Patient J.B., 
including 26 prescriptions for 60 units of MS Contin 30 mg, 32 
prescriptions for 108-120 units of oxycodone 30 mg, 33 prescriptions 
for 90 units of Xanax 1 mg, and 9 prescriptions for 30 units of Soma 
350 mg. Information regarding the controlled substance prescriptions 
dispensed to Patient J.B. is accurately set forth in Government 
Exhibits 6-7, 23, 35, and 41-42.
    47. All of the prescriptions filled by Patient J.B. at Respondent 
pharmacy from March 22, 2017, through September 7, 2018, were paid for 
in cash. GX 6-7, 23, 48 ] 7(b).
    48. Dr. Schossow examined the prescriptions dispensed to Patient 
J.B. and identified multiple red flags with respect to those 
prescriptions, including prescriptions for the Trinity cocktail, 
prescriptions for cocktail combinations of opioids and benzodiazepines, 
cash payment for controlled substances, high prices paid for 
prescriptions for oxycodone 30 mg, and dosing of long- and short-acting 
opioids in a manner that did not make pharmacological sense. Tr. at 
485- 91, 498-500, 503-04, 513-16, 520-28, 530-34, 851-57. Dr. 
Schossow's conclusions with respect to specific prescriptions dispensed 
to Patient J.B. are set forth in Appendix A at 1-3.
    49. Dr. Schossow reviewed the patient profile maintained by 
Respondent for Patient J.B., and concluded that the red flags she had 
found with respect to the prescriptions filled for Patient J.B. were 
not mentioned, addressed, resolved or documented on the patient 
profile. GX 5 at 1; Gov't Ex. 35 at 1; Tr. at 857-59.
    50. Dr. Schossow reviewed the medical records maintained by 
Respondent for Patient J.B. and concluded that those documents did not 
address, resolve, or document any of the red flags she had found with 
respect to the prescriptions filled for Patient J.B. GX 35 at 2-5; Tr. 
at 858.
    51. Dr. Schossow reviewed the dispensing logs maintained by 
Respondent for Patient J.B. and concluded that those documents did not 
address, resolve, or document any of the red flags she had found with 
respect to the prescriptions filled for Patient J.B. GX 35 at 8-9; Tr. 
at 858.
    52. Dr. Schossow testified that, based on her review of the 
prescriptions, patient profiles, and medical records that Respondent 
maintained for Patient J.B., a reasonable pharmacist acting in the 
usual course of professional practice would not have filled the 
prescriptions for Patient J.B. without addressing, resolving, or 
documenting the red flags that she had identified. Tr. at 859-60.
VI. Patient A.B.
    53. At all times relevant to this matter, Patient A.B. resided at 
12175 Harry Street, Bokeelia, Florida 33922. GX. 36 at 1; GX 41-42. 
Patient A.B.'s approximate roundtrip travel distance from his 
residence, to his physician, to Respondent, and returning to his 
residence, is 44 miles. ALJ Ex. 21 Attachs. A-B, Attach. C at 1-3; ALJ 
Ex. 23 at 3.
    54. Between November 8, 2017, and July 17, 2017, Respondent filled 
at least 69 prescriptions for Patient A.B., including 23 prescriptions 
for 60 units of MS Contin 15 mg, 23 prescriptions for 120 units of 
hydromorphone 8 mg, and 23 prescriptions for 30-40 units of Valium 10 
mg. Information regarding the controlled substance prescriptions 
dispensed to Patient A.B. is accurately set forth in Government 
Exhibits 8, 24, 36, and 41-42.

[[Page 72720]]

    55. All of the prescriptions filled by Patient A.B. at Respondent 
were paid for in cash. GX 8, 24, 36, 48 ] 7(b).
    56. Dr. Schossow examined the prescriptions dispensed to Patient 
A.B. and identified multiple red flags with respect to those 
prescriptions, including prescriptions for cocktail combinations of 
opioids and benzodiazepines, cash payment for controlled substances, 
high prices paid for prescriptions for hydromorphone 8 mg, dosing of 
long- and short-acting opioids in a manner that did not make 
pharmacological sense, and the distance traveled by Patient A.B. to 
obtain and fill prescriptions for controlled substances. Tr. at 535-42, 
813-17, 819-50. Dr. Schossow's conclusions with respect to specific 
prescriptions dispensed to Patient A.B. are set forth in Appendix A at 
4-7.
    57. Dr. Schossow reviewed the patient profile maintained by 
Respondent for Patient A.B., and concluded that the red flags she had 
found with respect to the prescriptions filled for Patient A.B. were 
not mentioned, addressed, resolved or documented on the patient 
profile. GX 36 at 1; Tr. at 844-45.
    58. Dr. Schossow reviewed the medical records maintained by 
Respondent for Patient A.B. and concluded that those documents did not 
address, resolve, or document any of the red flags she had found with 
respect to the prescriptions filled for Patient J.B. GX 36 at 2-11; Tr. 
at 845.
    59. Dr. Schossow reviewed the dispensing logs maintained by 
Respondent for Patient A.B. and concluded that those documents did not 
address, resolve, or document any of the red flags she had found with 
respect to the prescriptions filled for Patient J.B. GX. 36 at 12; Tr. 
at 845.
    60. Dr. Schossow testified that, based on her review of the 
prescriptions, patient profiles, and medical records that Respondent 
maintained for Patient A.B., a reasonable pharmacist acting in the 
usual course of professional practice would not have filled the 
prescriptions for Patient A.B. without addressing, resolving, or 
documenting the red flags that she had identified. Tr. at 850-51.
VII. Patient B.Da.
    61. At all times relevant to this matter, Patient B.Da. resided at 
5512 Avenue D, Bokeelia, Florida 33922. GX 37 at 1; GX 41-42. Patient 
B.Da.'s approximate roundtrip travel distance from his residence, to 
his physician, to Respondent, and returning to his residence, is 48.8 
miles. ALJ Ex. 21 Attachs. A-B, Attach. C at 4-6; ALJ Ex. 23 at 3.
    62. Between October 25, 2017, and August 5, 2019, Respondent filled 
at least 39 prescriptions for Patient B.Da., including 5 prescriptions 
for 90 units of methadone 10 mg, 8 prescriptions for 30 units of MS 
Contin 30 mg, 13 prescriptions for 120-150 units of hydromorphone 8 mg, 
and 13 prescriptions for 30 units of Xanax 2 mg. Information regarding 
the controlled substance prescriptions dispensed to Patient B.Da. is 
accurately set forth in Government Exhibits 9, 25, 37, and 41-42.
    63. All of the prescriptions filled by Patient B.Da. at Respondent 
were paid for in cash. GX 9, 25, 37, 48 ] 7(b).
    64. Dr. Schossow examined the prescriptions dispensed to Patient 
B.Da. and identified multiple red flags with respect to those 
prescriptions, including prescriptions for cocktail combinations of 
opioids and benzodiazepines, cash payment for controlled substances, 
high prices paid for prescriptions for hydromorphone 8 mg, dosing of 
long-and short-acting opioids in a manner that did not make 
pharmacological sense, and the distance traveled by Patient B.Da. to 
obtain and fill prescriptions for controlled substances. Tr. at 745-56. 
Dr. Schossow's conclusions with respect to specific prescriptions 
dispensed to Patient B.Da. are set forth in Appendix A at 8-10.
    65. Dr. Schossow testified that a Florida pharmacist acting within 
the standard of care should have evaluated the red flags she noted and 
addressed them with the physician, care giver, or patient as 
appropriate and should have documented the resolution of those red 
flags if they could be resolved. Tr. at 757.
    66. Dr. Schossow reviewed the patient profile and prescriptions 
maintained by Respondent for Patient B.Da., and concluded that the red 
flags she had found with respect to the prescriptions filled for 
Patient B.Da. were not mentioned, addressed, resolved or documented on 
the patient profile or prescriptions. GX 37 at 1; Tr. at 756-57.
    67. Dr. Schossow reviewed the medical records maintained by 
Respondent for Patient B.Da. and concluded that those documents did not 
address, resolve, or document any of the red flags she had found with 
respect to the prescriptions filled for Patient B.Da. GX 37 at 4-8; Tr. 
at 757.
    68. Dr. Schossow testified that, based on her review of the 
prescriptions, patient profiles, and medical records that Respondent 
maintained for Patient B.Da., a reasonable pharmacist acting in the 
usual course of professional practice would not have filled the 
prescriptions for Patient B.Da. without addressing, resolving, or 
documenting the red flags that she had identified. Tr. at 757.
VIII. Patient R.D.
    69. At all times relevant to this matter, Patient R.D. resided at 
5459 Thomas Street, Bokeelia, Florida 33922. Gov't Ex. 19 at 1; Gov't 
Exs. 41-42. Patient B.Da.'s approximate roundtrip travel distance from 
his residence, to his physician, to Respondent, and returning to his 
residence, is 40.6 miles. ALJ Ex. 21 Attachs. A-B, Attach. C at 2, 7-8; 
ALJ Ex. 23 at 3.
    70. Between December 20, 2017, and April 10, 2019, Respondent 
filled at least 36 prescriptions for Patient R.D., including 18 
prescriptions for 120-140 units of hydromorphone 8 mg, and 18 
prescriptions for 30 units of Ativan 2 mg. Information regarding the 
controlled substance prescriptions dispensed to Patient R.D. is 
accurately set forth in Government Exhibits 10, 26, and 41-42.
    71. All of the prescriptions filled by Patient R.D. at Respondent 
were paid for in cash. GX 10, 26, 48 ] 7(b).
    72. Dr. Schossow examined the prescriptions dispensed to Patient 
R.D. and identified multiple red flags with respect to those 
prescriptions, including prescriptions for cocktail combinations of 
opioids and benzodiazepines, cash payment for controlled substances, 
high prices paid for prescriptions for hydromorphone 8 mg, and the 
distance traveled by Patient R.D. to obtain and fill prescriptions for 
controlled substances. Tr. at 675-701. Dr. Schossow's conclusions with 
respect to specific prescriptions dispensed to Patient R.D. are set 
forth in Appendix A at 11-13.
    73. Dr. Schossow testified that a Florida pharmacist acting within 
the standard of care should have evaluated the red flags she noted and 
addressed them with the physician, care giver, or patient as 
appropriate and should have documented the resolution of those red 
flags if they could be resolved. Tr. at 701.
    74. Dr. Schossow reviewed the patient profile and prescriptions 
maintained by Respondent for Patient R.D., and concluded that there was 
no evidence to suggest that the Respondent had investigated or assessed 
any of the red flags that she had identified with respect to the 
prescriptions filled by Patient R.D. GX 19 at 1; Tr. at 702.
    75. Dr. Schossow testified that the Respondent's comments on the 
patient profile that Respondent maintained for Patient R.D. did not 
address any of the red flags that she had identified with respect to 
the prescriptions filled by Patient R.D. GX 19 at 1; Tr. at 702.

[[Page 72721]]

    76. Dr. Schossow testified that, based on her review of the 
prescriptions, patient profiles, and medical records that Respondent 
maintained for Patient R.D., a reasonable pharmacist acting in the 
usual course of professional practice would not have filled the 
prescriptions for Patient R.D. without addressing, resolving, or 
documenting the red flags that she had identified. Tr. at 702.
IX. Patient B.Di.
    77. Between April 21, 2017, and July 17, 2019, Respondent filled at 
least 85 prescriptions for Patient B.Di., including 28 prescriptions 
for 60 units of MS Contin 30 mg, 28 prescriptions for 120 units of 
hydromorphone 8 mg, 28 prescriptions for 60-90 units of Xanax 1 mg, and 
1 prescription for 60 units of Adderall 20 mg. Information regarding 
the controlled substance prescriptions dispensed to Patient B.Di. is 
accurately set forth in Government Exhibits 11, 27, 38, and 41-42.
    78. All of the prescriptions filled by Patient B.Di. at Respondent 
were paid for in cash. GX 11, 27, 38, 48 ] 7(b).
    79. Dr. Schossow examined the prescriptions dispensed to Patient 
B.Di. and identified multiple red flags with respect to those 
prescriptions, including prescriptions for cocktail combinations of 
opioids and benzodiazepines, cash payment for controlled substances, 
high prices paid for prescriptions for hydromorphone 8 mg, and dosing 
of long- and short-acting opioids in a manner that did not make 
pharmacological sense. Tr. at 718-43. Dr. Schossow's conclusions with 
respect to specific prescriptions dispensed to Patient B.Di. are set 
forth in Appendix A at 14-17.
    80. Dr. Schossow testified that a Florida pharmacist acting within 
the standard of care should have evaluated the red flags she noted and 
addressed them with the physician, care giver, or patient as 
appropriate and should have documented the resolution of those red 
flags if they could be resolved. Tr. at 743-44.
    81. Dr. Schossow reviewed the patient profile and prescriptions 
maintained by Respondent for Patient B.Di., and concluded that there 
was no evidence to suggest that the Respondent had addressed, 
investigated, resolved, or documented the resolution of any of the red 
flags that she had identified with respect to the prescriptions filled 
by Patient B.Di. GX 38 at 1; Tr. at 744.
    82. Dr. Schossow testified that, based on her review of the 
prescriptions and patient profile that Respondent maintained for 
Patient B.Di., a reasonable pharmacist acting in the usual course of 
professional practice would not have filled the prescriptions for 
Patient B.Di. without addressing, resolving, or documenting the red 
flags that she had identified. Tr. at 744.
X. Patient T.G.
    83. Between April 5, 2017, and April 22, 2019, Respondent filled at 
least 32 prescriptions for Patient T.G., including 14 prescriptions for 
60 units of MS Contin 60 mg, 1 prescription for 56 units of oxycodone 
15 mg, and 17 prescriptions for 84-120 units of oxycodone 30 mg. 
Information regarding the controlled substance prescriptions dispensed 
to Patient T.G. is accurately set forth in Government Exhibits 12, 28, 
and 41-42.
    84. All of the prescriptions filled by Patient T.G. at Respondent 
were paid for in cash. GX 12, 28, 48 ] 7(b).
    85. Dr. Schossow examined the prescriptions dispensed to Patient 
T.G. and identified multiple red flags with respect to those 
prescriptions, including cash payment for controlled substances and 
high prices paid for prescriptions for oxycodone 30 mg. Tr. at 556-57, 
563-64, 579-94. Dr. Schossow's conclusions with respect to specific 
prescriptions dispensed to Patient T.G. are set forth in Appendix A at 
18-19.
    86. Dr. Schossow reviewed the patient profiles and prescriptions 
maintained by Respondent for Patient T.G., and concluded that there was 
no evidence to suggest that the Respondent had investigated or assessed 
any of the red flags that she had identified with respect to the 
prescriptions filled by Patient T.G. GX 5 at 2; GX 20 at 1; Tr. at 595-
96.
    87. Dr. Schossow testified that, based on her review of the 
prescriptions and patient profiles that Respondent maintained for 
Patient T.G., a reasonable pharmacist acting in the usual course of 
professional practice would not have filled the prescriptions for 
Patient T.G. without addressing, resolving, or documenting the red 
flags that she had identified. Tr. at 596-97.
XI. Patient S.K.
    88. Between March 8, 2017, and May 1, 2019, Respondent filled at 
least 79 prescriptions for Patient S.K., including 29 prescriptions for 
60 units of MS Contin 15 mg, 29 prescriptions for 98-110 units of 
hydromorphone 8 mg, and 21 prescriptions for 28-60 units of Klonopin 1 
mg. Information regarding the controlled substance prescriptions 
dispensed to Patient S.K. is accurately set forth in Government 
Exhibits 13, 29, and 41-42.
    89. All of the prescriptions filled by Patient S.K. at Respondent 
were paid for in cash. GX 19, 29, 48 ] 7(b).
    90. Dr. Schossow examined the prescriptions dispensed to Patient 
S.K. and identified multiple red flags with respect to those 
prescriptions, including prescriptions for cocktail combinations of 
opioids and benzodiazepines, cash payment for controlled substances, 
high prices paid for prescriptions for hydromorphone 8 mg, and dosing 
of long- and short-acting opioids in a manner that did not make 
pharmacological sense. Tr. at 597-624, 626-640. Dr. Schossow's 
conclusions with respect to specific prescriptions dispensed to Patient 
S.K. are set forth in Appendix A at 20-22.
    91. Dr. Schossow testified that a Florida pharmacist acting within 
the standard of care should have evaluated the red flags she noted and 
addressed them with the physician, care giver, or patient as 
appropriate and should have documented the resolution of those red 
flags if they could be resolved. Tr. at 640-41.
    92. Dr. Schossow reviewed the patient profile and prescriptions 
maintained by Respondent for Patient S.K., and concluded that there was 
no evidence to suggest that the Respondent had addressed, investigated, 
resolved, or documented the resolution of any of the red flags that she 
had identified with respect to the prescriptions filled by Patient S.K. 
GX 21 at 1; Tr. at 641.
    93. Dr. Schossow testified that, based on her review of the 
prescriptions and patient profile that Respondent maintained for 
Patient S.K., a reasonable pharmacist acting in the usual course of 
professional practice would not have filled the prescriptions for 
Patient S.K. without addressing, resolving, or documenting the red 
flags that she had identified. Tr. at 641.
XII. Patient J.R.
    94. Between February 27, 2019, and August 2, 2019, Respondent 
filled at least 23 prescriptions for Patient J.R., including 1 
prescription for 60 units of MS Contin 15 mg, 1 prescription for 120 
units of Norco 5-325 mg, 3 prescriptions for 120 units of Norco 7.5-325 
mg, 1 prescription for 120 units of Percocet 5-325 mg, 2 prescriptions 
for 60 units of Valium 2 mg, 4 prescriptions for 30-60 units of Valium 
5 mg, 5 prescriptions for 30 units of Restoril 30 mg, and 6 
prescriptions for 120 units of Soma 350 mg. Information regarding the 
controlled substance prescriptions dispensed to Patient J.R. is 
accurately set forth in Government Exhibits 30, 39, and 41-42.
    95. Dr. Schossow examined the prescriptions dispensed to Patient 
J.R. and identified multiple red flags with respect to those 
prescriptions, including

[[Page 72722]]

prescriptions for the Trinity cocktail and therapeutic duplication of 
benzodiazepine prescriptions. Tr. at 703-16. Dr. Schossow's conclusions 
with respect to specific prescriptions dispensed to Patient J.R. are 
set forth in Appendix A at 23.
    96. Dr. Schossow testified that a Florida pharmacist acting within 
the standard of care should have evaluated the red flags she noted and 
addressed them with the physician, care giver, or patient as 
appropriate and should have documented the resolution of those red 
flags if they could be resolved. Tr. at 716-17.
    97. Dr. Schossow reviewed the patient profile and prescriptions 
maintained by Respondent for Patient J.R., and concluded that there was 
no evidence to suggest that the Respondent had addressed, investigated, 
resolved, or documented the resolution of any of the red flags that she 
had identified with respect to the prescriptions filled by Patient J.R. 
GX 39 at 1; Tr. at 717.
    98. Dr. Schossow testified that, based on her review of the 
prescriptions and patient profile that Respondent maintained for 
Patient J.R., a reasonable pharmacist acting in the usual course of 
professional practice would not have filled the prescriptions for 
Patient J.R. without addressing, resolving, or documenting the red 
flags that she had identified. Tr. at 717.
XIII. Patient R.R.
    99. Between December 5, 2017, and August 6, 2019, Respondent filled 
at least 55 prescriptions for Patient R.R., including 15 prescriptions 
for 28-60 units of MS Contin 60 mg, 20 prescriptions for 120-168 units 
of hydromorphone 8 mg, 1 prescription for 60 units of Xanax 1 mg, and 
19 prescriptions for 30 units of Xanax 2 mg. Information regarding the 
controlled substance prescriptions dispensed to Patient R.R. is 
accurately set forth in Government Exhibits 14, 31, 40, and 41-42. All 
of the prescriptions filled by Patient R.R. at Respondent were paid for 
in cash. GX 14, 31, 40, 48 ] 7(b).
    100. Dr. Schossow examined the prescriptions dispensed to Patient 
R.R. and identified multiple red flags with respect to those 
prescriptions, including prescriptions for cocktail combinations of 
opioids and benzodiazepines, cash payment for controlled substances, 
high prices paid for prescriptions for hydromorphone 8 mg, dosing of 
long- and short-acting opioids in a manner that did not make 
pharmacological sense, and dosing of benzodiazepine medications in a 
manner that did not make pharmacological sense. Tr. at 642-72. Dr. 
Schossow's conclusions with respect to specific prescriptions dispensed 
to Patient R.R. are set forth in Appendix A at 24-26.
    101. Dr. Schossow testified that a Florida pharmacist acting within 
the standard of care should have evaluated the red flags she noted and 
addressed them with the physician, care giver, or patient as 
appropriate and should have documented the resolution of those red 
flags if they could be resolved. Tr. at 673.
    102. Dr. Schossow reviewed the patient profile and prescriptions 
maintained by Respondent for Patient R.R., and concluded that there was 
no evidence to suggest that the Respondent had addressed, investigated, 
resolved, or documented the resolution of any of the red flags that she 
had identified with respect to the prescriptions filled by Patient R.R. 
GX 40 at 1; Tr. at 672-73.
    103. Dr. Schossow testified that the Respondent's comments on the 
patient profile that Respondent maintained for Patient R.R. did not 
address any of the red flags that she had identified with respect to 
the prescriptions filled by Patient R.R. GX 40 at 1; Tr. at 673-74.
    104. Dr. Schossow reviewed the medical records and dispensing log 
maintained by Respondent for Patient R.R. and concluded that those 
documents did not address, resolve, or document any of the red flags 
she had found with respect to the prescriptions filled for Patient R.R. 
GX 40 at 2-7; Tr. at 674.
    105. Dr. Schossow testified that, based on her review of the 
prescriptions, patient profile, dispensing log and medical records that 
Respondent maintained for Patient R.R., a reasonable pharmacist acting 
in the usual course of professional practice would not have filled the 
prescriptions for Patient R.R. without addressing, resolving, or 
documenting the red flags that she had identified. Tr. at 674.
XIV. Patient L.V.
    106. Between March 2, 2017, and May 14, 2019, Respondent filled at 
least 93 prescriptions for Patient L.V., including 28 prescriptions for 
14-60 units of MS Contin 60 mg, 1 prescription for 120 units of 
oxycodone 20 mg, 27 prescriptions for 90-140 units of oxycodone 30 mg, 
16 prescriptions for 60-90 units of Xanax 1 mg, 8 prescriptions for 60 
units of Xanax 2 mg, and 13 prescriptions for 30 units of Ambien 10 mg. 
Information regarding the controlled substance prescriptions dispensed 
to Patient L.V. is accurately set forth in Government Exhibits 6, 15, 
32, and 41-42.
    107. All of the prescriptions for oxycodone 20 mg or oxycodone 30 
mg filled by Patient L.V. at Respondent were paid for in cash. GX 6, 
15, 32, 48 ] 7(b). All of the prescriptions for MS Contin filled by 
Patient L.V. at Respondent, with the exceptions of the prescriptions 
filled on January 22, 2019; February 19, 2019; and April 15, 2019, were 
paid for in cash. GX 6, 15, 32, 48 ] 7(b). The prescriptions for 60 
units of Xanax 1 mg filled by Patient L.V. at Respondent on March 2, 
2017; March 30, 2017; and April 27, 2017, were also paid for in cash. 
GX 6, 15, 48 ] 7(b).
    108. Dr. Schossow examined the prescriptions dispensed to Patient 
L.V. and identified multiple red flags with respect to those 
prescriptions, including prescriptions for cocktail combinations of 
opioids and benzodiazepines, cash payment for controlled substances, 
and high prices paid for prescriptions for oxycodone 30 mg. Tr. at 510-
11, 758-59, 767-79, 791-808. Dr. Schossow's conclusions with respect to 
specific prescriptions dispensed to Patient L.V. are set forth in 
Appendix A at 27-30.
    109. Dr. Schossow reviewed the patient profiles maintained by 
Respondent for Patient L.V., and concluded that there was no evidence 
to suggest that the Respondent had addressed, investigated, resolved, 
or documented the resolution of any of the red flags that she had 
identified with respect to the prescriptions filled by Patient L.V. GX 
5 at 3; GX 22 at 1; Tr. at 808-09, 812.
    110. Dr. Schossow reviewed the dispensing log maintained by 
Respondent for Patient L.V. and concluded that those documents did not 
address, resolve, or document any of the red flags she had found with 
respect to the prescriptions filled for Patient L.V. GX 6 at 5-6; Tr. 
at 809.
    111. Dr. Schossow testified that, based on her review of the 
prescriptions, patient profile, and dispensing log that Respondent 
maintained for Patient L.V., a reasonable pharmacist acting in the 
usual course of professional practice would not have filled the 
prescriptions for Patient L.V. without addressing, resolving, or 
documenting the red flags that she had identified. Tr. at 812-13.
The Respondent's Expert
    112. Dr. Buffington received his Doctor of Pharmacy (PharmD) degree 
and a Master of Business Administration degree from Mercer University 
in Atlanta, Georgia. RX 12; Tr. 1078-79.
    113. Dr. Buffington completed his clinical practice residency and 
clinical pharmacology research fellowship at

[[Page 72723]]

Emory University Hospital in Atlanta, Georgia. RX 12; Tr. 1078-79.
    114. Dr. Buffington represents clinical pharmacists on the American 
Medical Association (``AMA'') Current Procedural Terminology (``CPT'') 
Panel, and has served as a medication safety expert for the United 
States Department of Health and Human Services, Center for Medicare and 
Medicaid Services (``CMS''). Tr. 1078-79.
    115. Dr. Buffington is also a Clinical Associate Professor in both 
the College of Medicine, since 1991, and the College of Pharmacy, since 
2011, at the University of South Florida, in which settings he teaches 
clinical pharmacology, toxicology, pharmacy law, and a variety of 
aspects of healthcare administration and practice management. Tr. 1079.
    116. Dr. Buffington possesses over thirty (30) years of experience 
in clinical pharmacology, toxicology, pharmacy and medical malpractice, 
substance use disorders, and long-term care. Tr. 1079.
    117. The patients referred to Dr. Buffington's practice typically 
have high-risk medications for evaluation from a medication profile, 
but also a therapeutic and outcomes perspective. Tr. 1080.
    118. Additionally, Dr. Buffington's practice designs and manages, 
as a principle investigator, clinical pharmacology trials involving 
investigations of newly developed medications or comparison of existing 
prevailing medications, all for the purpose of improving patient safety 
and outcomes. Tr. 1080-81.
    119. Dr. Buffington's practice also provides a drug information 
service and forensic consulting services to both public and private 
clients in the healthcare sector. Tr. 1081. Dr. Buffington's consulting 
service clients include pharmacists, medical practitioners, healthcare 
facilities and organizations, and law enforcement agencies. Tr. 1081.
    120. Dr. Buffington has worked as a retail pharmacist for an 
independent pharmacy within the past year, including in the roles of 
practitioner and auditor. Tr. 1090-91.
    121. As a teacher of pharmacy law at various colleges and 
universities in Florida, Dr. Buffington's instruction includes review 
of Florida statutes and administrative code provisions. Tr. 1098. These 
provisions include Sec. Sec.  64B16-27.800, 810, and 831 of the Florida 
Administrative Code, the discussion of which is part of the pharmacy 
law curriculum Dr. Buffington teaches, and with which he is familiar. 
Tr. 1098.
    122. Dr. Buffington was engaged by the Respondent to serve as an 
expert witness in approximately February of 2020. Tr. 1076-77.
    123. Dr. Buffington was provided with all of Respondent's documents 
that were seized by or produced to the DEA in connection with the 
Government's investigation into the Respondent. Tr. 1077.
    124. Dr. Buffington has served as an expert witness and has been 
accepted as an expert in state and federal courts. Tr. 1078. He has 
also previously testified as an expert in administrative proceedings. 
Tr. 1078.
    125. Dr. Buffington is familiar with a wide variety of pharmacy 
business software platforms used by retail pharmacies to track the 
dispensing process. Tr. 1113-14.
    126. Dr. Buffington is familiar with the alert systems included in 
pharmacy business software platforms and has, in fact, served as an 
author of many of them. Tr. 1113-14.
    127. Dr. Buffington testified that individuals residing in the Fort 
Myers/Cape Coral area may often be required to travel inland toward the 
city center from their home on a barrier island to patronize retail or 
clinical support services because the services available on the quiet, 
non-commercial barrier islands are often sparce. Tr. 1141-1142.
    128. Dr. Buffington believes that there are many logical 
explanations for why a person may elect to patronize a pharmacy other 
than the one that is located nearest their home. Tr. 1142-44. For 
example, Dr. Buffington testified that they may elect to patronize a 
pharmacy near their place of employment or near their prescribing 
physician. Id.
    129. Dr. Buffington testified that there is no prohibition against 
a patient paying for a controlled substance prescription using cash or 
a cash equivalent. Tr. 1144.
    130. In forming his opinions in this proceeding, Dr. Buffington 
drew upon his experience, training and conducting drug diversion 
investigations with state and federal agencies, including law 
enforcement agencies. Tr. 1159-1160.
    131. Based on Dr. Buffington's review of the Government's exhibits, 
he believed that there were other relevant data fields within the 
PioneerRx software that DEA did not obtain. Tr. 1163-1164.
    132. In 2015 and 2016, Dr. Buffington participated in helping 
create a national stakeholders' statement or request to DEA seeking 
guidance on ``red flag'' issues. Tr. 1164-1165.

Expert Opinion

    [Omitted for brevity.] Drs. Schossow and Buffington were qualified 
as experts in the field of pharmacy and the professional standards for 
the practice of pharmacy in the State of Florida. They gave their 
opinions regarding the relevant standards in Florida for the practice 
of pharmacy, including the existence of red flags, or from Dr. 
Buffington's perspective, ``yellow lights.'' The relevant professional 
standards 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.] \51\
---------------------------------------------------------------------------

    \51\ [Footnote omitted.]
---------------------------------------------------------------------------

    As far as expert opinion, Dr. Schossow demonstrated a commanding 
grasp of pharmacy practice and the standard for pharmacists in 
addressing ``red flags.'' However, there were several matters for which 
she had diminished credibility. For one, she was apparently unaware of 
the CDC Press Release clarifying the 2016 Guidelines for Prescribing 
Controlled Substances. It clarified that the Guidelines were not 
intended to apply to patients who had been on high MME on a long term 
basis. She later explained that she was generally aware of it, however, 
this clearly diminished her credibility regarding issues related to 
high MME of long-term patients. [Omitted.]*\F\ Finally, her assertion 
that all pharmacies were fungible and dismissing the reality that a 
patient may have a preference for one pharmacy over another, all other 
factors being equal, was not credible.
---------------------------------------------------------------------------

    *\F\ I have omitted the RD's assertion that Dr. Schossow offered 
inconsistent testimony regarding the dosing of alprazolam for 
Patient R.R. Patient R.R. received a prescription to take half of a 
two-milligram tablet of alprazolam every twelve hours. Dr. Schossow 
testified that in general it is not unusual for a physician to 
advise a patient to take half of a pill, but it is a red flag when 
the prescription involves two-milligram tablets of alprazolam, which 
are highly abused and highly sought after on the street. Tr. 642-44. 
Dr. Schossow testified that she has never seen these directions on 
an alprazolam prescription. Id.
---------------------------------------------------------------------------

    [Omitted.]
    The Respondent made the point in his brief that Dr. Schossow did 
not confer with the subject patients or with their prescribing 
physicians. Dr. Schossow 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 infers that the fact Dr. Schossow did not discuss any red 
flags with the patients or with the prescribers renders Dr. Schossow's 
conclusions regarding red flags questionable as Dr.

[[Page 72724]]

Schossow did not attempt to determine if the subject red flags were 
resolvable.
    Although certainly the extent of Dr. Schossow's review of relevant 
material is critical to the conclusions she draws, the focus of Dr. 
Schossow'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. Schossow could have 
resolved her own concerns regarding the subject red flags by speaking 
to the patients and prescribers years later. Nor is it dispositive that 
Dr. Schossow could have determined that the subject red flags were 
resolvable at the time they were dispensed, if the Respondent failed to 
satisfy its corresponding responsibility to resolve them. So, I do not 
view the fact that Dr. Schossow did not speak with the subject patients 
or prescribers as diminishing the probity of her relevant opinions as 
to the Respondent's acts or omissions at all.
Dr. Buffington
    Dr. Buffington had very impressive credentials and experience. He 
seemed to know the Florida statutes and regulations, chapter and verse. 
[However, I find that Dr. Buffington's credibility was greatly 
diminished by his combative tone, his evasive and confusing 
descriptions of a pharmacist's professional obligations, his repeated 
criticism of the Government's investigation, and his attempts to argue 
the Respondent's case. For example, on cross examination, Dr. 
Buffington repeatedly stated that Government counsel's questions were 
irrelevant to the case.*\G\ I also find that Dr. Buffington's 
conclusion that Respondent dispensed prescriptions within the usual 
course of professional practice was entitled to little weight, because 
it does not appear to be based on a meaningful review of the evidence 
in this case. Although there is little-to-no documentation showing that 
Respondent addressed or resolved the red flags that Dr. Schossow 
identified, Dr. Buffington appears to believe that the fact that 
Respondent filled these prescriptions is proof that it exercised its 
professional responsibility. Dr. Buffington testified that ``the 
profound value that a pharmacist brings is their clinical oversight and 
interaction with the patient,'' but given the lack of documentation, it 
is unclear how Dr. Buffington was able to reach any conclusions about 
whether Respondent exercised any clinical oversight or had any 
meaningful interactions with the patients. Dr. Buffington seemed to 
believe that the fact that nobody showed him evidence that Respondent 
knew that the prescriptions Respondent filling were unlawful was proof 
that Respondent had exercised its corresponding responsibility. See, 
e.g., Tr. 1163 (``[N]othing I saw [ ] demonstrated an inability to 
evaluate as the professional judgment takes place.''). Dr. Buffington's 
credibility was diminished for the following additional reasons.]
---------------------------------------------------------------------------

    *\G\ See, e.g., Tr. 1240 (claiming that the length of time that 
Respondent's pharmacists spent responding to alerts within PioneerRX 
that notify the pharmacist of potential problems was ``irrelevant to 
the case given there is not a single requirement for documentation 
formatting and the documentation may not have transpired during that 
pathway''); id. at 1253 (``The question was did I think there is not 
an increased risk when you combine the three medications. My answer 
was no, there is, and this is what we're faced with every day when 
you combine a wide variety of medications. That's not relevant to 
this discussion.''); id. at 1255 (testifying, in response to a 
question about whether consuming the ``trinity'' cocktail could 
produce a high in illicit drug users: ``Yes. And made worse with 
alcohol but so can their base medications on their individual basis. 
That's irrelevant to the case'').
---------------------------------------------------------------------------

Dr. Buffington Misunderstands DEA's Jurisdiction
    Despite having testified at a number of DEA administrative 
hearings, being a consultant for federal agencies, and teaching 
pharmacy law, Dr. Buffington repeatedly demonstrated a surprising 
misconception that the DEA and the subject administrative hearings 
involved only criminal matters. Despite testifying at a hearing in 
which DEA was obviously evaluating, in part, the Respondent's 
controlled substance dispensing practices, he maintained that although 
the DEA administrator's findings are binding upon DEA registrants, this 
does not include every pharmacist, and such findings would relate to 
criminal issues rather than the scope of practice. Tr. 1237. 
Furthermore, he maintained that DEA is a law enforcement agency and 
determines criminality, not medical decision-making or pharmacologic 
decision-making over the use of medications. Tr. 1245. Accordingly, he 
argued, there is no requirement that a pharmacist *\H\ learn about DEA 
administrative decisions or be familiar with or read the Federal 
Register as the DEA does not have jurisdiction over pharmacy practice. 
Tr. 1168-69, 1176-77. The Respondent is not herein involved with the 
criminal arm of the DEA, it is involved with its regulatory arm. And in 
fact, the DEA [publishes final orders in administrative proceedings 
involving doctors, pharmacies, and other DEA registrants, which provide 
final adjudications on the public record of DEA's expectations for 
current and prospective members of the registrant community regarding 
their obligations under the CSA, in particular how the provisions of 
the CSA are adjudicated in enforcement actions.] \52\ [Omitted for 
clarity.] \53\
---------------------------------------------------------------------------

    *\H\ DEA regulates pharmacies, not pharmacists. Because the 
pharmacy is the registrant, it is incumbent on the pharmacy to be 
familiar with DEA decisions and create pharmacy policies that ensure 
that pharmacists are fulfilling their corresponding responsibility. 
See Suntree Pharmacy and Suntree Medical Equipment, LLC, 85 FR 
73,753, 73,770 (2020); see also S&S Pharmacy, Inc., 46 FR 13,051, 
13,052 (1981).
    \52\ [Omitted for clarity.]
    \53\ [Omitted for clarity.]
---------------------------------------------------------------------------

The ``Standard of Care'' Applied by Dr. Buffington Was Less Credible 
Than Dr. Schossow's
    Similarly, Dr. Buffington suffered diminished credibility in that 
he relied on the reasonable, prudent pharmacist \54\ ``standard of 
care'' applicable to medical malpractice negligence suits (Fla. Stat. 
Sec.  766.102) rather than on the pharmacist's professional standards, 
i.e., ``in the course of his professional practice.'' \55\ As the 
Government noted in its post-hearing brief, the medical malpractice 
standard of care under Sec.  766.102 is not wholly consistent with [the 
usual course of professional practice].\56\ See Fl. Admin. Code Ann. r. 
64B16-27.800, .810, and .831; Fl. St. Sec. Sec.  465.103(6)(14), 
465.016, 465.023, 893.04(1). [Furthermore, Sec.  766.102 does not even 
apply to pharmacists. It applies to ``healthcare providers,'' which is 
defined to exclude pharmacists.*\I\]
---------------------------------------------------------------------------

    \54\ [Omitted for clarity.]
    \55\ [Omitted for clarity.]
    \56\ The ``prevailing professional standard of care,'' which 
under Florida law is defined as ``that level of care, skill, and 
treatment which, in light of all relevant surrounding circumstances, 
is recognized as acceptable and appropriate for reasonably prudent 
similar heath care providers.'' Sec.  766.102, Fla. Stat. (emphasis 
added).
    *\I\ Florida Statute Sec.  766.102 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.
    Pharmacists are administered under chapter 465.
---------------------------------------------------------------------------

    [Omitted.] \57\ \58\ [Dr. Schossow's testimony on the standard of 
care and

[[Page 72725]]

the usual course of professional practice was informed by numerous 
materials, such as federal regulations, expert testimony from past DEA 
administrative decisions, relevant Florida statutes and regulations, 
Florida mandatory continuing education, on-the-job training, materials 
promulgated by the CDC and FDA, and accepted practices within the 
profession. Tr. 408-09, 434-36, 451-55, 476, 888-94, 912-16, 927-28. On 
the other hand, Dr. Buffington's testimony about the standard of care 
and the usual course of professional practice did not appear to be 
informed by all of these materials and appeared to rely in part on an 
inapplicable Florida Statute.] Thus, Dr. Buffington's conclusory 
opinions that the various red flags identified by Dr. Schossow were 
unfounded are accordingly diminished in credibility. Similarly, Dr. 
Buffington's refutation of Dr. Schossow's opinions regarding the 
standard of care, based upon a disjointed source, such as a single 
Florida regulation, have diminished credibility.
---------------------------------------------------------------------------

    \57\ [Omitted.]
    \58\ [Omitted.]
---------------------------------------------------------------------------

Dr. Buffington's Testimony Regarding Documentation Was Not Credible
    Dr. Buffington was not always clear in his testimony. He typically 
dismissed the requirement to document the resolution of red flags as 
not required by Florida regulation. However, he also testified that the 
standard of care for a pharmacist in Florida is based on the level of 
care that a reasonable pharmacist would use in like circumstances and 
reasonable pharmacists could disagree about what the requirements are 
for documentation of the resolution of red flags in the State of 
Florida. Tr. 1101, 1249. This nebulous standard leaves the requirement 
for documentation of the resolution of red flags apparently debatable 
among reasonable pharmacists--hardly a workable standard.
Dr. Buffington's Testimony About ``Red Flags'' Was Inconsistent and Not 
Credible
    Dr. Buffington expressed disdain for the use of the term ``red 
flags,'' \59\ but his understanding of the term was not always clear. 
He sometimes noted that a red flag was something which a pharmacist 
needed to consider, consistent with Dr. Schossow's testimony. However, 
he more frequently referred to it as a hard stop, precluding the 
filling of the prescription, which is inconsistent with Dr. Schossow's 
testimony.\60\ Tr. 1173. This was surprising, as his CV reveals he had 
officially conferred with the DEA over the use of the term red flags, 
but to no avail. He suggested ``yellow light'' as a more appropriate 
term for matters which required investigation. He also observed that 
any confusion was partly due to DEA's failure to provide meaningful 
guidance to the regulated community as to red flags.\61\ Later, as 
noted above, Dr. Buffington advised that the Florida professional 
standards did not require documentation of findings by the pharmacist. 
Tr. 1135, 1171. He counseled that reasonable pharmacists could disagree 
whether documentation was required by the pharmacist, a nebulous and 
unworkable standard. Yet Dr. Buffington testified that the Respondent 
complied with his obligation to document red flags, even though no 
documentation resolving the subject red flags appear in the records. 
Tr. 1109, 1112.
---------------------------------------------------------------------------

    \59\ [Omitted for clarity.]
    \60\ [Dr. Schossow defined ``red flags'' as circumstances 
surrounding a prescription that cause a pharmacist to take pause, 
including signs of diversion or the potential for patient harm. Tr. 
446. Omitted remainder of footnote.]
    \61\ Whether suspicious circumstances are referred to as ``red 
flags'' or ``yellow lights'', or whether the Agency updated its 
Pharmacist's Manual, the Agency has consistently [credited the 
testimony of pharmacy experts] in published decisions out of Florida 
that suspicious circumstances must be investigated and resolved, 
with such resolution documented.
---------------------------------------------------------------------------

    I credit Dr. Schossow's testimony over Dr. Buffington's regarding 
the requirement of documentation of red flags (yellow lights in Dr. 
Buffington's vernacular) within the applicable standard of care and 
Florida course of professional practice in pharmacy. Dr. Schossow's 
testimony in that regard was logical and internally consistent. [Dr. 
Schossow emphasized that documentation is important for patient safety 
and continuity of care. Tr. 441-42, 479-80, 640-41.]
    Although Dr. Buffington often noted that the Respondent complied 
with the regulatory requirements set out in the Florida statutes and 
regulations in defending his opinion that the Respondent acted 
appropriately as to the allegations (Tr. 1110-13, 1118, 1135, 1141, 
1144, 1171), it is important to note that compliance with the letter of 
the Florida statutes and regulations is no defense to a finding that 
the Respondent violated the standard of professional practice. Cohn v. 
Department of Professional Regulation, 477 So.2d 1039, 1042-43, 
District Court of Appeal of Florida, Third District (1985).
    [Omitted for brevity.]
Dr. Buffington's Testimony About a Pharmacist's Corresponding 
Responsibility Was Not Credible
    Dr. Buffington also applied a series of presumptions, which [are 
inconsistent with a pharmacist's] corresponding responsibility. He 
indicated that the presumption was to fill a prescription, unless 
evidence revealed that it should not be filled. However, the pharmacist 
has an affirmative, not passive, corresponding obligation to 
investigate each prescription. See 21 CFR 1306.04(a); see also Fla. 
Stat. Sec.  893.04(2)(a) (``[a] pharmacist may not dispense a 
controlled substance listed in Schedule II, Schedule III, or Schedule 
IV to any patient or patient's agent without first determining, in the 
exercise of her or his professional judgment, that the prescription is 
valid'') (emphasis added).*\J\ The onus is on the pharmacist to confirm 
the validity of each controlled prescription. Under federal law, a 
[pharmacy has a corresponding responsibility to ensure that a 
prescription for a controlled substance ``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).] \62\
---------------------------------------------------------------------------

    *\J\ I am not finding a violation of this statute because it was 
not referenced in the OSC.
    \62\ See JM Pharmacy Grp., Inc., d/b/a Farmacia Nueva & Best 
Pharma Corp., 80 FR 28667, 28669 (2015). Thus, the Government can 
prove a violation by showing either that the pharmacist filled a 
prescription (1) notwithstanding his/her actual knowledge that the 
prescription lacked a legitimate medical purpose, or (2) being 
willfully blind to (or deliberately ignorant of) the fact that the 
prescription lacked a legitimate medical purpose. See id. at 28,671-
72. [Omitted for clarity.]).
---------------------------------------------------------------------------

Dr. Buffington's Testimony on the ``Trinity'' Cocktail and Other Drug 
Combinations Was Inconsistent and Confusing
    Dr. Buffington's [testimony about a pharmacist's obligations when 
customers present prescriptions for potentially dangerous drug 
combinations, such as the ``trinity'' cocktail or the opioid/
benzodiazepine combination, was inconsistent and confusing. Although 
Dr. Buffington acknowledged that pharmacists need to consider the 
potential adverse effects of certain drug combinations,*\K\ at other

[[Page 72726]]

times he insisted that prescriptions for the ``trinity'' cocktail were 
always appropriate. For example, Dr. Buffington testified:
---------------------------------------------------------------------------

    *\K\ See, e.g., Tr. 1116 (Dr. Buffington's testimony that a 
pharmacist would be expected to ``look at the impact'' of a patient 
taking an opioid and a benzodiazepine concurrently, but that there 
is no default presumption that they cannot be prescribed together), 
id. at 1118 (testifying that the FDA's black box warning informs 
practitioners of ``potential complications,'' but that it does not 
mean a pharmacist cannot dispense these two drugs together), id. at 
1119 (testifying that a pharmacist should conduct an evaluation when 
a patient presents a prescription for an opioid, a benzodiazepine, 
and a muscle relaxant, and should have discussions with the 
patient).


    The three together is always okay. The decision to not fill 
based on another variable may absolutely be the final decision of 
the pharmacist. It doesn't make the fact that you can't do three 
together so the only thing would be is if you determined that it was 
for an inappropriate use. It's not that the three were used 
together. If you became knowing that it was for an inappropriate 
use, not that the three were prescribed together. If even the 
colloquial term and the slang of red flags is an inference to things 
that you should look at and evaluate, not these are something we 
count and you are in trouble if your count hits a threshold. That's 
---------------------------------------------------------------------------
a disingenuous attempt at an investigation.

Tr. 1254. When asked whether he would document his decision to fill the 
``trinity'' cocktail, Dr. Buffington testified that the act of filling 
the prescription was all the documentation that was needed:

    No, sir. I would document by the assessment and filling of the 
prescription. If it didn't get filled then it didn't get filled and 
that is documentation in and of itself. If it is filled then that's 
documentation that was filled. If you would only record additional 
notations--if you felt there was an issue to reconcile. The three 
together are not an issue to not be filled.

Tr. 1261. Dr. Buffington's testimony on drug cocktails was sometimes 
confusing and his attempts to advocate for Respondent colored his 
responses. However, I find that Dr. Buffington's testimony was 
generally consistent with Dr. Schossow's testimony that drug cocktails 
are a red flag (or yellow flag) that must be considered by the 
pharmacist prior to dispensing. Dr. Schossow testified that it is a red 
flag if opioids and benzodiazepines are prescribed together because 
they are both central nervous system depressants, which can cause 
sedation, respiratory depression, overdose, coma, and death. See, e.g. 
Tr. 530-34. Dr. Buffington also acknowledged that this drug combination 
can cause adverse effects (see, e.g., Tr. 1116, 1118-19), although he 
attempted to minimize the apparent danger posed by the combination of 
opioid, benzodiazepine and muscle relaxant, by highlighting that other 
even non-controlled medications, and alcohol, can produce dangerous 
reactions. Tr. 1243, 1255. Thus, while I find that Dr. Buffington's 
testimony on this issue is entitled to minimal weight because of its 
inconsistency, I find that it is generally supportive of my conclusion 
that prescriptions for the ``trinity'' cocktail or the opioid/
benzodiazepine combination are a red flag that a pharmacist must 
address and resolve before dispensing.] [Omitted.] *\L\ \63\ \64\ \65\
---------------------------------------------------------------------------

    *\L\ Dr. Buffington offered confusing testimony about how a 
pharmacist might react differently to prescriptions for opioids and 
benzodiazepines based on whether the patient was receiving multiple 
benzodiazepines and multiple opioids and based on whether these 
drugs were prescribed by different practitioners. Tr. 1117. In its 
Exceptions, Respondent argued that the RD mischaracterized this 
testimony. Resp Exceptions, at 16. I find that this testimony is 
irrelevant to my Decision and I have omitted the RD's references to 
it. Based on Dr. Schossow's credible expert testimony (supported by 
portions of Dr. Buffington's testimony), I find that concurrent 
prescriptions for an opioid and a benzodiazepine are a red flag that 
must be addressed, resolved, and documented, prior to dispensing. 
Dr. Buffington's contested testimony addresses what factors a 
pharmacist might consider in determining whether the drug cocktail 
red flag can be resolved in a particular situation. Dr. Buffington 
did not testify that any of these factors were relevant to any of 
Respondent's customers in this case, nor did he point to any 
documentation in Respondent's files indicating that these factors 
impacted Respondent's decision to fill any prescriptions. Therefore, 
this testimony does not impact my determination of whether 
Respondent's dispensing of controlled substances was within the 
usual course of professional practice in Florida.
    \63\ [Omitted for clarity.]
    \64\ [Omitted for clarity.]
    \65\ [Omitted for clarity.]
---------------------------------------------------------------------------

Dr. Buffington's Testimony on Tallying Red Flags Was Argumentative and 
Not Credible
    Dr. Buffington's position that it was improper to ``count'' red 
flags to increase the suspicion of improper behavior is contrary to 
[Dr. Schossow's credible testimony that a pharmacist must consider the 
combination of red flags presented by each prescription. See, e.g., Tr. 
956-57 (testifying that each prescription ``is its own individual 
entity'' and the distance red flag should be assessed along with the 
other red flags with the prescriptions). Dr. Buffington's testimony 
seemed to be aimed at criticizing DEA rather than offering a measured 
opinion about a pharmacist's obligations in the usual course of 
professional practice in Florida.].\66\
---------------------------------------------------------------------------

    \66\ [Prior Agency decisions have noted, based on credible 
expert testimony, that a] pharmacy's filling of multiple 
prescriptions containing a variety of red flags can support the 
conclusion that the pharmacy violated its corresponding 
responsibility under 21 CFR 1306.04 due to the pharmacy's actual 
knowledge or its willful blindness of the prescriptions' 
illegitimate nature. Pharmacy Doctors Enters. d/b/a Zion Clinic 
Pharmacy, 83 FR at 10,896-97 (citing Hills Pharmacy, L.L.C., 81 FR 
at 49836-39; The Medicine Shoppe, 79 FR 59,504, 59,512-13 (2014); 
Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 & 5195, 77 FR at 
62,317-22; and E. Main St. Pharmacy, 75 FR 66,149, 66,163-65 (2010).
---------------------------------------------------------------------------

Partiality
    Finally, Dr. Buffington displayed signs of partiality. The 
credibility of expert witnesses, and thus their value to the 
factfinder, is based first upon their evident impartiality. An expert 
witness's hiring by a party contestant presents the obvious profit 
consideration and potential motivation to appease his employer. Beyond 
the ubiquitous profit motivation, evidence of overt partiality can be 
telling. Indications of partiality may arise when an expert appears to 
argue its employer's case in his responses. Another may be where the 
expert is more amenable or solicitous to his employer's questions than 
of those posed by the party opponent, or is even contentious with 
properly posed inquiries by the opposing party. Dr. Buffington 
exhibited all of those features.
    Dr. Buffington exceeded the scope of his qualified expertise by 
commenting on the efficacy of the investigation, and, in his view, the 
ill motives of the investigators, despite being cautioned not to do 
so.\67\ Dr. Buffington exhibited other indications of partiality. He 
invaded the province of the factfinder. He concluded there was no 
intent on the part of the Respondent to violate his subject 
professional responsibilities.\68\ See, e.g., 1131-32, 1134-35. He 
volunteered that the Government presented insufficient evidence to 
prove their case. He was openly advocating the Respondent's case. His 
subjectivity and partiality were well exposed.
---------------------------------------------------------------------------

    \67\ The Tribunal advised Dr. Buffington not to give his opinion 
about whether the investigation was appropriate. Tr. 1254. The 
Tribunal reiterated that this not a criminal matter, but rather an 
administrative proceeding and directed Dr. Buffington to focus on 
his expertise as it relates to pharmacy law, etc. Tr. 1254-55.
    \68\ Specifically, Dr. Buffington testified that there was no 
evidence presented in this case that a pharmacist in the State of 
Florida at Gulf Med Pharmacy was knowingly aware. Tr. 1134. He 
believed that Gulf Med also did not ``turn a blind eye'' or ``bur[y] 
their head in the sand'' when Gulf Med pharmacists were presented 
with issues due to red flags because the Florida pharmacy statutes, 
and administrative rules require a pharmacist use professional 
judgment and there is no requirement that this needs to be 
documented. Tr. 1135. He testified that there were no breaches of 
the pharmacist's responsibilities or that the pharmacist had 
breached a duty. Tr. 1131-32.
---------------------------------------------------------------------------

    [The ALJ does not make an explicit credibility finding on Dr. 
Buffington's testimony, although he identifies multiple inconsistencies 
and highlights Dr. Buffington's partiality. Based on the RD's 
criticisms of Dr. Buffington's testimony, and based on the fact that 
the RD generally gave greater weight to Dr. Schossow's expert testimony 
than to Dr.

[[Page 72727]]

Buffington's in his legal analysis, it is evident that the ALJ found 
Dr. Buffington's opinions to be generally inconsistent, unreliable, and 
lacking in credibility. I agree with that conclusion. Regarding Dr. 
Schossow's credibility, I agree with the ALJ that she demonstrated a 
commanding grasp of pharmacy practice and the standard for pharmacists 
in addressing ``red flags.'' I also find that Dr. Schossow's opinions 
were consistent and credible and entitled to significant weight in my 
Decision.]
Credibility of Non-Expert Witnesses
    I found DI to be credible, despite several peripheral matters in 
which his memory failed him. I found both patient witnesses to be fully 
credible. However, L.V.'s anecdotal opinion that the Respondent's 
medication pricing she found reasonable does not diminish the 
credibility of Dr. Schossow's studied conclusion that the subject 
prices were exorbitant. I also found Dr. N. to be fully credible. Dr. 
Fertil's credibility will be discussed in the Analysis section.

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 red flags of diversion without documenting the resolution of 
those red flags, in violation of state law under the Florida 
Administrative Code, and state requirements for the minimum standard of 
care, and that its continued 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). ALJ Ex. 1.
    In the adjudication of a revocation or suspension of a DEA COR, the 
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 
20727, 20734 (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 38363, 38364 (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 v. DEA, 419 F.3d 477, 482 (6th Cir. 
2005). See also Ronald Lynch, M.D., 75 FR 78745, 78754 (2010) (holding 
that the Respondent's attempts to minimize misconduct undermined 
acceptance of responsibility); George C. Aycock, M.D., 74 FR 17529, 
17543 (2009) (finding that much of the respondent's testimony 
undermined his initial acceptance that he was ``probably at fault'' for 
some misconduct); Jayam Krishna-Iyer, M.D., 74 FR 459, 463 (2009) 
(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. Shoppe-Jonesborough, 73 FR at 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 v. DEA, 412 F.3d 165, 183 (D.C. Cir. 
2005), 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 Sec.  8 (1947).

Analysis of Dispensing Allegations

Failure To Resolve and To Document Red Flags
    The Government alleges that the Respondent filled numerous 
prescriptions for ten patients that raised red flags of drug abuse and/
or diversion, to include drug cocktails; dangerous combinations; 
traveling long distances; prescriptions for the highest commercially 
available strength; paying in cash; paying unusually high prices in 
cash; and therapeutic duplication. ALJ Ex. 1. The Government further 
alleges that the Respondent failed to resolve these red flags, or 
failed to document

[[Page 72728]]

their resolution. Id. The Government claims that by filling these ten 
patients' controlled substance prescriptions and failing to resolve the 
red flags they presented, 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. Furthermore, the Government claims that by failing to 
resolve red flags and to document that resolution in the patients' 
profiles, the Respondent violated Florida Administrative Rule 64B16-
27.800 and 27.810. Id.
    With respect to each patient, the Government presented documentary 
evidence and testimony from its pharmacy expert, Dr. Schossow, that the 
Respondent filled numerous controlled substance prescriptions that 
raised red flags, including drug cocktails, dangerous combinations, 
patients traveling long distances, prescriptions for the highest 
commercially available strength, patients paying in cash, and patients 
paying unusually high prices in cash. The Government further presented 
evidence that the Respondent failed to document any resolution of these 
red flags in the patients' profiles.
    The Government's expert conceded that each of the red flags that 
she identified were resolvable. Therefore, the question becomes, 
whether the Respondent resolved them prior to dispensing the controlled 
substance. The Government's expert testified that documentation of the 
resolution of red flags is required by the pharmacists' standard of 
professional responsibilities. The Respondent and his expert testified 
that no such documentation is required under Florida law or in the 
course of professional practice. Alternately, Dr. Buffington mused that 
reasonable pharmacists could differ whether documentation was required. 
However, despite believing that he had no professional responsibility 
to do so, the Respondent testified that he fully resolved all red flags 
and filled the subject prescriptions consistent with his professional 
judgment and with Florida law. Tr. 1360-64. The Respondent's expert 
testified that he observed no red flags within the record. Tr. 1162, 
1241, 1277-78. Furthermore, he testified that even if there were red 
flags, there was no requirement to document red flags, but the 
Respondent resolved all red flags and documented their resolution. 
However, there is little-to-no documentary resolution of the red flags 
credibly identified by Dr. Schossow (or yellow lights in Dr. 
Buffington's vernacular) in evidence, as far as I could discern.\69\ 
The evidentiary record consists of the relevant PDMP records; subject 
physical prescriptions; the subject patient profiles, including 
comments by the pharmacist in the comments section; dispensing logs; 
and any medical records which were part of the pharmacy records, all 
obtained through a series of administrative subpoenas. Tr. 466-67.
---------------------------------------------------------------------------

    \69\ The Respondent submitted an excel spreadsheet encompassing 
the information contained in the subject patient profiles within the 
PioneerRx program. I could [not discern any relevance to the 
spreadsheet in terms of documenting Respondent's attempts to address 
and resolve the red flags that Dr. Schossow identified].
---------------------------------------------------------------------------

    The Government suggests that the factfinder should infer the 
absence of the subject documentation resolving red flags demonstrates a 
failure to resolve the red flags. Superior Pharmacy, 81 FR 31,309, 
31,314 (2016). However, the Respondent's expert, who reported 
experience with the PioneerRx computer program testified that there 
were additional fields in the PioneerRx database referred to as 
Medication Therapy Management and that there were multiple other tabs 
and therefore [there might have been] additional information that the 
investigators failed to obtain from the Respondent. Tr. 1163-64. 
[However, as discussed in more detail below, Respondent was served with 
three subpoenas that required the production of all documents that 
contained any discussion or resolution of red flags. Thus, Dr. 
Buffington's testimony that there might have been additional materials 
resolving red flags appeared to be speculative and is not entitled to 
any weight.] Furthermore, Dr. Schossow testified that the few examples 
of the pharmacist's comments highlighted at the hearing did not resolve 
the subject red flags.
Administrative Subpoenas
    The Government's attempts to obtain documents from the Respondent 
began with the service of the AIW and administrative subpoena 
requesting various records from the Respondent on February 14, 2018. It 
should be noted that subpoenas are not requests, which can summarily be 
ignored by the recipient. They are duly authorized commands by the 
Attorney General and enforceable by the U.S. District Court. See 21 
U.S.C. 875, 876, 880.
    The first administrative subpoena was highly detailed and specific 
in its commands. It required, in part, copies of Respondent's patient 
profiles for certain listed patients, copies of ``[a]ny and all other 
records . . . maintained pursuant to the requirements of Florida 
Statutes and Florida Administrative Rule 64B16-27.800 documenting the 
steps taken to avoid or resolve any issues with the prescriptions 
presented by'' those same listed individuals; and copies of ``[a]ny 
other documentation kept by'' the Respondent ``in connection with the 
filling of prescriptions or providing medical treatment'' for those 
named individuals, including dispensing logs or reports, for those 
listed individuals. GX 3; Tr. 35, 41-42, 45, 64-65. Although, as Dr. 
Buffington noted, the term red flags does not appear in Florida 
regulations, the documents required by the subpoena would plainly 
include the type of documentation generated to resolve red flags.\70\
---------------------------------------------------------------------------

    \70\ [Footnote omitted.]
---------------------------------------------------------------------------

    At the February 14, 2018 visit and search of the Respondent 
pharmacy, the Government's team of investigators included a computer 
technician. By all accounts, Dr. Fertil was cooperative and assisted 
the investigators in locating pharmacy and patient records. He helped 
connect the Government personnel with a technician from PioneerRx in 
order for the investigators to retrieve information from the PioneerRx 
record system. Other than that, the evidence discloses that Dr. Fertil 
did not actively collect any documents in response to the warrant and 
first administrative subpoena. Rather, he left it to the investigators 
to collect the required documents, assisting them with access to 
records and to the PioneerRx system, as they required. He placed them 
in touch with personnel from PioneerRx, who apparently walked them 
through the process of downloading the required material from the 
PioneerRx system. I cannot fault Dr. Fertil's actions on February 14, 
2018. I think he did everything the law required and that the Agency 
would expect. The Government left after apparently retrieving all the 
documents they required. On February 14, 2018, the investigators did 
not retrieve all of the information stored on the PioneerRx system. In 
relevant part, they apparently only obtained screen shots of the first 
of multiple tabs of the PioneerRx system, by printing those.
    In May of 2019, the Government served a second subpoena on the 
Respondent pharmacy. It required production of hardcopies of controlled 
substance prescriptions that Respondent had dispensed from February 15, 
2018, through May 3, 2019, copies of the Respondent's patient profiles 
for certain listed individuals, and, like the first subpoena, copies of 
``[a]ny and all records . . . maintained pursuant to the

[[Page 72729]]

requirements of Florida Statutes and Florida Administrative Rule 64B16-
27.800 for Patient Records, documenting the steps taken to avoid or 
resolve any issues with the prescriptions presented by'' those same 
listed individuals ``reflecting efforts by the pharmacist to exercise 
their corresponding responsibility to assess the validity'' of 
controlled substance prescriptions dispensed to those listed 
individuals. Tr. at 119-21; GX 16.
    In August 2019, DI served a third administrative subpoena on 
Respondent seeking, with respect to Patients J.B., A.B., B.Da., B.Di., 
J.R., and R.R., hardcopies of controlled substance prescriptions that 
Respondent had dispensed to those patients from May 3, 2019, through 
August 9, 2019, copies of the Respondent's patient profiles for those 
patients, and copies of ``[a]ny and all records . . . maintained 
pursuant to the requirements of Florida Statutes and Florida 
Administrative Code 64B16-27.800 for Patient Records, documenting the 
steps taken to avoid or resolve any issues with the prescriptions 
presented by'' those patients ``reflecting efforts by the pharmacist to 
exercise their corresponding responsibility to assess the validity'' of 
controlled substance prescriptions dispensed to those patients. Tr. at 
179-82; GX 33.
Adverse Inference
    The Respondent, through Dr. Fertil, responded to the second and 
third subpoenas by providing records specific to the patients 
identified and dates included. However, the Respondent did not recall 
if he read the subpoenas, or if he supplied everything requested in the 
subpoenas. He only remembered that he supplied the same type of 
information that the Government seized during the service of the search 
warrant and first administrative subpoena on February 14, 2018.
    I can safely conclude that he read the second and third subpoenas, 
as he supplied highly specific information and documents required. 
Regarding the aspect of the May and August subpoenas relating to 
documents required by Florida Administrative Rule 64B16-27.800 for 
Patient Records, he testified he only supplied the same type of records 
the government seized on February 14, 2018, believing that those same 
type of records were what the Government wanted. It was unusual that 
Dr. Fertil could describe his deliberative process in gathering or 
screening records in response to the second and third subpoenas, when 
he could not remember whether he read the subpoenas, nor if he supplied 
everything requested in the subpoenas. The record is also unclear how, 
in May and in August, 2019, he knew exactly what records were retrieved 
by the Government on February 14, 2018, as he testified he left the 
investigators to retrieve the documents they required with the 
assistance of a PioneerRx technician, and the receipt provided him for 
those documents does not disclose that only the first tab of the 
PioneerRx system was copied and seized.\71\ His selective memory loss 
is not credible. If he did not remember even reading the subpoenas, his 
rationale for including and withholding records is not credible.
---------------------------------------------------------------------------

    \71\ In relevant part, the receipt for documents seized on 
February 14, 2018, only references ``profiles printouts'' for GI 18-
351298. GX 4.
---------------------------------------------------------------------------

    Either there were no [records documenting the resolution of red 
flags] in the Respondent's records, or Dr. Fertil ignored the subpoena 
requirements surrounding this [type of] documentation. In either case, 
we can infer that his failure to provide such highly exculpatory 
documentation suggests it does not exist. He testified that he was not 
obligated to resolve red flags and to document their resolution by the 
Florida regulations, but that he did resolve them and document them. 
However, he has not identified or presented any such documentation in 
evidence.\72\ Based on his failure to provide the required 
documentation to the Government in May and August 2019, we can fairly 
infer that no such documentation exists. [Omitted for clarity.]
---------------------------------------------------------------------------

    \72\ Where respondent testified that he had exculpatory 
inventories in his office, but failed to produce them at his 
hearing, the Administrator gave no credit to the testimony ``[i]n 
view of the level of professional exposure attendant upon the 
potential loss of his DEA registration. . . .'' Lesly Pompy, M.D., 
84 FR 57,749, 57,758 (2019). A physician may not expect to vindicate 
himself through oral representations at the hearing about his 
compliance with the standard of care that were not documented in 
appropriately maintained patient records. Lesly Pompy, M.D., 84 FR 
57,749, 57,760 (2019). Pharmacist's testimony that she resolved 
various red flags merited no weight because she failed to produce 
documentary evidence to corroborate her claim. Pharmacy Doctors 
Enters. d/b/a Zion Clinic Pharmacy, 83 FR at 10,887.
---------------------------------------------------------------------------

Failure To Resolve Red Flags
    The Government argues that I should apply the adverse inference 
that the absence of the subject documentation as to the resolution of 
red flags suggests no resolution occurred. [I find that such an 
inference is appropriate in this case.] *\M\ [Omitted.] \73\
---------------------------------------------------------------------------

    *\M\ The ALJ declined to draw an adverse inference that 
Respondent failed to resolve red flags based on Respondent's failure 
to document the resolution of the red flags, citing to the Agency's 
decision in Hills Pharmacy as support. See RD, at 127-28 (citing 
Hills Pharmacy, L.L.C., 81 FR 49,816, 49,835-36 (2016). However, in 
Hills Pharmacy, a former Acting Administrator declined to draw an 
adverse inference based solely on the respondent's failure to 
document red flags on the prescriptions themselves, when other 
materials (such as patient profiles) were not in evidence. The 
Acting Administrator noted that because there was no state or 
federal law that required red flags to be documented on the 
prescriptions themselves, the respondent may have documented the 
resolution elsewhere. Id. In this case, however, the Government 
admitted patient profiles, prescriptions, and other pharmacy records 
into evidence. Additionally, the Government admitted into evidence 
all documents that DEA obtained from Respondent in response to a 
subpoena requesting: (1) All documentation showing the steps taken 
to resolve red flags, and (2) all documentation reflecting efforts 
by Respondent's pharmacists to exercise their corresponding 
responsibility. Thus, I find that it is appropriate in this case to 
infer that Respondent failed to address and resolve red flags based 
on the absence of documentation evidencing attempts to address and 
resolve red flags. Therefore, I apply here, the ``adverse inference 
rule.'' As the D.C. Circuit explained, ``the rule provides that when 
a party has relevant evidence within his control which he fails to 
produce, that failure gives rise to an inference that the evidence 
is unfavorable to him.'' Int'l Union, United Auto., Aerospace & 
Agric. Implement Workers of Am. (UAW) v. Nat'l Labor Relations Bd., 
459 F.2d 1329, 1336 (D.C. Cir. 1972). The Court reiterated this rule 
in Huthnance v. District of Columbia, 722 F.3d 371, 378 (D.C. Cir. 
2013). According to this legal principle, Respondent Pharmacy's 
decision not to provide evidence within its control gives rise to an 
inference that any such evidence is unfavorable to Respondent 
Pharmacy.
    \73\ [Omitted for clarity.]
---------------------------------------------------------------------------

    Dr. Schossow testified that in evaluating a pharmacist's 
performance in the course of professional practice, the failure to 
document the resolution of red flags demonstrated the red flags were 
not resolved. Tr. 465-66. [Based on this testimony, the adverse 
inference, and the inconsistent and not credible testimony of the 
Pharmacist's PIC,] I will conclude [ ] that the failure to document the 
resolution of red flags establishes that the red flags were not 
resolved.

Specific Red Flags

Unusual Distance Traveled [Omitted.] *\N\ \74\
---------------------------------------------------------------------------

    *\N\ The ALJ determined that the Government failed to prove that 
the distances that Respondent's customers traveled to fill their 
prescriptions, which ranged from approximately thirty to fifty 
miles, represented a red flag in this case. I find that it is 
unnecessary for me to determine whether the distances traveled were 
a red flag in this case because the Government has proven that these 
prescriptions presented several additional red flags that Respondent 
did not resolve. I thus conclude that Respondent dispensed 
prescriptions outside the usual course of professional practice in 
Florida based on its failure to resolve these red flags, and I find 
it unnecessary to determine whether the distances traveled 
represented yet another red flag that Respondent failed to resolve.
    \74\ [Omitted.]
---------------------------------------------------------------------------

Payment in Cash
    The Government argues that, in the context of this case, payment in 
cash for

[[Page 72730]]

controlled substances is a red flag, as it may represent an attempt by 
the patient to avoid scrutiny of an insurance carrier, who may 
investigate the propriety of the controlled prescription.\75\ [Dr. 
Schossow testified that cash payments are a red flag because ``drug 
seeker[s] [are] willing to pay more for a drug if they can get the 
drug. They're willing to pay whatever they want, you know, whatever 
they need to pay to obtain the medication.'' Tr. 585-86.] [Omitted.] 
*\O\
---------------------------------------------------------------------------

    \75\ Payment in cash actually refers to payment in currency, 
credit card, or even by check. It does not include payment through 
an insurance carrier or government program payer.
    *\O\ I agree with the ALJ's ultimate conclusion that cash 
payments were a red flag in this case, but I disagree with his 
statement that cash payments were not ``a huge red flag.'' RD, at 
130. I give minimal weight to Dr. Buffington's testimony about the 
red flag of cash payments because it was not grounded in a 
discussion of the Florida usual course of professional practice. Dr. 
Buffington testified that the prices he saw ``were not surprising or 
astonishing,'' but even if they were high, it is ``the patient's 
prerogative'' to pay those prices. Tr. 1193. Dr. Buffington also 
testified that there are many reasons that a patient may pay in 
cash, which is something that the pharmacist can discuss with the 
patient. Id. However, Dr. Buffington did not adequately address the 
concern that cash payments are a red flag because drug seekers are 
willing to pay high prices for a drug. Tr. 585-86. Although I agree 
with Dr. Buffington that there are legitimate reasons that a patient 
may pay in cash, I find based on Dr. Schossow's credible expert 
testimony that cash payments were a red flag in this case, and it 
was outside the usual course of professional practice for Respondent 
to fail to address, resolve, and document this red flag, 
particularly in combination with the other red flags.
---------------------------------------------------------------------------

Unusually High Cash Payments
    The Government argues that the payment of inflated prices for 
controlled substances creates a red flag of diversion or abuse. 
[Omitted.] *\P\ The Government offered the expert opinion of Dr. 
Schossow, who, although she has not served a customer in seven years, 
has had extensive and recent experience in the average pricing of the 
subject medications in Florida. Tr. 405, 564-65. She managed a 
rejection que, and more recently reviews ``High Dollar Reports'' for 
Blue Cross/Blue Shield of Florida. Tr. 403-04. She testified that 
pharmacies throughout Florida charge twenty to twenty five percent over 
acquisitions costs, while the Respondent's prices were in excess of 
that, sometimes more than triple the market rate. Tr. 565-66. Dr. 
Schossow testified that the excessive prices charged by the Respondent 
represented a red flag, which were not resolved by the Respondent. Her 
subject opinion is credible and consistent with Agency [decisions that 
have credited expert testimony that cash payments at high prices for a 
large quantity of controlled substances are suspicious.\76\ I find 
based on Dr. Schossow's credible expert testimony that it was a red 
flag that Respondent's customers were willing to pay very high prices 
in cash for controlled substances.]
---------------------------------------------------------------------------

    *\P\ I have omitted, for brevity, the RD's discussion of his 
decision to exclude the Government's evidence of national average 
costs of drugs, which was intended to show that Respondent charged 
high prices for controlled substances. There is other evidence on 
the record that shows that Respondent charged high prices for 
controlled substances--specifically, Dr. Schossow's testimony (which 
is also discussed in this section) that Respondent's prices greatly 
exceeded its acquisition costs. Therefore, the Government adequately 
supported its contention that Respondent charged high prices even 
without evidence of national average drug costs. Thus, I need not 
resolve whether the ALJ properly excluded the evidence of national 
average costs of drugs.
    \76\ `` `[A]ny reasonable pharmacist knows that a patient that . 
. . wants to pay cash for a large quantity of controlled substances 
is immediately suspect.' '' Jones Total Health Care Pharmacy, 
L.L.C., 81 FR 79,188, 79,194 (2016), pet. for rev. denied, 881 F.3d 
823 (11th Cir. 2018) (quoting East Main Street Pharmacy, 75 FR 
66149, 66158 (2010)). Where a pharmacy's prices for controlled 
substances far exceed prices charged by other pharmacies, it may be 
inferred that the pharmacy knows that those purchasing those high-
priced controlled substances are either abusing or diverting them. 
Jones Total Health Care Pharmacy, L.L.C., 81 FR 79,188, 79,199-200 
(2016), pet. for rev. denied, 881 F.3d 823 (11th Cir. 2018) (citing 
United States v. Leal, 75 F.3d 219, 223 (6th Cir. 1996)).
---------------------------------------------------------------------------

Dangerous Combinations

    The Government highlighted two medication combinations the 
Respondent dispensed. They argued these combinations represented red 
flags, which were not resolved by the Respondent. They were the 
combination of an opioid and a benzodiazepine, which has a ``black 
box'' warning from the FDA. This combination has the risk of 
respiratory suppression and overdose. Although it may ultimately be 
justified as therapeutic depending on the circumstances, it requires 
investigation, resolution and documentation by the pharmacist.
    The Respondent also filled numerous prescriptions of an opioid, a 
benzodiazepine, and a muscle relaxant, that raised multiple red flags 
of drug abuse and/or diversion. Not only did Dr. Schossow opine that 
these red flags are recognized by Florida's standard of pharmacy 
practice, but all of these red flags [have been recognized by DEA as 
indicators] of drug abuse and/or diversion.\77\
---------------------------------------------------------------------------

    \77\ Oxycodone, carisoprodol, and alprazolam are a combination 
of drugs that the DEA has encountered in investigations of 
registrants ``engaged in blatant drug dealing.'' Sigrid Sanchez, 
M.D., 78 FR at 39,332 n.2 (2013) (citing Paul H. Volkman, M.D., 73 
FR 30,630 (2008)). ``The combination of a benzodiazepine, a narcotic 
and carisoprodol is `well known in the pharmacy profession' as being 
used `by patients abusing prescription drugs.' '' Jones Total Health 
Care Pharmacy, L.L.C., & SND Health Care, L.L.C., 81 FR 79,188, 
79,194 (2016), aff'd, 881 F.3d 823 (11th Cir. 2018) (quoting E. Main 
St. Pharmacy, 75 FR 66149, 66163 (2010)). Several DEA decisions have 
discussed the abuse of the ``trinity'' cocktail, which typically 
consists of carisoprodol, oxycodone, and alprazolam. Holiday CVS, 77 
FR at 62,321 n.22 (citing East Main Street Pharmacy, 75 FR 66,149, 
66,158 (2010) (noting expert's testimony that ``[i]t is well known 
in the pharmacy profession [that] the combination of a 
benzodiazepine, narcotic pain killer, and Soma [the branded version 
of carisoprodol] [is] being used by patients abusing prescriptions 
drugs'') and Paul J. Volkman, M.D., 73 FR at 30,637-38, aff'd, 
Volkman v. DEA, 567 F.3d 215 (6th Cir. 2009) (discussing expert's 
testimony regarding abuse of drug cocktails of oxycodone, 
alprazolam, and carisoprodol)).
---------------------------------------------------------------------------

    Furthermore, the Government's evidence shows that the Respondent 
failed to document sufficient resolution of these red flags. Although 
the Respondent testified that he resolved all red flags or suspicious 
circumstances, there's no documentary evidence to corroborate his 
claim. Pharmacy Doctors Enters. d/b/a Zion Clinic Pharmacy, 83 FR 
10876, 10887 (2018).
Dispensing Immediate Release Opioids in Combination With Long-Acting 
Opioids
    Dr. Schossow testified that dispensing immediate release opioids in 
combination with long-acting opioids, in which the MME of the immediate 
release is greater than the MME of the long-term opioids does not make 
pharmacologic sense and creates a dangerous risk of overdose. Tr. 599-
600. She explained that the long-acting opioids had a long half-life 
and remained in the patient's system for a long period, relieving pain. 
This would reduce the need for large amounts of immediate release 
opioids. Although Dr. Buffington defended the use of long-acting 
opioids in combination with immediate release opioids, he did not 
directly address Dr. Schossow's point relating to the comparative MME 
levels of the two. Tr. 1121-22, 1129-30. I credit Dr. Schossow's 
testimony that this combination of opioids represented a red flag and 
that the red flag went unresolved by the Respondent.
    [Omitted for clarity and brevity.*\Q\ As discussed in more detail 
below, I find

[[Page 72731]]

that Respondent acted outside the usual course of professional practice 
by repeatedly filling prescriptions without addressing and resolving 
red flags, and without documenting the resolution. See 21 CFR 1306.06. 
I further find that Respondent violated its corresponding 
responsibility by filling prescriptions that Respondent knew were not 
prescribed for a legitimate medical purpose, or was willfully blind to 
such. See 21 CFR 1306.04.] \78\
---------------------------------------------------------------------------

    *\Q\ The ALJ concluded that Florida law requires pharmacists to 
document in the patient profile the steps that they take to resolve 
red flags. See, e.g., RD, at 134-35 (citing Fla. Admin. Code r. 
64B16-27.800). The Respondent takes Exception to this conclusion, 
arguing that there is no Florida law or regulation that mandates 
pharmacists to document the resolution of red flags. Resp 
Posthearing, at 5-12. I need not address whether Florida law 
requires pharmacists to document red flag resolution, however, 
because Dr. Schossow offered credible expert testimony that failing 
to document red flag resolution is outside the usual course of 
professional practice in Florida. Although Dr. Buffington offered 
conflicting testimony that documentation is not required in the 
usual course of professional practice, I agree with the ALJ that Dr. 
Schossow's testimony regarding documentation requirements was more 
credible.
    \78\ [Footnote omitted.]
---------------------------------------------------------------------------

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 \79\ 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'':
---------------------------------------------------------------------------

    \79\ 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 15227, 15230 (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 37507, 37508 (1993); see also Morall, 412 
F.3d at 173-74 (D.C. Cir. 2005); Henry J. Schwarz, Jr., M.D., 54 FR 
16422, 16424 (1989). Moreover, the Agency is ``not required to make 
findings as to all of the factors,'' Hoxie, 419 F.3d at 482; 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.'' Krishna-Iyer, 74 FR at 462.

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.\80\
---------------------------------------------------------------------------

    \80\ 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).
---------------------------------------------------------------------------

    The DEA often analyzes Factor Two and Factor Four 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); Id. This analysis focuses on the registrant's acts 
that are inconsistent with the public interest, rather than on a 
registrant's neutral or positive acts and experience. Kansky J. 
Delisma, M.D., 85 FR 23,845, 23,852 (2020) (citing Randall L. Wolff, 
M.D., 77 FR 5106, 5121 n.25 (2012). The Agency has acknowledged that 
even a considerable level of benign or even commendable experience 
could be easily outweighed by evidence demonstrating that continued 
registration was inconsistent with the public interest.\81\
---------------------------------------------------------------------------

    \81\ See, e.g., Paul J. Caragine, Jr., 63 FR 51,592, 51,560 
(1998) (``[E]ven though the patients at issue are only a small 
portion of Respondent Pharmacy's patient population, his prescribing 
of controlled substances to these individuals raises serious 
concerns regarding [his] ability to responsibly handle controlled 
substances in the future.''); Med. Shoppe-Jonesborough, 73 FR at 386 
(finding that the misconduct outweighed the fact that only a 
relatively small portion of the respondent's patient population was 
involved).
---------------------------------------------------------------------------

    Likewise, under Factor Four, the DEA analyzes an applicant's 
compliance with Federal and state controlled substance laws with the 
analysis focusing on violations of state and Federal laws and 
regulations concerning controlled substances. Delisma, 85 FR at 852 
(citing Volkman v. DEA, 567 F.3d 215, 223-24 (6th Cir. 2009)) 
(citations omitted). As DEA has held in the past, a registrant's 
``ignorance of the law is no excuse'' for actions that are inconsistent 
with responsibilities attendant upon a registration. Daniel A. Glick, 
D.D.S., 80 FR 74,800, 74,809 (2015) (quoting Sigrid Sanchez, M.D., 78 
FR 39,331, 39,336 (2013) (citing Patrick W. Stodola, 74 FR 20,727, 
20,735 (2009) and Hageseth v. Superior Ct., 59 Cal. Rptr. 3d 385, 403 
(Ct. App. 2007) (a ``licensed health care provider cannot `reasonably 
claim ignorance' of state provisions regulating medical practice''))). 
Under Agency precedent, ``[a]ll registrants are charged with knowledge 
of the CSA, its implementing regulations, as well as applicable state 
laws and rules.'' Id. at 74809 (internal citations omitted).
    [Omitted.] *\R\
---------------------------------------------------------------------------

    *\R\ I disagree with the ALJ's assertion that the testimony of 
J.R. and L.V. constitutes positive dispensing experience under 
Factor Two, and I disagree with the ALJ's conclusion that Factor Two 
weighs in Respondent's favor based on this testimony. Dr. Schossow 
identified several red flags with J.R.'s and L.V.'s prescriptions. 
Dr. Schossow testified that L.V. presented prescriptions for the 
potentially dangerous combination of opioids and benzodiazepines, 
she paid for some prescriptions in cash and others with insurance, 
and she made unusually high cash payments. Tr. 510-28, 758, 767-68, 
772-74, 776, 778. Dr. Schossow reviewed Respondent's records for 
L.V. and did not find any indication that Respondent addressed or 
resolved these red flags. Tr. 529. Respondent did not successfully 
rebut these conclusions. Dr. Fertil testified briefly about his 
interactions with L.V. Respondent's counsel asked him whether he 
``ha[d] any occasion to discuss with patients like J.R. and L.V. 
their restrictions presented for combinations that included a 
benzodiazepine, an opioid, and, in some cases, Soma or 
carisoprodol.'' Tr. 1360. Dr. Fertil confirmed that he had, and he 
also confirmed that he had provided those customers with information 
regarding potential side effects of the combination and discussed 
with them the potential sedative effects. Id. at 1361. Dr. Fertil, 
however, did not testify that he addressed or resolved the red flag 
that the patient was receiving this potentially dangerous drug 
combination, or that he resolved the red flags of unusually high 
cash payments and alternating cash and insurance payments. L.V.'s 
testimony also did not shed light on whether Respondent made any 
attempts to address or resolve these red flags. L.V. testified that 
she was rejected by other pharmacies, and she chose Gulf Med because 
they filled her prescriptions in a timely manner and at a reasonable 
price. Tr. 1303. L.V.'s belief that the prices were reasonable is 
not sufficient to rebut Dr. Schossow's credible expert testimony 
that the prices were high, and that it was a red flag for L.V. to 
pay those prices in cash.
     Likewise, Respondent did not offer testimony or evidence that 
suggested that Respondent made adequate attempts to address or 
resolve the red flags that Dr. Schossow identified with J.R.'s 
prescriptions. Dr. Schossow testified that J.R. presented 
prescriptions for the potentially dangerous ``trinity'' cocktail and 
for multiple benzodiazepines. Although J.R. testified that he 
discussed his many medical problems with Respondent's pharmacists, 
and they answered his questions and provided him with instructional 
material, there is not sufficient evidence on the record that 
Respondent addressed and resolved the red flags with J.R.'s 
prescriptions. Dr. Buffington testified that Respondent made some 
notations in J.R.'s records about conversations with J.R.'s 
physicians and J.R.'s treatment, but he did not point to any 
notations that indicated that Respondent adequately addressed the 
red flags that Dr. Schossow identified. Therefore, I credit Dr. 
Schossow's testimony that Respondent failed to address and resolve 
red flags with J.R.'s and L.V.'s prescriptions prior to dispensing, 
and that Respondent dispensed controlled substances to these 
customers outside the usual course of professional practice in 
Florida and in violation of its corresponding responsibility.

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

[[Page 72732]]

*\S\ Standard of Care as to Charged Violations
---------------------------------------------------------------------------

    *\S\ I am replacing portions of the Standard of Care section in 
the RD with preferred language regarding prior Agency decisions; 
however, the substance is primarily the same.
---------------------------------------------------------------------------

    [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. 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 at 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 at 4730. When a 
pharmacist's suspicions are aroused by a red flag, the pharmacist must 
question the prescription and, if unable to resolve the red flag, 
refuse to fill the prescription. Id.; Medicine Shoppe-Jonesborough, 300 
F. App'x 409, 412 (6th Cir. 2008) (``When pharmacists' suspicions are 
aroused as reasonable professionals, they must at least verify the 
prescription's propriety, and if not satisfied by the answer they must 
refuse to dispense.'').
    Finally, ``[t]he corresponding responsibility to ensure the 
dispensing of valid prescriptions extends to the pharmacy itself.'' 
Holiday CVS, 77 FR at 62,341 (citing Med. Shoppe--Jonesborough, 73 FR 
at 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 at 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 at 62,341.]
    [Text omitted.] *\T\
---------------------------------------------------------------------------

    *\T\ 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)).
---------------------------------------------------------------------------

    In the case before me, the Government presented no evidence that 
the Respondent's pharmacists filled a prescription with actual 
knowledge that the prescriptions were not legitimate. Absent actual 
knowledge, the Government can establish scienter by showing that a 
pharmacist was ``willfully blind (or deliberately ignorant) to the fact 
that the prescription lacked a legitimate medical purpose.'' Id. To 
establish willful blindness, it is necessary to show that a pharmacist 
subjectively believed that there was a high probability that the 
prescription lacked a legitimate medical purpose and that the 
pharmacist deliberately avoided learning the truth. Id. Here, the 
Government argues that the Respondent's failure to document the 
resolution of numerous red flags when it filled many prescriptions 
establishes that the Respondent was willfully blind as to the medical 
legitimacy of those prescriptions. Gov Posthearing, at 34-35.

[[Page 72733]]

    The Government has introduced a preponderance of evidence to prove 
that the Respondent dispensed numerous controlled substance 
prescriptions for at least ten patients. Those prescriptions raised 
classic red flags of drug abuse and/or diversion, to include paying in 
cash, paying high prices in cash, dangerous drug cocktails, and 
combining extended release and immediate release opioids, highest 
strength of the medication, among others.*\U\ The Government also 
introduced the supplied patient profiles for each of these ten 
patients, as well as hardcopy prescriptions, dispensing reports and 
PDMP information. The profiles contain insufficient information, and in 
some cases no information, that [indicates that Respondent took 
adequate steps to address or resolve the red flags raised by each 
prescription]. The evidence reveals a concerning pattern of a pharmacy 
that repeatedly [acted outside the usual course of professional 
practice by failing] to document information needed to resolve red 
flags. This concerning pattern demonstrates that regardless of the 
obvious signs of drug abuse and diversion that are well-known to the 
pharmacy community, the Respondent repeatedly dispensed controlled 
substances and rarely, if ever, documented any information in response 
to those red flags in the patient records. And when the Respondent 
documented information, it was always insufficient to resolve all the 
concerns raised by the prescription.
---------------------------------------------------------------------------

    *\U\ 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. 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).
---------------------------------------------------------------------------

    With respect to the prescriptions in evidence, the Government has 
further demonstrated a violation of the Respondent's corresponding 
responsibility under 21 CFR 1306.04(a). The Government has proven this 
violation through documentary evidence and testimony from its expert 
witness.*\V\
---------------------------------------------------------------------------

    *\V\ Further, the Government introduced evidence that is 
consistent with violations of Florida law. 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.
    I find that the evidence on the record is consistent with 
violations of Florida law, based on Respondent's repeated filling of 
prescriptions without documenting any attempts to address or resolve 
red flags. However, I find that it is unnecessary for me to 
determine whether Respondent violated Florida law, because 
Respondent's repeated violations of federal law are sufficient for 
me to conclude that Respondent's registration is inconsistent with 
the public interest. I do find, however, that the Florida laws in 
this case bolster Dr. Schossow's credible expert testimony that 
pharmacists must conduct a drug utilization review on every 
prescription.
---------------------------------------------------------------------------

    Furthermore, the Respondent failed to rebut or meaningfully 
discredit the Government's case. For the reasons discussed, the 
Respondent and Respondent's expert had diminished credibility. In light 
of the record as to this factor, I find that the Government has proven 
that the Respondent failed to comply with federal law [and the usual 
course of professional practice in Florida] with respect to resolving 
and documenting resolution of red flags of drug abuse and/or diversion, 
and with respect to its corresponding responsibility for the 
prescriptions in evidence.
    The totality of this evidence demonstrates a concerning lack of 
compliance with applicable federal law [and state professional practice 
standards] 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 Factors 
Two and Four significantly favor revoking the Respondent's 
registration. [The record evidence establishes that Respondent filled 
controlled substance prescriptions in violation of its corresponding 
responsibility and outside the usual course of professional practice. 
Thus, I conclude that Respondent has engaged in misconduct which 
supports the revocation of its registration. I therefore find that the 
Government has established a prima facie case that Respondents' 
continued registrations ``would be inconsistent with the public 
interest.'' 21 U.S.C. 823(f).]

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 
at 387 (2008); Samuel S. Jackson, 72 FR 23,848, 23,853 (2007). 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., 54 F.3d at 452; Medicine Shoppe, 73 FR at 
387; see also Hoxie, 419 F.3d at 483 (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.
    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 at 62,346; Daniel A. Glick, D.D.S., 80 FR at 74,801.
    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 pharmacist-in-charge testified at the hearing, but 
denied all wrongdoing. The Respondent's post-hearing brief is silent on 
this issue.

[[Page 72734]]

Resp't Posthearing Br. 29, ] (i); 32, ] (ii); 36, ] (iii).
    The Respondent took the similar approach in its opening statement, 
arguing that the Government has failed to satisfy its burden; accusing 
the DEA of never intending to clearly or objectively evaluate the 
evidence; attacking the credentials of the Government's expert; 
claiming that the Respondent exercised appropriate judgment when 
dispensing the relevant controlled substance prescriptions in 
compliance with Florida law; and complaining about the 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

    [Omitted for brevity.] 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 38,363, 38,364 (2013).]
    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 standards of practice with respect 
to documenting red flag resolution. Continuously dispensing high-
strength schedule II opioids, sometimes dangerously combined with high-
strength benzodiazepines, and failing to document any investigation 
into those red flags, constitutes egregious misconduct because it 
allowed for the potential of unchecked diversion of controlled 
substances into illegitimate channels.
    [Omitted for brevity.] *\W\
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    *\W\ 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).
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    I further find that general 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 failing to resolve and document the resolution of red flags 
in accordance with [the usual course of professional practice]. 
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.

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 Acting 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 and in fact, as discussed supra, the 
Respondent does not appear to believe it has done anything wrong. 
[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.

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. FG6290061 
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: November 25, 2020
MARK M. DOWD
U.S. Administrative Law Judge

The Respondent's Exceptions

    On December 15, 2020, Respondent filed its Exceptions to the RD. I 
find that Respondent's seven Exceptions are either without merit or 
irrelevant to my Decision. Therefore, I reject Respondent's Exceptions 
and affirm the RD's conclusion that Respondent's continued registration 
is inconsistent with the public interest, and that revocation is the 
appropriate sanction.

Exception 1

    In the first Exception, Respondent 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 5-11. 
Respondent argues that the provisions of the Florida Administrative 
Code that the RD cites to do not support this conclusion. Id.
    I do not need to address Respondent's arguments about the Florida 
Administrative Code, because I have concluded, based on Dr. Schossow's 
credible expert testimony, that a pharmacist operating in the usual 
course of professional practice in Florida must address, resolve, and 
document red flags prior to dispensing a controlled substance. Dr. 
Schossow testified that such documentation is necessary to ensure 
patient safety and continuity of care. I have thus concluded that, by 
repeatedly filling prescriptions without adequately addressing, 
resolving, or documenting red flags, Respondent violated its 
corresponding responsibility because the pharmacists knew these 
controlled substances 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 Respondent 
dispensed controlled substances outside the usual course of 
professional practice, in violation of 21 CFR 1306.04(a) and 1306.06. 
Because documentation of red flags is required in the usual course of 
professional practice in Florida, I find that it is irrelevant whether 
Respondent took

[[Page 72735]]

adequate steps under Florida law to document any attempts to resolve 
the red flags.

Exceptions 2 and 6

    Respondent next argues that the ALJ's conclusion that Respondent 
failed to document the resolution of red flags was ``unsupported by 
substantial evidence and otherwise arbitrary and capricious,'' because 
the government failed to offer complete copies of the relevant patient 
profiles. Resp Exceptions, at 12. Respondent similarly argues that the 
ALJ arbitrarily and capriciously concluded that the absence of 
documentation resolving red flags supports the inference that no such 
documentation exists. Id. at 16-17 (Exception 6). These Exceptions are 
disingenuous and lend further support for my conclusion that Respondent 
cannot be entrusted with a DEA registration.
    The Government served three administrative subpoenas on Respondent 
throughout the course of the investigation, each of which required 
Respondent to produce ``[a]ny and all records . . . maintained pursuant 
to the requirements of Florida Statutes and Florida Administrative Rule 
64B16-27.800 for Patient Records, documenting the steps taken to avoid 
or resolve any issues with the prescriptions presented by'' the listed 
patients. Gov't Exs. 3, 16, 33; RD, at 125. The second and third 
subpoenas further specified that Respondent was required to produce all 
documentation ``reflecting efforts by the pharmacist to exercise their 
corresponding responsibility to assess the validity'' of controlled 
substance prescriptions dispensed to those listed patients. Gov't Exs. 
16, 33. At the hearing, the Government admitted into evidence all 
records that it obtained from Respondent pursuant to these subpoenas. 
See RD, at 84-87. Thus, if the record is devoid of relevant records 
documenting the resolution of red flags, then Respondent is at fault 
for failing to comply with the subpoenas.*\X\ If Respondent realized 
during the course of the administrative litigation that there were 
additional materials that it had omitted from its subpoena response, 
then Respondent should have produced those materials immediately. As 
discussed in more detail above, I find that it is appropriate in this 
case to infer that no additional documentation of red flags exists 
based on Respondent's failure to produce this potentially exculpatory 
evidence.
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    *\X\ One of the three subpoenas was served in conjunction with 
an administrative inspection warrant, during which DEA obtained 
certain materials, such as patient profiles, directly from 
Respondent's computer system. Respondent faults DEA for failing to 
obtain complete patient profiles from the computer. Resp Exceptions, 
at 12. However, as the Government points out in its response to 
Respondent's Exceptions, only three of the named patients in the OSC 
were included in the initial warrant and subpoena. See Gov't 
Response, at 5. The remaining seven patients were listed in the 
subsequent two subpoenas, meaning that all of the documents that DEA 
obtained for those patients were produced by Respondent.
---------------------------------------------------------------------------

Exception 3

    I declined to rule on whether the distances that Respondent's 
customers traveled in this case were a red flag, because there was 
sufficient evidence on the record that the prescriptions presented 
several additional red flags that should have been addressed, resolved, 
and documented. Therefore, I need not address Respondent's third 
Exception, which addresses the adequacy of Respondent's evidence 
regarding the distance red flag.

Exception 4

    Respondent argues that the ALJ erred in discrediting Dr. 
Buffington's testimony that there is no presumption in pharmacy 
practice that concurrent prescriptions for opioids and benzodiazepines 
cannot be issued or filled. Resp Exceptions, at 15. Respondent believes 
that the ALJ gave too much weight to the FDA's ``black box'' warning 
over Dr. Buffington's expert testimony. However, my conclusion 
regarding the opioid/benzodiazepine combination is not that this drug 
combination should never be prescribed or dispensed, but rather that it 
is a red flag that a pharmacist must address, resolve, and document. As 
stated above, this conclusion was supported by Dr. Schossow's credible 
testimony and by portions of Dr. Buffington's testimony. This 
conclusion is further supported by Respondent's Exceptions, which 
acknowledge that the opioid/benzodiazepine combination poses potential 
complications. Id. (``Dr. Buffington . . . credibly testified that the 
[``black box''] warning exists to alert healthcare professionals as to 
potential complications with a particular drug combination.'').

Exception 7 *\Y\
---------------------------------------------------------------------------

    *\Y\ I addressed Respondent's fifth Exception above. See supra 
n.*L.
---------------------------------------------------------------------------

    Finally, Respondent argues that the ALJ arbitrarily and 
capriciously concluded that Dr. Buffington suffered diminished 
credibility based on the ALJ's erroneous conclusion that Dr. Buffington 
``conflated the reasonable, prudent pharmacist `standard of care' 
applicable to medical malpractice negligence suits with a pharmacist's 
professional standards, i.e., `in the usual course of professional 
practice.' '' Resp Exceptions, at 17. Respondent cites to a 2001 case 
from the Florida District Court of Appeals to support its argument that 
Dr. Buffington's articulation of the standard care--which relied in 
part on a medical malpractice statute, Fla. Stat. Sec.  766.102, that 
applies to ``health care providers,''--was in fact correct. However, as 
discussed in more detail above, the definition of ``health care 
providers'' specifically excludes pharmacists. See supra n.*I. Thus, I 
agree with the ALJ's conclusion that Dr. Buffington suffered diminished 
credibility based on his inaccurate reliance on an inapplicable 
statute, and based on a number of additional factors, such as his overt 
partiality and his inconsistent testimony. Overall, I agree with the 
ALJ's assessment of Dr. Buffington's credibility.
    Accordingly, I reject Respondent's Exceptions and affirm the RD's 
conclusion that Respondent's registration should be revoked.

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. FG6290061 issued to Gulf Med Pharmacy. 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 Gulf Med Pharmacy 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 any controlled substances seized 
pursuant to the Order of Immediate Suspension of Registration are 
forfeited to the United States. This Order is effective January 21, 
2022.

Anne Milgram,
Administrator.
[FR Doc. 2021-27718 Filed 12-21-21; 8:45 am]
BILLING CODE 4410-09-P