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1Although Registrant’s COR has expired, the 

Agency has discretion to adjudicate this Order to 

Show Cause to finality. See Jeffrey D. Olsen, M.D., 

84 FR 68474, 68479 (2019) (declining to dismiss an 

immediate suspension order as moot when the 

registrant allowed the subject registration to expire 

before final adjudication). As my predecessor 

identified in Olsen, ‘‘[b]ecause nothing in the CSA 

Continued 

blamed others, and has no concrete 

remedial plan. Given these facts, the 

tribunal can only conclude that granting 

Respondent a COR would put the public 

at risk of Respondent’s previous 

fraudulent behavior. Moreover, with 

respect to general deterrence, the 

Agency bears the responsibility to deter 

conduct similar to Respondent’s past 

misconduct. Ruben, 78 FR at 38385. 

Granting a COR to an applicant who has 

neither unequivocally taken 

responsibility for his misconduct, nor 

demonstrated sufficient remedial 

measures to ensure such conduct will 

not happen again, would send a 

message to all that there will be few 

consequences to defrauding federal 

health care programs. 

C. Egregiousness 

Finally, this tribunal finds that 

Respondent’s behavior was egregious. 

While Respondent did not divert 

controlled substances, defrauding 

federal health care programs is 

egregious. See Stein, 84 FR at 46973 

(finding that the respondent’s actions 

were egregious because he defrauded 

the government of taxes and misused 

his position of trust); Ramirez-Gonzalez, 

58 FR at 52788 (‘‘fraud perpetrated by 

the respondent casts doubt upon his 

integrity, and as such supports an action 

against his registration’’); Osafo, 58 FR 

at 37509 (‘‘Respondent’s submission of 

fraudulent medical claims and 

subsequent convictions of larceny 

indicated that Respondent placed 

monetary gain above the welfare of his 

patients, and in so doing, endangered 

the public health and safety.’’). 

Respondent engaged in a four-year 

conspiracy to defraud federal health 

care programs and the cost of that fraud, 

as reflected in the restitution amount 

imposed at his sentencing, was 

$5,991,417.13. Tr. 71–73; Gov. Ex. 5 at 

2–5. 

Moreover, the Agency ‘‘relies heavily 

on a registrant’s honesty and integrity 

‘to complete its mission of preventing 

diversion within such a large regulated 

population.’ ’’ Michael Jones, M.D., 86 

FR 20728, 20731 (2021) (quoting Stein, 

84 FR at 46974). ‘‘Because DEA depends 

on the integrity of those it entrusts with 

controlled substance privileges, it takes 

a close look at a registrant’s fraudulent 

activity.’’ Jones, 86 FR at 20731 (citing 

Ramirez-Gonzalez, 58 FR at 52788). 

Even if the fraud does not involve 

controlled substances, ‘‘fraudulent 

activity indicates that a registrant places 

monetary gain above the welfare of his 

patients, and in so doing, endangers the 

public health and safety.’’ Jones, 86 FR 

at 20731–32 (internal quotations 

omitted); see also Osafo, 58 FR at 37509. 

Respondent’s behavior demonstrates 

that he lacks integrity and cannot be 

trusted. In particular, his admission that 

he ‘‘was not 100 percent truthful on 

[being a manager]’’ when he pleaded 

guilty under oath (Tr. 100) is stark proof 

that the Agency cannot rely on 

Respondent’s honesty as a registrant. 

His lack of remorse and acceptance of 

responsibility further shows that he 

does not recognize the seriousness of his 

actions, so he should not be entrusted 

with a COR. 

Accordingly, it is herein respectfully 

recommended that Respondent’s 

application for a DEA registration be 

denied. 

Dated: October 12, 2021. 

Teresa A. Wallbaum, 

Administrative Law Judge. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 824 

and 823(f), I hereby deny the pending 

application for a Certificate of 

Registration, Control Number 

W20055916C, submitted by Gilbert Y. 

Kim, D.D.S. as well as any other 

pending application of Gilbert Y. Kim, 

D.D.S. for additional registration in New 

York. This Order is effective May 9, 

2022. 

Anne Milgram, 

Administrator. 

[FR Doc. 2022–07717 Filed 4–8–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

George Pharmacy, Inc.; Decision and 

Order 

On August 1, 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 George 

Pharmacy, Inc. (hereinafter, Registrant) 

of Dayton Beach, Florida. Government’s 

Request for Final Agency Action 

(hereinafter, RFAA) Exhibit 1 (OSC). 

The OSC informed Registrant of the 

immediate suspension of its DEA 

Certificate of Registration Number 

FG5612127 (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 

Registrant’s ‘‘continued registration is 

inconsistent with the public interest.’’ 

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

823(f)). 

The OSC notified Registrant of its 

right to request a hearing on the 

allegations or to submit a written 

statement while waiving its right to a 

hearing, the procedures for electing 

either option, and the consequence of 

failing to elect either option. Id. at 10– 

11 (citing 21 CFR 1301.43). 

In response to the OSC, Registrant 

filed a timely request for an 

administrative hearing. RFAAX 3 

(Request for Hearing). After both parties 

filed prehearing statements, and 

Registrant moved to continue the 

hearing, the Chief Administrative Law 

Judge (hereinafter, Chief ALJ), set a 

hearing date of December 17, 2019, in 

Arlington, Virginia. RFAAX 4. On 

December 12, 2019, Registrant filed a 

motion to terminate proceedings, stating 

that Registrant ‘‘respectfully withdraws 

its prior request for hearing and desires 

that the administrative hearing 

presently scheduled be cancelled, and 

the proceedings terminated.’’ RFAAX 5. 

On the same day, the Chief ALJ granted 

Registrant’s motion and cancelled the 

hearing. RFAAX 6. 

On March 12, 2020, the Government 

forwarded an RFAA, along with the 

evidentiary record for this matter, to my 

office. Having considered the record in 

its entirety, I find that the record 

establishes, by substantial evidence, that 

Registrant committed acts rendering its 

continued registration inconsistent with 

the public interest. I further find that 

Registrant’s conduct was egregious, and 

that Registrant’s failure to respond to 

the Government’s allegations weighs 

strongly against continuation of its 

registration. Accordingly, I conclude 

that the appropriate sanction is the 

revocation of Registrant’s DEA 

registration. 

I. Findings of Fact 

A. Registrant’s DEA Registration 

Registrant was registered with DEA as 

a retail pharmacy in Schedules II 

through V under DEA registration 

number FG5612127, at the registered 

address of 948 Orange Avenue, Dayton 

Beach, Florida 32114–0000. RFAAX 8 

(DEA Certificate of Registration). 

According to Agency records, this 

registration expired on February 28, 

2019. Id.1


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prohibits an individual or an entity from applying 

for a registration even when there is . . . a history 

of having a registration suspended or 

revoked[,]. . . . having a final, official record of 

allegations, evidence, and the Administrator’s 

decisions regarding those allegations and evidence, 

assists and supports future interactions between the 

Agency and the registrant or applicant.’’ Id. Here, 

absent a final adjudication, there would be no final 

record of the allegations and evidence from this 

matter. Adjudicating this matter to finality will 

create an official record the Agency can use in any 

future interactions with Registrant’s owners, 

employees, or other persons who were associated 

with Registrant. Moreover, ‘‘a final adjudication is 

a public record of the Agency’s expectations for 

current and prospective members of that 

community,’’ which ‘‘helps current and prospective 

registrants comply with the CSA and avoid ISOs/ 

OSCs.’’ Id. 

2 DI has been a DI for approximately two years. 

RFAAX 10, at 1. She was originally assigned to the 

Orlando District Office, but is currently assigned to 

the Jacksonville District Office. Id. 

3 GS has worked for DEA for approximately 30 

years and has been a GS for approximately two 

years. RFAAX 10, at 1. He is currently assigned to 

the Orlando District Office of the Miami Field 

Division. Id. 

4 DEA presented Registrant with a Notice of 

Inspection Form, which Registrant signed. RFAAX 

9, App’x A. 

B. Government’s Allegation That 

Registrant Dispensed Controlled 

Substances Unlawfully 

In its RFAA, the Government alleged 

that Registrant violated federal and state 

law by ‘‘fill[ing] prescriptions outside 

the usual course of professional practice 

and in violation of the minimum 

standard of care that governs the 

practice of pharmacy in the State of 

Florida.’’ RFAAX 1, at 3. Specifically, 

the Government alleged that for a threeyear period from December 12, 2016, to 

March 26, 2019, Registrant repeatedly 

filled controlled substance prescriptions 

for numerous patients without 

addressing or resolving red flags of drug 

abuse or diversion. Id. 

To support this allegation, the 

Government submitted declarations of 

the DEA Diversion Investigator 

(hereinafter, DI) 2 and Group Supervisor 

(hereinafter, GS),3 who were assigned to 

the investigation of Registrant, as well 

as a declaration of Dr. Thomas 

Hamilton, who was retained by the 

Government to opine on Registrant’s 

dispensing patterns. See RFAAX 9 

(Declaration of DI); RFAAX 10 

(Declaration of GS); RFAAX 11 

(Declaration of Dr. Thomas Hamilton). 

The Government also submitted copies 

of administrative subpoenas, 

prescription data, patient profiles, and 

google maps printouts showing the 

distances traveled by Registrant’s 

customers. RFAAX 9, at App’x A–AY. 

1. The Investigation 

DI’s and GS’s declarations summarize 

DEA’s investigation, including DEA’s 

onsite inspections, subpoena requests, 

and meetings with Registrant. 

i. October 31, 2018 Onsite Inspection 

On October 31, 2018, GS, DI, and two 

additional DIs performed an onsite 

inspection of Registrant. RFAAX 9, at 

1–3; RFAAX 10, at 1–2.4 They spoke to 

Vivian Khalil, Registrant’s owner, and 

Maher Hanna, Registrant’s pharmacistin-charge. Id. According to GS and DI, 

DEA asked Mr. Hanna to explain how 

Registrant resolves red flags. Id. Mr. 

Hanna stated that before filling a 

prescription, someone will obtain a 

copy of the patient’s identification, 

contact the doctor’s office to verify the 

prescription, check the patient’s 

information on Florida’s Prescription 

Data Monitoring Program (E–FORSCE), 

and check that the prescribing doctor’s 

license is valid on the Florida 

Department of Health (hereinafter, DOH) 

website. Id. He stated that someone 

would make notes on the back of the 

prescription (including indicating who 

verified the prescription) and attach a 

printed copy of the patient’s E–FORSCE 

report to the prescription. Id. All of the 

due diligence that Registrant’s 

pharmacists perform is noted on the 

back of the prescriptions. Id. As long as 

the physician’s license is legitimate, 

Registrant would fill the prescription. 

Id. Mr. Hanna asked the DEA what other 

red flags would have to be addressed ‘‘if 

the doctor is legitimate and the script is 

legitimate.’’ Id. Mr. Hanna stated that 

checking E–FORSCE and DOH was 

enough due diligence. Id. 

According to GS and DI, DEA warned 

Mr. Hanna that Registrant had been 

filling prescriptions for controlled 

substances in the face of obvious red 

flags of abuse and diversion. Id. DEA 

also questioned Mr. Hanna and Mrs. 

Khalil about the high cash payments 

made by Registrant’s patients, as well as 

the long distances traveled by 

Registrant’s customers to obtain and fill 

their prescriptions. Id. DEA also warned 

Mr. Hanna and Mrs. Khalil about the 

large quantities of hydromorphone 

prescriptions that Registrant purchased. 

Id. In response, Mr. Hanna and Mrs. 

Khalil asked for one more chance and 

the opportunity to take continuing 

education classes. Id. 

ii. November 2018 Administrative 

Subpoena 

On November 7, 2018, DEA served an 

administrative subpoena on Registrant 

for pharmacy records and patient 

profiles, including but not limited to 

due diligence documentation, 

prescriptions, electronic dispensing 

logs, and other files related to the 

dispensing of controlled substances for 

certain patients between November 1, 

2015, and October 31, 2018. RFAAX 9, 

App’x B (November 2018 

Administrative Subpoena). In 

approximately February 2019, DEA 

hired Dr. Thomas E. Hamilton as a 

pharmacy expert in this case. Id. at 3. 

DEA provided Dr. Hamilton with 

Registrant’s dispensing log, 

prescriptions, patient profiles, and E– 

FORSCE reports for the patients listed 

in the November 7, 2018 subpoena. Id. 

iii. March 12, 2019 Meeting With 

Registrant 

On March 12, 2019, GS, DI, and 

another DI visited Registrant again and 

spoke with both Mrs. Khalil and Mr. 

Hanna. RFAAX 9, at 3–4; RFAAX 10, at 

3. At this meeting, DI told Mrs. Khalil 

and Mr. Hanna that DEA had hired a 

Florida pharmacy expert to review 

prescriptions and patient profiles of 

some of Registrant’s customers. Id. DI 

explained Dr. Hamilton’s expert opinion 

about Registrant’s dispensing behavior. 

Id. In particular, DI stated that Dr. 

Hamilton had identified numerous red 

flags with many of the prescriptions that 

Registrant had filled, and found no 

documentation supporting adequate 

resolution of these red flags. Id. In 

response, Mr. Hanna informed DI that 

Registrant had stopped filling 

prescriptions for those patients whose 

prescriptions were the subject of Dr. 

Hamilton’s opinion (including Patients 

J.Y., J.S., C.A., L.K., A.O., M.S., M.J., 

A.M., K.S., and L.S.). Id. 

DI told Mr. Hanna and Mrs. Khalil 

that DEA was pursuing administrative 

action for the revocation of Registrant’s 

COR and asked them to surrender 

Registrant’s COR. Id. Mr. Hanna and 

Mrs. Khalil refused to surrender. Id. 

iv. Further Investigation in April and 

July 2019 

Upon reviewing Registrant’s E– 

FORSCE report, DEA identified several 

additional customers whose 

prescriptions presented red flags of 

abuse and diversion, such as large cash 

payments and long distances traveled. 

See RFAAX 9, at 4–5. DEA served 

additional administrative subpoenas 

and performed additional onsite 

inspections in order to obtain 

documents related to Registrant’s 

dispensing to those additional patients. 

Id. at App’x C (April 22, 2019 Notice of 

Inspection Form); App’x D (July 15, 

2019 Administrative Subpoena); App’x 

E (July 23, 2019 Notice of Inspection 

Form). DEA provided these additional 

materials to Dr. Hamilton. Id. at 5. 


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5This rule was amended in 2018, during the 

timeframe that relevant misconduct in this case 

took place; however, there were no relevant, 

substantive modifications to this regulation in 2018. 

6There were no substantive changes to the 

relevant portions of Fla. Admin. Code r. 64B16– 

27.810 (2022) during the time period of the 

allegations in this case. 

7 Dr. Hamilton’s Declaration does not identify 

supporting sources for his findings as to the average 

prices of these controlled substances; however, Dr. 

Hamilton’s opinions in this matter were based on 

his 19 years of training and experience as a Florida 

pharmacist. RFAAX 11, at 1. As a pharmacy 

supervisor with Publix Supermarkets for eight 

years, Dr. Hamilton operated 40 Publix pharmacies 

and opened new Publix pharmacies. Id. He was also 

involved in evaluating other Florida retail 

pharmacies for potential purchase, which included 

‘‘inspect[ing] key areas including their inventory, 

invoices, sales, and purchasing habits.’’ Id. There is 

no evidence to rebut Dr. Hamilton’s opinions 

regarding average prices. Additionally, as explained 

further below, the differences in the prices charged 

by Registrant are so vastly in excess of the average 

prices identified by Dr. Hamilton that I find that the 

evidence weighs in favor of a finding that Registrant 

was charging excessive prices. 

2. Dr. Hamilton’s Unrebutted Expert 

Opinion 

Dr. Hamilton is a doctor of pharmacy 

with 19 years of experience as a 

pharmacist. RFAAX 11, at 2, App’x A. 

He received his Doctor of Pharmacy 

from Nova Southeastern University in 

May 1999 and was licensed by the 

Florida Board of Pharmacy in August 

1999. Id. He is also a member of the 

Broward County Pharmacy Association. 

Id. 

Dr. Hamilton currently works as a 

full-time pharmacy manager with Publix 

Supermarkets and has worked for 

Publix for most of his career. RFAAX 

11, at 1. His responsibilities include 

ensuring that the pharmacy follows all 

federal, state, and local regulations; 

overseeing the ordering and quality of 

inventory; reviewing patient records; 

reviewing prescriptions to ensure 

accuracy and identify possible 

interactions; and dispensing prescribed 

medications for patient care. Id. He also 

provides information to pharmacy 

customers regarding drug interactions, 

side effects, and proper dosage, and 

monitors patient profiles. Id. 

From February 2006 until April 2014, 

Dr. Hamilton was a pharmacy 

supervisor with Publix Supermarkets, 

where he was responsible for the 

operation of 40 pharmacies. Id. During 

this time, his responsibilities consisted 

of opening new stores and ensuring that 

staff was properly trained and operating 

within the rules and standards set forth 

by the Florida Board of Pharmacy. Id. 

He was also involved in the analysis, 

evaluation, and purchase of other retail 

pharmacies from Key West to West Palm 

Beach. Id. While evaluating pharmacies, 

he inspected several key areas including 

their inventory, invoices, sales, and 

purchasing habits. Id. 

i. Corresponding Responsibility and 

Course of Professional Practice in 

Florida 

Dr. Hamilton opined that pharmacists 

have a corresponding responsibility to 

ensure that a prescription for a 

controlled substance is issued for a 

legitimate medical purpose by an 

individual practitioner acting in the 

usual course of professional practice. Id. 

at 2 (referencing 21 CFR 1306.04 (2022). 

Dr. Hamilton also opined that Florida 

pharmacists must ‘‘exercise[e] sound 

professional judgment’’ and ‘‘attempt to 

work with the patient and the prescriber 

to assist in determining the validity of 

the prescription.’’ Id. (referencing Fla. 

Admin. Code r. 64B16–27.831) (2022).5

Additionally, Florida pharmacists must 

review every new and refill prescription 

to identify red flags of abuse and 

diversion, such as (a) Over-utilization or 

under-utilization; (b) Therapeutic 

duplication; (c) Drug-disease 

contraindications; (d) Drug-drug 

interactions; (e) Incorrect drug dosage or 

duration of drug treatment; (f) Drugallergy interactions; (g) Clinical abuse/ 

misuse. Id. (referencing Fla. Admin. 

Code r. 64B16–27.810 (2022)).6

Dr. Hamilton identified additional red 

flags that pharmacists must ‘‘address or 

resolve’’ prior to filling a prescription, 

including long distances traveled, 

cocktail medications, cash payments at 

inflated prices, inappropriate drug 

dosages and durations of treatment, and 

pattern prescribing. Id. at 3–5. 

Long Distances Traveled 

Dr. Hamilton opined that patients 

traveling extremely long distances to 

obtain or fill their controlled substances 

prescriptions is a well-known red flag of 

abuse or diversion that Florida 

pharmacists must ‘‘address or resolve.’’ 

Id. at 3. 

Cocktail Medications 

Dr. Hamilton opined that another 

common red flag of abuse that Florida 

pharmacists must ‘‘address or resolve’’ 

is when a physician prescribes ‘‘cocktail 

medications.’’ Id. He explained that 

cocktail medications are potent 

combinations of controlled substances 

that are widely known to be abused or 

diverted. Id. He further explained that 

one well-known cocktail medication is 

the ‘‘Trinity’’ cocktail, which is a 

combination of opioids (Schedule II 

controlled substances), benzodiazepines 

(Schedule IV controlled substances, 

such as alprazolam and clonazepam), 

and muscle relaxants (Schedule IV 

controlled substances, such as 

carisoprodol, or non-controlled drugs 

such as cyclobenzaprine). Id. Dr. 

Hamilton opined that these drugs are 

widely known to be abused, because 

when taken together, their 

pharmacological impact is similar to 

heroin. Id. 

Cash Payments at Inflated Prices 

Dr. Hamilton opined that another red 

flag of abuse or diversion that Florida 

pharmacists must ‘‘address or resolve’’ 

is when patients are willing to pay 

inflated prices for their prescriptions 

with cash. Id. He explained that when 

a patient is willing to pay for their 

prescriptions at prices that exceed what 

other pharmacies would charge, a 

Florida pharmacist must be concerned 

that it is dispensing controlled 

substances to someone who is abusing 

or diverting the drugs. Id. Dr. Hamilton 

opined that a reasonable Florida 

pharmacist must also be suspicious for 

the same reasons when patients are 

paying cash for a large quantity of 

controlled substances. Id. He explained 

that between 2017 and 2019, other 

pharmacies in Florida sold 

hydromorphone for approximately 

$1.60 per pill and oxycodone for 

approximately $1.40 7 per pill. Id. 

Therefore, he opined that patients 

willing to pay in cash well above those 

prices is a red flag of abuse or diversion 

that Florida pharmacists must address 

or resolve. Id. For example, as discussed 

in more detail below, Registrant’s 

customers often paid more than five 

times the prices charged at other Florida 

pharmacies, which Dr. Hamilton 

determined to be a red flag. See supra, 

I.B.2.ii. Dr. Hamilton opined that 

customers taking prescriptions for 

legitimate medical needs would not pay 

such extreme prices for medication that 

could have been purchased elsewhere 

for a fraction of the amount. Id. at 3–4. 

Inappropriate Drug Dosages and 

Durations of Treatment 

Dr. Hamilton opined that Florida 

pharmacists must review patient records 

and prescriptions for inappropriate drug 

dosages and durations of treatment 

before dispensing controlled substances. 

Id. at 4 (referencing Fla. Admin. Code r. 

64B16–27.810). He explained that this is 

based upon the pharmacist’s obligation 

to promote the therapeutic 

appropriateness of prescribed 

medication. Id. 

Dr. Hamilton opined that Patients 

receiving prescriptions for immediaterelease opioids, such as hydromorphone 

and oxycodone, for several months at a 

time is a red flag of abuse or diversion. 


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8There were no substantive changes to the 

relevant portions of Fla. Admin. Code r. 64B16– 

27.800 (2022) during the time period of the 

allegations in this case. 

9These prescriptions were filled on January 13, 

February 10, March 10, April 7, May 5, and June 

30, 2017. Id. 

10Cyclobenzaprine is not a controlled substance. 

Therefore, it is only relevant to my Decision to the 

extent that Dr. Hamilton opined that is potentially 

dangerous to prescribe cyclobenzaprine 

concurrently with opioids and benzodiazepines, 

and that Registrant should have addressed and 

resolved this red flag before filling the controlled 

substance prescriptions. 

11These prescriptions were filled on February 23, 

March 27, April 26, May 23, June 20, July 18, 

August 15, September 7, October 6, and November 

2, 2017; and February 23, and June 1, 2018. Id. 

12These prescriptions were filled on November 

30, 2017 (150 tablets of oxycodone-acetaminophen 

10-325 mg and 30 tablets of carisoprodol 350 mg); 

December 22, 2017 (150 tablets of oxycodoneacetaminophen 10-325 mg and 60 tablets of 

carisoprodol 350 mg); January 12, 2018 (150 tablets 

of oxycodone-acetaminophen 10-325 mg); January 

19, 2018 (60 tablets of carisoprodol 350 mg); 

February 2, 2018 (150 tablets of oxycodoneacetaminophen 10-325 mg); February 16, 2018 (60 

tablets of carisoprodol 350 mg); March 22, 2018 

(150 tablets of oxycodone-acetaminophen 10-325 

mg and 60 tablets of carisoprodol 350 mg); May 8, 

2018 (150 tablets of oxycodone-acetaminophen 10- 

325 mg); May 10, 2018 (60 tablets of carisoprodol 

350 mg); June 27, 2018 (150 tablets of oxycodoneacetaminophen 10-325 mg and 60 tablets of 

carisoprodol 350 mg); July 23, 2018 (150 tablets of 

oxycodone-acetaminophen 10-325 mg); July 24, 

2018 (30 tablets of carisoprodol 350 mg); August 17, 

2018 (150 tablets of oxycodone-acetaminophen 10- 

325 mg); and August 30, 2018 (60 tablets of 

carisoprodol 350 mg). Id. 

Id. He explained that this is because 

immediate-release medication should 

only be used to treat short-term, acute 

pain, and patients with legitimate 

chronic pain would eventually be 

switched to safer, long-term pain 

medication. Id. Moreover, Dr. Hamilton 

opined that Florida pharmacists should 

also address and resolve the red flag of 

patients receiving large quantities of 

opioids at their highest available 

strengths. Id. He explained that the 

Centers for Disease Control and 

Prevention (CDC) recommends avoiding 

or carefully adjusting Morphine 

Milligram Equivalent (MME) dosages 

prescribed beyond 90 mg a day. Id. 

Dr. Hamilton opined that opiate-naive 

patients receiving more than 24 mg per 

day of hydromorphone (96 MME) or 

more than 80 mg per day of oxycodone 

(120 MME) is a red flag of abuse or 

diversion. Id. He explained that starting 

dosages this high are potentially lethal 

for opiate-naive patients. Id. 

Pattern Prescribing 

Dr. Hamilton opined that another 

common red flag of abuse or diversion 

that Florida pharmacists must address 

before filling is ‘‘pattern prescribing,’’ 

which refers to a physician who 

regularly prescribes common drugs of 

abuse or diversion in the same dosages 

and quantities to many patients sharing 

the same surnames and/or addresses, 

and uses the same diagnosis codes to 

justify these prescriptions. Id. at 5. He 

explained that ‘‘pattern prescribing’’ is a 

red flag of abuse or diversion because it 

indicates that the physician is focused 

on distributing drugs with high street 

value rather than on examining his 

patients and developing individualized 

treatment plans. Id. 

Dr. Hamilton opined that the manner 

in which a Florida pharmacist addresses 

and resolves red flags of abuse or 

diversion must be documented on the 

prescription and/or in the patient’s 

profile. Id. He explained that Florida 

pharmacists must maintain a patient 

record system, or patient profile, that 

documents how the pharmacists 

resolved the red flags of abuse or 

diversion. Id. (referencing Fla. Admin. 

Code r. 64B16–27.800 (2022)).8

ii. Dr. Hamilton’s Opinion That 

Registrant Repeatedly Dispensed 

Controlled Substances Outside the 

Usual Course of Professional Practice 

Dr. Hamilton reviewed prescriptions, 

patient profiles, and E–FORSCE reports 

for Registrant’s customers J.Y., J.S., C.A., 

L.K., A.O., M.S., B.B., E.R., S.R., M.J., 

C.K., K.L., A.M., K.S., and L.S. Id. 

(referencing RFAAX 9, at App’x F–AX). 

Dr. Hamilton opined that each 

prescription that he reviewed presented 

red flags of abuse and diversion, and 

that Registrant failed to address these 

red flags on the customers’ prescriptions 

or in their patient profiles. Id. Dr. 

Hamilton concluded that Registrant 

failed to follow the minimum 

requirements for Florida pharmacists, 

and therefore acted outside the usual 

course of professional practice in filling 

each prescription. Id. 

J.Y. 

Registrant filled the following three 

prescriptions for J.Y. on six separate 

occasions from January 13, 2017, to June 

30, 2017: (1) 112 tablets of 

hydromorphone 8 mg, (2) 28 tablets of 

morphine sulfate extended release (ER) 

30 mg, and (3) 28 tablets of clonazepam 

2 mg. RFAAX 9, at App’x H 

(Prescriptions for J.Y.); see also id. at 

App’x G (J.Y.’s E–FORSCE report), 

App’x F (J.Y.’s Patient Profile).9 On each 

occasion, Registrant also dispensed 

cyclobenzaprine, which is a noncontrolled muscle relaxant. Id. at App’x 

H. Dr. Hamilton opined that J.Y.’s 

prescriptions presented the red flags of 

cocktail medications and long distances 

traveled. RFAAX 11, at 6–7. 

Dr. Hamilton opined that it was a red 

flag that Registrant dispensed the 

widely-abused ‘‘Trinity’’ cocktail on 

each occasion specified above. Id. at 6. 

In this case, the ‘‘Trinity’’ cocktail 

consisted of two opioids 

(hydromorphone and morphine sulfate 

ER), a benzodiazepine (clonazepam), 

and a muscle relaxant 

(cyclobenzaprine),10 all of which were 

prescribed by the same prescriber. Id. 

Additionally, Dr. Hamilton opined that 

it was a red flag that J.Y. traveled at least 

106 miles roundtrip to obtain and fill 

her prescriptions. Id. J.Y.’s residence 

was at least 53 miles from her doctor’s 

office and 37 miles from Registrant, and 

her doctor’s office was approximately 16 

miles from Registrant. RFAAX 9, at 11, 

App’x AY; see also RFAAX 11, at 6. 

Dr. Hamilton did not see any evidence 

that Registrant addressed these red flags 

of abuse or diversion on J.Y.’s 

prescriptions or patient profile. RFAAX 

11, at 7. Therefore, Dr. Hamilton opined 

that these prescriptions were filled 

outside the usual course of professional 

practice. Id. 

J.S. 

On 12 separate occasions between 

February 23, 2017, and June 1, 2018, 

Registrant filled prescriptions for J.S. for 

90 tablets of oxycodone 30 mg. RFAAX 

9, at App’x K (Prescriptions for J.S.); see 

also id. at App’x I (J.S.’s patient profile), 

App’x J (J.S.’s E–FORSCE report).11

Additionally, on at least nine occasions 

between November 30, 2017, and 

August 30, 2018, Registrant filled 

prescriptions for J.S. for 150 tablets of 

oxycodone-acetaminophen 10/325 mg 

and a range of 30 to 60 tablets of 

carisoprodol 350 mg within the same 

month. Id.12 On at least six of these 

occasions, Registrant dispensed both of 

the prescriptions within two or fewer 

days of each other. Id. 

Dr. Hamilton opined that J.S.’s 

prescriptions presented the red flags of 

cocktail medications and cash payments 

at inflated prices. RFAAX 11, at 7–8. Dr. 

Hamilton opined that it was a red flag 

that Registrant repeatedly filled 

prescriptions for J.S. for oxycodoneacetaminophen (an opioid) and 

carisoprodol (a muscle relaxant), even 

though J.S. was filling prescriptions for 

benzodiazepines at another pharmacy 

during the same timeframe. Id. at 7. 

Thus, J.S. was receiving the ‘‘Trinity’’ 

cocktail, and on several occasions, all 

three prescriptions were written by the 

same prescriber. Id. Additionally, Dr. 

Hamilton opined that it was also a red 

flag that J.S. paid approximately $903 in 

cash for 90 tablets of oxycodone 30 mg 

on at least 12 occasions, which 

amounted to approximately $10.03 per 

tablet. Id. Dr. Hamilton opined that 


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13These prescriptions were filled on November 

30, 2017 (J.S. and L.S.); December 22, 2017 (J.S. and 

L.S.); January 12, 2018 (J.S.), and January 19, 2018 

(L.S.); February 16, 2018 (L.S.), February 23, 2018 

(J.S.); March 15, 2018 (L.S.), and March 22, 2018 

(J.S.); April 13, 2018 (L.S.), and April 14, 2018 (J.S.); 

May 8, 2018 (J.S.), May 10, 2018 (L.S.); June 27, 

2018 (J.S.), and July 6 (L.S.); July 23, 2018 (J.S.), and 

August 2, 2018 (L.S.); August 17, 2018 (J.S.), and 

August 30, 2018 (L.S.); September 21, 2018 (J.S.), 

and October 1, 2018 (L.S.). Id. 

14The prescriptions were issued on the same day 

on November 30, 2017; December 22, 2017; 

February 2, 2018; February 22, 2018; April 16, 2018; 

June 26, 2018; and August 16, 2018. Id. 

15These prescriptions were filled on April 3, May 

4, June 2, June 30, July 28, August 25, September 

22, October 19, November 15, 2017; and January 29 

and February 26, 2018. Id. 

16These prescriptions were filled on January 9, 

February 6, March 6, April 3, May 1, May 30, June 

27, July 25, August 22, September 19, October 17, 

November 14, and December 12, 2017; and January 

9, February 6, March 6, April 3, and May 2, 2018. 

Id. 

17These prescriptions were filled on April 7, May 

5, June 2, July 7, August 1, August 25, September 

26, October 23, November 20, and December 15, 

2017. Id. 

other pharmacies charge approximately 

$1.40 per tablet, which is approximately 

seven times less than what J.S. paid. Id. 

at 8. 

Finally, on at least 11 occasions 

between November 30, 2017, and 

October 1, 2018, Registrant filled a range 

of 120 to 150 tablets of oxycodoneacetaminophen 10–325 mg for two 

patients with the same address and 

same surname, J.S. and L.S., within 14 

days of each other. RFAAX 9, at App’x 

I, J, K, AV, AW, AX.13 On at least seven 

occasions, the prescriptions were issued 

on the same day. Id.14 Dr. Hamilton 

opined that these prescriptions were 

indicative of pattern prescribing. 

RFAAX 11, at 8. 

Dr. Hamilton did not find any 

evidence that Registrant addressed the 

red flags of abuse or diversion on J.S.’s 

prescriptions or patient profile. Id. Dr. 

Hamilton also opined that there was no 

justification for Registrant to have 

repeatedly filled prescriptions written 

by a pattern-prescribing physician. Id. 

Therefore, Dr. Hamilton opined that 

these prescriptions were filled outside 

the usual course of professional 

practice. Id. 

C.A. 

Between April 3, 2017, and February 

26, 2018, Registrant filled 11 

prescriptions for C.A. for a range of 84 

to 112 tablets of hydromorphone 8 mg. 

RFAAX 9, at App’x N (C.A.’s 

Prescriptions); see also id. at App’x M 

(C.A.’s E–FORSCE report), App’x L 

(C.A.’s patient profile).15 Dr. Hamilton 

opined that C.A.’s prescriptions 

presented the red flags of long distances 

traveled and long duration of treatment 

with high-dose, immediate-release 

opioids. RFAAX 11, at 9. 

Dr. Hamilton opined that it was a red 

flag that C.A. traveled at least 107 miles 

roundtrip to obtain and fill her 

prescriptions. Id. C.A.’s residence was at 

least 37 miles from her doctor’s office 

and 20 miles from Registrant, and her 

doctor’s office was approximately 50 

miles from Registrant. RFAAX 9, at 11– 

12, App’x AY; see also RFAAX 11, at 9. 

Dr. Hamilton also opined that it was a 

red flag that C.A. received a large 

quantity of an immediate-release opioid 

at the highest available strength for 

nearly 11 months, in a dosage that 

amounted to approximately 96 to 158.12 

MME per day. RFAAX 11, at 9. Dr. 

Hamilton did not see any evidence that 

Registrant addressed these red flags of 

abuse or diversion on C.A.’s 

prescriptions or patient profile. Id. at 9– 

10. Therefore, Dr. Hamilton opined that 

these prescriptions were filled outside 

the usual course of professional 

practice. Id. 

L.K. 

Registrant filled 18 prescriptions for 

L.K. for a range of 112 to 126 tablets of 

hydromorphone 8 mg from January 9, 

2017, to May 2, 2018. RFAAX 9, at 

App’x Q (L.K.’s Prescriptions); see also 

id. at App’x P (L.K.’s E–FORSCE 

Report), App’x O (L.K.’s Patient 

Profile).16 Dr. Hamilton opined that 

L.K.’s prescriptions presented the red 

flags of long distances traveled, cash 

payments at inflated prices, and long 

duration of treatment with high-dose, 

immediate-release opioids. RFAAX 11, 

at 10–11. 

Dr. Hamilton opined that it was a red 

flag that L.K. traveled at least 120 miles 

roundtrip to obtain and fill his 

prescriptions. Id. L.K.’s residence was at 

least 27 miles from his doctor’s office 

and 57 miles from Registrant, and his 

doctor’s office was approximately 36 

miles from Registrant. RFAAX 9, at 12, 

App’x AY; see also RFAAX 11, at 10. Dr. 

Hamilton also opined that it was a red 

flag that L.K. received the highest 

available strength of hydromorphone for 

approximately 16 months, which 

amounted to approximately 128 to 

161.28 MME per day. RFAAX 11, at 11. 

Finally, Dr. Hamilton opined that it was 

a red flag that J.S. paid between $1,150 

and $1,294 in cash for each 

prescription, or $10.27 per tablet. Id. at 

10. Dr. Hamilton opined that other 

pharmacies charge approximately $1.60 

per tablet for hydromorphone, which is 

approximately six times less than what 

L.K. paid. Id. 

Dr. Hamilton did not see any evidence 

that Registrant addressed these red flags 

of abuse or diversion on L.K.’s 

prescriptions or patients profile. Id. at 

11. Therefore, Dr. Hamilton opined that 

these prescriptions were filled outside 

the usual course of professional 

practice. Id. 

A.O. 

On November 13, 2017, Registrant 

filled a prescription for A.O. for 112 

tablets of oxycodone 30 mg. RFAAX 9, 

at App’x T (A.O.’s Prescriptions); see 

also id. at App’x S (A.O.’s E–FORSCE 

Report), App’x R (A.O.’s Patient Profile). 

On December 18, 2017, Registrant filled 

a prescription for A.O. for 140 tablets of 

oxycodone 30 mg. Id. Dr. Hamilton 

opined that it was a red flag that A.O. 

traveled at least 380 miles roundtrip to 

obtain and fill her prescriptions. Id. 

A.O.’s residence was at least 67 miles 

from her doctor’s office and 194 miles 

from Registrant, and her doctor’s office 

was approximately 128 miles from 

Registrant. RFAAX 9, at 12, App’x AY; 

see also RFAAX 11, at 11–12. Dr. 

Hamilton did not see any evidence that 

Registrant addressed this red flag of 

abuse or diversion on A.O.’s 

prescriptions or patient profile. RFAAX 

11, at 12. Therefore, Dr. Hamilton 

opined that these prescriptions were 

filled outside the usual course of 

professional practice. Id. 

M.S. 

Between April 7, 2017, and December 

15, 2017, Registrant filled 11 

prescriptions for M.S. for a range of 60 

to 112 tablets of hydromorphone 8 mg. 

RFAAX 9, at App’x W (M.S.’s 

Prescriptions); see also id. at App’x V 

(M.S.’s E–FORSCE Report), App’x U 

(M.S.’s Patient Profile).17 Dr. Hamilton 

opined that M.S.’s prescriptions 

presented the red flags of long distances 

traveled and cash payments at inflated 

prices. RFAAX 11, at 12–13. 

Dr. Hamilton opined that it was a red 

flag that M.S. traveled at least 548 miles 

roundtrip to obtain and fill his 

prescriptions. Id. M.S.’s residence was 

at least 242 miles from his doctor’s 

office and 258 miles from Registrant, 

and his doctor’s office was 

approximately 50 miles from Registrant. 

RFAAX 9, at 12, App’x AY; see also 

RFAAX 11, at 12. Additionally, Dr. 

Hamilton opined that it was a red flag 

that M.S. paid between $509 and $969 

in cash for each prescription, or 

between $8.48 and $8.68 per tablet. 

RFAAX 11, at 12–13. Dr. Hamilton 

opined that other pharmacies charge 

approximately $1.60 per pill tablet for 

hydromorphone, which is 

approximately five times less than what 

M.S. paid. Id. 


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18These prescriptions were filled on November 7, 

December 4, 2018, January 4, January 29, February 

26, and March 26, 2019. Id. 

19These prescriptions were filled on November 

20 and December 19, 2018, and January 16, 

February 19, and March 18, 2019. Id. 

20These prescriptions were filled on November 2, 

November 29, and December 26, 2018; and January 

24, February 20, and March 20, 2019. 

21These prescriptions were filled on January 31, 

February 27, March 24, April 21, May 22, June 16, 

July 14, August 11, September 8, October 5, 

November 6, and December 6, 2017. Id. 

22These prescriptions were filled on November 6 

and December 4, 2018, and January 2, January 30, 

and March 1, 2019. Id. 

23These prescriptions were filled on November 5, 

December 3, and December 31, 2018; and January 

28, February 25, and March 25, 2019. Id. 

Dr. Hamilton did not see any evidence 

that Registrant addressed these red flags 

of abuse or diversion on M.S.’s 

prescriptions or patient profile. Id. at 12. 

Therefore, Dr. Hamilton opined that 

these prescriptions were filled outside 

the usual course of professional 

practice. Id. 

B.B. 

Between November 7, 2018, and 

March 26, 2019, Registrant filled six 

prescriptions for B.B. for a range of 84 

to 100 tablets of oxycodone 30 mg. 

RFAAX 9, at App’x Z (B.B.’s 

Prescriptions); see also id. at App’x Y 

(B.B.’s E–FORSCE Report), App’x X 

(B.B.’s Patient Profile).18 Dr. Hamilton 

opined that B.B.’s prescriptions 

presented the red flags of long distances 

traveled, cash payments at inflated 

prices, and long duration of treatment 

with high-dose, immediate-release 

opioids. RFAAX 11, at 13–14. 

Dr. Hamilton opined that it was a red 

flag that B.B. traveled at least 101 miles 

roundtrip to obtain and fill his 

prescriptions. Id. B.B.’s residence was at 

least 34 miles from his doctor’s office 

and 23 miles from Registrant, and his 

doctor’s office was approximately 50 

miles from Registrant. RFAAX 9, at 12, 

App’x AY; RFAAX 11, at 13. Dr. 

Hamilton also opined that it was a red 

flag that B.B. received the highest 

available strength of oxycodone for 

nearly five months, which amounted to 

approximately 135 to 184.09 MME per 

day. RFAAX 11, at 13. Finally, Dr. 

Hamilton opined that it was a red flag 

that B.B. paid between $637 and $726 

in cash for each prescription, or 

between $7.26 and $7.59 per tablet. Id. 

at 13–14. Dr. Hamilton opined that other 

pharmacies charge approximately $1.40 

per tablet for oxycodone, which is 

approximately five times less than what 

B.B. paid. Id. 

Dr. Hamilton did not see any evidence 

that Registrant addressed these red flags 

of abuse or diversion on B.B.’s 

prescriptions or patient’s profile. Id. at 

14. Therefore, Dr. Hamilton opined that 

these prescriptions were filled outside 

the usual course of professional 

practice. Id. 

E.R. 

Between November 20, 2018, and 

March 18, 2019, Registrant filled five 

prescriptions for E.R. for 70 tablets of 

oxycodone 30 mg. RFAAX 9, at App’x 

AC (E.R.’s Prescriptions); see also id. at 

App’x AB (E.R.’s E–FORSCE Report), 

App’x AA (E.R.’s Patient Profile).19 Dr. 

Hamilton opined that it was a red flag 

that M.S. traveled at least 158 miles 

roundtrip to obtain and fill his 

prescriptions. RFAAX 11, at 14–15. 

E.R.’s residence was at least 51 miles 

from her doctor’s office and 24 miles 

from Registrant, and her doctor’s office 

was approximately 73 miles from 

Registrant. RFAAX 9, at 13, App’x AY; 

see also RFAAX 11, at 14–15. Dr. 

Hamilton did not see any evidence that 

Registrant addressed this red flag of 

abuse or diversion on E.R’s 

prescriptions or in E.R.’s patient’s 

profile. RFAAX 11, at 15. Therefore, Dr. 

Hamilton opined that these 

prescriptions were filled outside the 

usual course of professional practice. Id. 

S.R. 

Between November 2, 2018 and 

March 20, 2019, Registrant filled six 

prescriptions for S.R. for 100 tablets of 

hydromorphone 8 mg. RFAAX 9, at 

App’x AF (S.R.’s Prescriptions); see also 

id. at App’x AE (S.R.’s E–FORSCE 

Report), App’x AD (S.R.’s Patient 

Profile).20 Dr. Hamilton opined that it 

was a red flag that S.R. traveled at least 

108 miles roundtrip to obtain and fill 

her prescriptions. RFAAX 11, at 15–16. 

S.R.’s residence was at least 35 miles 

from her doctor’s office and 23 miles 

from Registrant, and her doctor’s office 

was approximately 50 miles from 

Registrant. RFAAX 9, at 13, App’x AY; 

RFAAX 11, at 15. Dr. Hamilton did not 

see any evidence that Registrant 

addressed this red flag of abuse or 

diversion on S.R.’s prescriptions or 

patient profile. RFAAX 11, at 16. 

Therefore, Dr. Hamilton opined that 

these prescriptions were filled outside 

the usual course of professional 

practice. Id. 

M.J. 

Between January 31, 2017, and 

December 6, 2017, Registrant filled 12 

prescriptions for M.J. for 112 tablets of 

hydromorphone 8 mg. RFAAX 9, at 

App’x AI (M.J.’s Prescriptions); see also 

id. at App’x AH (M.J.’s E–FORSCE 

Report), App’x AG (M.J.’s Patient 

Profile).21 Dr. Hamilton opined that 

M.J.’s prescriptions presented the red 

flags of cash payments at inflated prices 

and long duration of treatment with 

high-dose, immediate-release opioids. 

RFAAX 11, at 16–17. 

Dr. Hamilton opined that it was a red 

flag that M.J. received a large quantity 

of the highest available strength of 

hydromorphone for at least ten months, 

which amounted to approximately 128 

MME per day. Id. at 16. Additionally, 

Dr. Hamilton opined that it was a red 

flag that M.J. paid between $919 and 

$967 in cash for each prescription, or 

between $8.20 and $8.63 per tablet. Id. 

Dr. Hamilton opined that other 

pharmacies charge approximately $1.60 

per tablet for hydromorphone, which is 

approximately five times less than what 

M.J. paid. Id. 

Dr. Hamilton did not see any evidence 

that Registrant addressed these red flags 

of abuse or diversion on M.J.’s 

prescriptions or patient’s profile. Id. at 

17. Therefore, Dr. Hamilton opined that 

these prescriptions were filled outside 

the usual course of professional 

practice. Id. 

C.K. 

Between November 6, 2018, and 

March 1, 2019, Registrant filled five 

prescriptions for C.K. for 84 tablets of 

oxycodone 30 mg. RFAAX 9, at App’x 

AL (C.K.’s Prescriptions); see also id. at 

App’x AK (C.K.’s E–FORSCE Report), 

App’x AJ (C.K.’s Patient Profile).22 Dr. 

Hamilton opined that it was a red flag 

that C.K. paid $684 in cash for each 

prescription, or $8.14 per tablet. RFAAX 

11, at 17. Dr. Hamilton opined that other 

pharmacies charge approximately $1.40 

per tablet for oxycodone, which is 

approximately five times less than what 

C.K. paid. Id. Dr. Hamilton did not see 

any evidence that Registrant addressed 

this red flag of abuse or diversion on 

C.K.’s prescriptions or patient profile. 

Id. Therefore, Dr. Hamilton opined that 

these prescriptions were filled outside 

the usual course of professional 

practice. Id. 

K.L. 

Between November 5, 2018, and 

March 25, 2019, Registrant filled six 

prescriptions for K.L. for 112 tablets of 

oxycodone 30 mg. RFAAX 9, at App’x 

AO (K.L.’s Prescriptions); see also id. at 

App’x AN (K.L.’s E–FORSCE Report), 

App’x AM (K.L.’s Patient Profile).23 Dr. 

Hamilton opined that it was a red flag 

that K.L. received a large quantity of the 

highest available strength of oxycodone 

for nearly five months, which amounted 

to approximately 180 MME per day. 


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RFAAX 11, at 18. Dr. Hamilton did not 

see any evidence that Registrant 

addressed this red flag of abuse or 

diversion on K.L.’s prescriptions or 

patient profile. Id. Therefore, Dr. 

Hamilton opined that these 

prescriptions were filled outside the 

usual course of professional practice. Id. 

A.M. 

On November 1, 2017, Registrant 

filled a prescription for A.M. for 112 

tablets of hydromorphone 8 mg, at a 

starting dosage of 32 mg of 

hydromorphone per day (128 MME). 

RFAAX 11, at 18; RFAAX 9, at App’x 

AR (A.M.’s Prescriptions); see also id. at 

App’x AQ (A.M.’s E–FORSCE Report), 

App’x AP (A.M.’s Patient Profile). In the 

two years prior to filling this 

prescription, A.M. had not filled any 

opioid prescriptions in Florida. See 

RFAAX 9, at App’x AQ. Dr. Hamilton 

opined that this meant that A.M. was 

opiate naı ̈ve. RFAAX 11, at 18. Dr. 

Hamilton opined that it is a red flag for 

an opiate-naı ̈ve patient to receive more 

than 24 mg per day of hydromorphone 

(96 MME), because these doses could be 

potentially lethal. RFAAX 11, at 4. 

A.M.’s starting dose of 128 MME was 

well above 96 MME. RFAAX 11, at 18– 

19. 

Dr. Hamilton did not see any evidence 

that Registrant addressed this red flag of 

abuse or diversion on A.M.’s 

prescriptions or in A.M’s patient’s 

profile. Id. at 19. Therefore, Dr. 

Hamilton opined that these 

prescriptions were filled outside the 

usual course of professional practice. Id. 

K.S. 

On September 21, 2017, Registrant 

filled a prescription for K.S. for 84 

tablets of hydromorphone 8 mg, at a 

starting dosage of 32 mg of 

hydromorphone per day (128 MME). 

RFAAX 11, at 19; RFAAX 9, at App’x 

AU (K.S.’s Prescriptions); see also id. at 

App’x AT (K.S.’s E–FORSCE Report), 

App’x AS (K.S.’s Patient Profile). In the 

two years prior to filling this 

prescription, K.S. had only filled one 

opioid prescription in Florida, 

approximately six months before the 

September 21 prescription. See RFAAX 

9, at App’x AT. Dr. Hamilton opined 

that this meant that K.S. was opiate 

naı ̈ve. RFAAX 11, at 19. Dr. Hamilton 

opined that it is a red flag for an opiatenaı ̈ve patient to receive more than 24 

mg per day of hydromorphone (96 

MME), because these doses could be 

potentially lethal. RFAAX 11, at 4. 

K.S.’s starting dose of 128 MME was 

well above 96 MME. Id. at 19. Dr. 

Hamilton did not see any evidence that 

Registrant addressed this red flag of 

abuse or diversion on K.S.’s 

prescriptions or patient profile. Id. at 

19–20. Therefore, Dr. Hamilton opined 

that these prescriptions were filled 

outside the usual course of professional 

practice. Id. 

L.S. 

As discussed in more detail above, on 

at least 11 occasions between November 

30, 2017, and October 1, 2018, 

Registrant filled a range of 120 to 150 

tablets of oxycodone-acetaminophen 

10–325 mg for two patients with the 

same address and same last name, J.S. 

and L.S., within 14 days of each other. 

RFAAX 9, at App’x AX (L.S.’s 

Prescriptions), App’x AW (L.S.’s E– 

FORSCE Report), App’x AV (L.S.’s 

Patient Profile). On at least seven 

occasions, the prescriptions were issued 

on the same day. Id. Dr. Hamilton 

opined that these prescriptions were 

written by a pattern-prescribing 

physician. RFAAX 11, at 8, 20. 

Dr. Hamilton did not find any 

evidence that Registrant addressed this 

red flag on L.S.’s prescriptions or 

patient profile. Id. at 20. Dr. Hamilton 

also opined that there was no 

justification for Registrant to have 

repeatedly dispensed these 

prescriptions written by a patternprescribing physician. Id. at 8. 

Therefore, Dr. Hamilton opined that 

these prescriptions were filled outside 

the usual course of professional 

practice. Id. at 20. 

II. Discussion 

A. Registrant’s Registration Is 

Inconsistent With the Public Interest 

The Government alleged that 

Registrant’s DEA registration should be 

revoked because Registrant committed 

acts that would render its registration 

inconsistent with the public interest as 

provided in 21 U.S.C. 823(f). The 

Government’s case centers on 

Registrant’s unlawful dispensing of 

controlled substances to 15 customers. 

Under the Controlled Substances Act 

(hereinafter, the CSA), ‘‘[a] registration 

. . . to . . . dispense a controlled 

substance . . . may be suspended or 

revoked by the Attorney General upon 

a finding that the registrant . . . has 

committed such acts as would render 

his registration under section 823 of this 

title inconsistent with the public 

interest as determined under such 

section.’’ 21 U.S.C. 824(a)(4). In the case 

of a ‘‘practitioner,’’ which is defined in 

21 U.S.C. 802(21) to include a 

pharmacy, Congress directed the 

Attorney General to consider the 

following factors in making the public 

interest determination: 

(1) The recommendation of the appropriate 

State licensing board or professional 

disciplinary authority. 

(2) The [registrant]’s experience in 

dispensing . . . controlled substances. 

(3) The [registrant]’s conviction record 

under Federal or State laws relating to the 

. . . 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). 

According to Agency decisions, I 

‘‘may rely on any one or a combination 

of factors and may give each factor the 

weight [I] deem[ ] appropriate in 

determining whether’’ to revoke a 

registration. Id.; see also Jones Total 

Health Care Pharm., LLC v. Drug Enf’t 

Admin., 881 F.3d 823, 830 (11th Cir. 

2018) (citing Akhtar-Zaidi v. Drug Enf’t 

Admin., 841 F.3d 707, 711 (6th Cir. 

2016); MacKay v. Drug Enf’t Admin., 

664 F.3d 808, 816 (10th Cir. 2011); 

Volkman v. Drug Enf’t Admin., 567 F.3d 

215, 222 (6th Cir. 2009); Hoxie v. Drug 

Enf’t Admin., 419 F.3d 477, 482 (6th Cir. 

2005). Moreover, while I am required to 

consider each of the factors, I ‘‘need not 

make explicit findings as to each one.’’ 

MacKay, 664 F.3d at 816 (quoting 

Volkman, 567 F.3d at 222); see also 

Hoxie, 419 F.3d at 482. ‘‘In short, . . . 

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; what matters is the seriousness 

of the registrant’s misconduct.’’ Jayam 

Krishna-Iyer, M.D., 74 FR 459, 462 

(2009). Accordingly, findings under a 

single factor can support the revocation 

of a registration. MacKay, 664 F.3d at 

821. 

The Government has the burden of 

proving that the requirements for 

revocation of a DEA registration in 21 

U.S.C. 824(a) are satisfied. 21 CFR 

1301.44(e). When the Government has 

met its prima facie case, the burden 

then shifts to the registrant to show that 

revoking its registration would not be 

appropriate, given the totality of the 

facts and circumstances on the record. 

Med. Shoppe-Jonesborough, 73 FR 364, 

387 (2008). 

In this matter, while I have 

considered all of the factors, the 

Government’s evidence in support of its 

prima facie case is most appropriately 

considered under Factors Two and 


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24 In this case, I find that Factors One and Three 

weigh neither for nor against revocation. The record 

does not contain a ‘‘recommendation of the 

appropriate State licensing board or professional 

disciplinary authority.’’ 21 § U.S.C. 823(f)(1) Prior 

Agency decisions have found that where the record 

contains no evidence of a recommendation by a 

state licensing board, that absence does not weigh 

for or against revocation. See, e.g., Ajay S. Ahuja, 

M.D., 84 FR 5479, 5490 (2019) (finding that ‘‘where 

the record contains no evidence of a 

recommendation by a state licensing board that 

absence does not weigh for or against revocation.’’); 

Holiday CVS LLC dba CVS Pharmacy Nos 219 and 

5195, 77 FR 62316, 62340 (2012); Roni Dreszer, 

M.D., 76 FR 19434, 19444 (2011). Additionally, 

there is no evidence related to any convictions 

‘‘relating to the manufacture, distribution, or 

dispensing of controlled substances.’’ 21 § U.S.C. 

823(f)(3). However, as Agency cases have noted, 

there are a number of reasons why a person who 

has engaged in criminal misconduct may never 

have been convicted of an offense under this factor, 

let alone prosecuted for one. Dewey C. MacKay, 

M.D., 75 FR 49956, 49973 (2010). Agency cases 

have therefore held that ‘‘the absence of such a 

conviction is of considerably less consequence in 

the public interest inquiry’’ and is therefore not 

dispositive. Id. 

25See, e.g., Pharmacy Doctors Enterprises d/b/a 

Zion Clinic Pharmacy, 83 FR 10876, 10898, pet. for 

Four.24 I find that the Government has 

satisfied its prima facie burden of 

showing that Registrant’s continued 

registration would be ‘‘inconsistent with 

the public interest.’’ 21 U.S.C. 824(a)(4). 

1. Factors Two and Four—The 

Registrant’s Experience in Dispensing 

Controlled Substances and Compliance 

With Applicable Laws Related to 

Controlled Substances 

In determining the public interest 

under Factors Two and Four, I consider 

evidence of Registrant’s compliance (or 

non-compliance) with laws related to 

controlled substances and Registrant’s 

experience dispensing controlled 

substances. The Government’s case 

relies primarily on the actions of 

Registrant’s dispensing pharmacists. 

Furthermore, the Agency ‘‘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.’’ 

Perry Cty. Food & Drug, 80 FR 70084, 

70109 (2015) (citing EZRX, LLC, 69 FR 

63178, 63181 (1988); Plaza Pharmacy, 

53 FR 36910, 36911 (1988)). 

The Government alleged that 

Registrant violated federal and state 

laws related to controlled substances by 

repeatedly dispensing controlled 

substances to 15 customers without 

addressing or resolving red flags of drug 

abuse and diversion. OSC, at 2–3 (citing 

violations of 21 CFR 1306.06 and 

1306.04(a); and Fla. Admin. Code. r. 

64B16–27.800, 64B16–27.810, and 

64B16–27.831). 

i. Violations of Federal Law 

According to the CSA’s implementing 

regulations, a lawful controlled 

substance order or prescription is one 

that is ‘‘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 relevant caselaw could not be more 

explicit. A pharmacist has his own 

responsibility to ensure that controlled 

substances are not dispensed for nonmedical 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 that a pharmacist violated 

his 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 28667, 28670–72 (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.; Med. ShoppeJonesborough, 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.’’). 

In this case, I find that the 

Government has proven through Dr. 

Hamilton’s unrebutted expert opinion 

that Registrant repeatedly filled 

prescriptions for controlled substances 

that presented obvious red flags of abuse 

or diversion, in violation of its 

corresponding responsibility under 21 

CFR 1306.04(a), and outside the usual 

course of the professional practice of 

pharmacy in Florida, in violation of 21 

CFR 1306.06. Registrant’s customers 

traveled round-trip distances of up to 

580 miles, paid enormous cash sums of 

up to $1,294, and presented 

prescriptions for high dosages and 

dangerous combinations of controlled 

substances, such as the ‘‘Trinity’’ 

cocktail, whose pharmacological effect 

is similar to heroin. See supra B.2.ii. 

Additionally, several of Registrant’s 

customers presented prescriptions 

written by physicians who were pattern 

prescribing. Id. As discussed above, 

there is no evidence that Registrant 

made any attempt to address or resolve 

these red flags. Id. Agency decisions 

have consistently found based on 

credible expert testimony that 

prescriptions with similar red flags were 

so suspicious as to support a finding 

that the pharmacists who filled them 

violated the Agency’s corresponding 

responsibility rule due to actual 

knowledge of, or willful blindness to, 

the prescriptions’ illegitimacy.25


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Federal Register / Vol. 87, No. 69 / Monday, April 11, 2022 / Notices 21153 

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 

49816, 49836–39 (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 59504, 59507, 59512–13 

(2014) (unusually large quantity of a controlled 

substance; pattern prescribing; irregular dosing 

instructions; drug cocktails); Holiday CVS, 77 FR 

62316, 62317–22 (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 66149, 

66163–65 (2010) (long distances; lack of 

individualized therapy or dosing; drug cocktails; 

early fills/refills; other pharmacies’ refusals to fill 

the prescriptions). 

26See Fla. Admin. Code. r. 64B16–27.831 (2022). 

27See Fla. Admin. Code. r. 64B16–27.810 (2022). 

I am not including a finding based on Fla. Admin. 

Code. r. 64B16–27.800 because there is more than 

enough evidence on the record to revoke 

Registrant’s registration based on consideration of 

the other found violations under Factors Two and 

Four. 28 Gonzales v. Oregon, 546 U.S. at 274. 

Registrant’s flagrant violations of 

federal law weigh strongly against a 

finding that Registrant’s continued 

registration is consistent with the public 

interest. 

ii. Violations of State Law 

In addition to alleging that Registrant 

violated 21 CFR 1306.04(a) and 1306.06, 

the Government alleges that Registrant 

violated Florida State law by: (1) Failing 

to ‘‘exercis[e] sound professional 

judgment’’ and ‘‘work with the patient 

and the prescriber to assist in 

determining the validity of the 

prescription’’; 26 and by (2) failing to 

review each prescription for potential 

problems, such as ‘‘[o]ver utilization or 

under-utilization’’ and ‘‘[c]linical abuse/ 

misuse,’’ and failing to ‘‘take 

appropriate steps to avoid or resolve the 

potential problems.’’ 27

I find that the Government has 

provided substantial evidence that 

Registrant violated these state laws by 

dispensing controlled substances to the 

15 customers outlined above without 

documenting any attempt to address or 

resolve the numerous red flags with 

these prescriptions. The records clearly 

do not support a finding that Registrant 

‘‘exercise[d] sound professional 

judgment’’ or ‘‘work[ed] with the patient 

and the prescriber to assist in 

determining the validity of the 

prescription,’’ as required by Fla. 

Admin. Code. r. 64B16–27.831. Instead, 

Registrant repeatedly dispensed 

controlled substances to 15 customers 

without documenting any attempt to 

address or resolve the blatant red flags 

with these prescriptions, such as 

patients traveling extreme distances and 

paying enormous cash sums. See supra 

B.2.ii. Additionally, Registrant failed to 

identify and respond to factors that 

indicated a lack of ‘‘therapeutic 

appropriateness’’ of the drugs 

dispensed, as outlined in Fla. Admin. 

Code. r. 64B16–27.810. For example, on 

numerous occasions, Registrant 

dispensed dangerous and potentiallylethal combinations and dosages of 

controlled substances without 

documenting any attempt to address or 

resolve the red flags with these 

prescriptions. See, e.g., supra B.2.ii 

(J.Y., J.S., A.M., K.S.). 

In light of Registrant’s repeated failure 

to address or resolve blatant red flags of 

abuse or diversion, I conclude that 

Factors Two and Four overwhelmingly 

demonstrate that Registrant ‘‘has 

committed such acts as would render 

[its] registration . . . inconsistent with 

the public interest.’’ 21 U.S.C. 824(a)(4). 

I further conclude that Registrant has 

not rebutted the Government’s prima 

facie case. 

III. Sanction 

Where, as here, the Government has 

met its prima facie burden of showing 

that Registrant’s continued registration 

is inconsistent with the public interest, 

the burden shifts to the Registrant to 

show why it can be entrusted with a 

registration. Garrett Howard Smith, 

M.D., 83 FR 18882, 18910 (2018) 

(collecting cases). 

The CSA authorizes the Attorney 

General to ‘‘promulgate and enforce any 

rules, regulations, and procedures 

which he may deem necessary and 

appropriate for the efficient execution of 

his functions under this subchapter.’’ 21 

U.S.C. 871(b). This authority 

specifically relates ‘‘to ‘registration’ and 

‘control,’ and ‘for the efficient execution 

of his functions’ under the statute.’’ 

Gonzales, 546 U.S. at 259. ‘‘Because 

‘past performance is the best predictor 

of future performance, ALRA Labs, Inc. 

v. Drug Enf’t Admin., 54 F.3d 450, 452 

(7th Cir. 1995), [the Agency] has 

repeatedly held that where a registrant 

has committed acts inconsistent with 

the public interest, the registrant must 

accept responsibility for [the 

registrant’s] actions and demonstrate 

that [registrant] will not engage in future 

misconduct.’ ’’ Jayam Krishna-Iyer, 74 

FR at 463 (quoting Med. Shoppe, 73 FR 

at 387 (2008)); see also Samuel S. 

Jackson, 72 FR 23848, 23853 (2007); 

John H. Kennnedy, M.D., 71 FR 35705, 

35709 (2006); Prince George Daniels, 

D.D.S., 60 FR 62884, 62887 (1995). The 

issue of trust is necessarily a factdependent determination based on the 

circumstances presented by the 

individual registrant; therefore, the 

Agency looks at factors, such as the 

acceptance of responsibility, and the 

credibility of that acceptance as it 

relates to the probability of repeat 

violations or behavior, and the nature of 

the misconduct that forms the basis for 

sanction, while also considering the 

Agency’s interest in deterring similar 

acts. See Arvinder Singh, M.D., 81 FR 

8247, 8248 (2016). 

Here the Registrant did not avail itself 

of the opportunity to refute the 

Government’s case. In light of 

Registrant’s egregious violations, which 

go to the heart of the CSA’s purpose of 

‘‘prevent[ing] addiction and recreational 

abuse’’ of controlled substances,28

Registrant’s silence weighs against the 

Registrant’s continued registration. Zvi 

H. Perper, M.D., 77 FR at 64142 (citing 

Med. Shoppe, 73 FR at 387); see also 

Jackson, 72 FR at 23853. 

Accordingly, I find that the factors 

weigh in favor of revocation, and I shall 

order the sanctions that the Government 

requested, as contained in the Order 

below. 

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. FG5612127 issued to George 

Pharmacy, Inc. 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 George 

Pharmacy for additional 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 May 11, 

2022. 

Anne Milgram, 

Administrator. 

[FR Doc. 2022–07692 Filed 4–8–22; 8:45 am] 

BILLING CODE 4410–09–P 


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