[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Notices]
[Pages 21145-21153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07692]


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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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    \1\ Although 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 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.

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[[Page 21146]]

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 three-year 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.
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    \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.
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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 pharmacist-in-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.
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    \4\ DEA presented Registrant with a Notice of Inspection Form, 
which Registrant signed. RFAAX 9, App'x A.
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    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.

[[Page 21147]]

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) Drug-allergy interactions; 
(g) Clinical abuse/misuse. Id. (referencing Fla. Admin. Code r. 64B16-
27.810 (2022)).\6\
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    \5\ This 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.
    \6\ There 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.
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    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.
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    \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.
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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 
immediate-release opioids, such as hydromorphone and oxycodone, for 
several months at a time is a red flag of abuse or diversion.

[[Page 21148]]

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\
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    \8\ There 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.
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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 non-
controlled 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.
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    \9\ These prescriptions were filled on January 13, February 10, 
March 10, April 7, May 5, and June 30, 2017. Id.
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    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.
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    \10\ Cyclobenzaprine 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.
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    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.
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    \11\ These 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.
    \12\ These 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 oxycodone-
acetaminophen 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 oxycodone-acetaminophen 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 oxycodone-acetaminophen 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.
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    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 oxycodone-
acetaminophen (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

[[Page 21149]]

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 
oxycodone-acetaminophen 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.
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    \13\ These 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.
    \14\ The 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.
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    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.
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    \15\ These 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.
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    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.
---------------------------------------------------------------------------

    \16\ These 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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

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

    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.

[[Page 21150]]

    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.
---------------------------------------------------------------------------

    \18\ These prescriptions were filled on November 7, December 4, 
2018, January 4, January 29, February 26, and March 26, 2019. Id.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \19\ These prescriptions were filled on November 20 and December 
19, 2018, and January 16, February 19, and March 18, 2019. 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.
---------------------------------------------------------------------------

    \20\ These prescriptions were filled on November 2, November 29, 
and December 26, 2018; and January 24, February 20, and March 20, 
2019.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \21\ These 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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \22\ These prescriptions were filled on November 6 and December 
4, 2018, and January 2, January 30, and March 1, 2019. 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.

[[Page 21151]]

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.
---------------------------------------------------------------------------

    \23\ These prescriptions were filled on November 5, December 3, 
and December 31, 2018; and January 28, February 25, and March 25, 
2019. 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 na[iuml]ve. RFAAX 11, at 18. Dr. Hamilton 
opined that it is a red flag for an opiate-na[iuml]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 na[iuml]ve. RFAAX 11, at 19. Dr. Hamilton 
opined that it is a red flag for an opiate-na[iuml]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 pattern-
prescribing 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

[[Page 21152]]

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).
---------------------------------------------------------------------------

    \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 Sec.  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 Sec.  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.
---------------------------------------------------------------------------

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 [Sec.  ] 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 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 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. 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.'').
    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\
---------------------------------------------------------------------------

    \25\ See, e.g., Pharmacy Doctors Enterprises d/b/a Zion Clinic 
Pharmacy, 83 FR 10876, 10898, 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 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).

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[[Page 21153]]

    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\
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    \26\ See Fla. Admin. Code. r. 64B16-27.831 (2022).
    \27\ See 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.
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    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 
potentially-lethal 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 fact-dependent 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.
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    \28\ Gonzales v. Oregon, 546 U.S. at 274.
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    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