[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]
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
[[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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\4\ DEA presented Registrant with a Notice of Inspection Form,
which Registrant signed. RFAAX 9, App'x A.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\9\ These prescriptions were filled on January 13, February 10,
March 10, April 7, May 5, and June 30, 2017. Id.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
[[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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\28\ Gonzales v. Oregon, 546 U.S. at 274.
---------------------------------------------------------------------------
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