    [Federal Register Volume 85, Number 168 (Friday, August 28, 2020)]
    [Notices]
    [Pages 53402-53421]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 2020-18975]

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    DEPARTMENT OF JUSTICE

    Drug Enforcement Administration

    [Docket No. 16-33]

    Heavenly Care Pharmacy; Decision and Order

        On August 3, 2016, the Deputy Assistant Administrator, Office of
    Diversion Control, Drug Enforcement Administration issued an Order to
    Show Cause (``OSC'') to Heavenly Care Pharmacy (hereinafter, Respondent
    or Respondent Pharmacy), which sought to revoke Respondent's DEA
    Certificate of Registration FH4377291, at the registered location of
    617 9th Ave., Bessemer, Alabama, and to deny any pending or current
    applications for renewal or modifications of FH4377291. Administrative
    Law Judge Exhibit (ALJX) 1 (OSC), at 1-2, 7 (citing 21 U.S.C. 823(f),
    824(a)(4)). The OSC alleged that Respondent's continued registration is
    inconsistent with the public interest. Id. at 1. Specifically, the OSC
    alleged that Respondent (1) failed to exercise its corresponding
    responsibility to assess the legitimacy of prescriptions that it filled
    in violation of 21 CFR 1306.04(a) and failed to dispense controlled
    substances within the bounds of the pharmacy profession in violation of
    21 CFR 1306.06, id. at 2; (2) failed to maintain certain records
    required under federal and Alabama

    [[Page 53403]]

    state law and have them available for inspection, id. at 5-7 (citing 21
    CFR 1304.11(a) and (b); 1304.11(e)(1)(iii) and (iv); 1304.11(e)(6);
    1304.21(a); and 1305.04(a)); and (3) inaccurately reported its
    dispensing data to the Alabama Prescription Drug Monitoring Program
    (PDMP), which the OSC alleged ``clearly constitutes `such other conduct
    which may threaten the public health and safety' that counsels against
    [Respondent's] maintenance of a DEA registration,'' id. at 7 (citing 21
    U.S.C. 823(f)(5)). The Government also alleged via its Supplemental
    Prehearing Statement that Respondent provided materially false
    responses in a registration renewal application filed on September 8,
    2016. ALJX 16, at 1.
        In a letter from its counsel dated September 7, 2016, Respondent
    requested a hearing on the allegations. ALJX 2. The matter was placed
    on the docket of the Office of the Administrative Law Judges and
    assigned to Chief Administrative Law Judge John J. Mulrooney, II
    (hereinafter, Chief ALJ). Prehearing proceedings were initiated, ALJX
    3, and the Government filed a Prehearing Statement, ALJX 4; however,
    the case was terminated on October 13, 2016, due to the Respondent's
    non-compliance with the Chief ALJ's orders, ALJX 3, 5-7. On June 15,
    2017, the Acting Administrator of the DEA issued an order remanding the
    matter to the Office of the Administrative Law Judges for a hearing.
    ALJX 12. The case was reassigned to ALJ Mark M. Dowd. ALJX 21.
        Respondent filed a Prehearing Statement and the Government filed a
    Supplemental Prehearing Statement on July 19, 2017. ALJX 16 and 17. The
    ALJ issued an order with a consolidated list of the parties'
    stipulations on August 2, 2017, ALJX 23, and a hearing was conducted on
    August 29-31, 2017, in Birmingham, Alabama, ALJX 14. Both the
    Government and the Respondent filed Posthearing Briefs.
        On November 6, 2017, the ALJ issued and served his recommended
    decision, which included the ALJ's recommendation that I revoke
    Respondent's registration and deny its pending application for renewal.
    Recommended Decision (hereinafter, RD), at 61. Neither the Government
    nor Respondent filed exceptions to the ALJ's RD, and the record was
    forwarded to me for final agency action.
        Having considered the record in its entirety, I agree with the RD
    that the record established, by substantial evidence, two independent
    grounds for the revocation of Respondent's registration: (1)
    Respondent's continued registration is inconsistent with the public
    interest; and (2) Respondent materially falsified its renewal
    application. I further agree with the RD that Respondent's acceptance
    of responsibility is insufficient and that, even if it were sufficient,
    Respondent did not offer adequate remedial measures.
        Accordingly, I conclude that the appropriate sanctions are (1) for
    Respondent's DEA Registration FH4377291 to be revoked; and (2) for any
    pending application by Respondent to renew or modify its registration
    be denied. I make the following findings.

    I. Findings of Fact

    A. Respondent's DEA Registration

        Respondent Heavenly Care Pharmacy holds DEA registration FH4377291,
    which authorizes it to dispense controlled substances in schedules II
    through V as a retail pharmacy at the registered location of 617 9th
    Ave. N., Bessemer, Alabama 35020. RD, at 7. The registration was set to
    expire on October 31, 2016, but Respondent submitted a timely renewal
    application on September 8, 2016.\1\ Id.
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        \1\ The status of a registration under an OSC, such as
    Respondent's, does not impact my jurisdiction or prerogative under
    the Controlled Substances Act (hereinafter, CSA) to adjudicate the
    OSC to finality. Jeffrey D. Olsen, M.D., 84 FR 68,474 (2019).
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        Respondent's answers on the renewal application were certified as
    true and correct by Santonia Davison, Respondent Pharmacy's owner/
    proprietor and Pharmacist-in-Charge (PIC) (hereinafter, PIC Davison).
    Government Exhibit (hereinafter, GX) 26, at 1; Transcript (hereinafter,
    Tr.) 693. On the renewal application, Respondent answered ``No'' to the
    question ``Has the applicant ever surrendered (for cause) or had a
    federal controlled substance registration revoked, suspended,
    restricted or denied, or is any such action pending?'' GX 26, at 1; Tr.
    214. I find by clear, unequivocal, and convincing evidence that
    Respondent's answer was false because Respondent acknowledged that it
    was served the OSC on August 9, 2016. See ALJX 2, at 1.

    B. The Investigation of Respondent

    1. Forgery Investigation
        In October 2014, a Diversion Investigator (hereinafter, DI One) and
    a Birmingham Police Department Sergeant (hereinafter, Police Sergeant)
    were working a prescription forgery ring, which involved approximately
    ten pharmacies, including the Respondent Pharmacy.\2\ Tr. 130-31, 138-
    39, 814-16. Prescription pads had been stolen from The University of
    Alabama Medical Center (UAB) and were being forged to obtain controlled
    substances. Id. at 135, 231-32.
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        \2\ DI One has been a DEA Diversion Investigator since July
    2012. She was assigned to the Birmingham DEA Office in September
    2012. Tr. 129.
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        Along with the Police Sergeant, DI One proceeded to the Respondent
    Pharmacy to obtain hard copies of the forged prescriptions filled
    there. Id. at 131, 234; GX 6. Of the ten pharmacies involved in the
    investigation, DI One testified that Respondent Pharmacy had the most
    forged prescriptions filled--at least seven during a two-week time
    frame. Tr. 138-39, 233-35. While there, PIC Davison notified the Police
    Sergeant and DI One that one of the forged prescriptions had only been
    partially filled, and that the individual was expected to return
    shortly to fill the remainder of the prescription. Id. at 133, 816-19.
    When the subject individual sought to fill the remainder of the
    prescription, he was arrested by the Police Sergeant and removed to a
    back room at the pharmacy for questioning. Id. at 134, 817-18. Again
    with PIC Davison's assistance, two other individuals were questioned at
    the Respondent Pharmacy in connection with the forgery ring that day.
    Id. at 134, 586-87, 817-18.
    2. Administrative Inspection
        On May 20, 2015, DEA Investigators executed an Administrative
    Inspection Warrant (AIW) at Respondent. GX 1, at 4; Tr. 30. The lead
    Diversion Investigator for the audit (hereinafter, DI Two) \3\
    presented the AIW to PIC Davison. Tr. 30. DI Two was accompanied on the
    inspection by another diversion investigator, a DEA intelligence
    analyst, two local police officers, and two Alabama Board of Pharmacy
    investigators. Id. at 30, 31. DI Two testified that when she entered
    the pharmacy there were papers everywhere ``like someone had turned on
    a fan in there'' and that there was trash on the counter. Id. at 32.
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        \3\ DI Two has been a DEA diversion investigator since February
    2011. Tr. 24, 25. DI Two is assigned to investigate DEA registrants,
    and in that capacity, typically inspects ten to twelve pharmacies a
    year. Tr. 25-26.
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        During the inspection, the investigators requested Respondent's
    ``initial inventory,'' the annual inventory required by the State of
    Alabama, controlled substance ordering records, controlled substance
    receipt records, and records accounting for all controlled substances
    dispensed from the pharmacy, to date. Id. at 31-34, 83. DI Two
    testified that she requested these records for two reasons: (1) To
    audit the

    [[Page 53404]]

    number of controlled substances--the drugs entering and leaving the
    pharmacy; and (2) to review the records for completeness. Id. at 34
        PIC Davison was unable to produce an initial inventory of the
    controlled substances at the pharmacy to DI Two. Id. at 32-33. During
    the hearing, she testified that she did not know that she was required
    to have an initial inventory, id. at 543, but conceded that the
    Pharmacy Manual, which she studied in pharmacy school and used in
    developing her policies and procedures, contained a detailed
    explanation of the initial inventory report requirements, id. at 700.
    PIC Davison was also unable to produce the annual inventory required by
    the state to be completed on January 15, 2015, id. at 33, and during
    the hearing she stated that she could not produce the inventory record
    because she did not complete the inventory on January 15, 2015, id. at
    714.
        PIC Davison did produce records during the inspection for the
    ordering, receipt, and dispensation of controlled substances. For
    Schedule II substances, Respondent ordered drugs using both DEA Form
    222s and through an electronic Controlled Substance Ordering System
    (CSOS). Id. at 35, 46-49, 562. DI Two testified that fifteen of
    Respondent's DEA Form 222s lacked documentation to evidence the receipt
    of the number of packages received and the date received, Tr. 46-48; GX
    3, and that Respondent had failed to record that it had received the
    ordered drugs for sixteen orders in Respondent's CSOS, Tr. 35-36, 98-
    99; GX 2. DI Two acknowledged that documentation of receipt would not
    exist for drugs that were ordered and not received, Tr. 48-49, and that
    there was no set amount of time in which a pharmacy must record receipt
    on a DEA Form 222 or in the CSOS, id. at 40-42, but expressed doubt
    that the orders were not received, because they dated back to 2014 and
    the pharmacist had not written ``VOID'' on the DEA Form 222s, id. at
    36-37, 43-44, 48-49. PIC Davison confirmed that Respondent Pharmacy
    had, in fact, received the orders. Id. at 92, 564-65.
        DI Two testified that she also found the records for Respondent's
    orders of schedule III-V controlled substances to be incomplete because
    they did not indicate the date or the amount received. Id. at 50; GX 4.
    On some of the receipt invoices, Respondent had circled the quantity
    shipped, which DI Two inferred could indicate the amount received was
    correct, but on other receipt invoices, there were no circled
    quantities. Tr. 50-51; GX 4. PIC Davison did sign the invoices, which
    she testified she did to document receipt of the order and confirm that
    the quantity and date listed on the invoice were correct. Tr. 578; GX
    4.
        DI Two further testified that, in her experience, it was unusual to
    find such a large number of record-keeping discrepancies at a new
    pharmacy, such as Respondent Pharmacy. Tr. 112. She stated that the
    paperwork at newer pharmacies is generally very compliant and that, in
    general, it is not until a pharmacy is busier that the record-keeping
    becomes ``sloppier.'' Id. at 112-13.
        As part of executing the AIW, DI Two completed a closing inventory
    (count) of the generic versions of six controlled substances--
    hydrocodone 10/325, hydrocodone 7.5/325, promethazine with codeine
    cough syrup, oxycodone 10/325, oxycodone 15, and oxycodone 30. Id. at
    34, 115, 120-21. Using Respondent's receipt and dispensation records,
    the DI conducted an audit of Respondent's handling of these six
    controlled substances. Id. at 34. These records included Respondent's
    DEA Form 222s, CSOS records, schedule III-V receipt invoices, and
    dispensation records printed by PIC Davison from her electronic system
    and provided to the investigators. Tr. 55-57, 555-57; GX 27. DI Two
    stated that for the purposes of the audit, she assumed all drug orders
    had been received by the pharmacy even though, as described above,
    Respondent had not documented receipt of all orders. Tr. 53. DI Two's
    audit found both shortages and overages among the six drugs, including
    a 22% shortage of oxycodone 10/325 and a 92% overage of hydrocodone
    7.5/325. GX 5.\4\
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        \4\ DI Two explained that a shortage occurs when a pharmacy
    cannot account for drugs received, i.e., the drug is not in the
    pharmacy's inventory but there is no record of it being dispensed or
    otherwise leaving the pharmacy, and an overage reflects the presence
    of controlled substances in the pharmacy's inventory in excess of
    the recorded amount received. Tr. 58.
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        Respondent disputes the accuracy of DI Two's audit. Tr. 551-57. PIC
    Davison testified that she completed her own closing inventory of the
    six controlled substances on May 20, 2015, and had a different count
    than DI Two's for five of the six drugs. Tr. 551-52; GX. 7, at 3. PIC
    Davison also testified that she believes DI Two's tabulations for the
    amounts distributed for five of the six drugs were inaccurate, because
    they were based on an incorrect report that PIC Davison provided at the
    inspection. Tr. 553-57. PIC Davison stated that she did not know how to
    run the report in her computer system for the information that DI Two
    requested, and it was not until July 6, 2015, that PIC Davison ran the
    ``correct'' report, on which she based her own tabulations.\5\ Tr. 555,
    561; GX 7, at 3. PIC Davison does not dispute that the July 6 report,
    which she claims to be the report that should have been used for the
    audit, was not available to the DEA Investigators during the inspection
    of Respondent Pharmacy. Tr. 561.
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        \5\ PIC Davison's own tabulations using the July 6 report still
    showed a shortage for one and overages for three of the six audited
    drugs. GX 7, at 3. At the hearing, after seeing the July 6 report
    and PIC Davison's tabulations, DI Two testified that she believed at
    least one of PIC Davison's tabulations was incorrect. Tr. 823-24.
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        DI Two returned to the Respondent Pharmacy on May 21, 2015, to
    discuss with PIC Davison each regulatory violation, the audit
    discrepancies that DI Two discovered, and instructions regarding steps
    to correct these violations. Id. at 62-64, 81, 85, 112.\6\ DI Two did
    not recall any explanation by PIC Davison for the regulatory violations
    or audit discrepancies discussed. Id. at 63-64.
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        \6\ DI Two testified that after the May 21, 2015 conversation
    with PIC Davison she had no other interaction with the Respondent
    Pharmacy. Tr. 65. However, DI Two did learn through DI One that PIC
    Davison believed that either DI Two or one of the individuals on the
    day of the AIW took with them a notebook that had the missing
    records, or improperly kept records from it. Id. at 66. DI Two
    testified that this was not possible, as the alleged notebook had
    been reviewed multiple times on May 20, 2015. Id. at 66. Moreover,
    DI Two did not believe that a notebook that had been taken from the
    Respondent Pharmacy contained any missing/incomplete records as DI
    Two and the other investigators spent five to six hours in the
    Respondent Pharmacy, and the Respondent Pharmacy was not very large,
    and DI Two believed that if the record was there, it would have been
    found. Id. at 68. Moreover, DI Two stated that everything taken from
    the Respondent Pharmacy was recorded in Government Exhibit 1. Id. at
    69; see GX 1.
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        The ALJ found, and I agree, that the testimony of DI Two regarding
    the execution of the AIW, the audit, and all other aspects of her
    testimony was fully credible. RD, at 13.
    3. July 6, 2015 Meeting
        DI One reviewed the results of the AIW at Respondent Pharmacy and
    invited PIC Davison to attend a meeting on July 6, 2015, at the
    Birmingham DEA Office with DI One, two of DI One's supervisors, and two
    investigators from the Alabama Board of Pharmacy, including its Chief
    Investigator, to discuss bringing the Respondent Pharmacy ``into
    compliance'' with the relevant regulations and professional standards.
    Tr. 143-44. The officials contemplated entering into a Memorandum of
    Agreement (MOA) with Respondent Pharmacy for what was essentially a
    probationary period in which the DEA would agree not to seek

    [[Page 53405]]

    sanctions as long as the Respondent Pharmacy cooperated with the DEA to
    bring the Respondent Pharmacy into compliance. Id. at 144-45. At some
    point during the meeting,\7\ the officials decided that an MOA would
    not be appropriate, and that proceedings would be initiated to pursue
    revocation of the Respondent Pharmacy's registration. Id. at 144. DI
    One explained that this decision was reached because PIC Davison did
    not concede that the reported violations had occurred, deflected direct
    questions, and wished to dispose of the matter by simply paying a fine.
    Id. at 145-47.
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        \7\ DI One could not remember how long into the meeting the
    decision was made to move for revocation, and Counsel for the
    Respondent Pharmacy suggested the meeting only lasted perhaps 90
    seconds; however, PIC Davison later suggested the meeting lasted at
    least 30-40 minutes. Tr. 549.
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        PIC Davison testified that she learned about the requirement to
    have an initial inventory during the July 6 meeting and, after the
    meeting, went to the pharmacy to look through her records and ``see if
    [she] could find perhaps what they could be looking for.'' Id. at 543-
    44. PIC Davison found a ``Narcotics Sales Report'' generated from
    Cardinal Health, Respondent Pharmacy's sole pharmaceutical distributor,
    which listed Respondent's controlled substance purchases from May 1 to
    May 31, 2014, and which PIC Davison thought was ``as close to what they
    were explaining to me I should have [for an initial inventory].'' Id.
    at 544-45. PIC Davison then handwrote ``Initial Inventory'' on the
    report. Id. at 545.
        The next morning, July 7, 2015, at 1:54 a.m., DI One received an
    email from PIC Davison explaining that her ``initial inventory'' had
    been in a three-ring binder that had been ``retrieved'' by one of the
    DEA Agents during the May 20, 2015, inspection.\8\ Tr. 149-50. The
    email included a two-page attachment, the ``Narcotics Sales Report,''
    which PIC Davison purported to be the Respondent Pharmacy's ``initial
    inventory.'' Tr. 151; GX 7, at 58-59. DI One suspected that the report
    was produced on the evening of July 6, 2015.\9\ Tr. 150-53, 246-48,
    253. The ``Narcotics Sales Report'' included a list of the schedule III
    through V controlled substances procured by the Respondent Pharmacy
    from Cardinal Health from May 1, 2014, through May 31, 2014. Tr. 151-
    55; GX 7, at 58-59. The Respondent Pharmacy opened for business on May
    26, 2014. Besides perhaps not being a timely report--that is, not
    created at the time the Respondent Pharmacy began dispensing controlled
    substances, Tr. 151-156--DI One opined that it was not a fully
    compliant initial inventory report, as it lacked several other
    necessary elements. It did not include the initial inventory of
    schedule I and II controlled substances. It also lacked a specific date
    and whether it was taken at the open or close of business on that date.
    Id. at 154, 250.
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        \8\ PIC Davison later explained to DI One that the initial
    inventory had been picked up by a DEA Agent during the May 20, 2015
    audit, and was not discovered by PIC Davison until later that
    evening. Tr. 258.
        \9\ The time of the document's creation was suggested to the
    Government by review of other documents apparently created
    coincident to the subject document. Tr. 150-56.
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    4. DI One's Investigation
        Sometime following the July 6, 2015 meeting with PIC Davison, DI
    One received a call from a local Alabama doctor, (hereinafter, Dr. F.),
    complaining that the Respondent Pharmacy had filled a prescription and
    attributed it to him (Dr. F.) in the Alabama Prescription Drug
    Monitoring Program, PDMP, which the doctor denied prescribing. Id. at
    157-59. To investigate the matter further, DI One retrieved the PDMP
    report for the subject prescription and a PDMP report for the
    Respondent Pharmacy from August 2014-August 2015, revealing all
    controlled substances dispensed by the Respondent Pharmacy during that
    period. Id. at 159-60; see GX 8. DI One further retrieved the original
    prescription from the Respondent Pharmacy, which identified a different
    doctor as the prescriber, yet the Respondent Pharmacy label incorrectly
    identified Dr. F. as the prescriber. Tr. 162-68; see GX. 9.
        Using the August 2014-August 2015 PDMP report, DI One located two
    other instances where the wrong doctor was identified as the prescriber
    in the subject Respondent Pharmacy PDMP report. Id. at 170-71. DI One
    also found instances where duplicate prescriptions were entered into
    the PDMP. Id. at 172-73; see GX 10, at 36. DI One additionally
    identified a twenty-one day period in which no controlled substance
    prescriptions were entered into the PDMP by the Respondent Pharmacy,
    yet nearly 100 prescriptions were filled there during that period. Tr.
    174; see GX 10, at 36. These discrepancies prompted DI One to retrieve
    a number of original prescriptions from the Respondent Pharmacy. Tr.
    180-81; see GX 11-17, 28.
        DI One also testified regarding the two administrative subpoenas
    the DEA issued to Respondent. Tr. 197. The first was issued on February
    16, 2016, and requested any documentation on prescriptions for specific
    patients, specific prescribers, and patients and prescribers that met
    certain characteristics. GX 18. Respondent replied to this subpoena
    with a single document describing Respondent's interactions with and
    knowledge of the patients and prescribers in narrative, summary form.
    GX 19. The DEA issued a second subpoena on May 6, 2016, requesting
    ``any and all documents or records (paper or electronic) reflecting
    efforts by pharmacists at Heavenly Care Pharmacy to exercise their
    corresponding responsibility to assess the prescriptions for controlled
    substances they were asked to fill or dispense from March 1, 2013,
    through December 31, 2015.'' GX 20. The subpoena was delivered to
    Respondent's counsel along with a letter clarifying that the DEA was
    not asking Respondent to ``create documents that do not already exist''
    but rather was seeking ``contemporaneous documents or records that fit
    the description provided in the subpoena.'' Id.; see Tr. 202. DI One
    testified that the DEA served the second subpoena because it wanted to
    be sure that Respondent ``provided any and all documentation regarding
    patient profiles of dispensing controlled substances to the specific
    patients and prescribers on the administrative subpoena.'' Tr. 204.
    Respondent replied to this subpoena with printouts of patient profiles
    that Respondent kept in its computer system regarding the patients
    identified by the DEA. GX 22; see Tr. 209-10. DI One provided
    Respondent's responses to the subpoenas to Dr. Alverson to use in her
    review. Tr. 197.
        The ALJ found, and I agree, that, although DI One reported some
    memory lapse regarding uncritical aspects of the investigation, her
    testimony was credible in all relevant respects. RD, at 15.

    C. Testimony of Dr. Susan Alverson

    1. Dr. Alverson's Credentials
        Dr. Susan Alverson, a licensed pharmacist for forty-nine years, has
    been the Executive Secretary for the Alabama Board of Pharmacy for the
    preceding four years. Dr. Alverson was qualified as an expert in retail
    pharmacy and the standards for retail pharmacists under both Alabama
    and federal law and regulations. Id. at 309-12. The ALJ found that Dr.
    Alverson testified convincingly as an expert witness and Respondent
    conceded Dr. Alverson is a renowned expert. RD, at 20.
    2. Auburn University Encounter
        Prior to offering her expert opinion testimony, Dr. Alverson
    testified as a fact witness regarding an encounter she had with PIC
    Davison approximately

    [[Page 53406]]

    one month prior to the hearing. Tr. 313. Dr. Alverson was at Auburn
    University for a continuing education program. Following the program,
    Dr. Alverson was approached by PIC Davison, one of Dr. Alverson's
    former students at Samford University. Id. at 313-316. PIC Davison told
    Dr. Alverson that DEA wanted to ``take [her] license.'' Id. at 315-16.
    PIC Davison began to explain the circumstances of her situation to Dr.
    Alverson. She explained, in essence, that patients from a nearby
    pharmacy who appeared to be addicted to prescription drugs had
    gravitated to her pharmacy. Id. PIC Davison suggested she could not
    ``just cut them off and leave them with no options.'' Id. at 317. PIC
    Davison also voiced her concern to Dr. Alverson about disparate
    treatment of black patients by the medical/pharmaceutical establishment
    and law enforcement. Id.
        On cross-examination, Dr. Alverson conceded PIC Davison's comments
    may have been less exacting. Dr. Alverson testified that it was
    possible PIC Davison did not use the word ``addicted'' and may have
    instead said that the subject patients were receiving the same
    medication from another pharmacy before coming to Respondent Pharmacy
    and that ``[w]hatever problems they had when they got to [Respondent
    Pharmacy], they had those problems before they got to [Respondent
    Pharmacy].'' Id. at 329-30.
        Dr. Alverson was unaware of the name of the pharmacist involved in
    her review of Respondent Pharmacy (and therefore did not immediately
    connect PIC Davison to Respondent Pharmacy), but as their conversation
    progressed, Dr. Alverson recognized the circumstances described by PIC
    Davison as involving the instant investigation. Id. PIC Davison then
    reported that she had read Dr. Alverson's statement on the matter. Dr.
    Alverson advised PIC Davison to confer with PIC Davison's attorney for
    advice, and took her leave. Id. at 316-17.
        The ALJ found, and I agree, that Dr. Alverson testified credibly as
    a fact witness. RD, at 20.
    3. Dr. Alverson's Expert Opinion
        Dr. Alverson testified about an Alabama pharmacy's/pharmacist's
    standard of practice when presented with a controlled substance
    prescription. See Tr. 331-356. Dr. Alverson explained the evolution of
    the professional responsibilities of pharmacists to the contemporary
    healthcare team-concept, in which the pharmacist has a ``corresponding
    responsibility'' to the prescribing physician to make an independent
    evaluation of each prescription. Tr. 334-35, 347. A pharmacist cannot
    assume that a prescription is legitimate just because it was written by
    a physician. Id. at 348. The pharmacist acts as the final
    ``gatekeeper'' in dispensing prescribed medication, with the patient's
    health and safety of paramount concern. Id. at 347-52. The pharmacist
    must make her own determination that a prescribed drug is safe and
    appropriate for the patient and look for indicators that the drug was
    prescribed for illegitimate reasons or outside the norms of the medical
    profession. Id. at 332, 347-48, 377, 474.
        Dr. Alverson noted that the State of Alabama had adopted this
    concept and codified it in several provisions of the Alabama
    Administrative Code. See Tr. 335; GX 25; Ala. Admin. Code 680-X-2-.21.
    For example, Ala. Admin. Code 680-X-2-.21(2) provides that ``[e]ach new
    prescription and, where appropriate, refill prescription, should be
    reviewed for, but not limited to, the following: (a) Therapeutic
    duplication; (b) drug-disease contraindication where indicated; (c)
    drug-drug interaction; (d) incorrect dosage/duration; (e) drug allergy
    interactions; and (f) clinical abuse/misuse.'' Dr. Alverson explained
    the practical application of these requirements, what is expected of
    Alabama pharmacists in these regards, and the potential fatal
    consequences to patients upon the pharmacist's failure to comply with
    any of these provisions. Tr. 336-40. Dr. Alverson discussed the
    pharmacist's codified responsibility to develop, document, and maintain
    patient medication profiles and patient notes, and explained the
    critical importance of this provision. Tr. 341, 518-23; see Ala. Admin.
    Code 680-X-2-.21(5). In addition to their internal documentation, Dr.
    Alverson testified that pharmacies in Alabama are required to report
    each dispensation of a controlled substance to the State's PDMP. Tr.
    507-08.
        Dr. Alverson explained the various warning signs--``red flags''--of
    diversion or abuse of which a pharmacist must be cognizant to protect
    the safety of the patient and community. These included: Doctor-
    shopping; pharmacy-shopping; the doctor and practice specialty; \10\
    over-prescribing or duplication of pain medication; traveling long
    distances to obtain or fill prescriptions; drug combinations
    susceptible to abuse, e.g., a combination of pain medication with
    anxiety medication and a muscle relaxant, which is informally referred
    to as a ``cocktail,'' and well-known as evidence of abuse or diversion;
    among others. Tr. 348-52, 401. In the face of these red flags, a
    pharmacist is expected to investigate the matter, to either satisfy her
    concerns or, failing that, to decline to fill the prescription. Tr.
    352, 391. Dr. Alverson explained the investigation would include steps
    such as interviewing the patient, calling the prescribing physician,
    reviewing the patient's records in the PDMP, and checking the Alabama
    Medical Board's website to determine the prescribing physician's
    registration status, location, and specialty. Tr. 378-381. If the
    pharmacist fills the prescription, the pharmacist is obliged to
    document the results of her investigation in the electronic patient
    notes or on the prescription and the documentation should always be
    contemporaneous. Tr. 353, 361, 378. These notes are used upon a
    patient's return to the pharmacy to demonstrate to the pharmacist or to
    the next pharmacist that red flags have been investigated and resolved,
    and to demonstrate that the pharmacist is practicing their due
    diligence. Tr. 353, 520.
    ---------------------------------------------------------------------------

        \10\ Dr. Alverson testified that it is important to know the
    doctor's specialty to determine if a prescription is appropriate.
    She used the example of an oncologist prescribing higher doses of
    pain medication to end-stage/hospice patients. Tr. 351. As a counter
    example, she explained that she would question the appropriateness
    of a dentist prescribing 30 days of a pain medication for a tooth
    pull. Tr. 349.
    ---------------------------------------------------------------------------

        Dr. Alverson discussed how pharmacists must use the professional
    judgment that they develop from education and training. Id. at 345. She
    explained that accredited pharmacy schools offer a class in pharmacy
    law covering both state and federal law and lessons on pharmacists'
    responsibilities under the law are integrated into the curriculum of
    other classes. Id. at 346. In order to obtain a pharmacy license, one
    must pass both a clinical examination, as well as a law exam, which
    covers both state and federal law. Id. Dr. Alverson testified that the
    corresponding responsibility of a pharmacist is included in the law
    exam and taught under the pharmacy school curriculum. Id. at 347. Dr.
    Alverson also emphasized that the Alabama Code of Professional Conduct
    requires a pharmacist to stay abreast of developments in the field,
    including patterns of abuse and diversion. Id. at 343-44; GX 24; Ala.
    Admin. Code 680-X-2-.22.
        In her testimony, Dr. Alverson reacted to the comments made to her
    at Auburn University by PIC Davison a month prior to the hearing to the
    effect the subject patients had already been on the subject medications
    when they reached the Respondent Pharmacy, and had

    [[Page 53407]]

    already developed addiction problems. Dr. Alverson deemed that
    rationale inconsistent with a pharmacist's responsibility, and
    suggested appropriate responses: Counsel the patient to see a different
    doctor, refer them to treatment programs, and refuse to fill such
    prescriptions. Tr. 447-48. Dr. Alverson also dismissed a suggestion
    that Respondent Pharmacy's responsibilities to investigate red flags
    were in some way lessened when the prescription was a transfer from
    another pharmacy--noting that a pharmacy should review transfer
    prescriptions the same as any new patient prescription. Id. at 453.
        Dr. Alverson reviewed a number of documents provided by the DEA
    including patient records from Respondent Pharmacy, corresponding
    prescriptions from those patients, and a record Respondent Pharmacy
    produced in response to a DEA subpoena. Dr. Alverson also reviewed
    records from the Alabama PDMP. She noted that from November 10, 2014,
    until December 1, 2014, the Respondent Pharmacy made no reports of
    dispensing controlled substances to the PDMP, despite the presence of
    original prescriptions evidencing the filling of controlled substances
    during that period. Id. at 393-95. On cross-examination, Dr. Alverson
    conceded that the pharmaceutical knowledge base was ever-growing and
    the professional standards ever-evolving, but confirmed that she
    evaluated the Respondent Pharmacy based upon the standards in place at
    the time of the dispensations. Id. at 460-73.
    a. Patient M.A. (Male) \11\
    ---------------------------------------------------------------------------

        \11\ The parties stipulated that Respondent filled the following
    prescriptions for controlled substances for patient M.A. (male): on
    December 1, 2014, 30 tablets of carisoprodol 350mg and 120 tablets
    of hydrocodone-acetaminophen 10-325 mg; on December 8, 2014, 60
    tablets of oxycodone 15mg; on January 6, 2015, 30 tablets of
    carisoprodol 350mg, 120 tablets of oxycodone 15mg, and 120 tablets
    of hydrocodone-acetaminophen 10-325mg; on February 9, 2015, 30
    tablets of carisoprodol 350mg, 120 tablets of oxycodone 15mg, and
    120 tablets of hydrocodone-acetaminophen 10-325mg; on March 9, 2015,
    30 tablets of carisoprodol 350mg, 120 tablets of oxycodone 15mg, 120
    tablets of hydrocodone-acetaminophen 10-325mg, and 30 tablets of
    zolpidem 10mg; on April 13, 2015, 30 tablets of carisoprodol 350mg,
    120 tablets of oxycodone 15mg, 120 tablets of hydrocodone-
    acetaminophen 10-325mg, and 30 tablets of zolpidem 10mg; on May 11,
    2015, 30 tablets of carisoprodol 350mg, 120 tablets of oxycodone
    15mg, 120 tablets of hydrocodone-acetaminophen 10-325mg, and 30
    tablets of zolpidem 10mg; on June 8, 2015, 120 tablets of oxycodone
    15mg, 120 tablets of hydrocodone-acetaminophen 10-325mg, and 30
    tablets of zolpidem 10mg; on July 13, 2015, 30 tablets of
    carisoprodol 350mg, 120 tablets of oxycodone 15mg, and 120 tablets
    of hydrocodone-acetaminophen; on August 17, 2015, 30 tablets of
    carisoprodol 350mg, 120 tablets of oxycodone 15mg, and 120 tablets
    of hydrocodone-acetaminophen. RD, at 3-4.
    ---------------------------------------------------------------------------

        For the first patient discussed, male M.A., Dr. Alverson noted that
    the patient arrived at Respondent Pharmacy in December 2014 with
    prescriptions for a risky combination of drugs, but that none of the
    records included any patient notes by PIC Davison, as would be expected
    in light of the red flags revealed by the prescriptions. Id. at 359-68,
    382, 494; GX 11, 22. The medications prescribed to M.A. included both
    hydrocodone and oxycodone, which are two opioid pain medications and
    respiratory depressants that ``potentiate'' each other, or magnify the
    other's effects. Tr. 369. These medications were coupled with
    carisoprodol, a muscle relaxant, which further acts to depress
    respiration. Id. at 368-70. Dr. Alverson testified that a responsible
    pharmacist would have investigated why this combination of drugs, all
    of which cause respiratory depression and work the same way, were
    prescribed and would have declined to dispense the drugs unless
    satisfied that she could dispense them safely. Id. at 377.
        Dr. Alverson noted that M.A.'s dose of pain medication (oxycodone)
    was doubled from 60 tablets to 120 tablets over a thirty-day period,
    when the best practice is to increase by no more than 25% at a time.
    Id. at 383-84. The increase also troubled Dr. Alverson, because the
    oxycodone was prescribed for breakthrough pain but was being prescribed
    at the level for a maintenance pain drug, id. at 386; and then, in June
    2015, the doctor switched which pain medication was for maintenance and
    which was for breakthrough pain, id. at 386-390. Dr. Alverson testified
    that this switch was a red flag for abuse because it indicated the
    doctor ``didn't really care about providing legitimate medical
    treatment.'' Id. at 390. In June 2015, the patient was also prescribed
    zolpidem, a fourth respiratory depressant. Id. at 385. In addition,
    patient M.A. continued to receive repeated refills of carisoprodol
    despite a Food and Drug Administration (FDA) approval saying that the
    drug should not be used for more than three weeks. Id. at 370.
        Dr. Alverson opined the prescribing pattern for M.A. was
    inconsistent with accepted pharmaceutical standards and posed a danger
    to the patient. Id. at 379, 502-03. She stated that in addition to an
    investigation at the initial prescription (of which there was no
    record), Respondent Pharmacy should have done further investigations
    based on the increased quantities and number of drugs prescribed. Id.
    at 391. Dr. Alverson found no indication in the records before her,
    which included copies of the front and back of the original hard-copy
    prescription and the patient's profile from Respondent's electronic
    system, that an appropriate, timely investigation was ever performed by
    the Respondent Pharmacy regarding the above-noted red flags. Id. at
    392, 500, 504. Dr. Alverson testified that the prescriptions should not
    have been filled without investigation, and that even if the pharmacist
    had completed an investigation and just failed to document the
    investigation, the lack of documentation is itself a violation of the
    standard of care in Alabama. Id. at 502-504.
    b. Patient C.W.\12\
    ---------------------------------------------------------------------------

        \12\ The parties stipulated Respondent filled the following
    prescriptions for controlled substances for patient C.W. On December
    5, 2014, 30 tablets of carisoprodol 350mg; on December 9, 2014, 31
    tablets of alprazolam 2mg and 60 tablets of oxycodone 30mg; on
    January 16, 2015, 180ml of promethazine-codeine syrup; on February
    18, 2015, 90 tablets of oxycodone 30mg, 100 tablets of hydrocodone-
    acetaminophen 10-325mg, and 30 tablets of alprazolam 2mg; on March
    18, 2015, 30 tablets of alprazolam 2mg and 30 tablets of
    carisoprodol 350mg; on June 15, 2015, 30 tablets of carisoprodol
    350mg, 30 tablets of alprazolam 2mg, another 30 tablets of
    alprazolam 2mg, 100 tablets of hydrocodone-acetaminophen, and 100
    tablets of oxycodone 30mg; on June 16, 2015, 180ml of promethazine-
    codeine syrup; on July 15, 2015, 30 tablets of carisoprodol 350mg,
    30 tablets of alprazolam 2mg, 100 tablets of hydrocodone-
    acetaminophen, and 100 tablets of oxycodone 30mg; on August 18,
    2015, 30 tablets of carisoprodol 350mg, 60 tablets of alprazolam
    2mg, 100 tablets of hydrocodone-acetaminophen, and 100 tablets of
    oxycodone 30mg. RD, at 4.
    ---------------------------------------------------------------------------

        The next patient discussed, C.W., had controlled substances
    prescribed by two different doctors--a red flag--as well as pain
    medication coupled with a muscle relaxant and benzodiazepine, or in Dr.
    Alverson's words a drug ``cocktail,'' as discussed above. Id. at 393,
    396-98; GX 10, 12, 22. Despite the red flags, Dr. Alverson found no
    evidence that any investigation was undertaken by the Respondent
    Pharmacy, which Dr. Alverson stated was contrary to what was expected
    of a pharmacist acting in the usual course of the retail pharmacy
    profession in Alabama. Tr. 399-400.
        The physician later added promethazine and codeine cough syrup to
    C.W.'s prescriptions, an additional controlled substance with a high
    street value. Id. at 401; GX 22, at 23. The patient also received an
    unusual increase in medication amounts and there was a three-month gap
    in treatment. Dr. Alverson noted no investigation evident by the
    Respondent Pharmacy into these, and other, red flags and said that
    without investigation and documentation a pharmacist within

    [[Page 53408]]

    the usual course of professional practice could not continue to fill
    prescriptions for C.W. Tr. 402-05.
    c. Patient D.B.\13\
    ---------------------------------------------------------------------------

        \13\ The parties stipulated that Respondent filled the following
    prescriptions for controlled substances for patient D.B.: On
    December 2, 2014, 180 tablets of methadone 10mg and 90 tablets of
    carisoprodol 350mg; on December 29, 2014, 180 tablets of methadone
    10mg, 90 tablets of carisoprodol 350mg, and 90 tablets of alprazolam
    2mg; on January 20, 2015, 90 tablets of Lyrica 100mg; on January 26,
    2015, 210 tablets of methadone 10mg, 90 tablets of carisoprodol
    350mg, and 90 tablets of alprazolam 2mg; on February 23, 2015, 210
    tablets of methadone 10mg, 90 tablets of carisoprodol 350mg, 90
    tablets of alprazolam 2mg, and 90 tablets; on March 20, 2015, 210
    tablets of methadone 10mg, 90 tablets of carisoprodol 350mg, 90
    tablets of alprazolam 2mg, and 90 tablets of Lyrica 100mg; on April
    20, 2015, 210 tablets of methadone 10mg, 90 tablets of carisoprodol
    350mg, and 90 tablets of alprazolam 2mg; on May 11, 2015, 90 tablets
    of Lyrica 100mg; on May 18, 2015, 210 tablets of methadone 10mg, 90
    tablets of carisoprodol 350mg, and 90 tablets of alprazolam 2mg; on
    June 5, 2015, 90 tablets of Lyrica 100mg; on June 15, 2015, 210
    tablets of methadone 10mg, 90 tablets of carisoprodol 350mg, and 90
    tablets of alprazolam 2mg; on July 7, 2015, 150 tablets of methadone
    10mg, 90 tablets of carisoprodol 350mg, and 90 tablets of alprazolam
    2mg; on August 4, 2015, 90 tablets of Lyrica 100mg; on August 10,
    2015, 90 tablets of carisoprodol 350mg and 90 tablets of alprazolam
    2mg; on August 12, 2015, 180 tablets of methadone 10mg. RD, at 4-5.
    ---------------------------------------------------------------------------

        The third patient discussed, D.B., was prescribed 180 tablets of
    methadone-10 milligrams and 90 tablets of carisoprodol-350 milligrams
    by two different doctors. Tr. 413-14; GX 13, 22, 25.\14\ Dr. Alverson
    explained the heightened danger caused by methadone, as methadone
    creates its own form of sleep apnea and is responsible for a
    disproportionate number of deaths among the synthetic opioids,
    especially when prescribed in conjunction with another respiratory
    depressant, as was done for this patient. Tr. 414-15. Alprazolam, a
    benzodiazepine, was later added to this patient's prescription creating
    the red flag drug ``cocktail.'' Id. at 418-19. Dr. Alverson noted that
    as of September 1, 2016, alprazolam became the subject of a ``black
    box'' warning issued by the FDA, putting all pharmacists on notice of
    the heightened risk of fatal consequences when combining the drug with
    an opioid. Id. at 418-19, 495. Although the ``black box'' warning was
    issued after the subject prescription was filled, Dr. Alverson noted
    that the dangerous combination of alprazolam and opioids was well-known
    within the pharmacy community in 2014. Id. at 420. Despite the danger
    of D.B.'s prescriptions, no investigation by the Respondent Pharmacy
    was evident in the records reviewed by Dr. Alverson. Id. at 420-21.
    ---------------------------------------------------------------------------

        \14\ On cross-examination, Dr. Alverson conceded that her
    concern regarding prescriptions from two separate doctors would be
    alleviated by learning that they were partners at the same clinic.
    Tr. 514-15.
    ---------------------------------------------------------------------------

    d. Prescriptions Issued by Dr. U.I.\15\
    ---------------------------------------------------------------------------

        \15\ The parties stipulated that Respondent filled the following
    prescriptions from Dr. U.I.: On April 28, 2015, 90 tablets of
    carisoprodol 350mg, 120 tablets of hydrocodone-acetaminophen 10-
    325mg, and 60 tablets of alprazolam 1mg to [female] M.A.; on April
    30, 2015, 60 tablets of carisoprodol 350mg, 90 tablets of
    hydrocodone-acetaminophen 10-325mg, and 60 tablets of alprazolam 1mg
    to T.K.; on May 1, 2015, 30 tablets of zolpidem tartrate 10mg, 30
    tablets of lorazepam 1mg, 60 tablets of hydrocodone-acetaminophen
    10-325mg, and 60 tablets of carisoprodol 350mg to J.K. RD, at 5.
    ---------------------------------------------------------------------------

        Dr. Alverson then reviewed three prescriptions issued to three
    different patients by the same doctor, Dr. U.I., for the
    benzodiazepine/opioid/muscle relaxant ``cocktail.'' Tr. 421; GX 14. She
    noted that it was ``strange'' to see a physician write this combination
    of drugs repeatedly for a variety of patients and was indicative of a
    problem because the ``cocktail'' is rarely prescribed for legitimate
    medical reasons. Tr. 421-22. Dr. Alverson also found it highly
    suspicious that two of the three patients shared the same last name and
    lived at the same address, suggesting they were related. Id. at 422.
    She stated that it would be extraordinarily rare for two people living
    at the same address to receive this combination of drugs for legitimate
    medical purposes. Id. at 424. Dr. Alverson opined that after the second
    cohabitant presented a prescription for this cocktail, Respondent
    Pharmacy should have declined to fill the prescription and that a
    pharmacist could not fill the prescription consistent with their
    professional responsibilities.
    e. Prescriptions Issued by Dr. S.H.\16\
    ---------------------------------------------------------------------------

        \16\ The parties stipulated that on August 13, 2015, Respondent
    dispensed 84 tablets of oxycodone 15mg to patient T.M., 112 tablets
    of oxycodone 30mg to patient P.I., and 112 tablets of oxycodone 30mg
    to patient J.C. based on prescriptions issued by Dr. S.H. RD, at 5.
    ---------------------------------------------------------------------------

        Dr. Alverson also reviewed several opioid prescriptions issued by
    the same doctor, Dr. S.H., to three separate patients, which were
    filled at the Respondent Pharmacy within minutes of each other,
    suggesting the patients arrived together. Tr. 427-28; GX 15. Dr.
    Alverson described this circumstance as suspicious, in that, three
    patients from different parts of the area would be highly unlikely to
    appear together at the same pharmacy at the same time, unless they were
    involved in diversion. Tr. 429-33.
    f. Patient A.C.\17\
    ---------------------------------------------------------------------------

        \17\ The parties stipulated that on September 23 and 24, 2015,
    Respondent dispensed 30 tablets of carisoprodol 350mg and 30 tablets
    of hydrocodone-acetaminophen 7.5-325mg to A.C. RD, at 5.
    ---------------------------------------------------------------------------

        Dr. Alverson's review of patient A.C.'s records revealed a patient
    who was prescribed opioids by multiple doctors and filled at multiple
    pharmacies within a 30-day period, which was suggestive of doctor-
    shopping and pharmacy-shopping. Tr. 434-38; GX 16, 28. Dr. Alverson
    noted that a review of the PDMP by the pharmacist would have disclosed
    these suspicious circumstances. For example, if PIC Davison had
    reviewed the PDMP before dispensing a prescription of hydrocodone to
    A.C. on September 24, 2015, she would have seen that A.C. had five
    different prescriptions for hydrocodone in the previous month. Tr. 438;
    GX 28. Dr. Alverson stated that, under the circumstances, the
    prescriptions should not have been filled, and the prescribing doctors
    and the police should have been notified. Tr. 439-440.
    g. Patient R.D.\18\
    ---------------------------------------------------------------------------

        \18\ The parties stipulated that Respondent that on October 11,
    2014, Respondent dispensed 90 tablets of oxycodone 30mg to R.D., and
    on October 6, 2014, Respondent dispensed 120 tablets of hydrocodone-
    acetaminophen 10-325mg and 90 tablets of alprazolam 2mg to R.D. RD,
    at 5-6.
    ---------------------------------------------------------------------------

        The Respondent Pharmacy filled opioid prescriptions for patient
    R.D., which turned out to be forgeries. The filled prescriptions
    included a month's supply of hydrocodone and a month's supply of
    oxycodone, which Respondent Pharmacy filled within a week of each
    other. Id. at 441; GX 17. Dr. Alverson testified that there is no
    ``logical reason'' narcotics would be prescribed in this way and that
    an Alabama pharmacist acting in the bounds of her profession would be
    expected to investigate the prescriptions by calling the prescriber and
    checking the PDMP. Tr. at 441; see also, GX 31, at 26. Dr. Alverson
    conducted a brief investigation of the prescriptions by accessing the
    Alabama Medical Board website, which revealed the prescribing doctor to
    be an OB-GYN. Tr. at 444-45. Patient R.D. was a man. Id. at 445.

    D. Testimony of Dr. Santonia Davison

        PIC Davison was born in Bessemer, Alabama, attended the local high
    school, graduated from Miles College with a B.S. in biology, and then
    graduated from Samford University with a Doctorate of Pharmacy in 2011.
    Tr. 530-31. PIC Davison began her pharmacy career at CVS Pharmacy,
    where she ultimately worked at all 43

    [[Page 53409]]

    stores within the district. Id. at 532. The CVS stores shared the same
    policies and procedures and computer programs. Id. at 535-36. Their
    pharmacy computer program performed many pharmacist functions
    automatically, including a ``medication conflict check,'' a drug
    interaction check, and a therapeutic duplication check. Id. at 536.
    When the program recognized a problem with a prescription, the
    interactive program required the pharmacist to check a box designating
    how the pharmacist resolved the issue, such as, ``review of patient
    history,'' ``medication review,'' and ``prescriber consult,'' before
    the system would permit a prescription to be filled. The CVS software
    also allowed the pharmacists to make patient notes and automatically
    reported each prescription dispensed to the PDMP. Id. at 541. PIC
    Davison reported that although the combination of an opioid and a
    benzodiazepine would trigger an alert for ``therapeutic duplication,''
    CVS had no official policy restricting the filling of that drug
    combination between 2011 and 2013. Id. at 538.
        PIC Davison left CVS in 2013 in preparation for opening her own
    pharmacy. Id. at 538. She opened Respondent Pharmacy, Heavenly Care
    Pharmacy, on May 26, 2014, as the Pharmacist-in-Charge. Id. at 539,
    693. PIC Davison developed the policies and procedures for the pharmacy
    by borrowing from ``care pharmacy'' association and from CVS. Id. at
    540. She purchased her pharmacy software system from Abacus. Id.
    Although similar to the CVS software, PIC Davison testified the Abacus
    software became unreliable in automatically reporting dispensed
    prescriptions to the PDMP. Id. at 541. After discussions with DEA
    officials regarding missing PDMP data, which included a three-week
    lapse in reporting to the PDMP, PIC Davison began manually reporting to
    the PDMP. Id. at 541-42, 619, 753-55. PIC Davison explained that the
    Respondent Pharmacy also submitted a file to the PDMP that included
    data from the time the pharmacy opened. Id. at 753-55.
        PIC Davison described her understanding of her record-keeping
    responsibilities as an ongoing process, prompted by the visits to her
    pharmacy by DEA. Id. at 558-60, 812. PIC Davison conceded that she had
    not properly documented the ordering and receipt of controlled
    substances to the pharmacy through inadvertence, computer issues,
    prioritizing patient consultation over record-keeping, and
    procrastination. Id. at 560-80, 675, 689-92. PIC Davison apologized for
    her ``lack of documentation [causing] all of this uproar.'' Id. at 691.
        PIC Davison's testimony then addressed the specific prescriptions
    the Government identified in the Order to Show Cause and the ``red
    flags'' on those prescriptions that Dr. Alverson discussed in her
    testimony. See Tr. 591-671. PIC Davison described her personal
    interactions with the subject patients. PIC Davison testified that she
    was certain or ``pretty sure'' that she had contacted the prescribing
    physicians for all patients other than patient R.D. (the patient who
    presented the forged prescription). Id. at 608-09, 620-28, 630-31, 635,
    640, 651, 659, 666, 670, 751. PIC Davison described her discussions
    with the doctors in her testimony but was largely unable to produce any
    contemporaneous documentation of those discussions.\19\ Id.; GX 19, 22
    (Respondent's responses to Government subpoenas requesting the
    documentation). For some of the patients, she conceded that no
    documentation existed and that she made a mistake not to document her
    investigations. Id. at 602, 608-09. For other patients, PIC Davison
    testified that the documentation would have been written on the
    original prescription, usually on the first fill script, but that those
    prescriptions were seized by the DEA, and were not offered into
    evidence. Id. at 634-35, 637-38, 641, 663-64, 673.\20\ PIC Davison
    stated she now records her notes both on the original prescription and
    electronically in her patient notes. Id. at 674.
    ---------------------------------------------------------------------------

        \19\ There was a handwritten note on one of patient C.W.'s
    prescriptions documenting PIC Davison's discussion with the doctor
    regarding a missing dosage on a prescription. Tr. 612; see GX 12, at
    17.
        \20\ This testimony was permitted over the Government's
    objection that it was not properly noticed within the Respondent
    Pharmacy's Prehearing Notices. Tr. 663. However, the ALJ determined
    that Respondent Pharmacy's Prehearing statements provided adequate
    notice that this was part of its defense. Tr. 663; ALJX 17, at Ex. A
    2, 15; GX 19, 47.
    ---------------------------------------------------------------------------

        PIC Davison testified that she checked the PDMP before filling
    prescriptions for some, but not all, of the subject patients.\21\ For
    male patient M.A., PIC Davison could not recall if she had searched the
    PDMP prior to filling his prescriptions, but when shown the record of
    her PDMP searches, which she had produced for the hearing, conceded the
    record showed she did not conduct a search. Id. at 744-45; RX 1, at 39
    and 40. PIC Davison also said that she did not check the PDMP before
    filling the forged prescription for patient R.D. Tr. 795. PIC Davison
    affirmatively testified that she checked the PDMP for patients C.W.,
    A.C., and one of Dr. S.H.'s patients, patient T.M. Tr. 609, 652, 658,
    670. On cross examination, the DEA attorney questioned PIC Davison on
    her decisions to fill certain prescriptions for C.W. and A.C. after
    having viewed their prescription history in the PDMP. For C.W., PIC
    Davison testified that she did not recall seeing on the PDMP report
    that C.W. had received ten months of alprazolam in the prior five
    months. She explained that perhaps there was a software error, or that
    she had only reviewed the previous 30 days of the patient's history, or
    maybe that she just did not notice it. Id. at 764-66. For Patient A.C.,
    PIC Davison testified that she had checked the PDMP report on A.C. on
    July 14, 2015, and had declined to fill one of A.C's pain medication
    prescriptions, because it was too early for a refill according to the
    PDMP. Id. at 670. PIC Davison also stated that the Government may have
    improperly attributed PDMP data to patient A.C., because the PDMP
    report used by the Government compiled data from patient profiles with
    the same name and birthdate but with four different street addresses in
    Bessemer, Alabama. Id. at 788-91.
    ---------------------------------------------------------------------------

        \21\ PIC Davison stated on cross that ``at first, I wasn't using
    the PDMP because it wasn't being reported daily.'' Tr. 758.
    ---------------------------------------------------------------------------

        As to the two patients with the same last name, living at the same
    address, PIC Davison did not recognize that coincidence as being
    concerning, as family members often see the same physician, but stated
    that after her interactions with DI Two, she now knows it is something
    a pharmacy should explore. Id. at 640-47; see Tr. 421; GX 14. Regarding
    the three patients who apparently came to the pharmacy together with
    similar prescriptions, yet from different parts of the area, PIC
    Davison explained that two of the three patients, P.I. and T.M.,
    carpooled, because P.I. had an arm amputation. Tr. 650. PIC Davison
    stated that both lived in Jasper, Alabama. Id. at 665.\22\ P.I. and
    T.M. had difficulty finding their prescribed medications, which were
    available at the Respondent Pharmacy. Id. at 651. The third of the
    trio, J.C., was a local individual, who frequented a commercial
    cleaning business a few doors down from the Respondent Pharmacy. Id. at
    665-67. For these reasons, the appearance of these three individuals
    arriving at the Respondent Pharmacy at the same time did not raise any
    concerns for PIC Davison. Id. at 668-69; see id. at 427-28; GX 15. PIC
    Davison explained that she ``figured that perhaps the doctor [at the
    pain

    [[Page 53410]]

    management clinic] scheduled them all the same day.'' \23\ Tr. 669.
    ---------------------------------------------------------------------------

        \22\ However, according to the scripts in evidence, P.I. lived
    in Jasper at the time her script was filled, while T.M. lived in
    Quinton. GX 15.
        \23\ Based on the copies of the prescriptions, which were
    submitted into evidence and stipulated by the parties to be true and
    correct copies, the prescriptions for P.I. and T.M were issued on
    the same day, July 30, 2015. The prescription for J.C. was issued
    the following day, July 31, 2015. The three patients did not bring
    the prescriptions to Respondent Pharmacy to be filled until August
    13, 2015, approximately two weeks after the prescriptions were
    issued. GX 15.
    ---------------------------------------------------------------------------

        PIC Davison testified that she gave less scrutiny to prescriptions
    from pain management clinics, because she thought they had procedures
    to detect abuse and diversion, such as pill counts and urine analysis.
    Id. at 653-54, 784-85. Similarly, PIC Davison acknowledged she did not
    scrutinize transfers from other pharmacies as she did new patients. She
    reported that she had confidence that prescriptions filled at other
    pharmacies were proper, explaining that all pharmacists are under the
    same obligation and liability to perform their jobs as she. Id. at 628.
    PIC Davison said she now scrutinizes transfers as she would a new
    patient. Id. at 629.
        The ALJ found that PIC Davison's testimony lacked credibility. RD,
    at 58. He stated that ``[i]n testifying as to factual matters regarding
    the initial inventory, the timing and extent of her purported
    investigations, and documentation of her investigations, [PIC]
    Davison's testimony was marked with a level of equivocation,
    implausibility, and inconsistency . . . .'' Id. I concur.

    E. Allegations That Respondent Filled Prescriptions Without
    Investigating and Resolving Red Flags

        The Government alleged that Respondent filled prescriptions that
    displayed red flags of abuse and diversion without resolving those red
    flags in violation of the pharmacist's corresponding responsibility to
    assess the legitimacy of the prescription. To support its allegations,
    the Government presented hard copies of prescriptions; copies of
    Respondent's electronic profiles for these patients; and the expert
    testimony of Dr. Alverson regarding the red flags presented by the
    patients' prescriptions. Respondent disputes the allegations and argues
    that she upheld her corresponding responsibility to assess the
    legitimacy of all of the subject prescriptions. In defense of these
    allegations, PIC Davison testified at the hearing regarding the due
    diligence that she conducted on the prescriptions and presented written
    summaries of her investigations in response to a Government subpoena
    and in a prehearing statement.\24\
    ---------------------------------------------------------------------------

        \24\ In addition to the testimony and evidence described below
    regarding the subject prescriptions, PIC Davison also supplied
    testimony and medical articles related to correlations between race
    and prescribing of controlled substances. See Tr. 679-686; RX 2. PIC
    Davison testified that these articles demonstrated that the medical
    establishment was less likely to prescribe opioid pain medications
    to Black patients. Tr. 684-86. In the course of her testimony and in
    Respondent's Prehearing Statement, PIC Davison stated some of the
    patients with prescriptions at issue in this case are Black, some
    white, and did not provide testimony on the race of others. See,
    e.g., ALJX 17, Ex. A. PIC Davison testified, however, that the
    information in the articles did not influence the scrutiny she
    applied to prescriptions for controlled substances and that she
    engaged in the same level of scrutiny regardless of the race of the
    patient. Tr. 798-801. PIC Davison stated that she does not consider
    the race of the patient when determining whether an investigation is
    necessary when presented with prescriptions for controlled
    substances; therefore, I conclude that this evidence is irrelevant
    to the allegations that PIC Davison failed to properly investigate
    and document her investigation into any red flags presented by the
    subject prescriptions.
    ---------------------------------------------------------------------------

        As Dr. Alverson explained in her expert testimony regarding the
    standards of practice for an Alabama pharmacist, which is summarized in
    further detail supra at I.C.3, pharmacists are required under Alabama
    law to review each prescription for, among other things, therapeutic
    duplication, drug-drug interactions, incorrect dose/duration, and
    clinical abuse/misuse of medications. Ala. Admin. Code 680-X-2-.21. The
    law also requires pharmacists to maintain patient medication profiles,
    which includes the pharmacists' comments on consultation with the
    patient. Id.
        Dr. Alverson identified various red flags that pharmacists are
    trained to be aware of to identify suspicious and unlawful
    prescriptions, which include patients traveling significant or unusual
    distances, patterns from prescribers who repeatedly issue prescriptions
    or groupings of prescriptions for drugs susceptible to abuse or misuse
    (``pattern prescribing''), doctor or pharmacy shopping, different
    family members who receive substantially similar prescriptions,
    prescribers issuing prescriptions for large quantities of narcotics or
    other controlled substances, and prescriptions that are therapeutically
    duplicative or other combinations that do not make clinical sense with
    each other or do not make sense for the patient. Dr. Alverson testified
    that, at the time the subject prescriptions were filled, an Alabama
    pharmacist would be expected to know about the red flags she identified
    and emphasized that the Alabama Code of Professional Conduct requires a
    pharmacist to stay abreast of developments in the field, including
    patterns of abuse and diversion. Id. at 343-44; GX 24; Ala. Admin. Code
    680-X-2-.22. She further testified that when such red flags are
    present, Alabama pharmacists, acting in the normal course of their
    professional practice and in fulfillment of their corresponding
    responsibility, will investigate the circumstances, document their
    investigation, and decline to fill the prescription if they cannot
    resolve the red flags. Pharmacists will generally document the
    investigation as part of the ``comments'' maintained within the patient
    profiles the pharmacist is required by law to maintain, but they can
    also put the documentation on the prescriptions themselves.
        The Government and Respondent Pharmacy presented conflicting
    testimony on two overarching factual matters relevant to Respondent's
    investigation and resolution of red flags, or lack thereof, for the
    prescriptions at issue. First, Respondent claims to have conducted due
    diligence investigations for all of the prescriptions at issue, but the
    Government suggests that any reported investigation by Respondent
    Pharmacy occurred after the fact, following the initiation of the
    Agency investigation. The Government supported this allegation by
    eliciting testimony demonstrating how the Respondent Pharmacy's
    explanations changed in reaction to the Government's filings. The
    Government subpoenaed certain of Respondent Pharmacy's patient records
    in February 2016 and May 2016, including any records Respondent
    Pharmacy held regarding the subject prescriptions. GX 18; Tr. 721.
    Respondent Pharmacy did not provide any records with contemporaneous
    documentation of investigations for any of the subject prescriptions in
    response, instead providing a single document describing its due
    diligence as to these patients in narrative form and the relevant
    patient profiles (the profiles required by Alabama law) none of which
    contained pharmacist comments. See GX 19; GX 22; Tr. 723. The
    Respondent Pharmacy's due diligence, described in Government Exhibit
    19, were mostly in summary form, and except for one prescribing
    physician, did not include calls to the prescribing doctor as part of
    its due diligence. In fact, for a number of patients, PIC Davison
    reported, ``I cannot remember anything about this patient.'' GX 19.
        The Government noted that following the Respondent Pharmacy's
    review of Dr. Alverson's report, the Respondent Pharmacy bolstered its
    claimed due diligence in its Prehearing statement to include steps
    described by Dr. Alverson

    [[Page 53411]]

    as necessary due diligence. Govt Posthearing, at 22-24; Tr. 728-39,
    778-81.
        Respondent Pharmacy categorically denies this allegation and
    detailed investigations on several of the subject patients in PIC
    Davison's testimony. Respondent Pharmacy argues that its claims of
    extensive, timely investigations were uncontroverted and should be
    accepted as credible. The ALJ, however, found, and I agree, that PIC
    Davison's testimony was ``sometimes implausible and inconsistent'' and
    described her testimony of one patient investigation as ``misleading
    and equivocating.'' RD, at 58.
        I agree with the ALJ's finding that it is more believable than not
    that Respondent Pharmacy's investigations were not as timely or
    extensive as PIC Davison testified. RD, at 48. See Wilbur-Ellis Co. v.
    M/V Captayannis ``S'', 451 F.2d 973, 974 (9th Cir. 1971) (the court is
    not bound to accept uncontroverted testimony at face value if it is
    improbable, unreasonable, or otherwise questionable) (citing Quock Ting
    v. United States, 140 U.S. 417, 420-21 (1891)); Koivunen v. States
    Line, 371 F.2d 781, 783 (9th Cir. 1967) (evidence of witnesses,
    especially those who have a biased or prejudiced interest in the result
    of the trial in which they testify, need not be accepted at face
    value). Respondent Pharmacy has provided no documentary evidence in
    support of its claims of timely investigation. Furthermore, as the ALJ
    found, the propensity of the subject prescription forgery ring to
    concentrate their efforts at Respondent Pharmacy strongly suggests that
    the criminal diversion community had identified Respondent Pharmacy
    ``as a location where investigation was minimal and diversion would
    likely be successful.'' RD, at 48. See Tr. 431 (testimony from Dr.
    Alverson that patients seeking legitimate pain management do not tend
    to travel in groups, but that those not seeking legitimate pain
    management do, because they learn which pharmacies will fill their
    prescriptions).
        As to the second preliminary matter, Respondent Pharmacy alleged in
    its Prehearing Statement that PIC Davison noted the results of her
    investigations on the initial prescriptions of the patients (first fill
    prescriptions), however, these prescriptions were seized by DEA, and
    while they were not listed as evidence, they were not returned to her.
    See ALJX 17, Ex. A, at 2, 15. At the hearing, however, PIC Davison was
    less certain about recording the results of her patient investigations
    on the initial prescriptions and only conditionally indicated that if
    she recorded her investigation, it would have been on the initial
    prescription, or in her patient notes. Tr. 634-35, 637-38, 663-64, 673,
    805.
        The Government did not offer all of the subject ``missing'' first
    fill prescriptions into evidence. In past cases, this Agency has
    applied the ``adverse inference rule'' against parties that failed to
    produce records. See, e.g., Pharmacy Doctors Enterprises d/b/a Zion
    Clinic Pharmacy, 83 FR 10,876, 10,890 (2018) pet. for rev. denied, 789
    F. App'x 724 (11th Cir. 2019). As the D.C. Circuit explained,
    ``[s]imply stated, the rule provides that when a party has relevant
    evidence within his control which he fails to produce, that failure
    gives rise to an inference that the evidence is unfavorable to him.''
    Int'l Union, United Auto., Aerospace & Agric. Implement Workers of Am.
    (UAW) v. Nat'l Labor Relations Bd., 459 F.3d 1329, 1336 (D.C. Cir.
    1972). See also Huthnance v. District of Columbia, 722 F.2d 371, 378
    (D.C. Cir. 2013). In this case, however, I agree with the ALJ that the
    Respondent Pharmacy's conditional assertion of favorable evidence under
    the sole control of the Government is insufficient to justify an
    adverse inference. RD, at 43 (citing Beau Bashers, 76 FR 194,401,
    19,404 (2011); UAW v. NLRB, 459 F.2d at 1335-39). The credibility of
    Respondent's conditional assertions of favorable evidence is also drawn
    into question by the first fill prescriptions the Government did
    produce, none of which contained documentation of Respondent's alleged
    investigations. Furthermore, PIC Davison failed to produce any
    prescriptions with documentation of an investigation for any
    prescription filled at Respondent Pharmacy--documentation that she was
    required to make as an Alabama pharmacist--and conceded that she failed
    to document the results of her investigation for several of the subject
    prescriptions, relying instead on her memory.
    1. Prescriptions for Patients M.A., C.W., and D.B.
        The Government alleged that from December 2014 through August 2015,
    Respondent filled prescriptions for patients M.A. (male), C.W., and
    D.B. for large quantities of narcotics, in combinations reflecting
    therapeutic duplication, in combinations known to be susceptible to
    abuse or diversion, and unlikely to be issued for legitimate medical
    purposes by prescribers operating within the bounds of their
    profession. The Government further alleged that Respondent filled these
    prescriptions without appropriate investigation, documentation, and
    resolution of these circumstances in violation of its corresponding
    responsibility. ALJX 1, at 3.
        In regard to patient M.A. (male), Dr. Alverson testified that his
    prescriptions presented multiple red flags: Therapeutic duplication; a
    rapid increase in the quantity of a prescribed opioid; the prescriber
    switching which drug was for maintenance and which for breakthrough
    pain; and repeated refills of a drug contrary to FDA approval. Dr.
    Alverson opined the prescribing pattern for M.A. was inconsistent with
    accepted pharmaceutical standards and posed a danger to the patient.
    Tr. 379, 502-03. She further found no contemporaneous documentation on
    the record that PIC Davison had conducted any investigation of the red
    flags.\25\ PIC Davison acknowledged at the hearing that she did not
    document her investigation, but testified that she determined the
    prescriptions were appropriate based on conversations with the patient
    and the prescribing physician which revealed M.A. was a delivery driver
    who suffered from chronic back pain.\26\ Id. at 593-96.
    ---------------------------------------------------------------------------

        \25\ In its Prehearing Statement, Respondent wrote that any
    documentation for PIC Davison's investigation of patient M.A. (male)
    would be on the original fill prescription. The Government
    introduced the original fill prescription into evidence. It
    contained no documentation by PIC Davison. See GX 11.
        \26\ In its Prehearing Statement, Respondent stated that PIC
    Davison had contacted the prescribing physician to confirm the
    diagnosis and validity of the prescription and to discuss safety and
    possible therapeutic duplication. GX 47, at 4. During the hearing,
    however, PIC Davison's testimony on this matter wavered. She
    testified that she spoke with the prescribing physician on the phone
    regarding M.A.'s consecutive therapies and ``why Soma was prescribed
    with two different narcotics,'' Tr. 727-28, but later admitted that
    she could only specifically recall calling the doctor to discuss a
    change in the prescription from extended-release to immediate-
    release oxycodone, Tr. 751.
    ---------------------------------------------------------------------------

        For patient C.W., Dr. Alverson testified that the patient's
    prescriptions presented several red flags including controlled
    substances prescribed by different doctors, the combination of an
    opiate and a benzodiazepine or ``drug cocktail'' popular with drug
    abusers, an unusual increase in medication amounts, and a three-month
    gap in treatment. Id. at 393, 396-98, 401-404. PDMP data for C.W. that
    Respondent Pharmacy submitted into evidence also revealed red flags
    including that C.W. had frequented multiple pharmacies and received 10
    months of alprazolam in the five months prior to transferring his
    prescription to Respondent Pharmacy. Tr. 761-62; RX 1, at 14-16.
    Despite the evidence of red flags, there was no evidence that
    Respondent

    [[Page 53412]]

    Pharmacy undertook any investigation. PIC Davison said she conducted
    due diligence on C.W.'s prescriptions by talking with the patient, who
    told her he was a factory worker doing repetitive actions, and that she
    was ``pretty sure'' she called the prescribing doctor before filling
    C.W.'s prescriptions for the first time. Tr. 608. PIC Davison also
    suggested that the PDMP report she viewed in December 2014, when C.W.
    came to Respondent Pharmacy, could have looked different than the one
    she offered into evidence at the hearing, but she offered no evidence
    to support her claim. Id. at 763-66.
        For patient D.B., Dr. Alverson testified that the patient's
    prescriptions evinced several red flags including doctor shopping and
    the opioid/benzodiazepine ``cocktail.'' Supra I.C.3.c. PIC Davison
    discussed the investigation she conducted on patient D.B., but yet
    again conceded she failed to properly document it. Tr. 620-28, 630. PIC
    Davison testified that she was not suspicious that D.B. paid for her
    carisoprodol prescription with cash, while her other prescriptions were
    covered by insurance or Medicare. Tr. 768-69, 810; RX 1, at 27.
        For both C.W. and D.B., PIC Davison argued that at the time the
    subject prescriptions were filled, 2014-15, the opioid/benzodiazepine
    drug combination was not known to be a red flag and that a reasonable
    pharmacist at the time would not necessarily be suspicious of
    prescriptions with that drug combination. To support her argument, PIC
    Davison submitted evidence that the U.S. Department of Health and Human
    Services (HHS) issued guidelines in March 2016 regarding the risks of
    opioid pain medications, after the subject prescriptions were issued.
    See RX 2, at 9. However, Dr. Alverson, who Respondent conceded was a
    renowned expert in the field, testified that while HHS did not issue
    those guidelines or add a ``black box'' \27\ warning to benzodiazepines
    that they should not be combined with an opioid until 2016, the dangers
    of the ``cocktail,'' and its propensity for abuse, were well known in
    the pharmacy community in 2014. Tr. 420, 494. She further testified
    that when reviewing the subject prescriptions, she applied the
    standards of professional practice that were applicable at the time of
    the dispensations. Id. at 460-73. I credit Dr. Alverson's testimony on
    this matter and find that, at the time Respondent Pharmacy dispensed
    the subject prescriptions to C.W. and D.B., an Alabama pharmacist
    should have been aware of the risks posed by an opioid/alprazolam drug
    combination.
    ---------------------------------------------------------------------------

        \27\ Dr. Alverson testified that a ``black box'' warning is a
    type warning that is required to be placed on the package insert for
    certain drugs and is formatted with a black border around that text.
    Tr. 419.
    ---------------------------------------------------------------------------

        Based on the evidence in the record, I find that Respondent filled
    prescriptions for patients M.A. (male), C.W., and D.B. that raised red
    flags and that PIC Davison knew or should have known that the
    prescriptions raised red flags.\28\ I further find that, even if these
    red flags were resolvable, there was no credible evidence that
    Respondent addressed or resolved them before filling the prescriptions.
    I cannot, and do not, place any weight on PIC Davison's testimony that
    she resolved the red flags, because she produced no contemporaneous
    documentary evidence to support her claim that she attempted to and, in
    fact, did resolve them before filling the prescriptions and because the
    ALJ found, and I agree, that her testimony on this matter was not
    credible. See RD, at 56.
    ---------------------------------------------------------------------------

        \28\ In a prehearing statement, Respondent argued that M.A.,
    C.W., and D.B. had the same or similar prescriptions filled at other
    area pharmacies before or after they were patients at Respondent
    Pharmacy and that this demonstrates the ``common prescribing
    practices amongst the physicians in the area.'' GX 47, at 5-7.
    Respondent supported this argument with data from the PDMP that it
    presented as evidence during the hearing. RX 1, at 1-17, 43-58. The
    best that this evidence shows, however, is that the red flags
    presented by M.A., C.W., and D.B.'s prescriptions may be resolvable
    with proper investigation. At worst, it shows that in some cases the
    patients had to go to several pharmacies to receive the same
    combination of drugs they received from Respondent Pharmacy. I will
    not fully explore this argument because Respondent seems to have
    abandoned it by failing to elicit testimony at the hearing and not
    discussing it in its Posthearing brief.
    ---------------------------------------------------------------------------

    2. Prescriptions Issued by Dr. U.I.
        From April 2015 to August 2015, Respondent Pharmacy filled
    prescriptions issued by prescriber U.I. RD, at 5. The Government
    alleged that three patients of Dr. U.I. ``presented prescriptions that
    indicated a pattern of prescribing the same combinations of controlled
    substances to patient after patient, combinations including large
    quantities of narcotics and combinations known to be susceptible to
    abuse or diversion and unlikely to be issued for legitimate purposes by
    prescribers operating within the bounds of their profession.'' ALJX 1,
    at 4. The Government additionally alleged that ``these patterned
    prescriptions were presented by patients who shared the same home
    address and last name, issued within one date of one another.'' Id. The
    Government further alleged that Respondent filled the prescriptions
    with red flags from Dr. U.I. to numerous patients without appropriate
    investigation, documentation, and resolution of the alleged red flags.
    Id.
        To support these allegations, the Government submitted
    prescriptions into evidence from Dr. U.I. for patients M.A. (female),
    T.K, and J.K. GX 14. Dr. Alverson testified that these prescriptions
    showed red flags. Tr. 421. All three patients were prescribed a
    combination of an opioid, benzodiazepine, and a muscle relaxant--a drug
    ``cocktail'' known to be susceptible to diversion and abuse--and a red
    flag in and of itself. Dr. Alverson testified that a pattern of
    prescriptions from a prescriber for this ``cocktail'' is also a red
    flag because the ``cocktail'' is rarely prescribed for legitimate
    medical reasons and further, that it would be extraordinarily rare for
    two people living at the same address to receive this ``cocktail'' for
    legitimate purposes. Tr. 421-22.
        PIC Davison testified that she was ``pretty sure'' she had
    investigated the prescriptions from Dr. U.I. by calling the doctor, Tr.
    635-43,\29\ but she did not claim to have conducted any due diligence
    on prescriptions from Dr. U.I. in either her response to the
    Government's subpoena, GX 19, or in the Prehearing statement, where she
    summarized the due diligence she conducted on the subject
    prescriptions, GX 47, at 8. During the hearing, PIC Davison stated that
    two patients sharing an address and receiving similar controlled
    substances ``would raise a flag,'' but also testified that at the time
    she did not think it was a red flag for two patients with the same last
    name, living at the same address, to receive prescriptions for the same
    doctor, because, in her experience, family members often see the same
    physician. She conceded, however, that she learned this circumstance
    should be investigated by pharmacies during her discussions with DI
    One. Tr. 645-47.
    ---------------------------------------------------------------------------

        \29\ PIC Davison testified that she would have written any
    documentation of her investigations on the first fill script of the
    patients M.A. (female) and T.K. but that the DEA had taken those
    scripts and not submitted them into evidence. Tr. 638-42. As
    discussed, supra, I do not give weight to PIC Davison's testimony on
    this matter. The Government did submit copies of the front and back
    of the first fill script from patient J.K., which did not contain
    any documentation of an investigation by Respondent. GX 14 at 5-6.
    ---------------------------------------------------------------------------

        Based on the evidence in the record, I find that Respondent filled
    prescriptions from prescriber U.I. that raised red flags that PIC
    Davison knew or should have known that the prescriptions raised red
    flags. I further find that, even if these red flags were resolvable,
    there was no credible evidence that Respondent addressed or resolved
    them before filling the

    [[Page 53413]]

    prescriptions. I cannot, and do not, place any weight on PIC Davison's
    testimony that she resolved the red flags because she produced no
    contemporaneous documentary evidence to support her claim that she
    attempted to and, in fact, did resolve them before filling the
    prescriptions and because the ALJ found that the testimony was not
    credible. See RD, at 56.
    3. Prescriptions Issued by Dr. S.H.
        On August 13, 2015, Respondent filled three different prescriptions
    for oxycodone presented by three different patients from Dr. S.H. in
    Moody, Alabama. RD, at 5. The Government alleged the patients traveled
    unusual distances to obtain and fill the prescriptions, and that the
    timing of the prescription fills indicates the patients may have
    traveled together, and that despite these circumstances, Respondent
    ``filled the prescriptions without appropriate investigation,
    documentation, and resolution of these circumstances.'' ALJX 1, at 4.
        The Government presented testimony at the hearing that Moody,
    Alabama, where the prescribing physician was located, is on the
    southeast-side of Birmingham and approximately a 40-minute drive from
    Respondent Pharmacy; that Jasper, Alabama, where one of the patients
    resided, is on the north-side of Birmingham and approximately a 50-
    minute drive from Respondent Pharmacy; and that Quinton, Alabama, where
    a second patient resided, is proximate to Jasper. Tr. 428-29. The third
    patient resided in Bessemer, Alabama, the same city as Respondent
    Pharmacy. The Government presented prescriptions from the patients with
    dispensing labels showing they were filled at Respondent Pharmacy
    within minutes of one another. GX 15. Dr. Alverson testified that it is
    a red flag for patients from three different cities to visit the same
    doctor in a fourth city ``quite a distance from where they live,'' to
    receive prescriptions from that prescriber for the same controlled
    substance, and then to take those prescriptions to the same pharmacy at
    the same time (and at a pharmacy that is distant from the residence of
    two of the three patients). Tr. 429-32. She further testified that
    patients seeking legitimate pain management care do not tend to travel
    in groups, but that it is a common practice for patients abusing or
    diverting drugs to do so, because ``patients who are seeking drugs
    usually learn pretty quickly the physicians that will write those
    prescriptions for them, and they learn which pharmacies will fill those
    prescriptions . . . . With no questions asked.'' Id. at 431-32.
        PIC Davison testified that she ``sort of, but not really'' found it
    suspicious that the three patients from Dr. S.H. arrived at her
    pharmacy at the same time because she ``figured that perhaps the doctor
    scheduled them all the same day'' and the two patients from Jasper and
    Quinton carpooled (one was an amputee without transportation) and the
    third was a local resident, who frequented a cleaner by the pharmacy.
    Tr. 667-69; GX 47, at 9. She stated that the two patients who carpooled
    came to her pharmacy because they were unable to find another pharmacy
    with their medication (oxycodone) in stock. Tr. 650-58; GX 47, at 8-9.
    PIC Davison further testified that she investigated the prescriptions
    by calling the pain management clinic where Dr. S.H. worked to validate
    the prescriptions and checking the PDMP, Tr. 651-53, 658-59, but she
    equivocated on whether or not she documented her investigations, which
    she asserted would have been on prescriptions the DEA had seized and
    not returned, Tr. 662-66. PIC Davison conceded that she generally
    conducted less due diligence on prescriptions from pain clinics like
    the subject prescriptions. Tr. 654.
        Based on the evidence in the record, I find that Respondent filled
    prescriptions from prescriber S.H. that raised red flags and that PIC
    Davison knew or should have known that the prescriptions raised red
    flags. Carpooling explains why two of the patients arrived at the same
    time, but it does not explain the unusual distances they traveled or
    why the third patient arrived at the pharmacy with them. PIC Davison's
    explanation that she was not suspicious of them all arriving together,
    because she assumed the doctor had seen the patients on the same day
    also lacks credibility--Respondent Pharmacy filled the prescriptions
    approximately two weeks after they were prescribed.\30\ I further find
    that, even if these red flags were resolvable, there was no credible
    evidence that Respondent addressed or resolved them before filling the
    prescriptions. I cannot, and do not, place any weight on PIC Davison's
    testimony that she resolved the red flags because she produced no
    contemporaneous documentary evidence to support her claim that she
    attempted to and, in fact, did resolve them before filling the
    prescriptions and because the ALJ found that the testimony was not
    credible. See RD, at 56.
    ---------------------------------------------------------------------------

        \30\ The three patients' prescriptions were written on July 29
    and 30, 2015. The patients had the prescriptions filled at
    Respondent Pharmacy on August 13, 2015. See GX 15.
    ---------------------------------------------------------------------------

    4. Patient A.C.
        On September 23 and 24, 2015, Respondent filled prescriptions for
    patient A.C. for 30 tablets of carisoprodol 350 mg, identified as a 7-
    day supply, and 30 tablets of hydrocodone-acetaminophen 7.5-325mg,
    identified as a 4-day supply. RD, at 5. The Government alleged that
    patient A.C. ``presented prescriptions for a high volume of narcotics
    for a small period of time'' and were ``non-periodic in nature'' and
    ``presented prescriptions from two different doctors in the prior
    month.'' ALJX 1, at 4-5. The Government further alleged that
    investigation of these circumstances would have revealed that A.C.
    ``had presented numerous prescriptions from different prescribers to
    different pharmacies,'' but that Respondent had filled A.C.'s
    prescriptions without appropriate investigation, documentation, and
    resolution of the circumstances. Id.
        Dr. Alverson testified that A.C.'s prescriptions had several red
    flags. She stated that A.C.'s records were suggestive of doctor and
    pharmacy shopping and that if PIC Davison had reviewed the PDMP data
    before dispensing the prescription of hydrocodone to A.C. on September
    24, 2015, PIC Davison would have seen that A.C. had filled five
    different prescriptions for hydrocodone in the previous month. Tr. 434-
    38, GX 16 and 28. Dr. Alverson testified that the red flags for A.C.'s
    prescriptions were so egregious that, in her opinion, an Alabama
    pharmacist acting in accordance with appropriate professional standards
    could not resolve them. Tr. 440.
        PIC Davison argues that the subject prescription was appropriately
    dispensed based on the investigation she conducted. PIC Davison spoke
    in detail regarding information she learned directly from A.C.;
    however, her testimony regarding the rest of her investigation was
    inconsistent. PIC Davison testified that she had called a Dr. S. to
    verify A.C.'s prescriptions, but the prescriptions at issue were
    prescribed by a different doctor, Dr. C. Tr. 670, see GX 16. Then on
    cross examination, PIC Davison implied that she had spoken with Dr.
    C.\31\ Tr. 792. Additionally, during the hearing, PIC Davison
    speculated the Government and

    [[Page 53414]]

    Dr. Alverson may have improperly attributed PDMP data to patient A.C.
    because the PDMP report used by the Government compiled data from
    patient profiles with the same name and birthdate but with four
    different street addresses in Bessemer, Alabama. Tr. 788-91. Yet, PIC
    Davison also testified that she declined to fill a prescription for
    A.C. in July of 2015 based on the same PDMP data. Tr. 670.
    ---------------------------------------------------------------------------

        \31\ When asked if she would fill the subject prescription
    today, PIC Davison replied ``I know after talking with Dr. [C.]
    then, yes, I would've filled it.''
    ---------------------------------------------------------------------------

        Based on the evidence in the record, I find that Respondent filled
    prescriptions for patient A.C. that raised red flags and that PIC
    Davison knew or should have known that the prescriptions raised red
    flags. I further find that, even if these red flags were resolvable--
    and there was credible testimony from Dr. Alverson that they were not--
    there was no credible evidence that Respondent addressed or resolved
    them before filling the prescriptions. I cannot, and do not, place any
    weight on PIC Davison's testimony that she resolved the red flags,
    because she produced no contemporaneous documentary evidence to support
    her claim that she attempted to and, in fact, did resolve them before
    filling the prescriptions and because her testimony was inconsistent
    and the ALJ found that it was not credible. RD, at 56.
    5. Patient R.D.
        On October 11, 2014, Respondent filled a prescription for a
    narcotic for Patient R.D. The Government alleged the patient presented
    this prescription days after filling another prescription for a large
    volume of narcotics and that the prescriber specialized in obstetrics
    and gynecology (an unusual fact since R.D. was a male) and that despite
    these circumstances, Respondent ``filled the prescription without
    appropriate investigation, documentation, and resolution of these
    circumstances.'' ALJX 1, at 5. The Government also presented testimony
    that the prescription was a forgery. See Tr. 142.
        Dr. Alverson testified that it is a red flag that Patient R.D.
    received a month's supply of a narcotic within a week of receiving a
    month's supply of another narcotic and that an Alabama pharmacist would
    be expected to investigate and resolve the red flag before filling the
    second (the October 11) prescription. Tr. at 441. Dr. Alverson further
    testified that a brief investigation would have revealed that the
    ``prescribing doctor'' was an obstetric gynecologist--another red flag
    as Patient R.D. is male. Id. at 445. PIC Davison conceded at the
    hearing that she had not conducted any investigation before filling
    Patient R.D.'s October 11, 2104 prescription. Tr. 795-96.
        Based on the evidence in the record, I find that Respondent filled
    a prescription for patient R.D. that raised red flags and that PIC
    Davison knew or should have known that the prescription raised red
    flags. I further find that Respondent did not investigate or resolve
    the red flags--which were unresolvable as the prescription was a
    forgery--before filling the prescription.
        In sum, I find that between October 2014 and September 2015,
    Respondent filled prescriptions that presented red flags that an
    Alabama pharmacist acting in the usual course of her professional
    practice and in fulfillment of her corresponding responsibility should
    have recognized, investigated, documented, and resolved prior to
    filling the prescriptions. I further find that Respondent did not
    conduct proper investigations of these prescriptions before filling
    them and did not document the results of any investigation she did
    conduct as is standard practice for an Alabama pharmacist and required
    by Ala. Admin. Code 680-X-2-.21.

    II. Discussion

        The Government alleged that the Respondent Pharmacy's registration
    should be revoked because the Respondent Pharmacy has materially
    falsified its renewal application and has committed acts that would
    render its registration inconsistent with the public interest as
    provided in 21 U.S.C. 823(f). The gravamen of the Government's
    allegations and evidence in this case focuses on allegations that
    Respondent Pharmacy provided false and material responses in the
    renewal application for registration and that it violated federal and
    state laws relating to controlled substances when it improperly filled
    prescriptions and failed to properly maintain certain records.\32\
    ---------------------------------------------------------------------------

        \32\ In Respondent's Prehearing statement and in the prehearing
    conversation she had with Dr. Alverson, PIC Davison implied that DEA
    may not have treated her fairly based on her race, Tr. 329; Resp
    Prehearing, at 23, but Respondent did not actively pursue this issue
    as a defense during the hearing, Tr. 686-87. Before the hearing, the
    ALJ advised the parties that if the issue was pursued, he would
    consider it within the context of ``unequal treatment'' by the
    Agency and asked Respondent's counsel if he planned to pursue a
    defense of unfair or unequal treatment by the Agency. Tr. 19.
    Respondent Counsel responded that he agreed with the ALJ that the
    legal issue presented would be one of disparate impact but stated
    that he would not know if Respondent would pursue disparate impact
    as a defense until after hearing the testimony at the hearing. Tr.
    20-21. After the hearing, Respondent filed a Posthearing Brief with
    the ALJ that presented Respondent's arguments and defenses against
    the Government's case. Respondent did not allege unequal treatment
    in that brief. Because Respondent did not pursue the defense at
    hearing or in its Posthearing Brief, I consider Respondent to have
    abandoned the defense and will not consider it in my decision.
    ---------------------------------------------------------------------------

    A. Materially False Statement in Renewal Application

        The Government's allegation that Respondent Pharmacy materially
    falsified its renewal application arose with the Respondent Pharmacy's
    application to renew its registration during the pendency of this
    action. In the renewal application, Respondent Pharmacy answered ``No''
    to the question: ``[h]as the applicant ever surrendered (for cause) or
    had a federal controlled substance registration revoked, suspended,
    restricted, or denied, or is any such action pending?'' GX 26, at 1.
    The Government alleged that Respondent materially falsified its renewal
    application on the basis of its ``No'' response to the above
    question.\33\
    ---------------------------------------------------------------------------

        \33\ This allegation does not appear in the Order to Show Cause
    because it did not arise until after the OSC was issued. The
    Government did, however, clearly include the allegation in its
    Supplemental Prehearing Statement, Respondent did not challenge the
    timeliness of the allegation, see, e.g., Resp Prehearing Statement,
    and the allegation was fully litigated during the hearing, see RD,
    at 25. The ALJ found Respondent received sufficient notice of the
    allegation, and the allegation was properly before him. Id. at 26. I
    concur.
    ---------------------------------------------------------------------------

        Pursuant to 21 U.S.C. 824(a)(1), a registration ``may be suspended
    or revoked . . . upon a finding that the registrant (1) has materially
    falsified any application filed pursuant to or required by subchapter
    or subchapter II of this chapter . . . .'' There is no question that
    Respondent knew or should have known that it submitted a registration
    renewal application with a false response to the question asking if the
    applicant had an action pending to have a federal controlled substance
    registration revoked. Supra I.A. Respondent, however, argued that its
    false response to that question was not material and therefore cannot
    serve as a ground to revoke its registration. First, Respondent argued
    that DEA had issued the OSC and was obviously aware that there was a
    pending revocation of Respondent's registration. Resp Posthearing, at
    6. Second, Respondent argued that, even if DEA were deceived, ``that
    deception would not have had an effect on the renewal, which in this
    case was automatic.'' Id. I reject Respondent's arguments, as the ALJ
    did, for the reasons that follow. See RD, at 28-29.
        Respondent's submission of a renewal application containing a false
    response to a liability question is material, because such false
    information is ``predictably capable of affecting, i.e., ha[s] a
    natural tendency to affect, the

    [[Page 53415]]

    official decision.'' Kungys v. United States, 485 U.S. 759, 771 (1988).
    All of the form's liability questions implicate at least one of the
    factors I am required to consider in carrying out my registration-
    related responsibilities under 21 U.S.C. 823(f). Respondent's false
    response to liability question number two is material because of this
    question's connection to the second, third, and fourth factors listed
    in section 824(f) and, therefore, my ability to carry out my statutory
    responsibilities. 21 U.S.C. 823(f). Thus, I reject Respondent's
    argument that ``the omission was not material because it had no
    capacity to affect the official decision.'' Resp Post Hearing, at 6.
        I also reject Respondent's argument that ``not only could the
    failure to alert the DEA what the DEA was doing possibly deceive the
    DEA, but even if it could, then that deception would not have had an
    effect on the renewal, which in this case was automatic.'' \34\ Id.
    First, having an ``effect on the renewal'' plays no role in the
    assessment of ``materiality.'' As Respondent acknowledges in its Post
    Hearing Brief, the Supreme Court made this clear decades ago when it
    stated that ``[i]t has never been the test of materiality that the
    misrepresentation or concealment would more likely than not have
    produced an erroneous decision, or even that it would more likely than
    not have triggered an investigation.'' Kungys, 485 U.S. at 771
    [emphases in original]. Second, while some Agency decisions mention
    deception,\35\ they mention it in the context of determining the
    appropriate sanction, not in determining whether a falsity is material.
    I decline Respondent's suggestion that I disregard Supreme Court
    precedent by injecting the notion of deception into my assessment of
    materiality.
    ---------------------------------------------------------------------------

        \34\ Respondent's argument that DEA's acceptance of its renewal
    application is ``automatic'' is baseless and I reject it. Infra.
        \35\ See e.g., Daniel A. Glick, D.D.S., 80 FR 74,800, 74,808
    (2015) (lack of intent to deceive can be a ``relevant consideration
    []'').
    ---------------------------------------------------------------------------

        Respondent additionally argues that an existing registration is
    renewed automatically, thereby precluding any affirmative finding of
    materiality. Respondent misreads 21 CFR 1301.36(i).\36\ Nothing in it
    grants a registrant the automatic renewal of its registration. The
    renewal of Respondent's registration is not ``automatic,'' and I
    disagree with Respondent that 21 CFR 1301.36(i) is relevant to whether
    or not Respondent's false submission is material.
    ---------------------------------------------------------------------------

        \36\ 21 CFR 1301.36(i) states, in part, that ``[i]n the event
    that an applicant for reregistration (who is doing business under a
    registration previously granted and not revoked or suspended) has
    applied for reregistration at least 45 days before the date on which
    the existing registration is due to expire, and the Administrator
    has issued no order on the application on the date on which the
    existing registration is due to expire, the existing registration of
    the applicant shall automatically be extended and continue in effect
    until the date on which the Administrator so issues his/her order .
    . . .''
    ---------------------------------------------------------------------------

        For the reasons stated above, I find that Respondent's false
    response on its renewal application is material, which is an
    independent ground for revocation pursuant to section 824(a)(1).

    B. Public Interest Factors

        Section 304(a) of the Controlled Substances Act provides that ``[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 [its]
    registration under section 823 of this title inconsistent with the
    public interest as determined under such section.'' 21 U.S.C. 824(a).
    In the case of a practitioner, which includes a pharmacy, the CSA
    requires the Agency consider the following factors in determining
    whether Respondent's registration would be inconsistent with the public
    interest:
        (1) The recommendation of the appropriate State licensing board or
    professional disciplinary authority.
        (2) The [registrant's] experience in dispensing, or conducting
    research with respect to controlled substances.
        (3) The [registrant's] conviction record under Federal or State
    laws relating to the manufacture, distribution, or dispensing of
    controlled substances.
        (4) Compliance with applicable State, Federal, or local laws
    relating to controlled substances.
        (5) Such other conduct which may threaten the public health and
    safety.
    21 U.S.C. 823(f).
        The DEA considers these public interest factors separately. Ajay S.
    Ahuja, M.D., 84 FR 5479, 5488 (2019); Robert A. Leslie, M.D., 68 FR
    15,227, 15,230 (2003). Each factor is weighed on a case-by-case basis.
    Morall v. Drug Enf't Admin., 412 F.3d 165, 173-74 (D.C. Cir. 2005). Any
    one factor, or combination of factors, may be decisive. David H.
    Gillis, M.D., 58 FR 37,507, 37,508 (1993). Thus, there is no need to
    enter findings on each of the factors. Hoxie v. Drug Enf't Admin., 419
    F.3d 477, 482 (6th Cir. 2005). Furthermore, there is no requirement to
    consider a factor in any given level of detail. Trawick v. Drug Enf't
    Admin., 861 F.2d 72, 76-77 (4th Cir. 1988). The balancing of the public
    interest factors ``is not a contest in which score is kept; the Agency
    is not required to mechanically count up the factors and determine how
    many favor the Government and how many favor the registrant. Rather, it
    is an inquiry which focuses on protecting the public interest . . . .''
    Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (2009). When deciding whether
    registration is in the public interest, the DEA must consider the
    totality of the circumstances. See generally Joseph Gaudio, M.D., 74 FR
    10,083, 10,094-95 (2009) (basing sanction on all evidence on record).
        In the adjudication of a revocation of a DEA registration, the
    Government has the burden of proving that the requirements of
    revocation are satisfied. 21 CFR 1301.44(e). When the Government has
    met its prima facie case, the burden then shifts to the Respondent to
    show that, given the totality of the facts and circumstances on the
    record, revoking registration would not be appropriate. Med. Shoppe-
    Jonesborough, 73 FR 364, 387 (2008).
        While I have considered all of the public interest factors, the
    Government's case invoking the public interest factors of 21 U.S.C.
    824(f) seeks the revocation of the Respondent Pharmacy's registration
    based primarily on conduct most aptly considered under Public Interest
    Factors Two and Four.\37\ The Government also alleged certain ``other
    conduct which threatens the public health and safety,'' which is
    properly considered under Factor Five. I find that the Government's
    evidence with respect to Factors Two and Four satisfies its prima facie
    burden of showing that Respondent's continued registration would be
    ``inconsistent with the public interest.'' 21 U.S.C. 823(f). I further
    find that Respondent failed to provide sufficient evidence to rebut the
    Government's prima facie case.

    [[Page 53416]]

    Specifically, I find that the record contains substantial evidence that
    Respondent's Pharmacist-in-Charge, PIC Davison, violated her
    corresponding responsibility when she dispensed multiple prescriptions.
    I also find there is substantial evidence on the record that Respondent
    violated multiple federal and state recordkeeping requirements.
    ---------------------------------------------------------------------------

        \37\ There is nothing in the record to suggest that a state
    licensing board made any recommendation regarding the disposition of
    the Respondent Pharmacy's DEA registration (Factor One). However,
    the fact that a state has not acted against a registrant's license
    is not dispositive in this administrative determination as to
    whether continuation of a registration is consistent with the public
    interest. E.g., Holiday CVS LLC dba CVS Pharmacy Nos 219 and 5195,
    77 FR 62,316, 62,340 (2012); Patrick W. Stodola, M.D., 74 FR 20,727,
    20,730 (2009). Likewise, the record contains no evidence that the
    Respondent Pharmacy, its owner, or any pharmacist or key employee of
    pharmacy has been convicted of (or charged with) a crime related to
    controlled substances (Factor Three). 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. Dewey C. MacKay, M.D., 75 FR 49,956, 49,973
    (2010), pet. for rev. denied, MacKay v. Drug Enf't Admin., 664 F.3d
    808 (10th Cir. 2011). 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 Respondent's Experience in Dispensing
    Controlled Substances and Compliance With Applicable Laws Related to
    Controlled Substances
        Evidence is considered under Public Interest Factors Two and Four
    when it reflects a registrant's compliance (or non-compliance) with
    laws related to controlled substances and registrant's experience
    dispensing controlled substances. Established violations of the
    Controlled Substances Act, DEA regulations, or other laws regulating
    controlled substances at the state or local level are cognizable when
    considering if a registration is consistent with the public interest.
    As DEA has held in the past, a registrant's ``ignorance of the law is
    no excuse'' for actions that are inconsistent with responsibilities
    attendant upon a registration. Daniel A. Glick, D.D.S., 80 FR 74,800,
    74,809 (2015) (quoting Sigrid Sanchez, M.D., 78 FR 39,331, 39,336
    (2013)). Under Agency precedent, ``[a]ll registrants are charged with
    knowledge of the CSA, its implementing regulations, as well as
    applicable state laws and rules.'' Id. at 74,809 (internal citations
    omitted). Agency precedent has also consistently held that the
    registration of a pharmacy may be revoked as the result of the unlawful
    activity of the pharmacy's owners, majority shareholders, officers,
    managing pharmacist, or other key employee. EZRX, LLC, 69 FR 63,178,
    63,181 (2004); Plaza Pharmacy, 53 FR 36,910, 36,911 (1988).\38\
    ---------------------------------------------------------------------------

        \38\ The Order to Show Cause alleged that ``Respondent''
    violated its corresponding responsibility. It is undisputed that
    Respondent is owned and operated by Santonia Davison, who is also
    Respondent's pharmacist-in-charge and Respondent's only pharmacist.
    Thus, for purposes of finding and attributing liability in this
    case, I find that the actions and inactions of Respondent's Owner
    and PIC were the actions and inactions of Respondent.
    ---------------------------------------------------------------------------

        In this case, the Government alleged and presented evidence that
    the Respondent Pharmacy's pharmacist, in violation of 21 CFR
    1306.04(a), failed to exercise her corresponding responsibility to
    assess the legitimacy of numerous controlled substance prescriptions
    she filled. ALJX 1, at 2-5. The Government also alleged that, in
    violation of 21 CFR 1306.06, the Respondent Pharmacy's pharmacist
    failed to dispense those same prescriptions for controlled substances
    within the lawful bounds of the pharmacy profession. Id. Additionally,
    the Government alleged and presented evidence that the Respondent
    Pharmacy failed to maintain an initial inventory required under federal
    law pursuant to 21 CFR 1304.11, or an initial inventory and an annual
    inventory required under Alabama law pursuant to Ala. Admin. Code 680-
    X-3-.08. ALJX 1, at 5 and 6. The Government also alleged and presented
    evidence that the Respondent Pharmacy failed to notate whether
    individual controlled substances that it ordered were actually
    received, and if so, on what date they were received, in the CSOS, on
    DEA Form 222s, and on its invoices. Id. at 6. Perhaps as a result of
    those alleged recordkeeping violations, the Government also alleged
    that an audit revealed ``significant discrepancies'' in the amounts of
    certain controlled substances at the pharmacy compared with the amounts
    the Respondent Pharmacy's records indicated should have been present.
    Id. Finally, the Government alleged and presented evidence that the
    Respondent Pharmacy inaccurately reported certain information to the
    Alabama PDMP, undermining the purpose of that database. Id. at 7. These
    allegations and the evidence of record are addressed below.
    a. Unlawful Dispensing Allegations
        According to the CSA's implementing regulations, a lawful
    controlled substance order or prescription is one that is ``issued for
    a legitimate medical purpose by an individual practitioner acting in
    the usual course of his professional practice.'' 21 CFR 1306.04(a).
    While the ``responsibility for the proper prescribing and dispensing of
    controlled substances is upon the prescribing practitioner, . . . a
    corresponding responsibility rests with the pharmacist who fills the
    prescription.'' Id. The regulations establish the parameters of the
    pharmacy's corresponding responsibility.

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

        Id. ``The language in 21 CFR 1306.04 and caselaw could not be more
    explicit. A pharmacist has his own responsibility to ensure that
    controlled substances are not dispensed for non-medical reasons.''
    Ralph J. Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55 FR 4729, 4730
    (1990) (citing United States v. Hayes, 595 F.2d 258 (5th Cir. 1979),
    cert. denied, 444 U.S. 866 (1979); United States v. Henry, 727 F.2d
    1373 (5th Cir. 1984) (reversed on other grounds)). As the Supreme Court
    explained in the context of the CSA's requirement that schedule II
    controlled substances may be dispensed only by written prescription,
    ``the prescription requirement . . . ensures patients use controlled
    substances under the supervision of a doctor so as to prevent addiction
    and recreational abuse . . . [and] also bars doctors from peddling to
    patients who crave the drugs for those prohibited uses.'' Gonzales v.
    Oregon, 546 U.S. 243, 274 (2006).
        To prove a pharmacist violated his corresponding responsibility,
    the Government must show that the pharmacist acted with the requisite
    degree of scienter. See 21 CFR 1306.04(a) (``[T]he person knowingly
    filling [a prescription issued not in the usual course of professional
    treatment] . . . shall be subject to the penalties provided for
    violations of the provisions of law relating to controlled
    substances.'') (emphasis added). DEA has also consistently interpreted
    the corresponding responsibility regulation such that ``[w]hen
    prescriptions are clearly not issued for legitimate medical purposes, a
    pharmacist may not intentionally close his eyes and thereby avoid
    [actual] knowledge of the real purpose of the prescription.''
    Bertolino, 55 FR at 4730 (citations omitted); see, also JM Pharmacy
    Group, Inc. d/b/a Pharmacia Nueva and Best Pharmacy Corp., 80 FR
    28,667, 28,670-72 (2015) (applying the standard of willful blindness in
    assessing whether a pharmacist acted with the requisite scienter).
    Pursuant to their corresponding responsibility, pharmacists must
    exercise ``common sense and professional judgment'' when filling a
    prescription issued by a physician. Bertolino, 55 FR at 4730. When a
    pharmacist's suspicions are aroused by a red flag, the pharmacist must
    question the prescription and, if unable to resolve the red flag,
    refuse to fill the prescription. Id.; Medicine Shoppe-Jonesborough, 300
    F. App'x 409, 412 (6th Cir. 2008) (``When pharmacists' suspicions are
    aroused as reasonable professionals, they must at least verify the
    prescription's propriety, and if not satisfied by the answer they must
    refuse to dispense.'').

    [[Page 53417]]

        Here, the Government does not claim that Respondent dispensed the
    subject prescriptions having actual knowledge that the prescriptions
    lacked a legitimate medical purpose. Rather, the Government argues that
    Respondent violated the corresponding responsibility rule when she
    dispensed controlled substance prescriptions while ``repeatedly
    ignor[ing] obvious and apparent signs of abuse and diversion--signs
    that a professional pharmacist, operating in the bounds of the
    profession with eyes open to such indicia, would detect and resolve.''
    Govt Posthearing, at 37.
        As I found above, Respondent dispensed prescriptions for controlled
    substances without resolving red flags presented by the prescriptions,
    including the red flags of drug cocktails, multiple customers filling
    prescriptions from the same prescriber for the same drugs (``pattern
    prescribing''), customers with the same last name and street address
    presenting the same prescriptions within a short period of time,
    traveling unusual distances, doctor shopping, pharmacy shopping,
    therapeutic duplication, and unusual increases in drug quantities.
    Prior Agency decisions have found that prescriptions with the same red
    flags at issue here 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. See, e.g., Zion Clinic Pharmacy,
    83 FR at 10,898 (long distances; pattern prescribing; customers with
    the same street address presenting the same prescriptions on the same
    day; drug cocktails; cash payments; early refills); Hills Pharmacy, 81
    FR 49,816, 49,836-39 (2016) (multiple customers filling 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; two short-acting
    opiates prescribed together; long distances; drug cocktails); The
    Medicine Shoppe, 79 FR 59,504, 59,507, 59,512-14 (2014) (unusually
    large quantity of a controlled substance; pattern prescribing; drug
    cocktails); Holiday CVS, 77 FR at 62,317-22 (long distances; multiple
    customers filling 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); East Main Street Pharmacy, 75 FR 66,149, 66,163-65
    (2010) (long distances; lack of individualized therapy or dosing; drug
    cocktails; early fills/refills; other pharmacies' refusals to fill
    prescriptions). The Government also presented credible testimony that
    PIC Davison knew, or should have known, there were red flags on the
    prescriptions at the time they were dispensed. Alabama law requires
    pharmacists to review all new prescriptions, and refill prescriptions
    where appropriate, for, among other things, therapeutic duplication,
    drug-disease contraindication, incorrect dosage/duration, and clinical
    abuse/misuse. Ala Admin. Code 680-X-2-.21. Dr. Alverson testified that
    an Alabama pharmacist is trained to and should have recognized the red
    flags on the subject prescriptions, which included red flags explicitly
    named in Alabama law, and that an Alabama pharmacist exercising her
    corresponding responsibility and acting in the usual course of
    professional practice will not dispense controlled substances without
    investigating, documenting the investigation, and resolving any red
    flags. Furthermore, PIC Davison's comments to Dr. Alverson that the
    subject patients were receiving the same controlled substances from
    another pharmacy before they came to Respondent Pharmacy and
    ``[w]hatever problems they had when they got to [Respondent Pharmacy],
    they had those problems before they got to [Respondent Pharmacy]''
    reflects an abdication of PIC Davison's corresponding responsibility.
        Accordingly, I find the Government has proven by substantial
    evidence that Respondent filled prescriptions for controlled substances
    that it knew were not prescribed for legitimate medical purposes, or
    was willfully blind to such, in violation of its corresponding
    responsibility under 21 CFR 1306.04(a) and outside the usual course of
    its professional practice in violation of 21 CFR 1306.06.
        In its Posthearing Brief, Respondent contended that the evidence
    produced during the hearing ``demonstrated that the prescriptions at
    issue were neither per-se unreasonable or issued without an appropriate
    investigation'' \39\ and that Respondent, therefore, did not violate
    its corresponding responsibility. Resp Posthearing, at 1. I disagree.
    First, as discussed supra, PIC Davison's testimony regarding the extent
    of her investigations on the subject prescriptions lacked credibility
    and was unsupported by any documentation. Second, it was Dr. Alverson's
    expert testimony that some of the subject prescriptions--those with
    combinations of oxycodone, hydrocodone, and alprazolam, all prescribed
    in high doses--were sufficiently dangerous that they ``on their face
    were invalid.'' Tr. 487. Dr. Alverson also testified that there were
    red flags on patient A.C.'s prescriptions that, in her expert opinion,
    were unresolvable and were, in fact, so egregious that if presented
    with the prescription, she not only would have declined to fill it, she
    would have notified the police. Id. at 439-40. PIC Davison's decisions
    to dispense these prescriptions despite the unresolvable red flags
    indicate that she either did not conduct the thorough investigation she
    claims to have conducted or was willfully blind to the results of her
    own investigation. It is also uncontroverted that Respondent conducted
    no investigation before filling forged prescriptions for patient R.D.
    ---------------------------------------------------------------------------

        \39\ In its Posthearing Brief, Respondent seemed to agree with
    the Government that the subject prescriptions had red flags, but it
    is difficult to make a blanket statement on Respondent's
    acknowledgement of the red flags identified by Dr. Alverson because
    PIC Davison's testimony at the hearing was equivocal. For example,
    she described two patients from the same household presenting
    substantially similar prescriptions from the same prescriber as a
    circumstance that ``would raise a flag'' but then said that she did
    not find the circumstances suspicious because it was common for
    family members to see the same doctor. Tr. 646-47. In its
    Posthearing Brief, however, Respondent did not contest any of the
    red flags identified by Dr. Alverson. Instead, Respondent only
    argued that PIC Davison had properly investigated all subject
    prescriptions by calling the issuing physicians to verify the
    validity and medical necessity of the prescription.
    ---------------------------------------------------------------------------

        Finally, Respondent has argued that the Government's case must fail
    because the Government did not produce any of the subject physicians,
    or physicians' representatives, to rebut PIC Davison's testimony that
    she had contacted the prescribing physicians to verify the subject
    prescriptions were legitimate and medically necessary given the
    conditions of the patients. Resp Posthearing, at 2. Respondent did not
    elaborate on its argument or cite any legal precedent for it, and it is
    contrary to Agency decisions. See, e.g., Zion Clinic Pharmacy, 83 FR at
    10,899. Accordingly, I reject it.\40\
    ---------------------------------------------------------------------------

        \40\ Furthermore, as discussed supra at I.E., I do not place any
    weight on PIC Davison's testimony that she adequately investigated
    and resolved the red flags on the subject prescriptions because she
    produced no contemporaneous documentary evidence to support her
    claim and because the ALJ found, and I agree, that the testimony was
    not credible.
    ---------------------------------------------------------------------------

    b. Recordkeeping Allegations
        In addition to its mandate that controlled substances be dispensed
    properly, the CSA also recognizes that controlled substances are
    fungible and that a truly closed system requires that

    [[Page 53418]]

    certain records and inventories be kept by all registrants who either
    generate or take custody of controlled substances in any phase of the
    distribution chain until they reach the ultimate user. Satinder Dang,
    M.D., 76 FR 51,424, 51,429 (2011) (``Recordkeeping is one of the
    central features of the CSA's closed system of distribution.'')
    (internal citations omitted); Paul H. Volkman, 73 FR 30,630, 30,644
    (2008), pet. for rev. denied 567 F.3d 215, 224 (6th Cir. 2009)
    (``Recordkeeping is one of the CSA's central features; a registrant's
    accurate and diligent adherence to this obligation is absolutely
    essential to protect against the diversion of controlled
    substances.'').
        The OSC alleged that Respondent violated multiple federal
    regulations and Alabama state laws related to the maintenance of
    records. The CSA requires registrants like Respondent to ``maintain, on
    a current basis, a complete and accurate record of each [controlled]
    substance . . . received, sold, delivered, or otherwise disposed of,''
    21 U.S.C. 827(a), in accordance with and with such relevant information
    as required by the CSA implementing regulations, 21 U.S.C. 827(b). The
    State of Alabama also imposes separate recordkeeping requirements on
    pharmacies.
    i. Inventories
        Registrant pharmacies are required to make an initial inventory of
    controlled substances ``on hand'' on the date they first engage in
    dispensing of controlled substances. 21 CFR 1304.11(b). ``In the event
    a person commences business with no controlled substances on hand, he/
    she shall record this fact as the initial inventory.'' Id. The initial
    inventory must be available for at least two years from the date of the
    inventory for inspection and copying by the DEA. 21 CFR 1304.04(a).
        DI Two requested the Respondent Pharmacy's initial inventory during
    the May 20, 2015 administrative inspection. PIC Davison was unable to
    produce the initial inventory and conceded at the hearing that she did
    not know she was supposed to have an initial inventory. Supra I.B.2.
    After the July 6, 2015 meeting with the DEA, PIC Davison emailed DI One
    and representatives of the Alabama Board of Pharmacy a computer-
    generated record, entitled ``Narcotic Sales Report,'' which included a
    list of the schedule III through V controlled substances procured by
    Respondent Pharmacy from Cardinal Health, the pharmacy's sole
    pharmaceutical distributer, from May 1, 2014 through May 31, 2014. GX
    7, at 58-59. PIC Davison wrote ``Initial Inventory'' at the top of the
    report before faxing it.
        PIC Davison's post hoc attempts to create an initial inventory do
    not meet the requirements of 21 CFR 1304.11(b). Even assuming the
    ``Narcotic Sales Report'' record was in the pharmacy during the May 20,
    2015 inspection as PIC Davison claims (a claim which is refuted by DI
    Two whose testimony the ALJ found credible), there is no evidence that
    the report was created when the Respondent Pharmacy commenced
    dispensing controlled substances, and PIC Davison testified that she
    did not mark the report as an ``initial inventory'' until after the
    July 6, 2015 meeting with the DEA. The report also does not meet the
    requirements for an initial inventory because it does not have a
    specific date or a notation of whether it was taken on the open or
    close of business on that date. I find, therefore, that there is
    substantial evidence that Respondent Pharmacy violated 21 CFR
    1304.11(b) by failing to create and maintain a record of an initial
    inventory.
        Alabama state law, like under federal law, also required Respondent
    to conduct an inventory on the ``date it first engages in dispensing of
    controlled substances.'' Ala. Admin. Code 680-x-3-.08(3). After the
    initial inventory, Respondent was required to conduct an annual
    inventory of controlled substances on or around January 15 of each
    calendar year. Ala Admin. Code 680-X-3-.08(1). The inventories must be
    signed and dated and indicate whether they were taken as of the close
    or opening of business. Ala. Admin. Code 680-x-3-.08(4).
        Respondent did not produce either the initial or the January 15
    inventory required by state law at the May 20, 2015 inspection, supra
    I.B.2, and PIC Davison conceded during the hearing that she did not
    conduct an inventory on or about January 15, 2015, as required by state
    law, Tr. 714. I therefore find that there is substantial evidence that
    Respondent did not conduct the required inventories in violation of
    680-x-3-.08 of the Alabama Administrative Code.
    ii. Allegations Respondent Violated Regulations Related to Schedule II
    Orders
        The Government alleged that Respondent violated DEA recordkeeping
    regulations for ordering schedule II controlled substances in both its
    paper and electronic ordering systems. ALJX 1, at 6. Specifically, the
    Government alleged that on sixteen electronic records of controlled
    substances ordered by Respondent through the CSOS between March 24,
    2015 and May 19, 2015, Respondent did not indicate that the orders were
    received and that on fifteen records of controlled substances ordered
    by Respondent on DEA Form 222s from November 13, 2014 to March 10,
    2015, Respondent did not notate whether the orders were received. Id.
    (citing 21 CFR 1305.13(e) and 1305.22(g)).
        As support for the allegation that Respondent did not properly
    maintain DEA Form 222s, the Government submitted copies of 15
    ``purchaser's Copy 3'' of order forms Respondent submitted to its
    distributer. GX 3. Under DEA's regulations, ``[t]he purchaser must
    record on Copy 3 of the DEA Form 222 the number of commercial or bulk
    containers furnished on each item and the dates on which the containers
    are received by the purchaser.'' 21 CFR 1305.13(e). PIC Davison
    testified that she received the fifteen orders, supra I.B.2., but the
    DEA Form 222s for the orders do not have a record of the date received
    or the number of items received, GX 3. Respondent thus violated 21 CFR
    1305.13(e).
        As support for the allegation that Respondent did not properly
    maintain records or receipt of orders made electronically in the CSOS,
    the Government submitted print-outs of Respondent's CSOS orders from
    March 13, 2015 to May 19, 2015. GX 2. Sixteen of the twenty orders are
    not recorded as ``Received.'' Id. Under DEA regulation 21 CFR
    1305.22(g), ``[w]hen a purchaser receives a shipment [of controlled
    substances from an electronic order], the purchaser must create a
    record of the quantity of each item received and the date received''
    and ``the record must be electronically linked to the original order
    and archived.'' PIC Davison testified that Respondent Pharmacy received
    the sixteen orders not recorded as ``Received,'' supra I.B.2, but the
    CSOS does not have a record of the date received or the number of items
    received, GX 3. Respondent thus violated 21 CFR 1305.22(g).
    iii. Allegation Respondent Violated Schedule III-V Orders Recordkeeping
    Requirements
        Under 21 CFR 1304.22(a)(2)(iv) and (c), Respondent Pharmacy was
    required to maintain a record of each order of controlled substances
    that included the date of receipt, the quantity acquired, and the name,
    address, and registration number of the person from whom the substances
    were acquired. The Government alleged that Respondent violated this
    requirement by failing to record the date and amount of controlled
    substances ``actually

    [[Page 53419]]

    received.'' ALJX 1, at 6 (citing 21 CFR 1304.21(d)). To support this
    allegation, the Government submitted 64 invoices for orders of schedule
    III-V controlled substances from Respondent Pharmacy.\41\ GX 4. The
    invoices all listed the name, address and registration number of the
    person from whom the substances were acquired and the quantity of
    substances and date shipped. On some of the receipt invoices,
    Respondent had circled the quantity shipped, which DI Two inferred
    could indicate the amount received was correct, but on other receipt
    invoices, there were no circled quantities. Tr. 50-51; GX 4. PIC
    Davison did sign the invoices, which she testified she did to document
    receipt of the order and confirm that the quantity and date listed on
    the invoice were correct. Tr. 578; GX 4.
    ---------------------------------------------------------------------------

        \41\ The Government submitted copies of 69 invoices but conceded
    at the hearing and in the Government's Posthearing Brief that only
    64 of the invoices contained orders for controlled substances. Govt
    Posthearing, at 3.
    ---------------------------------------------------------------------------

        I find that PIC Davison's signature on the invoices was
    insufficient to meet the record requirements of 21 CFR
    1304.22(a)(2)(iv) and that, therefore, Respondent violated the
    regulation. The regulation requires registrants to record the date of
    receipt and quantity acquired. The invoices from Respondent Pharmacy do
    contain the date and quantity shipped but they do not list the date
    received, and the regulation and the Pharmacy Manual, which was
    introduced at the hearing and which PIC Davison testified she used to
    develop her policies and procedures, clearly state that the registrant
    must ``record[] the date the drugs were received and confirm that the
    order is accurate.'' GX 50. While the regulation does not specify the
    manner in which the registrant must make the notations in the record,
    Respondent Pharmacy failed to meet this requirement because it did not
    record the date of receipt on the invoices in any manner and can only
    argue that it confirmed the accuracy of the order on the invoices where
    the quantities were circled.
    iv. Audit Discrepancies
        The Agency has also considered a pharmacy registrant's inability to
    account for controlled substances under Factor Four. Ideal Pharmacy
    Care, Inc., 76 FR 51,415, 51,416 (2011). Under the CSA, every
    registrant ``distributing, or dispensing a controlled substance or
    substances shall maintain, on a current basis, a complete and accurate
    record of each such substance . . . received, sold, delivered, or
    otherwise disposed of by [it].'' 21 U.S.C. 827(a)(3). In evaluating
    shortages under Factor Four, the Agency has held that, ``[w]hether the
    shortages are attributable to outright diversion by either pharmacy or
    store employees, theft, or the failure to maintain accurate records,
    does not matter.'' Ideal Pharmacy Care, 76 FR at 51,416. As the Agency
    has explained, the ``inability to account for [a] significant number of
    dosage units creates a grave risk of diversion.'' Fred Samimi, 79 FR
    18,698, 18,712 (2014). The Agency has also made it clear that it is not
    only concerned with shortages, but that overages are equally indicative
    that a pharmacy registrant has ``failed to maintain complete and
    accurate records as required by the CSA.'' Superior Pharmacy I &
    Superior Pharmacy II, 81 FR 31,310, 31,341 (2016); see also Hills
    Pharmacy, 81 FR at 49,843-45 (considering allegations of overages and
    shortages).
        The audit of six oft-diverted controlled substances at the
    Respondent Pharmacy revealed dramatic discrepancies with both shortages
    and overages of drugs. The Respondent Pharmacy conceded most of the
    discrepancies, but explained that they resulted from her unfamiliarity
    with her drug supplier's computer software and the wrong inventory list
    being mistakenly downloaded at the time of the audit. This explanation
    provides no defense. The Respondent Pharmacy is obliged to ``maintain,
    on a current basis, a complete and accurate record of each controlled
    substance,'' 21 CFR 1304.21(a), and to make its records readily
    available for review by DEA, see 21 CFR 1304.04(a). Additionally, even
    Respondent's own ``self-audit,'' which PIC Davison testified she made
    using an inventory report she did not produce during the DEA audit,
    contained discrepancies for four of the six audited controlled
    substances.
        I find, therefore, there is substantial evidence to support the
    allegation that Respondent Pharmacy failed to keep a current and
    accurate record of controlled substances, pursuant to 21 CFR
    1304.21(a).
    v. Twenty-One Day Absence of PDMP Inputs
        Under Alabama state law, a licensed pharmacy is required to report
    each dispensation of a controlled substance to the Alabama Prescription
    Drug Monitoring Program. Ala. Code Sec.  20-2-213; Tr. 507-08. Dr.
    Alverson testified that from November 10, 2014, until December 1, 2014,
    the Respondent Pharmacy made no reports of dispensing controlled
    substances to the PDMP, despite the presence of original prescriptions
    evidencing the filling of controlled substances during that period. Tr.
    393-95. See Tr. 174; GX 10, at 36; GX 12; GX 22, at 23.
        PIC Davison explained that she ``guessed'' this lapse was due to a
    software glitch in Respondent Pharmacy's computer system. Tr. 754. This
    provides no defense for Respondent Pharmacy's failure to report for
    three weeks and its failure to make any corrective measures until
    prompted to do so by the Alabama Board of Pharmacy.\42\ Respondent
    Pharmacy has a legal responsibility to report each controlled substance
    dispensation. In his Recommended Decision, the ALJ noted that the long
    lapse begs the questions: ``why did the lapse go on for so long; why
    did the Respondent Pharmacy not quickly correct the lapse? It suggests
    the Respondent Pharmacy was not checking the PDMP frequently.'' RD, at
    56.
    ---------------------------------------------------------------------------

        \42\ It is not clear from PIC Davison's testimony when or how
    she learned of the three week gap in reporting, but her testimony
    strongly implies she did not know about it until she was alerted by
    the Alabama Board of Pharmacy. ``Q [from DEA Attorney Hill]: `When
    were you alerted to the fact that you had stopped reporting any
    controlled substances to PDMP?' A [from PIC Davison]: `I cannot tell
    you at this point. I've had numerous run-ins with the Board of
    Pharmacy, you guys from several cases. I can't actively tell you
    that particular date, but when we did learn about it, we submitted
    the file.''' Tr. 755.
    ---------------------------------------------------------------------------

        Accordingly, I find that Respondent Pharmacy failed to submit
    records to the PDMP in violation of Alabama law.
    2. Factor Five
        Under Factor Five, the Administrator is authorized to consider
    ``other conduct which may threaten the public health and safety.'' 21
    U.S.C. 823(f)(5). This factor encompasses ``conduct which creates a
    probable or possible threat (and not only an actual [threat]) to public
    health and safety.'' Jacobo Dreszer, M.D., 76 FR 19,386, 19,401 n.2
    (2011). The Government argues that Respondent Pharmacy's inaccurate
    reporting to the Alabama Prescription Drug Monitoring Program and the
    confusion that the inaccurate reporting caused threatened public safety
    and weigh in favor of revocation under Factor Five.
        The record reveals that the Respondent Pharmacy did submit
    incorrect information to the Alabama PDMP on several occasions. DI One
    had received a call from a local doctor, Dr. F., complaining that the
    Respondent Pharmacy had filled a prescription and attributed it to Dr.
    F. on the PDMP, which this doctor had not prescribed. Tr. 157-60; GX 8.
    DI One retrieved the original prescription from the Respondent
    Pharmacy, which identified

    [[Page 53420]]

    a different doctor as prescriber, yet the pharmacy label incorrectly
    identified Dr. F. as the prescriber. Tr. 162-68. DI One also found
    instances where duplicate prescriptions were entered into the PDMP by
    the Respondent Pharmacy and where Respondent Pharmacy had input
    prescriptions under a prescriber DEA number with insufficient digits.
    Id. at 172-73; see GX 10, at 36 and 40. But there is also evidence in
    the record that the PDMP is subject to error, delayed reporting, and
    correction. Dr. Alverson testified that a pharmacy cannot correct a
    PDMP entry itself and must contact the PDMP staff with the correction.
    Tr. 412, 506. She further testified that the pharmacy is under no
    obligation to ensure the correction was made, Tr. 507, and DI One
    testified that she did not, as part of her investigation, contact the
    PDMP to determine if Respondent Pharmacy had submitted corrected
    information for any of the incorrect entries, Tr. 272.
        The Government concedes that stray errors in PDMP reports would not
    render a registration inconsistent with the public interest and argues
    only that such errors should be considered to ``threaten the public
    health safety'' under Factor Five when they are ``sufficiently
    persistent and widespread that they are credibly said to impede
    regulatory investigations.'' Govt Posthearing, at 47 n.23. The
    Government has failed to meet the standard it set for itself. While I
    agree with the Administrative Law Judge's assessment that errors within
    the PDMP compromise the important role the program plays in the state
    in preventing the abuse and diversion of controlled substances, RD, at
    56, the handful of PDMP submission errors by Respondent Pharmacy that
    are supported by evidence on the record were not so widespread or
    egregious in this case that they threatened the public health and
    safety.
        The Government has demonstrated that Respondent's omissions to the
    PDMP were sufficiently persistent and widespread that they could pose a
    threat to public health and safety, but in this case, those failures
    were a violation of state law and were considered under Factor Four.
    Because Factor Five only implicates ``such other conduct,'' it
    necessarily follows that conduct considered in Factors One through Four
    may not be considered under Factor Five. Holiday CVS, 77 FR at 62,345.
    Accordingly, Factor Five does not weigh for or against revocation.
    3. Summary of the Public Interest Factors
        As found above, Respondent Pharmacy filled controlled substance
    prescriptions for nearly a dozen patients in violation of its
    corresponding responsibility and outside the usual course of
    professional practice. 21 CFR 1306.04, 1306.06. It also violated
    numerous federal and state record keeping regulations related to
    controlled substances. Thus, I conclude that Respondent has engaged in
    misconduct which supports the revocation of its registration. I
    therefore hold that the Government has established a prima facie case
    that Respondent's continued registration ``would be inconsistent with
    the public interest.'' 21 U.S.C. 823(f).

    III. Sanction

        Where, as here, the Government has met its prima facie burden of
    showing that Respondent's continued registration is inconsistent with
    the public interest due to its violations pertaining to controlled
    substance dispensing and recordkeeping, the burden shifts to Respondent
    to show why it can be entrusted with the responsibility carried by its
    registration. Garret Howard Smith, M.D., 83 FR 18,882, 18,910 (2018)
    (citing Samuel S. Jackson, 72 FR 23848, 23853 (2007)). DEA cases have
    repeatedly found that when a registrant has committed acts inconsistent
    with the public interest, ``the Respondent is required not only to
    accept responsibility for [the established] misconduct, but also to
    demonstrate what corrective measures [have been] undertaken to prevent
    the reoccurrence of similar acts.'' Holiday CVS, 77 FR at 62,339
    (internal quotations omitted). See, also, Hoxie v. DEA, 419 F.3d 477,
    483 (6th Cir. 2005); Ronald Lynch, M.D., 75 FR 78,745, 78,749, 78,754
    (2010) (holding that respondent's attempts to minimize misconduct held
    to undermine acceptance of responsibility); Medicine Shoppe-
    Jonesborough, 73 FR 364, 387 (2008) (noting that the respondent did not
    acknowledge recordkeeping problems, let alone more serious violations
    of federal law, and concluding that revocation was warranted). The
    issue of trust is necessarily a fact-dependent determination based on
    the circumstances presented by the individual respondent; 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. Jeffrey Stein, M.D., 84 FR 46,968, 46,972 (2019).
    A registrant's candor during the investigation and hearing is an
    important factor in determining acceptance of responsibility and the
    appropriate sanction, Garret Howard Smith, M.D., 83 FR at 18,910
    (collecting cases); as is whether the registrant's acceptance of
    responsibility is unequivocal, Lon F. Alexander, M.D., 82 FR 49,704,
    49,728 (2017) (collecting cases).\43\
    ---------------------------------------------------------------------------

        \43\ Here, the Respondent Pharmacy testified that there were
    five instances, out of the 69 alleged invoice violations for orders
    of schedule III-V controlled substances, in which the Government had
    mistakenly included non-controlled substances. The Government
    credibly explained the cause of the charging error and amended the
    charges accordingly. The ALJ did not consider this legal challenge
    by the Respondent as compromising her potential acceptance of
    responsibility, RD, at 58, and neither will I.
    ---------------------------------------------------------------------------

        In determining whether and to what extent a sanction is
    appropriate, consideration must be given to both the egregiousness of
    the offense established by the Government's evidence and the Agency's
    interest in both specific and general deterrence. Wesley Pope, 82 FR
    14,944, 14,985 (2017) (citing Joseph Gaudio, 74 FR 10,083, 10,095
    (2009)); David A. Ruben, M.D., 78 FR 38,363, 38,364 (2013). Cf.
    McCarthy v. SEC, 406 F.3d 179, 188-89 (2d Cir. 2005) (upholding SEC's
    express adoption of ``deterrence, both specific and general as a
    component in analyzing the remedial efficacy of sanctions.''). Normal
    hardships to the practitioner and even to the surrounding community
    that are attendant upon the lack of registration are not relevant
    considerations. Linda Sue Cheek, M.D., 76 FR 66,972, 66,973 (2011).
        Here, the ALJ recommended that I find that Respondent did not
    ``meet[] the evidence with an acceptance of responsibility.'' RD, at
    57. PIC Davison testified during the hearing that she took
    responsibility for many of the established violations but her
    acceptance was equivocal, did not cover the full scope of her
    violations, and lacked credibility. PIC Davison acknowledged many of
    her recordkeeping failures but did not acknowledge the impropriety of a
    single dispensing of a controlled substance at issue in this case.\44\
    Dr. Alverson's fact testimony, which the ALJ found credible, also
    belied PIC Davison's acceptance of responsibility at the hearing. Just
    a month before the hearing, PIC Davison was eschewing her

    [[Page 53421]]

    professional responsibility telling Dr. Alverson that whatever problems
    her patients had with controlled substances, they already had those
    problems when they arrived at her pharmacy.
    ---------------------------------------------------------------------------

        \44\ The closest PIC Davison came to acknowledging that she
    improperly filled a prescription was to say that if presented with
    female M.A.'s prescription today she would perhaps not fill it based
    on 2016 guidelines on the dangers of opioid and benzodiazepine
    combinations, but Dr. Alverson testified that the danger was widely
    known in the pharmacy community when PIC Davison filled female
    M.A.'s prescription. See Tr. 420, 773-75.
    ---------------------------------------------------------------------------

        PIC Davison also failed to recognize the real harm that could
    result to her patients and the public from her violations and minimized
    the severity of her misconduct. She seemed more concerned with
    preventing another DEA investigation than preventing diversion
    repeatedly testifying that she was sorry her violations ``caused all
    this uproar.'' Tr. 691-92.
        Additionally, the ALJ found that PIC Davison was not fully candid
    during the investigation and hearing, which tends to rebut any
    acceptance of responsibility. The ALJ stated that ``[i]n testifying as
    to factual matters regarding the initial inventory, the timing and
    extent of her purported investigations, and documentation of her
    investigations, PIC Davison's testimony was marked with a level of
    equivocation, implausibility, and inconsistently that profoundly
    undermined her efforts to diminish her culpability.'' RD, at 58. For
    example, Respondent conceded that it failed to properly document PIC
    Davison's due diligence investigations as to some of the subject
    patients, while suggesting to have properly documented her
    investigation as to other patients; however, the ALJ specifically found
    that PIC Davison's testimony regarding her documentation of
    investigations was not always credible. Id. Finally, PIC Davison's
    false statements on her registration renewal application, which were
    made during the pendency of the instant matter, undermine any claims of
    contrition and her argument that she can be trusted with the
    responsibilities of a registration.
        In Respondent's favor, PIC Davison testified that she has
    undertaken corrective measures to prevent the reoccurrence of
    violations of her regulatory and professional responsibilities. She has
    instituted new policies to remedy Respondent Pharmacy's numerous
    recordkeeping violations including contemporaneous electronic notations
    of communications with physicians, up to date ordering processes for
    all controlled substances, and manual input of PDMP information to
    avoid errors. The ALJ also found that PIC Davison's in-hearing
    ``impromptu evaluation of patient cases demonstrated that she was fully
    aware of her responsibilities to investigate suspicious prescriptions,
    and the steps she reported she would take to investigate largely
    mirrored those recommended by Dr. Alverson.'' RD, at 60. The ALJ was
    skeptical, however, that PIC Davison ``would consistently honor her
    commitment to regulatory compliance . . . in light of her conflicting
    priorities.'' Id. (referencing PIC Davison's repeated statements that
    she prioritized patient consultation over documentation and other legal
    requirements). He also referred to her remedial measures as
    ``dilatory.'' Id. at 58. I am similarly skeptical that PIC Davison will
    consistently comply with her new recordkeeping procedures. The record
    demonstrates that for some of the established recordkeeping violations,
    such as the improperly documented paper and electronic orders of
    schedule II substances, PIC Davison was aware of and capable of
    fulfilling her obligations, but she chose not to prioritize compliance.
    ``Past performance is the best predictor of future performance,'' Leo
    R. Miller, M.D., 53 FR 21,931, 21,932 (1998); and the ALJ found, and I
    agree, that the allegations sustained on the record in this matter
    ``exhibit a near deliberate policy to de-prioritize the Respondent
    Pharmacy's record-keeping and corresponding prescription investigation
    responsibilities,'' RD, at 60.
        The ALJ recommended that ``the record supports the imposition of a
    sanction.'' RD, at 58. I agree that is the appropriate result on the
    record in this case.
        Respondent has not presented sufficient mitigating evidence to
    assure me that it can be entrusted with the responsibility carried by a
    DEA registration. As the ALJ noted in his Recommended Decision ``[t]he
    Respondent Pharmacy's case is characterized by non-compliance ab
    initio. The Respondent Pharmacy opened for business without a
    demonstrated commitment to regulatory compliance, both in [PIC]
    Davison's corresponding responsibility and its record-keeping, and only
    appears to have become compliant with the prospect of losing its
    registration.'' RD, at 59. The evidence shows that PIC Davison
    committed extensive violations of federal and state recordkeeping
    requirements, filled prescriptions that were not issued for a
    legitimate medical purpose in violation of her corresponding
    responsibility, and, perhaps most egregiously, continued to fill
    prescriptions lacking a legitimate medical purpose even after multiple
    discussions with DEA and state pharmacy board officials regarding her
    regulatory noncompliance. She also continued to violate federal law
    after the initiation of the proceedings to revoke her registration by
    submitting false statements on her registration renewal and
    falsification on an application for registration cannot be tolerated.
    Peter A. Ahles, M.D., 71 FR at 50,099; Hoxie, 419 F.3d at 483.
        Regarding general deterrence, the Agency bears the responsibility
    to deter similar misconduct on the part of others for the protection of
    the public at large. David A. Ruben, 78 FR at 38,385. I agree with the
    ALJ's conclusion that ``the Agency's interest in general deterrence is
    . . . best served here by the revocation of the Respondent Pharmacy's
    COR.'' RD, at 60. Based on the number and variety of the established
    violations in this case, a sanction less than revocation would send a
    message to the regulated community that ``due diligence is not a
    required condition precedent to operating as a registrant.'' Zion
    Clinic Pharmacy, 83 FR at 10,903.
        The ALJ recommended revocation as the appropriate sanction. RD, at
    60. A balancing of the statutory public interest factors, coupled with
    consideration of the Respondent Pharmacy's failure to accept full
    responsibility, the absence of record evidence of timely and committed
    remedial measures to guard against recurrence, and the Agency's
    interest in deterrence, supports the conclusion that the Respondent
    Pharmacy should not continue to be entrusted with a registration. The
    Respondent Pharmacy's false statements within its registration renewal
    application also supply an independent ground for revocation pursuant
    to section 824(a)(1). Accordingly, I shall order the sanctions the
    Government requested, as contained in the Order below.

    IV. Order

        Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
    U.S.C. 824(a), I hereby revoke DEA Certificate of Registration
    FH4377291 issued to Heavenly Care Pharmacy. Further, pursuant to 28 CFR
    0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby
    deny any pending application of Heavenly Care Pharmacy to renew or
    modify this registration. This order is effective September 28, 2020.

    Timothy J. Shea,
    Acting Administrator.
    [FR Doc. 2020-18975 Filed 8-27-20; 8:45 am]
    BILLING CODE 4410-09-P