Neumann's Pharmacy, LLC; Decision and Order, 8039-8048 [2025-01536]
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Federal Register / Vol. 90, No. 14 / Thursday, January 23, 2025 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 24–1]
Neumann’s Pharmacy, LLC; Decision
and Order
On September 12, 2023, the Drug
Enforcement Administration (DEA or
Government) issued an Order to Show
Cause (OSC) to Neumann’s Pharmacy,
LLC, of Tallulah, Louisana
(Respondent). OSC, at 1. The OSC
proposed the revocation of
Respondent’s DEA Certificate of
Registration Number FN4373293,
alleging that Respondent’s continued
registration is inconsistent with the
public interest. Id. (citing 21 U.S.C.
824(a)(4), 823(g)(1)).
A hearing was held before DEA
Administrative Law Judge Teresa A.
Wallbaum (the ALJ), who, on June 18,
2024, issued her Recommended Rulings,
Findings of Fact, Conclusions of Law,
and Decision (Recommended Decision
or RD), recommending that
Respondent’s registration be revoked.
RD, at 41. Respondent filed exceptions
to the RD.1 Having reviewed the entire
record, the Agency adopts and hereby
incorporates by reference the entirety of
the ALJ’s rulings, credibility findings,2
findings of fact, conclusions of law,
sanctions analysis, and recommended
sanction as found in the RD and
summarizes and clarifies portions
thereof herein.
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I. Louisiana Standard of Care
Dr. DiGi Graham testified as the
Government’s expert regarding the
standard of care for pharmacy practice
in the State of Louisiana. Id. at 5; Tr.
96–97. Dr. Graham has been licensed as
a pharmacist in Oklahoma 3 for
approximately thirty years and has
extensive experience dispensing
medications in retail pharmacies. RD, at
6; Tr. 90–91. Dr. Graham has worked for
several independent pharmacies,
including opening her own
1 The Agency has reviewed and considered
Respondent’s exceptions and addresses them
herein, but ultimately agrees with the ALJ’s
recommendation.
2 The Agency adopts the ALJ’s summary of each
witness’s testimony, as well as the ALJ’s assessment
of each witness’s credibility. See RD, at 3–19.
3 Although Dr. Graham is not licensed as a
pharmacist in Louisiana, she familiarized herself
with the standard of care for dispensing controlled
substances in Louisiana by reviewing provisions of
the Louisiana Administrative Code. RD, at 6; Tr.
96–98. She testified that the law governing the
practice of pharmacy in Louisiana is substantially
similar to the law governing the practice of
pharmacy in Oklahoma, the State in which she is
licensed, and that she has consulted on other cases
in Louisiana. RD, at 6; Tr. 97, 99, 101–02.
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compounding and retail pharmacy in
2002, and she currently works as a
consultant. Id. The Agency agrees with
the ALJ that Dr. Graham was a reliable
and persuasive witness who drew on
her own experience in retail pharmacy,
clearly articulated the standard of care
in Louisiana,4 and ‘‘clearly identified
each source [that] she consulted to form
her opinion on the standard of care for
pharmacies in Louisiana.’’ Id. at 7; Tr.
7. Thus, the Agency agrees with the ALJ
that Dr. Graham’s testimony was fully
credible and reliable. RD, at 7.
Dr. Julie Akers, a Washingtonlicensed pharmacist,5 and Laura
Neumann, Respondent’s owner and
Pharmacist-in-Charge (PIC), testified on
Respondent’s behalf. Dr. Akers has been
working as a pharmacist for
approximately twenty-five years. Id. at
8; Tr. 275. Dr. Akers started her career
as a retail pharmacist, eventually
progressing to a management position
where she oversaw compliance of thirty
pharmacies, before transitioning to
academia in 2013.6 RD, at 8; Tr. 274–75.
The Agency agrees with the ALJ that Dr.
Akers ‘‘has limited reliability as an
expert’’ because her testimony regarding
the standard of care ‘‘was, at times,
unclear and contradictory.’’ RD, at 9.
For example, as discussed in more
detail below, Dr. Akers offered
contradictory testimony about whether
the standard of care requires
pharmacists to document the resolution
of red flags.7 Id. Thus, the Agency agrees
with the ALJ that Dr. Akers’s testimony
is ‘‘diminished relative to Dr.
Graham’s,’’ and credits Dr. Graham’s
testimony where the two experts
disagree.8 Id.
4 For Dr. Graham’s full qualifications, see RD, at
5–6; GX 10.
5 Dr. Akers is not licensed as a pharmacist in
Louisiana. RD, at 8; Tr. 278–79. However, Dr. Akers
reviewed the statutes and regulations pertaining to
pharmacy practice in Louisiana, including the
portions of the Louisiana Administrative Code cited
by the Government in this case, and performed her
own individual research on Louisiana pharmacy
practice to determine where Louisiana law
overlapped with Federal law. RD, at 8; Tr. 278.
6 For Dr. Akers’s full qualifications, see RD, at 8–
9; RX 1.
7 Respondent argues in its Exceptions that Dr.
Akers’s testimony regarding the standard of care for
documenting red flags was not contradictory, and
that the ALJ erred in finding that Dr. Akers had only
‘‘limited reliability’’ as an expert. Exceptions, at 7.
As discussed in more detail herein, the Agency
agrees with the ALJ’s assessment of Dr. Akers’s
testimony regarding documentation, and with the
ALJ’s credibility assessment. RD, at 9.
8 The ALJ also found that Dr. Akers’s testimony
was diminished relative to Dr. Graham’s because
‘‘Dr. Akers did not actually articulate many portions
of the standard of care until she was testifying about
a specific patient.’’ RD, at 9 (citing, e.g., Tr. 325–
26). Respondent takes exception to this finding,
arguing that it is not necessarily helpful or relevant
for an expert to opine on the standard of care in
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Ms. Neumann, Respondent’s owner
and PIC, has been licensed as a
pharmacist in Louisiana since 1995. Ms.
Neumann worked for several
independent pharmacies until she
bought Respondent in 2014. Id. at 9–10;
Tr. 398–400. The Agency agrees with
the ALJ that Ms. Neumann had
diminished credibility because she was
generally guarded and not forthcoming,
and her testimony regarding the
standard of care was internally
inconsistent and confusing. RD, at 13.
For example, Ms. Neumann offered
contradictory testimony about whether
the standard of care requires
pharmacists to document the resolution
of red flags. RD, at 14; compare Tr. 457
(agreeing that the standard of care
requires documenting conversations
with prescribers and resolution of red
flags), with Tr. 458 (testifying that there
was no obligation to document red flags
until 2023). Additionally, Ms.
Neumann’s testimony primarily
consisted of providing post hoc
justifications for Respondent’s
dispensing decisions, which are not
documented in any of Respondent’s
records. The Agency does not credit
these justifications. See infra Section I,
Resolving and Documenting Red Flags.
Accordingly, the Agency agrees with the
ALJ that Ms. Neumann’s testimony is
entitled to little weight. RD, at 14.
The Corresponding Responsibility
Dr. Graham testified that the
Louisiana standard of care requires
knowledge of, and compliance with, all
applicable Federal and State laws. Id.;
Tr. 105 (Graham). As relevant here, the
Louisiana standard of care is informed
by several provisions of the Louisiana
Administrative Code. Dr. Graham and
Dr. Akers testified that while a
prescribing practitioner has the primary
responsibility for the proper prescribing
of controlled substances, the pharmacist
who dispenses the prescription has a
the abstract, because ‘‘[w]hat is required in a given
situation depends on what is known to the
pharmacist and the unique circumstances peculiar
to a patient.’’ Exceptions, at 19–20. While the
Agency agrees that it is important for an expert
witness to testify about the specific circumstances
surrounding each patient, it is also important for an
expert witness to summarize certain fundamental
principles of the standard of care to help the
Agency assess whether the expert’s opinions are
consistent with State and Federal law and to help
the Agency adjudicate any disagreements among
experts regarding the standard of care. As discussed
in the RD and throughout this Decision, Dr. Akers’s
testimony on the standard of care was often vague
and amorphous, which allowed her to draw
opportunistic conclusions about each patient based
on curated information from patient files. Thus, the
Agency agrees with the ALJ’s assessment of Dr.
Akers’s credibility and reliability and with the
amount of weight that she afforded Dr. Akers’s
testimony. RD, at 8–9.
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‘‘corresponding responsibility’’ to
ensure that each prescription was issued
for a legitimate medical purpose in the
usual course of professional practice.
RD, at 14–15; Tr. 107–09 (Graham), 284
(Akers); La. Admin. Code tit. 46, part
LIII, sections 2745(B)(1), 2747(E)(2)
(2023).9
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Identifying Red Flags of Abuse or
Diversion
To determine whether a prescription
was issued for a legitimate medical
purpose in the usual course of
professional practice, a pharmacist must
examine each prescription for ‘‘red
flags’’ of abuse or diversion of
controlled substances. RD, at 15; Tr. 110
(Graham), 285 (Akers). A red flag is
‘‘any little alert that requires [a
pharmacist] to dig a little deeper and
clarify information prior to dispensing.’’
RD, at 15; Tr. 110 (Graham); see also Tr.
285 (Akers) (red flags are ‘‘things that
are deemed cautionary to where a
pharmacist should take pause and use
their clinical judgment to review that
patient’s file and make a determination
if it’s appropriate, if it meets that
legitimate purpose or if it does not’’).
The Louisiana Administrative Code
requires pharmacists to review ‘‘the
patient record and each prescription’’
for seven ‘‘potential situations,’’
including ‘‘drug over-utilization or
under-utilization; therapeutic
duplication; drug-disease
contradictions; drug-drug interactions;
inappropriate drug dosage or treatment
duration, drug-allergy interactions; or
clinical abuse/misuse.’’ 10 La. Admin.
Code tit. 46, part LIII, section 515(a)
(2024); RD, at 15; Tr. 109 (Graham). Dr.
Graham and Dr. Akers testified about
9 There were no substantive changes to the
relevant portions of the Louisiana Administrative
Code cited herein during the time period of the
allegations in this case.
10 Respondent argues that Dr. Graham’s
articulation of a red flag as ‘‘any little alert that
requires [a pharmacist] to dig a little deeper and
clarify information prior to dispensing’’ is
inherently vague and ‘‘contradicts with the clear
and express requirements of La. Admin. Code tit.
46, part LIII, section 515(a).’’ Exceptions, at 22.
While Dr. Graham’s articulation of a red flag is
certainly broader than the Louisiana statute in that
it requires pharmacists to investigate suspicious
circumstances beyond those enumerated,
Respondent has not offered any explanation for
why it believes that Dr. Graham’s articulation
‘‘contradicts’’ the statute. Both Dr. Graham and Dr.
Akers (who articulated a similarly broad definition
of red flags) testified that the concept of a red flag
derives from the pharmacist’s corresponding
responsibility under State and Federal law to
review each prescription to ensure that it was
issued for a legitimate medical purpose prior to
dispensing. Tr. 109–11 (Graham), 284 (Akers). The
experts’ testimony suggests that the corresponding
responsibility imposes more expansive prescription
review requirements on pharmacists than Louisiana
Administrative Code title 46, part LIII, section
515(a).
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additional red flags that pharmacists
must address and resolve before
dispensing a controlled substance.
Dr. Graham testified that drug
cocktails are combinations of controlled
substances that are known to be
diverted and may cause significant
patient harm. RD, at 15; Tr. 118–20
(Graham), 288 (Akers). For example,
opioids and benzodiazepines are both
respiratory depressants that can result
in a drug-drug interaction causing
significant sedation, respiratory
depression, coma, or death when taken
together. RD, at 15; Tr. 119–20
(Graham). Thus, Dr. Graham testified
that concurrent prescriptions for opioids
and benzodiazepines are a red flag in
Louisiana. Id. Therapeutic duplication
is when two or more drugs are
prescribed together that ‘‘essentially do
the same thing in the body.’’ RD, at 15;
Tr. 120 (Graham). Dr. Graham testified
that this is a red flag because it can
cause patient harm. RD, at 15; Tr. 119–
20 (Graham).
Dr. Graham further testified that
making a ‘‘cash payment’’ for a
controlled substance, rather than billing
insurance, is a red flag, because a
patient may pay in cash to evade the
insurance company’s attempts to
monitor for abuse and diversion. RD, at
15; Tr. 81, 121–22, 137–38, 145–46
(Graham). A ‘‘cash payment’’—also
known as ‘‘private pay’’—refers to any
type of payment that is made without
billing insurance, and can include
actual cash, or payments with a debit or
credit card. Id.
Resolving and Documenting Red Flags
of Abuse or Diversion
Two points on which Dr. Graham and
Dr. Akers disagreed were the methods of
resolving a red flag and the methods of
documenting that resolution. RD, at 16.
According to Dr. Graham, a pharmacist
can resolve a red flag by speaking to the
prescriber or the patient, depending on
the type of red flag, to obtain more
information about whether the
prescription was issued for a legitimate
medical purpose. Id.; Tr. 113. The
pharmacist must then document the
resolution of the red flag on the hard
copy prescription, in the pharmacy’s
computer system, or in a logbook. RD,
at 16; Tr. 112; see also La. Admin. Code
tit. 46, part LIII, section 1123(L) (2021)
(setting forth the recordkeeping
requirements for patient profiles,
including documenting ‘‘any other
comments that are relevant to that
patient or a specific drug’’).11 Dr.
11 Dr. Graham testified that if a pharmacist
identifies, resolves, and documents the resolution
of a red flag on an initial fill of a medication, that
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Graham testified that in the practice of
pharmacy, ‘‘we document, or it doesn’t
happen.’’ RD, at 16; Tr. 112, 118.
Consistent with Dr. Graham’s testimony,
Louisiana law requires pharmacists to
maintain a patient record system that
documents the resolution of red flags,
including a pharmacist’s comments
‘‘relevant to the individual patient’s
drug therapy, including any other
necessary information unique to the
specific patient or drug.’’ La. Admin
Code tit. 46, pt. LIII, section 1123(L).
According to Dr. Akers, a pharmacist
may resolve a red flag by examining
‘‘the totality of the patient’s file’’ with
the pharmacy, including the fill history,
the diagnosis code on the prescription,
and the type of provider who issued the
prescription. RD, at 16; see Tr. 290–99.
Essentially, the pharmacist can look to
see whether the patient’s file ‘‘tells a
clinically appropriate story’’ to
determine if a prescription was issued
for a legitimate medical purpose,
without contacting the doctor or
speaking to the patient. See, e.g., Tr.
290–92, 295–97, 306–13, 315, 325–26,
335, 359. Although Dr. Akers testified
that the standard of care in Louisiana
requires pharmacists to identify and
document the resolution of red flags, Tr.
361, she implied that the patient profile
itself could serve as the requisite
documentation of the resolution of a red
flag as long as the patient profile
contained facts that justify the
prescription. Id. at 361–62. Under Dr.
Akers’s view, a pharmacist’s
documentation can be adequate even if
the patient profile does not contain any
documentation indicating that the
pharmacist actually identified and
resolved the red flags, as long as the
patient’s file ‘‘tells a clinically
appropriate story.’’ Id.
On both points, the ALJ found, and
the Agency agrees, that Dr. Graham’s
testimony is more credible than Dr.
Akers’s. RD, at 16. Dr. Akers’s testimony
on resolving and documenting red flags
is inconsistent with the pharmacist’s
independent corresponding
responsibility, because it allows the
pharmacist to make assumptions about
the patient’s treatment based on the
prescriptions issued rather than
investigating the actual purpose of the
prescription by speaking to the
prescriber or patient. Id. at 17. It also
allows pharmacists to fabricate any
undocumented, post hoc explanation
that may seem plausible, which would
make it impossible for DEA or any other
resolution may carry forward to future refills. RD,
at 16; Tr. 113. The resolution of red flags on refills
may be documented by pulling the hard copy of the
prescription and signing and dating a note that the
pharmacist referenced the resolution. Tr. 114–15.
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regulatory body to determine whether
the pharmacist actually exercised its
corresponding responsibility before
filling the prescription.12 Id. As the
Eleventh Circuit stated, a respondent
pharmacy ‘‘fail[s] to comply with its
corresponding responsibility not to fill
prescriptions written for illegitimate
purposes’’ when it fails to ‘‘tak[e] and
document[ ] steps to resolve . . . red
flags or refusing to fill prescriptions
with unresolvable red flags.’’ Pharmacy
Doctors Enterprises Inc., d.b.a. Zion
Clinic Pharmacy, 789 F. App’x 724, 731
(11th Cir. 2020). The Eleventh Circuit
also categorically labeled ‘‘false’’
respondent’s suggestion that ‘‘DEA itself
has held that the lack of documentation
of resolution of a red flag is ‘not
evidence that a pharmacist failed to
resolve a red flag.’ ’’ Id.
Dr. Graham’s testimony was
consistent with the longstanding
principle that documentation is a
critical step in resolving red flags and
dispensing a lawful prescription. When
asked whether a failure to document the
resolution of a red flag invalidates any
efforts to resolve the red flag, Dr.
Graham replied, ‘‘Correct. Because if it’s
not documented, it wasn’t done.’’ Tr.
191. Thus, the Agency credits Dr.
Graham’s formulation of the standard of
care regarding the resolution of red
flags, and finds that if a pharmacist
identifies a red flag when presented
with a prescription, the Louisiana
standard of care requires the pharmacist
to: (1) speak to the prescriber or patient
to obtain more information about
whether the prescription was issued for
a legitimate medical purpose; and (2)
document the resolution of the red flag
on the hard copy prescription, in the
pharmacy’s computer system, or in a
logbook prior to dispensing. RD, at 16,
19; Tr. 112–13.
II. Findings of Fact
Respondent’s Improper Dispensing to
C.E.
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Respondent filled prescriptions for
C.E. in July 2021, October 2021, and
December 2021 for hydrocodoneacetaminophen (a Schedule II opioid)
and clonazepam (a Schedule IV
benzodiazepine).13 RD, at 19; ALJX 11,
12 DEA has made clear that ‘‘it is unwilling to
credit post hoc written or oral justifications for
actions taken as a registrant that were not
documented,’’ AARRIC, Inc. d/b/a at Cost RX, 87
FR 2905, 2916 (2022).
13 The prescriptions for hydrocodoneacetaminophen and clonazepam were filled on
different days, but always within the same week.
RD, at 19 n.20; GX 4, at 2. Dr. Graham testified that
the fact that the prescriptions were filled on
different days does not eliminate the requirement
to resolve the red flag because the patient would
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at 2–3, stips. 11–12, 18; GX 5, at 2; Tr.
127. Dr. Graham testified that this drug
cocktail raised a red flag due to the
drug-drug interaction. RD, at 19; Tr. 127.
Dr. Graham testified that the standard of
care required Respondent to resolve this
red flag, usually by speaking to the
prescriber, and to document the
resolution on the hard copy of the
prescription, in the pharmacy’s
computer system, or in a logbook. RD,
at 19; Tr. 131.
As for Respondent, Ms. Neumann
testified that she resolved the red flag
based on the diagnosis codes on the
prescriptions and having ongoing
conversations with C.E. regarding his
medical conditions.14 RD, at 19; Tr.
443–45. According to Ms. Neumann,
C.E. was receiving prescriptions for
hydrocodone for ‘‘injuries or shoulder
pain’’ from Dr. T.N., Ms. Neumann’s
father, while C.E. was between
specialists. RD, at 12; Tr. 443. Regarding
still be taking the medications at the same time. RD,
at 19 n.20; Tr. 128–29.
14 The Agency does not credit Dr. Akers’s
testimony about C.E. In order to resolve the red
flags associated with the drug cocktail prescribed to
C.E., Dr. Akers reviewed C.E.’s patient profile and
made several assumptions about his treatment,
including that the prescriptions came from a
surgical hospital and a neurosurgery clinic, and that
there was a ‘‘very realistic probability’’ that the
prescribing doctor (Dr. C.) was a neurosurgeon. RD,
at 17–18 n.17; Tr. 295–99, 306–13. Significantly,
however, Dr. Akers’s testimony ignored that the
majority of the controlled substances at issue, and
specifically those alleged in the OSC, were not
issued by Dr. C., a neurosurgeon, but by Dr. T.N.,
Ms. Neumann’s father. RD, at 17–18 n.17; GX 4 at
2, 9–10, 23–26, 48–51; GX 5, at 2; see also Tr. 443.
Moreover, Ms. Neumann did not testify that she
conducted the analysis outlined by Dr. Akers to
resolve the red flag. Thus, Dr. Akers’s testimony
highlights that her holistic approach of reviewing
the record and making assumptions about the
patient’s treatment allows a registrant to fabricate
post hoc justifications that do not necessarily align
with the facts.
Furthermore, even assuming, arguendo, that Dr.
Akers had been able to ‘‘tell[ ] a clinically
appropriate story’’ about C.E.’s prescriptions that
was not contradicted by the record or by Ms.
Neumann’s testimony, that would not negate
Respondent’s corresponding responsibility to
address, resolve, and document red flags prior to
dispensing. Dr. Akers acknowledged that she does
not know whether Respondent conducted a red flag
review, and she testified that a red flag review was
necessary in order for Respondent’s dispensing to
fall within the standard of care in Louisiana. Tr.
315, 364. The ALJ asked Dr. Akers whether
‘‘dispensing the prescriptions for C.E. [would] fall
within the Louisiana standard of care,’’ and Dr.
Akers replied, ‘‘Yes, it would. If the pharmacist did
their clinical review and made sure that the
medications were for a legitimate purpose and that
red flags were resolved.’’ Id. at 315. She later
testified that ‘‘[t]here’s nothing on the prescriptions
that were provided . . . that documents the review
. . . . [T]here’s nothing that would tell me a
pharmacist did or did not do a [drug utilization
review] . . . .’’ Id. at 364. Thus, the Agency does
not credit Dr. Akers’s testimony regarding C.E., and
rejects Respondent’s arguments in its Exceptions
that Respondent adequately addressed and resolved
the red flags for C.E. Exceptions 11–13.
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the clonazepam, Ms. Neumann testified,
‘‘I think that on the prescription for the
clonazepam, it indicates that he was
having some anxiety, which is natural
when you’re in pain.’’ Id. Ms. Neumann
testified that she ‘‘did not see that there
was a risk of overdose’’ because C.E.
only received a few prescriptions. Id.
Ms. Neumann also testified that C.E.
informed her that he had some type of
cervical issue. RD, at 12–13; Tr. 444.
However, Ms. Neumann did not
document any of these discussions, and
there was no documentation resolving
the red flag in C.E.’s patient profile or
on the hard copy prescriptions. RD, at
19; GX 4, at 1–2, 9–10, 23–26, 48–51; Tr.
130–31, 445. Thus, Dr. Graham opined,
and the Agency finds substantial
evidence that, Respondent’s failure to
resolve this red flag and document the
resolution rendered Respondent’s
dispensing to C.E. outside the usual
course of professional practice and
beneath the Louisiana standard of
care.15 RD, at 20; Tr. 132.
Respondent’s Improper Dispensing to
J.H.R.
Respondent filled monthly
prescriptions for J.H.R. between
September 2020 and January 2022 for
hydrocodone-acetaminophen and
alprazolam (a Schedule IV
benzodiazepine). RD, at 20; ALJX 11, at
2–3, stips. 11, 13, 19; GX 7, at 1; Tr.
133–36. Dr. Graham, Dr. Akers, and Ms.
Neumann testified that this drug
cocktail raised a red flag due to drugdrug interaction. RD, at 20; Tr. 133–34
(Graham), 383 (Akers), 420, 434, 454
(Neumann). Additionally, from March
2021 through September 2021, J.H.R.
made cash payments for her controlled
substance prescriptions, while billing
insurance for her non-controlled
substance prescriptions. RD, at 22–23;
GX 6, at 2–3; GX 7, at 1–2; Tr. 137–38
(Dr. Graham testifying that the method
of payment for non-controlled
substances was ‘‘Copay Generic,’’ which
indicates that insurance was billed,
while the method of payment for
controlled substances was ‘‘RX
Generic,’’ which indicates that
insurance was not billed). Dr. Graham
testified that J.H.R.’s cash payments
raised an additional red flag. RD, at 23–
15 At the hearing, Respondent’s counsel argued
that C.E.’s billing of insurance for these
prescriptions, the fact that the insurance company
did not reject the claims, and that there was no
evidence of early refills, ‘‘lends further support to
the legitimacy of the prescriptions.’’ RD, at 20 n.22;
Tr. 300–03. The Agency agrees with the ALJ that
these inferences are attenuated and that they do not
absolve Respondent from exercising its
corresponding responsibility to ensure the
legitimacy of the prescriptions prior to dispensing.
RD, at 20 n.22.
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24; Tr. 112, 121–22, 138–39. Dr. Graham
testified that the standard of care
required Respondent to resolve these
red flags and document their resolution
on the hard copy of the prescription, in
the pharmacy’s computer system, or in
a logbook. RD, at 20, 24; Tr. 112, 136.
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J.H.R.’s Cash Payments
Regarding the cash payments red flag,
Ms. Neumann testified that J.H.R. has
been a patient at Respondent since
2015. RD, at 11; Tr. 422–23, 426. Until
March 2021, J.H.R. used insurance to
pay for all medications, including
controlled substances and noncontrolled substances. See GX 6, at 2–
3 (listing the method of payment for all
drugs as ‘‘Copay Generic’’). Ms.
Neumann testified that, at some point
around March 2021, J.H.R.’s insurance
company rejected coverage for one of
her prescriptions. RD, at 11; Tr. 408–09.
Ms. Neumann recalled asking J.H.R.
whether she had a new insurance card,
but J.H.R. reported that she had lost her
job and no longer had insurance. Id. Ms.
Neumann testified that from that point
onward, J.H.R. paid for all of her
prescriptions out of pocket. RD, at 11;
Tr. 410. However, J.H.R.’s patient profile
shows that from March 2021 through
September 2021, the method of payment
for controlled substances was ‘‘RX
Generic,’’ while the method of paying
for non-controlled substances was
‘‘Copay Generic,’’ which suggests that
J.H.R. still had insurance but chose not
to bill insurance for her controlled
substances.16 GX 6, at 2–3.
Ms. Neumann testified that she did
not document her conversations with
J.H.R., and there was no documentation
resolving the cash payments red flag in
J.H.R.’s patient profile or on the hard
16 Respondent argues, based on Dr. Akers’s
testimony, that from March 2021 through
September 2021, the non-controlled substance
prescriptions were actually paid for using a
discount prescription card, rather than insurance.
Exceptions, at 14–16; ALJX 27, at 4; RD, at 23. Thus,
according to Respondent, J.H.R.’s cash payments
were not a red flag, because J.H.R. did not have
insurance. Id. However, Respondent did not
produce any evidence to corroborate Dr. Akers’s
testimony that a discount prescription card was
used, nor is there any documentation in J.H.R.’s
patient file indicating that J.H.R. lost her insurance
in March 2021. Notably, Ms. Neumann did not
testify that J.H.R. used a discount prescription card,
nor did she offer any explanation for why J.H.R.’s
non-controlled prescriptions continued to show up
as ‘‘Copay Generic’’ after she allegedly lost her
insurance in March of 2021. See Tr. 407–10
(testifying that J.H.R.’s insurance card was rejected
in March of 2021, and from that point onward,
J.H.R. ‘‘paid the total out-of-pocket cost [of the
prescriptions] herself.’’) Thus, the Agency credits
Dr. Graham’s testimony that the record indicates
that the non-controlled substance prescriptions
were paid for using insurance from March 2021
through September 2021, and that this is a red flag
that was not resolved. Id.; Tr. 137.
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copy prescriptions. RD, at 11; Tr. 412.
Thus, Dr. Graham opined, and the
Agency finds substantial evidence that,
Respondent’s failure to resolve this red
flag and document the resolution
rendered Respondent’s dispensing to
J.H.R outside the usual course of
professional practice and in violation of
the Louisiana standard of care. RD, at
22–24; Tr. 139–40.
J.H.R.’s Drug Cocktails
Regarding the drug cocktails, Ms.
Neumann acknowledged that the
combination of hydrocodoneacetaminophen and alprazolam raised a
red flag. RD, at 11; Tr. 420, 434. Ms.
Neumann testified that when J.H.R. first
became a patient in 2015, she contacted
the prescriber, Dr. T.N. (Ms. Neumann’s
father), and resolved this red flag. RD,
at 11; Tr. 420. She testified that she
documented the resolution of the red
flag on the back of prescriptions issued
on August 17, 2015, November 16, 2015,
and December 19, 2015, using the
notations ‘‘DD,’’ ‘‘M0,’’ and ‘‘1G.’’ RD, at
11; Tr. 420, 422; RX 6 at 2, 4, 6. Dr.
Akers testified that ‘‘DD’’ indicates a
drug duplication, ‘‘M0’’ indicates a
consultation with the prescriber, and
‘‘1G’’ indicates the prescription was
filled after consultation with the
prescriber. RD, at 11; Tr. 316–318.
The Agency rejects Respondent’s
arguments that her documentation in
2015 regarding the drug cocktails
resolved the red flag for prescriptions
issued between 2020 and 2022.17 There
17 Dr. Akers testified that the prescriptions issued
from 2020 through 2022 were a ‘‘continuation of
therapy’’ from the prescriptions in 2015, and that
Respondent’s notations on the 2015 prescriptions
were sufficient to resolve the red flags for the later
prescriptions. RD 20–21; Tr. 325–26; Exceptions, at
14–16. On the other hand, Dr. Graham testified that
a pharmacist may only carry over a red flag
resolution for a refill of a prescription, and refills
are not permitted for hydrocodone, a Schedule II
controlled substance. RD, at 21; Tr. 113–15; La.
Admin. Code tit. 46, part LIII, section 2745(F)(3)(a)
(‘‘The refilling of a prescription for a controlled
substance listed in Schedule II is prohibited.’’).
The ALJ found, and the Agency agrees, that Dr.
Graham’s testimony on this issue was more credible
than Dr. Akers’s. RD, at 21–22, 21 n.23. Neither Dr.
Akers nor Respondent produced convincing
evidence, supported by concurrent documentation,
to establish that the 2020 prescriptions were a
‘‘continuation of therapy’’ from 2015. RD, at 21–22
n.23. As the ALJ noted, there is a significant gap
between the 2015 prescriptions and the first
prescription charged in the OSC dated September
2020. Id. It is entirely possible that the prescriptions
did change between 2015 and 2020. Id.
Respondent’s failure to produce relevant documents
for that time period showing that the prescriptions
did not change gives rise to an inference that those
documents do not exist. Huthnance v. DC, 722 F.3d
371, 378 (D.C. Cir. 2013) (‘‘Respondent’s decision
not to provide records gives rise to an inference that
any such evidence is unfavorable to Respondent.’’)),
Int’l Union, United Auto., Aerospace & Agric.
Implement Workers of Am. (UAW) v. Nat’l Labor
Relations Bd., 459 F.2d 1329, 1336 (D.C. Cir. 1972);
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was no documentation resolving the red
flag for the prescriptions issued from
2020 through 2022 in J.H.R.’s patient
profile or on the hard copy
prescriptions. RD, at 21; GX 6, at 1–3,
24–27, 42–45; Tr. 136. Thus, Dr. Graham
opined, and the Agency finds
substantial evidence that, Respondent’s
failure to resolve this red flag and
document the resolution rendered
Respondent’s dispensing to J.H.R
outside the usual course of professional
practice and in violation of the
Louisiana standard of care. RD, at 20–
22; Tr. 139.
Respondent’s Improper Dispensing to
S.W.
On six occasions between May 2020
and December 2021, Respondent
dispensed diazepam (a Schedule IV
benzodiazepine) along with three forms
of butalbital (a Schedule III sedative) 18
to S.W. on the same day. RD, at 24;
ALJX 11 at 3–4, stips. 9, 10, 14, 20; GX
9; Tr. 140–42. One of the butalbital
products contained codeine (a Schedule
III controlled opioid). ALJX 11 at 3–4,
stips. 9–10. Combining diazepam with
codeine and butalbital can increase the
risk of respiratory depression, coma,
and death, and both Dr. Graham and Dr.
Akers testified that this drug cocktail
raised a red flag due to the drug-drug
interaction. RD, at 24; Tr. 141 (Graham),
335 (Akers). Dr. Graham testified that
these prescriptions also raised the red
flag of therapeutic duplication. RD, at
25; ALJX 11, at 4, stip. 20; GX 9; Tr.
143–44. Dr. Graham testified that
‘‘there[ is] no rationale to use three
different [butalbital] products like this
together.’’ Tr. 143.19 Dr. Graham
see also RD, at 21–22 n.23. Id. Thus, without
documentation confirming that the prescriptions
were a ‘‘continuation of therapy,’’ Respondent
cannot substantiate its argument. RD, at 21–22 n.23
(citing Coconut Grove Pharmacy, 89 FR 50372,
50374 (2024)). Moreover, Dr. Akers acknowledged
that she asked Respondent’s counsel for J.H.R.’s
records for the intervening years, but did not
receive them. RD, at 21–22 n.23; Tr. 381–82. Dr.
Akers conceded that the missing documents
undermined the weight of her opinion. RD, at 21–
22 n.23; Tr. 382, 385.
18 The three butalbital prescriptions included the
following combinations: butalbital-aspirin-caffeine,
butalbital-acetaminophen-caffeine, and butalbitalaspirin-caffeine with codeine. GX 9.
19 S.W. paid for all of her controlled substance
and non-controlled substance prescriptions using
cash, which Dr. Graham testified raised another red
flag of abuse or diversion. RD, at 24; Tr. 145; GX
8 at 1–2; GX 9. Respondent argues, based on Dr.
Akers’s testimony, that cash payments are only a
red flag if a patient has insurance, but chooses to
pay for controlled substances with cash. RD, at 22
n.25; ALJX 27 at 14; Exceptions, at 5–7. The ALJ
found, based on Dr. Graham’s testimony, that cash
payments are a red flag even if the patient does not
have insurance, and concluded that Respondent
failed to address and resolve the cash payments red
flag for S.W. RD, at 22 n.25, 33; Tr. 121–22, 145.
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testified that the standard of care
required Respondent to resolve these
red flags and document their resolution
on the hard copy of the prescription, in
the pharmacy’s computer system, or in
a logbook prior to dispensing. RD, at 24–
25; Tr. 142, 145.
S.W.’s Drug Cocktails
As for Respondent, Ms. Neumann
testified that she resolved the drug
cocktail red flag through conversations
with the prescriber, Dr. T.N. (Ms.
Neumann’s father), who told her that
diazepam was indicated for muscle
relaxation. RD, at 12; Tr. 436–37.
However, there was no documentation
of Ms. Neumann’s discussions with Dr.
T.N., nor was there any documentation
resolving the drug-drug interaction red
flag in S.W.’s patient profile or on the
hard copy prescriptions. RD, at 24–25;
Tr. 142, 414, 419; GX 8. Thus, Dr.
Graham opined, and the Agency finds
substantial evidence that, Respondent’s
failure to resolve this red flag and
document the resolution rendered
Respondent’s dispensing to S.W.
outside the usual course of professional
practice and in violation of the
Louisiana standard of care. RD, at 24–
26; Tr. 147.
S.W.’s Therapeutic Duplication
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Ms. Neumann testified that Dr. T.N.
informed her that S.W. was taking each
medication for a specific type of
headache, and S.W. knew when to take
each medication. RD, at 12; Tr. 419. Ms.
Neumann testified that she spoke to
S.W., and S.W. reported that she was
alternating the butalbital products.20
RD, at 12; Tr. 465. Ms. Neumann
testified that S.W. is ‘‘highly intelligent
and very focused,’’ and she counseled
S.W. to avoid exceeding acetaminophen
dosage limits. Id. Ms. Neumann testified
that she would not have filled these
prescriptions if she had not spoken to
Dr. T.N. and S.W., and that these
conversations allowed her to resolve
this red flag. Tr. 419.
Based on the overwhelming nature of the evidence
establishing Respondent’s other misconduct in its
dispensing of controlled substances, the Agency
need not reach a factual finding with regard to the
cash payment red flag for S.W.
20 Dr. Akers testified that she deduced from
looking at S.W.’s records that S.W. was alternating
between the medications rather than taking them at
the same time because there was a three-to-fourmonth gap between the prescriptions. RD, at 17
n.17, 25 n.28; Tr. 335. This alleviated Dr. Akers’s
concerns about the therapeutic duplication red flag.
Tr. 335. However, Dr. Akers acknowledged that
there were no instructions on the prescriptions
telling the patient to alternate the medications, and
there was no documentation in the record
indicating that the patient was doing so. Id. at 369–
71.
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8043
in making the public interest
determination. 21 U.S.C. 823(g)(1)(A–
E).22 The five factors are considered in
the disjunctive. Gonzales v. Oregon, 546
U.S. 243, 292–93 (2006) (Scalia, J.,
dissenting) (‘‘It is well established that
these factors are to be considered in the
disjunctive,’’ citing In re Arora, 60 FR
4447, 4448 (1995)); 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. Penick Corp. v. Drug
Enf’t Admin., 491 F.3d 483, 490 (D.C.
Cir. 2007); Morall, 412 F.3d. at n.2;
David H. Gillis, M.D., 58 FR 37507,
Respondent’s Improper Dispensing to
37508 (1993).
L.N.
According to DEA regulations, ‘‘[a]t
On February 7, 2020 and March 6,
any hearing for the revocation . . . of a
2021, Respondent filled controlled
registration, the . . . [Government] shall
substance prescriptions for Ms.
have the burden of proving that the
Neumann that were issued by Dr. T.N.,
requirements for such revocation . . .
Ms. Neumann’s father.21 RD, at 26; ALJX pursuant to . . . 21 U.S.C. 824(a) . . .
11, at 3, stip. 16; GX 3; Tr. 347–48, 403.
are satisfied.’’ 21 CFR 1301.44(e); see
Louisiana law prohibits physicians from also Morall, 412 F.3d. at 174.
prescribing controlled substances to
In this matter, while all of the 21
certain relatives, including children,
U.S.C. 823(g)(1) factors have been
except in cases of emergency. RD, at 26; considered, the Agency finds that the
La. Admin. Code, tit. 46, part XLV,
Government’s evidence in support of its
section 7603(A)(11) (2024). Ms.
prima facie case is confined to factors B
Neumann acknowledged that these
and D. RD, at 26–28; see also id. at 28
prescriptions were not lawful and that
n.30 (finding that Factors A, C, and E do
the Louisiana Administrative Code
not weigh for or against revocation).
prohibits providers from issuing
Having reviewed the record and the
prescriptions to family members. RD, at RD, the Agency agrees with the ALJ,
26; Tr. 405, 347–48. Thus, the Agency
adopts the ALJ’s analysis, and finds
finds substantial evidence that
substantial record evidence that the
Respondent did not dispense these
Government satisfies its prima facie
prescriptions in accordance with the
burden of showing that Respondent’s
standard of care in Louisiana, and that
continued registration is ‘‘inconsistent
these prescriptions were not dispensed
with the public interest.’’ 21 U.S.C.
in the usual course of professional
824(a)(4); RD, at 26–34.
practice. RD, at 26.
B. Allegation That Respondent’s
II. Discussion
Registration Is Inconsistent With the
A. The Controlled Substances Act (CSA) Public Interest
However, there was no
documentation of Ms. Neumann’s
discussions with Dr. T.N. or S.W., nor
was there any documentation resolving
the therapeutic duplication red flag in
S.W.’s patient profile or on the hard
copy prescriptions. RD, at 24–25; Tr.
142, 414, 419; GX 8. Thus, Dr. Graham
opined, and the Agency finds
substantial evidence that, Respondent’s
failure to resolve this red flag and
document the resolution rendered
Respondent’s dispensing to S.W.
outside the usual course of professional
practice and in violation of the
Louisiana standard of care. RD, at 24–
26; Tr. 147.
Under Section 304 of the CSA, ‘‘[a]
registration . . . to . . . distribute[ ] or
dispense a controlled substance . . .
may be suspended or revoked by the
Attorney General upon a finding that
the registrant . . . has committed such
acts as would render his registration
under . . . [21 U.S.C. 823] inconsistent
with the public interest as determined
by such section.’’ 21 U.S.C. 824(a)(4). In
the case of a ‘‘practitioner,’’ which is
defined in 21 U.S.C. 802(21) to include
a ‘‘pharmacy,’’ Congress directed the
Attorney General to consider five factors
21 These prescriptions were for guaifenesincodeine, a Schedule V controlled substance
(February 7, 2020), butalbital-aspirin-caffeine with
codeine (March 6, 2021), and butalbital-aspirincaffeine (March 6, 2021). ALJX 11 at 3, stips. 8, 16,
17; GX 3; Tr. 347–48, 403.
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Fmt 4703
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Factors B and/or D—Respondent’s
Experience in Dispensing Controlled
Substances and Compliance With
Applicable Laws Related to Controlled
Substances
According to the CSA’s implementing
regulations, a lawful prescription for
22 The five factors of 21 U.S.C. 823(g)(1)(A–E) are:
(A) The recommendation of the appropriate State
licensing board or professional disciplinary
authority.
(B) The [registrant’s] experience in dispensing, or
conducting research with respect to controlled
substances.
(C) The [registrant’s] conviction record under
Federal or State laws relating to the manufacture,
distribution, or dispensing of controlled substances.
(D) Compliance with applicable State, Federal, or
local laws relating to controlled substances.
(E) Such other conduct which may threaten the
public health and safety.
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controlled substances 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); see
Gonzales v. Oregon, supra, 546 U.S. at
274, United States v. Hayes, 595 F.2d
258 (5th Cir. 1979), rehearing den., 598
F.2d 620 (5th Cir. 1979), cert. denied,
444 U.S. 866 (1979); see also La. Admin.
Code tit. 46, part LIII, sections
2745(B)(1), 2747(E)(2); GX 11, at 2;
supra section I. Additionally, Louisiana
law prohibits physicians from
prescribing controlled substances to
certain relatives, including children,
except in cases of emergency. RD, at 26;
La. Admin. Code, tit. 46, part XLV,
section 7603(A)(11).
The Agency agrees with the
Government expert’s opinion and the
ALJ’s analysis, and finds that there is
substantial record evidence that
Respondent’s dispensing fell below the
Louisiana standard of care, and thus
was outside the usual course of
professional practice. This is because, as
detailed above, the Agency finds that
there is substantial record evidence that
Respondent: (1) repeatedly dispensed
controlled substances to three patients
without properly addressing and
resolving clear red flags of abuse and
diversion, including dangerous drug
cocktails with drug-drug interactions,
therapeutic duplication, and cash
payments for controlled substances; (2)
failed to maintain appropriate records
that documented the resolution of these
red flags; and (3) filled several
prescriptions for Ms. Neumann that
were issued by Ms. Neumann’s father,
in violation of State law. See RD, at 19–
34.
In sum, the Agency finds substantial
record evidence that the Government
established a prima facie case that
Respondent violated Federal and State
law. Accordingly, the Agency finds that
the Government established a prima
facie case, that Respondent did not
successfully rebut that prima facie case,
and that there is substantial record
evidence supporting the revocation of
Respondent’s registration. 21 U.S.C.
824(a)(4).
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 numerous violations
pertaining to controlled substances, the
burden shifts to Respondent to show
why it can be entrusted with a
registration. Morall, 412 F.3d. at 174;
Jones Total Health Care Pharmacy, 881
F.3d 823, 830 (11th Cir. 2018); Garrett
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Howard Smith, M.D., 83 FR 18882
(2018). The issue of trust is necessarily
a fact-dependent determination based
on the circumstances presented by the
individual respondent. Jeffrey Stein,
M.D., 84 FR 46968, 46972 (2019); see
also Jones Total Health Care Pharmacy,
881 F.3d at 833. Moreover, as past
performance is the best predictor of
future performance, DEA
Administrators have required that a
registrant who has committed acts
inconsistent with the public interest
must accept responsibility for those acts
and demonstrate that it will not engage
in future misconduct. Jones Total
Health Care Pharmacy, 881 F.3d at 833.
A registrant’s acceptance of
responsibility must be unequivocal. Id.
at 830–31. In addition, a registrant’s
candor during the investigation and
hearing has been an important factor in
determining acceptance of
responsibility and the appropriate
sanction. Id. Further, DEA
Administrators have found that the
egregiousness and extent of the
misconduct are significant factors in
determining the appropriate sanction.
Id. at 834 and n.4. DEA Administrators
have also considered the need to deter
similar acts by the respondent and by
the community of registrants. Jeffrey
Stein, M.D., 84 FR 46972 and 46973.
A. Acceptance of Responsibility
Here, the ALJ found, and the Agency
agrees, that there is substantial record
evidence that Respondent failed to
unequivocally accept responsibility for
its repeated violations of Federal and
State law. RD, at 35–37. Ms. Neumann
explicitly denied responsibility for
failing to address and resolve red flags.
See, e.g., Tr. 410, 420 (testifying that she
resolved the red flags for J.H.R), 412–13,
418–19, 435–37 (testifying that she
resolved the red flags for SW), 443–45
(testifying that she resolved the red flags
for C.E.).23 Although Ms. Neumann
23 Respondent argues in its Exceptions that the
ALJ erred in finding that Ms. Neumann failed to
accept responsibility. Exceptions, at 22–23.
Respondent argues that the Government only
proved that Respondent failed to document the
resolution of red flags, but it did not prove that
Respondent failed to address and resolve red flags,
so Ms. Neumann is only required to accept
responsibility for her failure to document. Id. The
Agency rejects this argument. As discussed
throughout this Decision, documentation is a
critical component of addressing and resolving red
flags. Dr. Graham testified that in the practice of
pharmacy, ‘‘we document, or it doesn’t happen.’’
RD, at 16; Tr. 112, 118 (Graham). See also La.
Admin. Code tit. 46, part LIII, section 1123(L)
(2021) (setting forth the recordkeeping requirements
for patient profiles, including documenting ‘‘any
other comments that are relevant to that patient or
a specific drug’’). The Agency may infer from a
registrant’s failure to document that the registrant
failed to address and resolve red flags. See supra
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Frm 00039
Fmt 4703
Sfmt 4703
acknowledged that she failed to
document the resolution of red flags,
she denied that this failure rendered
Respondent’s dispensing beneath the
standard of care. Id. at 395–96. She
testified that until 2023, it was ‘‘best
practice’’ to document the resolution of
red flags, but it was not required by the
standard of care. RD, at 12, 36; Tr. 458.
However, she offered no support for
how she chose this arbitrary date, which
was conveniently outside the date of the
allegations in the OSC. As explained
above, Ms. Neumann’s testimony
conflicted with the testimony of
Respondent’s and the Government’s
expert, who both testified that
documentation was required as part of
the standard of care during the time
period at issue here. RD, at 36. As the
ALJ observed, if Ms. Neumann cannot
even acknowledge that Respondent’s
failure to document fell below the
standard of care, she cannot accept
responsibility for it. Id.24
Ms. Neumann also made statements
that minimized Respondent’s
misconduct. Id. The most glaring
example was Ms. Neumann’s
characterization of the prescriptions that
Respondent filled for Ms. Neumann that
were written by Ms. Neumann’s father,
in violation of Louisiana law. Id. Ms.
Neumann argues that Respondent’s
mistakes were ‘‘inadvertent,’’ and that
she believed ‘‘in good faith’’ that the
prescriptions were valid. Id.; ALJX 27,
at 17. However, the law prohibiting
physicians from prescribing controlled
substances to their family members had
been in effect for at least five years
when Respondent filled the
prescriptions at issue in this case, which
indicates that Respondent’s misconduct
Section I, Resolving and Documenting Red Flags.
The Agency makes that inference here, because
Respondent’s documentation in this case does not
reflect any attempt to identify, address, or resolve
red flags. Thus, in order to unequivocally accept
responsibility, Respondent must accept
responsibility for failing to address and resolve red
flags, as well as for failing to document the
resolution. Respondent did not unequivocally
accept responsibility for either failure.
24 See Pharmacy Doctors Enterprises Inc., d.b.a.
Zion Clinic Pharmacy, 789 F. App’x at 732–33
(‘‘ ‘Because the record supports the Acting
Administrator’s findings that [the respondent’s PIC]
. . . did not understand the scope of her
responsibilities under the CSA, we conclude that
the [Acting Administrator’s] determination that [the
respondent’s PIC] did not fully accept responsibility
for [the respondent’s] misconduct was rational and
supported by substantial evidence.’ ’’); Jones Total
Health Care Pharmacy, 881 F.3d at 833 (‘‘Because
the record supports the Acting Administrator’s
findings that [the respondent] did not acknowledge
the prior misconduct and still did not understand
the scope of her responsibilities under the CSA, we
conclude that the determination that [the
respondent] did not fully accept responsibility for
[respondent’s] misconduct was rational and
supported by substantial evidence.’’).
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was much more serious than
inadvertent, good faith violations.25 See
41 La. Reg. 2146 (Oct. 20, 2015).
Respondent’s attempts to minimize this
egregious misconduct undermine any
purported acceptance of responsibility.
Michael A. White v. Drug Enf’t Admin.,
626 F. App’x 493, 496–97 (5th Cir.
2015); RD, at 36 (citing Medical
Pharmacy, 86 FFR 72030, 72054 (2021)
(‘‘[T]he agency has long considered
statements that are aimed at minimizing
the egregiousness of its conduct to
weigh against a finding of acceptance of
full responsibility.’’); Ronald Lynch,
M.D., 75 FR 78745, 78754 (2010).
Respondent’s counsel also attempted
to shift blame for Respondent’s
violations to DEA, which further
detracts from Respondent’s acceptance
of responsibility. RD, at 37 (citing Ester
Mark, M.D., 86 FR 16760, 16762 (2021)
(finding that the respondent did not
accept responsibility because she
‘‘pass[ed] blame on DEA for not telling
her how to comply with recordkeeping
requirements’’)). For example,
Respondent’s counsel blamed DEA for
not providing records from outside the
timeframe of the OSC—which were
likely in Respondent’s control—and
argued that these records would support
Respondent’s assertion that it fulfilled
its corresponding responsibility. RD, at
37; see Tr. 385. Further, in its Post
Hearing Brief, Respondent argues that
there is a ‘‘profound dearth of regulation
or guidance clarifying the nature, scope
and extent of a pharmacy’s
‘corresponding responsibility’ and what
it specifically requires.’’ ALJX 27, at 6.
On the contrary, DEA regularly
publishes detailed decisions sanctioning
pharmacies for violating their
corresponding responsibility, which
summarize DEA’s interpretation of the
25 Ms. Neumann testified that she regularly filled
her prescriptions from her father at another local
pharmacy, and that the pharmacy was ‘‘absolutely’’
aware of her relationship with her father. Tr. 405.
The ALJ interpreted this testimony as an attempt to
shift blame for Respondent’s misconduct on others,
and stated that ‘‘Ms. Neumann testified that she
believed the prescriptions issued to her by her
father were valid because another pharmacy had
been filling the prescription.’’ RD, at 37.
Respondent argues in its Exceptions that this
testimony was not meant to shift blame, but was
‘‘merely to show that [Ms. Neumann] was not acting
in bad faith.’’ Exceptions, at 23. The Agency
appreciates the distinction that Respondent is
drawing between shifting blame and justifying her
conduct, but the Agency agrees with the ALJ that
this testimony was troubling because it implies that
Ms. Neumann believes it is reasonable to be
unaware of the law if other pharmacists are also
unaware. In other words, it reflects an attempt to
minimize the egregious conduct of filling
prescriptions that were clearly unlawful in
Louisiana, and suggests that the Agency cannot
trust Respondent to exercise her independent
responsibility to ensure compliance with all State,
Federal, and local laws.
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relevant statutes, cite to relevant Federal
court decisions and prior Agency
decisions, and apply the legal principles
to the facts of the case. These decisions
provide ample notice to the registrant
community of DEA’s expectations.
Moreover, Respondent’s violations do
not involve the application of complex
or obscure statutes or regulations.
Rather, Respondent’s deficiencies
outlined in this Decision—such as
failure to resolve and document blatant
red flags of drug abuse—are core failures
that violate bedrock principles of the
CSA and the Louisiana standard of care.
Accordingly, the ALJ found, and the
Agency agrees, that Respondent has not
fully and unequivocally accepted
responsibility for its misconduct. RD, at
35–37.
B. Remedial Measures
When a registrant fails to make the
threshold showing of acceptance of
responsibility, the Agency need not
address the registrant’s remedial
measures. Ajay S. Ahuja, M.D., 84 FR
5479, 5498 n.33 (2019) (citing Jones
Total Health Care Pharmacy, 81 FR
79202 and 79203); Daniel A. Glick,
D.D.S., 80 FR 74800, 74801, 74810
(2015). Even so, the Agency agrees with
the ALJ that Respondent’s evidence of
remedial measures would not change
the result of this case, even if
Respondent had unequivocally accepted
responsibility. RD, at 38. The only
‘‘remedial measures’’ that Respondent
offered at the hearing were Ms.
Neumann’s testimony that she now
takes continuing education courses
regarding Federal and Louisiana law
and that she keeps current with
bulletins from Louisiana and the DEA.
Id.; Tr. 407. As Ms. Neumann herself
acknowledged, she should have already
known the Federal and Louisiana law
regarding controlled substance
prescribing. Tr. 405. Testifying that she
is now doing what she should have
done before these proceedings is
inadequate to demonstrate that
Respondent can now be entrusted with
a DEA registration. See Mireille Lalanne,
M.D., 78 FR 47750, 47777 (2013) (‘‘The
Agency has recognized that a cessation
of illegal behavior only when DEA
comes knocking at one’s door can be
afforded a diminished weight borne of
its own opportunistic timing.’’) (internal
quotation marks and citation omitted);
see also Noah David, P.A., 87 FR 21165,
21173 n.*G (2022) (‘‘I do not find
significant value to the important
question of whether [the respondent]
can be entrusted with a CSA registration
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8045
in remedial measures that meet
continuing education requirements.’’).26
C. Deterrence and Egregiousness
In addition to unequivocally
accepting responsibility, the Agency
considers both specific and general
deterrence when determining an
appropriate sanction. Daniel A. Glick,
80 FR 74810. In this case, the Agency
agrees with the ALJ that the interests of
specific deterrence militate in favor of
revocation given that Respondent’s
owner filled many of the prescriptions
at issue, yet failed to unequivocally
accept responsibility and minimized the
egregiousness of Respondent’s
violations. RD, at 40–41. Respondent
also failed to demonstrate that it has
undertaken sufficient remedial
measures to assure the Agency that a
sanction short of revocation would be
sufficient to prevent future misconduct.
Id. at 40. The interests of general
deterrence also support revocation, as a
lack of sanction in the current matter
would send a message to the registrant
community that the failure to properly
address and document resolution of red
flags can be excused. Id.
26 Respondent discusses additional remedial
measures in its Post Hearing Brief and Exceptions
that were not addressed at the hearing, and argues
that the ALJ erred in finding that its remedial
measures were insufficient. ALJX 27, at 20;
Exceptions, at 24–26. Respondent further asserts in
its Exceptions that ‘‘Respondent wished to discuss
remedial measures further at the hearing, but the
Government objected to such testimony.’’
Exceptions, at 24 (citing Tr. 395). The Agency
rejects the implication that Respondent was not
given the opportunity to present its evidence of
remedial measures at the hearing. Although the
Government did object to Ms. Neumann offering
testimony about remedial measures that was not
disclosed in its Prehearing Statement or
Supplemental Prehearing Statement, RD, at 38 n.26;
ALJX 10, 16, the ALJ clearly stated that she would
give Respondent the opportunity to present that
evidence: ‘‘As you know, I tend to let the
respondent make her case and I’ll weigh it
afterwards with that in mind.’’ Tr. 295. The ALJ
later reiterated that she had ‘‘given [Respondent’s
counsel] some latitude to have any summary about
acceptance of responsibility or remedial measures’’
that was not disclosed in the Prehearing Statements.
Id. at 416–17.
Even though the ALJ offered repeated assurances
that she would allow Respondent to present
undisclosed testimony about remedial measures,
Respondent’s counsel chose not to do so. Thus, the
ALJ correctly declined to consider evidence of
remedial measures that Respondent did not raise at
the hearing, and the Agency declines to consider
that evidence in this Decision. See RD, at 38 n.26.
As the ALJ noted, the evidence of remedial
measures that Respondent summarizes in its Post
Hearing Brief and Exceptions is unsworn and
filtered through Respondent’s counsel, and the
Government has not had an opportunity to
challenge this evidence. Id.; ALJX 27 at 20;
Exceptions, at 24–26. Thus, the Agency agrees with
the ALJ that Respondent’s remedial measures are
not sufficient to restore the Agency’s trust,
especially in light of Respondent’s failure to accept
responsibility.
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Moreover, the Agency agrees with the
ALJ that Respondent’s actions were
egregious. Pharmacy Doctors
Enterprises Inc., d.b.a. Zion Clinic
Pharmacy, 789 F. App’x at 732 (‘‘In
sum, given the plentiful instances of
[respondent] breaking federal and state
law in filling prescriptions with indicia
that the drugs would be used for nonmedical uses, substantial evidence
supports the Acting Administrator’s
findings that [respondent’s] conduct
was ‘‘egregious’’ and that its
‘‘experience in dispensing’’ and
‘‘compliance with applicable State[ ]
[and] Federal . . . laws relating to
controlled substances’’ counseled
against registration.’’); RD, at 39–40. As
the ALJ noted, Respondent repeatedly
dispensed dangerous combinations of
controlled substances to three patients
for several years without resolving
multiple red flags indicative of abuse
and diversion. RD, at 39. Dr. Graham
testified that the opioid and
benzodiazepine drug cocktail that
Respondent repeatedly dispensed is
frequently abused and diverted and can
result in significant sedation, respiratory
depression, coma, or death.27 Id. at 15;
Tr. 118–20 (Graham), 288. Adding to the
egregiousness, many of the prescriptions
that Respondent filled were issued by
Dr. T.N., Ms. Neumann’s father, and
several were issued in clear violation of
the Louisiana law prohibiting
prescribing controlled substances to
family members. The egregiousness of
Respondent’s conduct is also enhanced
by Ms. Neumann’s failure to accept
responsibility and her lack of
knowledge of the Louisiana standard of
care and applicable State and Federal
laws.
Respondent’s Exceptions 28
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Exceptions 1–2, 6
Dr. Graham testified that she was
suspended by the Oklahoma Board of
27 Respondent argues that there was no evidence
of actual diversion, harm to patients, or gross
negligence, and its misconduct was not intentional.
RD, at 39; ALJX 27, at 8, 21. However, it is not
necessary for the Agency to find harm to revoke a
registration. Melanie Baker, N.P., 86 FR 23998,
24009 (2021); Larry C. Daniels, M.D., 86 FR 61630,
61660 and 61661 (2021); Jeanne E. Germeil, M.D.,
85 FR 73786, 73799 n.32 (2020). Nor is it necessary
for the Agency to prove that a registrant committed
intentional violations of the CSA to revoke a
registration. The Agency has repeatedly held that
‘‘just because misconduct is unintentional,
innocent, or devoid of improper motive, [it] does
not preclude revocation or denial. Careless or
negligent handling of controlled substances creates
the opportunity for diversion and [can] justify the
revocation of an existing registration . . .’’ Paul J.
Caragine, Jr., 63 FR 51592, 51601 (1998).
28 Many of the arguments in Respondent’s
Exceptions were previously raised in Post Hearing
Briefs or at the hearing, and were adequately
addressed in the RD. To the extent that
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Pharmacy for two years related to
misconduct when she was an employee
at the Apothecary Shoppe from 2000 to
2002. Tr. 93–94. The ALJ found that this
testimony enhanced Dr. Graham’s
credibly and reliability because she
exhibited candor and took responsibility
for her misconduct. RD, at 7 n.9.
Respondent takes Exception to this
finding, as well as to the ALJ’s finding
that Dr. Graham was a ‘‘reliable and
persuasive witness.’’ Exceptions, at 1–3.
Respondent asserts that Dr. Graham’s
explanations of her misconduct were
‘‘vague,’’ that she ‘‘mischaracterized her
transgressions,’’ and that she
‘‘minimized the severity of her
wrongdoing.’’ Id. Respondent further
argues that the ALJ’s findings regarding
this testimony reflect a lack of
impartiality, because the ALJ did not
similarly find that Ms. Neumann’s
credibility was enhanced by her
testimony about her disciplinary
history. Id. at 7.
The Agency rejects Respondent’s
characterizations of the record and
adopts the ALJ’s credibility findings
with respect to Dr. Graham and Ms.
Neumann. Although the Agency agrees
that Dr. Graham’s initial statements
about her misconduct were vague, this
is not surprising because the
misconduct occurred over 20 years ago,
and the hearing was about Respondent’s
misconduct, not Dr. Graham’s. Dr.
Graham’s decision to disclose her
distant disciplinary history when
testifying about her professional history
reflects candor. Respondent’s counsel
cross examined Dr. Graham about the
specifics of the disciplinary charges,
and she readily answered his questions,
while acknowledging that she did not
recall all of the specifics. Tr. 151–52.
The Agency does not find that Dr.
Graham mischaracterized her
disciplinary history, because Dr.
Graham’s statements about her
misconduct were not meant to be an
exhaustive summary of the charges, and
there is insufficient evidence on the
record about the charges to assess the
accuracy of Dr. Graham’s
characterizations.
Moreover, the record does not support
Respondent’s contention that Dr.
Graham attempted to minimize the
severity of her misconduct. On the
contrary, Dr. Graham acknowledged that
her behavior was wrong, Tr. 153, that
her conduct was intentional and
knowing, Tr. 158, and that she failed to
exercise her corresponding
Respondent’s Exceptions have already been
adequately addressed in the RD, or throughout this
Decision, they are not discussed again in this
section.
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responsibility. Id. She testified that the
owner asked her to do things that ‘‘were
in the dark shades of [a] gray [area]’’ that
she knew were wrong, but she felt that
she could not stand up against the
owner for fear of being fired. RD, at 7
n.9; Tr. 93–94, 153. She testified that
this was ‘‘easily . . . the worst time in
[her] life,’’ but ‘‘she learned so much
[from] it,’’ and it helped her gain
confidence as a pharmacist and human
being. Tr. 95. Dr. Graham left her job at
the Apothecary Shoppe in 2002 and
started her own pharmacy so she could
‘‘do what [she] felt was the right thing
to do.’’ RD, at 7 n.9; Tr. 94. Thus, the
Agency rejects Respondent’s arguments,
finds that this testimony did not detract
from Dr. Graham’s credibility, and
adopts the ALJ’s finding that Dr.
Graham’s testimony was fully credible
and reliable. RD, at 7.
Finally, the Agency rejects
Respondent’s argument that the ALJ
exhibited a lack of impartiality when
assessing Dr. Graham’s and Ms.
Neumann’s testimony. As the ALJ
observed, Ms. Neumann’s credibility
was diminished by her inconsistent
statements about whether
documentation is required by the
standard of care. RD, at 13–14.
Additionally, much of Ms. Neumann’s
testimony consisted of providing
undocumented, post hoc explanations
for her conduct, which are entitled to
little weight. Moreover, the record
reflects that Ms. Neumann’s testimony
about her disciplinary history was not
as forthcoming as Dr. Graham’s, and
therefore detracted from her credibility.
Ms. Neumann testified on direct
examination that she had not had any
disciplinary issues with the licensing
board since 1997, but when prompted
by Government counsel on cross
examination, she acknowledged that
Respondent was sanctioned in 2023 for
missing narcotics. RD, at 10 n.12; Tr.
403, 461–63. In contrast, Dr. Graham has
had a clean record for 20 years, and she
affirmatively disclosed her past
transgressions on direct examination.
Tr. 93–94
Exceptions 3, 15
Respondent argues that Dr. Graham’s
opinions were conclusory and ‘‘without
any factual support whatsoever to assert
that certain prescriptions were not
issued for a legitimate medical
purpose.’’ ALJX 27, at 7; RD, at 7 n.10;
Exceptions, at 3–5 (‘‘Dr. Graham gave no
factual support for her entirely
conclusory answers to these
questions.’’). Respondent further asserts
that ‘‘the Government failed to offer any
evidence that [Ms. Neumann] knew or
should have known that any of the
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prescriptions at issue were not written
for a legitimate medical purpose.’’
Exceptions, at 24.
Importantly, the Government need not
prove that the prescriptions were not
issued for a legitimate medical purpose,
but rather that Respondent failed to
exercise its corresponding responsibility
to ensure that the prescriptions were
issued for a legitimate medical purpose.
Suntree Pharmacy and Suntree Medical
Equipment, LLC v. Drug Enf’t Admin,
2022 WL 444,357, *6 (11th Cir. Feb. 14,
2022) (‘‘[T]he Administration ‘has long
interpreted [21 CFR 1306.04(a)] as
prohibiting a pharmacist from filling a
prescription for a controlled substance
when he either ‘knows or has reason to
know that the prescription was not
written for a legitimate medical
purpose.’’ JM Pharmacy Grp., Inc., d/b/
a Farmacia Nueva & Best Pharma Corp.,
80 FR 28667, 28670 (May 19, 2015)
(citation omitted and emphasis added);
see also [United States v. ] Hayes, 595
F.2d at 261 n.6 (‘[A] pharmacist can
know that prescriptions are issued for
no legitimate medical purpose without
his needing to know anything about
medical science.’ ’’); RD, at 33–34. Dr.
Graham testified that an essential
element of the corresponding
responsibility is that a pharmacist must
identify any red flags present with a
prescription, resolve those red flags, and
document their resolution prior to
dispensing. RD, at 15–16; Tr. 110–13.
Dr. Graham testified about the specific
red flags that she identified for each
patient, and she testified that there was
no documentation in Respondent’s files
reflecting any attempt to address or
resolve those red flags. RD, at 7 n.10; Tr.
96–122. Dr. Graham thus concluded that
Respondent violated its corresponding
responsibility and acted beneath the
standard of pharmacy practice in
Louisiana when it dispensed controlled
substances to each patient. RD, at 7
n.10.; Tr. 132, 140, 146.29 The Agency
finds that Dr. Graham provided
sufficient factual support for these
conclusions.
Respondent also asserts that Dr.
Graham ‘‘did not address the detailed
reasoning provided by [Ms.] Neumann
regarding how she resolved the red flags
for the subject prescriptions, nor did she
address the data contained in the
patient profiles that supported [Ms.]
29 See also Holiday CVS, L.L.C., 77 FR 62341
(finding that the Government can prove that a
registrant violated its corresponding responsibility
by showing that: (1) the registrant dispensed a
controlled substance, (2) a red flag was or should
have been recognized at or before the time the
controlled substance was dispensed, and (3) the
question created by the red flag was not resolved
conclusively prior to the dispensing of the
controlled substance).
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Neumann’s decision to resolve the red
flags and dispense the prescriptions as
written.’’ Exceptions, at 5–6. Dr. Graham
did, in fact, address the data contained
within the patient profiles. She testified
that she reviewed the patient profiles
and prescriptions for each patient and
identified red flags for each patient for
which no resolution was documented.
Tr. 122. Respondent’s contention that
Dr. Graham should have addressed all of
Ms. Neumann’s undocumented, post
hoc justifications reflects a
misunderstanding of DEA’s prior
Agency decisions, which highlight the
importance of documentation. As
discussed throughout this decision, the
Agency has long found that it will not
credit a Respondent’s undocumented,
post hoc justifications for its prescribing
or dispensing. Pharmacy Doctors
Enterprises Inc., d.b.a. Zion Clinic
Pharmacy, 789 F. App’x at 731 (A
respondent pharmacy ‘‘fail[s] to comply
with its corresponding responsibility
not to fill prescriptions written for
illegitimate purposes’’ when it fails to
‘‘tak[e] and document[ ] steps to resolve
. . . red flags or refusing to fill
prescriptions with unresolvable red
flags.’’). This principle is critical to the
Agency’s ability to enforce against
violations of the CSA, because
enforcement would be impractical if the
viability of the Government’s case
hinged on the plausibility of a
Respondent’s undocumented, post hoc
justifications. Respondent’s failure to
document any resolution of the red flags
in this case rendered its dispensing
beneath the standard of care and outside
the usual course of professional
practice.
Exceptions 7–8
Respondent asserts that the ALJ erred
in inferring that Respondent failed to
resolve red flags from Respondent’s
failure to document their resolution,
because Ms. Neumann testified that she
did take steps to address and resolve
each red flag. Exceptions, at 7–11.
Respondent cites to Superior Pharmacy,
81 FR 31310, at 31335 n.55, as support
for the assertion that ‘‘a lack of
documentation is not, on its own,
sufficient evidence to prove that a red
flag was not resolved.’’ Exceptions, at 8.
However, Superior Pharmacy does
not support this assertion. In Superior
Pharmacy, the Agency found that the
Government had not met its burden of
demonstrating that Respondent had
failed to document the resolution of red
flags because the Government had only
offered prescriptions (and not patient
profiles) into evidence, and the
Government’s investigators had not
asked respondent’s pharmacists if there
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8047
were other places, aside from the
prescriptions, where they might have
documented the resolution of the red
flags. Superior Pharmacy, 81 FR 31335
n.55. Superior Pharmacy makes clear
that in a case where the Government has
provided sufficient evidence to establish
that the red flags were not documented
anywhere, ‘‘it would be reasonable to
draw an adverse inference that a
pharmacist failed to resolve a red flag
(or flags) from the failure to document
the resolution . . . .’’ 30 Id. at 31,335
(emphasis added); see also Hills
Pharmacy, LLC, 81 FR 49816, 49836
(2016) (citing Superior Pharmacy, and
finding that ‘‘the absence of
documentation on the prescriptions
[was] not conclusive proof’’ of a failure
to document the resolution of the red
flags because the respondent’s PIC
testified that his practice was to
document red flags on a due diligence
checklist, which was not admitted into
evidence). Here, the Government
admitted prescriptions and patient
profiles into evidence, and Respondent
has not asserted that there was any other
location where Respondent documented
the resolution of red flags.
Respondent also cites to several prior
Agency decisions, including the
Agency’s recent decision in Coconut
Grove, that purportedly show that the
Government may not meet its burden of
proof simply by demonstrating that a
pharmacy failed to document the
resolution of red flags. Exceptions, at 9–
11 (‘‘The only evidence the Government
has offered in this matter is the absence
of documentation. That alone is not
enough to satisfy the Government’s
burden of proof.’’). Respondent argues
that these cases all involved ‘‘additional
evidence which pointed to
wrongdoing,’’ beyond a failure to
document, which Respondent argues is
further support that the Government did
not meet its burden of proof. Id. at 9.
30 Respondent argues that it ‘‘excepts to any
negative inference drawn from any evidence which
it did not introduce,’’ because ‘‘the Government has
failed to meet its burden that the prescriptions were
not written for a legitimate medical purpose.’’
Exceptions, at 18–19. Respondent asserts that it is
‘‘under no obligation to introduce evidence to
strengthen its case’’ because of the Government’s
failure to meet its burden. Id. However, Respondent
does not cite to any particular findings in the RD
that it objects to, and instead refers generally back
to Exception 7. Id. This Exception lacks the level
of specificity required under 21 CFR 1316.66,
which provides that exceptions should be
supported by ‘‘specific and complete citations of
the pages of the transcript and exhibits.’’ Moreover,
the Agency found that the Government did meet its
prima facie burden of demonstrating that
Respondent’s registration was inconsistent with the
public interest, which shifted the burden to
Respondent to demonstrate that it could be
entrusted with a registration. Respondent did not
make that showing.
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The Agency rejects these arguments.
First, as discussed throughout this
Decision, the Agency may infer from
Respondent’s failure to document that
Respondent failed to address and
resolve red flags, and the Agency has
repeatedly held that it will not credit a
registrant’s undocumented, post hoc
justifications. Second, the Agency
regularly revokes registrations based on
documentation failures. For example, in
Coconut Grove, the Agency revoked a
pharmacy’s registration based on the
pharmacy’s failure to document
resolutions of red flags in ways and for
reasons that are very similar to this case.
The pharmacy’s expert in Coconut
Grove argued that the pharmacy’s PIC
had resolved the relevant red flags ‘‘over
time in continuing conversations with
the patients and the doctors,’’ but the
Agency rejected these arguments,
because the pharmacy’s only notation
on the prescription was ‘‘verified,’’
which was not sufficient to resolve the
red flag. 89 FR 50374. Based on the
pharmacy’s failure to document the
resolution of the red flags, the Agency
found that the pharmacy had failed to
address and resolve those red flags. Id.
The Agency further concluded that the
pharmacy’s dispensing was outside the
usual course of professional practice
and beneath the standard of care. Id.
The Agency drew similar conclusions in
Heavenly Care Pharmacy, 85 FR 53402
(2020), also cited by Respondent.
Respondent is correct in observing that
the prescriptions in Heavenly Care
raised more red flags than the
prescriptions in this case, and that there
was an additional ground for revocation
in that case. However, the Government
need not identify multiple grounds for
revocation, and the Agency has never
tallied a registrant’s legal violations and
required the Government to meet a
certain numerical threshold.
Here, the Government proved that
Respondent filled numerous
prescriptions without adequately
addressing and resolving several red
flags, which rendered Respondent’s
dispensing beneath the standard of care,
outside the usual course of professional
practice, and in violation of Federal and
State law. The Government also proved
that Respondent filled unlawful
prescriptions that were written for Ms.
Neumann by Ms. Neumann’s father.
These violations are sufficient to revoke
a registration.
In sum, Respondent has not offered
any credible evidence on the record that
rebuts the Government’s case for
revocation of its registration and
Respondent has not demonstrated that it
can be entrusted with the responsibility
of registration. Accordingly, the Agency
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will order that Respondent’s registration
be revoked.
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 No. FN4373293 issued to
Neumann’s Pharmacy, LLC. Further,
pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(g)(1), I hereby deny any pending
applications of Neumann’s Pharmacy,
LLC, to renew or modify this
registration, as well as any other
pending application of Neumann’s
Pharmacy, LLC, for additional
registration in Louisiana. This Order is
effective February 24, 2025.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on January 16, 2025, by Administrator
Anne Milgram. That document with the
original signature and date is
maintained by DEA. For administrative
purposes only, and in compliance with
requirements of the Office of the Federal
Register, the undersigned DEA Federal
Register Liaison Officer has been
authorized to sign and submit the
document in electronic format for
publication, as an official document of
DEA. This administrative process in no
way alters the legal effect of this
document upon publication in the
Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2025–01536 Filed 1–22–25; 8:45 am]
resolved in a Consent Decree, which
was approved by the Court in August
2006. Under the Consent Decree, the
MDC is required to, among other things,
eliminate all sanitary sewer overflow
(‘‘SSO’’) outfalls by a date certain and
submit and implement control projects
and schedules to reduce inflow and
infiltration (‘‘I/I’’), which can dilute
sanitary sewers and in turn, decrease
treatment efficiency. Since 2006, the
MDC has eliminated all but three of its
SSO outfalls and has proposed several
I/I reduction projects and schedules.
The proposed modification extends the
deadline for eliminating the remaining
SSO outfalls by about 4 years and
incorporates a schedule for
implementing I/I reduction projects.
The publication of this notice opens
a period for public comment on the
proposed First Material Modification to
the 2006 Consent Decree. Comments
should be addressed to the Assistant
Attorney General, Environment and
Natural Resources Division, and should
refer to United States et al. v.
Metropolitan District of Hartford,
Connecticut, D.J. Ref. No. 90–5–1–1–
08404. All comments must be submitted
no later than thirty (30) days after the
publication date of this notice.
Comments may be submitted either by
email or by mail:
To submit
comments:
Send them to:
By e-mail ......
pubcomment-ees.enrd@
usdoj.gov.
Assistant Attorney General,
U.S. DOJ—ENRD, P.O.
Box 7611, Washington,
D.C. 20044–7611.
By mail .........
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed First
Amended Consent Decree Under the
Clean Water Act
On January 16, 2025, the Department
of Justice lodged a proposed First
Material Modification to the 2006
Consent Decree with the United States
District Court for the District of
Connecticut in the lawsuit entitled
United States et al. v. Metropolitan
District of Hartford, Connecticut, Civil
Action No. 3:06–cv–00728.
In this action, the United States and
the State of Connecticut sought civil
penalties and injunctive relief for
violations of the Clean Water Act, 33
U.S.C. 1251 et seq., in connection with
the Metropolitan District of Hartford,
Connecticut’s (‘‘MDC’s’’) operation of its
municipal wastewater treatment facility
and sewer system. These claims were
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During the public comment period,
the Consent Decree may be examined
and downloaded at this Justice
Department website: https://
www.justice.gov/enrd/consent-decrees.
If you require assistance accessing the
proposed Consent Decree, you may
request assistance by email or by mail
to the addresses provided above for
submitting comments.
Eric D. Albert,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
[FR Doc. 2025–01559 Filed 1–22–25; 8:45 am]
BILLING CODE 4410–15–P
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Agencies
[Federal Register Volume 90, Number 14 (Thursday, January 23, 2025)]
[Notices]
[Pages 8039-8048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-01536]
[[Page 8039]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 24-1]
Neumann's Pharmacy, LLC; Decision and Order
On September 12, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Neumann's Pharmacy,
LLC, of Tallulah, Louisana (Respondent). OSC, at 1. The OSC proposed
the revocation of Respondent's DEA Certificate of Registration Number
FN4373293, alleging that Respondent's continued registration is
inconsistent with the public interest. Id. (citing 21 U.S.C. 824(a)(4),
823(g)(1)).
A hearing was held before DEA Administrative Law Judge Teresa A.
Wallbaum (the ALJ), who, on June 18, 2024, issued her Recommended
Rulings, Findings of Fact, Conclusions of Law, and Decision
(Recommended Decision or RD), recommending that Respondent's
registration be revoked. RD, at 41. Respondent filed exceptions to the
RD.\1\ Having reviewed the entire record, the Agency adopts and hereby
incorporates by reference the entirety of the ALJ's rulings,
credibility findings,\2\ findings of fact, conclusions of law,
sanctions analysis, and recommended sanction as found in the RD and
summarizes and clarifies portions thereof herein.
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\1\ The Agency has reviewed and considered Respondent's
exceptions and addresses them herein, but ultimately agrees with the
ALJ's recommendation.
\2\ The Agency adopts the ALJ's summary of each witness's
testimony, as well as the ALJ's assessment of each witness's
credibility. See RD, at 3-19.
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I. Louisiana Standard of Care
Dr. DiGi Graham testified as the Government's expert regarding the
standard of care for pharmacy practice in the State of Louisiana. Id.
at 5; Tr. 96-97. Dr. Graham has been licensed as a pharmacist in
Oklahoma \3\ for approximately thirty years and has extensive
experience dispensing medications in retail pharmacies. RD, at 6; Tr.
90-91. Dr. Graham has worked for several independent pharmacies,
including opening her own compounding and retail pharmacy in 2002, and
she currently works as a consultant. Id. The Agency agrees with the ALJ
that Dr. Graham was a reliable and persuasive witness who drew on her
own experience in retail pharmacy, clearly articulated the standard of
care in Louisiana,\4\ and ``clearly identified each source [that] she
consulted to form her opinion on the standard of care for pharmacies in
Louisiana.'' Id. at 7; Tr. 7. Thus, the Agency agrees with the ALJ that
Dr. Graham's testimony was fully credible and reliable. RD, at 7.
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\3\ Although Dr. Graham is not licensed as a pharmacist in
Louisiana, she familiarized herself with the standard of care for
dispensing controlled substances in Louisiana by reviewing
provisions of the Louisiana Administrative Code. RD, at 6; Tr. 96-
98. She testified that the law governing the practice of pharmacy in
Louisiana is substantially similar to the law governing the practice
of pharmacy in Oklahoma, the State in which she is licensed, and
that she has consulted on other cases in Louisiana. RD, at 6; Tr.
97, 99, 101-02.
\4\ For Dr. Graham's full qualifications, see RD, at 5-6; GX 10.
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Dr. Julie Akers, a Washington-licensed pharmacist,\5\ and Laura
Neumann, Respondent's owner and Pharmacist-in-Charge (PIC), testified
on Respondent's behalf. Dr. Akers has been working as a pharmacist for
approximately twenty-five years. Id. at 8; Tr. 275. Dr. Akers started
her career as a retail pharmacist, eventually progressing to a
management position where she oversaw compliance of thirty pharmacies,
before transitioning to academia in 2013.\6\ RD, at 8; Tr. 274-75. The
Agency agrees with the ALJ that Dr. Akers ``has limited reliability as
an expert'' because her testimony regarding the standard of care ``was,
at times, unclear and contradictory.'' RD, at 9. For example, as
discussed in more detail below, Dr. Akers offered contradictory
testimony about whether the standard of care requires pharmacists to
document the resolution of red flags.\7\ Id. Thus, the Agency agrees
with the ALJ that Dr. Akers's testimony is ``diminished relative to Dr.
Graham's,'' and credits Dr. Graham's testimony where the two experts
disagree.\8\ Id.
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\5\ Dr. Akers is not licensed as a pharmacist in Louisiana. RD,
at 8; Tr. 278-79. However, Dr. Akers reviewed the statutes and
regulations pertaining to pharmacy practice in Louisiana, including
the portions of the Louisiana Administrative Code cited by the
Government in this case, and performed her own individual research
on Louisiana pharmacy practice to determine where Louisiana law
overlapped with Federal law. RD, at 8; Tr. 278.
\6\ For Dr. Akers's full qualifications, see RD, at 8-9; RX 1.
\7\ Respondent argues in its Exceptions that Dr. Akers's
testimony regarding the standard of care for documenting red flags
was not contradictory, and that the ALJ erred in finding that Dr.
Akers had only ``limited reliability'' as an expert. Exceptions, at
7. As discussed in more detail herein, the Agency agrees with the
ALJ's assessment of Dr. Akers's testimony regarding documentation,
and with the ALJ's credibility assessment. RD, at 9.
\8\ The ALJ also found that Dr. Akers's testimony was diminished
relative to Dr. Graham's because ``Dr. Akers did not actually
articulate many portions of the standard of care until she was
testifying about a specific patient.'' RD, at 9 (citing, e.g., Tr.
325-26). Respondent takes exception to this finding, arguing that it
is not necessarily helpful or relevant for an expert to opine on the
standard of care in the abstract, because ``[w]hat is required in a
given situation depends on what is known to the pharmacist and the
unique circumstances peculiar to a patient.'' Exceptions, at 19-20.
While the Agency agrees that it is important for an expert witness
to testify about the specific circumstances surrounding each
patient, it is also important for an expert witness to summarize
certain fundamental principles of the standard of care to help the
Agency assess whether the expert's opinions are consistent with
State and Federal law and to help the Agency adjudicate any
disagreements among experts regarding the standard of care. As
discussed in the RD and throughout this Decision, Dr. Akers's
testimony on the standard of care was often vague and amorphous,
which allowed her to draw opportunistic conclusions about each
patient based on curated information from patient files. Thus, the
Agency agrees with the ALJ's assessment of Dr. Akers's credibility
and reliability and with the amount of weight that she afforded Dr.
Akers's testimony. RD, at 8-9.
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Ms. Neumann, Respondent's owner and PIC, has been licensed as a
pharmacist in Louisiana since 1995. Ms. Neumann worked for several
independent pharmacies until she bought Respondent in 2014. Id. at 9-
10; Tr. 398-400. The Agency agrees with the ALJ that Ms. Neumann had
diminished credibility because she was generally guarded and not
forthcoming, and her testimony regarding the standard of care was
internally inconsistent and confusing. RD, at 13. For example, Ms.
Neumann offered contradictory testimony about whether the standard of
care requires pharmacists to document the resolution of red flags. RD,
at 14; compare Tr. 457 (agreeing that the standard of care requires
documenting conversations with prescribers and resolution of red
flags), with Tr. 458 (testifying that there was no obligation to
document red flags until 2023). Additionally, Ms. Neumann's testimony
primarily consisted of providing post hoc justifications for
Respondent's dispensing decisions, which are not documented in any of
Respondent's records. The Agency does not credit these justifications.
See infra Section I, Resolving and Documenting Red Flags. Accordingly,
the Agency agrees with the ALJ that Ms. Neumann's testimony is entitled
to little weight. RD, at 14.
The Corresponding Responsibility
Dr. Graham testified that the Louisiana standard of care requires
knowledge of, and compliance with, all applicable Federal and State
laws. Id.; Tr. 105 (Graham). As relevant here, the Louisiana standard
of care is informed by several provisions of the Louisiana
Administrative Code. Dr. Graham and Dr. Akers testified that while a
prescribing practitioner has the primary responsibility for the proper
prescribing of controlled substances, the pharmacist who dispenses the
prescription has a
[[Page 8040]]
``corresponding responsibility'' to ensure that each prescription was
issued for a legitimate medical purpose in the usual course of
professional practice. RD, at 14-15; Tr. 107-09 (Graham), 284 (Akers);
La. Admin. Code tit. 46, part LIII, sections 2745(B)(1), 2747(E)(2)
(2023).\9\
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\9\ There were no substantive changes to the relevant portions
of the Louisiana Administrative Code cited herein during the time
period of the allegations in this case.
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Identifying Red Flags of Abuse or Diversion
To determine whether a prescription was issued for a legitimate
medical purpose in the usual course of professional practice, a
pharmacist must examine each prescription for ``red flags'' of abuse or
diversion of controlled substances. RD, at 15; Tr. 110 (Graham), 285
(Akers). A red flag is ``any little alert that requires [a pharmacist]
to dig a little deeper and clarify information prior to dispensing.''
RD, at 15; Tr. 110 (Graham); see also Tr. 285 (Akers) (red flags are
``things that are deemed cautionary to where a pharmacist should take
pause and use their clinical judgment to review that patient's file and
make a determination if it's appropriate, if it meets that legitimate
purpose or if it does not''). The Louisiana Administrative Code
requires pharmacists to review ``the patient record and each
prescription'' for seven ``potential situations,'' including ``drug
over-utilization or under-utilization; therapeutic duplication; drug-
disease contradictions; drug-drug interactions; inappropriate drug
dosage or treatment duration, drug-allergy interactions; or clinical
abuse/misuse.'' \10\ La. Admin. Code tit. 46, part LIII, section 515(a)
(2024); RD, at 15; Tr. 109 (Graham). Dr. Graham and Dr. Akers testified
about additional red flags that pharmacists must address and resolve
before dispensing a controlled substance.
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\10\ Respondent argues that Dr. Graham's articulation of a red
flag as ``any little alert that requires [a pharmacist] to dig a
little deeper and clarify information prior to dispensing'' is
inherently vague and ``contradicts with the clear and express
requirements of La. Admin. Code tit. 46, part LIII, section
515(a).'' Exceptions, at 22. While Dr. Graham's articulation of a
red flag is certainly broader than the Louisiana statute in that it
requires pharmacists to investigate suspicious circumstances beyond
those enumerated, Respondent has not offered any explanation for why
it believes that Dr. Graham's articulation ``contradicts'' the
statute. Both Dr. Graham and Dr. Akers (who articulated a similarly
broad definition of red flags) testified that the concept of a red
flag derives from the pharmacist's corresponding responsibility
under State and Federal law to review each prescription to ensure
that it was issued for a legitimate medical purpose prior to
dispensing. Tr. 109-11 (Graham), 284 (Akers). The experts' testimony
suggests that the corresponding responsibility imposes more
expansive prescription review requirements on pharmacists than
Louisiana Administrative Code title 46, part LIII, section 515(a).
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Dr. Graham testified that drug cocktails are combinations of
controlled substances that are known to be diverted and may cause
significant patient harm. RD, at 15; Tr. 118-20 (Graham), 288 (Akers).
For example, opioids and benzodiazepines are both respiratory
depressants that can result in a drug-drug interaction causing
significant sedation, respiratory depression, coma, or death when taken
together. RD, at 15; Tr. 119-20 (Graham). Thus, Dr. Graham testified
that concurrent prescriptions for opioids and benzodiazepines are a red
flag in Louisiana. Id. Therapeutic duplication is when two or more
drugs are prescribed together that ``essentially do the same thing in
the body.'' RD, at 15; Tr. 120 (Graham). Dr. Graham testified that this
is a red flag because it can cause patient harm. RD, at 15; Tr. 119-20
(Graham).
Dr. Graham further testified that making a ``cash payment'' for a
controlled substance, rather than billing insurance, is a red flag,
because a patient may pay in cash to evade the insurance company's
attempts to monitor for abuse and diversion. RD, at 15; Tr. 81, 121-22,
137-38, 145-46 (Graham). A ``cash payment''--also known as ``private
pay''--refers to any type of payment that is made without billing
insurance, and can include actual cash, or payments with a debit or
credit card. Id.
Resolving and Documenting Red Flags of Abuse or Diversion
Two points on which Dr. Graham and Dr. Akers disagreed were the
methods of resolving a red flag and the methods of documenting that
resolution. RD, at 16. According to Dr. Graham, a pharmacist can
resolve a red flag by speaking to the prescriber or the patient,
depending on the type of red flag, to obtain more information about
whether the prescription was issued for a legitimate medical purpose.
Id.; Tr. 113. The pharmacist must then document the resolution of the
red flag on the hard copy prescription, in the pharmacy's computer
system, or in a logbook. RD, at 16; Tr. 112; see also La. Admin. Code
tit. 46, part LIII, section 1123(L) (2021) (setting forth the
recordkeeping requirements for patient profiles, including documenting
``any other comments that are relevant to that patient or a specific
drug'').\11\ Dr. Graham testified that in the practice of pharmacy,
``we document, or it doesn't happen.'' RD, at 16; Tr. 112, 118.
Consistent with Dr. Graham's testimony, Louisiana law requires
pharmacists to maintain a patient record system that documents the
resolution of red flags, including a pharmacist's comments ``relevant
to the individual patient's drug therapy, including any other necessary
information unique to the specific patient or drug.'' La. Admin Code
tit. 46, pt. LIII, section 1123(L).
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\11\ Dr. Graham testified that if a pharmacist identifies,
resolves, and documents the resolution of a red flag on an initial
fill of a medication, that resolution may carry forward to future
refills. RD, at 16; Tr. 113. The resolution of red flags on refills
may be documented by pulling the hard copy of the prescription and
signing and dating a note that the pharmacist referenced the
resolution. Tr. 114-15.
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According to Dr. Akers, a pharmacist may resolve a red flag by
examining ``the totality of the patient's file'' with the pharmacy,
including the fill history, the diagnosis code on the prescription, and
the type of provider who issued the prescription. RD, at 16; see Tr.
290-99. Essentially, the pharmacist can look to see whether the
patient's file ``tells a clinically appropriate story'' to determine if
a prescription was issued for a legitimate medical purpose, without
contacting the doctor or speaking to the patient. See, e.g., Tr. 290-
92, 295-97, 306-13, 315, 325-26, 335, 359. Although Dr. Akers testified
that the standard of care in Louisiana requires pharmacists to identify
and document the resolution of red flags, Tr. 361, she implied that the
patient profile itself could serve as the requisite documentation of
the resolution of a red flag as long as the patient profile contained
facts that justify the prescription. Id. at 361-62. Under Dr. Akers's
view, a pharmacist's documentation can be adequate even if the patient
profile does not contain any documentation indicating that the
pharmacist actually identified and resolved the red flags, as long as
the patient's file ``tells a clinically appropriate story.'' Id.
On both points, the ALJ found, and the Agency agrees, that Dr.
Graham's testimony is more credible than Dr. Akers's. RD, at 16. Dr.
Akers's testimony on resolving and documenting red flags is
inconsistent with the pharmacist's independent corresponding
responsibility, because it allows the pharmacist to make assumptions
about the patient's treatment based on the prescriptions issued rather
than investigating the actual purpose of the prescription by speaking
to the prescriber or patient. Id. at 17. It also allows pharmacists to
fabricate any undocumented, post hoc explanation that may seem
plausible, which would make it impossible for DEA or any other
[[Page 8041]]
regulatory body to determine whether the pharmacist actually exercised
its corresponding responsibility before filling the prescription.\12\
Id. As the Eleventh Circuit stated, a respondent pharmacy ``fail[s] to
comply with its corresponding responsibility not to fill prescriptions
written for illegitimate purposes'' when it fails to ``tak[e] and
document[ ] steps to resolve . . . red flags or refusing to fill
prescriptions with unresolvable red flags.'' Pharmacy Doctors
Enterprises Inc., d.b.a. Zion Clinic Pharmacy, 789 F. App'x 724, 731
(11th Cir. 2020). The Eleventh Circuit also categorically labeled
``false'' respondent's suggestion that ``DEA itself has held that the
lack of documentation of resolution of a red flag is `not evidence that
a pharmacist failed to resolve a red flag.' '' Id.
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\12\ DEA has made clear that ``it is unwilling to credit post
hoc written or oral justifications for actions taken as a registrant
that were not documented,'' AARRIC, Inc. d/b/a at Cost RX, 87 FR
2905, 2916 (2022).
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Dr. Graham's testimony was consistent with the longstanding
principle that documentation is a critical step in resolving red flags
and dispensing a lawful prescription. When asked whether a failure to
document the resolution of a red flag invalidates any efforts to
resolve the red flag, Dr. Graham replied, ``Correct. Because if it's
not documented, it wasn't done.'' Tr. 191. Thus, the Agency credits Dr.
Graham's formulation of the standard of care regarding the resolution
of red flags, and finds that if a pharmacist identifies a red flag when
presented with a prescription, the Louisiana standard of care requires
the pharmacist to: (1) speak to the prescriber or patient to obtain
more information about whether the prescription was issued for a
legitimate medical purpose; and (2) document the resolution of the red
flag on the hard copy prescription, in the pharmacy's computer system,
or in a logbook prior to dispensing. RD, at 16, 19; Tr. 112-13.
II. Findings of Fact
Respondent's Improper Dispensing to C.E.
Respondent filled prescriptions for C.E. in July 2021, October
2021, and December 2021 for hydrocodone-acetaminophen (a Schedule II
opioid) and clonazepam (a Schedule IV benzodiazepine).\13\ RD, at 19;
ALJX 11, at 2-3, stips. 11-12, 18; GX 5, at 2; Tr. 127. Dr. Graham
testified that this drug cocktail raised a red flag due to the drug-
drug interaction. RD, at 19; Tr. 127. Dr. Graham testified that the
standard of care required Respondent to resolve this red flag, usually
by speaking to the prescriber, and to document the resolution on the
hard copy of the prescription, in the pharmacy's computer system, or in
a logbook. RD, at 19; Tr. 131.
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\13\ The prescriptions for hydrocodone-acetaminophen and
clonazepam were filled on different days, but always within the same
week. RD, at 19 n.20; GX 4, at 2. Dr. Graham testified that the fact
that the prescriptions were filled on different days does not
eliminate the requirement to resolve the red flag because the
patient would still be taking the medications at the same time. RD,
at 19 n.20; Tr. 128-29.
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As for Respondent, Ms. Neumann testified that she resolved the red
flag based on the diagnosis codes on the prescriptions and having
ongoing conversations with C.E. regarding his medical conditions.\14\
RD, at 19; Tr. 443-45. According to Ms. Neumann, C.E. was receiving
prescriptions for hydrocodone for ``injuries or shoulder pain'' from
Dr. T.N., Ms. Neumann's father, while C.E. was between specialists. RD,
at 12; Tr. 443. Regarding the clonazepam, Ms. Neumann testified, ``I
think that on the prescription for the clonazepam, it indicates that he
was having some anxiety, which is natural when you're in pain.'' Id.
Ms. Neumann testified that she ``did not see that there was a risk of
overdose'' because C.E. only received a few prescriptions. Id. Ms.
Neumann also testified that C.E. informed her that he had some type of
cervical issue. RD, at 12-13; Tr. 444.
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\14\ The Agency does not credit Dr. Akers's testimony about C.E.
In order to resolve the red flags associated with the drug cocktail
prescribed to C.E., Dr. Akers reviewed C.E.'s patient profile and
made several assumptions about his treatment, including that the
prescriptions came from a surgical hospital and a neurosurgery
clinic, and that there was a ``very realistic probability'' that the
prescribing doctor (Dr. C.) was a neurosurgeon. RD, at 17-18 n.17;
Tr. 295-99, 306-13. Significantly, however, Dr. Akers's testimony
ignored that the majority of the controlled substances at issue, and
specifically those alleged in the OSC, were not issued by Dr. C., a
neurosurgeon, but by Dr. T.N., Ms. Neumann's father. RD, at 17-18
n.17; GX 4 at 2, 9-10, 23-26, 48-51; GX 5, at 2; see also Tr. 443.
Moreover, Ms. Neumann did not testify that she conducted the
analysis outlined by Dr. Akers to resolve the red flag. Thus, Dr.
Akers's testimony highlights that her holistic approach of reviewing
the record and making assumptions about the patient's treatment
allows a registrant to fabricate post hoc justifications that do not
necessarily align with the facts.
Furthermore, even assuming, arguendo, that Dr. Akers had been
able to ``tell[ ] a clinically appropriate story'' about C.E.'s
prescriptions that was not contradicted by the record or by Ms.
Neumann's testimony, that would not negate Respondent's
corresponding responsibility to address, resolve, and document red
flags prior to dispensing. Dr. Akers acknowledged that she does not
know whether Respondent conducted a red flag review, and she
testified that a red flag review was necessary in order for
Respondent's dispensing to fall within the standard of care in
Louisiana. Tr. 315, 364. The ALJ asked Dr. Akers whether
``dispensing the prescriptions for C.E. [would] fall within the
Louisiana standard of care,'' and Dr. Akers replied, ``Yes, it
would. If the pharmacist did their clinical review and made sure
that the medications were for a legitimate purpose and that red
flags were resolved.'' Id. at 315. She later testified that
``[t]here's nothing on the prescriptions that were provided . . .
that documents the review . . . . [T]here's nothing that would tell
me a pharmacist did or did not do a [drug utilization review] . . .
.'' Id. at 364. Thus, the Agency does not credit Dr. Akers's
testimony regarding C.E., and rejects Respondent's arguments in its
Exceptions that Respondent adequately addressed and resolved the red
flags for C.E. Exceptions 11-13.
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However, Ms. Neumann did not document any of these discussions, and
there was no documentation resolving the red flag in C.E.'s patient
profile or on the hard copy prescriptions. RD, at 19; GX 4, at 1-2, 9-
10, 23-26, 48-51; Tr. 130-31, 445. Thus, Dr. Graham opined, and the
Agency finds substantial evidence that, Respondent's failure to resolve
this red flag and document the resolution rendered Respondent's
dispensing to C.E. outside the usual course of professional practice
and beneath the Louisiana standard of care.\15\ RD, at 20; Tr. 132.
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\15\ At the hearing, Respondent's counsel argued that C.E.'s
billing of insurance for these prescriptions, the fact that the
insurance company did not reject the claims, and that there was no
evidence of early refills, ``lends further support to the legitimacy
of the prescriptions.'' RD, at 20 n.22; Tr. 300-03. The Agency
agrees with the ALJ that these inferences are attenuated and that
they do not absolve Respondent from exercising its corresponding
responsibility to ensure the legitimacy of the prescriptions prior
to dispensing. RD, at 20 n.22.
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Respondent's Improper Dispensing to J.H.R.
Respondent filled monthly prescriptions for J.H.R. between
September 2020 and January 2022 for hydrocodone-acetaminophen and
alprazolam (a Schedule IV benzodiazepine). RD, at 20; ALJX 11, at 2-3,
stips. 11, 13, 19; GX 7, at 1; Tr. 133-36. Dr. Graham, Dr. Akers, and
Ms. Neumann testified that this drug cocktail raised a red flag due to
drug-drug interaction. RD, at 20; Tr. 133-34 (Graham), 383 (Akers),
420, 434, 454 (Neumann). Additionally, from March 2021 through
September 2021, J.H.R. made cash payments for her controlled substance
prescriptions, while billing insurance for her non-controlled substance
prescriptions. RD, at 22-23; GX 6, at 2-3; GX 7, at 1-2; Tr. 137-38
(Dr. Graham testifying that the method of payment for non-controlled
substances was ``Copay Generic,'' which indicates that insurance was
billed, while the method of payment for controlled substances was ``RX
Generic,'' which indicates that insurance was not billed). Dr. Graham
testified that J.H.R.'s cash payments raised an additional red flag.
RD, at 23-
[[Page 8042]]
24; Tr. 112, 121-22, 138-39. Dr. Graham testified that the standard of
care required Respondent to resolve these red flags and document their
resolution on the hard copy of the prescription, in the pharmacy's
computer system, or in a logbook. RD, at 20, 24; Tr. 112, 136.
J.H.R.'s Cash Payments
Regarding the cash payments red flag, Ms. Neumann testified that
J.H.R. has been a patient at Respondent since 2015. RD, at 11; Tr. 422-
23, 426. Until March 2021, J.H.R. used insurance to pay for all
medications, including controlled substances and non-controlled
substances. See GX 6, at 2-3 (listing the method of payment for all
drugs as ``Copay Generic''). Ms. Neumann testified that, at some point
around March 2021, J.H.R.'s insurance company rejected coverage for one
of her prescriptions. RD, at 11; Tr. 408-09. Ms. Neumann recalled
asking J.H.R. whether she had a new insurance card, but J.H.R. reported
that she had lost her job and no longer had insurance. Id. Ms. Neumann
testified that from that point onward, J.H.R. paid for all of her
prescriptions out of pocket. RD, at 11; Tr. 410. However, J.H.R.'s
patient profile shows that from March 2021 through September 2021, the
method of payment for controlled substances was ``RX Generic,'' while
the method of paying for non-controlled substances was ``Copay
Generic,'' which suggests that J.H.R. still had insurance but chose not
to bill insurance for her controlled substances.\16\ GX 6, at 2-3.
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\16\ Respondent argues, based on Dr. Akers's testimony, that
from March 2021 through September 2021, the non-controlled substance
prescriptions were actually paid for using a discount prescription
card, rather than insurance. Exceptions, at 14-16; ALJX 27, at 4;
RD, at 23. Thus, according to Respondent, J.H.R.'s cash payments
were not a red flag, because J.H.R. did not have insurance. Id.
However, Respondent did not produce any evidence to corroborate Dr.
Akers's testimony that a discount prescription card was used, nor is
there any documentation in J.H.R.'s patient file indicating that
J.H.R. lost her insurance in March 2021. Notably, Ms. Neumann did
not testify that J.H.R. used a discount prescription card, nor did
she offer any explanation for why J.H.R.'s non-controlled
prescriptions continued to show up as ``Copay Generic'' after she
allegedly lost her insurance in March of 2021. See Tr. 407-10
(testifying that J.H.R.'s insurance card was rejected in March of
2021, and from that point onward, J.H.R. ``paid the total out-of-
pocket cost [of the prescriptions] herself.'') Thus, the Agency
credits Dr. Graham's testimony that the record indicates that the
non-controlled substance prescriptions were paid for using insurance
from March 2021 through September 2021, and that this is a red flag
that was not resolved. Id.; Tr. 137.
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Ms. Neumann testified that she did not document her conversations
with J.H.R., and there was no documentation resolving the cash payments
red flag in J.H.R.'s patient profile or on the hard copy prescriptions.
RD, at 11; Tr. 412. Thus, Dr. Graham opined, and the Agency finds
substantial evidence that, Respondent's failure to resolve this red
flag and document the resolution rendered Respondent's dispensing to
J.H.R outside the usual course of professional practice and in
violation of the Louisiana standard of care. RD, at 22-24; Tr. 139-40.
J.H.R.'s Drug Cocktails
Regarding the drug cocktails, Ms. Neumann acknowledged that the
combination of hydrocodone-acetaminophen and alprazolam raised a red
flag. RD, at 11; Tr. 420, 434. Ms. Neumann testified that when J.H.R.
first became a patient in 2015, she contacted the prescriber, Dr. T.N.
(Ms. Neumann's father), and resolved this red flag. RD, at 11; Tr. 420.
She testified that she documented the resolution of the red flag on the
back of prescriptions issued on August 17, 2015, November 16, 2015, and
December 19, 2015, using the notations ``DD,'' ``M0,'' and ``1G.'' RD,
at 11; Tr. 420, 422; RX 6 at 2, 4, 6. Dr. Akers testified that ``DD''
indicates a drug duplication, ``M0'' indicates a consultation with the
prescriber, and ``1G'' indicates the prescription was filled after
consultation with the prescriber. RD, at 11; Tr. 316-318.
The Agency rejects Respondent's arguments that her documentation in
2015 regarding the drug cocktails resolved the red flag for
prescriptions issued between 2020 and 2022.\17\ There was no
documentation resolving the red flag for the prescriptions issued from
2020 through 2022 in J.H.R.'s patient profile or on the hard copy
prescriptions. RD, at 21; GX 6, at 1-3, 24-27, 42-45; Tr. 136. Thus,
Dr. Graham opined, and the Agency finds substantial evidence that,
Respondent's failure to resolve this red flag and document the
resolution rendered Respondent's dispensing to J.H.R outside the usual
course of professional practice and in violation of the Louisiana
standard of care. RD, at 20-22; Tr. 139.
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\17\ Dr. Akers testified that the prescriptions issued from 2020
through 2022 were a ``continuation of therapy'' from the
prescriptions in 2015, and that Respondent's notations on the 2015
prescriptions were sufficient to resolve the red flags for the later
prescriptions. RD 20-21; Tr. 325-26; Exceptions, at 14-16. On the
other hand, Dr. Graham testified that a pharmacist may only carry
over a red flag resolution for a refill of a prescription, and
refills are not permitted for hydrocodone, a Schedule II controlled
substance. RD, at 21; Tr. 113-15; La. Admin. Code tit. 46, part
LIII, section 2745(F)(3)(a) (``The refilling of a prescription for a
controlled substance listed in Schedule II is prohibited.'').
The ALJ found, and the Agency agrees, that Dr. Graham's
testimony on this issue was more credible than Dr. Akers's. RD, at
21-22, 21 n.23. Neither Dr. Akers nor Respondent produced convincing
evidence, supported by concurrent documentation, to establish that
the 2020 prescriptions were a ``continuation of therapy'' from 2015.
RD, at 21-22 n.23. As the ALJ noted, there is a significant gap
between the 2015 prescriptions and the first prescription charged in
the OSC dated September 2020. Id. It is entirely possible that the
prescriptions did change between 2015 and 2020. Id. Respondent's
failure to produce relevant documents for that time period showing
that the prescriptions did not change gives rise to an inference
that those documents do not exist. Huthnance v. DC, 722 F.3d 371,
378 (D.C. Cir. 2013) (``Respondent's decision not to provide records
gives rise to an inference that any such evidence is unfavorable to
Respondent.'')), Int'l Union, United Auto., Aerospace & Agric.
Implement Workers of Am. (UAW) v. Nat'l Labor Relations Bd., 459
F.2d 1329, 1336 (D.C. Cir. 1972); see also RD, at 21-22 n.23. Id.
Thus, without documentation confirming that the prescriptions were a
``continuation of therapy,'' Respondent cannot substantiate its
argument. RD, at 21-22 n.23 (citing Coconut Grove Pharmacy, 89 FR
50372, 50374 (2024)). Moreover, Dr. Akers acknowledged that she
asked Respondent's counsel for J.H.R.'s records for the intervening
years, but did not receive them. RD, at 21-22 n.23; Tr. 381-82. Dr.
Akers conceded that the missing documents undermined the weight of
her opinion. RD, at 21-22 n.23; Tr. 382, 385.
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Respondent's Improper Dispensing to S.W.
On six occasions between May 2020 and December 2021, Respondent
dispensed diazepam (a Schedule IV benzodiazepine) along with three
forms of butalbital (a Schedule III sedative) \18\ to S.W. on the same
day. RD, at 24; ALJX 11 at 3-4, stips. 9, 10, 14, 20; GX 9; Tr. 140-42.
One of the butalbital products contained codeine (a Schedule III
controlled opioid). ALJX 11 at 3-4, stips. 9-10. Combining diazepam
with codeine and butalbital can increase the risk of respiratory
depression, coma, and death, and both Dr. Graham and Dr. Akers
testified that this drug cocktail raised a red flag due to the drug-
drug interaction. RD, at 24; Tr. 141 (Graham), 335 (Akers). Dr. Graham
testified that these prescriptions also raised the red flag of
therapeutic duplication. RD, at 25; ALJX 11, at 4, stip. 20; GX 9; Tr.
143-44. Dr. Graham testified that ``there[ is] no rationale to use
three different [butalbital] products like this together.'' Tr.
143.\19\ Dr. Graham
[[Page 8043]]
testified that the standard of care required Respondent to resolve
these red flags and document their resolution on the hard copy of the
prescription, in the pharmacy's computer system, or in a logbook prior
to dispensing. RD, at 24-25; Tr. 142, 145.
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\18\ The three butalbital prescriptions included the following
combinations: butalbital-aspirin-caffeine, butalbital-acetaminophen-
caffeine, and butalbital-aspirin-caffeine with codeine. GX 9.
\19\ S.W. paid for all of her controlled substance and non-
controlled substance prescriptions using cash, which Dr. Graham
testified raised another red flag of abuse or diversion. RD, at 24;
Tr. 145; GX 8 at 1-2; GX 9. Respondent argues, based on Dr. Akers's
testimony, that cash payments are only a red flag if a patient has
insurance, but chooses to pay for controlled substances with cash.
RD, at 22 n.25; ALJX 27 at 14; Exceptions, at 5-7. The ALJ found,
based on Dr. Graham's testimony, that cash payments are a red flag
even if the patient does not have insurance, and concluded that
Respondent failed to address and resolve the cash payments red flag
for S.W. RD, at 22 n.25, 33; Tr. 121-22, 145. Based on the
overwhelming nature of the evidence establishing Respondent's other
misconduct in its dispensing of controlled substances, the Agency
need not reach a factual finding with regard to the cash payment red
flag for S.W.
---------------------------------------------------------------------------
S.W.'s Drug Cocktails
As for Respondent, Ms. Neumann testified that she resolved the drug
cocktail red flag through conversations with the prescriber, Dr. T.N.
(Ms. Neumann's father), who told her that diazepam was indicated for
muscle relaxation. RD, at 12; Tr. 436-37. However, there was no
documentation of Ms. Neumann's discussions with Dr. T.N., nor was there
any documentation resolving the drug-drug interaction red flag in
S.W.'s patient profile or on the hard copy prescriptions. RD, at 24-25;
Tr. 142, 414, 419; GX 8. Thus, Dr. Graham opined, and the Agency finds
substantial evidence that, Respondent's failure to resolve this red
flag and document the resolution rendered Respondent's dispensing to
S.W. outside the usual course of professional practice and in violation
of the Louisiana standard of care. RD, at 24-26; Tr. 147.
S.W.'s Therapeutic Duplication
Ms. Neumann testified that Dr. T.N. informed her that S.W. was
taking each medication for a specific type of headache, and S.W. knew
when to take each medication. RD, at 12; Tr. 419. Ms. Neumann testified
that she spoke to S.W., and S.W. reported that she was alternating the
butalbital products.\20\ RD, at 12; Tr. 465. Ms. Neumann testified that
S.W. is ``highly intelligent and very focused,'' and she counseled S.W.
to avoid exceeding acetaminophen dosage limits. Id. Ms. Neumann
testified that she would not have filled these prescriptions if she had
not spoken to Dr. T.N. and S.W., and that these conversations allowed
her to resolve this red flag. Tr. 419.
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\20\ Dr. Akers testified that she deduced from looking at S.W.'s
records that S.W. was alternating between the medications rather
than taking them at the same time because there was a three-to-four-
month gap between the prescriptions. RD, at 17 n.17, 25 n.28; Tr.
335. This alleviated Dr. Akers's concerns about the therapeutic
duplication red flag. Tr. 335. However, Dr. Akers acknowledged that
there were no instructions on the prescriptions telling the patient
to alternate the medications, and there was no documentation in the
record indicating that the patient was doing so. Id. at 369-71.
---------------------------------------------------------------------------
However, there was no documentation of Ms. Neumann's discussions
with Dr. T.N. or S.W., nor was there any documentation resolving the
therapeutic duplication red flag in S.W.'s patient profile or on the
hard copy prescriptions. RD, at 24-25; Tr. 142, 414, 419; GX 8. Thus,
Dr. Graham opined, and the Agency finds substantial evidence that,
Respondent's failure to resolve this red flag and document the
resolution rendered Respondent's dispensing to S.W. outside the usual
course of professional practice and in violation of the Louisiana
standard of care. RD, at 24-26; Tr. 147.
Respondent's Improper Dispensing to L.N.
On February 7, 2020 and March 6, 2021, Respondent filled controlled
substance prescriptions for Ms. Neumann that were issued by Dr. T.N.,
Ms. Neumann's father.\21\ RD, at 26; ALJX 11, at 3, stip. 16; GX 3; Tr.
347-48, 403. Louisiana law prohibits physicians from prescribing
controlled substances to certain relatives, including children, except
in cases of emergency. RD, at 26; La. Admin. Code, tit. 46, part XLV,
section 7603(A)(11) (2024). Ms. Neumann acknowledged that these
prescriptions were not lawful and that the Louisiana Administrative
Code prohibits providers from issuing prescriptions to family members.
RD, at 26; Tr. 405, 347-48. Thus, the Agency finds substantial evidence
that Respondent did not dispense these prescriptions in accordance with
the standard of care in Louisiana, and that these prescriptions were
not dispensed in the usual course of professional practice. RD, at 26.
---------------------------------------------------------------------------
\21\ These prescriptions were for guaifenesin-codeine, a
Schedule V controlled substance (February 7, 2020), butalbital-
aspirin-caffeine with codeine (March 6, 2021), and butalbital-
aspirin-caffeine (March 6, 2021). ALJX 11 at 3, stips. 8, 16, 17; GX
3; Tr. 347-48, 403.
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II. Discussion
A. The Controlled Substances Act (CSA)
Under Section 304 of the CSA, ``[a] registration . . . to . . .
distribute[ ] or dispense a controlled substance . . . may be suspended
or revoked by the Attorney General upon a finding that the registrant .
. . has committed such acts as would render his registration under . .
. [21 U.S.C. 823] inconsistent with the public interest as determined
by such section.'' 21 U.S.C. 824(a)(4). In the case of a
``practitioner,'' which is defined in 21 U.S.C. 802(21) to include a
``pharmacy,'' Congress directed the Attorney General to consider five
factors in making the public interest determination. 21 U.S.C.
823(g)(1)(A-E).\22\ The five factors are considered in the disjunctive.
Gonzales v. Oregon, 546 U.S. 243, 292-93 (2006) (Scalia, J.,
dissenting) (``It is well established that these factors are to be
considered in the disjunctive,'' citing In re Arora, 60 FR 4447, 4448
(1995)); 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. Penick Corp. v. Drug Enf't Admin., 491
F.3d 483, 490 (D.C. Cir. 2007); Morall, 412 F.3d. at n.2; David H.
Gillis, M.D., 58 FR 37507, 37508 (1993).
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\22\ The five factors of 21 U.S.C. 823(g)(1)(A-E) are:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
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According to DEA regulations, ``[a]t any hearing for the revocation
. . . of a registration, the . . . [Government] shall have the burden
of proving that the requirements for such revocation . . . pursuant to
. . . 21 U.S.C. 824(a) . . . are satisfied.'' 21 CFR 1301.44(e); see
also Morall, 412 F.3d. at 174.
In this matter, while all of the 21 U.S.C. 823(g)(1) factors have
been considered, the Agency finds that the Government's evidence in
support of its prima facie case is confined to factors B and D. RD, at
26-28; see also id. at 28 n.30 (finding that Factors A, C, and E do not
weigh for or against revocation).
Having reviewed the record and the RD, the Agency agrees with the
ALJ, adopts the ALJ's analysis, and finds substantial record evidence
that the Government satisfies its prima facie burden of showing that
Respondent's continued registration is ``inconsistent with the public
interest.'' 21 U.S.C. 824(a)(4); RD, at 26-34.
B. Allegation That Respondent's Registration Is Inconsistent With the
Public Interest
Factors B and/or D--Respondent's Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Related to Controlled
Substances
According to the CSA's implementing regulations, a lawful
prescription for
[[Page 8044]]
controlled substances 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); see Gonzales v. Oregon,
supra, 546 U.S. at 274, United States v. Hayes, 595 F.2d 258 (5th Cir.
1979), rehearing den., 598 F.2d 620 (5th Cir. 1979), cert. denied, 444
U.S. 866 (1979); see also La. Admin. Code tit. 46, part LIII, sections
2745(B)(1), 2747(E)(2); GX 11, at 2; supra section I. Additionally,
Louisiana law prohibits physicians from prescribing controlled
substances to certain relatives, including children, except in cases of
emergency. RD, at 26; La. Admin. Code, tit. 46, part XLV, section
7603(A)(11).
The Agency agrees with the Government expert's opinion and the
ALJ's analysis, and finds that there is substantial record evidence
that Respondent's dispensing fell below the Louisiana standard of care,
and thus was outside the usual course of professional practice. This is
because, as detailed above, the Agency finds that there is substantial
record evidence that Respondent: (1) repeatedly dispensed controlled
substances to three patients without properly addressing and resolving
clear red flags of abuse and diversion, including dangerous drug
cocktails with drug-drug interactions, therapeutic duplication, and
cash payments for controlled substances; (2) failed to maintain
appropriate records that documented the resolution of these red flags;
and (3) filled several prescriptions for Ms. Neumann that were issued
by Ms. Neumann's father, in violation of State law. See RD, at 19-34.
In sum, the Agency finds substantial record evidence that the
Government established a prima facie case that Respondent violated
Federal and State law. Accordingly, the Agency finds that the
Government established a prima facie case, that Respondent did not
successfully rebut that prima facie case, and that there is substantial
record evidence supporting the revocation of Respondent's registration.
21 U.S.C. 824(a)(4).
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 numerous violations pertaining to
controlled substances, the burden shifts to Respondent to show why it
can be entrusted with a registration. Morall, 412 F.3d. at 174; Jones
Total Health Care Pharmacy, 881 F.3d 823, 830 (11th Cir. 2018); Garrett
Howard Smith, M.D., 83 FR 18882 (2018). The issue of trust is
necessarily a fact-dependent determination based on the circumstances
presented by the individual respondent. Jeffrey Stein, M.D., 84 FR
46968, 46972 (2019); see also Jones Total Health Care Pharmacy, 881
F.3d at 833. Moreover, as past performance is the best predictor of
future performance, DEA Administrators have required that a registrant
who has committed acts inconsistent with the public interest must
accept responsibility for those acts and demonstrate that it will not
engage in future misconduct. Jones Total Health Care Pharmacy, 881 F.3d
at 833. A registrant's acceptance of responsibility must be
unequivocal. Id. at 830-31. In addition, a registrant's candor during
the investigation and hearing has been an important factor in
determining acceptance of responsibility and the appropriate sanction.
Id. Further, DEA Administrators have found that the egregiousness and
extent of the misconduct are significant factors in determining the
appropriate sanction. Id. at 834 and n.4. DEA Administrators have also
considered the need to deter similar acts by the respondent and by the
community of registrants. Jeffrey Stein, M.D., 84 FR 46972 and 46973.
A. Acceptance of Responsibility
Here, the ALJ found, and the Agency agrees, that there is
substantial record evidence that Respondent failed to unequivocally
accept responsibility for its repeated violations of Federal and State
law. RD, at 35-37. Ms. Neumann explicitly denied responsibility for
failing to address and resolve red flags. See, e.g., Tr. 410, 420
(testifying that she resolved the red flags for J.H.R), 412-13, 418-19,
435-37 (testifying that she resolved the red flags for SW), 443-45
(testifying that she resolved the red flags for C.E.).\23\ Although Ms.
Neumann acknowledged that she failed to document the resolution of red
flags, she denied that this failure rendered Respondent's dispensing
beneath the standard of care. Id. at 395-96. She testified that until
2023, it was ``best practice'' to document the resolution of red flags,
but it was not required by the standard of care. RD, at 12, 36; Tr.
458. However, she offered no support for how she chose this arbitrary
date, which was conveniently outside the date of the allegations in the
OSC. As explained above, Ms. Neumann's testimony conflicted with the
testimony of Respondent's and the Government's expert, who both
testified that documentation was required as part of the standard of
care during the time period at issue here. RD, at 36. As the ALJ
observed, if Ms. Neumann cannot even acknowledge that Respondent's
failure to document fell below the standard of care, she cannot accept
responsibility for it. Id.\24\
---------------------------------------------------------------------------
\23\ Respondent argues in its Exceptions that the ALJ erred in
finding that Ms. Neumann failed to accept responsibility.
Exceptions, at 22-23. Respondent argues that the Government only
proved that Respondent failed to document the resolution of red
flags, but it did not prove that Respondent failed to address and
resolve red flags, so Ms. Neumann is only required to accept
responsibility for her failure to document. Id. The Agency rejects
this argument. As discussed throughout this Decision, documentation
is a critical component of addressing and resolving red flags. Dr.
Graham testified that in the practice of pharmacy, ``we document, or
it doesn't happen.'' RD, at 16; Tr. 112, 118 (Graham). See also La.
Admin. Code tit. 46, part LIII, section 1123(L) (2021) (setting
forth the recordkeeping requirements for patient profiles, including
documenting ``any other comments that are relevant to that patient
or a specific drug''). The Agency may infer from a registrant's
failure to document that the registrant failed to address and
resolve red flags. See supra Section I, Resolving and Documenting
Red Flags. The Agency makes that inference here, because
Respondent's documentation in this case does not reflect any attempt
to identify, address, or resolve red flags. Thus, in order to
unequivocally accept responsibility, Respondent must accept
responsibility for failing to address and resolve red flags, as well
as for failing to document the resolution. Respondent did not
unequivocally accept responsibility for either failure.
\24\ See Pharmacy Doctors Enterprises Inc., d.b.a. Zion Clinic
Pharmacy, 789 F. App'x at 732-33 (`` `Because the record supports
the Acting Administrator's findings that [the respondent's PIC] . .
. did not understand the scope of her responsibilities under the
CSA, we conclude that the [Acting Administrator's] determination
that [the respondent's PIC] did not fully accept responsibility for
[the respondent's] misconduct was rational and supported by
substantial evidence.' ''); Jones Total Health Care Pharmacy, 881
F.3d at 833 (``Because the record supports the Acting
Administrator's findings that [the respondent] did not acknowledge
the prior misconduct and still did not understand the scope of her
responsibilities under the CSA, we conclude that the determination
that [the respondent] did not fully accept responsibility for
[respondent's] misconduct was rational and supported by substantial
evidence.'').
---------------------------------------------------------------------------
Ms. Neumann also made statements that minimized Respondent's
misconduct. Id. The most glaring example was Ms. Neumann's
characterization of the prescriptions that Respondent filled for Ms.
Neumann that were written by Ms. Neumann's father, in violation of
Louisiana law. Id. Ms. Neumann argues that Respondent's mistakes were
``inadvertent,'' and that she believed ``in good faith'' that the
prescriptions were valid. Id.; ALJX 27, at 17. However, the law
prohibiting physicians from prescribing controlled substances to their
family members had been in effect for at least five years when
Respondent filled the prescriptions at issue in this case, which
indicates that Respondent's misconduct
[[Page 8045]]
was much more serious than inadvertent, good faith violations.\25\ See
41 La. Reg. 2146 (Oct. 20, 2015). Respondent's attempts to minimize
this egregious misconduct undermine any purported acceptance of
responsibility. Michael A. White v. Drug Enf't Admin., 626 F. App'x
493, 496-97 (5th Cir. 2015); RD, at 36 (citing Medical Pharmacy, 86 FFR
72030, 72054 (2021) (``[T]he agency has long considered statements that
are aimed at minimizing the egregiousness of its conduct to weigh
against a finding of acceptance of full responsibility.''); Ronald
Lynch, M.D., 75 FR 78745, 78754 (2010).
---------------------------------------------------------------------------
\25\ Ms. Neumann testified that she regularly filled her
prescriptions from her father at another local pharmacy, and that
the pharmacy was ``absolutely'' aware of her relationship with her
father. Tr. 405. The ALJ interpreted this testimony as an attempt to
shift blame for Respondent's misconduct on others, and stated that
``Ms. Neumann testified that she believed the prescriptions issued
to her by her father were valid because another pharmacy had been
filling the prescription.'' RD, at 37. Respondent argues in its
Exceptions that this testimony was not meant to shift blame, but was
``merely to show that [Ms. Neumann] was not acting in bad faith.''
Exceptions, at 23. The Agency appreciates the distinction that
Respondent is drawing between shifting blame and justifying her
conduct, but the Agency agrees with the ALJ that this testimony was
troubling because it implies that Ms. Neumann believes it is
reasonable to be unaware of the law if other pharmacists are also
unaware. In other words, it reflects an attempt to minimize the
egregious conduct of filling prescriptions that were clearly
unlawful in Louisiana, and suggests that the Agency cannot trust
Respondent to exercise her independent responsibility to ensure
compliance with all State, Federal, and local laws.
---------------------------------------------------------------------------
Respondent's counsel also attempted to shift blame for Respondent's
violations to DEA, which further detracts from Respondent's acceptance
of responsibility. RD, at 37 (citing Ester Mark, M.D., 86 FR 16760,
16762 (2021) (finding that the respondent did not accept responsibility
because she ``pass[ed] blame on DEA for not telling her how to comply
with recordkeeping requirements'')). For example, Respondent's counsel
blamed DEA for not providing records from outside the timeframe of the
OSC--which were likely in Respondent's control--and argued that these
records would support Respondent's assertion that it fulfilled its
corresponding responsibility. RD, at 37; see Tr. 385. Further, in its
Post Hearing Brief, Respondent argues that there is a ``profound dearth
of regulation or guidance clarifying the nature, scope and extent of a
pharmacy's `corresponding responsibility' and what it specifically
requires.'' ALJX 27, at 6. On the contrary, DEA regularly publishes
detailed decisions sanctioning pharmacies for violating their
corresponding responsibility, which summarize DEA's interpretation of
the relevant statutes, cite to relevant Federal court decisions and
prior Agency decisions, and apply the legal principles to the facts of
the case. These decisions provide ample notice to the registrant
community of DEA's expectations. Moreover, Respondent's violations do
not involve the application of complex or obscure statutes or
regulations. Rather, Respondent's deficiencies outlined in this
Decision--such as failure to resolve and document blatant red flags of
drug abuse--are core failures that violate bedrock principles of the
CSA and the Louisiana standard of care. Accordingly, the ALJ found, and
the Agency agrees, that Respondent has not fully and unequivocally
accepted responsibility for its misconduct. RD, at 35-37.
B. Remedial Measures
When a registrant fails to make the threshold showing of acceptance
of responsibility, the Agency need not address the registrant's
remedial measures. Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019)
(citing Jones Total Health Care Pharmacy, 81 FR 79202 and 79203);
Daniel A. Glick, D.D.S., 80 FR 74800, 74801, 74810 (2015). Even so, the
Agency agrees with the ALJ that Respondent's evidence of remedial
measures would not change the result of this case, even if Respondent
had unequivocally accepted responsibility. RD, at 38. The only
``remedial measures'' that Respondent offered at the hearing were Ms.
Neumann's testimony that she now takes continuing education courses
regarding Federal and Louisiana law and that she keeps current with
bulletins from Louisiana and the DEA. Id.; Tr. 407. As Ms. Neumann
herself acknowledged, she should have already known the Federal and
Louisiana law regarding controlled substance prescribing. Tr. 405.
Testifying that she is now doing what she should have done before these
proceedings is inadequate to demonstrate that Respondent can now be
entrusted with a DEA registration. See Mireille Lalanne, M.D., 78 FR
47750, 47777 (2013) (``The Agency has recognized that a cessation of
illegal behavior only when DEA comes knocking at one's door can be
afforded a diminished weight borne of its own opportunistic timing.'')
(internal quotation marks and citation omitted); see also Noah David,
P.A., 87 FR 21165, 21173 n.*G (2022) (``I do not find significant value
to the important question of whether [the respondent] can be entrusted
with a CSA registration in remedial measures that meet continuing
education requirements.'').\26\
---------------------------------------------------------------------------
\26\ Respondent discusses additional remedial measures in its
Post Hearing Brief and Exceptions that were not addressed at the
hearing, and argues that the ALJ erred in finding that its remedial
measures were insufficient. ALJX 27, at 20; Exceptions, at 24-26.
Respondent further asserts in its Exceptions that ``Respondent
wished to discuss remedial measures further at the hearing, but the
Government objected to such testimony.'' Exceptions, at 24 (citing
Tr. 395). The Agency rejects the implication that Respondent was not
given the opportunity to present its evidence of remedial measures
at the hearing. Although the Government did object to Ms. Neumann
offering testimony about remedial measures that was not disclosed in
its Prehearing Statement or Supplemental Prehearing Statement, RD,
at 38 n.26; ALJX 10, 16, the ALJ clearly stated that she would give
Respondent the opportunity to present that evidence: ``As you know,
I tend to let the respondent make her case and I'll weigh it
afterwards with that in mind.'' Tr. 295. The ALJ later reiterated
that she had ``given [Respondent's counsel] some latitude to have
any summary about acceptance of responsibility or remedial
measures'' that was not disclosed in the Prehearing Statements. Id.
at 416-17.
Even though the ALJ offered repeated assurances that she would
allow Respondent to present undisclosed testimony about remedial
measures, Respondent's counsel chose not to do so. Thus, the ALJ
correctly declined to consider evidence of remedial measures that
Respondent did not raise at the hearing, and the Agency declines to
consider that evidence in this Decision. See RD, at 38 n.26. As the
ALJ noted, the evidence of remedial measures that Respondent
summarizes in its Post Hearing Brief and Exceptions is unsworn and
filtered through Respondent's counsel, and the Government has not
had an opportunity to challenge this evidence. Id.; ALJX 27 at 20;
Exceptions, at 24-26. Thus, the Agency agrees with the ALJ that
Respondent's remedial measures are not sufficient to restore the
Agency's trust, especially in light of Respondent's failure to
accept responsibility.
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C. Deterrence and Egregiousness
In addition to unequivocally accepting responsibility, the Agency
considers both specific and general deterrence when determining an
appropriate sanction. Daniel A. Glick, 80 FR 74810. In this case, the
Agency agrees with the ALJ that the interests of specific deterrence
militate in favor of revocation given that Respondent's owner filled
many of the prescriptions at issue, yet failed to unequivocally accept
responsibility and minimized the egregiousness of Respondent's
violations. RD, at 40-41. Respondent also failed to demonstrate that it
has undertaken sufficient remedial measures to assure the Agency that a
sanction short of revocation would be sufficient to prevent future
misconduct. Id. at 40. The interests of general deterrence also support
revocation, as a lack of sanction in the current matter would send a
message to the registrant community that the failure to properly
address and document resolution of red flags can be excused. Id.
[[Page 8046]]
Moreover, the Agency agrees with the ALJ that Respondent's actions
were egregious. Pharmacy Doctors Enterprises Inc., d.b.a. Zion Clinic
Pharmacy, 789 F. App'x at 732 (``In sum, given the plentiful instances
of [respondent] breaking federal and state law in filling prescriptions
with indicia that the drugs would be used for non-medical uses,
substantial evidence supports the Acting Administrator's findings that
[respondent's] conduct was ``egregious'' and that its ``experience in
dispensing'' and ``compliance with applicable State[ ] [and] Federal .
. . laws relating to controlled substances'' counseled against
registration.''); RD, at 39-40. As the ALJ noted, Respondent repeatedly
dispensed dangerous combinations of controlled substances to three
patients for several years without resolving multiple red flags
indicative of abuse and diversion. RD, at 39. Dr. Graham testified that
the opioid and benzodiazepine drug cocktail that Respondent repeatedly
dispensed is frequently abused and diverted and can result in
significant sedation, respiratory depression, coma, or death.\27\ Id.
at 15; Tr. 118-20 (Graham), 288. Adding to the egregiousness, many of
the prescriptions that Respondent filled were issued by Dr. T.N., Ms.
Neumann's father, and several were issued in clear violation of the
Louisiana law prohibiting prescribing controlled substances to family
members. The egregiousness of Respondent's conduct is also enhanced by
Ms. Neumann's failure to accept responsibility and her lack of
knowledge of the Louisiana standard of care and applicable State and
Federal laws.
---------------------------------------------------------------------------
\27\ Respondent argues that there was no evidence of actual
diversion, harm to patients, or gross negligence, and its misconduct
was not intentional. RD, at 39; ALJX 27, at 8, 21. However, it is
not necessary for the Agency to find harm to revoke a registration.
Melanie Baker, N.P., 86 FR 23998, 24009 (2021); Larry C. Daniels,
M.D., 86 FR 61630, 61660 and 61661 (2021); Jeanne E. Germeil, M.D.,
85 FR 73786, 73799 n.32 (2020). Nor is it necessary for the Agency
to prove that a registrant committed intentional violations of the
CSA to revoke a registration. The Agency has repeatedly held that
``just because misconduct is unintentional, innocent, or devoid of
improper motive, [it] does not preclude revocation or denial.
Careless or negligent handling of controlled substances creates the
opportunity for diversion and [can] justify the revocation of an
existing registration . . .'' Paul J. Caragine, Jr., 63 FR 51592,
51601 (1998).
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Respondent's Exceptions \28\
---------------------------------------------------------------------------
\28\ Many of the arguments in Respondent's Exceptions were
previously raised in Post Hearing Briefs or at the hearing, and were
adequately addressed in the RD. To the extent that Respondent's
Exceptions have already been adequately addressed in the RD, or
throughout this Decision, they are not discussed again in this
section.
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Exceptions 1-2, 6
Dr. Graham testified that she was suspended by the Oklahoma Board
of Pharmacy for two years related to misconduct when she was an
employee at the Apothecary Shoppe from 2000 to 2002. Tr. 93-94. The ALJ
found that this testimony enhanced Dr. Graham's credibly and
reliability because she exhibited candor and took responsibility for
her misconduct. RD, at 7 n.9. Respondent takes Exception to this
finding, as well as to the ALJ's finding that Dr. Graham was a
``reliable and persuasive witness.'' Exceptions, at 1-3. Respondent
asserts that Dr. Graham's explanations of her misconduct were
``vague,'' that she ``mischaracterized her transgressions,'' and that
she ``minimized the severity of her wrongdoing.'' Id. Respondent
further argues that the ALJ's findings regarding this testimony reflect
a lack of impartiality, because the ALJ did not similarly find that Ms.
Neumann's credibility was enhanced by her testimony about her
disciplinary history. Id. at 7.
The Agency rejects Respondent's characterizations of the record and
adopts the ALJ's credibility findings with respect to Dr. Graham and
Ms. Neumann. Although the Agency agrees that Dr. Graham's initial
statements about her misconduct were vague, this is not surprising
because the misconduct occurred over 20 years ago, and the hearing was
about Respondent's misconduct, not Dr. Graham's. Dr. Graham's decision
to disclose her distant disciplinary history when testifying about her
professional history reflects candor. Respondent's counsel cross
examined Dr. Graham about the specifics of the disciplinary charges,
and she readily answered his questions, while acknowledging that she
did not recall all of the specifics. Tr. 151-52. The Agency does not
find that Dr. Graham mischaracterized her disciplinary history, because
Dr. Graham's statements about her misconduct were not meant to be an
exhaustive summary of the charges, and there is insufficient evidence
on the record about the charges to assess the accuracy of Dr. Graham's
characterizations.
Moreover, the record does not support Respondent's contention that
Dr. Graham attempted to minimize the severity of her misconduct. On the
contrary, Dr. Graham acknowledged that her behavior was wrong, Tr. 153,
that her conduct was intentional and knowing, Tr. 158, and that she
failed to exercise her corresponding responsibility. Id. She testified
that the owner asked her to do things that ``were in the dark shades of
[a] gray [area]'' that she knew were wrong, but she felt that she could
not stand up against the owner for fear of being fired. RD, at 7 n.9;
Tr. 93-94, 153. She testified that this was ``easily . . . the worst
time in [her] life,'' but ``she learned so much [from] it,'' and it
helped her gain confidence as a pharmacist and human being. Tr. 95. Dr.
Graham left her job at the Apothecary Shoppe in 2002 and started her
own pharmacy so she could ``do what [she] felt was the right thing to
do.'' RD, at 7 n.9; Tr. 94. Thus, the Agency rejects Respondent's
arguments, finds that this testimony did not detract from Dr. Graham's
credibility, and adopts the ALJ's finding that Dr. Graham's testimony
was fully credible and reliable. RD, at 7.
Finally, the Agency rejects Respondent's argument that the ALJ
exhibited a lack of impartiality when assessing Dr. Graham's and Ms.
Neumann's testimony. As the ALJ observed, Ms. Neumann's credibility was
diminished by her inconsistent statements about whether documentation
is required by the standard of care. RD, at 13-14. Additionally, much
of Ms. Neumann's testimony consisted of providing undocumented, post
hoc explanations for her conduct, which are entitled to little weight.
Moreover, the record reflects that Ms. Neumann's testimony about her
disciplinary history was not as forthcoming as Dr. Graham's, and
therefore detracted from her credibility. Ms. Neumann testified on
direct examination that she had not had any disciplinary issues with
the licensing board since 1997, but when prompted by Government counsel
on cross examination, she acknowledged that Respondent was sanctioned
in 2023 for missing narcotics. RD, at 10 n.12; Tr. 403, 461-63. In
contrast, Dr. Graham has had a clean record for 20 years, and she
affirmatively disclosed her past transgressions on direct examination.
Tr. 93-94
Exceptions 3, 15
Respondent argues that Dr. Graham's opinions were conclusory and
``without any factual support whatsoever to assert that certain
prescriptions were not issued for a legitimate medical purpose.'' ALJX
27, at 7; RD, at 7 n.10; Exceptions, at 3-5 (``Dr. Graham gave no
factual support for her entirely conclusory answers to these
questions.''). Respondent further asserts that ``the Government failed
to offer any evidence that [Ms. Neumann] knew or should have known that
any of the
[[Page 8047]]
prescriptions at issue were not written for a legitimate medical
purpose.'' Exceptions, at 24.
Importantly, the Government need not prove that the prescriptions
were not issued for a legitimate medical purpose, but rather that
Respondent failed to exercise its corresponding responsibility to
ensure that the prescriptions were issued for a legitimate medical
purpose. Suntree Pharmacy and Suntree Medical Equipment, LLC v. Drug
Enf't Admin, 2022 WL 444,357, *6 (11th Cir. Feb. 14, 2022) (``[T]he
Administration `has long interpreted [21 CFR 1306.04(a)] as prohibiting
a pharmacist from filling a prescription for a controlled substance
when he either `knows or has reason to know that the prescription was
not written for a legitimate medical purpose.'' JM Pharmacy Grp., Inc.,
d/b/a Farmacia Nueva & Best Pharma Corp., 80 FR 28667, 28670 (May 19,
2015) (citation omitted and emphasis added); see also [United States v.
] Hayes, 595 F.2d at 261 n.6 (`[A] pharmacist can know that
prescriptions are issued for no legitimate medical purpose without his
needing to know anything about medical science.' ''); RD, at 33-34. Dr.
Graham testified that an essential element of the corresponding
responsibility is that a pharmacist must identify any red flags present
with a prescription, resolve those red flags, and document their
resolution prior to dispensing. RD, at 15-16; Tr. 110-13. Dr. Graham
testified about the specific red flags that she identified for each
patient, and she testified that there was no documentation in
Respondent's files reflecting any attempt to address or resolve those
red flags. RD, at 7 n.10; Tr. 96-122. Dr. Graham thus concluded that
Respondent violated its corresponding responsibility and acted beneath
the standard of pharmacy practice in Louisiana when it dispensed
controlled substances to each patient. RD, at 7 n.10.; Tr. 132, 140,
146.\29\ The Agency finds that Dr. Graham provided sufficient factual
support for these conclusions.
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\29\ See also Holiday CVS, L.L.C., 77 FR 62341 (finding that the
Government can prove that a registrant violated its corresponding
responsibility by showing that: (1) the registrant dispensed a
controlled substance, (2) a red flag was or should have been
recognized at or before the time the controlled substance was
dispensed, and (3) the question created by the red flag was not
resolved conclusively prior to the dispensing of the controlled
substance).
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Respondent also asserts that Dr. Graham ``did not address the
detailed reasoning provided by [Ms.] Neumann regarding how she resolved
the red flags for the subject prescriptions, nor did she address the
data contained in the patient profiles that supported [Ms.] Neumann's
decision to resolve the red flags and dispense the prescriptions as
written.'' Exceptions, at 5-6. Dr. Graham did, in fact, address the
data contained within the patient profiles. She testified that she
reviewed the patient profiles and prescriptions for each patient and
identified red flags for each patient for which no resolution was
documented. Tr. 122. Respondent's contention that Dr. Graham should
have addressed all of Ms. Neumann's undocumented, post hoc
justifications reflects a misunderstanding of DEA's prior Agency
decisions, which highlight the importance of documentation. As
discussed throughout this decision, the Agency has long found that it
will not credit a Respondent's undocumented, post hoc justifications
for its prescribing or dispensing. Pharmacy Doctors Enterprises Inc.,
d.b.a. Zion Clinic Pharmacy, 789 F. App'x at 731 (A respondent pharmacy
``fail[s] to comply with its corresponding responsibility not to fill
prescriptions written for illegitimate purposes'' when it fails to
``tak[e] and document[ ] steps to resolve . . . red flags or refusing
to fill prescriptions with unresolvable red flags.''). This principle
is critical to the Agency's ability to enforce against violations of
the CSA, because enforcement would be impractical if the viability of
the Government's case hinged on the plausibility of a Respondent's
undocumented, post hoc justifications. Respondent's failure to document
any resolution of the red flags in this case rendered its dispensing
beneath the standard of care and outside the usual course of
professional practice.
Exceptions 7-8
Respondent asserts that the ALJ erred in inferring that Respondent
failed to resolve red flags from Respondent's failure to document their
resolution, because Ms. Neumann testified that she did take steps to
address and resolve each red flag. Exceptions, at 7-11. Respondent
cites to Superior Pharmacy, 81 FR 31310, at 31335 n.55, as support for
the assertion that ``a lack of documentation is not, on its own,
sufficient evidence to prove that a red flag was not resolved.''
Exceptions, at 8.
However, Superior Pharmacy does not support this assertion. In
Superior Pharmacy, the Agency found that the Government had not met its
burden of demonstrating that Respondent had failed to document the
resolution of red flags because the Government had only offered
prescriptions (and not patient profiles) into evidence, and the
Government's investigators had not asked respondent's pharmacists if
there were other places, aside from the prescriptions, where they might
have documented the resolution of the red flags. Superior Pharmacy, 81
FR 31335 n.55. Superior Pharmacy makes clear that in a case where the
Government has provided sufficient evidence to establish that the red
flags were not documented anywhere, ``it would be reasonable to draw an
adverse inference that a pharmacist failed to resolve a red flag (or
flags) from the failure to document the resolution . . . .'' \30\ Id.
at 31,335 (emphasis added); see also Hills Pharmacy, LLC, 81 FR 49816,
49836 (2016) (citing Superior Pharmacy, and finding that ``the absence
of documentation on the prescriptions [was] not conclusive proof'' of a
failure to document the resolution of the red flags because the
respondent's PIC testified that his practice was to document red flags
on a due diligence checklist, which was not admitted into evidence).
Here, the Government admitted prescriptions and patient profiles into
evidence, and Respondent has not asserted that there was any other
location where Respondent documented the resolution of red flags.
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\30\ Respondent argues that it ``excepts to any negative
inference drawn from any evidence which it did not introduce,''
because ``the Government has failed to meet its burden that the
prescriptions were not written for a legitimate medical purpose.''
Exceptions, at 18-19. Respondent asserts that it is ``under no
obligation to introduce evidence to strengthen its case'' because of
the Government's failure to meet its burden. Id. However, Respondent
does not cite to any particular findings in the RD that it objects
to, and instead refers generally back to Exception 7. Id. This
Exception lacks the level of specificity required under 21 CFR
1316.66, which provides that exceptions should be supported by
``specific and complete citations of the pages of the transcript and
exhibits.'' Moreover, the Agency found that the Government did meet
its prima facie burden of demonstrating that Respondent's
registration was inconsistent with the public interest, which
shifted the burden to Respondent to demonstrate that it could be
entrusted with a registration. Respondent did not make that showing.
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Respondent also cites to several prior Agency decisions, including
the Agency's recent decision in Coconut Grove, that purportedly show
that the Government may not meet its burden of proof simply by
demonstrating that a pharmacy failed to document the resolution of red
flags. Exceptions, at 9-11 (``The only evidence the Government has
offered in this matter is the absence of documentation. That alone is
not enough to satisfy the Government's burden of proof.''). Respondent
argues that these cases all involved ``additional evidence which
pointed to wrongdoing,'' beyond a failure to document, which Respondent
argues is further support that the Government did not meet its burden
of proof. Id. at 9.
[[Page 8048]]
The Agency rejects these arguments. First, as discussed throughout
this Decision, the Agency may infer from Respondent's failure to
document that Respondent failed to address and resolve red flags, and
the Agency has repeatedly held that it will not credit a registrant's
undocumented, post hoc justifications. Second, the Agency regularly
revokes registrations based on documentation failures. For example, in
Coconut Grove, the Agency revoked a pharmacy's registration based on
the pharmacy's failure to document resolutions of red flags in ways and
for reasons that are very similar to this case. The pharmacy's expert
in Coconut Grove argued that the pharmacy's PIC had resolved the
relevant red flags ``over time in continuing conversations with the
patients and the doctors,'' but the Agency rejected these arguments,
because the pharmacy's only notation on the prescription was
``verified,'' which was not sufficient to resolve the red flag. 89 FR
50374. Based on the pharmacy's failure to document the resolution of
the red flags, the Agency found that the pharmacy had failed to address
and resolve those red flags. Id. The Agency further concluded that the
pharmacy's dispensing was outside the usual course of professional
practice and beneath the standard of care. Id. The Agency drew similar
conclusions in Heavenly Care Pharmacy, 85 FR 53402 (2020), also cited
by Respondent. Respondent is correct in observing that the
prescriptions in Heavenly Care raised more red flags than the
prescriptions in this case, and that there was an additional ground for
revocation in that case. However, the Government need not identify
multiple grounds for revocation, and the Agency has never tallied a
registrant's legal violations and required the Government to meet a
certain numerical threshold.
Here, the Government proved that Respondent filled numerous
prescriptions without adequately addressing and resolving several red
flags, which rendered Respondent's dispensing beneath the standard of
care, outside the usual course of professional practice, and in
violation of Federal and State law. The Government also proved that
Respondent filled unlawful prescriptions that were written for Ms.
Neumann by Ms. Neumann's father. These violations are sufficient to
revoke a registration.
In sum, Respondent has not offered any credible evidence on the
record that rebuts the Government's case for revocation of its
registration and Respondent has not demonstrated that it can be
entrusted with the responsibility of registration. Accordingly, the
Agency will order that Respondent's registration be revoked.
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 No.
FN4373293 issued to Neumann's Pharmacy, LLC. Further, pursuant to 28
CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of Neumann's Pharmacy, LLC, to
renew or modify this registration, as well as any other pending
application of Neumann's Pharmacy, LLC, for additional registration in
Louisiana. This Order is effective February 24, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
January 16, 2025, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-01536 Filed 1-22-25; 8:45 am]
BILLING CODE 4410-09-P