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[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.
---------------------------------------------------------------------------

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

    \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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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

    \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.
---------------------------------------------------------------------------

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

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\
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    \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
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