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1The Agency has reviewed and considered 

Respondent’s exceptions and addresses them 

herein, but ultimately agrees with the ALJ’s 

recommendation. 

2The 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. 

3Although 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. 

4For 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. 

6For Dr. Akers’s full qualifications, see RD, at 8– 

9; RX 1. 

7Respondent 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. 

8The 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. 

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. 

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. 

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. 

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 


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9There 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. 10Respondent 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). 

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. 

‘‘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

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. 

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). 

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 


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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). 

13The 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 

still be taking the medications at the same time. RD, 

at 19 n.20; Tr. 128–29. 

14The 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. 

15At 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. 

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. 

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, 

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 

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– 


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16Respondent 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. 

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. 

18The three butalbital prescriptions included the 

following combinations: butalbital-aspirin-caffeine, 

butalbital-acetaminophen-caffeine, and butalbitalaspirin-caffeine with codeine. GX 9. 

19S.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. 

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 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 

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 

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 


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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. 

21These 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. 

22The 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. 

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 

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. 

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. 

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). 

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 


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23Respondent 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. 

24See 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.’’). 

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

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 


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25Ms. 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. 

26Respondent 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. 

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 

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

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. 


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8046 Federal Register / Vol. 90, No. 14 / Thursday, January 23, 2025 / Notices 

27Respondent 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). 

28Many 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. 

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

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 


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Federal Register / Vol. 90, No. 14 / Thursday, January 23, 2025 / Notices 8047 

29See 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). 

30Respondent 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. 

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.] 

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. 

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. 


ddrumheller on DSK120RN23PROD with NOTICES1
8048 Federal Register / Vol. 90, No. 14 / Thursday, January 23, 2025 / Notices 

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 

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 

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. 

By mail ......... Assistant Attorney General, 

U.S. DOJ—ENRD, P.O. 

Box 7611, Washington, 

D.C. 20044–7611. 

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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