Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Notices 75573 

1Respondent argues in its Exceptions to the 

Recommended Decision (Exceptions) that the ISO 

‘‘led to the ‘wrongful takings’ of its DEA license’’ 

because the hearing established that no diversion 

occurred and there was ‘‘no imminent harm, no 

harm, and no damage, threat or harm to the ‘public 

interest.’ ’’ Exceptions, at 1 (citing Tr. 8, 14, 52–53, 

55, 69, 179–81, 192). However in this case, the 

evidence showed that Respondent repeatedly 

dispensed dangerous combinations of controlled 

substances that posed serious risks to patients 

without first resolving blatant red flags of drug 

abuse and diversion. Respondent’s repeated 

dispensing of controlled substances outside the 

usual course of the professional practice and in 

violation of federal and state law established ‘‘a 

substantial likelihood of an immediate threat that 

death, serious bodily harm, or abuse of a controlled 

substance . . . [would] occur in the absence of the 

immediate suspension’’ of Respondent’s 

registration. 21 U.S.C. 824(d). Thus, the Agency 

finds that at the time the Government issued the 

OSC/ISO, there was clear evidence of imminent 

danger. Moreover, the immediate suspension aspect 

of the Government’s case was final as of the date 

the OSC/ISO was issued by the Administrator, and 

is not the subject of these proceedings. 21 U.S.C. 

824(d)(1) (‘‘A[n immediate] suspension . . . shall 

continue in effect until the conclusion of 

[administrative enforcement] proceedings, 

including judicial review thereof, unless sooner 

withdrawn by the Attorney General or dissolved by 

a court of competent jurisdiction.’’); 21 CFR 

1301.36(h) (‘‘Any suspension shall continue in 

effect until the conclusion of all proceedings upon 

the revocation or suspension, including any judicial 

review thereof, unless sooner withdrawn by the 

Administrator or dissolved by a court of competent 

jurisdiction.’’). 

2The Agency has reviewed and considered the 

Respondent’s exceptions and addresses them 

herein, but ultimately agrees with the ALJ’s 

recommendation. 

3The Agency adopts the ALJ’s summary of each 

witness’ testimony, as well as the ALJ’s assessment 

of each witness’ credibility, except as clarified 

herein. See RD, at 4–53. 

4Respondent argues in its Exceptions that the ALJ 

was biased towards the Government. Respondent’s 

only record support for this assertion is a citation 

to the transcript where the ALJ thanks the 

Government for printing certain documents in large 

enough font for him to read. Exceptions, at 3 (citing 

Tr. 46–47). Respondent cites no authority 

suggesting that the ALJ’s expression of appreciation 

for a chosen font size reflects bias especially where, 

as here, the ALJ thanked both parties at the end of 

the hearing for their zealous advocacy. Tr. 522. 

5For Ms. Salinas’s full qualifications, see RD, at 

6–7, Government Exhibit (GX) 10. 

6The Agency incorporates herein the entire 

summary of Dr. Okpala’s testimony. RD, at 19–24. 

7The ALJ found Dr. Okpala’s testimony to be 

‘‘generally credible,’’ while noting that Dr. Okpala 

failed to lay an adequate foundation for his 

testimony that the patients in this case suffered 

from chronic pain. RD, at 24. The ALJ determined 

that ‘‘[t]o the extent that [Dr. Okpala’s] testimony 

differs from the testimony of other testifying 

witnesses, I will consider his personal interest in 

this case, and I will give his testimony the weight 

it deserves in light of other evidence and testimony 

presenting during the hearing.’’ Id. The Agency 

agrees with the amount of weight that the ALJ 

afforded Dr. Okpala’s testimony, except as clarified 

herein. 

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. FV3660037 issued to 

Mary A. Vreeke, M.D. 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 Mary A. Vreeke, M.D. to renew or 

modify this registration, as well as any 

other pending application of Mary A. 

Vreeke, M.D., for additional registration 

in California. This Order is effective 

October 16, 2024. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on September 10, 2024, 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. 2024–20939 Filed 9–13–24; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 23–48] 

Awesome Care Pharmacy, Inc.; 

Decision and Order 

On June 1, 2023, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause and Immediate Suspension of 

Registration (OSC/ISO) to Awesome 

Care Pharmacy, Inc., (Respondent) of 

Houston, Texas. OSC/ISO, at 1. The 

OSC/ISO informed Respondent of the 

immediate suspension of its DEA 

Certificate of Registration Number 

FA2332346 (registration), pursuant to 21 

U.S.C. 824(d), alleging that 

Respondent’s continued registration 

constitutes ‘‘an imminent danger to the 

public health or safety.’’ Id. at 1 (quoting 

21 U.S.C. 824(d)).1 The OSC/ISO also 

proposed the revocation of 

Respondent’s registration, alleging that 

Respondent’s continued registration is 

inconsistent with the public interest. Id. 

(citing 21 U.S.C. 824(a)(4)). 

A hearing was held before DEA 

Administrative Law Judge Paul E. 

Soeffing (the ALJ), who, on February 6, 

2024, issued his Recommended Rulings, 

Findings of Fact, Conclusions of Law, 

and Decision (Recommended Decision 

or RD), which recommended revocation 

of Respondent’s registration. RD, at 59. 

Following the issuance of the RD, 

Respondent filed exceptions.2 Having 

reviewed the entire record, the Agency 

adopts and hereby incorporates by 

reference the entirety of the ALJ’s 

rulings, credibility findings,3 findings of 

fact, conclusions of law, sanctions 

analysis, and recommended sanction as 

found in the RD and summarizes and 

clarifies portions thereof herein.4

I. Findings of Fact 

Texas Standard of Care 

Katherine Salinas testified as the 

Government’s expert regarding the 

standard of care for pharmacy practice 

in the State of Texas. RD, at 6; Tr. 96– 

97. Ms. Salinas has been licensed as a 

pharmacist in Texas for over thirty years 

and has dispensed medications in retail 

pharmacies since 1992. RD, at 6; Tr. 89– 

91, 167. Ms. Salinas served as a 

Compliance Officer with the Texas 

Board for approximately nine years, 

where she inspected approximately 

2,700 pharmacies, and she currently 

works as the Medication Safety and 

Drug Diversion Supervisor for the 

University of Texas Medical Branch. 

RD, at 6–7; Tr. 93–95.5

Dr. Okpala, Respondent’s owner and 

Pharmacist-in-Charge (PIC), testified on 

Respondent’s behalf. Dr. Okpala 

testified that he has been licensed as a 

pharmacist in Texas since 1993. RD, at 

20; Tr. 373, 376–77; RX 2, at 2.6 The 

Agency agrees with the ALJ that Dr. 

Okpala has a significant personal 

interest in the outcome of these 

proceedings. RD, at 24. Additionally, 

the Agency finds that Dr. Okpala’s 

testimony at times contradicted the 

language of Texas’s regulations. 

Therefore, to the extent that Dr. 

Okpala’s testimony diverges from the 

Texas regulations and the testimony of 

Ms. Salinas, the Agency will credit Ms. 

Salinas’s testimony.7

Ms. Salinas testified that the standard 

of care in Texas is informed by DEA 

regulations and Texas laws and 

regulations, including Texas 

Administrative Code § 291.29(b), which 

requires pharmacists to ‘‘make every 

reasonable effort to ensure that any 

prescription drug order . . . has been 

issued for a legitimate medical purpose 

by a practitioner in the course of 

medical practice.’’ 22 Tex. Admin. Code 

§ 291.29(b); RD, at 7–8; Tr. 98–100. Ms. 


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8 DI Fernandez similarly testified that 

hydrocodone-acetaminophen and carisoprodol are 

‘‘very popular in Houston and are highly diverted,’’ 

and they are considered ‘‘a dangerous 

combination.’’ RD, at 34; Tr. 24–25. 

Salinas testified that this obligation is 

known as the pharmacist’s 

‘‘corresponding responsibility,’’ and it is 

the ‘‘foundation . . . of good pharmacy 

practice.’’ RD, at 7; Tr. 98, 327. 

Ms. Salinas testified that the Texas 

Administrative Code ‘‘lists out several 

patterns that the pharmacist needs to be 

aware of to assess [a] prescription and 

determine if [it] was indeed issued for 

a legitimate medical purpose.’’ RD, at 7; 

Tr. 98. Consistent with Ms. Salinas’s 

testimony, Texas Administrative Code 

§ 291.29(f) states that ‘‘[a] pharmacist 

shall make every reasonable effort to 

prevent inappropriate dispensing due to 

fraudulent, forged, invalid, or medically 

inappropriate prescriptions in violation 

of a pharmacist’s corresponding 

responsibility,’’ and provides a list of 

nineteen ‘‘patterns (i.e., red flag factors) 

[that] are relevant to preventing the nontherapeutic dispensing of controlled 

substances.’’ 22 Tex. Admin. Code 

§ 291.29(f). The statute further states 

that these red flags ‘‘shall be considered 

by evaluating the totality of the 

circumstances rather than any single 

factor.’’ Id. Ms. Salinas testified that the 

statute’s list of red flags is not 

exhaustive. RD, at 8; Tr. 98, 104–06. A 

red flag is ‘‘anything that should make 

the pharmacist question [a] prescription 

and whether or not [it] is safe and 

appropriate.’’ Tr. 106. Ms. Salinas 

identified some examples of red flags, 

including that multiple patients are 

receiving essentially the same pattern of 

prescriptions from a small number of 

prescribers, or that prescriptions are for 

commonly abused drugs, such as 

opioids, benzodiazepines, and cough 

syrups. Tr. 105. 

Ms. Salinas testified that a pharmacist 

should evaluate a prescription for red 

flags by looking at all of the details on 

the face of the prescription (e.g., name, 

address, date of birth, quantity of drug 

prescribed), checking the Prescription 

Monitoring Program (PMP), running a 

public search for the provider to see if 

there are any disciplinary orders, talking 

to the patient, and calling the 

prescribing doctor to discuss any 

potential red flags. RD, at 8; Tr. 106–08. 

If the pharmacist identifies any red flags 

that indicate that the prescription might 

not be legitimate, then the pharmacist 

must attempt to resolve those red flags 

by ‘‘taking into account [the] bigger 

picture,’’ including conversations with 

the patient and prescriber, relevant 

statutes and laws, discussions with 

colleagues, and PMP data. RD, at 8, 10; 

Tr. 106–08, 209–10, 304–05, 307–08, 

313, 317–18, 327. Ms. Salinas testified 

that if the pharmacist determines that 

the red flag cannot be resolved, then the 

pharmacist should not fill the 

prescription. RD, at 8; Tr. 107. If, on the 

other hand, the pharmacist determines 

that the red flag can be resolved, Ms. 

Salinas testified that the pharmacist 

must document the resolution of the red 

flag, the rationale behind the decision to 

dispense the medication, and the 

pharmacist’s discussions with the 

prescriber. RD, at 8–10; Tr. 107–12, 142, 

327. 

Consistent with Ms. Salinas’s 

testimony, the Texas Administrative 

Code states that ‘‘[p]rior to dispensing, 

any questions regarding a prescription 

drug order must be resolved with the 

prescriber and written documentation of 

these discussions made and maintained 

as specified in subparagraph (C) of this 

paragraph.’’ 22 Tex. Admin. Code 

§ 291.33(c)(2)(A)(iv). Subparagraph C 

specifies that the following information 

about the pharmacist’s consultation 

with the prescriber shall be documented 

‘‘on the prescription or in the 

pharmacy’s data processing system 

associated with the prescription’’: ‘‘(i) 

date the prescriber was consulted; (ii) 

name of the person communicating the 

prescriber’s instructions; (iii) any 

applicable information pertaining to the 

consultation; and (iv) initials or 

identification code of the pharmacist 

performing the consultation clearly 

recorded for the purpose of identifying 

the pharmacist who performed the 

consultation.’’ Id. at § 291.33(c)(2)(C); 

RD, at 9; Tr. 112. Ms. Salinas testified 

that the purpose of documentation is to 

show that the pharmacist saw the red 

flags and resolved them. RD, at 9; Tr. 

112. 

Finally, the Texas Administrative 

Code requires pharmacists to ‘‘exercise 

sound professional judgment with 

respect to the accuracy and authenticity 

of any prescription drug order they 

dispense, which requires ‘‘verify[ing] 

the order with the practitioner prior to 

dispensing’’ ‘‘[i]f the pharmacist 

questions the accuracy or authenticity of 

a prescription drug order.’’ 22 Tex. 

Admin. Code § 291.34(b)(1)(A). 

Respondent’s Improper Dispensing 

Ms. Salinas testified that she reviewed 

Respondent’s PMP history, dispensing 

history, and a subset of patient profiles, 

Tr. 115, and she testified about the red 

flags that she observed with the 

prescriptions for these patients, 

including drug cocktails, pattern 

prescribing, prescriptions lacking 

diagnosis codes, patients receiving 

controlled substances from multiple 

prescribers, and gaps in prescriptions 

exceeding one month. RD, at 11–19. 

Drug Cocktails 

One of the potential red flags 

identified by the Texas Administrative 

Code is when ‘‘prescriptions by a 

prescriber . . . are routinely for 

controlled substances commonly known 

to be abused drugs, including opioids, 

benzodiazepines, muscle relaxants, . . . 

or any combination of these drugs.’’ 22 

Tex. Admin. Code § 291.29(f)(3). Ms. 

Salinas testified that a combination of 

drugs is referred to as a ‘‘drug cocktail.’’ 

RD, at 11; Tr. 122, 328–29. For example, 

when combined, hydrocodone (an 

opioid) and carisoprodol (a muscle 

relaxant)—which are both highly 

abusable on their own—can create a 

potentially dangerous drug cocktail that 

increases the risk of respiratory 

depression, overdose, or death. RD, at 

11; Tr. 118–22, 136, 143, 147, 153, 290, 

328–29.8 Ms. Salinas testified that the 

risks to patients from taking these drugs 

together continue for as long as they are 

taking them, not just the first time they 

are prescribed. RD, at 11; Tr. 329. In this 

case, Ms. Salinas testified that A.T., 

T.B., K.B., and S.D. were all receiving a 

dangerous cocktail of hydrocodone and 

carisoprodol. RD, at 11; Tr. 118–22, 136, 

143, 147, 153, 328–29. 

As for Respondent, Dr. Okpala 

testified that the combination of 

hydrocodone-acetaminophen and 

carisoprodol did not present a red flag 

because these medications are combined 

to produce a ‘‘synergistic effect’’ that is 

more effective for treating chronic pain. 

RD, at 34–35; Tr. 419–20, 457. However, 

Dr. Okpala did not produce adequate 

evidence that these patients actually 

suffered from chronic pain or that these 

drugs were prescribed together to 

produce a synergistic effect. Nor did Dr. 

Okpala acknowledge that these drugs 

can be very dangerous when combined. 

Thus, the ALJ found, and the Agency 

agrees, that the frequent prescribing of 

the drug cocktail of hydrocodone and 

carisoprodol was a red flag that 

Respondent should have identified, 

resolved, and documented prior to 

dispensing. RD, at 36. 

Pattern Prescribing 

The Texas Administrative Code 

identifies several red flags that Ms. 

Salinas referred to as ‘‘pattern 

prescribing,’’ including that: (1) the 

pharmacy ‘‘dispenses a reasonably 

discernible pattern of substantially 

identical prescriptions for the same 

controlled substances, potentially 


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9Ms. Salinas testified that chronic pain is pain 

that ‘‘lasts greater than three months.’’ RD, at 14 

n.51; Tr. 150. 

10The ALJ found, and the Agency agrees, that Dr. 

Okpala’s testimony that he knew the patients had 

chronic pain based on the frequency of their visits 

was concerning. RD, at 39. As the ALJ noted, the 

fact ‘‘[t]hat these patients frequently visited 

prescribers and received repeated prescriptions for 

high quantities and similar dosage units of 

controlled substances on a monthly basis is the very 

red flag indicative of a lack of personalized care 

identified by Ms. Salinas and the Texas 

Administrative Code.’’ Id. 

paired with other drugs, for numerous 

persons, indicating a lack of individual 

drug therapy in prescriptions issued by 

the practitioner,’’ 22 Tex. Admin. Code 

§ 291.29(f)(1); (2) ‘‘the pharmacy 

operates with a reasonably discernible 

pattern of overall low prescription 

dispensing volume, maintaining 

relatively consistent [one-to-one] ratio of 

controlled substances to dangerous 

drugs and/or over-the-counter products 

dispensed as prescriptions,’’ id. at 

§ 291.29(f)(2); and/or (3) ‘‘prescriptions 

for controlled substances are commonly 

for the highest strength of the drug and/ 

or for large quantities (e.g., monthly 

supply), indicating a lack of individual 

drug therapy in prescriptions issued by 

the practitioner,’’ id. at § 291.29(f)(5). 

RD, at 11–12; Tr. 129, 339. 

In this case, Ms. Salinas testified that 

Respondent’s dispensing to A.T., T.B., 

K.B., and S.D. reflected a repeated 

pattern of large quantities of 

carisoprodol and hydrocodone in the 

highest strength available. RD, at 12, 37; 

Tr. 118–19, 132–33, 136, 143, 147, 339. 

The highest strength of carisoprodol is 

350 mg, and Respondent frequently 

dispensed 60 to 80 tablets per month to 

patients. RD, at 12; Tr. 121. The highest 

strength of hydrocodone-acetaminophen 

is 10/325 mg, and Respondent 

frequently dispensed quantities 

exceeding 100 tablets per month to 

patients, which Ms. Salinas testified is 

a red flag. RD, at 12, 37; Tr. 120–21, 143. 

Ms. Salinas testified that hydrocodoneacetaminophen is highly addictive and 

is ‘‘one of the pattern drugs that [she 

sees] most often . . . with patterns of 

. . . abuse.’’ RD, at 12–13; Tr. 120–21, 

149. Ms. Salinas testified that 

hydrocodone is best when limited to 

short-term use, so it is a red flag to see 

hydrocodone prescribed month after 

month. RD, at 12–13, 37; Tr. 122, 143, 

148–51, 339–40. Ms. Salinas testified 

that hydrocodone may be prescribed for 

over three months to patients suffering 

from chronic pain,9 but the pharmacist 

must still exercise the ‘‘corresponding 

responsibility to determine if that [is] 

appropriate.’’ Tr. 150. Ms. Salinas also 

testified that Respondent often 

dispensed hydrocodone and 

carisoprodol along with non-controlled 

drugs, such as ibuprofen, naproxen, or 

multivitamins, reflecting the one-to-one 

ratio identified in the Texas 

Administrative Code. RD, at 11; Tr. 121– 

22, 129, 153. 

As for Respondent, Dr. Okpala 

testified that the repeated prescriptions 

for maximum-strength controlled 

substances in large quantities over 

multiple months did not present a red 

flag because these patients all had 

chronic pain. RD, at 39; Tr. 406–08, 490, 

497, 510. However, the ALJ found, and 

the Agency agrees, that Dr. Okpala did 

not present sufficient evidence to 

establish that these patients had chronic 

pain. RD, at 39. Dr. Okpala testified that 

he concluded that they had chronic pain 

based on the frequency they saw their 

prescribing doctors,10 the conversations 

and interactions he had with the 

patients and prescribers, and the types 

of medications prescribed. RD, at 39; Tr. 

406–08, 490, 497, 510. Dr. Okpala 

testified that it was ‘‘common sense’’ for 

a pharmacist to conclude that a patient 

suffers from chronic pain when the 

patient is receiving monthly 

prescriptions for hydrocodoneacetaminophen. RD, at 39; Tr. 342, 497. 

He further testified that knowing the 

cause of the patients’ pain would not 

impact his decision to dispense the 

prescriptions presented in this case. RD, 

at 52; Tr. 501 

However, Ms. Salinas testified that 

the nature of the drug prescribed does 

not communicate a diagnosis to the 

pharmacist, and the pharmacist should 

not assume why the drug was 

prescribed. RD, at 16; Tr. 306, 329–30. 

Moreover, Ms. Salinas testified that 

there was no documentation on the 

prescriptions suggesting that the 

repeated hydrocodone prescriptions 

were for chronic pain. RD, at 15, 41–42; 

Tr. 150–51, 251–55. Finally, even 

assuming that Respondent did discuss 

the diagnoses with the patients or 

prescribers, the lack of any 

documentation of those conversations 

renders Respondent’s dispensing 

outside of the standard of care. RD, at 

14, 38; Tr. 150–51; 22 Tex. Admin. Code 

§ 291.33(c)(2)(A)(iv). 

Thus, the ALJ found, and the Agency 

agrees, that repeated prescriptions for 

high quantities and high strengths of 

commonly-abused drugs, sometimes in 

combination with non-controlled 

substances in a one-to-one ratio, was a 

red flag that Respondent should have 

identified, resolved, and documented 

prior to dispensing. RD, at 39–40. 

Prescriptions Lacking Specific 

Diagnoses 

Another potential red flag identified 

by the Texas Administrative Code is 

when prescriptions for controlled 

substances ‘‘contain nonspecific or no 

diagnoses, or lack the intended use of 

the drug.’’ 22 Tex. Admin. Code 

§ 291.29(f)(4); RD, at 14; Tr. 128. Ms. 

Salinas testified that the diagnosis code 

is especially important when 

hydrocodone or carisoprodol is 

prescribed, because those medications 

are a red flag. RD, at 14; Tr. 127. Ms. 

Salinas testified that in this case, there 

was generally no documentation on the 

face of a prescription related to a 

patient’s diagnosis, so she could not 

determine whether a patient was being 

prescribed hydrocodone for chronic or 

acute pain, which may impact the 

length of time a patient is prescribed 

hydrocodone. RD, at 15; Tr. 150–51. Ms. 

Salinas testified that diagnoses of 

‘‘pain’’ or ‘‘chronic pain syndrome’’ are 

not specific enough under the Texas 

Administrative Code, and should trigger 

a red flag analysis. RD, at 15; Tr. 331– 

32. Ms. Salinas testified that she was 

unable to determine the purpose of the 

prescriptions or the type of pain that the 

medications were intended to treat. RD, 

at 15–16; Tr. 252–53, 329. 

As for Respondent, Dr. Okpala 

presented conflicting testimony 

regarding whether ‘‘pain’’ was a 

diagnosis, but ultimately testified that 

pain may be used as a diagnosis. RD, at 

42; Tr. 484–85. Dr. Okpala also testified 

that neither DEA nor Texas regulations 

requires the inclusion of diagnosis 

codes on the face of a prescription. RD, 

at 42; Tr. 448, 507. Finally, Dr. Okpala 

testified that he knew that the patients 

in this case had chronic pain, although 

the Agency found above that this 

conclusion was not adequately 

supported. 

The ALJ found, and the Agency 

agrees, that Ms. Salinas’s testimony was 

more credible on this issue because it 

was supported by the relevant 

provisions of the Texas Administrative 

Code, which identify nonspecific 

diagnosis codes as a relevant red flag 

factor. RD, at 42; 22 Tex. Admin. Code 

§ 291.29(f)(4). Thus, the ALJ found, and 

the Agency agrees, that the lack of 

specific diagnoses to justify the 

controlled substance prescriptions was a 

red flag that Respondent should have 

identified, resolved, and documented 

prior to dispensing. RD, at 42–43. 

Gaps in Prescriptions 

Ms. Salinas testified that another 

potential red flag is when gaps between 

usually-consistent monthly 


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11Respondent, through counsel, argued in its 

closing argument that the Government is 

improperly tasking Respondent with 

communicating with prescribers during time 

periods where prescriptions are not presented to the 

pharmacy. RD, at 49; Tr. 520. Respondent argued 

that ‘‘[t]he societal interest, including that of 

pharmacies, is to minimize the use and abuse of 

opioids,’’ and thus Respondent should not be 

responsible for communicating with physicians 

when a patient is not prescribed controlled 

substances after previous, repeated monthly 

prescriptions. RD, at 49; Tr. 521. The ALJ found, 

and the Agency agrees, that this argument 

misconstrues Ms. Salinas’s testimony. RD, at 49. 

According to Ms. Salinas, lengthy gaps in habitual 

prescriptions provides evidence of potential abuse 

and diversion. RD, at 49; Tr. 140. Ms. Salinas is not 

testifying that Respondent must attempt to dispense 

more medication to a patient when that patient is 

not issued the typical monthly prescription. RD, at 

49. Rather, Respondent must contact the prescribing 

physician and document that communication when 

a patient returns to the pharmacy to receive the 

previously regular medication after a significant gap 

in treatment. Id.; Tr. 140–42, 154, 341–42. Aside 

from the argument presented in its closing 

statement, the Respondent presented no evidence to 

rebut Ms. Salinas’s expert testimony that gaps 

between prescriptions presented a red flag that 

required documented resolution prior to 

dispensing. RD, at 49. Therefore, the Agency agrees 

with the ALJ and credits Ms. Salinas’s unrebutted 

expert testimony about this red flag. Id. at 49–50. 

12The Texas Administrative Code identifies 

patients ‘‘obtaining similar drugs from multiple 

practitioners’’ as a potential red flag factor, and Ms. 

Salinas testified that this is a common red flag that 

must be identified, resolved, and documented prior 

to dispensing. 22 Tex. Admin. Code § 291.29(f)(10); 

RD, at 16; Tr. 123–34; 340. The ALJ found that the 

Government had not proven that multiple 

prescribers was a red flag in this case because Dr. 

Okpala testified that several of the prescribers 

worked together in a group practice, that he visited 

the group practice frequently to ensure that the 

patients were being treated appropriately, and that 

he maintained professional relationships with all of 

the prescribers. RD, at 23, 43–47; Tr. 386–89, 391, 

394, 398–99, 406, 467, 490, 502. However, Dr. 

Okpala’s testimony on this issue is more relevant 

to whether the red flag of multiple prescribers can 

be resolved in this case, not whether multiple 

prescribers is a red flag that warrants follow up. Dr. 

Okpala’s testimony actually supports the 

conclusion that multiple prescribers was a red flag. 

He testified that he visited the group practice on at 

least twenty occasions to ‘‘make sure [the 

prescribers] [did] what [they were] supposed to do 

for patients,’’ RD, at 23, 44; Tr. 387–89, 391, 394, 

which suggests that he felt the need to surveil the 

clinic, and he even testified that the doctors told 

him, ‘‘okay, if you’re doubting me, stay there and 

watch.’’ Tr. 393. Thus, the Agency credits Ms. 

Salinas’s credible expert testimony, as supported by 

Texas law, that multiple prescribers was a red flag 

that should have been identified, resolved, and 

documented. Dr. Okpala did not document any of 

his discussions with the prescribers or any other 

steps that he took to resolve this red flag, which is 

required by Texas law and the standard of care. 22 

Tex. Admin. Code § 291.33(c)(2)(A)(iv); RD, at 8–10; 

Tr. 107–12, 142, 327. Even without this finding, the 

combination of other red flags is ‘‘so suspicious as 

to support a finding that the pharmacists who filled 

them violated their corresponding responsibility 

due to actual knowledge of, or willful blindness to, 

the prescriptions’ illegitimacy.’’ Lewisville Medical 

Pharmacy, 87 FR at 59,459 (citing The Pharmacy 

Place, 86 FR 21,008, 21,013 (collecting Agency 

decisions)). 

13For more details about the prescriptions that 

Respondent filled for A.T. without identifying and 

resolving these red flags, see RD, at 30–50; GX 2– 

3. 14For more details about the prescriptions that 

Respondent filled for T.B. without identifying and 

resolving these red flags, see RD, at 30–50; GX 4– 

5. 

prescriptions exceed a month, because 

this indicates that the patient is not 

taking the controlled substance as 

prescribed. RD, at 18, 48–49; Tr. 140. 

Ms. Salinas testified that if a pharmacist 

observes a gap, the pharmacist should 

have a discussion with the patient to 

ensure that the patient is taking the 

medication correctly and document that 

discussion. RD, at 18–19; Tr. 140, 142. 

The pharmacist should also contact the 

prescribing physician to determine the 

purpose of the gap, and document that 

conversation if the red flag is resolved. 

RD, at 19; Tr. 341–42. The ALJ found, 

and the Agency agrees, that gaps 

between prescriptions exceeding one 

month was a red flag that Respondent 

should have identified, resolved, and 

documented prior to dispensing. RD, at 

49–50.11

Respondent’s Dispensing to A.T., T.B., 

K.B., and S.D. 

Ms. Salinas testified in more detail 

about the prescriptions that she 

reviewed for A.T., T.B., K.B., and S.D. 

Ms. Salinas testified that she identified 

the following red flags with the 

prescriptions that Respondent 

dispensed to A.T.: (1) A.T. was 

receiving pattern prescriptions for a 

dangerous cocktail of hydrocodone and 

carisoprodol, RD, at 12; Tr. 118–19, 

120–21; (2) A.T. was receiving the same 

controlled substances from at least six 

prescribers,12 RD, at 17; Tr. 118–19, 

136–38; (3) A.T. was also receiving noncontrolled substances, such as ibuprofen 

and biofreeze, which implicates the oneto-one controlled to non-controlled 

substances pattern identified in the 

Texas Administrative Code, RD, at 17; 

Tr. 132, 137–38; (4) A.T. repeatedly 

received a high quantity of carisoprodol 

along with a high quantity of 

hydrocodone, which is a strong opioid 

that is best when limited to short-term 

use, RD, at 12; Tr. 119, 122–23; (5) many 

of A.T.’s prescriptions lacked a 

diagnosis code or any language 

indicating the purpose of the 

prescription, and others contained a 

non-specific diagnosis code of ‘‘chronic 

pain syndrome,’’ RD, at 15; Tr. 136–37, 

331–32; GX 2, at 10–11, 84; and (6) there 

was a gap in A.T.’s prescriptions of over 

a month that indicated that she was not 

taking the medications as prescribed, 

RD, at 18–19; Tr. 139–41. Ms. Salinas 

testified that there was no 

documentation indicating that 

Respondent identified or resolved any 

of these red flags, and that Respondent 

therefore failed to exercise its 

corresponding responsibility and abide 

by the standard of care in its dispensing 

to A.T. RD, at 9; Tr. 139.13

Ms. Salinas testified that she 

identified the following red flags with 

the prescriptions that Respondent 

dispensed to T.B.: (1) T.B. was receiving 

pattern prescriptions for a dangerous 

cocktail of hydrocodone and 

carisoprodol, RD, at 11, Tr. 132–22; GX 

5; (2) T.B. was also receiving noncontrolled substances, such as ibuprofen 

and lisinopril, which implicates the 

one-to-one controlled to non-controlled 

substances pattern identified in the 

Texas Administrative Code, RD, at 12– 

13; Tr. 129–30, 131–32; GX 5; (3) T.B. 

was receiving these medications from 

multiple prescribers, RD, at 13, 17; Tr. 

130–33; (4) T.B. repeatedly received a 

high quantity of carisoprodol along with 

a high quantity of hydrocodone (always 

over 100 tablets), which is a strong 

opioid that is best when limited to 

short-term use, RD, at 12–13; Tr. 122– 

23, 129–33; and (5) none of T.B.’s 

prescriptions for a fifteen-month period 

contained diagnosis codes. RD, at 15; Tr. 

125–126, 333–34. Ms. Salinas testified 

that there was no documentation 

indicating that Respondent identified or 

resolved any of these red flags, and that 

Respondent therefore failed to exercise 

its corresponding responsibility and 

abide by the standard of care in its 

dispensing to A.T. RD, at 9; Tr. 134– 

35.14

Ms. Salinas testified that she 

identified the following red flags with 

the prescriptions that Respondent 

dispensed to K.B.: (1) K.B. was receiving 

pattern prescriptions for a dangerous 

cocktail of hydrocodone and 

carisoprodol in the same quantity each 

month, RD, at 11, 13; Tr. 143; GX 7; (2) 

K.B. was also receiving non-controlled 

substances, such as ibuprofen and 

biofreeze, which implicates the one-toone controlled to non-controlled 

substances pattern identified in the 

Texas Administrative Code, RD, at 17; 

Tr. 129–32, 144–45; GX 6, at 1–2; (3) 

K.B. was receiving these medications 

from multiple prescribers, RD, at 17; Tr. 

143–45; GX 6 at 1–2; (4) K.B. repeatedly 

received a high quantity of hydrocodone 

(over 100 tablets), which is a strong 

opioid that is best when limited to 

short-term use, RD, at 13; Tr. 122–23, 

143; and (5) the vast majority of K.B.’s 

prescriptions lacked a diagnosis code. 

RD, at 15; Tr. 143–44; GX 6, at 24–25. 

Ms. Salinas testified that there was no 

documentation indicating that 

Respondent identified or resolved any 

of these red flags, and that Respondent 


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15For more details about the prescriptions that 

Respondent filled for K.B. without identifying and 

resolving these red flags, see RD, at 30–50; GX 6– 

7. 

16For more details about the prescriptions that 

Respondent filled for S.D. without identifying and 

resolving these red flags, see RD, at 30–50; GX 8– 

9. 

17Regarding Respondent’s argument that the lack 

of disciplinary action against Respondent or Dr. 

Okpala was not given appropriate weight in the 

public interest analysis (Exceptions, at 2–3), this 

point was addressed by the ALJ in considering 

Public Interest Factors A, C, and E and the Agency 

agrees with the ALJ’s analysis. 

therefore failed to exercise its 

corresponding responsibility and abide 

by the standard of care in its dispensing 

to K.B. RD, at 9; Tr. 146, 155; GX 6, 7.15

Ms. Salinas testified that she 

identified the following red flags with 

the prescriptions that Respondent 

dispensed to S.D: (1) S.D was receiving 

pattern prescriptions for a dangerous 

cocktail of hydrocodone and 

carisoprodol in the same quantity each 

month, RD, at 11, 13; Tr. 147; GX 9; (2) 

S.D. was also receiving non-controlled 

substances, such as gabapentin and 

naproxen, which implicates the one-toone controlled to non-controlled 

substances pattern identified in the 

Texas Administrative Code, RD, at 13; 

Tr. 153; (3) S.D. was receiving these 

medications from multiple prescribers, 

RD, at 17; Tr. 132, 147, 151–52; GX 8 at 

1–2; (4) S.D. repeatedly received a high 

quantity of hydrocodone, which is a 

strong opioid that is best limited to 

short-term use, RD, at 13; Tr. 122–23, 

147; (5) none of S.D.’s prescriptions 

contain diagnosis codes, RD, at 15; Tr. 

151; GX 8, at 9–10; and (6) there were 

gaps in S.D’s prescriptions that 

indicated that S.D. was not taking the 

medications as prescribed. RD, at 19; Tr. 

154. Ms. Salinas testified that there was 

no documentation indicating that 

Respondent identified or resolved any 

of these red flags, and that Respondent 

therefore failed to exercise its 

corresponding responsibility and abide 

by the standard of care in its dispensing 

to S.D. RD, at 9; Tr. 153–54; GX 8, 9.16

As for Respondent, Dr. Okpala 

testified that he did not observe any red 

flags with any of the prescriptions in 

this case, so there was ‘‘[n]othing to 

resolve’’ and nothing to document. Tr. 

402. Respondent’s counsel asked Dr. 

Okpala what he did if he encountered 

‘‘[prescriptions] that looked like red 

flags,’’ and Dr. Okpala testified that he 

would follow up, call physicians, and 

speak to patients. RD, at 21; Tr. 402, 

467, 479–80. Dr. Okpala testified that he 

‘‘did that on all these prescriptions.’’ Tr. 

467. When Government counsel asked 

Dr. Okpala why there were no notes on 

the prescriptions or in the patient file, 

Dr. Okpala replied, ‘‘I mean, I know the 

patients; I know the doctors. I did my 

job professionally as a pharmacist, and 

I used my professional judgment, and 

that’s what I did.’’ Tr. 480. 

Dr. Okpala’s testimony that the 

prescriptions in this case did not 

present any red flags is simply not 

credible. The patterns presented by 

these prescriptions are specifically 

identified in the Texas Administrative 

Code as potential red flag factors, and 

Ms. Salinas offered credible expert 

testimony with respect to each red flag. 

Dr. Okpala testified that he took steps to 

verify the legitimacy of these 

prescriptions, despite his belief that 

there were no red flags. However, even 

assuming arguendo that Dr. Okpala did 

take these steps for the relevant 

prescriptions, he did not document his 

actions as required by the Texas 

standard of care. Moreover, it is unclear 

what Dr. Okpala would have discussed 

with the patients and physicians if he 

did not believe that any red flags 

existed. RD, at 51. Therefore, the 

Agency does not credit Dr. Okpala’s 

testimony that these prescriptions did 

not present red flags, or that Dr. Okpala 

satisfied his obligation to ensure that 

there were no red flags. RD, at 51. 

Thus, the ALJ found, and the Agency 

agrees, that the standard of care in Texas 

requires that any red flags present for a 

prescription must be resolved before 

dispensing and that the resolution must 

be documented. RD, at 27–53. The ALJ 

also found, and the Agency agrees, that 

Respondent failed to do this, rendering 

Respondent’s dispensing to A.T., T.B., 

K.B., and S.D. outside the usual course 

of professional practice and in violation 

of the Texas standard of care. Id. The 

Agency further finds that Respondent 

failed to exercise sound professional 

judgment in filling the prescriptions in 

this case. RD, at 9; Tr. 328. 

II. Discussion 

A. The Five Public Interest Factors 

Under the CSA, ‘‘[a] registration . . . 

to . . . dispense a controlled substance 

. . . may be suspended or revoked by 

the Attorney General upon a finding 

that the registrant . . . has committed 

such acts as would render [its] 

registration under section 823 of this 

title inconsistent with the public 

interest as determined under such 

section.’’ 21 U.S.C. 824(a). In making the 

public interest determination, the CSA 

requires consideration of the following 

factors: 

(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. 

21 U.S.C. 823(g)(1). 

The Agency considers these public 

interest factors in the disjunctive. Robert 

A. Leslie, M.D., 68 FR 15,227, 15,230 

(2003). Each factor is weighed on a caseby-case basis. Morall v. Drug Enf’t 

Admin., 412 F.3d 165, 173–74 (D.C. Cir. 

2005). Any one factor, or combination of 

factors, may be decisive. David H. Gillis, 

M.D., 58 FR 37,507, 37,508 (1993). 

The Government has the burden of 

proof in this proceeding. 21 CFR 

1301.44. While the Agency has 

considered all of the public interest 

factors in 21 U.S.C. 823(g)(1), the 

Government’s evidence in support of its 

prima facie case for revocation of 

Respondent’s registration is confined to 

Factors B and D. RD, at 27–33; see also 

id. at 27 n.78 (finding that Factors A, C, 

and E do not weigh for or against 

revocation 17). 

Having reviewed the record and the 

RD, the Agency agrees with the ALJ, 

adopts the ALJ’s analysis, and finds that 

the Government’s evidence satisfies its 

prima facie burden of showing that 

Respondent’s continued registration 

would be ‘‘inconsistent with the public 

interest.’’ 21 U.S.C. 824(a)(4); RD, at 27– 

54. 

B. Factors B and D 

Evidence is considered under Public 

Interest Factors B and D when it reflects 

compliance (or non-compliance) with 

laws related to controlled substances 

and experience dispensing controlled 

substances. See Sualeh Ashraf, M.D., 88 

FR 1095, 1097 (2023); Kareem Hubbard, 

M.D., 87 FR 21,156, 21,162 (2022). In 

the current matter, the Government has 

alleged that Respondent violated 

numerous federal and state laws 

regulating controlled substances. OSC/ 

ISO, at 2–9. Specifically, federal law 

requires that ‘‘[a] prescription for a 

controlled substance may only be filled 

by a pharmacist, acting in the usual 

course of his professional practice,’’ and 

that ‘‘[a] prescription for a controlled 

substance to be effective must be issued 

for a legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice.’’ 21 CFR 1306.04(a), 1306.06; 

see also 21 U.S.C. 829. Federal law also 


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18 Lewisville Medical Pharmacy, 87 FR at 59,459 

(citing The Pharmacy Place, 86 FR 21,008, 21,013 

(collecting Agency decisions)). 

emphasizes that although ‘‘[t]he 

responsibility for the proper prescribing 

and dispensing of controlled substances 

is upon the prescribing practitioner . . . 

a corresponding responsibility rests 

with the pharmacist who fills the 

prescription.’’ 21 CFR 1306.04(a). DEA 

has consistently interpreted this 

provision 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.’’ Medicine 

Shoppe-Jonesborough, 73 FR 364, 381 

(2008) (citing Medic-Aid Pharmacy, 55 

FR 30,043, 30,044 (1990)). DEA has 

further held that ‘‘[w]hen prescriptions 

are clearly not issued for legitimate 

medical purposes, a pharmacist may not 

intentionally close his eyes and thereby 

avoid [actual] knowledge of the real 

purpose of the prescription.’’ Ralph J. 

Bertolino, d/b/a Ralph J. Bertolino 

Pharmacy, 55 FR 4729, 4730 (1990). 

As for state law, Texas Administrative 

Code § 291.29(b) requires pharmacists to 

‘‘make every reasonable effort to ensure 

that any prescription drug order . . . 

has been issued for a legitimate medical 

purpose by a practitioner in the course 

of medical practice.’’ 22 Tex. Admin. 

Code § 291.29(b). The statute further 

requires pharmacists to ‘‘make every 

reasonable effort to prevent 

inappropriate dispensing due to 

fraudulent, forged, invalid, or medically 

inappropriate prescriptions in violation 

of a pharmacist’s corresponding 

responsibility,’’ by considering a list of 

nineteen ‘‘patterns (i.e., red flag factors) 

[that] are relevant to preventing the nontherapeutic dispensing of controlled 

substances.’’ Id. § 291.29(f). These red 

flag factors ‘‘shall be considered by 

evaluating the totality of the 

circumstances rather than any single 

factor.’’ Id. 

In addition, Texas law requires 

pharmacists to ‘‘exercise sound 

professional judgment with respect to 

the accuracy and authenticity of any 

prescription drug order they dispense,’’ 

which requires ‘‘verify[ing] the order 

with the practitioner prior to 

dispensing’’ ‘‘[i]f the pharmacist 

questions the accuracy or authenticity of 

a prescription drug order.’’ Id. 

291.34(b)(1)(A). Finally, Texas law 

requires that ‘‘[p]rior to dispensing, any 

questions regarding a prescription drug 

order must be resolved with the 

prescriber and written documentation of 

these discussions made and maintained 

. . . .’’ Id. § 291.33(c)(2)(A)(iv). 

In the current matter, the Agency 

agrees with the ALJ’s analysis that 

Respondent’s dispensing fell below the 

Texas standard of care, and thus was 

outside the usual course of professional 

practice, because, as detailed above, 

Respondent dispensed numerous 

controlled substance prescriptions to 

four patients without properly 

addressing and resolving clear red flags 

of abuse and diversion including 

dangerous drug cocktails, pattern 

prescriptions for high doses and 

quantities of commonly abused 

controlled substances, and patients 

receiving controlled substances from 

multiple prescribers. See RD, at 27–53. 

As Respondent’s conduct displays 

clear violations of the federal and state 

regulations described above, the Agency 

agrees with the ALJ and hereby finds 

that Respondent repeatedly violated 

federal and state law relating to 

controlled substances. RD, at 27–53. 

Accordingly, the Agency finds that 

Factors B and D weigh in favor of 

revocation of Respondent’s registration 

and thus finds Respondent’s continued 

registration to be inconsistent with the 

public interest in balancing the factors 

of 21 U.S.C. 823(g)(1). Id. 

Respondent’s Exceptions 

Respondent argues in its Exceptions 

that the determination of whether a red 

flag exists is subjective and it is made 

by the pharmacist based on the totality 

of circumstances at the time of 

dispensing. Exceptions, at 3, 8–11. 

Respondent argues that the ALJ erred by 

giving more weight to Ms. Salinas’s 

testimony about the existence of red 

flags than to Dr. Okpala’s, because ‘‘an 

expert witness’s testimony cannot 

replace the subjective thoughts of a 

pharmacist when they are filling a 

prescription.’’ Id. Respondent further 

argues that the duty to resolve and 

document the resolution of a red flag 

only arises if the pharmacist 

subjectively determines that a red flag 

exists. Id. 

The Agency has repeatedly rejected 

these arguments. In a recent case in 

Texas, the respondent’s owner and PIC 

testified, like Dr. Okpala, that red flags 

explicitly listed in Texas law were not 

actually red flags, and that there is no 

duty to document if the pharmacist does 

not identify any red flags. Lewisville 

Medical Pharmacy, 87 FR 59,456, 

59,459 (2022). The Agency found that 

this testimony was ‘‘evidence that 

Respondent was willfully blind to red 

flags on the prescriptions it filled,’’ and 

that it ‘‘evidences, at best, a deep and 

endemic understanding of Texas and 

federal law.’’ Id. at 59,459–60. Here, the 

Agency likewise finds that Dr. Okpala’s 

testimony reflects a troubling 

indifference towards Texas law and 

supports a finding that he was willfully 

blind to the numerous red flags 

presented by the prescriptions in this 

case. 

Respondent also argues in its 

Exceptions that Dr. Okpala knew that 

the prescriptions were issued for a 

legitimate medical purpose because he 

had spoken to the doctors and he knew 

that they had valid doctor-patient 

relationships with the patients at issue. 

Exceptions, at 7–10. This argument 

again reflects a deep misunderstanding 

of a pharmacist’s professional 

obligations under federal and Texas law. 

A pharmacist must always exercise his 

corresponding responsibility to identify, 

resolve, and document red flags, even 

where the prescriptions are ultimately 

determined to be legitimate, and even 

where there ultimately is a valid doctorpatient relationship. Respondent 

undeniably failed to fulfill this 

obligation. Respondent’s Exception also 

implies that every prescription that is 

issued in a valid doctor-patient 

relationship is legitimate, but 

Respondent offers no support for this 

assertion. And regardless of whether 

Respondent believed that the 

prescribers in this case had valid doctorpatient relationships with their patients, 

the evidence overwhelmingly suggests 

that the prescriptions that they issued 

were not legitimate. Prior Agency 

decisions have consistently found that 

prescriptions with a similar list of red 

flags were ‘‘so suspicious as to support 

a finding that the pharmacists who 

filled them violated their corresponding 

responsibility due to actual knowledge 

of, or willful blindness to, the 

prescriptions’ illegitimacy,’’ 18 and Ms. 

Salinas credibly testified that there were 

numerous red flags that created doubt as 

to whether the prescriptions in this case 

were legitimate. RD, at 9; Tr. 336. Ms. 

Salinas’s testimony that the 

prescriptions raised numerous 

suspicions—such as repeated pattern 

prescriptions for high-dose opioids and 

dangerous combinations of controlled 

substances—stands in stark contrast to 

Dr. Okpala’s testimony that it was 

‘‘common sense’’ to assume that 

hydrocodone was permissibly being 

prescribed for chronic pain. RD, at 39; 

Tr. 342, 497. This testimony reflects a 

troubling indifference towards the 

dangers posed by repeated prescriptions 

for a Schedule II controlled substance, 

and it further reinforces that Dr. Okpala 

does not understand his corresponding 

responsibility. 

Finally, Respondent argues in its 

Exceptions that the Government failed 

to prove that the prescriptions were 


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19When 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 5,479, 5,498 n.33 (2019) 

(citing Jones Total Health Care Pharmacy, 81 FR at 

79,202–303); Daniel A. Glick, D.D.S., 80 FR 74,800, 

74,801, 74,810 (2015). Even so, in the current 

matter, Respondent did not identify any relevant 

remedial measures. 

20Respondent noted in its Exceptions that none 

of the medications it dispensed caused adverse 

reactions, which Respondent argues supports a 

conclusion that ‘‘Respondent did not fill any 

‘unlawful’ prescription [sic].’’ Exceptions, at 7. 

However, it is not necessary for the Agency to find 

patient harm to revoke a registration. Melanie 

Baker, N.P., 86 FR 23,998, 24,009 (2021); Larry C. 

Daniels, M.D., 86 FR 61,630, 61,660–61 (2021); 

Jeanne E. Germeil, M.D., 85 FR 73,786, 73,799 n.32 

(2020). Moreover, Ms. Salinas testified that a 

pharmacist’s corresponding responsibility to 

address red flags remains in place even if a patient 

does not physically suffer any adverse effects from 

a medication or drug cocktail. RD, at 9; Tr. 329. 

invalid, that they were issued for nontherapeutic purposes, or that 

Respondent dispensed them 

inaccurately. Exceptions, at 2, 7–8. 

Again, Respondent’s Exception 

misconstrues the applicable legal 

standard. The Government need not 

demonstrate that a prescription was 

invalid, non-therapeutic, or illegitimate 

in order to prove that a pharmacist 

violated his corresponding 

responsibility. The Government need 

only prove that the pharmacist failed to 

identify, resolve, and document red 

flags presented by a prescription, which, 

here, Respondent repeatedly failed to 

do. 

III. Sanction 

Where, as here, the Government has 

established sufficient grounds to revoke 

Respondent’s registration, the burden 

shifts to the registrant to show why it 

can be entrusted with the responsibility 

carried by a registration. Garret Howard 

Smith, M.D., 83 FR 18,882, 18,910 

(2018). When a registrant has committed 

acts inconsistent with the public 

interest, it must both accept 

responsibility and demonstrate that it 

has undertaken corrective measures. 

Holiday CVS, L.L.C., dba CVS Pharmacy 

Nos 219 and 5195, 77 FR 62,316, 62,339 

(2012) (internal quotations omitted). 

Trust is necessarily a fact-dependent 

determination based on individual 

circumstances; therefore, the Agency 

looks at factors such as the acceptance 

of responsibility, the credibility of that 

acceptance as it relates to the 

probability of repeat violations or 

behavior, the nature of the misconduct 

that forms the basis for sanction, and the 

Agency’s interest in deterring similar 

acts. See, e.g., Robert Wayne Locklear, 

M.D., 86 FR 33,738, 33,746 (2021). 

Here, and as noted by the ALJ, 

Respondent’s PIC explicitly denied any 

responsibility for repeatedly filling 

prescriptions in violation of state and 

federal law. RD, at 55. Dr. Okpala 

repeatedly testified that he did not 

observe any red flags with any of the 

prescriptions in this case and that he 

strictly follows the relevant law and 

regulations. RD, at 55; Tr. 402, 414–15, 

452, 460, 467, 474–75, 503. As such, the 

ALJ concluded, and the Agency agrees, 

that Respondent has not demonstrated 

unequivocal acceptance of 

responsibility for its actions. RD, at 56– 

57 (citing Jones Total Health Care 

Pharmacy, L.L.C. & SND Health Care, 

L.L.C., 81 FR 79,188, 79,201–202 

(2016)).19

In addition to acceptance of 

responsibility, the Agency considers 

both specific and general deterrence 

when determining an appropriate 

sanction. Daniel A. Glick, D.D.S., 80 FR 

74,800, 74,810 (2015). In this case, the 

Agency agrees with the ALJ that the 

interests of specific deterrence motivate 

in favor of revocation given that 

Respondent’s PIC filled many of the 

prescriptions at issue, yet failed to 

acknowledge that any red flags existed 

or required resolution. RD, at 58–59. As 

the ALJ noted, Respondent continues to 

reject the notion that pharmacists have 

a duty to identify and resolve red flags 

prior to dispensing, which indicates that 

Respondent has not been rehabilitated. 

Id. at 55–56. Respondent argues in its 

Post-Hearing Brief (PHB) that ‘‘there is 

no cause of action in Texas for ‘red 

flags’ or failing to meet ‘corresponding 

duty,’ ’’ despite having been confronted 

in this proceeding with numerous 

federal and state laws that explicitly 

articulate this obligation. Id. (citing 

Respondent’s PHB, at 5). Portions of Dr. 

Okpala’s testimony indicate that Dr. 

Okpala is more focused on avoiding 

further government scrutiny than 

complying with federal and state law. 

RD, at 56. Dr. Okpala testified that he 

has never had a problem in his thirty 

years of practicing pharmacy, but that 

he will maintain better documentation 

in the future because ‘‘having this court 

order [ ] told [him] that.’’ RD, at 56; Tr. 

402–03, 468. Further, Dr. Okpala’s 

failure to acknowledge the dangers of 

concurrent prescriptions for opioids and 

benzodiazepines is troubling and 

indicates that Respondent cannot be 

trusted to safely dispense controlled 

substances. The Agency also agrees with 

the ALJ that the interests of general 

deterrence 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. at 59. 

Moreover, the Agency agrees with the 

ALJ that Respondent’s actions were 

egregious. Id. at 57–58. As the ALJ 

noted, Respondent dispensed dangerous 

combinations of controlled substances 

to four patients over a two-year period 

without resolving multiple red flags 

indicative of abuse and diversion. Id. at 

57–58. Ms. Salinas testified that the 

nature of the controlled substances 

issued by the Respondent ‘‘put people 

in danger.’’ 20 Id. at 58; Tr. 288. 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. 

RD, at 58–59. 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. FA2332346 issued to 

Awesome Care Pharmacy. 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 Awesome Care 

Pharmacy, to renew or modify this 

registration, as well as any other 

pending application of Awesome Care 

Pharmacy, for additional registration in 

Texas. This Order is effective October 

16, 2024. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on September 10, 2024, 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. 2024–20937 Filed 9–13–24; 8:45 am] 

BILLING CODE 4410–09–P 


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