84616 Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices 

1Based on the Government’s submissions in its 

RFAA dated November 29, 2023, the Agency finds 

that service of the OSC/ISO on Registrant was 

adequate. Specifically, the Government’s exhibit 

titled Notice of Service includes a copy of a Form 

DEA–12 signed by Registrant’s Pharmacist-inCharge, indicating that Registrant was personally 

served with the OSC/ISO on October 5, 2023. 

RFAA, at 1; RFAAX B, at 1, 3. 

2Because the 30-day deadline for responding to 

the OSC/ISO, November 4, 2023, fell on a Saturday, 

the deadline for responding was November 6, 2023. 

3The Government refers to an ‘‘Exhibit G’’ that is 

not included in the instant RFAA. 

4The Agency need not adjudicate the criminal 

violations alleged in the instant OSC/ISO. Ruan v. 

United States, 142 S. Ct. 2,370 (2022) (decided in 

the context of criminal proceedings). 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants, therefore, may submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before December 23, 2024. Such 

persons may also file a written request 

for a hearing on the application on or 

before December 23, 2024. 

ADDRESSES: The Drug Enforcement 

Administration requires that all 

comments be submitted electronically 

through the Federal eRulemaking Portal, 

which provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on August 26, 2024, Irvine 

Labs, Inc., 7305 Murdy Circle, 

Huntington Beach, California 92647– 

3533, applied to be registered as a bulk 

manufacturer of the following basic 

class(es) of controlled substance(s): 

Controlled substance Drug 

code Schedule 

Marihuana Extract .......... 7350 I 

Marihuana ....................... 7360 I 

Tetrahydrocannabinols ... 7370 I 

The applicant plans to manufacture 

bulk Active Pharmaceutical Ingredients 

for product development and 

distribution to DEA-registered 

researchers. No other activities for these 

drug codes are authorized for this 

registration. 

Matthew Strait, 

Deputy Assistant Administrator. 

[FR Doc. 2024–24554 Filed 10–22–24; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

BRX Pharmacy; Decision and Order 

On October 2, 2023, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause and Immediate Suspension of 

Registration (OSC/ISO) to BRX 

Pharmacy of Stafford, Texas 

(Registrant). Request for Final Agency 

Action (RFAA), Exhibit (RFAAX) A, at 

1. The OSC/ISO informed Registrant of 

the immediate suspension of its DEA 

Certificate of Registration, Control No. 

FB7301497, pursuant to 21 U.S.C. 

824(d), alleging that Registrant’s 

continued registration constitutes ‘‘ ‘an 

imminent danger to the public health or 

safety.’ ’’ Id. (quoting 21 U.S.C. 824(d)). 

The OSC/ISO also proposed the 

revocation of Registrant’s registration, 

alleging that Registrant’s continued 

registration is inconsistent with the 

public interest. Id. (citing 21 

U.S.C.823(g)(1), 824(a)(4)). 

The OSC/ISO notified Registrant of its 

right to file with DEA a written request 

for hearing. Id. at 10–11 (citing 21 CFR 

1301.43). The OSC/ISO also notified 

Registrant that if it requested a hearing 

but failed to timely file an answer, it 

would be deemed to have waived its 

right to a hearing and be in default. Id. 

(citing 21 CFR 1301.43(c)(2), (c)(3), (d)). 

On October 30, 2023, Registrant timely 

requested a hearing, however, Registrant 

failed to answer the allegations of the 

OSC/ISO. RFAA, at 1; RFAAX C, at 1.1

The matter was assigned to a DEA 

Administrative Law Judge (ALJ) who 

issued an Order for Prehearing 

Statements that, among other things, 

reminded Registrant to file a compliant 

answer within 30 days of receipt of the 

OSC/ISO.2 RFAA, at 1; RFAAX C, at 2. 

On November 7, 2023, Registrant filed 

an answer, but the ALJ found it 

‘‘substantively non-compliant’’ and 

ordered Registrant to refile. RFAA, at 2; 

RFAAX B, at 4–8; RFAAX D, at 1. 

Registrant ultimately failed to file a 

compliant answer. RFAA, at 2; RFAAX 

E, at 2. On November 13, 2023, the 

Government filed a Motion to Terminate 

Proceedings based on Registrant’s 

failure to file an answer. RFAA, at 2.3

Registrant did not file a response. Id. On 

November 27, 2023, the ALJ issued an 

order finding Registrant in default and 

terminating proceedings. Id.; RFAAX F, 

at 4–5. 

‘‘A default, unless excused, shall be 

deemed to constitute a waiver of the 

registrant’s . . . right to a hearing and 

an admission of the factual allegations 

of the [OSC/ISO].’’ 21 CFR 1301.43(e). 

Further, ‘‘[i]n the event that a registrant 

. . . is deemed to be in default . . . 

DEA may then file a request for final 

agency action with the Administrator, 

along with a record to support its 

request. In such circumstances, the 

Administrator may enter a default final 

order pursuant to [21 CFR] 1316.67.’’ Id. 

§ 1301.43(f)(1). Here, the Government 

has requested final agency action based 

on Registrant’s default pursuant to 21 

CFR 1301.43(c), (f), 1301.46. RFAA, at 2; 

see also 21 CFR 1316.67. 

I. Findings of Fact 

The Agency finds that, in light of 

Registrant’s default, the factual 

allegations in the OSC/ISO are 

admitted.4 Registrant is deemed to have 

admitted and the Agency finds that it 

repeatedly dispensed prescriptions in 

violation of the minimum practice 

standards that govern pharmacy practice 

in Texas. RFAAX A, at 4. Specifically, 

from at least January 2022 through June 

2023, Registrant repeatedly filled 

controlled substance prescriptions that 

contained multiple red flags of abuse 

and/or diversion without addressing or 

resolving the red flags, in violation of 

both federal and state law. Id. at 4–5. 

A. Pattern Prescribing, Substances of 

Abuse, and Strength and Quantity 

Texas regulations identify the 

following prescribing patterns as red 

flag factors: ‘‘[T]he pharmacy dispenses 

a reasonably discernible pattern of 

substantially identical prescriptions for 

the same controlled substances . . . .’’; 

‘‘[P]rescriptions . . . are routinely for 

controlled substances commonly known 

to be abused drugs . . . .’’; and 

‘‘[P]rescriptions for controlled 

substances are commonly for the highest 

strength of the drug and/or for large 

quantities . . . .’’ 22 Tex. Admin. Code 

§§ 291.29(f)(1), (3), (5); RFAAX A, at 5. 

Registrant is deemed to have admitted 

that it failed to identify and resolve the 

red flag of pattern prescribing, 

substances of abuse, and strength and 

quantity. RFAAX A, at 5. Specifically, 

between January 2022 and May 2023, 

Registrant filled prescriptions for 

oxycodone (a Schedule II opioid) issued 

by Dr. V.M. to C.B., E.B., K.B., T.H., and 

O.B. Id. Each prescription was for the 

highest strength of oxycodone, 30 mg, 

which is known to be frequently abused, 

and each prescription ranged from 70 to 

105 dosage units, approximately 3 or 4 

daily doses. Id. 


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5This Decision and Order does not address 

allegations concerning the high cash payment/high 

pricing red flag due to the number and 

egregiousness of the rest of the allegations. Coconut 

Grove Pharmacy, 89 FR 50,372, 50,375 n.20 (2024). 

6Texas regulations further identify as a red flag 

pattern, ‘‘[T]he practitioner’s clinic is not registered 

as, and not exempted from registration as, a pain 

management clinic by the Texas Medical Board, 

despite prescriptions by the practitioner presented 

to the pharmacy indicating that the practitioner is 

mostly prescribing opioids, benzodiazepines, 

barbiturates, or carisoprodol, but not including 

suboxone, or any combination of these drugs.’’ 22 

Tex. Admin. Code § 291.29(f)(8). The OSC alleges, 

and it is therefore deemed admitted, that ‘‘Dr. 

[V.M.] is not Board Certified in the area of pain 

management.’’ RFAAX A, at 6. However, there is 

not substantial evidence or an admission that the 

prescriptions issued by Dr. V.M. that were 

presented to the Registrant were mostly for opioids 

and the other listed controlled substances. 

Accordingly, the Agency cannot sustain this 

allegation or find that it presents an additional 

instance of the prescriber area of practice red flag. 

7Though long distances are not specifically 

mentioned in the Texas regulations, see infra II.B., 

the OSC/ISO notes that the Agency has found that 

traveling long distances to obtain or fill controlled 

substance prescriptions is an additional, wellknown red flag of abuse and/or diversion. Id. 

8Although the OSC/ISO refers to the following 

alleged conduct as ‘‘Other Red Flags,’’ these forms 

of alleged conduct are not specifically listed in the 

Texas regulations as red flags under 22 Tex. Admin. 

Code § 291.29(f). See infra II.B. Instead, the 

following alleged conduct constitutes violations of 

22 Tex. Admin. Code § 291.29(a)–(b) See infra II.B. 

Further, between January 2022 and 

June 2023, Registrant filled 

prescriptions for hydrocodoneacetaminophen (a Schedule II opioid) 

issued by Dr. V.M. to C.A., C.S., J.M., 

J.S., J.M2., and T.S. Id. Each 

prescription was for the highest strength 

of hydrocodone-acetaminophen, 10/325 

mg, which is known to be frequently 

abused, and the prescriptions ranged 

from 100 to 104 dosage units, 

approximately 4 daily doses. Id. 

Accordingly, the Agency finds that 

Registrant filled all these prescriptions 

without first resolving the prescriptions’ 

red flags of pattern prescribing, 

substances of abuse, and strength and 

quantity. Id. 

B. Controlled Substances Prescribed 

With Non-Controlled Substances 

Texas regulations identify the 

following prescribing pattern as a red 

flag factor: ‘‘[D]angerous drugs or overthe-counter products [OTC] . . . are 

consistently added by the prescriber to 

prescriptions for controlled substances 

presented to the pharmacy, indicating a 

lack of individual drug therapy . . . .’’ 

22 Tex. Admin. Code § 291.29(f)(6); 

RFAAX A, at 6. 

Registrant is deemed to have admitted 

that it failed to identify and resolve the 

red flag of similar prescriptions for 

controlled substances with OTC 

products issued by the same 

practitioner. RFAAX A, at 6. 

Specifically, between January 2022 and 

June 2023, Registrant filled 

prescriptions issued by Dr. V.M. to the 

eleven individuals listed above for 

opioids in combination with nonsteroidal anti-inflammatory drugs, 

muscle relaxers, laxatives, and multivitamins. Id. 

Accordingly, the Agency finds that 

Registrant filled all these prescriptions 

without first resolving the red flag of 

controlled substances being prescribed 

with non-controlled OTC products. Id. 

C. Shared Addresses 

Texas regulations identify the 

following prescribing pattern as a red 

flag factor: ‘‘[M]ultiple persons with the 

same address present substantially 

similar controlled substance 

prescriptions from the same 

practitioner.’’ 22 Tex. Admin. Code 

§ 291.29(f)(11); RFAAX A, at 6. 

Registrant is deemed to have admitted 

that it failed to identify and resolve the 

red flag of patients with the same 

address presenting the same, or 

substantially similar, prescriptions from 

the same practitioner. RFAAX A, at 6. 

Specifically, between January 2022 and 

May 2023, Registrant filled 

prescriptions for oxycodone 30 mg for 

E.B. and K.B., who both share the same 

address and received their prescriptions 

from the same practitioner, Dr. V.M. Id. 

Moreover, between January 2022 and 

May 2023, Registrant filled 

prescriptions for hydrocodoneacetaminophen 10/325 mg for J.M., 

J.M2., and T.S., who all share the same 

address and received their prescriptions 

from the same practitioner, Dr. V.M. Id. 

Accordingly, the Agency finds that 

Registrant filled all these prescriptions 

without first resolving the red flag of 

patients with the same address 

presenting the same, or substantially 

similar, prescriptions from the same 

practitioner. Id. 

D. Cash Payments 

Texas regulations identify the 

following prescribing pattern as a red 

flag factor: ‘‘[P]ersons consistently pay 

for controlled substance prescriptions 

with cash or cash equivalents more 

often than through insurance.’’ 22 Tex. 

Admin. Code § 291.29(f)(12); RFAAX A, 

at 6–7. 

Registrant is deemed to have admitted 

that it failed to identify and resolve the 

red flag of cash payments, which is a 

common red flag because it allows a 

patient to avoid the scrutiny associated 

with the use of insurance. RFAAX A, at 

6–7. Specifically, between January 2022 

and June 2023, Registrant routinely 

accepted cash payments for controlled 

substance prescriptions, including all of 

the prescriptions for the eleven 

individuals described above. Id. at 7.5

Accordingly, the Agency finds that 

Registrant filled all these prescriptions 

without first resolving the red flag of 

routinely accepting cash payments for 

controlled substance prescriptions. Id. 

E. Prescriber Area of Practice 

Texas regulations identify the 

following prescribing pattern as a red 

flag factor: ‘‘[T]he controlled 

substance(s) or the quantity of the 

controlled substance(s) prescribed are 

inconsistent with the practitioner’s area 

of medical practice.’’ 22 Tex. Admin. 

Code § 291.29(f)(9); RFAAX A, at 7. 

Registrant is deemed to have admitted 

that between January 2022 and June 

2023, Registrant repeatedly filled 

prescriptions for oxycodone and 

hydrocodone-acetaminophen issued by 

Dr. V.M., despite Dr. V.M. prescribing 

outside her family and administrative 

medicine area of practice. RFAAX A, at 

7.6 Accordingly, the Agency finds that 

Registrant filled all these prescriptions 

without first resolving the red flag 

arising from the prescriber’s area of 

practice. 

F. Long Distances 

Registrant is deemed to have admitted 

that it repeatedly filled prescriptions 

without identifying and resolving the 

red flag of patients traveling long 

distances to obtain or fill controlled 

substance prescriptions.7 RFAAX A, at 

7–8. Specifically, Registrant is deemed 

to have admitted that it filled 

prescriptions for at least four 

individuals, E.B., K.B., C.B., and C.S., 

whose residences were in ‘‘completely 

opposite areas of the Houston 

Metropolitan area’’ from their 

physician’s office (Dr. V.M.) and from 

their pharmacy (Registrant). Id. 

Registrant further admits that there were 

several pharmacies closer to both Dr. 

V.M.;s office and the four individuals’ 

residences. Id. 

Accordingly, the Agency finds that 

Registrant filled all these prescriptions 

without first resolving the red flag of 

patients traveling long distances to fill 

prescriptions for controlled substances. 

Id. 

G. Other Red Flags 8

Registrant is deemed to have admitted 

that it repeatedly filled controlled 

substance prescriptions when it had 

reason to doubt the accuracy or 

legitimacy of the prescriptions, and did 

so without identifying and resolving 

this red flag. Id. at 8–9. For example, 


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84618 Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices 

9As to Factor A, the record contains no evidence 

of a recommendation from any state licensing board 

or professional disciplinary authority. 21 U.S.C. 

823(g)(1)(A). Nonetheless, an absence of such 

evidence ‘‘does not weigh for or against a 

determination as to whether continuation of the 

[registrant’s] DEA certification is consistent with 

the public interest.’’ Roni Dreszer, M.D., 76 FR 

19,434, 19,444 (2011). As to Factor C, there is no 

evidence in the record that Registrant has been 

convicted of an offense under either federal or state 

law ‘‘relating to the manufacture, distribution, or 

dispensing of controlled substances.’’ 21 U.S.C. 

823(g)(1)(C). However, as Agency cases have noted, 

‘‘the absence of such a conviction is of considerably 

less consequence in the public interest inquiry’’ and 

is therefore not dispositive. Dewey C. MacKay, M.D., 

75 FR 49,956, 49,973 (2010). Finally, as to Factor 

E, the Government’s evidence fits squarely within 

the parameters of Factors B and D and does not 

raise ‘‘other conduct which may threaten the public 

health and safety.’’ 21 U.S.C. 823(g)(1)(E). 

Accordingly, Factor E does not weigh for or against 

Registrant. 

Registrant repeatedly filled 

prescriptions for individuals who, 

despite receiving controlled substances 

for supposedly chronic pain, were 

filling their prescriptions late. Id. at 8. 

On November 1, 2022, Registrant filled 

a prescription for oxycodone 30 mg for 

T.H. approximately seven days after the 

prescription was written. Id. On 

November 21, 2022, Registrant filled a 

prescription for oxycodone 30 mg for 

K.B. approximately eleven days after the 

prescription was written. Id. On 

February 16, 2023, Registrant filled a 

prescription for hydrocodoneacetaminophen 10/325 mg for J.S. nine 

days after the prescription was written. 

Id. Lastly, on March 23, 2023, and April 

27, 2023, Registrant filled prescriptions 

for oxycodone 30 mg for O.B. ten or 

more days after the prescriptions were 

written. Id. 

Moreover, Registrant repeatedly filled 

prescriptions for controlled substances 

when there were months when the 

prescriptions were neither prescribed 

nor filled. Id. Between November 16, 

2022, and February 28, 2023, C.A. failed 

to have a monthly controlled 

prescription filled, but filled other noncontrolled prescriptions at Registrant. 

Id. Between October 18, 2022, and April 

12, 2023, J.M2. failed to have a monthly 

controlled prescription filled. Id. at 9. 

Between November 23, 2022, and March 

3, 2023, as well as between March 3, 

2023, and June 5, 2023, C.S. failed to 

have a monthly controlled prescription 

filled, but filled other non-controlled 

prescriptions at Registrant. Id. Between 

November 17, 2022, and February 16, 

2023, J.S. failed to have a monthly 

controlled prescription filled, but filled 

other non-controlled prescriptions at 

Registrant. Id. Between April 28, 2022, 

and October 18, 2022, as well as 

between November 22, 2022, and May 4, 

2023, J.M. failed to have a monthly 

controlled prescription filled, but filled 

other non-controlled prescriptions at 

Registrant. Id. Between February 13, 

2023, and May 2, 2023, K.B. failed to 

have a monthly controlled prescription 

filled, but filled other non-controlled 

prescriptions at Registrant. Id. Between 

November 1, 2022, and April 25, 2023, 

T.H. failed to have a monthly controlled 

prescription filled. Id. Finally, between 

September 15, 2022, and February 15, 

2023, O.B. failed to have a monthly 

controlled prescription filled at 

Registrant, while on November 13, 2022, 

O.B. filled a controlled prescription at 

another pharmacy. Id. 

Registrant is also deemed to have 

admitted that it dispensed prescriptions 

for high dosages of controlled 

substances that, in combination with 

other substances, can cause respiratory 

depression and can lead to coma or 

death. Id. Specifically, Registrant 

dispensed oxycodone and 

cyclobenzaprine (a non-scheduled 

muscle relaxer) together to E.B. 

approximately eleven times. Id. 

Registrant also dispensed oxycodone 

and either gabapentin (a non-scheduled 

anticonvulsant) or tizanidine (a nonscheduled muscle relaxer) together to 

K.B. approximately seven times. Id. 

Accordingly, the Agency finds that 

Registrant filled all these prescriptions 

without first resolving the red flags of 

late fills, gaps in filling prescriptions, 

and high dosages of controlled 

substances in dangerous combinations. 

Id. 

H. Expert Review 

DEA retained an independent 

pharmacy expert who concluded that 

the above prescription data presented 

multiple red flags that were highly 

indicative of abuse and diversion. Id. 

Registrant is deemed to have admitted 

and the Agency finds that these red flags 

were not resolved by a pharmacist 

acting in the usual course of 

professional practice prior to 

dispensing, and, therefore, that each 

prescription was filled outside the 

Texas standard of care. Id. 

II. Discussion 

A. The Five Public Interest Factors 

Under the Controlled Substances Act 

(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 [21 U.S.C. 823] 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). 

While the Agency has considered all 

of the public interest factors in 21 U.S.C. 

823(g)(1),9 the Government’s evidence 

in support of its prima facie case for 

revocation of Registrant’s registration is 

confined to Factors B and D. See 

RFAAX A, at 5. Moreover, the 

Government has the burden of proof in 

this proceeding. 21 CFR 1301.44. 

Here, the Agency finds that the 

Government’s evidence satisfies its 

prima facie burden of showing that 

Registrant’s continued registration 

would be ‘‘inconsistent with the public 

interest.’’ 21 U.S.C. 824(a)(4). 

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 1,095, 1,097 (2023); Kareem 

Hubbard, M.D., 87 FR 21,156, 21,162 

(2022). In the current matter, the 

Government has alleged that Registrant 

violated both federal and state law 

regulating controlled substances. 

RFAAX A, at 2–4. 

Specifically, a pharmacist may only 

fill a prescription that was ‘‘issued for 

a legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice.’’ Id. § 1306.04(a). 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 


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Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices 84619 

who fills the prescription.’’ Id. Section 

1306.04(a) prohibits ‘‘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.’’ Wheatland Pharmacy, 78 FR 

69,441, 69,445 (2013) (internal 

quotations and alterations omitted); 

RFAAX 2, at 2. DEA regulations require 

‘‘pharmacists to identify and resolve 

suspicions that a prescription is 

illegitimate.’’ Trinity Pharmacy II, 83 FR 

7,304, 7,331 (2018); RFAAX 2, at 2. 

Further, under federal regulations, a 

prescription for a controlled substance 

‘‘may only be filled by a pharmacist, 

acting in the usual course of his 

professional practice.’’ 21 CFR 1306.06. 

As for state law, under Texas 

regulations, ‘‘[a] pharmacist may not 

dispense . . . a controlled substance 

. . . except under a valid prescription 

and in the course of professional 

practice.’’ Tex. Health & Safety Code 

§ 481.074(a). Regarding the specific 

standards for a pharmacist filing a new 

or refill prescription, ‘‘[f]or the purpose 

of promoting therapeutic 

appropriateness, a pharmacist shall, 

prior to or at the time of dispensing a 

prescription drug order, review the 

patient’s medication record. Such 

review shall at a minimum identify 

clinically significant: . . . (III) 

reasonable dose and route of 

administration; . . . (VI) drug-drug 

interactions; . . . [and] (X) proper 

utilization, including overutilization or 

underutilization.’’ 22 Tex. Admin. Code 

§ 291.33(c)(2)(A)(i). ‘‘Upon identifying 

any clinically significant conditions [or] 

situations . . . the pharmacist shall take 

appropriate steps to avoid or resolve the 

problem including consultation with the 

prescribing practitioner.’’ Id. 

§ 291.33(c)(2)(A)(ii). ‘‘Prior 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); see also id. 

§§ 291.29(a)–(b), 291.33(c)(2)(C) 

(describing the requirements for 

documentation). 

Regarding ‘‘red flag factors’’ that are 

‘‘relevant to preventing the nontherapeutic dispensing of controlled 

substances,’’ Texas regulations identify 

the following relevant circumstances as 

red flags: 

(1) the pharmacy dispenses a 

reasonably discernible pattern of 

substantially identical prescriptions for 

the same controlled substances, 

potentially paired with other drugs, for 

numerous persons, indicating a lack of 

individual drug therapy in prescriptions 

issued by the practitioner; . . . 

(3) prescriptions by a prescriber 

presented to the pharmacy are routinely 

for controlled substances commonly 

known to be abused drugs, including 

opioids, benzodiazepines, muscle 

relaxants, psychostimulants, and/or 

cough syrups containing codeine, or any 

combination of these drugs; 

(4) prescriptions for controlled 

substances by a prescriber presented to 

the pharmacy contain nonspecific or no 

diagnoses, or lack the intended use of 

the drug; 

(5) 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; . . . 

(8) the practitioner’s clinic is not 

registered as, and not exempted from 

registration as, a pain management 

clinic by the Texas Medical Board, 

despite prescriptions by the practitioner 

presented to the pharmacy indicating 

that the practitioner is mostly 

prescribing opioids . . . ; 

(9) the controlled substance(s) or the 

quantity of the controlled substance(s) 

prescribed are inconsistent with the 

practitioner’s area of medical practice; 

. . . 

(11) multiple persons with the same 

address present substantially similar 

controlled substance prescriptions from 

the same practitioner; [and] 

(12) persons consistently pay for 

controlled substance prescriptions with 

cash or cash equivalents more often 

than through insurance.’’ 

Id. § 291.29(f). Further, under Texas 

regulations, ‘‘[a] pharmacist shall not 

dispense a prescription drug if the 

pharmacist knows or should know the 

prescription drug order is fraudulent or 

forged.’’Id. 

Here, as found above, Registrant is 

deemed to have admitted and the 

Agency finds that Registrant repeatedly 

filled prescriptions for controlled 

substances that contained multiple red 

flags of abuse and/or diversion without 

addressing or resolving those red flags. 

RFAAX A, at 5–9. DEA’s pharmacy 

expert concluded that these red flags 

were highly indicative of abuse and 

diversion. Id. at 9. Registrant has further 

admitted that none of the abovereferenced controlled substance 

prescriptions were filled for a legitimate 

medical purpose in the usual course of 

professional practice. Id. As such, the 

Agency finds that Registrant violated 21 

CFR 1306.04, 1306.06; Texas Health & 

Safety Code § 481.074; and 22 Texas 

Administrative Code §§ 291.29, 291.33. 

Accordingly, the Agency finds that 

Factors B and D weigh in favor of 

revocation of Registrant’s registration 

and thus finds Registrant’s continued 

registration to be inconsistent with the 

public interest in balancing the factors 

of 21 U.S.C. 823(g)(1). The Agency 

further finds that Registrant failed to 

provide any evidence to rebut the 

Government’s prima facie case. 

III. Sanction 

Where, as here, the Government has 

established grounds for revocation, 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). To establish that 

it can be entrusted with registration, a 

registrant 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); see 

also Michele L. Martinho, M.D., 86 FR 

24,012, 24,019 (2021); George D. 

Gowder, III, M.D., 89 FR 76,152, 76,154 

(2024). Trust is necessarily a factdependent 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, Registrant failed to answer the 

allegations contained in the OSC/ISO 

and did not otherwise avail itself of the 

opportunity to refute the Government’s 

case. As such, Registrant has made no 

representations as to its future 

compliance with the CSA nor made any 

demonstration that it can be entrusted 

with registration. Moreover, the 

evidence presented by the Government 

shows that Registrant violated the CSA, 

further indicating that Registrant cannot 

be entrusted. 

Accordingly, the Agency will order 

the revocation of Registrant’s 

registration. 

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. FB7301497 issued to 

BRX 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 BRX 

Pharmacy to renew or modify this 


khammond on DSKJM1Z7X2PROD with NOTICES
84620 Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices 

1The record represents that this registration 

expired on November 30, 2023. RFAAX 1, at 1. The 

fact that a registrant allows its registration to expire 

during the pendency of an administrative 

enforcement proceeding does not impact the 

Agency’s jurisdiction or prerogative to adjudicate 

the OSC/ISO to finality. Jeffrey D. Olsen, M.D., 84 

FR 68474, 68479 (2019). 

2The Agency agrees with the Government and the 

Chief ALJ that the only individual with authority 

to request a hearing on Registrant’s behalf was its 

owner and PIC, Mr. Itani, as he has been 

Registrant’s only managing member and is the sole 

signatory and contact on Registrant’s registration. 

RFAAX 2, at 2–4; RFAAX 4, at 3–4; see also infra 

note 3. 

3See supra note 2. Given the Government’s 

unrefuted representations that Mr. Itani was 

unaware that a hearing had been requested and that 

he had no interest in a hearing, the Agency views 

Counsel’s extended silence in the face of multiple 

requests as sufficient evidence that the hearing 

request was not filed upon the direction of Mr. 

Itani, the only person entitled to request a hearing 

for Registrant. 

4Even if the hearing request had been valid, 

Registrant would be deemed to be in default based 

on its ‘‘fail[ure] to plead . . . or otherwise defend’’ 

itself. See 21 CFR 1301.43(c)(3) (‘‘In the event . . . 

a person who has requested a hearing fails to plead 

. . . or otherwise defend, said party shall be 

deemed to be in default and the opposing party may 

move to terminate the proceeding.’’). Here, as the 

Chief ALJ found, Registrant waived its right to a 

hearing by failing to respond to the Government’s 

motion to terminate, failing to respond to chambers 

staff at the Chief ALJ’s direction, failing to file 

exhibits, and failing to file a notarized power of 

attorney as ordered by the Chief ALJ. RFAAX 4, at 

4. 

registration, as well as any other 

pending application of BRX Pharmacy 

for additional registration in Texas. This 

Order is effective November 22, 2024. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 15, 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. 2024–24564 Filed 10–22–24; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Itani Family Pharmacy, PLC; 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 Itani Family 

Pharmacy, PLC, of Titusville, Florida 

(Registrant). Request for Final Agency 

Action (RFAA), Exhibit (RFAAX) 1, 

Attachment (Attach.) A (hereinafter, 

OSC/ISO), at 1, 6. The OSC/ISO 

informed Registrant of the immediate 

suspension of its DEA registration, No. 

FI2917702,1 pursuant to 21 U.S.C. 

824(d), alleging that Registrant’s 

continued registration constitutes ‘ ‘‘an 

imminent danger to the public health or 

safety.’ ’’ Id. at 1 (quoting 21 U.S.C. 

824(d)). The OSC/ISO also proposed the 

revocation of Registrant’s registration, 

alleging that Registrant’s continued 

registration is inconsistent with the 

public interest. Id. (citing 21 U.S.C. 

823(g)(1), 824(a)(4)). 

The OSC/ISO notified Registrant of its 

right to file with DEA a written request 

for hearing within 30 days after the date 

of receipt of the OSC/ISO. OSC/ISO, at 

5–6 (citing 21 CFR 1301.43(a)). The 

OSC/ISO also notified Registrant that if 

it failed to file such a request, it would 

be deemed to have waived its right to 

a hearing and be in default. Id. (citing 

21 CFR 1301.43(c)). The OSC/ISO 

further notified Registrant that 

‘‘[d]efault constitutes a waiver of 

[Registrant’s] right to a hearing and an 

admission of the factual allegations of 

this [OSC/ISO].’’ Id. (citing 21 CFR 

1301.43(e)). 

On June 19, 2023, the OSC/ISO was 

personally served on Registrant’s owner 

and pharmacist-in-charge (PIC), Mr. 

Basil Itani. RFAAX 1, at 1. On June 30, 

2023, a purported request for hearing 

was filed with the DEA Office of 

Administrative Law Judges (OALJ) and 

assigned to the Chief Administrative 

Law Judge (Chief ALJ). RFAA, at 2. A 

prehearing conference was then held on 

July 27, 2023. RFAA, at 2; RFAAX 2, at 

2; RFAAX 4, at 1–2. 

On September 22, 2023, the 

Government filed a motion to terminate 

the proceedings. RFAAX 2, at 4–5. In 

the motion, the Government represented 

that after the July 27 prehearing 

conference, ‘‘it came to DEA’s attention 

that Mr. Basil Itani was unaware of any 

administrative proceedings that had 

taken place’’ and that he had ‘‘no 

interest in proceeding forward with the 

administrative hearing.’’ Id. at 2. The 

Government further represented that 

Mr. Itani had informed DEA that he did 

not have interest in proceeding with a 

hearing, and ‘‘only his father . . . would 

possess any interest in moving forward 

with the DEA administrative hearing.’’ 

Id. After learning this information, 

Government counsel notified the 

attorney who filed the hearing request 

(hereinafter, Counsel) that the 

Government would file a motion to 

terminate the proceedings unless 

Counsel provided the Government with 

evidence ‘‘that [Counsel] represented 

[Mr. Itani] and his interests in this 

administrative hearing.’’ Id. The 

Government never received any 

response to this request and filed a 

motion to terminate, arguing that 

Registrant’s hearing request ‘‘was made 

without authority’’ because Mr. Itani— 

the only individual who had authority 

to request a hearing 2—did not ‘‘provide 

express authority to request a hearing on 

behalf of the pharmacy.’’ Id. at 3–5. 

On September 28, 2023, the Chief ALJ 

ordered Counsel to ‘‘provide . . . a 

notarized power of attorney showing the 

requisite authority to act as a 

representative [of Registrant] in these 

administrative enforcement 

proceedings.’’ RFAAX 3 (citing 21 CFR 

1316.50). Counsel never responded to 

the Government’s motion to terminate 

or the Chief ALJ’s directive, and never 

produced any evidence demonstrating 

that he had authority to represent 

Registrant. RFAAX 4, at 1, 3. Based on 

Registrant’s failure to respond, on 

October 5, 2023, the Chief ALJ granted 

the Government’s unopposed motion 

and terminated proceedings, finding 

that ‘‘there is simply no basis upon 

which to conclude that [Counsel] has 

authority to act on behalf of [Registrant], 

or that the [request for hearing] in this 

case is valid.’’ Id. at 4. 

The Agency agrees with the Chief 

ALJ. Counsel was given three 

opportunities to demonstrate that he 

was authorized to request a hearing for 

Registrant after the Government learned 

that Mr. Itani was unaware of the 

proceedings and had no interest in 

participating. In response to these 

opportunities, Counsel remained silent. 

Indeed, by the time the Chief ALJ 

terminated the case, it had been over 

two months since Counsel had 

communicated with OALJ or made any 

filings in the matter. RFAAX 4, at 2 

nn.3–4. Despite multiple requests, 

Counsel remained silent and, as the 

Chief ALJ found, failed to demonstrate 

that he had the authority to act for 

Registrant.3 RFAAX 4, at 3–4. 

Accordingly, the Agency finds that a 

valid hearing request was never filed in 

this matter and, consequently, that 

Registrant is deemed to be in default.4

21 CFR 1301.43(c)(1). ‘‘A default, unless 


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