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33While Respondent clearly violated both Federal 

and State law by failing to have inventories on hand 

during the June 2022 inspection, Respondent has 

accepted responsibility for and taken steps to 

remediate this particular violation. Respondent has 

also accepted responsibility, though perhaps not 

unequivocally, and attempted to remediate the 

improper storage of controlled substances at her 

home. However, acceptance of responsibility and 

remedial steps regarding these two violations does 

not lead the Agency to reduce the sanction here, 

because the evidence shows that Respondent has 

not unequivocally accepted responsibility nor taken 

any steps to remediate the egregious dispensing 

violations. See infra. 

34Citing Mireille Lalanne, M.D., 78 47750, 47777 

(2013) (quoting Liddy’s Pharmacy, L.L.C., 76 FR 

48887, 48897 (2011) (‘‘The Agency has recognized 

that a cessation of illegal behavior only when ‘DEA 

comes knocking at one’s door,’ can be afforded a 

diminished weight borne of its own opportunistic 

timing.’’)); Southwood Pharmaceuticals, Inc., 72 FR 

36487, 36503 (2007) (giving no weight to 

respondent’s ‘‘stroke-of-midnight decision’’ to cease 

supplying suspect pharmacies with controlled 

substances and to employ a compliance officer). 

Agency’s interest in deterring similar 

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

M.D., 86 FR 33738, 33746 (2021). 

Here, and as noted by the ALJ, 

Respondent, through its owner, 

admitted fault for its failure to maintain 

adequate inventories and failure to 

properly store controlled substances at 

its registered location.33 RD, at 63–64; 

Tr. 338–339, 348–349, 354. However, 

Respondent completely ‘‘failed to 

acknowledge [its] errors in handling 

prescriptions with red flags’’ and did 

not ‘‘accept responsibility for failing to 

identify, resolve, and document red 

flags.’’ RD, at 64–65. As such, the ALJ 

concluded, and the Agency agrees, that 

Respondent has not demonstrated 

unequivocal acceptance of 

responsibility for its actions. RD, at 64 

(citing Jones Total Health Care 

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

L.L.C., 81 FR 79188, 79201–202 (2016)). 

When a registrant fails to make the 

threshold showing of acceptance of 

responsibility, the Agency need not 

address the registrant’s remedial 

measures. Ajay S. Ahuja, M.D., 84 FR 

5479, 5498 n.33 (2019) (citing Jones 

Total Health Care Pharmacy, 81 FR at 

79202–303); Daniel A. Glick, D.D.S., 80 

FR 74800, 74801, 74810 (2015). Even so, 

in the current matter, Respondent did 

not provide any evidence of remedial 

measures related to its improper 

dispensing that demonstrate that 

Respondent would be able to spot, 

resolve, and document resolution of red 

flags in the future. The ALJ noted, and 

the Agency has considered, that 

Respondent’s owner testified, without 

documentary corroboration, that since 

the June 2022 inspection, Respondent 

has updated its ‘‘perpetual inventory’’ 

on a daily basis and keeps its controlled 

substances locked in the registered 

location’s safe. RD, at 65 n.120; Tr. 345, 

349. However, ‘‘remediation alone is not 

adequate to avoid a sanction and [ ] 

limited-to-no-weight is given to 

remedial measures when the effort is 

not made until after enforcement 

begins.’’ Morris & Dickson Co., LLC, 88 

FR 34523, 34540 (2023).34 Moreover, 

because the Respondent has not 

presented evidence of any remedial 

measures for its egregious dispensing 

failures, the Agency cannot entrust 

Respondent with a registration. 

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 

at 74810. In this case, the Agency agrees 

with the ALJ that given that 

Respondent’s pharmacist-in-charge 

filled every single prescription at issue 

and that Respondent’s owner testified 

that she was present for and involved in 

all filling of prescriptions, yet both 

individuals failed to acknowledge that 

any red flags existed or required 

resolution, ‘‘the interests of specific 

deterrence, even standing alone, 

motivate powerfully in favor of 

revocation.’’ RD, at 66–67; Tr. 321, 328– 

331. Further, the Agency agrees with the 

ALJ that the interests of general 

deterrence also support revocation, as a 

lack of sanction in the current matter 

would send a message to the registrant 

community that the failure to properly 

address and document resolution of red 

flags, the failure to keep adequate 

inventories, and/or the failure to 

securely store controlled substances can 

be excused. RD, at 67. 

Moreover, the Agency agrees with the 

ALJ that Respondent’s actions were 

egregious. Id. at 66. As stated by the 

ALJ, ‘‘Respondent dispensed many 

controlled substances over a one-and-ahalf-year period without any regard for 

its obligations to identify, resolve, or 

document any blatant red flags of 

potential diversion’’ and with awareness 

of both its obligations and the existence 

of numerous red flags in the 

prescriptions that it was filling and 

dispensing. Id.; Tr. 310, 364–365, 367, 

370. Further, regarding recordkeeping, 

inventory, and storage, Respondent not 

only failed to maintain proper 

inventories, thereby ‘‘precluding the 

ability of DEA to conduct an 

accountability audit,’’ but also failed to 

properly store controlled substances at 

its registered location, with 

Respondent’s owner instead 

transporting and storing controlled 

substances at a personal residence in 

complete disregard of security 

requirements. RD, at 66. 

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. Id. at 67. 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. FM2396427 issued to 

Midtown Specialty RX. 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 Midtown Specialty RX 

to renew or modify this registration, as 

well as any other pending application of 

Midtown Specialty RX for additional 

registration in Texas. This Order is 

effective November 12, 2024. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 4, 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. 2024–23482 Filed 10–9–24; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Halowells Pharmacy; Decision and 

Order 

On November 8, 2023, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause and Immediate Suspension of 

Registration (OSC/ISO) to Halowells 

Pharmacy (Registrant) of Pearland, 

Texas. 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. 


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1Based on the Government’s submissions in its 

RFAA dated January 4, 2024, the Agency finds that 

service of the OSC/ISO on Registrant was adequate 

and rendered on November 16, 2023. Specifically, 

the Government included as an attachment to its 

RFAA a Form DEA–12 signed by a representative 

of Registrant, indicating that Registrant was 

personally served with the OSC/ISO on November 

16, 2023. RFAA, at 1–2; RFAAX B. 

2The 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). 

3C.W., D.S.E., D.S.M., D.S.T., D.W., E.W., J.J., J.L., 

J.R., and L.T., the relevant individuals to whom 

prescriptions were improperly filled in this case, 

are referred to collectively as the ten individuals. 

4The OSC also alleges, and it is therefore 

admitted, that Registrant filled oxycodone 30 mg for 

D.S.T. who shared an address with D.S.E. and J.L. 

and saw the same practitioner. Id. This allegation 

is not sustained because there is not substantial 

evidence or an admission that clearly establishes 

that hydrocodone-acetaminophen 10/325 is a 

‘‘substantially similar controlled substance 

prescription’’ to oxycodone 30 mg such that the 

prescription presents an additional instance of the 

shared address red flag. Id. 

FH9037830, 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, and 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. at 9 (citing 21 CFR 

1301.43). Here, Registrant did not 

request a hearing. RFAA, at 2.1 ‘‘A 

default, unless excused, shall be 

deemed to constitute a waiver of the 

registrant’s/applicant’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 3; 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.2 Registrant is deemed to have 

admitted 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 July 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 

Texas regulations identify the 

following prescribing patterns as red 

flag factors: Dispensing to numerous 

persons substantially identical 

prescriptions by the same prescriber for 

the same controlled substances; a 

prescriber’s prescriptions are routinely 

for controlled substances commonly 

known to be abused drugs, including 

opioids; and a prescriber’s prescriptions 

for controlled substances are commonly 

for the highest strength of the drug and/ 

or for large quantities (e.g., monthly 

supply). 22 Tex. Admin. Code section 

291.29(f)(1), (3), (5); RFAAX A, at 3–4. 

Registrant is deemed to have admitted 

that it failed to identify and resolve the 

red flag that occurs when a practitioner 

prescribes the same controlled 

substance in identical or substantially 

similar quantities to multiple patients. 

RFAAX A, at 5. Specifically, between 

January 2022 and June 2023, Registrant 

filled over 90 prescriptions for 

oxycodone issued by Dr. V.M. to C.W., 

D.S.T., D.W., E.W., J.L., J.R., and L.T. Id. 

Each prescription was for the highest 

strength of oxycodone, 30 mg, which is 

known to be frequently abused, and 

each prescription ranged from 98 to 105 

dosage units. Id. 

Further, between January 2022 and 

June 2023, Registrant filled over 30 

prescriptions for hydrocodoneacetaminophen issued by Dr. V.M. to 

D.S.E., D.S.M., and J.J. 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 90 to 105 dosage units. Id. 

Accordingly, the Agency finds that 

Registrant filled over 120 controlled 

substance prescriptions without first 

resolving the pattern prescribing red 

flags. 

B. Prescriptions Lacking Specific 

Diagnosis 

Texas regulations identify the 

following prescribing pattern as a red 

flag factor: ‘‘[P]rescriptions for 

controlled substances by a prescriber 

presented to the pharmacy contain 

nonspecific or no diagnoses, or lack the 

intended use of the drug.’’ 22 Tex. 

Admin. Code section 291.29(f)(4); 

RFAAX A, at 3. 

Registrant is deemed to have admitted 

that it failed to identify and resolve the 

red flag of prescriptions lacking a 

specific diagnosis. RFAAX A, at 5. 

Specifically, between January 2022 and 

June 2023, Registrant filled 

prescriptions lacking specific diagnoses 

for all ten individuals 3 for oxycodone 

30 mg and hydrocodone-acetaminophen 

10/325 mg. Id. Accordingly, the Agency 

finds that Registrant filled controlled 

substance prescriptions without first 

resolving the red flag of prescriptions 

lacking a specific diagnosis. 

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 

section 291.29(f)(11); RFAAX A, at 4. 

Registrant is deemed to have admitted 

that it failed to identify and resolve the 

red flag of multiple persons with the 

same address presenting the same, or 

substantially similar, prescriptions from 

the same practitioner. RFAAX A, at 6. 

Specifically, between January 2022 and 

June 2023, Registrant filled 

prescriptions for oxycodone 30 mg for 

C.W. and D.W., who both share the 

same address and received their 

prescriptions from the same 

practitioner, Dr. V.M. Id. Between 

January 2022 and April 2023, Registrant 

filled prescriptions for hydrocodoneacetaminophen 10/325 mg for D.S.M. 

and J.J., who both share the same 

address and received their prescriptions 

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

Between February 2022 and June 2023, 

Registrant filled prescriptions for 

oxycodone 30 mg for J.R. and L.T., who 

both share the same address and 

received their prescriptions from the 

same practitioner, Dr. V.M. Id. Finally, 

between January 2022 and May 2023, 

Registrant filled prescriptions for 

hydrocodone-acetaminophen 10/325 mg 

for D.S.E. and J.L.,4 who both share the 

same address and received their 

prescriptions from the same 

practitioner, Dr. V.M. Id. 

Accordingly, the Agency finds that 

Registrant filled controlled substance 

prescriptions without first resolving the 

red flag of shared addresses. 


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5Texas 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 section 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. 

6The OSC additionally alleged, and it is therefore 

deemed admitted, that ‘‘between January 2022 and 

July 2023, [Registrant] routinely dispensed a 

quantity less than the amount prescribed by the 

physician and provided no documentation 

regarding approval from the physician.’’ Id. The 

OSC implies that this conduct violates 22 Texas 

Administrative Code section 291.33(c)(2)(A)(iv), 

which states: ‘‘[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. It is not clear from 

substantial record evidence or an admission that the 

Registrant filling a quantity less than what was 

prescribed means that Registrant must have had 

unresolved questions regarding the prescription 

drug order. Accordingly, this allegation regarding 

the red flag of dispensing less than prescribed is not 

sustained. The Agency finds that the founded 

allegations discussed above are more than sufficient 

to support the Government’s requested sanction of 

revocation under these circumstances. 

7As 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 

19434, 19444 (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). Agency cases have found that ‘‘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 49956, 49973 (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. 

D. 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 section 291.29(f)(9); RFAAX A, at 

6. 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 of her family and administrative 

medicine area of practice. RFAAX A, at 

6.5 Accordingly, the Agency finds that 

Registrant filled controlled substance 

prescriptions without first resolving the 

red flag arising from the prescriber’s 

area of practice. 

E. Long Distances 

Registrant is deemed to have admitted 

that individuals traveling long distances 

to obtain or fill controlled substance 

prescriptions is a well-known red flag of 

abuse or diversion. Registrant further 

admits that it repeatedly filled 

prescriptions without identifying and 

resolving the red flag of patients 

traveling long distances to obtain or fill 

controlled substance prescriptions. Id. 

at 7. Specifically, Registrant is deemed 

to have admitted that it filled 

prescriptions for seven individuals, 

C.W., D.W., D.S.M., J.J., E.W., J.R., and 

L.T., 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 seven individuals’ 

residences. Id. 

Accordingly, the Agency finds that 

Registrant filled controlled substance 

prescriptions without first resolving the 

red flag arising from long distances 

traveled. 

F. 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 section 291.29(f)(12); 

RFAAX A, at 7–8. 

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. Id. at 7–8. 

Specifically, between January 2022 and 

July 2023, Registrant routinely accepted 

cash payments for controlled substance 

prescriptions, including for each of the 

prescriptions filled for each of the ten 

individuals as described above. Id. at 8. 

Registrant is also deemed to have 

admitted that for L.T., Registrant 

routinely accepted cash payment for 

L.T.’s prescriptions between February 

2022 and July 2023, despite the Texas 

Prescription Drug Monitoring Program 

Report indicating that L.T. used 

insurance at other pharmacies on three 

occasions.6 Id. 

Accordingly, the Agency finds that 

Registrant filled controlled substance 

prescriptions without first resolving the 

red flag arising from cash payments. 

G. 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 

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 CFR 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 15227, 15230 

(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 37507, 37508 (1993). 

While the Agency has considered all 

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

823(g)(1),7 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 


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RFAAX A, at 4–5. 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 1095, 1097 (2023); Kareem Hubbard, 

M.D., 87 FR 21156, 21162 (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 

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 

69441, 69445 (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 7304, 7331 (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 

section 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 

section 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. section 

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. section 

291.33(c)(2)(A)(iv); see also id. sections 

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. section 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, Registrant has admitted that it 

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 

5–8. DEA’s pharmacy expert concluded 

that these red flags were highly 

indicative of abuse and diversion. Id. at 

8. Registrant has further admitted that 

none of the above-referenced 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 section 481.074, 

and 22 Texas Administrative Code 

sections 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 

18882, 18910 (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., d/b/a CVS/ 

Pharmacy Nos. 219 and 5195, 77 FR 

62316, 62339 (2012) (internal quotations 

omitted); see also Michele L. Martinho, 

M.D., 86 FR 24012, 24019 (2021); George 

D. Gowder, III, M.D., 89 FR 76152, 

76154 (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 33738, 

33746 (2021). 

Here, Registrant failed to answer the 

allegations contained in the OSC/ISO 


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Federal Register / Vol. 89, No. 197 / Thursday, October 10, 2024 / Notices 82271 

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. FH9037830 issued to 

Halowells 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 Halowells Pharmacy to renew or 

modify this registration, as well as any 

other pending application of Halowells 

Pharmacy for additional registration in 

Texas. This Order is effective November 

12, 2024. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 4, 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. 2024–23495 Filed 10–9–24; 8:45 am] 

BILLING CODE 4410–09–P 

NATIONAL SCIENCE FOUNDATION 

Agency Information Collection 

Activities: Comment Request; Louis 

Stokes Alliances for Minority 

Participation (LSAMP) Program 

Evaluation; Withdrawal 

AGENCY: National Science Foundation 

(NSF). 

ACTION: Notice; withdrawal. 

SUMMARY: The National Science 

Foundation published a notice in the 

Federal Register on September 23, 2024, 

that was inadvertently sent forward to 

publish and is a duplicate (with errors) 

of a notice published on October 2, 

2024. 

FOR FURTHER INFORMATION CONTACT: 

Suzanne H. Plimpton, Reports Clearance 

Officer, National Science Foundation, 

2415 Eisenhower Avenue, Alexandria, 

Virginia 22314; telephone (703) 292– 

7556; or send email to splimpto@

nsf.gov. Individuals who use a 

telecommunications device for the deaf 

(TDD) may call the Federal Information 

Relay Service (FIRS) at 1–800–877– 

8339, which is accessible 24 hours a 

day, 7 days a week, 365 days a year 

(including federal holidays). 

SUPPLEMENTARY INFORMATION: 

Background 

On September 23, 2024, the National 

Science Foundation published in the 

Federal Register a notice for comments 

(FR Doc 2024–21845) that was 

inadvertently published (with errors) 

and is a duplicate of a notice published 

October 2, 2024 (FR Doc 2024–22588). 

Retraction 

From the Federal Register of 

September 23, 2024, the notice in the 

second column of page 77898 to the 

second column of 77899, is withdrawn 

(FR Doc 2024–21845). As such, FR Doc 

2024–21845 should be disregarded. 

Dated: October 4, 2024. 

Suzanne H. Plimpton, 

Reports Clearance Officer, National Science 

Foundation. 

[FR Doc. 2024–23420 Filed 10–9–24; 8:45 am] 

BILLING CODE 7555–01–P 

NUCLEAR REGULATORY 

COMMISSION 

720th Meeting of the Advisory 

Committee on Reactor Safeguards 

(ACRS) 

In accordance with the purposes of 

sections 29 and 182b of the Atomic 

Energy Act (42 U.S.C. 2039, 2232(b)), 

the Advisory Committee on Reactor 

Safeguards (ACRS) will hold meetings 

on November 6–8, 2024. The Committee 

will be conducting meetings that will 

include some Members being physically 

present at the NRC while other Members 

participate remotely. Interested 

members of the public are encouraged to 

participate remotely in any open 

sessions via MS Teams or via phone at 

301–576–2978, passcode 887 935 620#. 

A more detailed agenda including the 

MSTeams link may be found at the 

ACRS public website at https://

www.nrc.gov/reading-rm/doccollections/acrs/agenda/index.html. If 

you would like the MSTeams link 

forwarded to you, please contact the 

Designated Federal Officer (DFO) as 

follows: Quynh.Nguyen@nrc.gov, or 

Lawrence.Burkhart@nrc.gov. 

Wednesday, November 6, 2024 

8:30 a.m.–8:35 a.m.: Opening 

Remarks by the ACRS Chair (Open)— 

The ACRS Chair will make opening 

remarks regarding the conduct of the 

meeting. 

8:35 a.m.–10:30 a.m.: Draft White 

Paper, ‘‘Nth-of-a-Kind Micro-Reactor 

Licensing and Deployment 

Considerations’’ (Open)—The 

Committee will have presentations and 

discussion with the NRC staff regarding 

the subject topic. 

10:30 a.m.–1:00 p.m.: Committee 

Deliberation on Draft White Paper, 

‘‘Nth-of-a-Kind Micro-Reactor Licensing 

and Deployment Considerations’’ 

(Open)—The Committee will deliberate 

with the NRC staff regarding the subject 

topic. 

1:00 p.m.–6:00 p.m.: Triennial Review 

and Evaluation of NRC Safety Research 

Program/Preparation of Reports 

(Open)—The Committee will have 

presentations and discussion with the 

NRC staff regarding the subject topic. 

Thursday, November 7, 2024 

8:30 a.m.–10:15 a.m.: TerraPower 

Natrium Topical Report on Plume 

Exposure Pathway Emergency Planning 

Zone (Open/Closed)—The Committee 

will have presentations and discussion 

with the NRC staff regarding the subject 

topic. 

[Note: Pursuant to 5 U.S.C. 552b(c)(4), 

a portion of this session may be closed 

in order to discuss and protect 

information designated as proprietary.] 

10:15 a.m.–11:15 a.m.: Committee 

Deliberation on the TerraPower Natrium 

Topical Report on Plume Exposure 

Pathway Emergency Planning Zone 

(Open/Closed)—The Committee will 

deliberate with the NRC staff regarding 

the subject topic. 

[Note: Pursuant to 5 U.S.C. 552b(c)(4), 

a portion of this session may be closed 

in order to discuss and protect 

information designated as proprietary.] 

1:15 p.m.–6:00 p.m.: Planning and 

Procedures Session/Future ACRS 

Activities/Reconciliation of ACRS 

Comments and Recommendations/ 

Preparation of Reports (Open/Closed)— 

The Committee will hear discussion of 

the recommendations of the Planning 

and Procedures Subcommittee regarding 

items proposed for consideration by the 


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