Federal Register / Vol. 89, No. 197 / Thursday, October 10, 2024 / Notices 82261 

1Effective December 2, 2022, the Medical 

Marijuana and Cannabidiol Research Expansion 

Act, Public Law 117–215, 136 Stat. 2257 (2022) 

(Marijuana Research Amendments or MRA), 

amended the Controlled Substances Act (CSA) and 

other statutes. Relevant to this matter, the MRA 

redesignated 21 U.S.C. 823(f), cited in the OSC/ISO, 

as 21 U.S.C. 823(g)(1). Accordingly, this Decision 

cites to the current designation, 21 U.S.C. 823(g)(1), 

and to the MRA-amended CSA throughout. 

2The only exception is with regards to allegations 

concerning the cash payment red flag, which this 

Decision and Order does not address due to the 

number and egregiousness of the rest of the 

allegations. 

3The Agency adopts the ALJ’s summary of each 

of the witnesses’ testimonies as well as the ALJ’s 

assessment of each of the witnesses’ credibility. See 

RD, at 4–28. The Agency agrees with the ALJ that 

the testimony from the Government’s expert 

witness, Ms. Katherine Salinas, R.Ph., which was 

focused on the Texas standard of care and 

Respondent’s dispensing to the patients listed in 

the OSC/ISO, was credible in that it was internally 

consistent, logically persuasive, and presented an 

objective analysis. RD, at 21. The ALJ found that 

Ms. Salinas’s testimony was credible and reliable, 

but ultimately gave her testimony less weight than 

he otherwise would have due to her prior 

interactions with Respondent during the course of 

her duties as a Compliance Officer. Id. at 21–22. 

Regarding the Respondent’s case, the Agency agrees 

with the ALJ that the testimony from Respondent’s 

former pharmacist-in-charge, E.W., which was 

focused on describing her process for filling 

prescriptions at Respondent, was generally credible 

and internally consistent, though, as noted by the 

ALJ, E.W.’s testimony was not specific to the 

prescriptions at issue and minimal evidence was 

offered in corroboration. Id. at 23. Finally, the 

Agency agrees with the ALJ that the testimony from 

Respondent’s owner, S.M., which addressed 

Respondent’s procedures for filling prescriptions, 

addressing red flags, keeping inventories, and 

securing controlled substances, was generally 

credible; however, minimal evidence was offered to 

corroborate her testimony and, as the ALJ noted, 

S.M. has a significant personal interest in the 

outcome of the proceedings. Id. at 28. 

4For Ms. Salinas’s full qualifications, see GX 43; 

RD, at 7–8. 

5Ms. Salinas clarified that prescriptions issued 

within a month or two of each other that list the 

same address for the same controlled substance and 

written by the same prescriber would create a 

shared address red flag, whereas prescriptions 

issued and filled at a longer period apart with those 

same characteristics may not be caught or noticed 

by a pharmacist; a red flag determination would be 

‘‘diminished’’ beyond the one-month timeframe. 

RD, at 11; Tr. 277–278. 

6Ms. Salinas testified that receiving prescriptions 

for two opioids is uncommon and indicative of 

potential diversion; illegitimate prescriptions for 

schedule II controlled substances are commonly 

prescribed with other controlled and noncontrolled 

substances to give the illusion of legitimacy. RD, at 

19; Tr. 233–234, 236. According to Ms. Salinas, the 

Texas State Board of Pharmacy rules and 

regulations warn pharmacists that a 1:1 ratio of 

controlled substances to noncontrolled or over-thecounter substances could indicate nontherapeutic 

dispensing and diversion. RD, at 19; Tr. 235. Ms. 

Salinas noted that these kinds of prescriptions are 

also referred to as ‘‘cocktail’’ or ‘‘cocktail-like’’ 

prescriptions. RD, at 19; Tr. 237. 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 23–22] 

Midtown Specialty RX; Decision and 

Order 

On January 25, 2023, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause and Immediate Suspension of 

Registration (OSC/ISO) to Midtown 

Specialty RX (Respondent) of Houston, 

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

informed Respondent of the immediate 

suspension of its DEA Certificate of 

Registration, Control No. FM2396427, 

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. (quoting 21 

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

proposed the revocation of 

Respondent’s registration, alleging that 

Respondent’s continued registration is 

inconsistent with the public interest 

because, among other reasons, 

Respondent repeatedly dispensed 

controlled substance prescriptions to 

over sixty patients without resolving red 

flags of drug abuse and diversion. Id. 

(citing 21 U.S.C. 823(g)(1),1 824(a)(4)). 

A hearing was held before DEA 

Administrative Law Judge Paul E. 

Soeffing (the ALJ) who, on July 13, 

2023, 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 67. 

Respondent did not file exceptions to 

the RD. Having reviewed the entire 

record, the Agency adopts and hereby 

incorporates by reference the entirety of 

the ALJ’s rulings,2 credibility findings,3

findings of fact, conclusions of law, 

sanctions analysis, and recommended 

sanction as found in the RD and 

summarizes and expands upon portions 

thereof herein. 

I. Findings of Fact 

Standard of Care—Dispensing 

Katherine Salinas, R.Ph., who is 

currently employed full-time as a 

Compliance Officer for the Texas State 

Board of Pharmacy, credibly testified for 

the Government as an expert in the 

standard of care and the professional 

responsibility required of a Texas 

pharmacy in its dispensing practices. 

RD, at 7–8, 21; Tr. 128, 131, 133–134; 

Government Exhibit (GX) 4, at 8.4

According to Ms. Salinas, prior to 

dispensing a prescription for a 

controlled substance, Texas pharmacists 

are required to determine whether the 

prescription was issued in the usual 

course of professional practice and to 

make every reasonable effort to ensure 

that the prescription was issued for a 

legitimate medical purpose. RD, at 8, 9; 

Tr. 134, 135. Further, in making that 

determination, Texas pharmacists are 

required to exercise sound professional 

judgment, meaning that they must 

evaluate the prescription in its entirety 

and must contact the prescriber if the 

authenticity of the prescription is in 

question. RD, at 8–9; Tr. 134–135. 

Ms. Salinas’s testimony is consistent 

with Texas law which states that ‘‘[a] 

pharmacist may not . . . dispense or 

deliver a controlled substance . . . 

except under a valid prescription and in 

the course of professional practice.’’ 

Tex. Health & Safety Code section 

481.074(a)(1). Texas law notes that ‘‘[a] 

pharmacist may not . . . dispense a 

controlled substance if the pharmacist 

knows or should have known that the 

prescription was issued without a valid 

patient-practitioner relationship.’’ Id. 

section 481.074(a)(2). Texas regulations 

require that a Texas pharmacist ‘‘shall 

exercise sound professional judgment 

with respect to the accuracy and 

authenticity of any prescription drug 

order’’ and ‘‘shall 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 

sections 291.29(a)–(b), 291.34(b)(1). 

Ms. Salinas also testified that Texas 

pharmacists must check the Prescription 

Drug Monitoring Program (PDMP) and 

must attempt to resolve and document 

the resolution of any ‘‘red flags’’— 

warning signs or problematic patterns 

that indicate a potential for diversion— 

prior to dispensing controlled 

substances. RD, at 9–10; Tr. 135–136, 

270. 

In discussing red flags, Ms. Salinas 

testified that some of the known red 

flags include: the same doctor or group 

of doctors repeatedly prescribing the 

same strength and dosage of medication 

over a long period of time and/or for 

multiple patients (also called ‘‘pattern 

prescribing’’); prescriptions from a small 

group of doctors; patients traveling long 

distances to the pharmacy; multiple 

patients sharing the same address and 

receiving prescriptions for the same 

controlled substances from the same 

prescribers; 5 and ‘‘non-therapeutic 

prescribing and dispensing’’ where 

controlled substances are illegitimately 

prescribed or dispensed with other 

controlled and/or noncontrolled 

(including over-the-counter) 

substances.6 RD, at 9, 10, 11, 14, 19; Tr. 

136, 144, 146, 147, 159–160, 171, 173– 

174, 233–234, 281. Ms. Salinas testified 

that one red flag is sufficient to ‘‘raise 

concern’’ and that pharmacists have an 

ongoing responsibility to resolve red 


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7See Tr. 148–159, 163–170, 195, 201–203, 219– 

220; GX 19, 26–28, 44 (Patients E.D., R.H., B.Y., 

D.S., J.J., S.B., G.V., J.L., B.G., D.G., B.J., K.M., M.B., 

D.O., C.P., T.P., Y.Y., C.B., L.N., B.B., D.P., J.C., 

M.H., L.M., R.T., T.M., D.A., R.P., S.S., T.C., C.H., 

E.H., L.S., R.J., W.J., and R.B.). 

8See Tr. 170–171, 207; GX 31, 44 (Patients V.R., 

H.L., T.H., and B.B.). 

9See Tr. 199; GX 22. (Patient J.A.). 

10See Tr. 235–236; GX 31 (Patient B.B.). 

11See Tr. 148–159; GX 44 (Patients E.D., R.H., 

B.Y., D.S., J.J., S.B., G.V., J.L., B.G., D.G., B.J., K.M., 

M.B., D.O., C.P., T.P., Y.Y., C.B., and L.N.). 

12Without a documented explanation, 

Respondent filled only 100 of the tablets. RD, at 47 

n. 84; Tr. 238–239. 

13See also Tr. 148–159; GX 44 (Patients E.D., and 

B.Y.; Patients J.J. and S.B.; Patients G.V., J.L., and 

B.G.; Patients K.M. and M.B.; Patients D.O. and 

C.P.; and Patients C.B. and L.N.). 

flags—even if they are resolving the 

same red flags repeatedly—and to 

document their resolution. RD, at 9; Tr. 

137–138, 143. Ms. Salinas also stated 

that if a pharmacist is unable to resolve 

a red flag, then he or she should not 

dispense the prescription. RD, at 9; Tr. 

137, 247–248. 

Similarly, the Texas Board of 

Pharmacy sets forth numerous 

operational standards for pharmacists 

filling prescriptions, requiring, firstly, 

that ’’ [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.’’ Id. section 

291.33(c)(2)(A)(i). Further, ‘‘[u]pon 

identifying any clinically significant 

conditions . . . 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). 

A Texas pharmacist must ensure that 

‘‘[p]rior to dispensing, any questions 

regarding a prescription drug order [] be 

resolved with the prescriber and written 

documentation of these discussions [be] 

made and maintained.’’ Id. section 

291.33(c)(2)(A)(iv). Such documentation 

must be made ‘‘on the prescription or in 

the pharmacy’s data processing system 

associated with the prescription . . . 

and shall include . . . (i) [the] date the 

prescriber was consulted; (ii) [the] name 

of the person communicating the 

prescriber’s instructions; (iii) any 

applicable information pertaining to the 

consultation; and (iv) [the] initials or 

identification code of the pharmacist 

performing the consultation clearly 

recorded for the purpose of identifying 

the pharmacist who performed the 

consultation.’’ Id. section 

291.33(c)(2)(C). 

Finally, a Texas pharmacist must 

consider the various ‘‘red flag factors’’ 

in ‘‘preventing the non-therapeutic 

dispensing of controlled substances,’’ 

including, among others: pattern 

prescribing; prescriptions for controlled 

substances commonly known to be 

abused; prescriptions for controlled 

substances at the highest strength and/ 

or in large quantities, indicating lack of 

individual drug therapy; multiple 

patients sharing the same address and 

obtaining similar controlled substance 

prescriptions from the same 

practitioner; and patients consistently 

paying for controlled substance 

prescriptions with cash rather than 

through insurance. Id. section 291.29(f). 

Respondent’s Inappropriate Dispensing 

Pattern Prescribing 

In reviewing the relevant PDMP data 

and patient profiles in the current 

matter, Ms. Salinas identified numerous 

instances and types of pattern 

prescribing. RD, at 10; Tr. 144–145. 

Specifically, Ms. Salinas noted that 

Respondent’s most frequently dispensed 

controlled substances were oxycodone,7

hydrocodone,8 and promethazine with 

codeine.9 RD, at 10; Tr. 144–145. Ms. 

Salinas explained that the opioids 

oxycodone and hydrocodone, the 

muscle relaxant carisoprodol, and 

promethazine cough syrup with codeine 

generate greater concern for diversion in 

instances of potential pattern 

prescribing because these drugs are 

commonly abused and diverted in the 

Houston area. RD, at 10–11; Tr. 141– 

142. Ms. Salinas also noted that 

prescriptions for ‘‘strong opioids’’ were 

written for and dispensed in ‘‘at least’’ 

a month’s supply (over 100 tablets).10

RD, at 10, 46; Tr. 144–145. Further, Ms. 

Salinas testified that 80 percent of the 

oxycodone prescriptions were written 

by the same three physicians, with a 

majority of these written by the same 

single physician, Dr. L.S.11 RD, at 10; Tr. 

144–145. Ms. Salinas testified that she 

reviewed the patient profiles, physician 

profiles, and the numerous 

prescriptions for oxycodone 30 mg, 

hydrocodone-acetaminophen 10–325 

mg, and promethazine with codeine, 

and found no notations resolving any of 

the red flags, let alone the pattern 

prescribing red flag. RD, at 46; Tr. 147– 

230. 

Moreover, Ms. Salinas testified 

regarding several examples of 

Respondent’s dispensing that suggested 

a lack of individualization, another 

indicator of the pattern prescribing red 

flag. RD, at 47–48. For example, Patient 

M.B. always received a prescription for 

oxycodone along with a rotation of 

noncontrolled and over-the-counter 

substances such as a stool softener, 

ibuprofen, a muscle relaxant, vitamin D, 

and folic acid; meanwhile, Patient W.J. 

received prescriptions of oxycodone 

paired with a 300-day supply 12 of stool 

softener, which Ms. Salinas opined was 

particularly odd based on the number of 

tablets prescribed. RD, at 47; Tr. 234– 

239; see also GX 28, at 2, 7–8; GX 30, 

at 2–20. 

In Ms. Salinas’s unrebutted expert 

opinion, the red flag of pattern 

prescribing present in these 

prescriptions needed to be resolved 

before they were dispensed and such 

resolution needed to be documented; 

because there was no documented 

resolution of these red flags, Ms. Salinas 

found that Respondent failed to meet its 

corresponding responsibility. RD, at 11, 

48; Tr. 146–147, 234, 239, 241–242. As 

such, the Agency agrees with the ALJ 

and finds that Respondent dispensed 

controlled substance prescriptions that 

presented the red flag of pattern 

prescribing and failed to properly 

document and resolve this red flag prior 

to dispensing; accordingly, Respondent 

filled these controlled substance 

prescriptions outside the usual course of 

professional practice in violation of the 

Texas standard of care. RD, at 49. 

Shared Addresses 

One of Texas’ red flag factors is 

‘‘multiple persons with the same 

address present[ing] substantially 

similar controlled substance 

prescriptions from the same 

practitioner.’’ 22 Tex. Admin. Code 

section 291.29(f)(11). Regarding the 

issue of shared addresses, Ms. Salinas 

provided many examples of 

Respondent’s dispensing that raised the 

shared address red flag. RD, at 51–52. 

For example, Patients J.J. and S.B., who 

share an address, were both prescribed 

oxycodone 30 mg from Dr. L.S.; 

Respondent dispensed these 

prescriptions on January 6, 2022, and 

January 7, 2022, respectively. RD, at 51– 

52 n. 89; GX 44, at 20.13 Dr. L.S. also 

issued prescriptions for 30 mg of 

oxycodone, all of which Respondent 

dispensed, to all of the following groups 

of patients with shared addresses: (1) 

G.V. on March 2, 2022, J.L. on March 10, 

2022, and B.G. on April 21, 2022; (2) 

K.M. on August 4, 2021, and M.B. on 

August 20, 2021; (3) D.O. on August 18, 

2021, and C.P. on August 19, 2021; and 

(4) C.B. and L.N. both on December 22, 

2021. RD, at 52 n. 90, 92–95. Moreover, 

Respondent dispensed substantially 


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14See Tr. 163–171; GX 44 (Patients B.B. and D.P.; 

Patients L.M. and R.T.; Patients T.C. and R.P.; 

Patients H.L. and T.H.). 

15See Tr. 215–225; RD, at 3–4, Stip. 12–17; GX 

19, 22, 24, 26–28 (Patients E.H., R.B., R.J., L.S., W.J., 

and J.A.). 

16E.W. testified that to verify ‘‘good standing’’ 

‘‘offices were called[,] . . . someone went out to 

check the doctors,’’ or she would check the Texas 

Medical Board’s website. RD, at 22 n.58, 23; Tr. 308, 

310. 

17The Agency notes that pharmacies have a 

‘‘corresponding responsibility’’ to ensure proper 

dispensing of controlled substances that exists 

independent of a prescriber’s responsibility. 21 CFR 

1306.04(a). Nothing in Ms. Salinas’s testimony 

suggests that making sure that prescribers are 

abiding by the red flag checklist is part of a 

pharmacy’s corresponding responsibility. See supra 

Standard of Care—Dispensing. 

18As evidence that Respondent generally took 

steps to identify red flags prior to dispensing, S.M. 

testified that she had sent at least one letter to the 

Texas Medical Board reporting physicians who 

Continued 

similar prescriptions for oxycodone 30 

mg and other opioids issued by Drs. 

D.A., W.K., B.R., and M.Q. that were 

also prescribed to patients who shared 

the same address.14 RD, at 12–13; Tr. 

147–172; GX 44. 

In Ms. Salinas’s credible and 

unrebutted expert opinion, the red flag 

of shared addresses present in these 

prescriptions needed to be resolved 

before they were dispensed and such 

resolution needed to be documented; 

because there was no documented 

resolution of this red flag, Ms. Salinas 

found that Respondent failed to meet its 

corresponding responsibility. RD, at 14, 

53; Tr. 162, 171–72, 279–280. As such, 

the Agency agrees with the ALJ and 

finds that Respondent dispensed 

controlled substances, issued less than 

two months apart, to patients who 

shared addresses and received 

prescriptions for the same controlled 

substances from the same prescriber. 

RD, at 54. Moreover, Respondent failed 

to properly resolve and document 

resolution of the shared address red flag 

prior to dispensing and, accordingly, 

filled these controlled substance 

prescriptions outside the usual course of 

professional practice in violation of the 

Texas standard of care. Id. 

Long Distances 

One of Texas’ red flag factors is ‘‘the 

geographical distance between the 

practitioner and the patient or between 

the pharmacy and the patient.’’ 22 Tex. 

Admin. Code section 291.29(c)(4) 

(emphasis added). Ms. Salinas testified 

that Houston pharmacies generally use 

30 miles as a guideline for when a 

distance traveled by a patient becomes 

a red flag. RD, at 16–17; Tr. 214. Ms. 

Salinas noted that the long-distance red 

flag can be resolved, but a pharmacist 

should have a conversation with the 

patient, document the specific issue or 

concern on the prescription, and 

document any reasonable explanation 

that resolves the red flag before 

dispensing the prescription. RD, at 17; 

Tr. 212–213, 229–230. 

Regarding the red flag of long 

distances, Ms. Salinas testified that she 

calculated the distances traveled in the 

current matter based on the home 

addresses listed on the patients’ 

prescriptions filled at Respondent. RD, 

at 18; Tr. 216–218. Based on her 

calculations, Ms. Salinas found that 

multiple patients traveled far beyond 

the guideline of 30 miles of their home 

addresses to fill prescriptions at 

Respondent.15 For example, the 

following patients all traveled the 

following miles one way to fill 

prescriptions for oxycodone 30 mg at 

Respondent: E.H., 84.1 miles one way 

(Tr. 215–218); R.J., 92.5 miles one way 

(Tr. 220–221); R.B., 88.5 miles one way 

(Tr. 219–220); L.S., 74 miles one way 

(Tr. 222–223); W.J., 79.5 miles one way 

(Tr. 223–224); J.A., 167.5 miles one way 

(Tr. 224–225). RD, at 56–57. Ms. Salinas 

further testified that there was no 

documentation providing alternate 

addresses, distances, or explanations 

that documented a resolution of these 

red flags. RD, at 18, 57; Tr. 216–218, 

225–229. 

In Ms. Salinas’s unrebutted expert 

opinion, the red flag of long distances 

present in these prescriptions needed to 

be resolved before they were dispensed 

and such resolution needed to be 

documented; because there was no 

documented resolution of this red flag, 

Ms. Salinas found that Respondent 

failed to meet its corresponding 

responsibility. RD, at 17, 20. Tr. 212– 

213, 241–242. As such, the Agency 

agrees with the ALJ and finds that 

Respondent dispensed controlled 

substances to patients who traveled long 

distances and failed to properly resolve 

and document resolution of the longdistance red flag prior to dispensing; 

accordingly, Respondent filled these 

controlled substance prescriptions 

outside the usual course of professional 

practice and in violation of the Texas 

standard of care. RD, at 59. 

Respondent’s Arguments Regarding 

Inappropriate Dispensing 

Regarding Respondent’s case, E.W. 

was the pharmacist-in-charge at 

Respondent at the time of the relevant 

events. RD, at 22; Tr. 304, 307. E.W. 

testified credibly, but with little 

corroborating evidence, regarding 

Respondent’s general dispensing 

practices; however, she did not testify 

specifically regarding the prescriptions 

at issue in this case. RD, at 23. With 

regard to Respondent’s general practice, 

E.W. testified that before dispensing 

prescriptions, she would get a phone 

number from the patient, discuss 

insurance with the patient, and then 

make a copy of the patient’s driver’s 

license. RD, at 22; Tr. 304. Next, after 

reviewing the full PDMP drug history of 

the patient, if ‘‘everything check[ed] 

out,’’ E.W. would enter the prescription, 

pull the medication, and ‘‘go through 

the process.’’ RD, at 22; Tr. 304–305. 

E.W. explained that she would check to 

make sure that prescribers were ‘‘proper 

by law’’ and Houston-based, adding that 

the pharmacy only filled prescriptions 

from Houston doctors ‘‘in good 

standing.’’ 16 RD, at 22; Tr. 305–307. 

E.W. testified that she never 

documented what she discovered 

through the verification process. RD, at 

22 n.58, 23; Tr. 308, 310. Then, E.W. 

would fill the prescription, counsel the 

patient, and have him or her sign 

documentation affirming that he or she 

had been counseled. RD, at 22; Tr. 305. 

E.W. noted that the pharmacy has 

refused to fill prescriptions in the past, 

but admitted that she would not 

document her concerns or reasons for 

refusing to fill the prescription. RD, at 

22–23; Tr. 308, 310–311. Again, E.W. 

did not testify specifically regarding the 

procedures followed with regard to the 

prescriptions at issue, but she did 

acknowledge that she knew that the 

PDMP data would have indicated that 

the same group of doctors was 

prescribing the same strength and 

quantity of medication to multiple 

patients. RD, at 22–23; Tr. 310. 

As for Respondent’s owner, S.M., she 

testified that though she is not a 

licensed pharmacist, she works as a 

pharmacy technician at Respondent. 

RD, at 23; Tr. 313–314. S.M.’s testimony 

was generally credible, but there was 

little corroborating evidence and the 

ALJ noted that she has a significant 

personal interest in the outcome of the 

proceedings. RD, at 28. S.M. testified 

generally regarding Respondent’s 

process, stating that the pharmacy only 

fills prescriptions written by doctors in 

the Houston area. RD, at 23; Tr. 315. 

When asked whether Respondent 

‘‘check[ed] to make sure the 

prescriptions were legitimate,’’ S.M. 

testified that Respondent ‘‘hired a third 

party to go out to the doctors’ offices to 

verify the doctors, check their licenses, 

[and] check to make sure that they were 

abiding by the red flag checklist.’’ 17 Tr. 

318; see also RD, at 23–24; Tr. 315–316, 

321.18 S.M. testified that when a patient 


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were writing questionable prescriptions. RD, at 24 

n.60; Tr. 318–20; Respondent Exhibit (RX) 7, at 1– 

2. Even so, there is no evidence that respondent 

identified and resolved the relevant red flags prior 

to dispensing the controlled substances at issue in 

this case. 

19S.M. agreed that PDMP data would show 

information pertaining to prescribers who write 

prescriptions for oxycodone 30 mg to multiple 

patients for multiple months. RD, at 25; Tr. 361– 

362. 

20S.M. testified that if Respondent needed 

information on a patient’s diagnosis or condition or 

any other additional information, someone working 

at Respondent would call the prescriber, who 

‘‘would let [Respondent] know at length about [the 

patient’s] medical records, if [the patient was] in an 

accident or if [the patient] had some kind of other 

ailment going on,’’; whoever called the prescriber 

would document the information by ‘‘[writing] it 

down sometimes in the patient’s profile and 

sometimes on the back of the prescription.’’ RD, at 

24; Tr. 328. S.M. testified that on the back of 

prescriptions, she would note ‘‘if something 

changed with the prescription, if the quantity was 

incorrect or the doctor wrote the SIG wrong, things 

like that.’’ RD, at 24; Tr. 329. However, there is no 

evidence of such documentation for the relevant 

prescriptions. 

21When S.M. was first asked what ‘‘counseled 

patient’’ written on the back of a prescription 

meant, she testified that that it meant that the 

pharmacist had counseled the patient ‘‘at length 

about [the] prescription.’’ Tr. 329. This testimony is 

consistent with Ms. Salinas’s testimony regarding 

the typical meaning of the notation. See infra; RD, 

at 16; Tr. 187–88; 209–10. 

22S.M. testified that Respondent was ‘‘never 

instructed to write . . . if the patient’s address was 

far away’’ and that ‘‘[Respondent has] been 

inspected several times by Ms. Salinas, and . . . 

[has] never been directed by her to do that.’’ RD, 

at 25; Tr. 364. Even if true, this does not relieve 

Respondent of its obligations under Texas law. 

23See, e.g., George Pursley, M.D., 85 FR 80162, 

80171 n.28 (2020) (‘‘Post hoc written or oral 

justifications . . . are not controlling.’’). 

entered the pharmacy, either a 

pharmacist or herself would ask the 

patient for identification, take down the 

patient’s allergy information and phone 

number, check the PDMP for ‘‘anything 

that might stand out,’’ and ‘‘verify’’ the 

prescription with the prescriber by 

calling the prescriber. RD, at 24; Tr. 

330–331.19 S.M. testified that if 

‘‘everything check[ed] out,’’ Respondent 

would fill the prescription, at which 

time the pharmacist would ‘‘counsel the 

patient about [the] medication’’ and 

answer any questions. RD, at 24; Tr. 

331.20

Regarding Respondent’s procedure for 

addressing and resolving red flags, S.M. 

agreed that Texas pharmacies are to 

determine the legitimacy of 

prescriptions by resolving red flags and 

that resolution of red flags must be 

properly documented. RD, at 25; Tr. 

370. S.M. testified that Respondent 

would ‘‘check the patient, contact the 

doctor, verify the prescription[,] . . . 

[and] verify any information that [it] 

could from the patient.’’ RD, at 24; Tr. 

321. S.M. also testified that Respondent 

has refused to fill prescriptions in the 

past if, upon review of PDMP data, the 

pharmacist found that the patient was 

presenting for an early refill, the 

prescription was fraudulent, or the 

pharmacist did not think the 

prescription was legitimate. RD, at 24– 

25; Tr. 314. S.M. testified that if the 

pharmacist refuses to fill a prescription, 

the pharmacy keeps no record of that 

refusal and shreds the unfilled 

prescription; S.M. also asserted that 

‘‘[the pharmacy does not] have to 

document that [it] didn’t fill the 

prescription.’’ RD, at 25; Tr. 314–315. 

S.M. testified that ‘‘patient 

counseled’’ written on prescriptions 21

reflects that the prescription was 

‘‘resolved to the pharmacist’s 

satisfaction’’ through the steps that S.M. 

testified Respondent takes prior to 

dispensing. RD, at 25; Tr. 363, 365. 

Notably, E.W. testified that she had 

written ‘‘consult,’’ not ‘‘patient 

counseled,’’ on the prescriptions at 

issue in this case to indicate that she 

had looked at the PDMP. RD, at 22; Tr. 

306, 363. However, review of the 

prescription records at issue indicates 

that only ‘‘counseled’’ or ‘‘patient 

counsel’’ (and not ‘‘consult’’) were ever 

written on the prescriptions at issue, 

and review of both E.W. and S.M.’s full 

testimony suggests there is no 

distinction between the use of the words 

‘‘consult’’ and ‘‘counsel.’’ This suggests 

an imprecise word choice by E.W. All 

that is relevant to this matter is that the 

prescriptions said ‘‘counseled’’ or 

‘‘patient counsel’’ and S.M. testified that 

more detailed patient notes were 

unnecessary because Respondent 

conducts the same process for all 

patients and all prescriptions, including 

refill prescriptions. RD, at 25; Tr. 363– 

364. 

Contrary to S.M.’s testimony, Ms. 

Salinas opined that the handwritten 

note to the effect of ‘‘patient counsel’’ 

present on the majority of the 

prescriptions at issue in the current 

matter does not constitute red flag 

resolution. First, she testified, patient 

counseling is a separate requirement 

under the Texas State Board of 

Pharmacy regulations, and ‘‘counseling 

usually entails talking about what the 

medication is, how to take it, what to do 

if you miss a dose, side effects to watch 

out for . . . that sort of thing.’’ RD, at 

16, 18; Tr. 187–188, 209–210, 229–230. 

Second, even if Respondent writing 

‘‘patient counsel’’ was meant to show 

red flag resolution, the notations in the 

current matter do not satisfy the 

requirement of documentation of red 

flag resolution because they ‘‘[do not] 

tell the story.’’ RD, at 16, 18; Tr. 187– 

188, 209–210, 229–230. The Agency 

credits Ms. Salinas’s expert opinion that 

Respondent failed to adequately 

document resolution of the relevant red 

flags prior to dispensing each of the 

prescriptions at issue in this case. See 

supra, at Respondent’s Inappropriate 

Dispensing; see also RD, at 28. 

Regarding the various red flags at 

issue in the current matter, S.M. 

testified that the patients who traveled 

to Respondent from non-Houston 

addresses did so because the 

pharmacies near their homes do not 

carry controlled substances prescribed 

to treat pain. RD, at 26; Tr. 325.22

Respondent did not present evidence to 

support this claim nor evidence that this 

information was documented in either 

patient profiles or on patients’ 

prescriptions.23

Standard of Care—Inventory, 

Recordkeeping, and Storage 

The CSA requires pharmacies to keep 

accurate and timely records of inventory 

and dispensing, including initial and 

biennial inventories. 21 CFR 

1304.11(a)–(c). Texas law also requires 

pharmacies to keep and maintain 

records, including ‘‘a perpetual 

inventory of any controlled substance 

listed in Schedule II.’’ 22 Tex. Admin. 

Code section 291.75(a)(1), (c)(4)–(5). 

Ms. Salinas testified that Texas 

pharmacies are required to keep and 

maintain accurate records of all 

prescriptions, invoices, signature logs 

for individuals participating in 

prescription processing, counseling 

documentation, and controlled 

substance inventories for at least two 

years. RD, at 10, 60; Tr. 138–139. Ms. 

Salinas also testified that Texas 

pharmacies are required by law to have 

inventories of all controlled substances 

available for inspection. RD, at 20–21; 

Tr. 243. Ms. Salinas noted that under 

the Texas standard of care, in the case 

of a disaster such as a flood, a pharmacy 

must notify the Texas State Board of 

Pharmacy within ten days and should 

immediately re-conduct an inventory. 

RD, at 21; Tr. 243–244. 

The CSA requires that ‘‘[c]ontrolled 

substances listed in Schedules II, III, IV, 

and V . . . be stored in a securely 

locked, substantially constructed 

cabinet.’’ 21 CFR 1301.75(b); RD, at 60. 

Regarding storage, Ms. Salinas testified 

that Texas pharmacies must keep their 

controlled substances stored, locked, 

and secured at their registered location 

as well as have written security policies 

and procedures, motion sensors, and an 

alarm system with offsite monitoring. 

RD, at 10, 21, 61; Tr. 139, 245. Ms. 

Salinas testified that she was not aware 


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24A DEA Diversion Investigator testified that 

during the June 2022 inspection, she retrieved 

controlled substances from S.M.’s home that were 

being kept in an unlocked suitcase in the closet. RD, 

at 61; Tr. 41–45; GX 41, at 1–2. 

25S.M. testified that she had called both DEA and 

the Texas State Board of Pharmacy regarding the 

attempted burglaries but that neither entity ‘‘did 

anything.’’ RD, at 27 n.63; Tr. 338. S.M. testified 

that ‘‘[she] thought [she] was doing the correct thing 

by taking the drugs and taking them away from an 

environment where [people] were breaking in and 

trying to rob[,] . . . [b]ut [she] [does] know now that 

[she] was not doing the right thing, and [she] would 

not do it again.’’ RD, at 28; Tr. 348. 

26The 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). 

of any exceptions to these requirements 

and that it would be concerning to her 

if a registrant was storing controlled 

substances at a personal residence; 

further, Ms. Salinas opined that there is 

no justification for removing controlled 

substances from the registered location 

and if drugs are ever moved, registrants 

are required to document the move. RD, 

at 21; Tr. 245–246. 

Respondent’s Case 

S.M. admitted that Respondent did 

not have initial, ending, or biennial 

inventories at the time of DEA’s June 1, 

2022 inspection and that the last annual 

inventory that Respondent had on file 

was for 2020. RD, at 26, 60; Tr. 339, 344, 

352–353. S.M. testified that in late 2021, 

a pipe burst in a neighboring business 

causing a flood that damaged 

Respondent’s inventories. RD, at 26; Tr. 

340–341, 344, 351. S.M. admitted that 

she ‘‘should have immediately 

recreated’’ the inventory and that not 

doing so was a mistake in judgment. RD, 

at 26–27; Tr. 348–349. S.M. testified that 

she has since taken remedial action by 

updating Respondent’s perpetual 

inventory on a daily basis. RD, at 27; Tr. 

349. S.M. acknowledged that 

Respondent’s current inventory was 

initially generated on June 1, 2022, 

during the DEA inspection when 

Respondent’s pharmacist-in-charge and 

DEA Diversion Investigators conducted 

a pill count upon return of the 

controlled substances from S.M.’s 

residence to Respondent’s registered 

location. RD, at 27; Tr. 353. S.M. also 

acknowledged that at least six months 

had passed between the date that she 

asserts Respondent’s inventories were 

damaged by flooding and the June 1, 

2022 inspection, with S.M. testifying 

that she tried to recreate the inventory 

during that time but that it ‘‘takes a lot 

to recreate an inventory.’’ RD, at 27; Tr. 

353–354. S.M. asserted that Respondent 

has since corrected the situation and 

that on the date that the OSC/ISO was 

issued in the current matter, 

Respondent had current inventories. 

RD, at 26; Tr. 345. 

S.M. also admitted that without 

permission from DEA or the Texas State 

Board of Pharmacy, she removed 

controlled substances from 

Respondent’s registered location and 

transported them to her personal 

residence on a daily basis. RD, at 27, 61; 

Tr. 111, 338. S.M. acknowledged that 

while she was transporting drugs to and 

from her home, there was a working safe 

at the pharmacy. RD, at 28; Tr. 360.24

S.M. testified that she took the 

controlled substances home ‘‘to ensure 

the safety of the drugs’’ after there were 

burglaries and robberies in the 

neighborhood where Respondent is 

located, including two instances of 

attempted burglary at Respondent itself. 

RD, at 27, 61; Tr. 336–338, 355–358; RX 

4–5.25 S.M. also testified that she 

removed the controlled substances from 

Respondent because ‘‘[w]hen the 

pandemic started, it was chaos[,] . . . 

[there was] no clear direction on what 

to do with anything[,] . . . [e]verybody 

was working from home . . . [and] 

[n]obody knew what to do . . . 

[because] [nobody could] get in contact 

with anyone.’’ RD, at 27–28; Tr. 338– 

339. S.M. testified that she has since 

taken remedial action by keeping 

Respondent’s controlled substances 

locked in the safe at the registered 

location and she has stopped 

transporting controlled substances to 

and from Respondent on a daily basis 

following the June 2022 inspection. RD, 

at 28; Tr. 349, 338–339. 

Based on Respondent’s admissions, 

the Agency agrees with the ALJ that 

Respondent did not take and/or keep 

initial or biennial inventories as of the 

date of DEA’s June 2022 inspection and 

did not store its controlled substances in 

a securely locked and substantially 

constructed cabinet. RD, at 60, 61; ALJ 

Exhibit 7 (Respondent’s Answer), at 2. 

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 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). 

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 31–32; see also 

id. at 31 n.66 (finding that Factors A, C, 

and E do not weigh for or against 

revocation). 

Having reviewed the record and the 

RD, the Agency agrees with the ALJ, 

adopts the ALJ’s analysis, and finds 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 31– 

62. 

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 Respondent violated 

numerous Federal and State laws 

regulating controlled substances. OSC/ 

ISO, at 2–10.26 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; 


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27Further, Federal law ‘‘prohibit[s] 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.’’ Id. 

28Registrants are required to take an ‘‘initial 

inventory,’’ meaning an ‘‘inventory of all stocks of 

controlled substances on hand on the date [they] 

first engage[ ] in the manufacture, distribution, or 

dispensing of controlled substances . . . ’’; ‘‘[a]fter 

the initial inventory is taken, the registrant shall 

take a new inventory of all stocks of controlled 

substances on hand at least every two years’’ and 

this ‘‘biennial inventory may be taken on any date 

which is within two years of the previous biennial 

inventory date.’’ Id. § 1304.11(b)–(c). 

29Texas law states that ‘‘[a] pharmacist may not 

. . . dispense a controlled substance if the 

pharmacist knows or should have known that the 

prescription was issued without a valid patientpractitioner relationship.’’ Id. section 481.074(a)(2). 

Further, it is unlawful in Texas for any ‘‘registrant 

or dispenser’’ to knowingly deliver a controlled 

substance in violation of sections 481.070–481.075 

of the Texas Health and Safety Code. Id. section 

481.128. Texas regulations require that a Texas 

pharmacist ‘‘shall exercise sound professional 

judgment with respect to the accuracy and 

authenticity of any prescription drug order’’ and 

‘‘shall 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 sections 291.29(a)–(b), 291.34(b)(1). 

30Such documentation must be ‘‘on the 

prescription or in the pharmacy’s data processing 

system associated with the prescription . . . and 

shall include . . . (i) [the] date the prescriber was 

consulted; (ii) [the] name of the person 

communicating the prescriber’s instructions; (iii) 

any applicable information pertaining to the 

consultation; and (iv) [the] initials or identification 

code of the pharmacist performing the consultation 

clearly recorded for the purpose of identifying the 

pharmacist who performed the consultation.’’ Id. 

section 291.33(c)(2)(C). 

31Although Ms. Salinas opined that different 

apartment or unit numbers at the same address 

would be considered a shared address red flag 

under the Texas standard of care, see supra, the ALJ 

found that ‘‘[w]hile different apartments in the 

same building or complex may share the same street 

number, the unit or apartment number that 

completes the address makes them unique 

addresses.’’ RD, at 54. However, the Agency has 

previously agreed with Ms. Salinas and found that 

different apartment or unit numbers at the same 

address constituted the shared address red flag 

under the Texas standard of care when the patients 

in question were receiving prescriptions for the 

same controlled substances from the same 

prescribers. Blue Mint Pharmacy, 88 FR 75326, 

75327–75328 (2023). 

32The Agency also agrees with the ALJ’s 

conclusions that none of Respondent’s arguments to 

the contrary, as detailed above, refute this analysis. 

RD, at 42–44, 48–50, 57–60. 

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

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).27

Regarding recordkeeping, inventory, 

and storage, Federal law requires that 

‘‘[c]ontrolled substances listed in 

Schedules II, III, IV, and V shall be 

stored in a securely locked, 

substantially constructed cabinet.’’ Id. 

§ 1301.75(b). In addition, pharmacies 

are required to keep and maintain 

accurate and timely records of 

dispensing and inventory, including 

initial and biennial inventories. Id. 

§ 1304.11(a)–(c).28

As for State law, Texas regulations 

require that ‘‘[a] pharmacist may not 

. . . dispense or deliver a controlled 

substance . . . except under a valid 

prescription and in the course of 

professional practice.’’ Tex. Health & 

Safety Code section 481.074(a)(1).29 The 

Texas Board of Pharmacy also sets forth 

numerous operational standards for 

pharmacists filling prescriptions, 

requiring, firstly, that pharmacists 

‘‘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.’’ Id. section 

291.33(c)(2)(A)(i). Further, ‘‘[u]pon 

identifying any clinically significant 

conditions . . . 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). A Texas pharmacist 

must also ensure that ‘‘[p]rior to 

dispensing, any questions regarding a 

prescription drug order [ ] be resolved 

with the prescriber and written 

documentation of these discussions [be] 

made and maintained.’’ Id. section 

291.33(c)(2)(A)(iv).30 Finally, a Texas 

pharmacist must consider the various 

‘‘red flag factors’’ in preventing the nontherapeutic dispensing of controlled 

substances, including, among others: 

pattern prescribing; prescriptions for 

controlled substances commonly known 

to be abused; prescriptions for 

controlled substances at the highest 

strength and/or in large quantities, 

indicating lack of individual drug 

therapy; multiple patients sharing the 

same address and obtaining similar 

controlled substance prescriptions from 

the same practitioner; and patients 

consistently paying for controlled 

substance prescriptions with cash rather 

than through insurance. Id. section 

291.29(f). ‘‘The geographical distance 

between the practitioner and the patient 

or between the pharmacy and the 

patient,’’ can present as an additional 

red flag factor under Texas regulations. 

22 Tex. Admin. Code section 

291.29(c)(4) (emphasis added). 

Regarding recordkeeping, inventory, 

and storage, Texas pharmacies are 

required to keep and maintain accurate 

and timely records of the inventory and 

distribution of controlled substances— 

including ‘‘a perpetual inventory of any 

controlled substance listed in Schedule 

II’’—and such documentation must be 

readily available upon request or 

inspection. Id. section 291.75(a)(1), 

(c)(4)–(5). 

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 repeatedly filled 

prescriptions for controlled substances 

for multiple patients without adhering 

to Texas’ operational standards for 

pharmacists filling prescriptions and 

without addressing or resolving 

numerous and blatant red flags of abuse 

and/or diversion; 31 in addition, 

Respondent repeatedly failed in its 

obligations regarding recordkeeping, 

inventory, and storage.32 Id. at 42–44, 

49–50, 53–55, 59–62. 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. Id. 

Accordingly, the Agency agrees with the 

ALJ and 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. at 61–62. 

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 18882, 18910 (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, 77FR 62316, 62339 (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 


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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. 


lotter on DSK11XQN23PROD with NOTICES1