75326 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 

none of Respondent’s patients engaged in illicit 

activity—refute this analysis. RD, at 21–23. 

9The record shows that in 2006, Respondent 

entered into a Memorandum of Understanding 

(MOU) with DEA in which Respondent admitted to 

prescribing controlled substances arguably in 

violation of generally accepted standard practices 

and Federal regulations; prescribing a large number 

of narcotics, with over half of his 1,500 patients 

prescribed narcotics; and keeping samples of 

controlled substances at an unregistered location. 

RD, at 3; Tr. 24; GX 12. 

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 

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 violated 21 U.S.C. 829; 

21 CFR 1306.04(a); and Ga. Code Ann. 

section 16–13–41(f)(2), (3). 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 23. 

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 he 

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, he 

must both accept responsibility and 

demonstrate that he has undertaken 

corrective measures. Holiday CVS, 

L.L.C., dba CVS Pharmacy Nos 219 and 

5195, 77 FR 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,9 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, the Agency agrees with the ALJ 

that ‘‘Respondent’s hearing testimony 

and post-hearing arguments constitute a 

blanket denial of any wrongdoing.’’ RD, 

at 25. Notably, Respondent testified that 

he did ‘‘everything [he is] supposed to 

do as far as the Georgia requirements for 

pain management’’ and that ‘‘[t]his 

hobgoblin of a drug problem exists 

primarily in the mind of an easily 

excitable DEA.’’ Id. at 24–25; Tr. 350; 

Respondent’s Post-Hearing Brief, at 6. 

As stated by the ALJ, ‘‘Respondent’s 

testimony and argument simply cannot 

be reconciled with the record 

evidence.’’ RD, at 25. As such, and 

because Respondent made no 

admittance of any wrongdoing on his 

part, the Agency agrees with the ALJ 

and finds that Respondent failed to 

unequivocally accept responsibility. Id. 

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, L.L.C. & 

SND Health Care, L.L.C., 81 FR 79188, 

79202–03 (2016)); Daniel A. Glick, 

D.D.S., 80 FR 74800, 74801, 74810 

(2015). Even so, in the current matter, 

Respondent did not present any 

evidence of remedial measures, and the 

Agency thus agrees with the ALJ that 

‘‘[Respondent’s] failure to put forth any 

evidence of steps he has taken to avoid 

similar misconduct in the future shows 

that he cannot be entrusted with a 

[registration].’’ RD, at 26. 

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 ‘‘failing to impose a 

significant sanction against Respondent 

would send the wrong message to 

registrants that the Agency does not take 

seriously a registrant who repeatedly 

prescribes dangerous drug cocktails and 

combinations.’’ RD, at 26. Regarding 

Respondent in particular, ‘‘[g]iven 

Respondent’s cavalier attitude regarding 

the standard of care, specific deterrence 

is necessary.’’ Id. Moreover, the Agency 

agrees with the ALJ that Respondent’s 

actions were egregious because 

Respondent not only ignored his 

obligations to issue prescriptions within 

the standard of care and instead 

prescribed combinations that he knew 

to be dangerous to his patients, but he 

also endangered the community at large 

given the risk of diversion when 

prescribing such combinations. Id. 

In sum, Respondent has not offered 

any credible evidence on the record to 

rebut the Government’s case for 

revocation of his registration and 

Respondent has not demonstrated that 

he can be entrusted with the 

responsibility of registration. RD, at 27. 

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. BS4103610 issued to 

Isaac Sved, M.D. Further, pursuant to 28 

CFR 0.100(b) and the authority vested in 

me by 21 U.S.C. 823(g)(1), I hereby deny 

any pending applications of Isaac Sved, 

M.D., to renew or modify this 

registration, as well as any other 

pending application of Isaac Sved, M.D., 

for additional registration in Georgia. 

This Order is effective December 4, 

2023. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 25, 2023, 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. 2023–24153 Filed 11–1–23; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Blue Mint Pharmacy; Decision and 

Order 

On July 26, 2022, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause and Immediate Suspension of 

Registration (OSC/ISO) to Blue Mint 

Pharmacy (Registrant) of Houston, 

Texas. Request for Final Agency Action 

(RFAA), Government Exhibit (RFAAX) 

2, at 1. The OSC/ISO informed 

Registrant of the immediate suspension 

of its DEA Certificate of Registration 

(registration), Control No. FB4121327, 

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


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 75327 

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. 

2Based on the Declaration from a DEA Diversion 

Investigator, the Agency finds that the 

Government’s service of the OSC/ISO on Registrant 

was adequate. RFAAX 3, at 5. Further, based on the 

Government’s assertions in its RFAA, the Agency 

finds that more than thirty days have passed since 

Registrant was served with the OSC/ISO and 

Registrant has neither requested a hearing nor 

submitted a corrective action plan and, therefore, 

has waived any such rights. RFAA, at 2; see also 

21 CFR 1301.43 and 21 U.S.C. 824(c)(2). 

3For Ms. Salinas’ qualifications, see RFAAX 4, 

Attachment P. Ms. Salinas is currently employed by 

the Texas State Board of Pharmacy as a Compliance 

Officer, and one of her duties is to inspect all 

classes of pharmacies for compliance with Texas 

pharmacy rules and regulations. RFAAX 4, at 1. 

4Pattern prescribing is when ‘‘ ‘a pharmacy 

dispenses a reasonably discernible pattern of 

substantially identical prescriptions for the same 

controlled substances, potentially paired with other 

controlled substances, for numerous persons, 

indicating a lack of individual drug therapy in 

prescriptions issued by the practitioner.’ ’’ Id. 5Such prescriptions can indicate a lack of 

individual drug therapy in prescriptions issued by 

the practitioner. Id. 

The Agency makes the following 

findings of fact based on the 

uncontroverted evidence submitted by 

the Government in its RFAA dated April 

17, 2023.2

I. Findings of Fact 

Texas Standard of Care 

DEA consulted Ms. Katherine Salinas, 

RPh, as an expert regarding the standard 

of care in the state of Texas for 

pharmacy practice.3 RFAAX 4, at 1. 

According to Ms. Salinas, the Texas 

standard of care requires that when 

dispensing a controlled substance, 

Texas pharmacists must ensure that the 

prescription for the controlled substance 

is valid, pursuant to a valid patientpractitioner relationship, and issued for 

a legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice. Id. at 1–2. Further, prior to 

dispensing a controlled substance, a 

pharmacist must resolve any questions 

regarding the prescription with the 

prescriber and maintain written 

documentation of any such discussions. 

Id. at 2. A pharmacist must also review 

the patient’s medication record and ‘‘at 

a minimum identify clinically 

significant: . . . (III) reasonable dose 

and route of administration; . . . (IV) 

drug-drug interactions; . . . and (X) 

proper utilization, including 

overutilization or underutilization.’’ Id.; 

see also 22 Tex. Admin. Code section 

291.33(c)(2)(A)(i). According to Ms. 

Salinas, ‘‘[a]ll [s]tate of Texas 

pharmacists have access to these 

requirements[ ] and are required to pass 

a jurisprudence examination in order to 

become a licensed pharmacist.’’ RFAAX 

4, at 2. Further, ‘‘[a]ll [s]tate of Texas 

pharmacists know [that they are] 

required to exercise reasonable caution 

in practice to prevent diversion by 

following common sense and proper 

dispensing practices.’’ Id. at 3. 

In particular, Ms. Salinas noted the 

Texas State Board of Pharmacy ‘‘Red 

Flag Checklist,’’ which is available to all 

Texas pharmacists on the Texas State 

Board of Pharmacy’s website and also 

provided during pharmacy compliance 

inspections. Id. The red flags listed on 

the checklist include pattern 

prescribing; 4 prescriptions for 

controlled substances commonly known 

to be abused such as opioids or muscle 

relaxants; prescriptions for controlled 

substances at the highest strength and/ 

or in large quantities; 5 patients 

obtaining similar controlled substance 

prescriptions from multiple 

practitioners; 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. at 3–4. Ms. 

Salinas stated that Texas pharmacists 

must document how they address and 

resolve any red flags and must have 

prevention techniques in place to deter 

the dispensing of fraudulent controlled 

substance prescriptions, such as 

contacting doctors to verify 

prescriptions, searching the Texas 

Medical Board website, talking with 

patients, and checking patient 

identification cards. Id. at 4. 

Ms. Salinas concluded her 

explanation of the Texas standard of 

care by stating that ‘‘a pharmacist must 

engage in a verification process of a 

prescription.’’ Id. at 5. Further, Ms. 

Salinas stated: ‘‘If a pharmacist does not 

believe a prescription is for a legitimate 

medical purpose, the pharmacist should 

not fill it.’’ Id. Ms. Salinas also noted 

that ‘‘[a]s a Compliance Officer, when 

[she identifies] a recurring pattern of 

certain combinations of controlled 

substances, with the same dosage and in 

large quantities to various patients, 

being paid for in cash instead of using 

insurance, [her] opinion is that the 

pharmacy is inappropriately dispensing 

controlled substance prescriptions and/ 

or engaging in diversion activity.’’ Id. 

Expert Review of Registrant’s 

Dispensing 

Applying the Texas standard of care, 

Ms. Salinas reviewed Registrant’s PMP 

data from approximately February 1, 

2021, through March 31, 2022, 

Registrant’s patient profiles for the 

fourteen patients at issue, and copies of 

certain controlled substance 

prescriptions issued to the fourteen 

patients. Id. Ultimately, Ms. Salinas 

concluded, and the Agency agrees, that 

between February 1, 2021, and March 

31, 2022, Registrant repeatedly filled 

prescriptions for controlled substances 

for the fourteen patients at issue without 

addressing or resolving red flags of 

abuse or diversion in violation of the 

Texas standard of care and thus outside 

the usual course of professional 

practice. Id. at 5–6, 18. 

Patients A.W., M.F., and D.H. 

Registrant filled nearly identical 

prescriptions for patients A.W., M.F., 

and D.H., who all shared an address. 

Specifically, between January 31, 2022, 

and March 2, 2022, Registrant filled 

prescriptions for Patient A.W. for 110 

tablets of 10/325 mg hydrocodone/ 

acetaminophen and 85 tablets of 350 mg 

carisoprodol. RFAAX 4, at 6; see also 

RFAAX 3, Attachment B. Further, 

between December 31, 2021, and March 

15, 2022, Registrant filled prescriptions 

for Patient M.F. for 120 tablets of 10/325 

mg hydrocodone/acetaminophen and 85 

tablets of 350 mg carisoprodol. RFAAX 

4, at 11; see also RFAAX 3, Attachment 

H. Finally, between June 17, 2021, and 

August 26, 2021, Registrant filled 

prescriptions for Patient D.H. for 110 

tablets of 10/325 mg hydrocodone/ 

acetaminophen and 90 tablets of 350 mg 

carisoprodol. RFAAX 4, at 14; see also 

RFAAX 3, Attachment K. 

In reviewing the prescriptions for 

these three individuals, Ms. Salinas 

found that all of the prescriptions were 

issued by the same practitioner, Dr. 

G.K., who prescribed the same 

controlled substances in identical or 

substantially similar quantities to 

multiple patients; both the 

hydrocodone/acetaminophen and the 

carisoprodol, controlled substances 

known to be abused, were prescribed in 

large quantities and at the highest 

dosage; the three patients shared the 

same address; and all three patients 

paid cash for all of the prescriptions. 

RFAAX 4, at 6, 11–12, 14–15; see also 

RFAAX 3, Attachments B, H, K. Ms. 

Salinas did not find any evidence that 

Registrant addressed these red flags of 

abuse or diversion and, as a result, 

opined that Registrant violated the 

minimum standard of care for a Texas 

pharmacy and operated outside of the 

usual course of professional practice. 

RFAAX 4, at 6–7, 12, 15; see also 

RFAAX 3, Attachments B, H, K. 


khammond on DSKJM1Z7X2PROD with NOTICES
75328 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 

Patient J.A., D.W., C.E, and S.F. 

Registrant filled nearly identical 

prescriptions for patients J.A., D.W., 

C.E., and S.F, who all shared an address. 

Specifically, between January 26, 2022, 

and March 25, 2022, Registrant filled 

prescriptions for Patient J.A. for 110 

tablets of 10/325 mg hydrocodone/ 

acetaminophen and 85 tablets of 350 mg 

carisoprodol. RFAAX 4, at 7; see also 

RFAAX 3, Attachment C. Further, 

between January 18, 2022, and March 

17, 2022, Registrant filled prescriptions 

for Patient D.W. for 110 tablets of 10/ 

325 mg hydrocodone/acetaminophen 

and 85 tablets of 350 mg carisoprodol. 

RFAAX 4, at 8; see also RFAAX 3, 

Attachment D. Between January 4, 2022, 

and March 3, 2022, Registrant filled 

prescriptions for Patient C.E. for 110 

tablets of 10/325 mg hydrocodone/ 

acetaminophen and 85 tablets of 350 mg 

carisoprodol. RFAAX 4, at 10; see also 

RFAAX 3, Attachment G. Finally, 

between December 30, 2021, and March 

24, 2022, Registrant filled prescriptions 

for Patient S.F. for 110 tablets of 10/325 

mg hydrocodone/acetaminophen and 90 

tablets of 350 mg carisoprodol. RFAAX 

4, at 12; see also RFAAX 3, Attachment 

I. 

In reviewing the above prescriptions 

issued to the four patients, Ms. Salinas 

found that all of the prescriptions were 

issued by the same practitioner, Dr. 

G.K., who prescribed the same 

controlled substances in identical or 

substantially similar quantities to 

multiple patients; both the 

hydrocodone/acetaminophen and the 

carisoprodol, controlled substances 

known to be abused, were prescribed in 

large quantities and at the highest 

dosage; the four patients shared the 

same address and three of the patients 

(J.A., D.W., and S.F.) shared the same 

phone number; and all four patients 

paid cash for all of the prescriptions. 

RFAAX 4, at 7–8, 10–11, 13; RFAAX 3, 

Attachments C, D, G, I. Ms. Salinas did 

not find any evidence that Registrant 

addressed these red flags of abuse or 

diversion and, as a result, opined that 

Registrant violated the minimum 

standard of care for a Texas pharmacy 

and operated outside of the usual course 

of professional practice. RFAAX 4, at 7– 

13; see also RFAAX 3, Attachments C, 

D, G, I. 

Patients A.B. and C.B. 

Between January 17, 2022, and March 

18, 2022, Registrant filled prescriptions 

for both Patient A.B. and Patient C.B. for 

120 tablets of 10/325 mg hydrocodone/ 

acetaminophen and 90 tablets of 350 mg 

carisoprodol. RFAAX 4, at 9–10; see 

also RFAAX 3, Attachment E, F. In 

reviewing the prescriptions, Ms. Salinas 

found that all of the prescriptions were 

issued by the same practitioner, Dr. 

G.K., who prescribed the same 

controlled substances in identical or 

substantially similar quantities to 

multiple patients; both the 

hydrocodone/acetaminophen and the 

carisoprodol, controlled substances 

known to be abused, were prescribed in 

large quantities and at the highest 

dosage; and Patients A.B. and C.B. paid 

cash for all of the prescriptions. Id. Ms. 

Salinas did not find any evidence that 

Registrant addressed these red flags of 

abuse or diversion and, as a result, 

opined that Registrant violated the 

minimum standard of care for a Texas 

pharmacy and operated outside of the 

usual course of professional practice. Id. 

Patient T.P. 

Between July 8, 2021, and September 

10, 2021, Registrant filled prescriptions 

for Patient T.P. for 110 tablets of 10/325 

mg hydrocodone/acetaminophen and 85 

tablets of 350 mg carisoprodol. RFAAX 

4, at 13–14; see also RFAAX 3, 

Attachment J. In reviewing the 

prescriptions, Ms. Salinas found that all 

of the prescriptions were issued by the 

same practitioner, Dr. G.K., who 

prescribed the same controlled 

substances in identical or substantially 

similar quantities to multiple patients; 

both the hydrocodone/acetaminophen 

and the carisoprodol, controlled 

substances known to be abused, were 

prescribed in large quantities and at the 

highest dosage; Patient T.P. shared the 

same phone number as Patient M.F.; 

and Patient T.P. paid cash for all of the 

prescriptions. RFAAX 4, at 14; see also 

RFAAX 3, Attachment J. Ms. Salinas did 

not find any evidence that Registrant 

addressed these red flags of abuse or 

diversion and, as a result, opined that 

Registrant violated the minimum 

standard of care for a Texas pharmacy 

and operated outside of the usual course 

of professional practice. RFAAX 4, at 

14; see also RFAAX 3, Attachment J. 

Patient G.A. 

Between February 24, 2021, and 

February 9, 2022, Registrant filled 

prescriptions for Patient G.A. for 120 

tablets of 10/325 mg hydrocodone/ 

acetaminophen and 90 tablets of 350 mg 

carisoprodol. RFAAX 4, at 15; see also 

RFAAX 3, Attachment L. In reviewing 

the prescriptions, Ms. Salinas found that 

the prescriptions were issued by 

multiple, different practitioners. RFAAX 

4, at 14–15; see also RFAAX 3, 

Attachment L. Ms. Salinas did not find 

any evidence that Registrant addressed 

this red flag of abuse or diversion and, 

as a result, opined that Registrant 

violated the minimum standard of care 

for a Texas pharmacy and operated 

outside of the usual course of 

professional practice. RFAAX 4, at 16; 

see also RFAAX 3, Attachment L. 

Patient K.G. 

Between February 1, 2021, and March 

15, 2022, Registrant filled prescriptions 

for Patient K.G. for 110 tablets of 10/325 

mg hydrocodone/acetaminophen and 80 

tablets of 350 mg carisoprodol. RFAAX 

4, at 16; see also RFAAX 3, Attachment 

M. In reviewing the prescriptions, Ms. 

Salinas found that the prescriptions 

were issued by multiple, different 

practitioners. Id. Ms. Salinas did not 

find any evidence that Registrant 

addressed this red flag of abuse or 

diversion and, as a result, opined that 

Registrant violated the minimum 

standard of care for a Texas pharmacy 

and operated outside of the usual course 

of professional practice. Id. 

Patient L.J. 

Between March 12, 2021, and March 

23, 2022, Registrant filled prescriptions 

for Patient L.J. for 112 tablets of 10/325 

mg hydrocodone/acetaminophen and 80 

tablets of 350 mg carisoprodol. RFAAX 

4, at 17; see also RFAAX 3, Attachment 

N. In reviewing the prescriptions, Ms. 

Salinas found that the prescriptions 

were issued by multiple, different 

practitioners. Id. Ms. Salinas did not 

find any evidence that Registrant 

addressed this red flag of abuse or 

diversion and, as a result, opined that 

Registrant violated the minimum 

standard of care for a Texas pharmacy 

and operated outside of the usual course 

of professional practice. Id. 

Patient T.T. 

Between February 4, 2021, and March 

8, 2022, Registrant filled prescriptions 

for Patient T.T. for 110 tablets of 10/325 

mg hydrocodone/acetaminophen and 80 

tablets of 350 mg carisoprodol. RFAAX 

4, at 17; see also RFAAX 3, Attachment 

O. In reviewing the prescriptions, Ms. 

Salinas found that the prescriptions 

were issued by multiple, different 

practitioners. Id. Ms. Salinas did not 

find any evidence that Registrant 

addressed this red flag of abuse or 

diversion and, as a result, opined that 

Registrant violated the minimum 

standard of care for a Texas pharmacy 

and operated outside of the usual course 

of professional practice. RFAAX 4, at 

17–18; see also RFAAX 3, Attachment 

O. 

II. Discussion 

A. The Five Public Interest Factors 

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

to . . . dispense a controlled substance 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 75329 

6As 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). However, as Agency cases have noted, 

there are a number of reasons why one who has 

engaged in criminal misconduct may never have 

been convicted of an offense under this factor. 

Dewey C. MacKay, M.D., 75 FR 49956, 49973 (2010). 

Agency cases have therefore found that ‘‘the 

absence of such a conviction is of considerably less 

consequence in the public interest inquiry’’ and is 

therefore not dispositive. Id. 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. 

7The 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). 

8Texas 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 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. 

. . . 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). 

While the Agency has considered all 

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

823(g)(1),6 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 RFAA, 

at 23–29. 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 

numerous federal and state laws 

regulating controlled substances. 

RFAAX 2, at 2.7 Specifically, federal 

law requires that ‘‘[a] prescription for a 

controlled substance may only be filled 

by a pharmacist, acting in the usual 

course of his professional practice,’’ and 

that ‘‘[a] prescription for a controlled 

substance to be effective must be issued 

for a legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

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

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

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). 

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).8 The 

Texas Board of Pharmacy sets forth 

numerous ‘‘operational standards’’ for 

pharmacists filling prescriptions, 

requiring, firstly, that pharmacists 

‘‘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). Further, 

‘‘[u]pon 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). A 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). Finally, a 

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; 

patients obtaining similar controlled 

substance prescriptions from multiple 

practitioners; 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). 

Here, the record demonstrates that 

Registrant 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. Because Registrant’s 

conduct clearly violates the Texas 

standard of care—thus rendering its 

dispensing outside the usual course of 

professional practice—and clearly 

violates the various federal and state 

regulations described above, the Agency 

hereby sustains the Government’s 

allegations that Registrant repeatedly 

violated federal and state law relating to 

controlled substances. 

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 sufficient evidence to rebut the 

Government’s prima facie case. 

III. Sanction 

Where, as here, the Government has 

established grounds to revoke 


khammond on DSKJM1Z7X2PROD with NOTICES
75330 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 

Registrant’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, 77 FR 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 

Agency’s interest in deterring similar 

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

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

Here, Registrant did not request a 

hearing, submit a corrective action plan, 

respond to the OSC/ISO, or 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 clearly 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. FB4121327 issued to 

Blue Mint 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 Blue Mint Pharmacy, to renew or 

modify this registration, as well as any 

other pending application of Blue Mint 

Pharmacy, for additional registration in 

Texas. This Order is effective December 

4, 2023. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 25, 2023, 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. 2023–24150 Filed 11–1–23; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Notice of Lodging of Proposed First 

Modification To Consent Decree Under 

the Clean Water Act 

On October 25, 2023, the Department 

of Justice lodged a proposed first 

modification to the consent decree 

(‘‘First Modification’’) with the United 

States District Court for the District of 

Massachusetts in the lawsuit entitled 

United States and Commonwealth of 

Massachusetts v. City of Revere, 

Massachusetts, Civil Action No. 1:10– 

cv–11460 (D. Mass.). 

The United States filed this lawsuit in 

2010 under the Clean Water Act (‘‘Act’’). 

The complaint sought injunctive relief 

and civil penalties for violations of the 

Act in connection with the City of 

Revere’s operation of its sewage 

collection system and municipal 

separate storm sewer system (‘‘MS4’’). 

The allegations in the Complaint were 

resolved in a consent decree entered on 

November 17, 2010 (‘‘Consent Decree’’) 

in which the City of Revere agreed, 

among other things, to develop and 

implement a Comprehensive 

Wastewater Management Plan and 

Comprehensive Stormwater 

Management Plan (‘‘CWMP/CSMP’’) to 

ensure identification and 

implementation of capital projects 

necessary to eliminate sanitary sewer 

overflows (‘‘SSOs’’) and bring its MS4 

into compliance with National Pollutant 

Elimination System (‘‘NPDES’’) permit 

requirements. 

The proposed First Modification 

replaces the Consent Decree CWMP/ 

CSMP provisions with new provisions 

that require the City of Revere to update 

portions of its CWMP/CSMP by 

December 31, 2026. This update must 

include a summary of work completed 

pursuant to the Consent Decree, 

assessment of the City of Revere sewer 

system current service level and 

associated review of capacity-related 

SSOs, development and assessment of 

alternatives to achieve the goal of the 

Consent Decree to prevent collection 

system surcharges or capacity-related 

SSOs events, and a recommended plan 

and implementation schedule 

identifying projects to attain the target 

level of sewer system service of a tenyear design storm. The new provisions 

also extend the deadline for completion 

of all work proposed under Revere’s 

CWMP/CSMP to December 31, 2038. 

The publication of this notice opens 

a period for public comment on the First 

Modification. Comments should be 

addressed to the Assistant Attorney 

General, Environment and Natural 

Resources Division, and should refer to 

United States and Commonwealth of 

Massachusetts v. City of Revere, 

Massachusetts, Civil Action No. 1:10– 

cv–11460, D.J. Ref. No. 90–5–1–1– 

09299. All comments must be submitted 

no later than thirty (30) days after the 

publication date of this notice. 

Comments may be submitted either by 

email or by mail: 

To submit 

comments: Send them to: 

By email ....... pubcomment-ees.enrd@

usdoj.gov. 

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

U.S. DOJ—ENRD, P.O. 

Box 7611, Washington, DC 

20044–7611. 

During the public comment period, 

the First Modification may be examined 

and downloaded at this Justice 

Department website: https://

www.justice.gov/enrd/consent-decrees. 

We will provide a paper copy of the 

First Modification upon written request 

and payment of reproduction costs. 

Please mail your request and payment 

to: Consent Decree Library, U.S. DOJ— 

ENRD, P.O. Box 7611, Washington, DC 

20044–7611. 

Please enclose a check or money order 

for $4.50 (25 cents per page 

reproduction cost) payable to the United 

States Treasury. 

Henry Friedman, 

Assistant Section Chief, Environmental 

Enforcement Section, Environment and 

Natural Resources Division. 

[FR Doc. 2023–24168 Filed 11–1–23; 8:45 am] 

BILLING CODE 4410–15–P 

DEPARTMENT OF JUSTICE 

Notice of Availability; Service Contract 

Inventory 

AGENCY: Justice Management Division, 

Department of Justice. 

ACTION: Notice of availability. 

SUMMARY: The Justice Management 

Division (JMD), Department of Justice 

(DOJ) is publishing this notice to advise 


khammond on DSKJM1Z7X2PROD with NOTICES