Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 75323 

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 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 3–17. The Agency agrees with the ALJ that 

the Diversion Investigator’s testimony, which was 

focused on the uncontroversial introduction of 

documentary evidence and her contact with the 

case, was credible in that it was sufficiently 

detailed, plausible, and internally consistent. Id. at 

4. Further, the Agency agrees with the ALJ that the 

testimony from the Government’s expert witness, 

Dr. Steven Lobel, M.D., which was focused on the 

Georgia standard of care and Respondent’s 

prescribing to the patients listed in the OSC/ISO, 

was credible in that it was consistent with Georgia 

statutes governing the prescribing of controlled 

substances, especially in the pain management 

context, and was clear, direct, substantial, and 

consistent with regards to the individual patients. 

Id. at 4–5. Finally, the Agency agrees with the ALJ 

that although Respondent’s testimony was credible 

as to general facts, including Respondent 

volunteering information regarding prior 

disciplinary actions, on the issue of whether his 

prescriptions were within the usual course of 

professional practice and for a legitimate medical 

purpose, Respondent’s testimony was not fully 

credible in that his interpretations of the Georgia 

standard of care were inconsistent with the Georgia 

state statutes. Id. at 9–10. 

3 During the hearing, both Government counsel 

and Dr. Lobel initially referenced a national 

standard of care established by the CDC Guidelines, 

see RD, at 10, but Dr. Lobel ultimately testified that 

the Georgia standard of care, upon which this 

decision is based, is grounded in the state medical 

board’s publications and Georgia state statutes, with 

the CDC Guidelines incorporated to the extent that 

they deal with the prescriptions of opioids. RD, at 

10; Tr. 114–115, 119, 125. 

The Administrator further proposes 

that aggregate production quotas for all 

other schedule I and II controlled 

substances included in 21 CFR 1308.11 

and 1308.12 remain at zero. 

These proposed 2024 quotas reflect 

the quantities that DEA believes are 

necessary to meet the estimated 

medical, scientific, research, and 

industrial needs of the United States, 

lawful export requirements; and the 

establishment and maintenance of 

reserve stocks. DEA remains committed 

to conducting continuous surveillance 

on the supply of schedule II controlled 

substances and list I chemicals 

necessary to treat patients with COVID– 

19, and, pursuant to her authority, the 

Administrator will move swiftly and 

decisively to increase any 2024 APQ 

that she determines is necessary to 

address an unforeseen increase in 

demand, should that occur. 

In accordance with 21 CFR 1303.13 

and 1315.13, upon consideration of the 

relevant factors, the Administrator may 

adjust the 2024 APQ and AAN as 

needed. 

Conclusion 

After consideration of any comments 

or objections, or after a hearing, if one 

is held, the Administrator will issue and 

publish in the Federal Register a final 

order establishing the 2024 APQ for 

controlled substances in schedules I and 

II and establishing an AAN for the list 

I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine, as directed by 21 

CFR 1303.11(c) and 1315.11(f). 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 30, 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. 

Scott Brinks, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

[FR Doc. 2023–24282 Filed 11–1–23; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 23–17] 

Isaac Sved, M.D.; Decision and Order 

On December 8, 2022, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause and Immediate Suspension of 

Registration (OSC/ISO) to Isaac Sved, 

M.D. (Respondent) of Buford, Georgia. 

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

Respondent of the immediate 

suspension of his DEA Certificate of 

Registration, Control No. BS4103610, 

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 has ‘‘committed such acts 

as would render [his] registration 

inconsistent with the public interest.’’ 

Id. at 1, 4 (citing 21 U.S.C. 823(g)(1),1

824(a)(4)). 

A hearing was held before DEA 

Administrative Law Judge Teresa A. 

Wallbaum (the ALJ) who, on June 20, 

2023, issued her Recommended Rulings, 

Findings of Fact, Conclusions of Law, 

and Decision (Recommended Decision 

or RD), which recommended revocation 

of Respondent’s registration. RD, at 27. 

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, credibility findings,2

findings of fact, conclusions of law, 

sanctions analysis, and recommended 

sanction as found in the RD. 

I. Findings of Fact 

Georgia Standard of Care 

DEA hired Dr. Lobel to testify as an 

expert in the standard of care for the 

practice of medicine and the prescribing 

of controlled substances in the state of 

Georgia, with a focus on pain 

management. RD, at 4; Tr. 105.3 Dr. 

Lobel defined ‘‘standard of care’’ as a 

‘‘minimum level of competence or care 

so as not to harm the patient,’’ and 

described how the Georgia standard of 

care requires a practitioner to, prior to 

prescribing controlled substances, 

obtain a patient’s prior medical records; 

obtain a medical history, including 

family medical history and mental 

health history; conduct an appropriate 

physical examination; obtain a urine 

drug screen; check the PDMP; obtain 

informed consent from the patient; and 

document all information. RD, at 11; Tr. 

120, 128–129, 134, 136. Further, the 

physical examination must be 

appropriate to the complaint, and for 

patients who have spinal pain, the 

practitioner should also conduct a 

complete neurologic exam. RD, at 11; 

Tr. 129–130. In addition, the Georgia 

standard of care requires that a 

practitioner determine and document 

the severity of pain. RD, at 11; Tr. 135– 

136. 

Dr. Lobel testified that under the 

Georgia standard of care, opioids ‘‘are 

not first-line treatment for chronic 

pain,’’ so a practitioner must ‘‘weigh the 

risks and benefits at every visit,’’ as well 

as look out for adverse effects, side 

effects, and aberrant behavior. RD, at 11; 

Tr. 132–133, 136–137. According to Dr. 

Lobel, under the Georgia standard of 

care, a practitioner should consider 

taking a patient off of opioids when 

there is a ‘‘lack of functional benefit, 

toxic effects of the medicine where 

they’re having end organ damage, . . . 

[or] someone [] showing any signs or 

symptoms of addiction,’’ and patients 


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4 Dr. Lobel testified that although Georgia law 

does not specifically prohibit prescribing the ‘‘Holy 

Trinity’’ or duplicative therapies, the standard of 

care described comes from the state medical board. 

RD, at 12 n.10; Tr. 173, 290. 

5Respondent testified that although he is not 

board-certified in pain management, he has 

completed many hours of training. RD, at 5; Tr. 372. 

Specifically, he ‘‘took specialized courses offered by 

. . . the American Academy of Pain Management.’’ 

RD, at 5; Tr. 347. Respondent is also a member of 

the American Academy of Pain Physicians, 

Integrative Pain Management, and performs 

immigration physicals. RD, at 6; Tr. 347, 363. 

6Regarding the combination of oxycodone, Soma, 

and Xanax, the ‘‘Holy Trinity’’, Respondent testified 

that the Medscape application reports three 

interactions of those drugs and says to ‘‘monitor 

closely’’ but does not say ‘‘severe adverse reaction.’’ 

RD, at 9; Tr. 355. 

should be tapered off of opioids if they 

are not in pain or if they are abusing the 

opioid prescription. RD, at 11–12; Tr. 

140, 146–147. Regarding the relevant 

red flags of abuse and diversion, Dr. 

Lobel testified that under the Georgia 

standard of care, there is never a 

legitimate medical purpose for 

prescribing the ‘‘Holy Trinity’’ because 

‘‘[e]ach medicine synergistically affects 

the other to augment a high’’ and it 

produces ‘‘respiratory drive’’ as a side 

effect. RD, at 12; Tr. 148–149, 173. 

Moreover, Dr. Lobel testified that 

duplicative therapies, that is, 

prescriptions for the same drugs in 

different strengths at high quantities, are 

not legitimate medical practice and fall 

out of the standard of care, with Dr. 

Lobel differentiating between 

prescribing ‘‘two dose units of the same 

medication to get a higher dose unit at 

high quantities’’ and prescribing a 

separate daytime and nighttime pain 

medicine. RD, at 12; Tr. 109, 149–151.4

Respondent 

In 2010, Respondent began a family 

medicine and pain management practice 

in Atlanta.5 RD, at 5; Tr. 335–336, 347, 

363, 372. Respondent testified that most 

of his patients are ‘‘hard-working bluecollar workers’’ and ‘‘laborers’’ and that 

his patients prefer short-acting opioids 

because they do not make them as 

drowsy as long-acting opioids, therefore 

allowing the patients to control their 

pain but still be able to work. RD, at 6; 

Tr. 343–345, 376–377. Respondent 

testified that his patients also worry 

about ‘‘cost-effectiveness’’ because 

‘‘they don’t have great insurance . . . 

[and] they can’t really afford to do 

physical therapy.’’ RD, at 7; Tr. 348. 

Respondent testified that he has seen 

many of his pain patients since 2010 or 

2012 and that he started these patients 

on lower doses of opioids that increased 

over time with changes in drugs and 

dosages. RD, at 7; Tr. 345. Respondent 

testified that he ‘‘do[es] the rational 

thoughts as to why [he] prescribe[s] 

these medications. [He] do[es not] willynilly prescribe 120 doses of anything 

without thinking it through.’’ RD, at 7; 

Tr. 345–346. According to Respondent, 

he is ‘‘kind of old school’’ and ‘‘spend[s] 

more time talking to [patients], 

examining them, and counseling them 

than writing notes.’’ RD, at 7; Tr. 346. 

Regarding opioids, Respondent 

acknowledged that an opioid 

prescription must be medically 

necessary. RD, at 7; Tr. 378. Respondent 

testified that he does ‘‘everything [he is] 

supposed to do as far as the Georgia 

requirements for pain management,’’ but 

that he does not ‘‘always write them 

down because . . . most of [his] practice 

is to take care of the patients and not 

write paper.’’ RD, at 8; Tr. 350, see also 

Tr. 375, 376. Respondent also testified 

that although he sometimes ‘‘missed’’ 

information in his notes, all of the 

patient information is documented in 

patient files in an ‘‘abbreviated form.’’ 

RD, at 8; Tr. 375–376. 

Regarding the prescription of the 

‘‘Holy Trinity,’’ Respondent 

acknowledged that it is a dangerous 

combination, but testified that ‘‘if 

[patients] failed other muscle relaxants, 

I usually have to go to . . . the one that 

seems to work the best.’’ RD, at 8; Tr. 

351, 353. Respondent asserted that he 

discusses the risk of combination 

prescriptions with patients. RD, at 8; 

355–356. Respondent testified that he 

uses an application on his phone called 

Medscape to check for interactions 

between medications. RD, at 9; Tr. 354– 

355.6 Ultimately, Respondent testified 

that his job is ‘‘to make people feel 

healthy and good.’’ RD, at 9; Tr. 360. 

Respondent testified that he is 

familiar with and adheres to the Georgia 

standard of care, as found in the laws 

published by the Georgia medical board 

website. RD, at 9; Tr. 338, 365–369. 

Regarding the patients listed in the 

OSC/ISO, Respondent testified that his 

patients were ‘‘fully informed as to the 

nature of [his] proposals’’ and that his 

prescriptions were within the standard 

of care, with his patients receiving 

‘‘more medical benefit than risk.’’ RD, at 

9; 365–366. Respondent also denied 

running a ‘‘pill mill’’ or having any 

arrangement with his patients regarding 

selling the controlled substance 

prescriptions and denied knowingly or 

directly profiting from any diversion, 

and according to Respondent, none of 

his patients have been arrested for 

diversion. RD, at 9; Tr. 342, 364–365. 

The Patients 

Patient J.W. 

On at least three occasions, 

Respondent issued prescriptions to 

Patient J.W. that in combination formed 

the ‘‘Holy Trinity.’’ Specifically, on May 

15, 2022, June 12, 2022, and July 17, 

2022, Respondent prescribed 30 mg 

oxycodone, 2 mg alprazolam, and 350 

mg carisoprodol. RD, at 13; Tr. 109, 274, 

277, 280; GX 2, at 14–15, 17–18, 20–21. 

On each date, Respondent also 

prescribed a second opioid, Percocet, a 

brand name for oxycodone/ 

acetaminophen, a schedule II opioid. 

RD, at 13; Tr. 274, 277, 280; GX 2, at 14, 

17, 20. Because there was no 

documentation justifying prescribing 

the ‘‘Holy Trinity,’’ Dr. Lobel 

concluded, and the Agency agrees, that 

the prescriptions were not issued within 

the Georgia standard of care. RD, at 13; 

Tr. 275, 277, 280–282; GX 2, at 16, 19, 

22. Accordingly, the ALJ found, and the 

Agency agrees, that the prescriptions 

were not issued for a legitimate medical 

purpose by a practitioner acting in the 

usual course of professional practice. 

RD, at 13. 

Patient S.D. 

On at least three occasions, 

Respondent issued prescriptions to 

Patient S.D. that in combination formed 

the ‘‘Holy Trinity.’’ Specifically, on 

April 27, 2022, May 25, 2022, and June 

22, 2022, Respondent prescribed 30 mg 

oxycodone, 2 mg alprazolam, and 350 

mg carisoprodol. RD, at 13–14; Tr. 265, 

268–269, 270; GX 3, at 213, 217, 219. 

Moreover, on each date, Respondent 

also prescribed Percocet and Valium, a 

brand name for diazepam, a schedule IV 

benzodiazepine, forming a ‘‘double’’ 

‘‘Holy Trinity’’ because there were two 

opioids and two benzodiazepines in 

combination with the carisoprodol. RD, 

at 14; Tr. 265, 268–270, 272; GX 3, at 

213, 217, 219. Because there was no 

documentation justifying the 

prescriptions, Dr. Lobel concluded, and 

the Agency agrees, that the prescriptions 

were not issued within the Georgia 

standard of care. RD, at 14; Tr. 266, 267, 

269, 271. Accordingly, the ALJ found, 

and the Agency agrees, that the 

prescriptions were not issued for a 

legitimate medical purpose by a 

practitioner acting in the usual course of 

professional practice. RD, at 14. 

Patient T.J. 

On at least three occasions, 

Respondent issued prescriptions to 

Patient T.J. that in combination formed 

the ‘‘Holy Trinity.’’ Specifically, on May 

9, 2022, June 6, 2022, and June 30, 2022, 

Respondent prescribed 30 mg 


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7 Dr. Lobel testified that the documentation for 

the June 30, 2022, prescriptions did not support 

prescribing the ‘‘Holy Trinity,’’ but the Government 

did not elicit any testimony regarding the adequacy 

of the documentation for the other two dates for 

Patient T.J. RD, at 15 n.15; Tr. 263. 

8The Agency also agrees with the ALJ’s 

conclusion that none of Respondent’s arguments— 

including, among others, that the case was initially 

based on unfounded criminal allegations; that the 

patients suffered no injuries as a result of 

Respondent’s treatment; that the Government’s case 

was only an attack on Respondent’s recordkeeping; 

that both public and private insurance companies 

saw fit to cover Respondent’s treatments; and that 

Continued 

oxycodone, 2 mg alprazolam, and 350 

mg carisoprodol. RD, at 14–15; Tr. 259, 

261, 263; GX 4, at 190, 192, 195. 

Because there was no documentation 

justifying prescribing the ‘‘Holy 

Trinity,’’ Dr. Lobel concluded, and the 

Agency agrees, that the prescriptions 

were not issued within the Georgia 

standard of care. RD, at 15; Tr. 260, 262, 

264.7 Accordingly, the ALJ found, and 

the Agency agrees, that the prescriptions 

were not issued for a legitimate medical 

purpose by a practitioner acting in the 

usual course of professional practice. 

RD, at 15. 

Patient A.A. 

On at least three occasions, 

Respondent issued prescriptions to 

Patient A.A. that were therapeutically 

duplicative. Specifically, on April 11, 

2022, June 6, 2022, and July 6, 2022, 

Respondent prescribed 30 mg 

oxycodone and Percocet. RD, at 15; Tr. 

245, 250–251, 255; GX 5, at 63, 64, 66. 

As Dr. Lobel testified, oxycodone and 

Percocet are both immediate release 

opioids and so prescribing them in 

combination is therapeutic duplication. 

RD, at 15; Tr. 245–246, 250–251, 257. 

Because there was no documentation 

justifying the therapeutic duplication, 

Dr. Lobel concluded, and the Agency 

agrees, that the prescriptions were not 

issued within the Georgia standard of 

care. RD, at 15; Tr. 246, 249, 251, 253, 

256–258; GX 5, at 37, 38, 40. 

Accordingly, the ALJ found, and the 

Agency agrees, that the prescriptions 

were not issued for a legitimate medical 

purpose by a practitioner acting in the 

usual course of professional practice. 

RD, at 15–16. 

Patient L.B. 

On at least three occasions, 

Respondent issued prescriptions to 

Patient L.B. that were therapeutically 

duplicative. Specifically, on May 15, 

2022, June 12, 2022, and July 10, 2022, 

Respondent prescribed 30 mg 

oxycodone and Percocet. RD, at 16; Tr. 

221, 235, 238–239, 241–242; GX 6, at 35, 

37, 39. Because there was no 

documentation justifying the 

therapeutic duplication, Dr. Lobel 

concluded, and the Agency agrees, that 

the prescriptions were not issued within 

the Georgia standard of care. RD, at 16; 

Tr. 236, 239 241; GX 5, at 36, 38, 40. 

Accordingly, the ALJ found, and the 

Agency agrees, that the prescriptions 

were not issued for a legitimate medical 

purpose by a practitioner acting in the 

usual course of professional practice. 

RD, at 16. 

Patient A.T. 

On at least three occasions, 

Respondent issued prescriptions to 

Patient A.T. that were therapeutically 

duplicative. Specifically, on April 6, 

2022, May 4, 2022, and June 2, 2022, 

Respondent prescribed 30 mg 

oxycodone and Percocet. RD, at 16; Tr. 

220–221, 225, 226, 228–229; GX 7, at 86, 

87, 88. Because there was no 

documentation justifying the 

therapeutic duplication, Dr. Lobel 

concluded, and the Agency agrees, that 

the prescriptions were not issued within 

the Georgia standard of care. RD, at 16– 

17; Tr. 221–222, 226–227, 231; GX 7, at 

31–33. Accordingly, the ALJ found, and 

the Agency agrees, that the prescriptions 

were not issued for a legitimate medical 

purpose by a practitioner acting in the 

usual course of professional practice. 

RD, at 17. 

I. 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 his 

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). 

DEA considers these public interest 

factors in the disjunctive. Robert A. 

Leslie, M.D., 68 FR 15227, 15230 (2003). 

Each factor is weighed on a case-by-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 18; see also RD, 

at 18 n.20 (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 17– 

23. 

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). DEA 

regulations require that for a 

prescription for a controlled substance 

to be effective, it must be issued for a 

legitimate medical purpose by an 

individual practitioner acting in the 

usual course of professional practice. 21 

CFR 1306.04(a); see also 21 U.S.C. 829. 

Georgia state law too provides that a 

practitioner may only issue 

prescriptions while acting in the usual 

course of his professional practice and 

for a legitimate medical purpose. Ga. 

Code Ann. section 16–13–41(f)(2), (3). 

In the current matter, the Agency 

agrees with the ALJ’s analysis that 

Respondent’s treatment of the six 

patients described above fell below the 

Georgia standard of care and thus 

violated Federal and State law because, 

as detailed above, Respondent 

continually prescribed the ‘‘Holy 

Trinity’’ and duplicative therapies while 

failing to establish a medical 

justification for the prescriptions; as 

such, Respondent’s prescribing was not 

within the usual course of professional 

practice and not for a legitimate medical 

purpose.8 RD, at 20–21. As 


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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