80152 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 

1Under the Administrative Procedure Act, an 

agency ‘‘may take official notice of facts at any stage 

in a proceeding—even in the final decision.’’ 

United States Department of Justice, Attorney 

General’s Manual on the Administrative Procedure 

Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 

1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an 

agency decision rests on official notice of a material 

fact not appearing in the evidence in the record, a 

party is entitled, on timely request, to an 

opportunity to show the contrary.’’ Accordingly, 

Registrant may dispute my finding by filing a 

properly supported motion for reconsideration 

within fifteen calendar days of the date of this 

Order. Any such motion shall be filed with the 

Office of the Administrator and a copy shall be 

served on the Government. In the event Registrant 

files a motion, the Government shall have fifteen 

calendar days to file a response. Any such motion 

and response may be filed and served by email 

(dea.addo.attorneys@dea.usdoj.gov). 

corrective action plan. 21 CFR 

1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, 

therefore, issue this Decision and Order 

based on the record submitted by the 

Government, which constitutes the 

entire record before me. 21 CFR 

1301.46. 

Findings of Fact 

REGISTRANT’S DEA REGISTRATION

Registrant is the holder of DEA 

Certificate of Registration No. 

AL1804409 at the registered address of 

2392 N. Euclid Ave, Upland, CA 91784. 

RFAAX 1 (Registrant’s DEA Certificate 

of Registration). Pursuant to this 

registration, Registrant is authorized to 

dispense controlled substances in 

schedules II through V as a practitioner. 

Id. Registrant’s registration will expire 

on its own terms on March 31, 2022. Id. 

THE STATUS OF REGISTRANT’S STATE

LICENSE

On March 5, 2019, Registrant and the 

Medical Board of California entered into 

a Stipulated Surrender of License and 

Order, whereby Registrant surrendered 

his California medical license. RFAAX 

3. The Medical Board of California’s 

online records, of which I take official 

notice, document that Registrant’s 

license is still surrendered. 1 Medical 

Board of California License Verification, 

https://www.mbc.ca.gov/Breeze/ 

License_Verification.aspx (last visited 

date of signature of this Order). 

Accordingly, I find that Registrant 

currently is not licensed to engage in the 

practice of medicine in California, the 

state in which Registrant is registered 

with the DEA. 

Discussion 

Pursuant to 21 U.S.C. 824(a)(3), the 

Attorney General is authorized to 

suspend or revoke a registration issued 

under section 823 of the CSA ‘‘upon a 

finding that the registrant . . . has had 

his State license or registration 

suspended . . . [or] revoked . . . by 

competent State authority and is no 

longer authorized by State law to engage 

in the . . . dispensing of controlled 

substances.’’ With respect to a 

practitioner, the DEA has also long held 

that the possession of authority to 

dispense controlled substances under 

the laws of the state in which a 

practitioner engages in professional 

practice is a fundamental condition for 

obtaining and maintaining a 

practitioner’s registration. See, e.g., 

James L. Hooper, M.D., 76 FR 71,371 

(2011), pet. for rev. denied, 481 Fed. 

Appx. 826 (4th Cir. 2012); Frederick 

Marsh Blanton, M.D., 43 FR 27,616, 

27,617 (1978). 

This rule derives from the text of two 

provisions of the CSA. First, Congress 

defined the term ‘‘practitioner’’ to mean 

‘‘a physician . . . or other person 

licensed, registered, or otherwise 

permitted, by . . . the jurisdiction in 

which he practices . . . , to distribute, 

dispense, . . . [or] administer . . . a 

controlled substance in the course of 

professional practice.’’ 21 U.S.C. 

802(21). Second, in setting the 

requirements for obtaining a 

practitioner’s registration, Congress 

directed that ‘‘[t]he Attorney General 

shall register practitioners . . . if the 

applicant is authorized to dispense . . . 

controlled substances under the laws of 

the State in which he practices.’’ 21 

U.S.C. 823(f). Because Congress has 

clearly mandated that a practitioner 

possess state authority in order to be 

deemed a practitioner under the CSA, 

the DEA has held repeatedly that 

revocation of a practitioner’s registration 

is the appropriate sanction whenever he 

is no longer authorized to dispense 

controlled substances under the laws of 

the state in which he practices. See, e.g., 

James L. Hooper, 76 FR at 71,371–72; 

Sheran Arden Yeates, M.D., 71 FR 

39,130, 39,131 (2006); Dominick A. 

Ricci, M.D., 58 FR 51,104, 51,105 (1993); 

Bobby Watts, M.D., 53 FR 11,919, 11,920 

(1988); Frederick Marsh Blanton, 43 FR 

at 27,617. 

According to California statute, ‘‘[n]o 

person other than a physician . . . shall 

write or issue a prescription.’’ Cal. 

Health & Safety Code § 11150 (West 

2020). Further, ‘‘physician,’’ as defined 

by California statute, is a person who is 

‘‘licensed to practice’’ in California. Id. 

at § 11024. 

Here, the undisputed evidence in the 

record is that Registrant currently lacks 

authority to practice medicine in 

California. As already discussed, a 

physician must be a licensed 

practitioner to dispense a controlled 

substance in California. Thus, because 

Registrant lacks authority to practice 

medicine in California and, therefore, is 

not authorized to handle controlled 

substances in California, Registrant is 

not eligible to maintain a DEA 

registration. Accordingly, I will order 

that Registrant’s DEA 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. AL1804409 issued to 

King Wong, M.D. Further, pursuant to 

28 CFR 0.100(b) and the authority 

vested in me by 21 U.S.C. 823(f), I 

hereby deny any pending application of 

King Wong, M.D. to renew or modify 

this registration. This Order is effective 

January 11, 2021. 

Timothy J. Shea, 

Acting Administrator. 

[FR Doc. 2020–27232 Filed 12–10–20; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Zeljko Stjepanovic, M.D.; Decision and 

Order 

On May 1, 2018, a former Acting 

Administrator of the Drug Enforcement 

Administration (hereinafter, DEA or 

Government) issued an Order to Show 

Cause and Immediate Suspension of 

Registration to Zeljko Stjepanovic, M.D. 

(hereinafter, Registrant). Government’s 

Request for Final Agency Action Exhibit 

(hereinafter, RFAAX) 3, at 1 (Order to 

Show Cause and Immediate Suspension 

Order (hereinafter, collectively OSC)). 

The OSC informed Registrant of the 

immediate suspension of his DEA 

Certificate of Registration FS3042885 

pursuant to 21 U.S.C. 824(d), ‘‘because 

[his] continued registration constitutes 

an imminent danger to public health 

and safety.’’ Id. 

The substantive ground for the 

proceeding, as alleged in the OSC, is 

that Registrant’s ‘‘continued registration 

is inconsistent with the public interest, 

as that term is defined in 21 U.S.C. 

823(f).’’ Id. Specifically, the OSC alleges 

that on August 31, 2017, January 19, 

2018, February 16, 2018, and March 15, 

2018, Registrant unlawfully prescribed 

controlled substances in violation of 21 

U.S.C. 841(a) and 842(a). The OSC 

further alleges that on those dates, 

Registrant prescribed controlled 

substances to individuals that he ‘‘knew 

were not for a legitimate medical 

purpose and were not in the usual 

course of [his] professional practice,’’ 

because he issued them ‘‘without 

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1The DI assigned to Registrant’s case declared 

that TFO One and TFO Two recorded all of their 

visits with Registrant. RFAAX 5, at 2. The 

Government, however, has only provided a partial 

transcript from the recording of one of those visits. 

See RFAAX 2 (Transcript of February 16, 2018 

undercover visit with Registrant). Exhibit Two to 

the Government’s RFAA is three pages of a twentyfour page transcript of the recording of the February 

16, 2018 visit. Id. The Government has provided no 

explanation for only including certain pages from 

the February 16, 2018 visit transcript and for not 

including any of the recordings or transcripts of the 

recordings from the other three visits. Although I 

do not have the recordings for the majority of the 

undercover visits in the evidence before me, there 

is no evidence in the record that contradicts the 

Government’s presentation of the facts in this 

matter. 

2Tramadol is a schedule IV controlled substance. 

21 CFR 1308.14(b). 

patient relationships’’ and ‘‘issued 

prescriptions in the name of one patient 

for use by another patient, despite 

acknowledging the illegality of this 

behavior, in violation of federal and 

state law.’’ Id. at 2 (citing 21 CFR 

1306.04(a); Va. Code Ann. §§ 54.1– 

3303.A, 54.1–2915.A(3), (8), (13), (16), 

(17), and 18.2.248). 

In issuing the OSC, which 

immediately suspended the registration, 

the former Acting Administrator 

concluded that Registrant’s ‘‘continued 

registration is inconsistent with the 

public interest’’ based on a preliminary 

finding that Registrant ‘‘issued 

prescriptions for controlled substances 

that [Registrant] knew were illegal, 

without a legitimate medical purpose 

and outside the usual course of 

professional practice’’ and that were 

‘‘indicative of [Registrant’s] general 

illegitimate practice of prescribing 

controlled substances in violation of 

State and Federal laws.’’ Id. at 7. Citing 

21 U.S.C. 824(d), he also made the 

preliminary finding that Registrant’s 

‘‘continued registration during the 

pendency of the proceedings would 

constitute an imminent danger to the 

public health or safety because of the 

substantial likelihood that [Registrant] 

will continue to unlawfully prescribe 

controlled substances, thereby allowing 

the diversion of controlled substances 

unless [Registrant’s] DEA COR is 

suspended.’’ Id. The former Acting 

Administrator authorized the DEA 

Special Agents and Diversion 

Investigators serving the OSC on 

Registrant to place under seal or remove 

for safekeeping all controlled substances 

Registrant possessed pursuant to the 

immediately suspended registration. Id. 

(citing 21 U.S.C. 824(f) and 21 CFR 

1301.36(f)). The former Acting 

Administrator also directed those DEA 

employees to take possession of 

Registrant’s Certificate of Registration 

FS3042886 and any unused prescription 

forms. Id. at 8. 

According to the Declaration of a DEA 

Diversion Investigator (hereinafter, DI) 

from the Richmond District Office, the 

DI personally served the OSC on 

Registrant on May 4, 2018, at his 

registered address. RFAAX 5, at 2. 

Based on the DI’s Declaration, and my 

review of the record, I find that the 

Government accomplished service of 

the OSC on Registrant on May 4, 2018. 

The OSC notified Registrant of his right 

to request a hearing on the allegations 

or to submit a written statement while 

waiving his right to a hearing, the 

procedures for electing each option, and 

the consequences for failing to elect 

either option. OSC at 7–8 (citing 21 CFR 

1301.43(c)). 

On July 25, 2018, the Government 

forwarded a Request for Final Agency 

Action (hereinafter, RFAA), along with 

the evidentiary record for this matter, to 

my office, and asserted that the 

Government had not received a request 

for a hearing. RFAA, at 2. I find that 

more than thirty days have now passed 

since the Government accomplished 

service of the OSC. I further find, based 

on the Government’s written 

representations, that neither Registrant, 

nor anyone purporting to represent the 

Registrant, requested a hearing, or 

submitted a written statement while 

waiving Registrant’s right to a hearing. 

Accordingly, I find that Registrant has 

waived the right to a hearing and the 

right to submit a written statement. 21 

CFR 1301.43(d). I, therefore, issue this 

Decision and Order based on the record 

submitted by the Government, which 

constitutes the entire record before me. 

21 CFR 1301.43(e). 

Having considered the record in its 

entirety, I find that the record 

establishes, by substantial evidence, that 

Registrant committed acts rendering his 

continued registration inconsistent with 

the public interest. I also find that 

Registrant has submitted no evidence 

that he accepts responsibility for his 

failures to meet the responsibilities of a 

registrant nor presented any evidence of 

mitigation or remedial measures. 

Accordingly, I conclude that the 

appropriate sanctions are (1) for 

Registrant’s DEA registration to be 

revoked; and (2) for any pending 

application by Registrant to be denied. 

Based on the representations of the 

Government in its RFAA, I make the 

following findings of fact. 

I. Findings of Fact 

A. Registrant’s DEA Registration 

Registrant is registered with DEA as a 

practitioner in schedules II through V 

under DEA Certificate of Registration 

No. FS3042885, at the registered address 

of 2004 Bremo Rd, Suite 200, 

Richmond, VA 23226. RFAAX 1. This 

registration expires on February 28, 

2021. Id. The registration was 

suspended pursuant to the Immediate 

Suspension Order dated May 1, 2018. 

OSC, at 7. 

B. The Investigation of Registrant 

In 2017, the Richmond District Office 

(hereinafter, RDO) of the DEA 

Washington Field Office began an 

investigation of Registrant that included 

the use of undercover investigators. 

RFAAX 5, at 1–2. Two RDO Task Force 

Officers (hereinafter, TFO One and TFO 

Two) were assigned to investigate 

Registrant. Id. at 2. According to the 

Government, TFO One first visited 

Registrant posing as a patient on August 

31, 2017, while Registrant was working 

for a practice located in Fredericksburg, 

VA. RFAAX 6 (Declaration of TFO One), 

at 1. TFO Two next went undercover to 

visit Registrant with TFO One on 

January 19, 2018 and February 16, 2018 

in Registrant’s Richmond Office. Id. at 2. 

Finally, TFO Two went undercover to 

visit Registrant by herself on March 15, 

2018. RFAAX 7 (Declaration of TFO 2), 

at 2. 

The Government submitted 

declarations from TFO One and TFO 

Two, which summarize the events of the 

undercover visits to Registrant. See 

RFAAX 6 and 7. The Government also 

submitted copies of controlled 

substance prescriptions written by 

Registrant to the aliases used by TFO 

One and TFO Two that support their 

accounting of their visits with 

Registrant, RFAAX 4 (Copies of 

prescriptions), and a partial transcript of 

a recording of the February 16 

undercover visit.1 RFAAX 2 (Transcript 

of February 16, 2018 undercover visit 

with Registrant). 

1. August 31, 2017 Undercover Visit 

TFO One first visited Registrant 

posing as a patient on August 31, 2017. 

RFAAX 6, at 1. At the time, Registrant 

was working for a practice located in 

Fredericksburg, VA. Id. During the 

August 31 visit, Registrant provided 

TFO One with a prescription for 

Tramadol (50 mg, QTY 84).2 RFAAX 4 

(copy of prescription); RFAAX 6, at 2. 

TFO One said that she ‘‘specifically 

asked for Tramadol by name because it 

made [her] feel good.’’ RFAAX 6, at 2. 

When Registrant checked the Virginia 

Prescription Monitoring Program and 

discovered that TFO One did not have 

a previous prescription for Tramadol, 

TFO One told Registrant that she ‘‘had 

previously been using [her] exboyfriend’s Tramadol prescription.’’ Id. 

According to TFO One, Registrant did 


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3TFO One declared that this visit occurred on 

January 19, 2018, while TFO Two declared that this 

visit occurred on January 18, 2018. RFAAX 7, at 2. 

I find that the one-day discrepancy between the two 

accounts of the date of this visit does not detract 

from TFO Two’s credibility, given the other 

supporting evidence for this visit, and is ultimately 

irrelevant in this matter. The Government presents 

the visit as having occurred on January 19, 2018, 

and a prescription Registrant issued during the visit 

supports a finding of that date; therefore, I am 

concluding that the visit occurred on that January 

19, 2018. 

4Oxycodone is a schedule II controlled 

substance. 21 CFR 1308.12(1). 

5 In their declarations, TFO One and TFO Two 

state that this visit occurred on February 26, 2018. 

RFAA 6, at 2; RFAAX 7, at 2. The Government 

stated in the RFAA that the date in the declarations 

was a typo and should read February 16, 2018. 

RFAA, at 4. The transcript of the recording of the 

interview states that the recording was made on 

February 16, 2018. RFAAX 2. I find that the date 

in the declarations was a typo and that the visit 

occurred on February 16, 2018. I find that this date 

discrepancy was a scrivener’s error and does not 

detract from the overall credibility of the 

Government’s evidence. 

not conduct a physical exam, use 

diagnostic tools, or complete a 

urinalysis during the August 31 visit. Id. 

TFO One also declared that she did not 

provide any medical records from a 

previous medical provider. Id. 

2. January 19, 2018 Undercover Visit 

On January 19, 2018, TFO One visited 

Registrant again in an undercover 

capacity at Registrant’s office in 

Richmond, Virginia. RFAAX 6, at 2. 

TFO One was accompanied on this visit 

by TFO Two, acting in an undercover 

capacity.3 Id. Registrant saw TFO One 

and Two together, in the same room, 

during the visit. Id. 

During the January 19 visit, TFO One 

asked Registrant for another 

prescription for Tramadol. Id. 

According to the declaration of TFO 

One, Registrant replied that he ‘‘could 

not write [TFO One] [her] own 

prescription due to [her] status as a 

former Fredericksburg patient.’’ Id. 

Instead, according to TFOs One and 

Two, Registrant issued TFO Two a 

double dose of oxycodone so TFO One 

and TFO Two ‘‘could share a 

prescription until [their] next office visit 

to [Registrant].’’ RFAAX 6, at 2; RFAAX 

7, at 2. A copy of the prescription from 

the January 19 visit shows that 

Registrant wrote TFO Two (in the name 

of her alias) a prescription for 

oxycodone (10mg, QTY 90).4 RFAAX 4. 

3. February 16, 2018 Undercover Visit 

TFO One and TFO Two visited 

Registrant in an undercover capacity 

together for a second time on February 

16, 2018.5 RFAAX 6, at 2. Registrant 

saw TFO One first, by herself, in 

Registrant’s office. Id. TFO One stated 

that the office was not an examination 

room—that it contained a desk, 

computer, and chairs but no 

examination bed or medical equipment. 

Id. Registrant again stated that he could 

not write TFO One a prescription due to 

her status as a former Fredericksburg 

patient and offered to write TFO One a 

Tramadol prescription in TFO Two’s 

name. Id.; see also RFAAX 2 (Excerpts 

from transcript of February 16 visit), at 

2. The transcript of the recording made 

of the visit demonstrates that Registrant 

said, ‘‘What I was thinking in the 

beginning according [sic], that you are 

so nice, and I know that it is illegal, but 

I technically can write down those 

medications on her name.’’ RFAAX 2, at 

2. 

TFO Two was then summoned into 

Registrant’s office with Registrant and 

TFO One. RFAAX 6, at 2. Registrant told 

TFO Two that he had been discussing 

with TFO One writing a Tramadol 

prescription for TFO One in TFO Two’s 

name. RFAAX 7, at 2. Registrant sought 

to confirm that TFO Two was 

comfortable with having the Tramadol 

prescription for TFO One written in 

TFO Two’s name. Id.; RFAAX 2, at 3. 

After TFO Two said that it was fine, 

Registrant told TFO Two what to say if 

a pharmacist questioned her on why a 

doctor was prescribing two short acting 

drugs. RFAAX 2, at 3. According to the 

transcript, Registrant then asked, ‘‘Is 

that Okay? I’m sorry is illegal, but you 

know.’’ Id. 

Registrant issued two prescriptions to 

TFO Two, one for oxycodone (10mg, 

QTY 90) and one for Tramadol (50mg, 

QTY 90). RFAAX 6, at 2; RFAAX 7, at 

2; RFAAX 4. Registrant then advised 

TFO Two that she should fill the 

prescriptions at the same pharmacy as 

the January 19, 2018 prescription to 

avoid any scrutiny. RFAAX 6, at 2; 

RFAAX 7, at 2; RFAAX 4. He said ‘‘just 

don’t change, because they’re looking if 

you’re changing doctors or changing 

pharmacies . . . .’’ RFAAX 2, at 4. 

According to TFO Two, Registrant did 

not perform any type of physical exam 

on her during the February 16 visit. 

RFAAX 7, at 2. 

4. March 15, 2018 Undercover Visit 

TFO Two visited Registrant by herself 

on March 15, 2018, and met with 

Registrant in his office. RFAAX 7, at 2. 

According to TFO Two, Registrant asked 

‘‘if I wanted him to ‘do the same stuff’’’ 

and ‘‘if I wanted him to issue another 

Tramadol prescription for TFO [One] in 

[TFO Two’s] name.’’ Id. Registrant then 

asked if she had any problems with the 

pharmacy filling the previous 

prescriptions for oxycodone and 

Tramadol. Id. When TFO Two told him 

there were no problems, Registrant 

‘‘again advised [her] that to avoid 

scrutiny of the illegal prescriptions he 

was writing, [she] should not change 

providers or pharmacies.’’ Id. 

Registrant wrote TFO Two a 

prescription for oxycodone (10mg, QTY 

90) and a prescription for Tramadol 

(50mg, QTY 90). Id.; RFAAX 4. TFO 

Two declared that during the visit 

Registrant ‘‘asked generally, how [she] 

was feeling but did not perform any 

physical examination.’’ RFAAX 7, at 2. 

In summary, based on the substantial 

evidence in the record, I find that 

Registrant issued a total of six 

prescriptions for controlled substances 

to TFO One and TFO Two without 

performing a physical examination of 

either undercover officer. I also find that 

Registrant wrote two controlled 

substance prescriptions for TFO One in 

TFO Two’s name even though he 

verbally stated that doing so was illegal. 

II. Discussion 

Under the Controlled Substances Act 

(CSA), ‘‘[a] registration . . . to . . . 

distribute[ ] or 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)(4). In the case 

of a ‘‘practitioner,’’ which is defined in 

21 U.S.C. 802(21) to include a 

‘‘physician,’’ Congress directed the 

Attorney General to consider the 

following factors in making the public 

interest determination: 

(1) The recommendation of the 

appropriate State licensing board or 

professional disciplinary authority. 

(2) The [registrant]’s experience in 

dispensing . . . controlled substances. 

(3) The [registrant]’s conviction record 

under Federal or State laws relating to 

the . . . distribution[ ] or dispensing of 

controlled substances. 

(4) Compliance with applicable State, 

Federal, or local laws relating to 

controlled substances. 

(5) Such other conduct which may 

threaten the public health and safety. 

21 U.S.C. 823(f). These factors are 

considered separately. Robert A. Leslie, 

M.D., 68 FR 15,227, 15,230 (2003). 

According to Agency decisions, I 

‘‘may rely on any one or a combination 

of factors and may give each factor the 

weight [I] deem[ ] appropriate in 

determining whether’’ to revoke a 

registration. Id.; see also Jones Total 

Health Care Pharm., LLC v. Drug Enf’t 

Admin., 881 F.3d 823, 830 (11th Cir. 

2018) (citing Akhtar-Zaidi v. Drug Enf’t 

Admin., 841 F.3d 707, 711 (6th Cir. 


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6As to Factor One, the Government alleged that 

Registrant holds a valid state medical license, and 

there is no evidence in the record of any 

recommendation from Registrant’s ‘‘State licensing 

board or professional disciplinary authority.’’ See 

OSC, at 2. State authority to practice medicine is 

‘‘a necessary, but not a sufficient condition for 

registration . . . .’’ Robert A. Leslie, M.D., 68 FR at 

15,230. Therefore, ‘‘[t]he fact that the record 

contains no evidence of a recommendation by a 

state licensing board does not weigh for or against 

a determination as to whether continuation of 

Respondent’s DEA certification is consistent with 

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

19,434, 19,444 (2011). 

As to Factor Three, there is no evidence in the 

record that Registrant has a ‘‘conviction record 

under Federal or State laws relating to the 

manufacture, distribution, or dispensing of 

controlled substances.’’ 21 U.S.C. 823(f)(3). 

However, as Agency cases have noted, there are a 

number of reasons why a person who has engaged 

in criminal misconduct may never have been 

convicted of an offense under this factor, let alone 

prosecuted for one. Dewey C. MacKay, M.D., 75 FR 

49,956, 49,973 (2010), pet. for rev. denied, MacKay 

v. Drug Enf’t Admin., 664 F.3d 808 (10th Cir. 2011). 

Agency cases have therefore held that ‘‘the absence 

of such a conviction is of considerably less 

consequence in the public interest inquiry’’ and is 

therefore not dispositive. Id. 

7 Virginia amended this portion of the code in 

2018 and 2020. This Decision cites to the law that 

was in effect during the time when Registrant 

issued the subject prescriptions to the undercover 

officers and when the OSC was issued. 

2016)); MacKay v. Drug Enf’t Admin., 

664 F.3d 808, 816 (10th Cir. 2011); 

Volkman v. Drug Enf’t Admin., 567 F.3d 

215, 222 (6th Cir. 2009); Hoxie v. Drug 

Enf’t Admin., 419 F.3d 477, 482 (6th Cir. 

2005). Moreover, while I am required to 

consider each of the factors, I ‘‘need not 

make explicit findings as to each one.’’ 

MacKay, 664 F.3d at 816 (quoting 

Volkman, 567 F.3d at 222); see also 

Hoxie, 419 F.3d at 482. ‘‘In short, . . . 

the Agency is not required to 

mechanically count up the factors and 

determine how many favor the 

Government and how many favor the 

registrant. Rather, it is an inquiry which 

focuses on protecting the public 

interest; what matters is the seriousness 

of the registrant’s misconduct.’’ Jayam 

Krishna-Iyer, M.D., 74 FR 459, 462 

(2009). Accordingly, findings under a 

single factor can support the revocation 

of a registration. MacKay, 664 F.3d at 

821. 

The Government has the burden of 

proving that the requirements for 

revocation of a DEA registration in 21 

U.S.C. 824(a) are satisfied. 21 CFR 

1301.44(e). When the Government has 

met its prima facie case, the burden 

then shifts to the registrant to show that 

revoking the registration would not be 

appropriate, given the totality of the 

facts and circumstances on the record. 

Med. Shoppe-Jonesborough, 73 FR 364, 

387 (2008). 

In this matter, while I have 

considered all of the Factors, the 

Government’s evidence in support of its 

prima facie case is confined to Factors 

Two and Four.6 I find the Government 

has satisfied 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). 

A. Factors Two and/or Four—The 

Registrant’s Experience in Dispensing 

Controlled Substances and Compliance 

With Applicable Laws Related to 

Controlled Substances 

The Government alleges that on 

August 31, 2017, January 19, 2018, 

February 16, 2018, and March 15, 2018, 

Registrant prescribed controlled 

substances to undercover officers posing 

as patients without establishing a bona 

fide practitioner-patient relationship, 

without a legitimate medical purpose, 

and outside the usual course of his 

professional practice in violation of 21 

CFR 1306.04(a) and Va. Code Ann. 

§ 54.1–3303.A. RFAA, at 8; OSC, at 2. 

The Government further alleges that 

Registrant’s actions violated 21 U.S.C. 

841(a), which states, in relevant part, 

that it is unlawful for any person to 

knowingly or intentionally dispense a 

controlled substance except as 

authorized by the CSA. OSC, at 2. 

According to the CSA’s implementing 

regulations, a lawful prescription for 

controlled substances is one that is 

‘‘issued for a legitimate medical purpose 

by an individual practitioner acting in 

the usual course of his professional 

practice.’’ 21 CFR 1306.04(a). This 

regulation further provides that ‘‘an 

order purporting to be a prescription 

issued not in the usual course of 

professional treatment . . . is not a 

prescription within the meaning and 

intent of [21 U.S.C. 829] and . . . the 

person issuing it, shall be subject to the 

penalties provided for violations of the 

provisions of law related to controlled 

substances.’’ Id. The Supreme Court has 

stated that ‘‘the prescription 

requirement . . . ensures patients use 

controlled substances under the 

supervision of a doctor so as to prevent 

addiction and recreational abuse . . . 

[and] also bars doctors from peddling to 

patients who crave the drugs for those 

prohibited uses.’’ Gonzales v. Oregon, 

546 U.S. 243, 274 (2006). 

DEA has consistently stated that a 

practitioner must establish and maintain 

a bona fide doctor-patient relationship 

in order to act ‘‘in the usual course of 

. . . professional practice’’ and to issue 

a prescription for a ‘‘legitimate medical 

purpose.’’ Ralph J. Chambers, 79 FR 

4962, 4970 (2014) (citing Paul H. 

Volkman, 73 FR 30,629, 30,642 (2008), 

pet. for rev. denied Volkman v. Drug 

Enf’t Admin., 567 F.3d 215, 223–24 (6th 

Cir. 2009)); see also U.S. v. Moore, 423 

U.S. 122, 142–43 (1975) (noting that 

evidence established that the physician 

exceeded the bounds of professional 

practice, when ‘‘he gave inadequate 

physical examinations or none at all,’’ 

‘‘ignored the results of the tests he did 

make,’’ and ‘‘took no precautions 

against . . . misuse and diversion’’). In 

recognition of the State’s primary role in 

regulating the practice of medicine, the 

CSA generally looks to state law to 

determine whether a doctor and patient 

have established a legitimate doctorpatient relationship. Mackay, 75 FR at 

49,973; Volkman, 73 FR at 30,642. 

The law of the Commonwealth of 

Virginia, the state in which Registrant is 

registered with DEA, to which the 

Government cited in the OSC, echoes 

the CSA requirement that a practitioner 

may only issue a prescription to a 

person with whom the practitioner has 

‘‘a bona fide practitioner-patient 

relationship.’’ Va. Code Ann. § 54.1– 

3303A (West 2018).7 At the time of the 

events at issue here, Virginia law 

defined a bona fide practitioner-patient 

relationship as ‘‘one in which a 

practitioner prescribes, and a 

pharmacist dispenses, controlled 

substances in good faith to his patient 

for a medicinal or therapeutic purpose 

within the course of his professional 

practice.’’ Id. The Virginia law further 

states that 

A bona fide practitioner-patient 

relationship means that the practitioner shall 

(i) ensure that a medical or drug history is 

obtained; (ii) provide information to the 

patient about the benefits and risks of the 

drug being prescribed; (iii) perform or have 

performed an appropriate examination of the 

patient, either physically or by the use of 

instrumentation and diagnostic equipment 

through which images and medical records 

may be transmitted electronically; except for 

medical emergencies, the examination of the 

patient shall have been performed by the 

practitioner himself, within the group in 

which he practices, or by a consulting 

practitioner prior to issuing a prescription; 

and (iv) initiate additional interventions and 

follow-up care, if necessary, especially if a 

prescribed drug may have serious side 

effects. 

Id. 

The Government typically establishes 

that a practitioner issued prescriptions 

without a legitimate medical purpose or 

outside the usual course of professional 

practice in violation of 21 CFR 

1306.04(a) through, or with the support 

of, expert testimony. However, DEA 

decisions have found that the nature of 

the allegations and the evidence on the 

record can establish violations of 

Section 1306.04(a) without necessitating 


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8Numerous federal courts have found in criminal 

cases, which require a higher standard of proof than 

is required in these proceedings, that expert 

testimony is not required to establish a violation of 

21 U.S.C. 841 or 21 CFR 1306.04(a) based on the 

particular facts of the case. See, e.g., United States 

v. Pellman, 668 F.3d 918, 924 (7th Cir. 2012) 

(holding that even without expert testimony there 

was ‘‘ample evidence’’ for a reasonable jury to 

determine the physician-defendant acted outside 

the usual course of his professional practice and not 

for a legitimate purpose); U.S. v. Armstrong, 550 

F.3d 382, 389 (5th Cir. 2008), overruled on other 

grounds by United States v. Balleza, 613 F.3d 382 

(5th Cir. 2010) (‘‘While expert testimony may be 

both permissible and useful, a jury can reasonably 

find that a doctor prescribed controlled substances 

not in the usual course of professional practice or 

for other than a legitimate medical purpose from 

adequate lay witness evidence surrounding the facts 

and circumstances of the prescriptions.’’); U.S. v. 

Word, 806 F.2d 658 663–64 (6th Cir. 1986). 

9 In the transcript of recording from the February 

16, 2018 visit, regarding prescribing in TFO Two’s 

name for TFO One, Registrant stated, ‘‘I know that 

is illegal, but I technically can write down those 

medications on her name,’’ and ‘‘Is that Okay? I’m 

sorry is illegal, but you know.’’ RFAAX 2, at 2–3. 

10The Government also alleged that Registrant’s 

actions violated Va. Code Ann. § 54.1–2915.A(3), 

(8), (13), (16), and (17), which provide grounds for 

which the Virginia Medical Board may refuse to 

issue, suspend, or revoke a medical license. While 

I find that these provisions buttress the 

Government’s argument that Registrant was acting 

outside the usual course of his professional 

practice, I do not find that they establish 

independent violations of state law and, as such, I 

am not including them in my findings herein. 

the support of expert opinion.8 Lawrence 

E. Stewart, M.D., 81 FR 54,822, 54,839 

(2016). DEA has not required expert 

testimony to establish a violation of 21 

CFR 1306.04(a) in past matters under 

factual circumstances that include: 

Where a prescriber engaged in drug 

deals; where a prescriber did not 

conduct a physical exam of the patient 

as required by law; where a controlled 

substance prescription was based on a 

patient’s request rather than the result of 

the application of the physician’s 

medical judgment; and where a 

prescriber falsified patients’ charts. See 

e.g., Stewart, 81 FR at 54,839–41 

(finding, without expert testimony, that 

prescriptions were issued outside the 

usual course of professional practice, 

where the physician failed to perform 

and document a physical exam, and 

lacked a legitimate medical purpose, 

where a physician prescribed controlled 

substances based on a patient’s request); 

Morris W. Cochran, M.D., 77 FR 17,505, 

17,519–20 (2011) (finding, without 

expert testimony, that prescriptions 

lacked a legitimate medical purpose, 

where a physician noted in patient 

medical records that patients had no 

pain, did not document any findings to 

support a diagnosis, and yet diagnosed 

patients as having chronic pain); Robert 

F. Hunt, D.O., 75 FR 49,995, 50,003 

(2010) (finding, without expert 

testimony, that a physician lacked a 

legitimate medical purpose based on 

statements made during undercover 

visits and falsification of patient chart). 

See also T.J. McNichol, M.D., 77 FR 

57,133, 57,147–48 (2012), pet. for rev. 

denied, 537 Fed. Appx. 905 (11th Cir. 

2013). 

I find that, with respect to the 

prescriptions Registrant issued to the 

undercover officers, expert testimony is 

not necessary to prove that Registrant 

lacked a legitimate medical purpose and 

acted outside of the usual course of 

professional practice in issuing them. 

Virginia law clearly states that to 

establish a practitioner-patient 

relationship, the practitioner must 

‘‘perform or have performed an 

appropriate examination of the patient, 

either physically or by the use of 

instrumentation and diagnostic 

equipment through which images and 

medical records may be transmitted 

electronically.’’ Va. Code Ann. § 54.1– 

3303A(iii). The uncontested evidence in 

this matter shows that Registrant issued 

prescriptions for controlled substances 

to TFOs One and Two without 

performing any physical examination or 

using any diagnostic tools. By issuing 

prescriptions to TFOs One and Two 

without first establishing a bona fide 

practitioner-patient relationship, 

Registrant violated Va. Code Ann. 

§ 54.1–3303A and thus acted outside the 

usual course of his professional 

practice. 

I also find that Registrant did not 

issue the prescriptions to the 

undercover officers for legitimate 

medical purposes. First, there is 

substantial evidence that Registrant 

knew that TFO One was not seeking 

treatment for a legitimate medical 

condition but was either engaged in selfabuse or diversion. During her first visit 

with Registrant on August 31, 2017, 

TFO One asked Registrant for a 

prescription for Tramadol ‘‘because it 

made [her] feel good’’ and told 

Respondent that she had been taking 

Tramadol that was not prescribed to her. 

Previous DEA decisions have found, 

without the support of expert testimony, 

that controlled substance prescriptions 

did not have a legitimate medical 

purpose when practitioners prescribed 

them based on a patient request rather 

than for the treatment of a legitimate 

medical condition. See Stewart, 81 FR at 

54,841; Henri Wetselaar M.D., 77 FR 

57,126, 57,132 (2012). 

Second, Registrant’s statements to 

TFOs One and Two during the course of 

their visits make clear that Registrant 

was prescribing controlled substances to 

TFO Two to intentionally divert drugs 

to TFO One. On their first visit together 

to Registrant on January 19, 2018, 

Registrant told the undercover officers 

that he was prescribing TFO Two a 

double dose of oxycodone, so that they 

‘‘could share a prescription until [their] 

next office visit to [Registrant].’’ RFAAX 

6, at 2; RFAAX 7, at 2. Then, during the 

undercover officers’ second visit 

together to Registrant on February 16, 

2018, Registrant told the undercover 

officers that he would write a 

prescription for Tramadol in TFO Two’s 

name for TFO Two to give to TFO One. 

RFAAX 2 at 2; see also RFAAX 4 

(prescription for Tramadol in TFO 

Two’s name). When TFO Two visited 

Registrant by herself on March 15, 2018, 

Registrant again issued TFO Two a 

prescription for Tramadol so that she 

could give the drugs to TFO One. 

RFAAX 7, at 2. Registrant’s actions 

‘‘completely betrayed any semblance of 

legitimate medical treatment.’’ Jack A. 

Danton, D.O, 76 FR 60,900, 60,904 

(quoting United States v. Feingold, 454 

F.3d 1001, 1010 (9th Cir. 2006)). 

Therefore, the evidence clearly supports 

a finding that Registrant issued the 

prescriptions without a legitimate 

medical purpose and outside the usual 

course of his professional practice in 

violation of 21 CFR 1306.04(a). 

Finally, despite Registrant’s failure to 

take his responsibilities as a registrant 

seriously, he did understand the 

potential legal consequences for his 

action and undoubtedly knew his 

actions were wrong. Registrant 

repeatedly stated that the prescriptions 

he wrote for TFO Two to give to TFO 

One were ‘‘illegal.’’ 9 RFAAX 2, at 2–3. 

He also gave the undercover officers 

instructions on how to evade scrutiny 

when filling the prescriptions. RFAAX 

2, at 3; RFAAX 7, at 2. This evidence 

supports the conclusion that Registrant 

knowingly engaged in an outright drug 

deal in violation of 21 U.S.C. 841(a). 

In summary, I find that Registrant 

committed flagrant violations of 21 CFR 

1306.04(a); violated state law, Va. Code 

Ann. § 54.1–3303.A; 10 and displayed an 

appalling disregard of a registrant’s duty 

under the CSA to prescribe controlled 

substances based on a legitimate doctorpatient relationship. 

B. Registrant’s Registration Is 

Inconsistent With the Public Interest 

and Presented an Imminent Danger 

Violations of the prescription 

requirement strike at the core of the 

CSA’s purpose of preventing the 

diversion of controlled substances. See 

United States v. Moore, 423 U.S. 122, 

135 (1975) (‘‘Congress was particularly 

concerned with the diversion of drugs 

from legitimate channels to illegitimate 

channels. It was aware that registrants, 


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Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 80157 

who have the greatest access to 

controlled substances and therefore the 

greatest opportunity for diversion, were 

responsible for a large part of the illegal 

drug traffic.’’). The Agency has 

previously found that proof of a single 

act of intentional or knowing diversion 

is sufficient to satisfy the Government’s 

prima facie burden of showing that a 

practitioner’s continued registration is 

inconsistent with the public interest. 

McNichol, 77 FR at 57,145–46 (2012); 

see also, Alan H. Olefsky, 57 FR 928, 

928–29 (1992) (revoking registration 

based on physician’s presentation of 

two fraudulent prescriptions to 

pharmacist in single act where 

physician failed to acknowledge his 

misconduct). Accordingly, I find that 

the evidence in this matter establishes 

Registrant ‘‘has committed such acts as 

would render his registration . . . 

inconsistent with the public interest.’’ 

See 21 U.S.C. 824(a)(4). 

For purposes of the imminent danger 

inquiry, my findings also lead to the 

conclusion that Registrant ‘‘fail[ed] . . . 

to maintain effective controls against 

diversion or otherwise comply with the 

obligations of a registrant’’ under the 

CSA. 21 U.S.C. 824(d)(2). The 

substantial evidence that Registrant was 

issuing prescriptions for controlled 

substances without a legitimate medical 

purpose and outside the usual course of 

professional practice also establishes 

that there was ‘‘a substantial likelihood 

[that an] . . . abuse of a controlled 

substance . . . [would] occur in the 

absence of the immediate suspension’’ 

of Registrant’s registration. Id. As I 

found above, the recording of the 

February 16, 2018 visit between 

Registrant and the undercover officers 

and the undercover officers’ accountings 

of their other visits establish that 

Registrant unlawfully prescribed 

controlled substances to the officers 

without conducting physical 

examinations and wrote controlled 

substance prescriptions in TFO Two’s 

name for her to give to TFO One. Thus, 

at the time the Government issued the 

OSC, the Government had clear 

evidence of Registrant’s violations of 

law. 

III. Sanction 

Where, as here, the Government has 

met its prima facie burden of showing 

that a Registrant’s continued registration 

is inconsistent with the public interest, 

the burden shifts to the Registrant to 

show why he can be entrusted with a 

registration. Garrett Howard Smith, 

M.D., 83 FR 18,882, 18,910 (2018) 

(collecting cases). Registrant did not 

present any evidence of remorse for his 

past misconduct or evidence of 

rehabilitative actions taken to correct 

his past unlawful behavior. Further, he 

provided no assurances that he would 

not engage in such conduct in the 

future. Absent such evidence and such 

assurances in this matter, I find that 

continued registration of Registrant is 

inconsistent with the public interest. 

Registrant’s silence weighs against his 

continued registration. Zvi H. Perper, 

M.D., 77 FR 64,131, 64,142 (2012 (citing 

Med. Shoppe-Jonesborough, 73 FR at 

387); see also Samuel S. Jackson, 72 FR 

23,848, 23,853 (2007). Accordingly, I 

find that the factors weigh in favor of 

sanction, and I shall order the sanctions 

the Government requested, as contained 

in the Order below. 

IV. 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 FS3042885 issued to 

Zelijko Stjepanovic, M.D. Further, 

pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 

823(f), I hereby deny any pending 

application of Zelijko Stjepanovic, M.D. 

to renew or modify this registration. 

This Order is effective January 11, 2021. 

Timothy J. Shea, 

Acting Administrator. 

[FR Doc. 2020–27231 Filed 12–10–20; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Anindita Nandi, M.D.; Decision and 

Order 

On January 31, 2020, the Assistant 

Administrator, Diversion Control 

Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause (hereinafter, OSC) to Anindita 

Nandi, M.D. (hereinafter, Registrant) of 

Jersey City, New Jersey. OSC, at 1. The 

OSC proposed the revocation of 

Registrant’s Certificate of Registration 

No. FN5040136. Id. It alleged that 

Registrant has ‘‘no state authority to 

handle controlled substances.’’ Id. 

(citing 21 U.S.C. 824(a)(3)). 

Specifically, the OSC alleged that, 

‘‘[o]n September 25, 2018, the New 

Jersey State Board of Medical Examiners 

(hereinafter, BME) issued an Order of 

Temporary Suspension of License, 

suspending . . . [Registrant’s] license to 

practice medicine and surgery in the 

State of New Jersey, effective September 

12, 2018.’’ OSC, at 2. The OSC further 

alleged that Registrant’s ‘‘State of New 

Jersey C[ontrolled] D[angerous] 

S[ubstance] (hereinafter, CDS) license is 

in an ‘Inactive’ status, having expired on 

October 31, 2018.’’ Id. The OSC 

concluded that ‘‘[c]onsequently, the 

DEA must revoke . . . [her] DEA 

registration based on . . . [her] lack of 

authority to handle controlled 

substances in the State of New Jersey.’’ 

Id. 

The OSC notified Registrant of the 

right to request a hearing on the 

allegations or to submit a written 

statement, while waiving the right to a 

hearing, the procedures for electing each 

option, and the consequences for failing 

to elect either option. Id. (citing 21 CFR 

1301.43). The OSC also notified 

Registrant of the opportunity to submit 

a corrective action plan. OSC, at 3 

(citing 21 U.S.C. 824(c)(2)(C)). 

Adequacy of Service 

In a sworn Declaration, dated May 21, 

2020, a DEA Diversion Investigator 

assigned to the Newark Division Office 

(hereinafter, DI) stated that he attempted 

personal service of the OSC on 

Registrant at the Hudson County 

Correctional Facility. Request for Final 

Agency Action (hereinafter, RFAA), EX 

5 (DI Declaration), at 1. Registrant, 

however, refused to meet with DI. Id. 

DI, therefore, sent the OSC to 

Registrant certified mail, return receipt 

requested. Id. He attached the executed 

return receipt card, dated February 26, 

to his Declaration. Id. at Attachment C. 

Further evidence of the adequacy of the 

Government’s service is Registrant’s 

proposed Corrective Action Plan 

(hereinafter, CAP) and waiver of hearing 

dated March 4, 2020. RFAA EX 6 (CAP), 

at 1. Accordingly, I find that the 

Government’s service of the OSC was 

adequate. 

Registrant’s Proposed CAP 

As already discussed, Registrant 

timely submitted a proposed CAP and 

waiver of hearing. Id. In her CAP, 

Registrant asked that this proceeding be 

discontinued or postponed. Id. She 

alleged that she received notification of 

the reactivation of her medical license 

in July 2019. Id. at 2. Further, she 

alleged that she timely renewed her 

‘‘second State of NJ CDS Account.’’ Id. 

I find that Registrant waived her right 

to a hearing and proposed a CAP. I find 

that the Assistant Administrator, 

Diversion Control Division, denied 

Registrant’s CAP request that the 

administrative proceeding be 

discontinued or deferred. RFAA EX 7 

(Letter Denying Proposed CAP), at 1. I 

also find that the Assistant 

Administrator concluded that ‘‘there is 

no potential modification of . . . [her 

proposedCAP] that could or would alter 


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