Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40621 

1The Government notified Registrant in its 

prehearing statement that Registrant’s DEA 

registration was subject to revocation on the 

additional ground that Registrant lacked authority 

to handle controlled substances in Florida, the state 

in which it is registered with the DEA. See 21 

U.S.C. 824(a)(3). The Prehearing Statement was 

mailed to Ms. Isemin at the address that Ms. Isemin 

designated for future filings in her December 20, 

2019 request for hearing. See RFAAX 2, at 2. 

2The Order Terminating Proceedings noted that 

Registrant was not currently represented by counsel 

and ‘‘it appear[ed] that Ms. Isemin [was] appearing 

on the [Registrant’s] behalf.’’ RFAAX 4, at 1 (citing 

21 CFR 1316.50). 

3 In the Order Terminating Proceedings, the Chief 

ALJ stated that ‘‘Agency precedent is clear that the 

unwillingness or inability of a party to comply with 

the directives of the [ALJ] may support an implied 

waiver of that party’s right to a hearing.’’ Id. (citing 

Robert M Brodkin, D.P.M, 77 FR 73,678, 73,679 

(2012); Kamir Garces-Mejias, M.D., 72 FR 54,931, 

54,932 (2007); Andrew Desonia, M.D., 72 FR 54,293, 

54,294 (2007); Alan R. Schankman, M.D., 63 FR 

45,260, 45,260 (1998)). 

4See 21 CFR 1301.43(d) (‘‘If any person entitled 

to a hearing or to participate in a hearing pursuant 

to § 1301.32 or §§ 1301.34–1301.36 . . . files [a 

request for a hearing] and fails to appear at the 

hearing, such person shall be deemed to have 

waived the opportunity for a hearing or to 

participate in the hearing, unless such person 

shows good cause for such failure’’); see also 

RFAAX 3, at 3–4 (notifying Registrant that ‘‘[f]ailure 

to timely file a prehearing statement that complies 

with the directions provided [therein] may result in 

a sanction, including (but not limited to) a waiver 

of hearing and an implied withdrawal of a request 

for hearing’’). 

Federal Energy Regulatory Commission, 

which is the Federal agency that would 

approve project construction and 

operations. The lease and supporting 

documentation, including required 

environmental compliance 

documentation and the notices that 

solicited competitive interest, can be 

found online at: https://www.boem.gov/ 

renewable-energy/state-activities/ 

pacwave-south-project. 

Authority: 43 U.S.C. 1337(p); 30 CFR 

585.238(f) and 30 CFR 585.206(a). 

Amanda Lefton, 

Director, Bureau of Ocean Energy 

Management. 

[FR Doc. 2021–15998 Filed 7–27–21; 8:45 am] 

BILLING CODE 4310–MR–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Care Point Pharmacy, Inc.; Decision 

and Order 

On November 20, 2019, the Assistant 

Administrator, Office of Diversion 

Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause (hereinafter, OSC) to Care 

Point Pharmacy, Inc. (hereinafter, 

Registrant). Government’s Request for 

Final Agency Action (hereinafter, 

RFAA) Exhibit (hereinafter, RFAAX) 1 

(OSC). The OSC proposed to revoke 

Registrant’s DEA Certificate of 

Registration Number BH9966904 

(hereinafter, registration) and to deny 

any pending applications for renewal or 

modification of the registration, 

pursuant to 21 U.S.C. 824(a)(4) and 

823(f), because Registrant’s ‘‘continued 

registration is inconsistent with the 

public interest.’’ Id. (citing 21 U.S.C. 

824(a)(4) and 823(f)). 

The OSC alleged that Registrant is 

licensed as a community pharmacy in 

the State of Florida. Id. at 2. It further 

alleged that Ekaette Isemin is 

Registrant’s sole corporate officer, and 

that she is licensed as a pharmacist in 

Florida. Id. 

The OSC alleged that ‘‘[o]n six 

occasions, [Registrant] dispensed 

controlled substances to a DEA 

confidential source pursuant to 

fraudulent prescriptions, despite clear 

evidence of diversion.’’ Id. at 2. The 

OSC further alleged that ‘‘[Registrant’s] 

dispensing of controlled substances in 

the face of clear evidence of diversion 

violated federal and state law.’’ Id. at 5 

(citing 21 CFR 1306.06, 1306.04(a); Fla. 

Stat. §§ 893.04(2)(a), 465.016(1)(i), 

456.072(1)(m); Fla. Admin. Code. Ann. 

r. 64B16–27.831, 64B16–27.810). 

The OSC notified Registrant of its 

right to request a hearing on the 

allegations or to submit a written 

statement while waiving its right to a 

hearing, the procedures for electing 

either option, and the consequence of 

failing to elect either option. Id. at 5–6 

(citing 21 CFR 1301.43). 

In response to the OSC, Ekaette 

Isemin filed a timely request for an 

administrative hearing on Registrant’s 

behalf, and requested that all future 

notices and mailings be mailed to her. 

RFAAX 2 (Request for Hearing). On 

December 26, 2019, the Chief 

Administrative Law Judge (hereinafter, 

Chief ALJ) established a schedule for the 

filing of prehearing statements. RFAAX 

3 (Order for Prehearing Statements). The 

Government filed a timely prehearing 

statement on January 6, 2020,1 but 

Registrant failed to file any prehearing 

statement by the deadline. RFAAX 4 

(Order Terminating Proceedings), at 1– 

2. 

On January 21, 2020, the Chief ALJ 

issued an Order Directing Compliance 

and Postponing Prehearing Conference, 

which afforded Registrant until 

February 5, 2020, to file its prehearing 

statement and to show good cause for 

the delay. Id. at 2. The Order Directing 

Compliance and the Order for 

Prehearing Statements were sent to Ms. 

Isemin via first class mail, and neither 

document was returned as 

undeliverable. Id. Neither Registrant nor 

Ms. Isemin filed a showing of good 

cause for the delay or a prehearing 

statement by the deadline set forth in 

the Order Directing Compliance.2 Id. 

Therefore, the Chief ALJ determined 

that Registrant had ‘‘effectively waived 

its right to a hearing,’’ and he 

terminated the proceedings on February 

6, 2020. Id.3 I agree with the Chief ALJ 

that Registrant waived its right to a 

hearing by failing to comply with the 

Chief ALJ’s order.4

On February 19, 2020, the 

Government forwarded an RFAA, along 

with the evidentiary record for this 

matter, to my office. Having considered 

the record in its entirety, I find that the 

record establishes, by substantial 

evidence, that Registrant committed acts 

rendering its continued registration 

inconsistent with the public interest. 

Additionally, I find that Registrant lacks 

authority to handle controlled 

substances in the State of Florida, the 

state where it is registered with DEA. 

Accordingly, I conclude that the 

appropriate sanction is for Registrant’s 

DEA registration to be revoked. 

I. Findings of Fact 

A. Registrant’s DEA Registration 

Registrant is registered with DEA as a 

retail pharmacy in Schedules II through 

V under DEA registration number 

BH9966904, at the registered address of 

1400 Hand Avenue, Suite 0, Ormond 

Beach, Florida 32174. RFAAX 5 (DEA 

Certificate of Registration). This 

registration expires on August 31, 2021. 

Id. 

B. The Status of Registrant’s State 

Authority 

Registrant was previously licensed as 

a community pharmacy in the State of 

Florida under license number PH22199. 

RFAAX 6 Appendix (hereinafter, App’x) 

B (Division of Corporations Printout), at 

1. Registrant’s sole corporate officer was 

Ekaette Isemin, id., who was previously 

registered as a pharmacist in Florida 

under license number PS28851. App’x 

A, at 1. 

On August 20, 2018, the Florida 

Department of Health (hereinafter, 

Florida DOH) ordered the emergency 

suspension of Ms. Isemin’s pharmacy 

license, based on its determination that 

‘‘Ms. Isemin’s continued practice as a 

pharmacist constitutes an immediate, 

serious danger to the health, safety, and 

welfare of the public . . . .’’ Id. at 18. 

The order concluded that Ms. Isemin 

repeatedly violated state law over the 

course of approximately sixteen months 

by dispensing controlled substances to a 


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5Under 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 of 

finding of fact within fifteen calendar days of the 

date of this Order. Any such motion and response 

shall be filed and served by email to the other party 

and to the Office of the Administrator, Drug 

Enforcement Administration, at 

dea.addo.attorneys@dea.usdoj.gov. 

6The DEA CS and D.S. are used interchangeably 

herein. 

7 DI’s declaration does not provide factual 

support for the conclusion that the prescriptions 

were fraudulent and not valid. Presumably, these 

prescriptions were fraudulent and not valid because 

they were issued to fake identities. However, I do 

not find that it is necessary for me to determine 

whether the prescriptions were fraudulent or 

invalid, because Registrant clearly violated federal 

and state law by repeatedly dispensing controlled 

substances to D.S. with actual knowledge that D.S. 

intended to divert the controlled substances that 

Registrant dispensed, based on the recorded 

conversations. See infra II.A.2. 

8Hydromorphone is a Schedule II controlled 

substance. See 21 CFR 1308.12(b)(1)(vii) (2017). 

9The photocopy of the May 19, 2017 prescription 

is difficult to read. See App’x E, at 1. However, the 

fill sticker that was generated during this 

transaction shows the strength and quantity of 

hydromorphone that was dispensed, and it is 

consistent with DI’s representation of the 

prescription that D.S. presented to Registrant at this 

visit. Compare App’x E, at 4 with GX 6, at 3. 

10See App’x A, at 3 (stating that D.S. first filled 

a prescription at Registrant on December 12, 2016). 

11The receipt from the transaction shows that 

Registrant charged D.S. $1,000.84, App’x E, at 2, 4, 

but D.S. paid Registrant $1,000 in cash. RFAAX 6, 

at 3. 

12The Government did not include a copy of the 

prescription that D.S. presented to Registrant on 

this date, but the Government provided a copy of 

the fill sticker, which is consistent with DI’s 

representation of the prescription that D.S. 

presented to Registrant at this visit. Compare App’x 

I with RFAAX 6, at 3. 

13Presumably, Ms. Isemin was referring to 

enforcement efforts by the state or federal 

government. 

DEA Confidential Source (hereinafter, 

DEA CS), despite the DEA CS’s repeated 

statements that he was diverting the 

controlled substances that Registrant 

dispensed. Id. at 14–18. 

Approximately sixteen months later, 

on December 12, 2019, the Florida DOH 

ordered the emergency suspension of 

Registrant’s license to operate as a 

community pharmacy in Florida. App’x 

D (Order of Emergency Suspension of 

Permit). The suspension was primarily 

based on the fact that Registrant had 

continued to order and dispense 

controlled substances for approximately 

one year while Ms. Isemin’s license was 

suspended. Id. at 9–10. The Florida 

DOH concluded that ‘‘[Registrant’s] 

continued operation as a community 

pharmacy presents an immediate, 

serious danger to the health, safety, and 

welfare of the public, and that this 

danger is likely to continue.’’ Id. at 9. 

The Florida DOH noted that 

‘‘[r]estricting [Registrant’s] permit 

would not adequately protect the public 

because any operation as a pharmacy 

would allow [Registrant] to continue 

engaging in the same illegal and 

dangerous conduct set forth above.’’ Id. 

According to Florida’s online records, 

of which I take official notice,5

Registrant’s Florida pharmacy license is 

‘‘revoked.’’ Therefore, I find that 

Registrant does not possess authority to 

handle controlled substances in Florida, 

the state in which Registrant is 

registered with DEA. 

C. Government’s Allegation That 

Registrant Dispensed Controlled 

Substances Unlawfully 

In its RFAA, the Government alleged 

that Registrant violated federal and state 

law by dispensing controlled substances 

to a DEA CS on six occasions in the face 

of clear evidence of diversion. OSC, at 

2, 5. To support this allegation, the 

Government submitted a declaration of 

the DEA Diversion Investigator 

(hereinafter, DI), who was assigned to 

the investigation of Registrant. RFAAX 

6 (Declaration of DI). DI has been a DI 

for approximately 30 years and is 

currently assigned to the Orlando 

District Office of the Miami Field 

Division. Id. at 1. DI’s declaration 

summarizes DEA’s investigation, 

including the details of six undercover 

visits conducted by the DEA CS at 

Registrant between June 8, 2017, and 

March 6, 2018. In addition to DI’s 

declaration, the Government submitted 

copies of controlled substance 

prescriptions that the DEA CS sought to 

fill at Registrant, along with the 

corresponding fill stickers. App’x E, I, 

M, Q, U, Y. The Government also 

submitted audio and video recordings of 

each undercover visit, as well as 

transcripts of the recordings. App’x F, 

G, J, K, N, O, R, S, V, W, ZA, AB 

(recordings); App’x H, L, P, T, X, ZC 

(transcripts). 

1. The Undercover Visits 

The DEA CS visited Registrant in an 

undercover capacity on six separate 

occasions using the fake identity D.S. 

RFAAX 6, at 2. At each visit, the DEA 

CS sought to fill a prescription for 

controlled substances that had been 

issued to D.S.6 or to A.D., the fake 

identity of the CS’s girlfriend. Id. at 2– 

8. DI’s declaration states that each 

prescription that D.S. sought to fill at 

Registrant was ‘‘fraudulent and [] not 

valid.’’ 7 Id. At each recorded undercover 

visit, D.S. admitted that he had diverted, 

or intended to divert, the controlled 

substances that Registrant dispensed to 

him. 

a. June 8, 2017 Undercover Visit 

On June 8, 2017, the DEA CS visited 

Registrant in an undercover capacity, 

posing as D.S. Id. at 3. The DEA CS 

sought to fill a controlled substance 

prescription that had been issued to his 

girlfriend’s fake identity, A.D., for one 

hundred eight-milligram tablets of 

hydromorphone.8 Id. at 3; App’x E (May 

19, 2017 Prescription).9 Prior to this 

visit, D.S. had filled hydromorphone 

prescriptions at Registrant, while acting 

in an undercover capacity.10 At this 

visit, D.S. told Ms. Isemin that he had 

given half of the hydromorphone 

prescription that he had previously 

filled at Registrant to his girlfriend, and 

some to a friend, so that he could afford 

Registrant’s high prices. App’x H, at 1. 

D.S. told Ms. Isemin that he would be 

‘‘splitting these again,’’ so that he could 

‘‘get ready for the next time [he] 

come[s].’’ Id. at 2. Registrant dispensed 

one hundred eight-milligram tablets of 

hydromorphone to D.S. in exchange for 

$1,000 in cash.11 App’x E, at 2–4; 

RFAAX 6, at 3. 

b. July 28, 2017 Undercover Visit 

The DEA CS visited Registrant again 

in an undercover capacity on July 28, 

2017, posing as D.S. RFAAX 6, at 3–4. 

The DEA CS presented Registrant with 

a controlled substance prescription that 

had been issued to D.S. for one hundred 

eight-milligram tablets of 

hydromorphone. Id.12 At this visit, D.S. 

again admitted to Ms. Isemin that he 

was diverting some of the 

hydromorphone that Registrant 

dispensed to him. App’x L, at 5–6. He 

said that he only takes a few tablets 

himself, because they make him 

‘‘woozy,’’ and he sells the rest to his 

employee. Id. at 6. D.S. told Ms. Isemin 

that he was going back to the doctor in 

a couple of weeks and he was ‘‘gonna 

try to get him to up ‘em, so [he] [could] 

sell a few more.’’ Id. at 6. Ms. Isemin 

advised D.S. not to obtain more than 

one hundred and thirty or one hundred 

and fifty tablets, because ‘‘they are 

checking.’’ 13 Id. 

Registrant dispensed one hundred 

eight-milligram tablets of 

hydromorphone to D.S. at this visit and 

charged D.S. $1,000.84. App’x I; RFAAX 

6, at 4. D.S. paid Registrant $1,020, and 

explained to Ms. Isemin that the extra 

money could cover what D.S owed 


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14Oxycodone is a Schedule II controlled 

substance. See 21 CFR 1308.12(b)(1)(xiii) (2017). 

Registrant for the other prescriptions 

that Registrant had filled. RFAAX 6, at 

4; App’x L, at 6. D.S. said, ‘‘That way 

I don’t owe you anything, cuz I don’t 

want you to one day be like, Hey, this 

guy owes me, so I’m not going to fill 

you, I’ll fill somebody else’s.’’ App’x L, 

at 6; App’x K, at 11:12:11–20. 

c. October 17, 2017 Undercover Visit 

The DEA CS visited Registrant again 

in an undercover capacity on October 

17, 2017, posing as D.S. RFAAX 6, at 4. 

The DEA CS presented Registrant with 

two controlled substance 

prescriptions—one that was issued to 

D.S. and one that was issued to A.D. Id. 

Each prescription was for one hundred 

and fifty eight-milligram tablets of 

hydromorphone. App’x M, at 1 (October 

12, 2017 Prescriptions). At this visit, 

D.S. again admitted to Ms. Isemin that 

he was diverting some of the 

hydromorphone that Registrant 

dispensed to him. App’x P, at 2. Ms. 

Isemin warned D.S. not to get caught, 

and D.S. assured her that he would not. 

Id. D.S. told Ms. Isemin that they have 

‘‘a very short window of catching 

[him],’’ because ‘‘[t]hey’ll be gone as fast 

as [he] get[s] them from [her], except for 

the ones [he] take[s].’’ Id. Registrant 

dispensed three hundred eightmilligram tablets of hydromorphone to 

D.S. and charged D.S. $3,000. App’x M, 

at 3, 5. D.S. paid Registrant $3,020 in 

cash. RFAAX 6, at 5. 

d. December 18, 2017 Undercover Visit 

The DEA CS visited Registrant in an 

undercover capacity again on December 

18, 2017, posing as D.S. RFAAX 6, at 5. 

The DEA CS sought to fill two 

controlled substance prescriptions—one 

that was issued to D.S. and one that was 

issued to A.D. Id. Each prescription was 

for one hundred and fifty eightmilligram tablets of hydromorphone. 

App’x Q (December 15, 2017 

Prescriptions). At this visit, Registrant 

dispensed three hundred eightmilligram tablets of hydromorphone to 

D.S. and charged D.S. $3,000. App’x Q 

at 3, 5. D.S. paid Registrant $3,200, 

explaining that the extra $200 was a 

‘‘Christmas bonus.’’ App’x T, at 2–3. 

D.S. said that he had fired the guy who 

had purchased the hydromorphone from 

him last time, but he found somebody 

else to buy the hydromorphone at 

higher prices. Id. at 2. Ms. Isemin asked 

D.S. if he was sure he wanted to give her 

a bonus, and he replied, ‘‘I’m positive, 

Christmas bonus. . . . I’m making 

pretty good now, so we good.’’ Id. at 3. 

e. January 23, 2018 Undercover Visit 

The DEA CS visited Registrant again 

in an undercover capacity on January 

23, 2018, posing as D.S. RFAAX 6, at 6. 

The DEA CS presented Registrant with 

a controlled substance prescription 

issued to D.S. for one hundred and fifty 

eight-milligram tablets of 

hydromorphone. Id.; App’x U (January 

22, 2018 Prescription). Ms. Isemin told 

D.S. that she did not have enough eightmilligram tablets to fill the prescription, 

so D.S. asked if she could provide fourmilligram tablets. App’x X, at 1–2. Ms. 

Isemin agreed, and dispensed two 

bottles of hydromorphone to D.S.—each 

containing a mixture of four and eightmilligram tablets. RFAAX 6, at 6. One 

bottle contained one hundred tablets 

and the other contained eighty-eight 

tablets. Id. The fill sticker generated by 

Registrant for this transaction falsely 

shows that Registrant dispensed one 

hundred and fifty eight-milligram 

tablets of hydromorphone to D.S. App’x 

U, at 3. 

Ms. Isemin again warned D.S. not to 

get caught by the police. App’x X, at 7. 

D.S. assured her that he is ‘‘pretty good, 

all safe,’’ when he sells the 

hydromorphone. Id. Ms. Isemin told 

D.S. that ‘‘if they catch [the purchaser] 

they’ll find out where he’s getting it 

from.’’ Id. D.S. laughed and told Ms. 

Isemin that they would not find out if 

he does not tell the purchaser where the 

tablets come from. Id. Ms. Isemin 

charged D.S. $1,410 for the prescription, 

but D.S. paid Ms. Isemin $1,500, 

explaining that ‘‘[t]hat way [he] can just 

pick them up’’ the next time, and joking 

that the extra money was so that Ms. 

Isemin did not ‘‘forget [him].’’ Id. at 8. 

Ms. Isemin told D.S. that she would owe 

him nine tablets at the next visit. Id. at 

6. 

f. March 6, 2018 Undercover Visit 

The DEA CS visited Registrant in an 

undercover capacity again on March 6, 

2018, posing as D.S. RFAAX 6 at 7. The 

DEA CS presented Registrant with a 

controlled substance prescription issued 

to D.S. for one hundred thirty-milligram 

tablets of oxycodone.14 Id.; App’x Y 

(March 5, 2018 Prescription). D.S. asked 

Ms. Isemin if she was going to get more 

tablets in stock, because the lack of 

stock was ‘‘killing [his] business.’’ 

App’x ZC, at 1–2. Ms. Isemin explained 

that she was trying to get more tablets 

in stock. Id. at 2. Registrant dispensed 

one hundred thirty-milligram tablets of 

oxycodone to D.S. and charged him 

$1,100 for the prescription, which D.S. 

paid in cash. RFAAX 6, at 7; App’x Y 

at 3. 

Registrant also dispensed nine 

twenty-milligram tablets of oxycodone 

to D.S., although D.S. did not present a 

prescription for twenty-milligram 

tablets. RFAAX 6, at 8; App’x Z 

(Photograph of the Oxycodone 

Dispensed). Ms. Isemin confirmed that 

Registrant owed D.S. these tablets from 

a prior visit. App’x ZC, at 2. As 

discussed above, see supra I.C.1.e, Ms. 

Isemin had explained to D.S. at the 

previous visit on January 23, 2018, that 

she owed him nine tablets of 

hydromorphone, because she was 

unable to completely fill D.S.’s 

prescriptions for one hundred and fifty 

tablets of hydromorphone on that day. 

App’x X, at 6. At this visit, Ms. Isemin 

substituted nine tablets of oxycodone 

for nine tablets of hydromorphone, even 

though D.S.’s previous prescription had 

been for hydromorphone. There was no 

corresponding prescription for the nine 

tablets of oxycodone that Ms. Isemin 

dispensed to D.S. 

II. Discussion 

A. Registrant’s Registration is 

Inconsistent With the Public Interest 

The Government alleged that 

Registrant’s DEA registration should be 

revoked because Registrant committed 

acts that would render its registration 

inconsistent with the public interest as 

provided in 21 U.S.C. 823(f). The 

Government’s case centers on six 

recorded undercover visits, during 

which Registrant repeatedly dispensed 

controlled substances to a DEA CS, 

notwithstanding the CS’s recurring 

statements that he was diverting the 

controlled substances that Registrant 

dispensed. 

Under the Controlled Substances Act 

(hereinafter, 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)(4). In the case 

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

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

pharmacy, 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. 


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15As to Factor Three, although the record 

contains evidence that Registrant’s sole corporate 

officer, Ms. Isemin, was arrested and charged with 

eight felony counts of drug trafficking, see App’x A, 

at 11; RFAAX 6 at 2, there is no evidence that 

Registrant has had 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). 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.; see also David D. 

Moon, D.O., 82 FR 19,385, 19,389 n.9 (finding that 

Factor Three was not dispositive where the 

registrant had been arrested for controlled 

substance-related charges, but there was no 

evidence of a conviction). 

16Additionally, because Florida revoked 

Registrant’s pharmacy license, I must revoke 

Registrant’s DEA registration because Registrant is 

not ‘‘authorized to dispense . . . controlled 

substances under the laws of the State in which [it] 

practices.’’ See infra II.B (citing 21 U.S.C. 823(f)); 

see also Kenneth Harold Bull, 78 FR at 62,672 

(noting in its Factor One analysis that where a state 

board takes action to restrict a practitioner’s 

authority to dispense controlled substances, ‘‘at a 

minimum, a practitioner’s [DEA] registration must 

be limited to authorize the dispensing of only those 

controlled substances, which he can lawfully 

dispense under state law’’); David W. Bailey, M.D., 

81 FR 6045, 6046 n.2 (2016) (‘‘As for Factor One, 

while the State has not made a recommendation to 

the Agency, the State has revoked Respondent’s 

medical license and thus, he no longer meets the 

CSA’s requirement that he is authorized to dispense 

controlled substances in the State where he is 

registered.’’). 

17The Government also alleged in the OSC that 

registrant violated Fla. Stat. § 456.072(1)(m), which 

prevents the use of ‘‘trick[s] or scheme[s] in or 

related to the practice of a profession.’’ OSC, at 3, 

5. Because the Government did not reference this 

statute in the RFAA, or argue its applicability, I will 

not consider this allegation. 

(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 in the disjunctive. 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. 

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 its 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 most appropriately 

considered under Factors One, Two, 

and Four.15 I find that 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). 

1. Factor One—The Recommendation of 

the Appropriate State Licensing Board 

or Professional Disciplinary Authority 

In determining the public interest 

under Factor One, the ‘‘recommendation 

of the appropriate State licensing board 

or professional disciplinary authority 

. . . shall be considered.’’ 21 U.S.C. 

823(f)(1). ‘‘Two forms of 

recommendations appear in Agency 

decisions: (1) A recommendation to 

DEA directly from a state licensing 

board or professional disciplinary 

authority . . ., which explicitly 

addresses the granting or retention of a 

DEA COR; and (2) the appropriate state 

entity’s action regarding the licensure 

under its jurisdiction on the same 

matter that is the basis for the DEA 

OSC.’’ John O. Dimowo, 85 FR 15,800, 

15,809 (2020); see also Kenneth Harold 

Bull, M.D., 78 FR 62,666, 62,672 (2013) 

(‘‘DEA . . . thus considers disciplinary 

actions taken by a state board as 

relevant in the public interest 

determination when they result in a loss 

of state authority, or are based on 

findings establishing that a registrant 

diverted controlled substances . . . .’’). 

Florida, the state in which Registrant 

is registered with DEA, immediately 

suspended Ms. Isemin’s pharmacy 

license on August 20, 2018. See supra 

I.b. The suspension was primarily based 

on Registrant’s unlawful dispensing of 

controlled substances to the DEA CS— 

the same misconduct that is at issue in 

this proceeding. Id. According to 

Florida’s online records, Registrant’s 

Florida pharmacy license has been 

‘‘revoked.’’ Id. Because the ‘‘appropriate 

State licensing board’’ has revoked 

Registrant’s state authority based on 

Registrant’s unlawful dispensing of 

controlled substances, I find that Factor 

One weighs strongly in favor of 

revocation.16

2. Factors Two and Four—The 

Registrant’s Experience in Dispensing 

Controlled Substances and Compliance 

With Applicable Laws Related to 

Controlled Substances 

In determining the public interest 

under Factors Two and Four, I am to 

consider evidence of Registrant’s 

compliance (or non-compliance) with 

laws related to controlled substances 

and Registrant’s experience dispensing 

controlled substances. The 

Government’s case relies primarily on 

the actions of Registrant’s sole corporate 

owner, Ms. Isemin. ‘‘Agency precedent 

has consistently held that the 

registration of a pharmacy may be 

revoked as the result of the unlawful 

activity of the pharmacy’s owners, 

majority shareholders, officers, 

managing pharmacist, or other key 

employee.’’ Perry Cty. Food & Drug, 80 

FR 70,084, 70,109 (2015) (citing EZRX, 

LLC, 69 FR 63,178, 63,181 (1988); Plaza 

Pharmacy, 53 FR 36,910, 36,911 (1988)). 

The Government alleged that 

Registrant violated several federal and 

state laws related to controlled 

substances by dispensing controlled 

substances to a DEA CS in the face of 

clear evidence of diversion. OSC, at 2, 

5 (citing violations of 21 CFR 1306.06 

and 1306.04(a); Fla. Stat. §§ 893.04(2)(a) 

and 465.016(1)(i); and Fla. Admin. 

Code. Ann. r. 64B16–27.831 and 64B16– 

27.810).17 The Government also alleged 

that Registrant violated federal and state 

law by dispensing a Schedule II 

controlled substance without a written 

prescription. Id. at 5 (citing 21 U.S.C. 

829(a); Fla. Stat. § 465.015(2)(c); Fla. 

Stat. § 465.016(1)(i)). 

(a) Violations of Federal Law 

According to the CSA’s implementing 

regulations, a lawful controlled 

substance order or prescription is one 

that is ‘‘issued for a legitimate medical 


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18See Ralph J. Bertolino Pharmacy, 55 FR at 4730 

(noting that a pharmacist’s corresponding 

responsibility requires him ‘‘to ensure that 

controlled substances are not dispensed for nonmedical reasons’’) (internal citations omitted); S & 

S Pharmacy, Inc., 78 FR at 57,660 (finding that 

respondent violated 21 U.S.C. 841(a)(1) and 21 CFR 

1306.04 by exchanging controlled substances for 

cash, knowing that the prescriptions provided by 

the DEA’s confidential source were fictitious). 

19 In relevant part, section 1306.06 provides that 

‘‘[a] prescription for a controlled substance may 

only be filled by a pharmacist, acting in the usual 

course of his professional practice.’’ In order to 

prove a violation of this regulation, the Government 

must ‘‘establish what the standards of pharmacy 

practice require, through either expert testimony or 

by reference to federal or state laws, pharmacy 

board or Agency regulations, or decisional law 

(whether of administrative bodies or the courts).’’ 

Farmacia Yani, 80 FR 29,053, 29,062 (2015). I find 

below that the Government has proven by 

substantial evidence that Registrant violated several 

Florida laws related to the proper dispensing of 

controlled substances. See infra II.A.2.b. 

20See Fla. Admin. Code. r. 64B16–27.831 (2015). 

This rule was amended in 2018, after the relevant 

misconduct in this case took place; however, there 

were no relevant, substantive modifications to this 

regulation in 2018. 

21See Fla. Admin. Code. r. 64B16–27.810. 

22See Fla. Stat. § 893.04(2)(a) (2016). This statute 

was amended in 2018, after the relevant misconduct 

in this case took place; however, there were no 

relevant, substantive modifications to this 

regulation in 2018. 

23See 21 U.S.C. 829(a); Fla. Stat. § 465.015(2)(c) 

(prohibiting the dispensing of ‘‘drugs as defined in 

[Fla. Stat. § ] 465.003(8) without first being 

furnished with a prescription’’); see also Fla. Stat. 

§ 465.003(8) (defining ‘‘[m]edicinal drugs or drugs’’ 

as ‘‘those substances or preparations commonly 

Continued 

purpose by an individual practitioner 

acting in the usual course of his 

professional practice.’’ 21 

CFR1306.04(a). While the 

‘‘responsibility for the proper 

prescribing and dispensing of controlled 

substances is upon the prescribing 

practitioner, . . . a corresponding 

responsibility rests with the pharmacist 

who fills the prescription.’’ Id. The 

regulations establish the parameters of 

the pharmacy’s corresponding 

responsibility: 

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 knowingly filling such 

a purported prescription, as well as the 

person issuing it, shall be subject to the 

penalties provided for violations of the 

provisions of law relating to controlled 

substances. 

Id. ‘‘The language in 21 CFR [§ ] 

1306.04 and relevant caselaw could not 

be more explicit. A pharmacist has his 

own responsibility to ensure that 

controlled substances are not dispensed 

for non-medical reasons.’’ Ralph J. 

Bertolino, d/b/a Ralph J. Bertolino 

Pharmacy, 55 FR 4729, 4730 (1990) 

(citing United States v. Hayes, 595 F.2d 

258 (5th Cir. 1979), cert. denied, 444 

U.S. 866 (1979); United States v. Henry, 

727 F.2d 1373 (5th Cir. 1984) (reversed 

on other grounds)). As the Supreme 

Court explained in the context of the 

CSA’s requirement that schedule II 

controlled substances may be dispensed 

only by written prescription, ‘‘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). 

To prove that a pharmacist violated 

his corresponding responsibility, the 

Government must show that the 

pharmacist acted with the requisite 

degree of scienter. See 21 CFR 

1306.04(a) (‘‘[T]he person knowingly 

filling [a prescription issued not in the 

usual course of professional treatment] 

. . . shall be subject to the penalties 

provided for violations of the provisions 

of law relating to controlled 

substances.’’) (emphasis added). DEA 

has also consistently interpreted the 

corresponding responsibility regulation 

such that ‘‘[w]hen prescriptions are 

clearly not issued for legitimate medical 

purposes, a pharmacist may not 

intentionally close his eyes and thereby 

avoid [actual] knowledge of the real 

purpose of the prescription.’’ Bertolino, 

55 FR at 4730 (citations omitted); see 

also JM Pharmacy Group, Inc. d/b/a 

Pharmacia Nueva and Best Pharmacy 

Corp., 80 FR 28,667, 28,670–72 (2015) 

(applying the standard of willful 

blindness in assessing whether a 

pharmacist acted with the requisite 

scienter). Pursuant to their 

corresponding responsibility, 

pharmacists must exercise ‘‘common 

sense and professional judgment’’ when 

filling a prescription issued by a 

physician. Bertolino, 55 FR at 4730. 

In this matter, the Government alleges 

that Registrant engaged in blatant drug 

dealing by dispensing controlled 

substances to a DEA CS, who ‘‘exhibited 

clear and unambiguous signs of 

diversion.’’ RFAA, at 21. The 

Government asserts that in cases 

involving blatant drug dealing, ‘‘this 

Agency has found that a pharmacy’s 

registration [is] inconsistent with the 

public interest under Factors Two and 

Four, even without the benefit of any 

expert opinion.’’ Id. at 20–21 (citing 

Lincoln Pharmacy, 75 FR 65,667, 65,668 

(2010) (revoking respondent’s 

registration and labeling its dispensing 

as ‘‘blatant drug dealing,’’ where a 

cooperating source told respondent’s 

pharmacist that he was selling the 

dispensed drugs); S & S Pharmacy, Inc., 

d/b/a Platinum Pharmacy & 

Compounding, 78 FR 57,656, 57,660 

(2013) (affirming immediate suspension 

of registration and labeling respondent’s 

dispensing as a ‘‘blatant drug deal,’’ 

where respondent’s pharmacist 

dispensed drugs pursuant to 

prescriptions that he knew were 

fictitious). 

I agree with the Government that this 

case involves blatant drug dealing, and 

I find that the Government has proven 

by substantial evidence that Registrant 

filled prescriptions for controlled 

substances that it knew were 

illegitimate, in violation of its 

corresponding responsibility under 21 

CFR1306.04(a),18 and that Registrant 

filled these prescriptions outside the 

usual course of the professional practice 

of pharmacy in Florida, in violation of 

21 CFR 1306.06.19 At each undercover 

visit, the DEA CS told Ms. Isemin that 

he was planning to divert, or already 

had diverted, the controlled substances 

that Registrant dispensed. See supra 

I.c.1. Ms. Isemin clearly understood that 

the DEA CS intended to divert the 

drugs, because she warned the DEA CS 

on several occasions not to get caught. 

Id. Ms. Isemin even accepted a cash tip 

from D.S. on several occasions, id., 

which further evidences her knowledge 

that she was engaging in blatant drug 

dealing. Respondent’s flagrant 

violations of federal law weigh strongly 

against a finding that Registrant’s 

continued registration is consistent with 

the public interest. 

(b) Violations of State Law 

In addition to alleging that Registrant 

violated 21 CFR 1306.04(a) and 1306.06, 

the Government alleges that Registrant 

violated Florida state law by: (1) Failing 

to ‘‘exercis[e] sound professional 

judgment’’ and ‘‘work with the patient 

and the prescriber to assist in 

determining the validity of the 

prescription’’; 20 (2) failing to review 

each prescription for potential 

problems, such as ‘‘[o]ver utilization or 

under-utilization’’ and ‘‘[c]linical abuse/ 

misuse,’’ and failing to ‘‘take 

appropriate steps to avoid or resolve the 

potential problems’’; 21 and (3) 

dispensing Schedule II controlled 

substances to a patient ‘‘without first 

determining, in the exercise of her or his 

professional judgment, that the 

prescription is valid.’’ 22 The 

Government also alleges that Registrant 

violated Florida and federal law on 

March 6, 2018, when it dispensed a 

Schedule II controlled substance 

without a written prescription of a 

practitioner.23


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known as prescription or legend drugs which are 

required by federal or state law to be dispensed 

only on a prescription’’) (internal quotations 

omitted). 

24 In the emergency order suspending Ms. 

Isemin’s state license, the Florida DOH concluded 

that Ms. Isemin ‘‘lacks the good judgment needed 

to practice as a pharmacist in the State of Florida,’’ 

because of her ‘‘repeated failure to require patient 

identification from D.S. or to verify whether D.S.’ 

prescriptions were valid prior to dispensing 

controlled substances; her continued sale of 

controlled substances to D.S., despite being 

informed on several occasions that he was selling 

them to unauthorized individuals; and her 

acceptance of a ‘bonus’ for assisting D.S. in his 

illegal sale of controlled substances . . . .’’ App’x 

A, at 12. The order also concluded that Ms. Isemin 

violated Fla. Stat. §§ 893.04(1) and (2)(a), in part, 

because she ‘‘[k]nowingly dispens[ed] controlled 

substances to a patient who stated he was selling 

the controlled substances to unauthorized persons.’’ 

Id. at 17. 

25See also Fla. Stat. § 893.04(2)(a) (prohibiting 

pharmacists from dispensing Schedule II controlled 

substances to a patient ‘‘without first determining, 

in the exercise of her or his professional judgment, 

that the prescription is valid’’). 

26See also Fla. Stat. Ann. § 465.015(1)(b) (‘‘It is 

unlawful for any person to own, operate, maintain, 

open, establish, conduct, or have charge of . . . a 

pharmacy . . . [i]n which a person not licensed as 

a pharmacist in this state . . . fills, compounds, or 

dispenses any prescription or dispenses medicinal 

drugs.) 

I find that the Government has 

provided substantial evidence that 

Registrant violated these federal and 

state laws by dispensing controlled 

substances to the DEA CS on the six 

occasions outlined above. Ms. Isemin 

clearly did not ‘‘exercise[e] sound 

professional judgment’’ 24 or ‘‘work with 

the patient and the prescriber to assist 

in determining the validity of the 

prescription,’’ as required by Fla. 

Admin. Code. r. 64B16–27.831.25 The 

DEA CS told Ms. Isemin that he 

intended to divert the controlled 

substances that she dispensed, and she 

simply warned him not to get caught. 

See supra I.c.1. Ms. Isemin also failed to 

identify and respond to factors that 

indicated a lack of ‘‘therapeutic 

appropriateness’’ of the drugs 

dispensed, as outlined in Fla. Admin. 

Code. r. 64B16–27.810. Rather, Ms. 

Isemin knew that the controlled 

substances that Registrant dispensed 

would not be used for legitimate 

medical purposes, but she dispensed 

them anyway. In fact, the DEA CS told 

Ms. Isemin on one occasion that he does 

not take many of the pills himself 

because they make him ‘‘woozy.’’ See 

supra I.c.1.b. Finally, I found above that 

Registrant dispensed nine tablets of 

oxycodone, a Schedule II controlled 

substance, on March 6, 2018, without a 

written prescription of a practitioner. Id. 

Therefore, Registrant violated federal 

and state law. See 21 U.S.C. 829(a); Fla. 

Stat. § 465.015(2)(c) (2016). 

In light of Registrant’s egregious 

conduct that has no resemblance to the 

professional practice of pharmacy, I 

conclude that Factors One, Two, and 

Four overwhelmingly demonstrate that 

Registrant ‘‘has committed such acts as 

would render [its] registration . . . 

inconsistent with the public interest.’’ 

21 U.S.C. 824(a)(4). I further conclude 

that Registrant has not rebutted the 

Government’s prima facie case. 

B. Registrant Lacks Authority To Handle 

Controlled Substances 

The Government alternatively alleged 

that Registrant’s DEA registration 

should be revoked because Registrant 

does not possess the requisite authority 

to dispense controlled substances in the 

State of Florida, where it is registered 

with DEA. RFAA, at 22. 

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 Agency has long stated 

that the possession of authority to 

dispense controlled substances under 

the laws of the state in which the 

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 F. App’x 

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 pharmacy . . . or other person 

licensed, registered, or otherwise 

permitted, by . . . the jurisdiction in 

which . . . [it] 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 Agency has repeatedly stated that 

revocation of a practitioner’s registration 

is the appropriate sanction whenever it 

is no longer authorized to dispense 

controlled substances under the laws of 

the state in which she practices. See, 

e.g., James L. Hooper, M.D., 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, M.D., 43 FR at 27,617. 

According to Florida statute, ‘‘It is 

unlawful for any person to own, 

operate, maintain, open, establish, 

conduct, or have charge of . . . a 

pharmacy . . . [w]hich is not registered 

under the professions of [Chapter 465].’’ 

Fla. Stat. Ann. § 465.015(1)(a) (West, 

current with chapters from the 2021 

First Regular Session of the TwentySeventh Legislature in effect through 

June 22, 2021). Further, ‘‘It is unlawful 

for any person . . . [t]o fill, compound, 

or dispense prescriptions or to dispense 

medicinal drugs if such person does not 

hold an active license as a pharmacist 

in [Florida] . . . .’’ Fla. Stat. Ann. 

§ 465.015(2)(b).26 Accordingly, holding 

a permit issued by the Florida Board of 

Pharmacy is a prerequisite to operating 

a pharmacy and dispensing a controlled 

substance in Florida. 

Here, the undisputed evidence in the 

record is that Registrant currently lacks 

authority to operate a pharmacy in 

Florida. As such, Registrant is not 

qualified to dispense controlled 

substances in Florida. Accordingly, I 

will order that Registrant’s DEA 

registration be revoked. 

III. Sanction 

Where, as here, the Government has 

met its prima facie burden of showing 

that Registrant’s continued registration 

is inconsistent with the public interest, 

the burden shifts to the Registrant to 

show why it can be entrusted with a 

registration. Garrett Howard Smith, 

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

(collecting cases). 

The CSA authorizes the Attorney 

General to ‘‘promulgate and enforce any 

rules, regulations, and procedures 

which he may deem necessary and 

appropriate for the efficient execution of 

his functions under this subchapter.’’ 21 

U.S.C. 871(b). This authority 

specifically relates ‘‘to ‘registration’ and 

‘control,’ and ‘for the efficient execution 

of his functions’ under the statute.’’ 

Gonzales, 546 U.S. at 259. ‘‘Because 

‘past performance is the best predictor 

of future performance, ALRA Labs, Inc. 

v. Drug Enf’t Admin., 54 F.3d 450, 452 

(7th Cir. 1995), [the Agency] has 

repeatedly held that where a registrant 

has committed acts inconsistent with 

the public interest, the registrant must 


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27 Gonzales v. Oregon, 546 U.S. at 274. 

1 I find that the Government’s service of the OSC 

was adequate. 

2Respondent Pharmacy’s proposed corrective 

action plan proposed, among other things, that 

Respondent Pharmacy put into place three new 

policies that would reflect requirements that 

already exist in law, enforce compliance with two 

existing policies that reflect requirements that 

already exist in law (without explaining how those 

policies would be enforced), and would stop 

working with the Pharmacist-in-charge (hereinafter, 

PIC) involved in this case. RFAAX 4. Additionally, 

the corrective action plan explained that the 

Respondent Pharmacy was trying to move to a 

‘‘close door pharmacy’’ model, and proposed 

putting in place policies saying that it no longer 

accepted walk-in prescriptions and would only 

accept ‘‘e-scripts’’ for controlled substances. Id. 

3 I find that Respondent waived her right to a 

hearing in this matter. 

accept responsibility for [the 

registrant’s] actions and demonstrate 

that [registrant] will not engage in future 

misconduct.’’’ Jayam Krishna-Iyer, 74 

FR at 463 (quoting Med. Shoppe, 73 FR 

364, 387 (2008)); see also Samuel S. 

Jackson, 72 FR 23,848, 23,853 (2007); 

John H. Kennnedy, M.D., 71 FR 35,705, 

35,709 (2006); Prince George Daniels, 

D.D.S., 60 FR 62,884, 62,887 (1995). The 

issue of trust is necessarily a factdependent determination based on the 

circumstances presented by the 

individual registrant; therefore, the 

Agency looks at factors, such as the 

acceptance of responsibility, and the 

credibility of that acceptance as it 

relates to the probability of repeat 

violations or behavior, and the nature of 

the misconduct that forms the basis for 

sanction, while also considering the 

Agency’s interest in deterring similar 

acts. See Arvinder Singh, M.D., 81 FR 

8247, 8248 (2016). 

Here the Registrant did not avail itself 

of the opportunity to refute the 

Government’s case. In light of 

Registrant’s egregious violations, which 

go to the heart of the CSA’s purpose of 

‘‘prevent[ing] addiction and recreational 

abuse’’ of controlled substances,27

Registrant’s silence weighs against the 

Registrant’s continued registration. Zvi 

H. Perper, M.D., 77 FR at 64,142 (citing 

Med. Shoppe, 73 FR at 387); see also 

Jackson, 72 FR at 23,853. 

Accordingly, I find that the factors 

weigh in favor of revocation, and I shall 

order the sanctions that the Government 

requested, as contained in the Order 

below. 

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 BH9966904 issued to 

Care Point Pharmacy, Inc. 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 Care Point Pharmacy, Inc. 

to renew or modify this registration. 

This order is effective August 27, 2021. 

Anne Milgram, 

Administrator. 

[FR Doc. 2021–16005 Filed 7–27–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Creekbend Community Pharmacy; 

Decision and Order 

On May 29, 2019, a former Assistant 

Administrator of the Drug Enforcement 

Administration (hereinafter, DEA or 

Government) issued an Order to Show 

Cause (hereinafter, OSC) to Creekbend 

Community Pharmacy (hereinafter, 

Respondent Pharmacy). Government’s 

Request for Final Agency Action Exhibit 

(hereinafter, RFAAX) 2 (OSC), at 1. The 

OSC proposed to revoke Respondent 

Pharmacy’s DEA Certificate of 

Registration Number FL4375730 

(hereinafter, registration) and to deny 

any pending applications for renewal or 

modification of the registration, 

pursuant to 21 U.S.C. 824(a)(4) and 

823(f), because Respondent Pharmacy’s 

‘‘continued registration is inconsistent 

with the public interest.’’ Id. (citing 21 

U.S.C. 824(a)(4) and 823(f)). 

I. Procedural History 

The OSC alleged that Respondent 

Pharmacy committed a number of 

record keeping violations. Id. at 2–4. 

Specifically, the OSC alleged failures in 

Respondent Pharmacy’s inventory 

documentation in violation of 21 CFR 

1304.11(a) and (c) and 1304.04(h)(1); 

failures to properly complete and 

execute DEA Form 222s in violation of 

21 CFR 1305.12(a)–(e); failures to record 

the receipt date on invoices in violation 

of 21 CFR 1304.21(a), (d), and 

1304.22(a)(2)(iv) and (c); and failure to 

maintain complete and accurate records 

of invoices, returns, and controlled 

substance transactions in violation of 

1304.21(a). Id. The OSC further alleged 

that Respondent Pharmacy lacked 

candor by failing to be candid and 

truthful in the DEA investigation. Id. at 

4–6. In particular, the OSC alleged that 

Respondent Pharmacy lacked candor 

with regard to its filling of fraudulent 

prescriptions and its hiding of 

controlled substances. Id. 

The OSC notified Registrant of the 

right to either request a hearing on the 

allegations or submit a written 

statement in lieu of exercising the right 

to a hearing, the procedures for electing 

each option, and the consequences for 

failing to elect either option. OSC, at 7 

(citing 21 CFR 1301.43). The OSC also 

notified Registrant of the opportunity to 

submit a corrective action plan. Id. at 8 

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

Following service of the OSC,1

Respondent Pharmacy sent a letter to 

the Government which appears to be a 

written response to the OSC, dated June 

25, 2019. RFAAX 3. The letter was not 

signed and the author was not explicitly 

identified; however, it appears to have 

been written by or from the perspective 

of Respondent Pharmacy’s owner, Binta 

Barry. RFAAX 3; RFAAX 1, at 1; 

RFAAX 47 (Declaration of Diversion 

Investigator), at 1–2. The letter did not 

state that Respondent Pharmacy 

intended to request an administrative 

hearing, and the Government did not 

otherwise receive a hearing request. 

RFAAX 3; RFAAX 5 (correspondence 

from the hearing clerk), at 1. The letter 

was accompanied by a document titled 

‘‘Corrective Action Plan,’’ which the 

Government submitted into the record. 

RFAAX 4. The Corrective Action Plan 

proposed nine changes and 

improvements to Respondent’s 

Pharmacy’s policies and practice.2

Then, Respondent Pharmacy’s Owner 

sent a signed letter dated July 29, 2019, 

stating that she would not ‘‘fight [her] 

case with the D.E.A.’’ and that she was 

planning to ‘‘sell [her] business.’’ 3

RFAAX 5, at 2 (hereinafter, RFAAX 3 

and RFAAX 5, at 2 are collectively 

referred to as the ‘‘written response’’). 

On September 10, 2019, the 

Government forwarded a Request for 

Final Agency Action, along with the 

evidentiary record for this matter, to my 

office. Having considered the record in 

its entirety, I find that the record 

establishes, by substantial evidence, that 

Respondent Pharmacy committed acts 

rendering its continued registration 

inconsistent with the public interest. 

Accordingly, I conclude that the 

appropriate sanction is for Respondent 

Pharmacy’s DEA registration to be 

revoked. 

II. Findings of Fact 

A. DEA Registration 

Respondent Pharmacy is registered 

with the DEA as a retail pharmacy 

authorized to handle controlled 

substances in schedules II–V under DEA 

Registration number FL4375730 at 8103 


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