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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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4Pursuant to DEA’s online registration database, 

Respondent Pharmacy’s registration did expire on 

August 31, 2020, and DEA records show that 

Respondent Pharmacy is ‘‘out of business.’’ Under, 

21 CFR 1301.52, a registration of any entity ‘‘shall 

terminate, without any further action by the 

Administration, if and when such [entity] . . . 

discontinues business. . . .’’ However, the Agency 

has discretion to adjudicate this Order to Show 

Cause to finality. See Jeffrey D. Olsen, M.D., 84 FR 

68,474, 68,479 (2019) (declining to dismiss an 

immediate suspension order as moot when the 

registrant allowed the subject registration to expire 

before final adjudication); Steven M. Kotsonis, M.D., 

85 FR 85,667, 85,668–69 (2020) (concluding that 

termination of a DEA registration under 21 CFR 

1301.52 does not preclude DEA from issuing a final 

decision on an order to show cause against that 

registration and stated that the Agency would assess 

such matters on a case-by-case basis to determine 

if a final adjudication is warranted or if the matter 

should be dismissed); The Pharmacy Place, 86 FR 

21,008, 21,008–09 (2021) (adjudicating to finality a 

registration terminated under 21 CFR 1301.52 in 

order to create a final record of allegations and 

evidence related to the matter). 

As in The Pharmacy Place, I have evaluated the 

particular circumstances of this matter and 

determined that the matter should be adjudicated 

to finality. 86 FR at 21,008–09. As my predecessor 

identified in Olsen, ‘‘[b]ecause nothing in the CSA 

prohibits an individual or an entity from applying 

for a registration even when there is . . . a history 

of having a registration suspended or revoked.* . . . 

having a final, official record of allegations, 

evidence, and the Administrator’s decisions 

regarding those allegations and evidence, assists 

and supports future interactions between the 

Agency and the registrant or applicant.’’ 84 FR at 

68,479. Here, absent a final adjudication, there 

would be no final record of the allegations and 

evidence from this matter. (Contrast with Kotsonis 

in which the plea agreement and judgment from the 

respondent’s concurrent criminal case provided a 

final record on which the Agency could rely in any 

future interactions with the respondent. 85 FR at 

85,667). Adjudicating this matter to finality will 

create an official record the Agency can use in any 

future interactions with Respondent Pharmacy’s 

owners, employees, or other persons who were 

associated with Respondent. Moreover, as in The 

Pharmacy Place, ‘‘adjudicating this matter to 

finality will create a public record to educate 

current and prospective registrants about the 

Agency’s expectations regarding the responsibilities 

of registrant pharmacies under the CSA and allow 

stakeholders to provide feedback regarding the 

Agency’s enforcement priorities and practices.’’ 86 

FR 21,008–09 (applying Olsen, 84 FR 68,479). 

5SI took physical custody of the original 

prescription records and provided scanned copies 

to DI thereafter. RFAAX 48, at 1. 

Creekbend Drive, Suite G, Houston, 

Texas 77071. RFAAX 1, at 6 (Certificate 

of Registration). According to the 

Certificate of Registration, the 

Registration expired on August 31, 

2020.4 Id. 

B. Government’s Case 

The Government attached to the 

RFAA forty-eight exhibits (over 850 

pages) consisting primarily of records 

from Respondent Pharmacy including, 

but not limited to, inventory records, 

DEA Form 222s (hereinafter, 222 Form), 

prescription logs, and invoices; and 

records related to DEA’s investigation 

and inspection including, but not 

limited to, audit records, a Texas 

Prescription Monitoring Profile Report, 

notices of inspection, and pictures. 

RFAAX 1–48. The Government also 

included declarations from a DEA 

Diversion Investigator (hereinafter, DI) 

and a Texas State Board of Pharmacy 

(hereinafter, State Board) Investigator 

(hereinafter, SI). RFAAX 47–48. 

DI’s declaration explained that she 

entered the DI training school in 2017, 

and that she was employed in the DEA 

Houston Division Office. RFAAX 47, at 

1. As a Diversion Investigator, DI stated 

that her work includes investigations of 

DEA registered pharmacies to ‘‘ensure 

compliance with all applicable DEA 

regulations.’’ Id. DI stated that her 

investigation revealed that Binta Barry 

was one of Respondent Pharmacy’s 

owners, and that Ms. Barry was also 

employed as one of Respondent 

Pharmacy’s pharmacy technicians. Id. at 

2. Additionally, DI explained that ‘‘[t]he 

Pharmacist-in-charge [was] Yucabeth 

Kumenda.’’ Id. 

On November 1, 2017, DEA 

conducted its first on-site inspection of 

Respondent Pharmacy. RFAAX 47, at 2; 

RFAAX 7 (Notice of November 1, 2017 

Inspection). PIC Kumenda signed the 

notice of inspection and participated in 

the inspection process; Ms. Barry was 

present and met with DEA only briefly 

during the inspection. RFAAX 47, at 2; 

RFAAX 7. As part of the inspection, 

DEA conducted a closing inventory of 

Respondent Pharmacy’s controlled 

substances, interviewed responsible 

management, and took custody of 

original controlled substance records 

including prescriptions and inventories. 

RFAAX 47, at 2. 

On May 24, 2018, DEA conducted its 

first on-site follow-up inspection of 

Respondent Pharmacy. RFAAX 47, at 5; 

RFAAX 33 (Notice of May 24, 2018 

Inspection). Ms. Barry signed the notice 

of inspection and both Ms. Barry and 

PIC Kumenda were present for and 

participated in the inspection process. 

RFAAX 47, at 5; RFAAX 33; RFAAX 48, 

at 1. The State Board investigator, SI, 

was also present during the follow-up 

investigation. RFAAX 47, at 5; RFAAX 

48, at 1. As part of the inspection, DEA 

requested and received updated 

prescriptions,5 purchase records, and 

dispensing logs. RFAAX 47, at 5; 

RFAAX 35 (DEA–12, Receipt for Cash or 

Other Items dated May 24, 2018); 

RFAAX 48, at 1. 

On April 3, 2019, DEA conducted its 

second on-site follow-up inspection of 

Respondent Pharmacy. RFAAX 47, at 6; 

RFAAX 36 (Notice of April 3, 2019 

Inspection). PIC Kumenda signed the 

notice of inspection, RFAAX 36, and, 

according to DI, called Ms. Barry to tell 

her that DEA was there to conduct an 

inspection. RFAAX 47, at 6. According 

to DI, Ms. Barry said ‘‘she was sick’’ but 

came into the pharmacy for the 

inspection. RFAAX 47, at 6; see also 

RFAAX 3, at 2. DI stated that following 

each of the three inspections, she 

audited and assessed the documents 

DEA had received to determine 

Respondent Pharmacy’s compliance 

with all applicable DEA regulations. 

RFAAX 47, at 1, 9–16. 

SI’s declaration explained that he had 

been an investigator with the State 

Board since October 2008. RFAAX 48, at 

1. As an investigator, SI conducted 

‘‘investigations and audits for the [State 

Board] regarding matters that concern 

diversion or any other violations of the 

Texas pharmacy act.’’ Id. SI stated that 

he was assigned to investigate 

Respondent Pharmacy in April 2018, 

and he participated in DEA’s May 24, 

2018 inspection of Respondent 

Pharmacy. Id. SI’s declaration also 

provided information about the Texas 

Prescription Monitoring Program (Texas 

PMP), and about prescriptions he 

obtained from Respondent Pharmacy 

following the May 24, 2018 inspection. 

Id. at 2. 

C. Respondent Pharmacy’s Case 

Respondent Pharmacy presented its 

case through its written response 

consisting of an unsigned, unsworn 

letter, a second letter signed by Ms. 

Barry, and no supporting 

documentation or evidence. RFAAX 3; 

RFAAX 5, at 2. Some of the factual 

assertions contained in the written 

response, though lacking in detail, align 

with the investigatory timeline and with 

DI’s declaration and the record as a 

whole. Compare RFAAX 3 and RFAAX 

5 with RFAAX 47. For example, the 

written response states that the 

Respondent Pharmacy’s license was 

renewed in February 2018, which is 

consistent with the certificate of 

registration. RFAAX 3, at 2; RFAAX 1, 

at 6. The written response also states 

that DEA conducted inspections on May 

24, 2018, and April 3, 2019, and 

contains factual assertions regarding 

those inspections that are consistent 

with the record as a whole. RFAAX 3, 

at 2; infra Section, II.D.2. The written 

response contains no facts and no 

evidence contradicting the allegations in 

the OSC and does not diminish the 

record evidence presented by the 

Government. 

Instead, the written response 

questions DEA’s motive in investigating 


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6The evidence on the record provides no 

indication of any sort of improper motive in 

commencing the investigation, and in fact, the 

evidence demonstrates that such an investigation is 

routine. On August 2017, Respondent Pharmacy 

submitted an application to renew its registration. 

RFAAX 47, at 2. In the application, Respondent 

Pharmacy answered ‘‘yes’’ when asked ‘‘has the 

applicant ever surrendered (for cause) or had a 

federal controlled substance registration revoked, 

suspended, restricted or denied, or is any such 

action pending?’’ Id. This prompted DEA to initiate 

an investigation into Respondent Pharmacy. Id. at 

1–2. It is routine for DEA to initiate investigations 

based on affirmative answers to the liability 

questions on the application. See e.g. Daniel A. 

Glick, D.D.S., 80 FR 74,800, 74,802 (2015) 

(including testimony that when a registrant answers 

yes to a liability question the file is assigned for 

further investigation); Barry H. Brooks, M.D., 66 FR 

18,305, 18,306 (2001). 

7The DI stated that, as relevant to this case, 

Hydrocodone is a Schedule II controlled substance, 

and Alprazolam and Carisoprodol are Schedule III– 

V controlled substances. RFAAX 47, at 9. 8 I found this 222 Form, RFAAX 13, at 1, to be 

deficient in the preceding paragraph. Supra. While 

I find RFAAX 13, at 1, to have multiple deficiencies 

representing multiple regulatory violations, infra, I 

have only included it once in my total count of 

deficient Form 222s. 

9The OSC alleged that there were thirteen DEA 

Form 222s missing information for the number of 

packages received and the date received. RFAAX 2, 

at 2. The RFAA only seeks final agency action as 

to eleven of the 222 Forms. RFAA, at 9. 

10The controlled substances identified in lines 1– 

3 on Form 222 No. 170706317, RFAAX 15, at 1, are 

supported by invoices or records. RFAAX 25 

(Invoices from Supplier QK Healthcare), at 1–3; and 

RFAAX 31 (QK Healthcare Controlled Substance 

History Report), at 5. And Respondent Pharmacy 

properly completed the corresponding ‘‘No. of 

Packages Received’’ and ‘‘Date Received’’ sections 

for those lines. RFAAX 15, at 1. 

the Respondent Pharmacy.6 RFAAX 3; 

RFAAX 5, at 2. The written response 

states that DEA had ‘‘an intent of closing 

[Respondent Pharmacy] and thus 

subject [sic] the pharmacy to various 

harassments and false accusations.’’ 

RFAAX 3, at 3. The written response 

also alleged that the DEA investigation 

was a ‘‘witch hunt . . . by an agent 

who [did not] hesitate to show her 

hatred and Might [sic] to the owner.’’ Id. 

at 2. I cannot find any evidence in the 

record that supports Respondent 

Pharmacy’s allegations of threats and 

bias. Instead the substantial evidence in 

the record validates each of the 

accusations. Infra Section, II.D. 

D. The Inspection and Audit of 

Respondent Pharmacy 

1. Respondent Pharmacy’s 

Recordkeeping 

a. Inventory Documentation Failures 

As part of the November 1, 2017 

inspection, DI obtained copies of 

Respondent Pharmacy’s biennial 

inventory, dated May 25, 2016 (RFAAX 

9), and of its most recent physical 

inventory dated October 24, 2017, at 

beginning of business (RFAAX 10). 

RFAAX 47, at 2. The OSC alleged that 

the biennial inventory failed to identify 

whether it was conducted at the 

beginning or end of the business day, 

and alleged that both inventories failed 

to separate Schedule II controlled 

substances from Schedule III through V 

controlled substances. OSC, at 2. I have 

reviewed the inventories at issue and 

agree with DI’s findings. 

According to DI, Respondent 

Pharmacy ‘‘failed to record on its 

biennial inventory (May 25, 2016) . . . 

whether the inventory was conducted at 

the beginning or end of the business day 

. . . .’’ RAAX 47, at 9. DI stated that 

Respondent Pharmacy ‘‘failed to 

separate on its biennial inventory . . . 

and on its October 24, 2016 inventory 

. . . Schedule II controlled substances 

from Schedule III through V controlled 

substances.’’ 7 Id. On both inventories, DI 

states, ‘‘a Schedule II controlled 

substance, hydrocodone, [was] listed 

with Schedule III–V controlled 

substance[s], including alprazolam and 

carisoprodol.’’ Id. at 9–10. Respondent 

Pharmacy offered no evidence to contest 

these facts. See RFAAX 3. 

b. Improperly Completed 222 Forms 

During the inspection, DI collected 

records related to Respondent 

Pharmacy’s purchases of controlled 

substances, including DEA Form 222s 

and invoices. The OSC alleges that 

Respondent ‘‘[f]ailed to properly 

complete and execute multiple DEA 

Form 222 order forms.’’ OSC at 2. 

Respondent Pharmacy broadly contests 

these allegations, stating in its response 

‘‘[c]ontrary to what [DEA] said, most of 

our D.E.A. forms are filled and signed.’’ 

RFAAX 3, at 2. I have reviewed all of 

the 222 Forms and largely agree with 

DI’s findings. 

First, according to DI, Respondent 

Pharmacy ‘‘failed to properly include 

information to be filled in by [the] 

purchaser, including the number of 

packages, size of package, and name of 

item, on four (4) DEA Form 222 order 

forms. . . .’’ RFAAX 47, at 10. 

Specifically, DI identified these failures 

in RFAAX 13 (222 Forms for Supplier 

Cochran), at pages 1, 24, and 56; and in 

RFAAX 14 (222 Forms for Supplier 

Nationwide), at page 3. I have reviewed 

these four Form 222s and agree with DI 

that each of the four forms has one or 

more blanks in the ‘‘No. of Packages,’’ 

‘‘Size of Package,’’ and ‘‘Name of Item’’ 

sections on lines that have other 

sections, namely ‘‘No. of Packages 

Received’’ and ‘‘Date Received,’’ 

completed. RFAAX 13, at 1, 24, 56; 

RFAAX 14, at 3. 

Second, according to DI, Respondent 

Pharmacy ‘‘failed to properly include 

the last line on a DEA Form 222 order 

form, specifically from [RFAAX 13, at 

3].’’ RFAAX 47, at 10. I agree with DI 

that the section ‘‘Last Line Completed’’ 

was left blank on the 222 Form at issue. 

Id. Third, DI states that the 222 Form at 

RFAAX 13, at 1,8 ‘‘failed to properly 

include the name and address of a 

supplier. . . .’’ RFAAX 47, at 10. I 

agree with the DI that the ‘‘To: (Name 

of Supplier),’’ and corresponding 

sections for the supplier’s address were 

left blank on the 222 Form at issue. 

RFAAX 13, at 1. Fourth, according to DI, 

Respondent Pharmacy ‘‘failed to 

properly sign and/or date a DEA Form 

222 order form’’ at RFAAX 13, at 4. 

RFAAX 47, at 10–11. I agree with the DI 

that the ‘‘Signature of Purchaser or 

Attorney or Agent’’ section was left 

blank. RFAAX 13, at 4. 

Finally, according to DI, Respondent 

Pharmacy ‘‘failed to properly include 

the number of packages received and 

the date received on eleven (11)[9] DEA 

Form 222 order forms.’’ RFAAX 47, at 

11. Specifically, DI identified these 

failures on RFAAX 12 (Invoices and 

Forms 222 for Supplier Apotheca, Inc.), 

at pages 4, 6, 10, 16, 18, and 20; RFAAX 

13, at pages 2, 5, 30, and 34; and 

RFAAX 15 (Forms 222 for Supplier QK 

Healthcare), at page 1. RFAAX 47, at 11. 

I agree with DI that each of these eleven 

222 Forms have otherwise completed 

lines with blanks for ‘‘No. of Packages 

Received’’ and ‘‘Date Received.’’ 

RFAAX 12, at 4, 6, 10, 16, 18, 20; 

RFAAX 13, at 2, 5, 30, 34; RFAAX 15, 

at 1. DI also identified corresponding 

invoices obtained either from 

Respondent Pharmacy showing that 

Respondent Pharmacy received the 

controlled substances, or from 

Respondent Pharmacy’s suppliers 

showing that the controlled substances 

were invoiced and shipped to 

Respondent Pharmacy to establish that 

the items were received by Respondent 

Pharmacy. RFAAX 47, at 11. The 

Government established Respondent 

Pharmacy’s receipt of the controlled 

substances, and therefore established 

Respondent Pharmacy’s obligation to 

complete the ‘‘No. of Packages 

Received’’ and ‘‘Date Received’’ 

sections, for ten of the 222 Forms at 

issue. See RFAAX 12, at 3, 5, 9, 15, 17, 

19; RFAAX 22, at 5, 6; RFAAX 29 

(Invoices from Supplier Cochran), at 5, 

9, 136, 140–44, 146, 148–53. However, 

I was not able to find invoices or other 

evidence that Respondent Pharmacy 

actually received the items identified on 

lines 4–8 of the eleventh Form 222,10

and accordingly, the Government has 

not demonstrated that the eleventh 


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11 In conducting the audit, DI stated that she 

determined the number of applicable controlled 

substances that Respondent Pharmacy was 

accountable for by adding the controlled substances 

listed in Respondent Pharmacy’s October 24, 2016 

inventory, found in RFAAX 10, to the total number 

of applicable controlled substances received from 

suppliers (according to invoices received from 

Respondent Pharmacy and from its suppliers), 

found in RFAAX 20–32. RFAAX 47, at 13. DI then 

determined the number of applicable controlled 

substances that Respondent Pharmacy had 

accounted for by adding the controlled substances 

on hand during Respondent Pharmacy’s November 

1, 2017 inventory, RFAAX 11, to the sum of the 

applicable controlled substances distributed by 

Respondent Pharmacy, RFAAX 16–19 (Respondent 

Pharmacy’s prescription logs). RFAAX 47, at 14. DI 

then subtracted the total controlled substances 

Respondent Pharmacy was accountable for from the 

total controlled substances accounted for to 

determine the ‘‘Total Difference.’’ According to DI, 

‘‘[i]f the registrant’s record keeping is accurate, the 

results of the ‘‘Total Difference’’ column for each 

controlled substance should be zero, as that would 

demonstrate that all accountable controlled 

substances are accounted for in registrant’s records 

and physical inventory.’’ RFAAX 47, at 14. She 

further explained that ‘‘[a] positive difference 

indicated that the registrant’s records show it has 

more controlled substances on hand and distributed 

than what its initial inventory and invoices show 

it has received, which means at the very least that 

the registrant’s record keeping is not accurate.’’ Id. 

‘‘A negative difference indicates the opposite, that 

the registrant’s records show it has received more 

controlled substances than it now has on hand or 

has distributed, which also means that the 

registrant’s record keeping is not accurate. 

Moreover, it likely demonstrated that diversion has 

occurred, as the registrant cannot account for all of 

the controlled substances it has received.’’ Id. 12Based on the record evidence and using on the 

methodology provided by the DI in the affidavit, I 

was able to confirm the presence of variances. 

RFAAX 47, at 14–15. The extent of the variances 

I calculated differed from the DI’s, sometimes 

significantly, and it is unclear to me why the 

numbers were so variable. But what is clear to me, 

is that there were shortfalls and surpluses that 

clearly demonstrate that Respondent Pharmacy was 

not maintaining adequate records. This finding is 

further supported by the fact that Registrant was 

missing invoices and did not properly complete the 

DEA Form 222s. See supra, II.D.1. 

13According to DI, the April 3, 2019 audit was 

conducted in the same manner as the November 2, 

2017 audit. Id. at 15–16. She first determined the 

number of applicable controlled substances that 

Respondent Pharmacy was accountable for by 

adding the controlled substances listed in 

Respondent Pharmacy’s May 24, 2018 inventory, 

found in RFAAX 34, to the total number of 

applicable controlled substances received from 

suppliers, which according to Respondent 

Pharmacy’s owner and PIC was zero because they 

‘‘had not received any controlled substances since 

the May 24, 2018 inspection.’’ Id. at 15. DI then 

determined the number of applicable controlled 

substances that Respondent Pharmacy had 

accounted for by adding the controlled substances 

on hand during Respondent Pharmacy’s April 3, 

2019 inventory, RFAAX 40, to the sum of the 

applicable controlled substances distributed by 

Respondent Pharmacy, RFAAX 42 (Respondent 

Pharmacy’s Dispensing Log from May 24, 2018 to 

April 3, 2019)13. RFAAX 47, at 15–16. DI then 

calculated the ‘‘Total Difference,’’ see RFAAX 46, 

which again revealed variances. RFAAX 47, at 16. 

Form 222 was incomplete. RFAAX 15, 

at 1. 

In total, I find the substantial 

evidence in the record establishes that 

Respondent Pharmacy failed to properly 

complete and execute sixteen Form 

222s: RFAAX 12, at 4, 6, 10, 16, 18, 20; 

RFAAX 13, at 1 (multiple deficiencies), 

2, 3, 4, 5, 24, 30, 34, 56; and RFAAX 14, 

at 3. 

c. Records of Receipt Date 

As part of the November 1, 2017 

inspection, DI obtained copies of 

Respondent Pharmacy’s invoices for 

Schedule III through V controlled 

substances. RFAAX 47, at 3, 12. The 

OSC alleged that Respondent Pharmacy 

‘‘failed to record the receipt date on 

nine (9) invoices for Schedule III 

through V controlled substances.’’ OSC, 

at 2. 

According to DI, Respondent 

Pharmacy ‘‘failed to properly record the 

receipt date’’ on these nine invoices: 

RFAAX 22 (Respondent Pharmacy’s 

Copy of Cochran Invoices), at 89; 

RFAAX 26 (Respondent Pharmacy’s 

Copy of QK Healthcare Invoices), at 78, 

79, 81, 86, and 90; RFAAX 27 

(Respondent Pharmacy’s Copy of 

RXChange Invoices), at 2; RFAAX 28 

(Respondent Pharmacy’s Copy of 

VitaRX Invoices), at 5 and 7. RAAX 47, 

at 12. I have reviewed the nine invoices 

identified by DI and agree with DI that 

they do not contain a receipt date. 

However, the undated VitaRX invoice 

located at RFAAX 28, at 7, is 

accompanied by a packing slip that is 

signed and dated with the receipt date 

and contains the same substantive 

information that the invoice contained. 

Compare RFAAX 28, at 7 with at 6. 

Respondent Pharmacy offered no 

evidence to contest these facts. See 

RFAAX 3. 

Accordingly, I find that the 

substantial evidence in the record 

establishes that the Respondent 

Pharmacy failed to properly record the 

receipt date on eight invoices. 

d. Improper Maintenance of Records 

Including Invoices and Returns 

DI declared that following the 

November 1, 2017 inspection and the 

April 3, 2019 second follow-up 

inspection, she ‘‘conducted 

accountability audits that revealed that 

Creekbend failed to keep complete and 

accurate records of controlled 

substances maintained.’’ 11 RFAAX 47, 

at 13. DI’s audit revealed that 

Respondent Pharmacy’s had a surplus of 

some controlled substances on hand, 

and a shortfall of others.12 RFAAX 47, 

at 14–15. DI also found variances during 

the audit conducted after the April 3, 

2019 second follow-up inspection, 

which looked at the records between 

May 24, 2018, and April 3, 2019.13

RFAAX 47, at 15. According to DI, 

‘‘[the] variances demonstrate that 

[Respondent Pharmacy] clearly failed to 

keep complete and accurate records of 

controlled substances maintained.’’ Id. 

at 16. While Respondent Pharmacy, in 

its response, generally asserted that it 

‘‘would be impossible’’ for the audit 

counts to be off, it provided no evidence 

to support the assertion. RFAAX 3, at 3. 

I find that the audit results and record 

as a whole clearly identify surpluses 

and shortfalls in Respondent 

Pharmacy’s controlled substances and 

clearly demonstrate that Respondent 

Pharmacy was not maintaining adequate 

records. 

To better understand the variances 

uncovered during the initial audit, DI 

verified all of the controlled substances 

transactions between Respondent 

Pharmacy and its suppliers from 

January 1, 2016, to November 1, 2017. 

RFAAX 47, at 12. To do so, DI ‘‘crossverified records maintained by 

[Respondent Pharmacy] ([RFAAX] 20– 

28) with those obtained from the various 

suppliers ([RFAAX] 29–32). Id. As a 

result of DI’s efforts, the OSC alleged 

that Respondent Pharmacy ‘‘failed to 

provide and maintain [certain] invoices 

and a record of returns.’’ OSC, at 2. 

Specifically, DI determined that 

Respondent Pharmacy ‘‘failed to 

properly provide and maintain [eight] 

invoices.’’ RFAAX 47, at 12. The 

invoices at issue are numbers I029975 

and I029976 from Nationwide Medical, 

located at RFAAX 30, at 1–2; numbers 

3427858 and 3831964 from QK 

Healthcare located at RFAAX 31, at 3, 

and 5; numbers 0019035–IN, 0022273– 

IN, 0025288–IN, and 0025702–IN from 

Cochran located at RFAAX 29, at 85, 

109, 145, and 150–51. RFAAX 47, at 12– 

13. I have reviewed Respondent 

Pharmacy’s records and agree that its 

records did not contain these eight 

invoices, which were obtained from 

Respondent Pharmacy’s suppliers. 

However, one of the invoices in 

question, Nationwide Medical Number 

I029976, reflected only the purchase of 

hydrocodone/acetaminophen, a 

Schedule II substance. RFAAX 30, at 2; 

supra note 7. In contrast to schedules 

III–V, pharmacies must record the 

necessary purchase and receipt 

information regarding schedule II 

substances on either the 222 Form or in 

the electronic Controlled Substances 

Ordering System, whichever was used 

to order the drugs. See supra Section 

II.D.1.b; infra Section, III.A.2. I did not 

see any purchase orders or other records 

containing the information that would 

have otherwise been reflected on the 

invoices for the remaining seven 

invoices at issue. Respondent Pharmacy 


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14 DI contacted Dr. C.K. who stated that, with 

regard to the eight prescriptions purporting to have 

been issued by Dr. C.K. and presented to 

Respondent Pharmacy on May 25 and 26, 2018, 

none of the individuals were patients of his. See 

RFAAX 47, at 18; RFAAX 44. I agree with DI’s 

determination that these eight prescriptions were 

fraudulent. See RFAAX 47, at 18. Respondent 

Pharmacy has not been charged with any violations 

related to dispensing these fraudulent prescriptions; 

however, the fact that the substantial evidence in 

the record shows these prescriptions were 

fraudulent, as Respondent Pharmacy no doubt 

knew or was willfully blind to, is relevant to my 

determination that Respondent Pharmacy lacked 

candor and impeded the investigation in a way that 

threatened public health and safety. 

15Respondent Pharmacy repeated this assertion 

in its written response. RFAAX 3, at 2. 

offered no evidence to contest these 

facts. See RFAAX 3. 

DI also determined that Respondent 

Pharmacy failed to maintain one record 

of return. RFAAX 47, at 12. According 

to DI, Respondent Pharmacy 

‘‘maintained an invoice that had a 

handwritten note that indicated that 

these controlled substances were 

received on September 5, 2017, as set 

forth in [RFAAX] 26, [at] 2.’’ Id. 

However, QK Healthcare Inc., verified 

that the product was initially lost in 

transit[, and] [w]hen it was finally found 

and delivered, [Respondent Pharmacy] 

no longer wanted it and it was returned 

to QK Healthcare Inc.’’ Id.; see also 

RFAAX 32 (QK Healthcare Records of 

Return from Respondent Pharmacy). I 

reviewed the Respondent’s records and 

agree with DI’s determination. 

Respondent Pharmacy offered no 

evidence to contest these facts. See 

RFAAX 3. 

Based on the evidence in the record, 

I find that Respondent Pharmacy 

generally maintained incomplete and/or 

inaccurate controlled substance records 

between October 24, 2016, and April 3, 

2019, and specifically failed to properly 

maintain seven invoices and one return 

record. 

2. Respondent Pharmacy’s Candor 

During the Investigation 

The Government has alleged that 

Respondent Pharmacy lacked candor 

during the course of DEA’s investigation 

regarding its filling of fraudulent 

prescriptions and regarding various 

controlled substances hidden 

throughout the pharmacy. 

a. Lack of Candor Regarding Filled 

Fraudulent Prescriptions 

During the November 1, 2017 

Inspection, DEA obtained a number of 

prescriptions that had been filled by 

Respondent Pharmacy and determined 

that they were fraudulent. RFAAX 47, at 

5. In making that determination, DI 

interviewed Dr. C.K. regarding fiftyseven prescriptions issued in his name 

that DI obtained from Respondent 

Pharmacy during the inspection. Id. 

According to DI, ‘‘Dr. [C.K.] reviewed 

the prescriptions and verified that they 

were not issued by him and that all 

were fraudulent.’’ Id. According to DI, 

the ‘‘prescriptions contained 

handwritten notes indicating that they 

had been verified by ‘Donna Lavender’ 

or ‘Gloria.’ ’’ Id. Dr. C.K. stated that ‘‘he 

had no idea who Donna Lavender was,’’ 

and that ‘‘a woman named ‘Gloria’ 

worked in this office, . . . [but] she had 

not verified the prescriptions.’’ Id. 

Based on this interview, DI determined 

that Respondent Pharmacy ‘‘was filling 

fraudulent prescriptions that had been 

issued in Dr. [C.K.’s] name.’’ Id. 

During the May 24, 2018, follow-up 

inspection, DI ‘‘observed a customer in 

the waiting area who was acting 

suspicious,’’ while waiting for a 

prescription purportedly issued by Dr. 

S.S. to be filled. Id. Specifically, DI 

observed that the customer ‘‘kept 

coming in and out of the pharmacy to 

ask about the status of her prescription’’ 

and when she left the pharmacy, ‘‘she 

would drive her car to the back of the 

parking lot and talk to someone in a 

black tinted Lincoln MKX with 

temporary tags.’’ Id. at 5–6. DEA asked 

PIC Kumenda to demonstrate how she 

verified the validity of the customer’s 

prescription. Id. at 6. According to DI, 

PIC Kumenda stated, that ‘‘[s]he called 

the [phone] number on the prescription 

and talked with a person named 

‘Melissa,’ who verified the 

prescription.’’ Id. DEA then ‘‘told PIC 

Kumenda to take additional steps to 

verify the contact information for the 

doctor, such as by looking at the Texas 

Medical Board . . . Website or doing a 

Google search.’’ Id. According to DI, PIC 

Kumenda found a different phone 

number for Dr. S.S., and the doctor’s 

office ‘‘verified that the customer was 

not a patient and that no one named 

Melissa worked there.’’ Id. DI and 

another diversion investigator then 

approached the customer in the waiting 

area and reported that the customer 

‘‘could not provide the exact location 

where Dr. S.S.’s office was located.’’ Id. 

The customer then left the pharmacy 

and drove off, and ‘‘[a] few minutes 

later, the black Lincoln also drove off.’’ 

Id. 

Also during the May 24, 2018, followup inspection, DI ‘‘saw prescriptions 

allegedly issued by Dr. [C.K.].’’ Id. 

Again, PIC Kumenda stated to DI, that 

‘‘she verified the prescriptions by the 

phone number on the prescription.’’ Id. 

Again, PIC Kumenda did a Google 

search for Dr. C.K. and called the 

resulting phone number. Id. And, like 

before, Dr. C.K.’s office ‘‘told PIC 

Kumenda that the prescriptions she had 

were fraudulent.’’ Id. 

According to DI, DEA then ‘‘informed 

PIC Kumenda and Ms. Barry that 

[Respondent Pharmacy] was filling 

fraudulent prescriptions.’’ Id. I find, that 

as of May 24, 2018, Respondent 

Pharmacy knew that it had been 

presented with and had filled 

fraudulent prescriptions that purported 

to be issued by Dr. C.K. See RFAAX 47, 

at 18. I further find that as of May 24, 

2018, Respondent Pharmacy was aware 

of the correct phone number for Dr. C.K. 

to verify future prescriptions. See Id. 

According to the Texas Prescription 

Monitoring Program (Texas PMP), 

Respondent Pharmacy went on to fill 

eight controlled substances 

prescriptions purportedly issued by Dr. 

C.K. on May 25, 2018 and May 26, 2018. 

Id. at 2–3. However, during the April 4, 

2019 second follow-up inspection, PIC 

Kumenda informed DI, and Ms. Barry 

later confirmed, that Respondent 

Pharmacy had not ordered or dispensed 

controlled substances since the DEA 

inspection on May 24, 2018. RFAAX 47, 

at 6 and 8. I find that these statements 

lacked candor. After these 

representations, DI ‘‘asked Ms. Barry to 

print out a dispensing log from May 24, 

2018, to April 3, 2019.’’ Id. at 8. 

According to DI, Ms. Barry then printed 

out a blank dispensing log that began on 

May 28, 2018. Id.; see also RFAAX 41. 

I find that in providing an incomplete 

dispensing log, Respondent Pharmacy 

lacked candor. DI stated that she noticed 

that the ‘‘dispensing report was not for 

the complete date range’’ and again 

requested and finally received a 

dispensing log starting May 24, 2018. 

RFAAX 47, at 8. This dispensing log 

showed that Respondent Pharmacy 

dispensed controlled substances for 

eight fraudulent 14 prescriptions 

purportedly issued by Dr. C.K. in the 

hours following DEA’s last inspection. 

Id.; see also RFAAX 42. 

However, contrary to the information 

contained in the Texas PMP and 

Respondent Pharmacy’s own dispensing 

log, Ms. Barry informed DI that ‘‘[SI] 

had returned to the pharmacy after the 

May 24, 2018 inspection and had taken 

the prescriptions[;] . . . the 

prescriptions were logged into the 

system, but were never filled.’’ 15

RFAAX 47, at 8. I find that this 

statement lacked candor. 

According to SI, his actions did not in 

any way interfere with Respondent 

Pharmacy’s ability to fill the eight 

controlled substance prescriptions that 

Respondent Pharmacy reported to the 

Texas PMP that it filled. RFAAX 48, at 


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16SI states that he has ‘‘looked for and verified 

that [his] office does not currently have the eight 

(8) prescriptions’’ identified in the Texas PMP, and 

he ‘‘cannot confirm whether or not [those] 

prescriptions [were] among the ones [he] obtained 

on May 31, 2018.’’ RFAAX 48, at 2. 

17 I note that PIC Kumenda made similar 

representations during the May 28, 2018 follow-up 

inspection. At that time DEA asked Respondent 

Pharmacy to show it all of the controlled substances 

it had in stock. RFAAX 47, at 5. According to DI, 

‘‘PIC Kumenda showed [DI] patient-ready bottles of 

controlled substances and stated those were all the 

controlled substances that the pharmacy had on 

hand.’’ Id. Later, DI ‘‘saw a box next to PIC 

Kumenda that contained additional controlled 

substances[, and] PIC Kumenda apologized for 

missing the box.’’ Id. 

18This factual assertion is repeated in 

Respondent Pharmacy’s written statement. RFAAX 

3, at 3. 

19See also Respondent’s written response, stating 

‘‘I turned to the pharmacist-in-charge and told her 

to go back and looked [sic.] for the medications 

because she hides controls like hydrocodone, Soma, 

Alprazolam in different places and ways. . . . 

[T]he agent again informed me that the 

hydrocodone is [short] as to the original count. 

. . . Again I instructed the pharmacist-in-charge to 

go and check in her hiding places she went and 

came back with the hydrocodone. . . .’’ RFAAX 3, 

at 3. 

20 DEA took pictures of some of the drugs which 

are part of the record, including pictures of ‘‘tablets 

of hydrocodone in plastic sandwich bags [or] 

wrapped up in a ball inside of a sheet of paper.’’ 

Id.; RFAAX 37–39 (Pictures from April 3, 2019). 

1–2. He also stated that shortly after the 

May 24, 2018 follow-up inspection, he 

was contacted by PIC Kumenda who 

asked him to ‘‘pick up a handful of 

prescriptions that had been filled after 

the inspection.’’ Id. at 2. SI retrieved 

prescriptions 16 from Respondent 

Pharmacy on May 31, 2018. Id. at 2. SI 

reported that on August 13, 2018, he 

returned to Respondent Pharmacy and, 

while there, obtained a dispensing 

record from Respondent Pharmacy, 

which reflected that the eight 

prescriptions purportedly issued by Dr. 

C.K. as discussed above ‘‘had been 

filled.’’ Id. at 2, 5. 

I find that substantial evidence in the 

record establishes that Respondent 

Pharmacy lacked candor during DEA’s 

investigation with regard to its filling of 

fraudulent prescriptions on May 25–26, 

2018. Specifically, I find Respondent 

Pharmacy lacked candor first when it 

stated that it had not dispensed any 

controlled substances since May 24, 

2018, then when it printed out a 

dispensing log that did not include the 

controlled substances dispensed from 

May 24 to May 26, 2018 (the exact dates 

on which the controlled substances at 

issue were dispensed), and finally when 

it represented that it did not fill the 

prescriptions logged in the dispensing 

log between May 24 and May 26, 2018. 

b. Lack of Candor Regarding Hidden 

Controlled Substances 

During the April 3, 2019 second 

follow-up inspection, DI requested that 

PIC Kumenda show the investigators all 

of the controlled substances at the 

pharmacy. Id. According to DI, PIC 

Kumenda took them to the back room 

where DI saw ‘‘two hydrocodone 10/325 

bottles on a black garbage bag that was 

spread out on the floor.’’ Id. PIC 

Kumenda told DI that ‘‘she had taken 

the hydrocodone bottles out because she 

was going to take an inventory.’’ Id. 

DEA asked PIC Kumenda if those two 

bottles of hydrocodone ‘‘were the only 

controlled substances on the premises, 

and she answered yes.’’ Id. at 6–7. PIC 

Kumenda also showed DI two safes; DI 

‘‘looked in and confirmed that there 

were no drugs in the smaller of the two 

safes.’’ Id. at 7. PIC Kumenda, unable to 

open the larger one, ‘‘represented there 

were no drugs inside.’’ Id. Everyone 

returned to the front of the pharmacy 

where DEA instructed Respondent 

Pharmacy to conduct a closing 

inventory of all controlled substances. 

Id. According to DI, PIC Kumenda then 

walked to the back of the pharmacy 

again. 

When DI returned to the back room, 

she observed ‘‘there now were three 

bottles of carisoprodol placed on the 

floor next to the hydrocodone.’’ Id. DEA 

asked ‘‘from where the carisoprodol 

bottles had come, [and] PIC Kumenda 

would not answer.’’ Id. DEA asked PIC 

Kumenda ‘‘if these were the only 

controlled substances at the pharmacy, 

and she affirmed that they were.’’ 17 Id. 

Ms. Barry and Respondent Pharmacy’s 

attorney arrived during the count. Id. 

When PIC Kumenda finished 

counting, DEA compared her counts to 

the closing inventory from the prior 

inspection on May 24, 2018. Id. 

According to DI, ‘‘[s]ince PIC Kumenda 

had confirmed to us that [Respondent 

Pharmacy] had not filled any controlled 

substances since that inspection, the 

counts should have matched up. They 

did not.’’ Id. According to DI, ‘‘Ms. 

Barry then informed [the DIs] that PIC 

Kumenda hides drugs in the pharmacy 

to avoid thefts, and instructed her to go 

back and find more drugs.’’ 18 Id. PIC 

Kumenda returned with plastic 

sandwich bags containing alprazolam 

2mg. Id. Thereafter, ‘‘PIC Kumenda 

again affirmed’’ that those ‘‘were the 

only drugs on the premise.’’ Id. 

According to DI, the inventory was 

still short, so Ms. Barry ‘‘again told PIC 

Kumenda to go and search for drugs in 

the back of the pharmacy.’’ Id.19 DI 

states that she ‘‘witnessed PIC Kumenda 

pulling plastic sandwich bags 

containing drugs from various hiding 

places, including taped underneath the 

sink and inside of plastic bins mixed 

under papers/records.’’ 20 Id. DI reports 

that PIC Kumenda ‘‘went to the back of 

the pharmacy about four times, and 

each time came back out with additional 

drugs that she had hidden.’’ Id. 

Eventually, PIC Kumenda completed the 

closing inventory. Id.; RFAAX 40 

(Closing Inventory dated April 3, 2019). 

I find that substantial evidence in the 

record establishes that Respondent 

Pharmacy lacked candor during DEA’s 

investigation with regard to identifying 

the location of and quantity of the 

controlled substances it had on hand. 

III. Discussion 

The Government alleged that 

Respondent Pharmacy’s registration 

should be revoked because Respondent 

Pharmacy committed acts, as detailed 

above, that would render its registration 

inconsistent with the public interest as 

defined in 21 U.S.C. 823(f). OSC, at 1. 

The gravamen of the Government’s 

allegations and evidence in this case 

focuses on whether Respondent 

Pharmacy violated federal laws relating 

to controlled substances when it failed 

to properly complete and maintain 

certain records. Id. at 2–4. The 

Government also alleged that 

Respondent Pharmacy’s representations 

to the DEA investigators during the 

investigation lacked candor in a way 

that impeded the investigation and 

threatened public safety. Id. at 4–7. 

Section 304(a) of the Controlled 

Substances Act (hereinafter, CSA) 

provides that ‘‘[a] registration . . . to 

. . . dispense a controlled substance 

. . . may be suspended or revoked by 

the Attorney General upon a finding 

that the registrant . . . has committed 

such acts as would render [its] 

registration under section 823 of this 

title inconsistent with the public 

interest as determined under such 

section.’’ 21 U.S.C. 824(a). In the case of 

a practitioner, which includes a 

pharmacy, the CSA requires the Agency 

consider the following factors in 

determining whether Respondent 

Pharmacy’s registration would be 

inconsistent with the public interest: 

(1) The recommendation of the appropriate 

State licensing board or professional 

disciplinary authority. 

(2) The [registrant’s] experience in 

dispensing, or conducting research with 

respect to controlled substances. 

(3) The [registrant’s] conviction record 

under Federal or State laws relating to the 

manufacture, distribution, or dispensing of 

controlled substances. 

(4) Compliance with applicable State, 

Federal, or local laws relating to controlled 

substances. 


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21As to Factor One, there is no evidence in the 

record to suggest that Respondent Pharmacy did not 

have a Texas license, see RFAAX 1, at 3, and there 

is no evidence in the record of any recommendation 

from Respondent’s state licensing board or 

professional disciplinary authority. 21 U.S.C. 

823(f)(1). 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 Respondent Pharmacy’s owner or any of 

its employees have been convicted of an offense 

under either federal or state law ‘‘relating to the 

manufacture, distribution, or dispensing of 

controlled substances.’’ 21 U.S.C. 823(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. 

(5) Such other conduct which may threaten 

the public health and safety. 

21 U.S.C. 823(f). 

The DEA considers these public 

interest factors in the disjunctive. Robert 

A. Leslie, M.D., 68 FR 15,227, 15,230 

(2003). Each factor is weighed on a caseby-case basis. Morall v. Drug Enf’t 

Admin., 412 F.3d 165, 173–74 (DC Cir. 

2005). Any one factor, or combination of 

factors, may be decisive. David H. Gillis, 

M.D., 58 FR 37,507, 37,508 (1993). Thus, 

there is no need to enter findings on 

each of the factors. Hoxie v. Drug Enf’t 

Admin., 419 F.3d 477, 482 (6th Cir. 

2005). Furthermore, there is no 

requirement to consider a factor in any 

given level of detail. Trawick v. Drug 

Enf’t Admin., 861 F.2d 72, 76–77 (4th 

Cir. 1988). The balancing of the public 

interest factors ‘‘is not a contest in 

which score is kept; 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. . . .’’ Jayam Krishna-Iyer, 

M.D., 74 FR 459, 462 (2009). When 

deciding whether registration is in the 

public interest, the DEA must consider 

the totality of the circumstances. See 

generally Joseph Gaudio, M.D., 74 FR 

10,083, 10,094–95 (2009) (basing 

sanction on all evidence on record). 

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 Respondent to show 

that revoking registration would not be 

appropriate, given the totality of the 

facts and circumstances on the record. 

Med. Shoppe-Jonesborough, 73 FR 364, 

387 (2008). 

While I have considered all of the 

public interest factors,21 the 

Government’s case invoking the public 

interest factors of 21 U.S.C. 823(f) seeks 

revocation of Respondent Pharmacy’s 

registration based solely under Public 

Interest Factors Two, Four, and Five. I 

find that the Government’s evidence 

with respect to Factors Two, Four and 

Five satisfies its prima facie burden of 

showing that Respondent Pharmacy’s 

continued registration would be 

‘‘inconsistent with the public interest.’’ 

21 U.S.C. 823(f). I further find that 

Respondent Pharmacy failed to provide 

sufficient evidence to rebut the 

Government’s prima facie case. 

Specifically, as to Factors Two and 

Four, I find that the record contains 

substantial evidence that Respondent 

Pharmacy violated multiple federal 

recordkeeping requirements, and as to 

Factor Five, I find the record contains 

substantial evidence that Respondent 

Pharmacy’s owner and PIC lacked 

candor during the course of the DEA 

investigation into Respondent 

Pharmacy. 

A. Factors Two and Four 

As already discussed, pursuant to 

section 304 of the CSA, in conjunction 

with section 303 of the CSA, I am to 

consider evidence of Respondent 

Pharmacy’s compliance (or noncompliance) with laws related to 

controlled substances and experience 

dispensing controlled substances in 

determining whether Respondent 

Pharmacy’s continued registration is 

‘‘consistent with the public interest.’’ 21 

U.S.C. 824(a)(4). ‘‘[A] registrant’s 

‘ignorance of the law is no excuse’ for 

actions that are inconsistent with 

responsibilities attendant upon a 

registration.’’ Daniel A. Glick, D.D.S., 80 

FR 74,800, 74,809 (2015) (quoting Sigrid 

Sanchez, M.D., 78 FR 39,331, 39,336 

(2013)). Instead, ‘‘[a]ll registrants are 

charged with knowledge of the CSA, its 

implementing regulations, as well as 

applicable state laws and rules.’’ Id. at 

74,809 (internal citations omitted). 

Further, the Agency has consistently 

concluded that a pharmacy’s 

registration is subject to revocation due 

to the unlawful activity of the 

pharmacy’s owners, majority 

shareholders, officers, managing 

pharmacist, or other key employees. 

EZRX, LLC, 69 FR 63,178, 63,181 (2004); 

Plaza Pharmacy, 53 FR 36,910, 36,911 

(1988). 

In this matter, the Government alleged 

and presented evidence that Respondent 

Pharmacy committed several 

recordkeeping violations. The CSA 

recognizes that controlled substances 

are fungible and that a truly closed 

system requires that certain records and 

inventories be kept by all registrants 

who either generate or take custody of 

controlled substances in any phase of 

the distribution chain until they reach 

the ultimate user. Satinder Dang, M.D., 

76 FR 51,424, 51,429 (2011) 

(‘‘Recordkeeping is one of the central 

features of the CSA’s closed system of 

distribution.’’) (internal citations 

omitted); Paul H. Volkman, 73 FR 

30,630, 30,644 (2008), pet. for rev. 

denied 567 F.3d 215, 224 (6th Cir. 2009) 

(‘‘Recordkeeping is one of the CSA’s 

central features; a registrant’s accurate 

and diligent adherence to this obligation 

is absolutely essential to protect against 

the diversion of controlled 

substances.’’). The OSC alleged that 

Respondent Pharmacy violated multiple 

federal laws related to the proper 

completion and maintenance of records. 

Specifically, the government alleged 

and established that Respondent 

Pharmacy did not properly document its 

inventories, did not properly complete 

multiple 222 Forms, failed to record the 

receipt date of Schedule III through V 

controlled substances, and failed to 

properly maintain invoices, records of 

returns, and other records. Supra 

Section II.D.1. 

1. Inventory Documentation Failures 

With regard to Respondent 

Pharmacy’s May 25, 2016 biennial 

inventory, the Government alleged that 

Respondent Pharmacy failed to record 

whether the inventory was conducted at 

the beginning or end of the business 

day, in violation of 21 CFR 1304.11(a) 

and (c). 21 CFR 1304.11(c) requires 

respondents to ‘‘take a new inventory of 

all stocks of controlled substances on 

hand at least every two years,’’ and 

§ 1304.11(a) provides that each biennial 

inventory ‘‘be taken either as of opening 

of business or as of the close of business 

on the inventory date and it shall be 

indicated on the inventory.’’ It is 

uncontroverted that Respondent 

Pharmacy failed to record on the May 

25, 2016 biennial inventory, whether 

the inventory was conducted at the 

opening or closing of the business day. 

Supra Section II.D.1.a. 

Regarding both the May 25, 2016 

biennial inventory and Respondent 

Pharmacy’s October 24, 2017 inventory, 

the Government alleged that 

Respondent Pharmacy failed to separate 


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Schedule II controlled substances from 

Schedule III through V controlled 

substances in violation of 21 CFR 

1304.04(h)(1). 21 CFR 1304.04(h)(1) 

states that registered pharmacies must 

maintain ‘‘[i]nventories and records of 

all controlled substances listed in 

Schedule I and II . . . separately from 

all other records of the pharmacy.’’ 

Here, it is uncontested that Respondent 

Pharmacy’s May 25, 2016 biennial 

inventory and its October 24, 2017 

inventory both comingled Schedule II 

controlled substances such as 

hydrocodone with Schedule III–V 

controlled substances such as 

alprazolam and carisoprodol. Supra 

Section II.D.1.a. 

I find, therefore, that there is 

substantial record evidence that 

Respondent Pharmacy failed to properly 

prepare its inventory records and, 

therefore, violated 21 CFR 1304.04(h)(1) 

and 1304.11(a)&(c). 

2. Improperly Completed 222 Forms 

Next, the Government alleges and I 

find that Respondent Pharmacy, as a 

purchaser of controlled substances, 

failed to properly complete and execute 

multiple 222 Forms. First, 21 CFR 

1305.12(a) requires purchasers to 

prepare and execute 222 Forms. As I 

have already found, four of Respondent 

Pharmacy’s 222 Forms did not include 

required information, such as the 

number of packages, size of package, 

and name of item. Supra Section 

II.D.1.b. Second, 21 CFR 1305.12(b) 

required Respondent Pharmacy to note 

at the bottom of the Form 222 ‘‘[t]he 

number of lines completed.’’ I have 

already found that the ‘‘Last Line 

Completed’’ section was left blank on 

one of the 222 Forms at issue. Supra 

Section II.D.1.b. Third, under 21 CFR 

1305.12(c), Respondent Pharmacy was 

required to include the ‘‘name and 

address of the supplier from whom the 

controlled substances are being 

ordered’’ on the 222 Forms, and I have 

found that information missing from 

one of the 222 Forms at issue. 21 CFR 

1305.12(c); supra Section II.D.1.b. 

Fourth, 21 CFR 1305.12(d) provides that 

‘‘[e]ach DEA Form 222 must be signed 

and dated[,]’’ and I have found that one 

of the 222 Forms at issue was not 

signed. Supra Section II.D.1.b. 

The Government also alleged, and I 

find, that Respondent Pharmacy 

violated 21 CFR 1305.13(e). Under 21 

CFR 1305.13(e), Respondent Pharmacy 

was required to ‘‘record on Copy 3 of 

the DEA Form 222 the number of 

commercial or bulk containers 

furnished on each item and the dates on 

which the containers are received by the 

purchaser.’’ I have found that 

Respondent Pharmacy received 

controlled substances but failed to 

record the ‘‘No. of Packages Received’’ 

and ‘‘Date Received’’ sections 

corresponding to those controlled 

substances, on ten of the 222 Forms at 

issue. Supra Section II.D.1.b. 

I find, therefore, that there is 

substantial record evidence that 

Respondent Pharmacy failed to properly 

complete and execute multiple 222 

Forms in violation of 21 CFR 1305.12 

and 1305.13(e). 

3. Failure To Maintain Record of 

Receipt Date 

The Government also alleged that 

Respondent Pharmacy violated 21 CFR 

1304.21(a) and (d) and 1304.22(a)(2)(iv) 

and (c) when it failed to record the date 

it received controlled substance 

shipments. Under 21 CFR 1304.21(a), 

Respondent Pharmacy was required to 

maintain ‘‘a complete and accurate 

record of each substance . . . received 

[or] sold, . . . and [of] returned mailback package[s.]’’ Under 21 CFR 

1304.21(d), Respondent Pharmacy was 

required to maintain a record of the date 

each controlled substance was received, 

sold, or returned. For the purposes of 

controlled substances on Schedules III– 

V, the received date is generally 

recorded on invoices or packing slips. 

See 21 CFR 1304.21(d); see also Rene 

Casanova, M.D., 77 FR 58,150, 58,153 

and 58,161 (2012). 21 CFR 1304.22(c), 

which incorporates § 1304.22(a)(2)(iv) 

also requires that Respondent Pharmacy 

record the ‘‘date of and number of units 

and/or commercial containers in each 

acquisition to inventory.’’ 21 CFR 

1304.22(a)(2)(iv). 

I have already found that Respondent 

Pharmacy failed to record the receipt 

date for eight shipments of controlled 

substances on the accompanying 

shipment invoices or packing slips. 

Supra Section II.D.1.c. Respondent 

Pharmacy thus failed to comply with its 

obligation to maintain an accurate 

record of each controlled substance it 

received in violation of 21 CFR 

1304.21(a) and (d) and 1304.22(a)(2)(iv) 

and (c). 

4. Improper Maintenance of Records 

Including Invoices and Returns 

Also relevant to Factors Two and 

Four, Respondent Pharmacy is required 

to ‘‘maintain, on a current basis, a 

complete and accurate record of each 

substance . . . received, sold, delivered, 

. . . or otherwise disposed of by [it], 

and each . . . unused and returned 

mail-back package, except that no 

registrant shall be required to maintain 

a perpetual inventory.’’ 21 CFR 

1304.21(a). As previously discussed, 

Respondent Pharmacy’s records related 

to the receipt of Schedule III–V 

controlled substances were generally 

recorded on invoices or packing slips 

which were maintained by the 

pharmacy. RFAAX 20–22, 24, 26–28; 21 

CFR 1304.21(d). Respondent Pharmacy 

kept records of controlled substances it 

sold or distributed in both electronic 

and handwritten prescription logs. 

RFAAX 16–19; 21 CFR 1304.22(c). DI 

declared that using Respondent 

Pharmacy’s records, she ‘‘conducted 

accountability audits that revealed that 

[Respondent Pharmacy] failed to keep 

complete and accurate records of 

controlled substances maintained.’’ 

RFAAX 47, at 13; supra Section II.D.1.d. 

More specifically, the audit revealed 

that Respondent Pharmacy had 

surpluses and shortfalls of various 

controlled substances and demonstrated 

that not all ‘‘controlled substances 

[were] accounted for in [Respondent 

Pharmacy’s] records and physical 

inventory.’’ RFAAX 47, at 14; supra 

Section II.D.1.d. 

In evaluating shortages under Factor 

Four, the Agency has held that, 

‘‘[w]hether the shortages are attributable 

to outright diversion by either pharmacy 

or store employees, theft, or the failure 

to maintain accurate records, does not 

matter.’’ Ideal Pharmacy Care, 76 FR at 

51,416. As the Agency has explained, 

the ‘‘inability to account for [a] 

significant number of dosage units 

creates a grave risk of diversion.’’ Fred 

Samimi, 79 FR 18,698, 18,712 (2014). 

The Agency has also made it clear that 

it is not only concerned with shortages, 

but that overages are equally indicative 

that a pharmacy registrant has ‘‘failed to 

maintain complete and accurate records 

as required by the CSA.’’ Superior 

Pharmacy, 81 FR at 31,341; see also 

Hills Pharmacy, 81 FR at 49,843–45 

(considering allegations of overages and 

shortages). In short, what matters to the 

public interest inquiry is the fact that 

Respondent could not account for a 

significant number of controlled 

substances by adequate documentation. 

Ideal Pharmacy Care, Inc., d/b/a 

Esplanade Pharmacy, 76 FR 51,415, 

51,416 (2011). 

Here, the Government took the 

additional step of identifying in 

evidence some of the specific 

documentation that Respondent 

Pharmacy was not able to produce. DI 

‘‘cross-verified records maintained by 

[Respondent Pharmacy] ([RFAAX] 20– 

28) with those obtained from the various 

suppliers ([RFAAX] 29–32).’’ Id. This 

effort established, as I found above, that 

Respondent Pharmacy failed to 

maintain invoices or perchance orders 

documenting the receipt of seven 


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22 21 CFR 1305.13(e) explicitly requires that the 

receipt date for Schedule II controlled substances be 

recorded on the Form 222 order form. I do not see 

a requirement that an invoice containing only 

Schedule II controlled substances has to be 

maintained. Morning Star Pharmacy and Medical 

Supply 1, 85 FR 51,045, 51,049 (2020) (‘‘In contrast 

to schedules III–V, pharmacies must record the date 

they receive schedule II substances on either the 

222 Form or in CSOS, whichever was used to order 

the drugs—pharmacies are not required to also 

record the date of receipt for schedule II substances 

on the invoice.’’). 

23 I have found that the substantial evidence in 

the record shows that the Respondent Pharmacy’s 

owner lacked candor when she told DI that the 

fraudulent prescriptions had not been filled (in 

effect finding that Respondent Pharmacy’s records 

saying the prescriptions were filled were more 

reliable than the owner’s representations). Supra, 

II.D.2. However, if arguendo Respondent Pharmacy 

did not actually fill the fraudulent prescriptions, 

then Respondent Pharmacy made a 

misrepresentation to the Texas PMP in reporting 

them as filled. Either way, Respondent Pharmacy 

lacked candor with regard to the filling (or not) of 

these fraudulent prescriptions. 

Schedule III–V 22 controlled substance 

orders. Supra Section II.D.1.d. I further 

found that Respondent Pharmacy failed 

to maintain a record of return. Id. 

In short, through both the audit which 

generally established that Respondent 

Pharmacy was missing records and 

through specifically identified missing 

records, I find that Respondent 

Pharmacy failed to comply with its 

obligation to maintain complete and 

accurate records in violation of 21 CFR 

1304.21(a). 

B. Factor Five 

Under Factor Five, the Administrator 

is authorized to consider ‘‘[s]uch other 

conduct which may threaten the public 

health and safety.’’ 5 U.S.C. 823(f)(5). 

Although Factor Five is broad, DEA 

decisions have qualified its breadth by 

limiting the considerations made under 

that factor to those where there is ‘‘a 

substantial relationship between the 

conduct and the CSA’s purpose of 

preventing drug abuse and diversion.’’ 

Zvi H. Perper, M.D., 77 FR 64,131, 

64,141 (2012) (citing Tony T. Bui, 75 FR 

49,979, 49,988 (2010)). ‘‘Candor during 

DEA investigations, regardless of the 

severity of the violations alleged, is 

considered by the DEA to be an 

important factor when assessing 

whether a physician’s registration is 

consistent with the public interest.’’ 

Jerri Hassman, M.D., 75 FR 8194, 8236 

(2010) (internal citations and quotations 

omitted); see also David A. Hoxie, M.D., 

v. Drug Enf’t Admin., 419 F.3d 477, 483 

(6th Cir. 2005). It is appropriate to 

consider lack of candor allegations 

under Factor Five when the alleged 

conduct raises a probable or possible 

threat to public safety. See e.g. Annicol 

Marrocco, M.D., 80 FR 28,695, 28,705 

(2015) (analyzing under Factor Five the 

allegation that respondent’s testimony 

regarding prescriptions issued to a 

particular individual, including 

prescriptions issued following a claim 

that the individual’s pet monkey opened 

the bottle and threw the pills in the 

pool, lacked candor); Ajay S. Ahuja, 

M.D., 84 FR 5479, 5494–95 (2019) 

(analyzing under Factor Five allegations 

of an attempt to mislead DEA 

investigators, but declining to analyze a 

simple statement of opinion made by 

the respondent under factor five); Island 

Wholesale, Inc., 68 FR 17,406, 17,407 

(2003) (analyzing under Factor Five the 

allegation that respondent provided a 

false customer list to DEA investigators). 

The Government alleged that 

Respondent Pharmacy’s lack of candor 

is ‘‘inconsistent with the public 

interest’’ and constitutes ‘‘other such 

conduct which may threaten the public 

health and safety.’’ RFAA at 15 (citing 

21 U.S.C. 823(f)(5)). I agree and find that 

Respondent’s alleged lack of candor 

impeded a DEA investigation. 

The Respondent Pharmacy lacked 

candor with regard to the fraudulent 

prescriptions filled between May 25, 

2018, and May 26, 2018. As I found 

above, Respondent Pharmacy took 

multiple steps to conceal its filling of 

prescriptions that it clearly knew or 

should have known were fraudulent. 

Supra Section II.D.2. Respondent 

Pharmacy initially provided a 

distribution log, omitting material 

portions of the requested timeframe, 

that supported the Pharmacy’s narrative 

that it had not filled any prescriptions 

since DEA’s prior inspection. Id. And 

then when the pharmacy’s own records 

showed that prescriptions it should 

have known to be fraudulent were 

filled, Respondent Pharmacy attempted 

to contradict its records by saying that 

SI had taken the prescriptions and they 

were not filled. Id. There can be no 

question here that Respondent 

Pharmacy lacked candor.23 Further, lack 

of candor during a DEA investigation 

about filling fraudulent prescriptions 

constitutes a threat to the public health 

and safety. 

Additionally, the OSC alleged that 

during the May 24, 2018 inspection, 

Respondent Pharmacy falsely stated that 

all controlled substances had been 

identified when controlled substances 

were actually still hidden throughout 

the pharmacy. As I have found, PIC 

Kumenda informed DEA that she had 

counted all of the controlled substances 

in Respondent Pharmacy’s inventory. 

Supra Section II.D.2. But when DEA 

identified discrepancies in the May 24, 

2018 inventory, Ms. Barry stated that 

‘‘PIC Kumenda hides drugs in the 

pharmacy to avoid thefts, and instructed 

her to go back and find more drugs.’’ Id. 

On multiple occasions thereafter, PIC 

Kumenda located more controlled 

substances throughout the pharmacy in 

sandwiches bags or wrapped up in 

wadded paper, represented to DEA that 

she had now identified all of 

Respondent Pharmacy’s controlled 

substances. Id. However, she was still 

able to find more upon discovering that 

discrepancies remained. Id. 

‘‘[A] DEA registrant is obligated at all 

times to act in the public interest.’’ Peter 

F. Kelly, D.P.M., 82 FR 28,676, 28,688 

(2017). Respondent Pharmacy’s layered 

efforts to conceal its filling of known 

fraudulent prescriptions and to 

physically hide controlled substances 

that were not immediately locatable for 

DEA’s investigation actively impeded 

DEA’s investigation. I find that 

Respondent Pharmacy impeded DEA’s 

investigation and in doing so, 

threatened public health and safety. 

C. Summary of the Public Interest 

Factors 

As found above, Respondent 

Pharmacy violated numerous federal 

record keeping requirements related to 

controlled substances and lacked 

candor. Thus, I conclude that 

Respondent Pharmacy has engaged in 

misconduct which supports the 

revocation of its registration. I therefore 

hold that the Government has 

established a prima facie case that 

Respondent Pharmacy’s continued 

registration ‘‘would be inconsistent with 

the public interest.’’ 21 U.S.C. 823(f). 

IV. Sanction 

Where, as here, the Government has 

met its prima facie burden of showing 

that the respondent’s continued 

registration is inconsistent with the 

public interest, the burden shifts to the 

respondent to show why it can be 

entrusted with the responsibility carried 

by its registration. Garret Howard Smith, 

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

(citing Samuel S. Jackson, 72 FR 23,848, 

23,853 (2007)). DEA cases have 

repeatedly found that when a registrant 

has committed acts inconsistent with 

the public interest, ‘‘the Respondent is 

required not only to accept 

responsibility for [the established] 

misconduct, but also to demonstrate 

what corrective measures [have been] 

undertaken to prevent the reoccurrence 

of similar acts.’’ Holiday CVS, 77 FR at 

62,339 (internal quotations omitted). 

See, also, Hoxie v. Drug Enf’t Admin., 

419 F.3d 477, 483 (6th Cir. 2005); 

Ronald Lynch, M.D., 75 FR 78,745, 

78,749, 78,754 (2010) (holding that 


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respondent’s attempts to minimize 

misconduct undermined acceptance of 

responsibility); Medicine ShoppeJonesborough, 73 FR 364, 387 (2008) 

(noting that the respondent did not 

acknowledge recordkeeping problems, 

let alone more serious violations of 

federal law, and concluding that 

revocation was warranted). 

The issue of trust is necessarily a factdependent determination based on the 

circumstances presented by the 

individual respondent; 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. Jeffrey Stein, M.D., 84 FR 

46,968, 46,972 (2019). A registrant’s 

candor during the investigation and 

hearing is an important factor in 

determining acceptance of 

responsibility and the appropriate 

sanction, Garret Howard Smith, M.D., 83 

FR at 18,910 (collecting cases); as is 

whether the registrant’s acceptance of 

responsibility is unequivocal, Lon F. 

Alexander, M.D., 82 FR 49,704, 49,728 

(2017) (collecting cases). In determining 

whether and to what extent a sanction 

is appropriate, consideration must be 

given to both the egregiousness of the 

offense established by the Government’s 

evidence and the Agency’s interest in 

both specific and general deterrence. 

Wesley Pope, 82 FR 14,944, 14,985 

(2017) (citing Joseph Gaudio, 74 FR 

10,083, 10,095 (2009)); David A. Ruben, 

M.D., 78 FR 38,363, 38,364 (2013). Cf. 

McCarthy v. SEC, 406 F.3d 179, 188–89 

(2d Cir. 2005) (upholding SEC’s express 

adoption of ‘‘deterrence, both specific 

and general as a component in 

analyzing the remedial efficacy of 

sanctions.’’). 

Here, Respondent Pharmacy has 

presented no evidence on the record 

that I could consider as accepting 

responsibility. I have considered the 

written response, which denies any 

misconduct, stating multiple times that 

it ‘‘would be impossible’’ for ‘‘the 

medications [to be] short of the original 

count[s],’’ and asserting that ‘‘we were 

far from deceit when we talked to 

[DEA].’’ RFAAX 3, at 2–3. The written 

response further seems to pass blame for 

the findings of violations against 

Respondent Pharmacy onto the DEA— 

claiming that DEA ‘‘raided the 

pharmacy,’’ on a ‘‘witch hunt waged 

against [Respondent] Pharmacy’’ arising 

from ‘‘hatred toward the owner.’’ Id. at 

2. It is clear from the written response 

that Respondent Pharmacy has not 

accepted responsibility for its actions. 

I have also considered the proposed 

Corrective Action Plan that the 

Government submitted into the record. 

RFAAX 4. The proposed Corrective 

Action Plan does not include any 

acceptance of responsibility; rather it 

proposes policies that essentially mirror 

the requirements already existing in 

law. Id. Even if I were to consider 

remedial measures, in spite of 

Respondent Pharmacy’s complete lack 

of acceptance of responsibility, these 

proposed remedial measures are 

insufficient to convince me to entrust 

Respondent Pharmacy with a 

registration. 21 U.S.C. 824(c)(3); see also 

Melanie Baker, N.P., 86 FR 23,998, 

24,011 (2021) (citing Jones Total Health 

Care Pharmacy, L.L.C., 81 FR 79,188, 

79,202–03 2016). 

Moreover, Respondent Pharmacy’s 

found lack of candor during the 

investigation demonstrates an 

unwillingness to cooperate with this 

agency in future compliance 

inspections. Truthful cooperation with 

agency requests for information ensures 

that agency officials can easily monitor 

and ensure compliance with the CSA 

and help to correct violations. See 

Jeffrey Stein, M.D., 84 FR 46,968, 46,973 

(2019) (finding that a registrant’s 

honesty during law enforcement 

regulations is ‘‘crucial to the Agency’s 

ability to complete its mission of 

preventing diversion within such a large 

regulated population’’). In order to 

entrust Respondent Pharmacy with a 

registration, I need to know that its 

personnel will not repeat their 

dishonest behavior, and in this case, 

Respondent Pharmacy has given me no 

reason to believe that I can trust it with 

a registration. 

In sanction determinations, the 

Agency has historically considered its 

interest in deterring similar acts, both 

with respect to the respondent in a 

particular case and the community of 

registrants. See Joseph Gaudio, M.D., 74 

FR 10,083, 10,095 (2009); Singh, 81 FR 

at 8248. I find that considerations of 

both specific and general deterrence 

weigh in favor of revocation in this case. 

There is simply no evidence that 

Respondent Pharmacy’s egregious 

behavior is not likely to recur in the 

future such that I can entrust it with a 

CSA registration; in other words, the 

factors weigh in favor of revocation as 

a sanction. Accordingly, I shall order 

the sanctions 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 FL4375730 issued to 

Creekbend Community Pharmacy. 

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 Creekbend Community 

Pharmacy to renew or modify this 

registration. This order is effective 

August 27, 2021. 

Anne Milgram, 

Administrator. 

[FR Doc. 2021–16000 Filed 7–27–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

William Ralph Kinkaid, M.D.; Decision 

and Order 

On November 7, 2018, the Assistant 

Administrator, Diversion Control 

Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause to William Ralph Kinkaid, M.D. 

(hereinafter, Respondent), of Johnson 

City, Tennessee. Order to Show Cause 

(hereinafter, OSC), at 1. The OSC 

proposed the denial of Respondent’s 

application for DEA Certificate of 

Registration, Control No. W18085586C, 

because Respondent was ‘‘mandatorily 

excluded . . . from participation in 

Medicare, Medicaid, and all Federal 

health care programs pursuant to 42 

U.S.C. 1320a–7(a)’’ and that such 

exclusion ‘‘warrants denial of 

[Respondent’s] application pursuant to 

21 U.S.C. 824(a)(5).’’ Id. at 1–2 (citing 

Richard Hauser, M.D., 83 FR 26,308 

(2018)). 

Specifically, the OSC alleged that, on 

June 24, 2013, the United States District 

Court for the Eastern District of 

Tennessee (hereinafter, E.D. Tenn.) 

issued a judgment against Respondent 

‘‘after [Respondent] pled guilty to one 

count of ‘Receiving in Interstate 

Commerce a Misbranded Drug with 

Intent to Defraud or Mislead,’ in 

violation of 21 U.S.C. 331(c).’’ Id. at 2 

(citing U.S. v. William Ralph Kinkaid, 

No. 2:12–CR–116 (E.D. Tenn. June 24, 

2013)). The OSC further alleged that 

‘‘based on [Respondent’s] conviction, 

the U.S. Department of Health and 

Human Services, Office of Inspector 

General (‘‘HHS/OIG’’), mandatorily 

excluded [Respondent] from 

participation in Medicare, Medicaid, 

and all Federal health care programs 

pursuant to 42 U.S.C. 1320a–7(a)’’ 

effective June 28, 2013, for a period of 

ten years. Id. 

The OSC notified Respondent 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 


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