Federal Register / Vol. 87, No. 12 / Wednesday, January 19, 2022 / Notices 2905 

3 ‘‘Medicinal Drugs’’ or ‘‘Drugs’’ means ‘‘those 

substances or preparations commonly known as 

‘prescription’ or ‘legend’ drugs which are required 

by federal or state law to be dispensed only on a 

prescription . . . .’’ Fla. Stat. Ann. 465.003(8). 

*A [This footnote has been relocated from RD n.5.] 

At all times prior to and during the hearing, the 

Respondent was represented by multiple, able 

counsel. The Respondent’s (then) counsels raised 

no issue during the proceedings or in the 

Respondent’s closing brief regarding the fairness of 

the proceedings. The day after its closing brief was 

filed, the Respondent sought to discharge its 

lawyers and opted to have itself represented by its 

(non-lawyer) owner. ALJ Ex. 56. Acting as a nonattorney representative (see 21 CFR 1316.50), the 

Respondent’s owner moved to disqualify the 

Government’s expert and to recuse me [the Chief 

ALJ]. ALJ Exs. 57, 58, 61. These motions have been 

disposed of in separate orders issued 

contemporaneously with this recommended 

decision. ALJ Exs. 67, 68. A joint motion to be 

excused from further representation of the 

Respondent (ALJ Ex. 60) filed by his lawyers (at the 

request of the tribunal) was granted for the reasons 

stated therein. ALJ Ex. 62. 

[I agree with the Chief ALJ’s procedural rulings 

in this case, including his dismissal of 

Respondent’s two recusal motions. In these 

motions, Respondent argued that the Chief ALJ 

‘‘den[ied] Respondent [the] right to a fair trial’’ by 

‘‘creat[ing] an atmosphere of prejudice and lack of 

impartiality.’’ ALJ Ex. 57, at 3. Respondent further 

argued that the Chief ALJ ‘‘morphed [the 

Government’s case] into a plausible case’’ by 

‘‘w[earing] the hat of the Government’s lawyer 

during most of the witness examination.’’ Id. at 2. 

Respondent’s motions reference portions of the 

record where the Chief ALJ assisted the 

Government in authenticating documents and 

questioning its witnesses. Although Respondent 

acknowledged that ALJs are permitted to question 

witnesses, Respondent argues that the Chief ALJ 

used his questioning authority to buttress the 

Government’s case and ‘‘patch[ ] up areas where 

there were obvious gaps in the Government’s case,’’ 

while not ‘‘provid[ing] the same helping hand to 

Respondent when Respondent was attempting to 

authenticate documents that Respondent believes 

were critical to its defense. Id. at 5, 10. 

Additionally, Respondent alleged that it was 

inappropriate for the Chief ALJ to ask Respondent’s 

representative, Dr. Howard, whether he agreed with 

certain testimony by Respondent’s expert, because 

it ‘‘placed . . . Dr. Howard in an awkward position 

to have to incriminate his own expert just to 

appease the ALJ.’’ Id. at 26, 30. 

I find that Respondent’s recusal motions are 

without merit. As the Chief ALJ stated in his neutral 

and carefully-reasoned dismissal order, 

Respondent—the proponent of the recusal motion— 

has the burden of demonstrating that the Chief ALJ 

exhibited a ‘‘deep-seated favoritism or antagonism 

that would make fair judgment impossible.’’ Order 

Denying the Respondent’s Recusal Motions, at 6. 

Respondent did not identify any evidence of 

favoritism or antagonism, much less the type of 

deep-seated favoritism or antagonism that would 

make fair judgment impossible. Rather, Respondent 

identified instances where the Chief ALJ was 

exercising his discretionary authority to regulate the 

hearing, by asking clarifying questions of counsel 

and witnesses and issuing evidentiary rulings. See 

Order, at 7 (citing 5 U.S.C. 556(c)(5); 21 CFR 

1316.52(e)). Courts have uniformly held that 

judicial rulings issued during the course of 

litigation rarely constitute evidence of cognizable 

bias. Id. (citing Liteky v. United States, 510 U.S. 

540, 555 (1994), Hamm v. Members of Bd. of 

Regents, 708 F.2d 647, 651 (11th Cir. 1983), Dewey 

C. Mackay, M.D., 75 FR 49,956, 49,958–59 (2010)). 

Additionally, as the Chief ALJ highlighted in his 

dismissal order, the Chief ALJ frequently clarified 

the record for Respondent’s benefit and 

overwhelmingly issued evidentiary rulings in 

Respondent’s favor. Id. at 8–9. Furthermore, 

Respondent’s recusal motions were untimely, 

which is an independent basis for their dismissal. 

Id. at 7, 15–16. 

Beyond the substantive and procedural defects of 

Respondent’s recusal motions, the motions convey 

a contemptuous tone towards the Chief ALJ, which 

supports my decision that Respondent’s registration 

is inconsistent with the public interest. Respondent 

was particularly outraged that the Chief ALJ 

questioned Respondent’s representative about 

whether he agreed with the Respondent’s expert’s 

expressions of hostility towards DEA as a regulator. 

Based on Respondent’s attitude towards DEA and 

the Chief ALJ, I find it unlikely that Respondent 

would modify its behavior and become a lawabiding, cooperative registrant. Certainly, 

Respondent’s focus on repudiating the Chief ALJ 

rather than acknowledging its own misconduct 

shows that it falls far short of the ‘‘true remorse’’ 

that is required when a registrant has committed 

acts that are inconsistent with the public interest. 

Michael S. Moore, M.D., 76 FR 45,867, 45,877 

(2011). 

For the same reasons stated above, I find that 

Respondent’s Exceptions to ALJ’s Denial of 

Respondent’s Motions for Recusal and Request for 

Expedited Ruling on the Order Denying Recusal are 

without merit. ALJ Ex. 69 (dated April 27, 2021).] 

James L. Hooper, 76 FR 71,371–72; 

Sheran Arden Yeates, M.D., 71 FR 

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

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

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

(1988); Frederick Marsh Blanton, 43 FR 

27,617. 

According to Florida statute, ‘‘It is 

unlawful for any person to own, 

operate, maintain, open, establish, 

conduct, or have charge of, either alone 

or with another person or persons, a 

pharmacy: (a) Which is not registered 

under the provisions of this chapter.’’ 

Fla. Stat. Ann. 465.015(1). Further, ‘‘the 

practice of the profession of pharmacy’’ 

definition ‘‘includes compounding, 

dispensing, and consulting concerning 

contents, therapeutic values, and uses of 

any medicinal drug 3 . . . .’’ Fla. Stat. 

Ann. 465.003(13) (West, 2021). 

Here, the undisputed evidence in the 

record is that Applicant currently lacks 

authority to operate a pharmacy in 

Florida. As already discussed, a 

pharmacy must be a licensed to 

dispense a medicinal drug, including a 

controlled substance, in Florida. Thus, 

because Applicant lacks authority to 

practice pharmacy in Florida and, 

therefore, is not authorized to dispense 

controlled substances in Florida, 

Applicant is not eligible to receive a 

DEA registration. Accordingly, I will 

order that Applicant’s application for a 

DEA registration be denied. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

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

823(f), I hereby order that the pending 

application for a Certificate of 

Registration, Control Number 

W16006664A, submitted by TelPharmacy, is denied, as well as any 

other pending application of TelPharmacy for additional registration in 

Florida. This Order is effective February 

18, 2022. 

Anne Milgram, 

Administrator. 

[FR Doc. 2022–00956 Filed 1–18–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 20–08] 

AARRIC, Inc. d/b/a at Cost RX; 

Decision and Order 

On January 3, 2020, a former Acting 

Administrator of the Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause and Immediate Suspension of 

Registration (hereinafter, OSC) to 

AARRIC, Inc. d/b/a AT COST RX 

(hereinafter, Respondent). 

Administrative Law Judge Exhibit 

(hereinafter, ALJ Ex.) 1, (OSC) at 1. The 

OSC/ISO informed Respondent of the 

immediate suspension of its DEA 

Certificate of Registration Number 

FA2125640 (hereinafter, registration or 

COR) and proposed its revocation, the 

denial of any pending applications for 

renewal or modification of such 

registration, and the denial of any 

pending applications for additional DEA 

registrations pursuant to 21 U.S.C. 

824(a)(4) and 823(f), because 

Respondent’s ‘‘continued registration is 

inconsistent with the public interest.’’ 

Id. (citing 21 U.S.C. 824(a)(4) and 

823(f)). 

In response to the OSC, Respondent 

timely requested a hearing before an 

Administrative Law Judge. ALJ Ex. 2. 

The hearing in this matter was 

conducted from November 16–20, 2020, 

at the DEA Hearing Facility in 

Arlington, Virginia, with the parties and 

their witnesses participating through 

video-teleconference.*A On April 7, 

2021, Chief Administrative Law Judge 

John J. Mulrooney, II (hereinafter, Chief 

ALJ) issued his Recommended Rulings, 

Findings of Fact, Conclusions of Law 

and Decision (hereinafter, 

Recommended Decision or RD). On 


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*B I have omitted the RD’s discussion of the 

procedural history to avoid repetition with my 

introduction. 

1 [Footnote relocated, see infra n. *M.] 

2 [Footnote relocated, see supra n.*A.] 

3 [Omitted for brevity.] 

4 In this recommended decision, initials have 

been substituted for the names of the Respondent’s 

customer-patients to preserve their personally 

identifiable information. The Ten Patients include 

Patients JA, EA, SD, LH, DH, DK, JM, ST, JW, and 

CW. 

5ALJ Ex. 38. 

6Multiple incorrect citations set forth in the 

proposed stipulations propounded by the parties 

have been corrected in this RD to reflect the current 

regulatory designation. 

December 15, 2020, the Government and 

Respondent filed exceptions to the 

Recommended Decision (hereinafter, 

Gov Exceptions and Resp Exceptions, 

respectively). Having reviewed the 

entire record, I find Respondent’s 

Exceptions without merit and I adopt 

the ALJ’s Recommended Decision with 

minor modifications, as noted herein. I 

have addressed each of Respondent’s 

Exceptions and I issue my final Order in 

this case following the Recommended 

Decision. 

Recommended Rulings, Findings of 

Fact, Conclusions of Law, and Decision 

of the Administrative Law Judge *B123

After carefully considering the 

testimony elicited at the hearing, the 

admitted exhibits, the arguments of 

counsel, and the record as a whole, I 

have set forth my recommended 

findings of fact and conclusions of law 

below. 

The Allegations 

The Government alleges that the 

Respondent Pharmacy’s COR should be 

revoked because on numerous occasions 

between February 2018 and September 

2019, it repeatedly dispensed 

prescriptions to ten patients 

(collectively, the Ten Patients) 4 without 

addressing or resolving factual indicia 

(i.e., ‘‘red flags’’) of potential drug 

diversion and in contravention of its 

corresponding responsibility to ensure 

the prescriptions were issued for a 

legitimate medical purpose. ALJ Ex. 1 at 

2. 

The Evidence 

The Stipulations 

The parties entered into factual 

stipulations prior to the litigation of this 

matter, which were accepted by the 

tribunal.5 By virtue of those 

stipulations, the following factual 

matters are deemed conclusively 

established in this case: 

1. The Respondent is registered with 

DEA to handle controlled substances in 

Schedules II through V under DEA COR 

No. FA2125640 at 16970 San Carlos 

Boulevard, Suite 110, Fort Myers, 

Florida 33908. 

2. DEA COR No. FA2125640 will 

expire by its own terms on June 30, 

2022. 

3. DEA lists Adderall (amphetamine– 

dextroamphetamine mixture) as a 

Schedule II controlled substance under 

21 CFR 1308.12(d)(1). 

4. DEA lists Ambien (zolpidem 

tartrate) as a Schedule IV controlled 

substance under 21 CFR 1308.14(c)(57).6

5. DEA lists Ativan (lorazepam) as a 

Schedule IV controlled substance under 

21 CFR 1308.14(c)(32). 

6. DEA lists hydromorphone as a 

Schedule II controlled substance under 

21 CFR 1308.12(b)(1)(vii). 

7. DEA lists Klonopin (clonazepam) as 

a Schedule IV controlled substance 

under 21 CFR 1308.14(c)(12). 

8. DEA lists methadone as a Schedule 

II controlled substance under 21 CFR 

1308.12(c)(15). 

9. DEA lists MS Contin (morphine 

sulfate extended release) as a Schedule 

II controlled substance under 21 CFR 

1308.12(b)(1)(ix). 

10. DEA lists Norco (hydrocodone– 

acetaminophen) as a Schedule II 

controlled substance under 21 CFR 

1308.12(b)(1)(vi). 

11. DEA lists oxycodone as a 

Schedule II controlled substance under 

21 CFR 1308.12(b)(1)(xiv). 

12. DEA lists Percocet (oxycodone– 

acetaminophen) as a Schedule II 

controlled substance under 21 CFR 

1308.12(b)(1)(xiv). 

13. DEA lists Restoril (temazepam) as 

a Schedule IV controlled substance 

under 21 CFR 1308.14(c)(53). 

14. DEA lists Soma (carisoprodol) as 

a Schedule IV controlled substance 

under 21 CFR 1308.14(c)(7). 

15. DEA lists Valium (diazepam) as a 

Schedule IV controlled substance under 

21 CFR 1308.14(c)(17). 

16. DEA lists Xanax (alprazolam) as a 

Schedule IV controlled substance under 

21 CFR 1308.14(c)(2). 

17. Between February 19, 2018, and at 

least September 2, 2019, the Respondent 

filled at least 21 prescriptions for 

Patient JA for 90–120 units of 

hydromorphone 8 mg. These 

prescriptions were filled on or about the 

following specific occasions: 

Fill date Drug dispensed Prescription No. 

2/19/2018 ..................... 112 units of hydromorphone 8 mg ............................................................................................ 535081 

3/19/2018 ..................... 112 units of hydromorphone 8 mg ............................................................................................ 535597 

4/16/2018 ..................... 120 units of hydromorphone 8 mg ............................................................................................ 536108 

5/14/2018 ..................... 120 units of hydromorphone 8 mg ............................................................................................ 536635 

6/11/2018 ..................... 120 units of hydromorphone 8 mg ............................................................................................ 537027 

7/10/2018 ..................... 120 units of hydromorphone 8 mg ............................................................................................ 537292 

8/7/2018 ....................... 120 units of hydromorphone 8 mg ............................................................................................ 537539 

9/4/2018 ....................... 120 units of hydromorphone 8 mg ............................................................................................ 537922 

10/2/2018 ..................... 120 units of hydromorphone 8 mg ............................................................................................ 538321 

10/30/2018 ................... 120 units of hydromorphone 8 mg ............................................................................................ 538758 

11/26/2018 ................... 120 units of hydromorphone 8 mg ............................................................................................ 539235 

12/21/2018 ................... 120 units of hydromorphone 8 mg ............................................................................................ 539671 

1/21/2019 ..................... 120 units of hydromorphone 8 mg ............................................................................................ 540097 

2/18/2019 ..................... 120 units of hydromorphone 8 mg ............................................................................................ 540569 

3/18/2019 ..................... 120 units of hydromorphone 8 mg ............................................................................................ 541028 

4/15/2019 ..................... 120 units of hydromorphone 8 mg ............................................................................................ 541503 

5/13/2019 ..................... 105 units of hydromorphone 8 mg ............................................................................................ 541983 

6/10/2019 ..................... 90 units of hydromorphone 8 mg .............................................................................................. 542444 

7/8/2019 ....................... 90 units of hydromorphone 8 mg .............................................................................................. 542892 

8/5/2019 ....................... 90 units of hydromorphone 8 mg .............................................................................................. 543372 

9/2/2019 ....................... 90 units of hydromorphone 8 mg .............................................................................................. 543802 


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18. Patient JA paid cash for all of the 

above-listed prescriptions for controlled 

substances that he filled with the 

Respondent. 

19. Between September 19, 2018, and 

at least September 16, 2019, the 

Respondent filled at least 42 

prescriptions for Patient EA for 28 units 

of MS Contin 30 mg, 120 units of 

oxycodone 30 mg, and 30 units of Xanax 

1 mg. These prescriptions were filled on 

or about the following specific 

occasions: 

Fill date Drug(s) dispensed Prescription Nos. 

9/19/2018 .......... 28 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 538184–538186

10/17/2018 ........ 28 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 538570–538572 

11/15/2018 ........ 28 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 539086–539088 

12/13/2018 ........ 28 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 539524–539525; 539527 

1/9/2019 ............ 28 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 539931–539932; 539935 

2/5/2019 ............ 28 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 540377–540378; 540381 

3/4/2019 ............ 28 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 540812–540814 

4/1/2019 ............ 28 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 541310–541311; 541314 

4/24/2019 .......... 28 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 541726–541728

5/22/2019 .......... 28 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 542191; 542193–542194 

6/25/2019 .......... 28 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 542751–542753

7/24/2019 .......... 28 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 543220–543221; 543223 

8/20/2019 .......... 28 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 543644–543646

9/16/2019 .......... 28 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 544051–544053

20. Patient EA paid cash for all of the 

above-listed prescriptions for controlled 

substances that he filled with the 

Respondent. 

21. Between February 20, 2018, and at 

least September 4, 2019, the Respondent 

filled at least 56 prescriptions for 

Patient SD for 21–30 units of MS Contin 

30 mg, 60 units of MS Contin 60 mg, 

92–135 units of oxycodone 30 mg, 30 

units of Xanax 0.5 mg, and 30 units of 

Xanax 1 mg. These prescriptions were 

filled on or about the following specific 

occasions: 

Fill date Drug(s) dispensed Prescription Nos. 

2/20/2018 .......... 60 units of MS Contin 60 mg; 135 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 535123–535125

3/21/2018 .......... 60 units of MS Contin 60 mg; 135 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 535637–535638; 535643 

4/17/2018 .......... 60 units of MS Contin 60 mg; 135 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 536133–536135

5/15/2018 .......... 30 units of Xanax 1 mg ..................................................................................................................... 536670 

8/9/2018 ............ 30 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 0.5 mg ....... 537591–537592; 537606 

9/7/2018 ............ 30 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 0.5 mg ....... 538017–538019

10/4/2018 .......... 30 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 538376–538377; 538379 

10/31/2018 ........ 30 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 538811–538813 

11/7/2018 .......... 92 units of oxycodone 30 mg ............................................................................................................ 538974 

11/27/2018 ........ 30 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 539262; 539264–539265 

12/24/2018 ........ 30 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 539680–539682 

1/22/2019 .......... 30 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 540132–540134

2/19/2019 .......... 30 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 540597–540598; 540600 

3/18/2019 .......... 30 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 541054; 541056–541057 

4/15/2019 .......... 30 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 541524; 541526–541527 

5/13/2019 .......... 30 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 542001–542003

6/11/2019 .......... 30 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 542498–542500

7/8/2019 ............ 30 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 542917–542919 

8/6/2019 ............ 30 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg .......... 543410–543412 

9/4/2019 ............ 30 units of MS Contin 30 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 0.5 mg ....... 543858–543860

22. Patient SD paid cash for all of the 

above-listed prescriptions for controlled 

substances that he filled with the 

Respondent on or after April 16, 2018. 

23. Between March 6, 2018, and at 

least September 11, 2019, the 

Respondent filled at least 34 

prescriptions for Patient LH for 28–60 

units of MS Contin 30 mg and 120–140 

units of oxycodone 30 mg. These 

prescriptions were filled on or about the 

following specific occasions: 

Fill date Drug(s) dispensed Prescription Nos. 

3/6/2018 ............ 60 units of MS Contin 30 mg; and 140 units of oxycodone 30 mg .................................................. 535451–535452 

4/3/2018 ............ 60 units of MS Contin 30 mg; and 140 units of oxycodone 30 mg .................................................. 535887–535888 

5/8/2018 ............ 60 units of MS Contin 30 mg; and 140 units of oxycodone 30 mg .................................................. 536542–536543 

8/28/2018 .......... 28 units of MS Contin 30 mg; and 120 units of oxycodone 30 mg .................................................. 537859–537860 

10/10/2018 ........ 28 units of MS Contin 30 mg; and 120 units of oxycodone 30 mg .................................................. 538473–538474 

11/7/2018 .......... 28 units of MS Contin 30 mg; and 120 units of oxycodone 30 mg .................................................. 538955–538956 

12/5/2018 .......... 28 units of MS Contin 30 mg; and 120 units of oxycodone 30 mg .................................................. 539397–539398 

1/3/2019 ............ 28 units of MS Contin 30 mg; and 120 units of oxycodone 30 mg .................................................. 539816–539817 

1/30/2019 .......... 28 units of MS Contin 30 mg; and 120 units of oxycodone 30 mg .................................................. 540243–540244 

2/27/2019 .......... 28 units of MS Contin 30 mg; and 120 units of oxycodone 30 mg .................................................. 540720–540721 

3/27/2019 .......... 28 units of MS Contin 30 mg; and 120 units of oxycodone 30 mg .................................................. 541246–541247 

4/24/2019 .......... 28 units of MS Contin 30 mg; and 120 units of oxycodone 30 mg .................................................. 541706–541707 


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Fill date Drug(s) dispensed Prescription Nos. 

5/22/2019 .......... 28 units of MS Contin 30 mg; and 120 units of oxycodone 30 mg .................................................. 542196–542197 

6/19/2019 .......... 28 units of MS Contin 30 mg; and 120 units of oxycodone 30 mg .................................................. 542646–542647 

7/17/2019 .......... 28 units of MS Contin 30 mg; and 120 units of oxycodone 30 mg .................................................. 543112–543113 

8/14/2019 .......... 28 units of MS Contin 30 mg; and 120 units of oxycodone 30 mg .................................................. 543557–543558 

9/11/2019 .......... 28 units of MS Contin 30 mg; and 120 units of oxycodone 30 mg .................................................. 543979; 543982 

24. Patient LH paid cash for all of the 

above-listed prescriptions for controlled 

substances that he filled with the 

Respondent. 

25. Between March 8, 2018, and at 

least September 11, 2019, the 

Respondent filled at least 59 

prescriptions for Patient DH for 60 units 

of MS Contin 30 mg, 120 units of 

hydromorphone 8 mg, and 60 units of 

Xanax 2 mg. These prescriptions were 

filled on or about the following specific 

occasions: 

Fill date Drug(s) dispensed Prescription Nos. 

3/8/2018 ............ 60 units of MS Contin 30 mg ............................................................................................................ 535478 

3/13/2018 .......... 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 535525–535526 

4/10/2018 .......... 60 units of MS Contin 30 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg .... 536047; 536050; 536053 

5/8/2018 ............ 60 units of MS Contin 30 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg .... 536566–536567; 536571 

6/5/2018 ............ 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 536993–536994 

6/15/2018 .......... 60 units of MS Contin 30 mg ............................................................................................................ 537081 

7/4/2018 ............ 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 537254; 537257 

7/13/2018 .......... 60 units of MS Contin 30 mg ............................................................................................................ 537339 

7/31/2018 .......... 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 537486; 537489 

8/28/2018 .......... 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 537853; 537857 

8/31/2018 .......... 60 units of MS Contin 30 mg ............................................................................................................ 537906 

9/25/2018 .......... 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 538255; 538258 

10/5/2018 .......... 60 units of MS Contin 30 mg ............................................................................................................ 538386 

10/23/2018 ........ 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 538663; 538666 

11/2/2018 .......... 60 units of MS Contin 30 mg ............................................................................................................ 538879 

11/20/2018 ........ 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 539162; 539165 

12/3/2018 .......... 60 units of MS Contin 30 mg ............................................................................................................ 539350 

12/18/2018 ........ 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 539596; 539599 

12/31/2018 ........ 60 units of MS Contin 30 mg ............................................................................................................ 539743 

1/15/2019 .......... 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 540031; 540035 

1/28/2019 .......... 60 units of MS Contin 30 mg ............................................................................................................ 540191 

2/12/2019 .......... 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 540467; 540473 

2/25/2019 .......... 60 units of MS Contin 30 mg ............................................................................................................ 540670 

3/11/2019 .......... 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 540938–540939 

3/25/2019 .......... 60 units of MS Contin 30 mg ............................................................................................................ 541179 

4/8/2019 ............ 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 541428–541429 

4/22/2019 .......... 60 units of MS Contin 30 mg ............................................................................................................ 541661 

5/6/2019 ............ 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 541914–541915 

5/20/2019 .......... 60 units of MS Contin 30 mg ............................................................................................................ 542133 

6/3/2019 ............ 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 542349; 542358 

6/17/2019 .......... 60 units of MS Contin 30 mg ............................................................................................................ 542587 

7/1/2019 ............ 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 542839–542840 

7/15/2019 .......... 60 units of MS Contin 30 mg ............................................................................................................ 543059 

7/29/2019 .......... 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 543275–543276 

8/12/2019 .......... 60 units of MS Contin 30 mg ............................................................................................................ 543489 

8/26/2019 .......... 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 543703–543704 

9/11/2019 .......... 60 units of MS Contin 30 mg ............................................................................................................ 543975 

26. Patient DH paid cash for all of the 

above-listed prescriptions for controlled 

substances that he filled with the 

Respondent. 

27. Between February 16, 2018, and at 

least September 12, 2019, the 

Respondent filled at least 59 

prescriptions for Patient DK for 60 units 

of MS Contin 30 mg, 60 units of MS 

Contin 60 mg, 90–120 units of 

hydromorphone 8 mg, 90 units of Xanax 

0.5 mg, 60 units of Xanax 1 mg, and 35– 

60 units of Soma 350 mg. These 

prescriptions were filled on or about the 

following specific occasions: 

Fill date Drug(s) dispensed Prescription Nos. 

2/16/2018 .......... 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; 60 units of Xanax 1 mg; and 

60 units of Soma 350 mg.

535071–535074 

3/14/2018 .......... 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 35 units of Soma 350 mg 535552; 535557–535558 

3/16/2018 .......... 60 units of Xanax 1 mg ..................................................................................................................... 535590 

5/16/2018 .......... 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 1 mg .... 536704; 536707–536708 

5/18/2018 .......... 60 units of Soma 350 mg .................................................................................................................. 536732 

6/13/2018 .......... 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 60 units of Soma 350 mg 537054–537056 

6/20/2018 .......... 60 units of Xanax 1 mg ..................................................................................................................... 537145 


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Fill date Drug(s) dispensed Prescription Nos. 

7/11/2018 .......... 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 1 mg .... 537307–537309 

8/8/2018 ............ 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 1 mg .... 537565–537566; 537568 

9/18/2018 .......... 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 1 mg .... 538219–538221 

10/17/2018 ........ 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 1 mg .... 538548–538550 

11/16/2018 ........ 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 1 mg .... 539113; 539115–539116 

12/14/2018 ........ 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 1 mg .... 539557–539558; 539560 

1/11/2019 .......... 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 1 mg .... 539990–539991; 539993 

2/13/2019 .......... 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 1 mg .... 540509–540510; 540512 

3/12/2019 .......... 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 1 mg .... 540971; 540977–540978 

4/11/2019 .......... 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 1 mg .... 541496; 541498; 541500 

5/9/2019 ............ 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 1 mg .... 541975–541977 

6/6/2019 ............ 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 1 mg .... 542430–542431; 542433 

7/5/2019 ............ 60 units of MS Contin 60 mg; 120 units of hydromorphone 8 mg; and 60 units of Xanax 1 mg .... 542882–542883; 542889 

8/13/2019 .......... 60 units of MS Contin 30 mg ............................................................................................................ 543528 

8/30/2019 .......... 90 units of hydromorphone 8 mg; and 90 units of Xanax 0.5 mg .................................................... 543798; 543800 

9/12/2019 .......... 60 units of MS Contin 30 mg ............................................................................................................ 544003 

28. Patient DK paid cash for all of the 

above-listed prescriptions for controlled 

substances that she filled with the 

Respondent. 

29. Between February 28, 2018, and at 

least September 17, 2019, the 

Respondent filled at least 78 

prescriptions for Patient JM for 60 units 

of MS Contin 30 mg, 120 units of 

hydromorphone 8 mg, 60 units of 

Restoril 15 mg, 30 units of Restoril 30 

mg, and 60 units of Xanax 2 mg. These 

prescriptions were filled on or about the 

following specific occasions: 

Fill date Drug(s) dispensed Prescription Nos. 

2/28/2018 .......... 30 units of Restoril 30 mg; and 60 units of Xanax 2 mg .................................................................. 535267; 535269 

3/5/2018 ............ 120 units of hydromorphone 8 mg .................................................................................................... 535393 

3/9/2018 ............ 60 units of MS Contin 30 mg ............................................................................................................ 535492 

3/28/2018 .......... 30 units of Restoril 30 mg; and 60 units of Xanax 2 mg .................................................................. 535799–535800 

4/2/2018 ............ 120 units of hydromorphone 8 mg .................................................................................................... 535842 

4/9/2018 ............ 60 units of MS Contin 30 mg ............................................................................................................ 536038 

5/1/2018 ............ 120 units of hydromorphone 8 mg; 30 units of Restoril 30 mg; and 60 units of Xanax 2 mg ......... 536422; 536424–536425 

5/8/2018 ............ 60 units of MS Contin 30 mg ............................................................................................................ 536574 

5/29/2018 .......... 120 units of hydromorphone 8 mg; 30 units of Restoril 30 mg; and 60 units of Xanax 2 mg ......... 536909–536911 

6/4/2018 ............ 60 units of MS Contin 30 mg ............................................................................................................ 536967 

6/26/2018 .......... 120 units of hydromorphone 8 mg; 30 units of Restoril 30 mg; and 60 units of Xanax 2 mg ......... 537182–537183; 537189 

7/5/2018 ............ 60 units of MS Contin 30 mg ............................................................................................................ 537266 

7/24/2018 .......... 120 units of hydromorphone 8 mg; 30 units of Restoril 30 mg; and 60 units of Xanax 2 mg ......... 537451; 537452; 537455 

8/1/2018 ............ 60 units of MS Contin 30 mg ............................................................................................................ 537508 

8/21/2018 .......... 120 units of hydromorphone 8 mg; 30 units of Restoril 30 mg; and 60 units of Xanax 2 mg ......... 537773; 537778–537779 

8/31/2018 .......... 60 units of MS Contin 30 mg ............................................................................................................ 537909 

9/18/2018 .......... 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 538160; 538162 

9/24/2018 .......... 30 units of Restoril 30 mg ................................................................................................................. 538235 

9/28/2018 .......... 60 units of MS Contin 30 mg ............................................................................................................ 538302 

10/17/2018 ........ 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 538541; 538543 

10/26/2018 ........ 60 units of MS Contin 30 mg; and 30 units of Restoril 30 mg ......................................................... 538728; 538730 

11/13/2018 ........ 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 539024; 539026 

11/26/2018 ........ 60 units of MS Contin 30 mg; and 30 units of Restoril 30 mg ......................................................... 539245; 539247 

1/9/2019 ............ 60 units of MS Contin 30 mg; 120 units of hydromorphone 8 mg; 30 units of Restoril 30 mg; and 

60 units of Xanax 2 mg.

539924–539925; 539927– 

539928 

2/6/2019 ............ 60 units of MS Contin 30 mg; 120 units of hydromorphone 8 mg; 30 units of Restoril 30 mg; and 

60 units of Xanax 2 mg.

540415; 540417; 540419– 

540420 

3/7/2019 ............ 60 units of MS Contin 30 mg; 120 units of hydromorphone 8 mg; 60 units of Restoril 15 mg; and 

60 units of Xanax 2 mg.

540900–540903 

4/3/2019 ............ 60 units of MS Contin 30 mg; 120 units of hydromorphone 8 mg; 60 units of Restoril 15 mg; and 

60 units of Xanax 2 mg.

541355–541358 

4/30/2019 .......... 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 541815–541816 

5/3/2019 ............ 60 units of MS Contin 30 mg ............................................................................................................ 541878 

5/28/2019 .......... 120 units of hydromorphone 8 mg; 30 units of Restoril 30 mg; and 60 units of Xanax 2 mg ......... 542248–542249; 542252 

5/30/2019 .......... 60 units of MS Contin 30 mg ............................................................................................................ 542315 

6/25/2019 .......... 120 units of hydromorphone 8 mg; and 60 units of Xanax 2 mg ..................................................... 542726; 542729 

6/27/2019 .......... 60 units of MS Contin 30 mg ............................................................................................................ 542801 

7/23/2019 .......... 120 units of hydromorphone 8 mg; 30 units of Restoril 30 mg; and 60 units of Xanax 2 mg ......... 543189–543190; 543194 

7/25/2019 .......... 60 units of MS Contin 30 mg ............................................................................................................ 543238 

8/20/2019 .......... 120 units of hydromorphone 8 mg; 30 units of Restoril 30 mg; and 60 units of Xanax 2 mg ......... 543628–543630 

8/23/2019 .......... 60 units of MS Contin 30 mg ............................................................................................................ 543696 

9/17/2019 .......... 120 units of hydromorphone 8 mg; 30 units of Restoril 30 mg; and 60 units of Xanax 2 mg ......... 544074–544076 


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30. Patient JM paid cash for all of the 

above-listed prescriptions for controlled 

substances that she filled with the 

Respondent. 

31. Between March 7, 2018, and at 

least August 21, 2019, the Respondent 

filled at least 40 prescriptions for 

Patient ST for 60 units of MS Contin 60 

mg and 150 units of oxycodone 30 mg. 

These prescriptions were filled on or 

about the following specific occasions: 

Fill date Drug(s) dispensed Prescription Nos. 

3/7/2018 ............ 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 535465–535466 

4/4/2018 ............ 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 535928–535929 

5/2/2018 ............ 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 536448–536449 

5/30/2018 .......... 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 536925; 536934 

6/27/2018 .......... 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 537209–537210 

7/25/2018 .......... 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 537471–537472 

8/22/2018 .......... 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 537781–537782 

9/19/2018 .......... 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 538182–538183 

10/17/2018 ........ 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 538555–538556 

11/14/2018 ........ 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 539062–539063 

12/12/2018 ........ 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 539505–539506 

1/9/2019 ............ 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 539913–539914 

2/6/2019 ............ 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 540400–540401 

3/7/2019 ............ 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 540894–540895 

4/3/2019 ............ 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 541363–541364 

5/1/2019 ............ 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 541831–541832 

5/29/2019 .......... 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 542282–542283 

6/26/2019 .......... 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 542762–542763 

7/24/2019 .......... 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 543217–543218 

8/21/2019 .......... 60 units of MS Contin 60 mg; and 150 units of oxycodone 30 mg .................................................. 543650–543651 

32. Patient ST paid cash for all of the 

above-listed prescriptions for controlled 

substances that he filled with the 

Respondent on or after April 4, 2018. 

33. Between April 19, 2018, and at 

least May 2, 2019, the Respondent filled 

at least 30 prescriptions for Patient JW 

for 28–90 units of methadone 10 mg, 

112–120 units of oxycodone 30 mg, and 

30 units of Xanax 1 mg. These 

prescriptions were filled on or about the 

following specific occasions: 

Fill date Drug(s) dispensed Prescription Nos. 

4/19/2018 .......... 90 units of methadone 10 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg ......... 536190–536191; 536194 

5/23/2018 .......... 90 units of methadone 10 mg; 120 units of oxycodone 30 mg; and 30 units of Xanax 1 mg ......... 536860–536862 

8/29/2018 .......... 28 units of methadone 10 mg; 112 units of oxycodone 30 mg; and 30 units of Xanax 1 mg ......... 537877–537878; 537881 

11/12/2018 ........ 28 units of methadone 10 mg; 112 units of oxycodone 30 mg; and 30 units of Xanax 1 mg ......... 539000–539002 

12/11/2018 ........ 28 units of methadone 10 mg; 112 units of oxycodone 30 mg; and 30 units of Xanax 1 mg ......... 539482–539484 

1/8/2019 ............ 28 units of methadone 10 mg; 112 units of oxycodone 30 mg; and 30 units of Xanax 1 mg ......... 539875; 539877–539878 

2/6/2019 ............ 28 units of methadone 10 mg; 112 units of oxycodone 30 mg; and 30 units of Xanax 1 mg ......... 540394; 540397–540398 

3/7/2019 ............ 28 units of methadone 10 mg; 112 units of oxycodone 30 mg; and 30 units of Xanax 1 mg ......... 540886–540888

4/3/2019 ............ 28 units of methadone 10 mg; 112 units of oxycodone 30 mg; and 30 units of Xanax 1 mg ......... 541369–541370; 541374 

5/2/2019 ............ 28 units of methadone 10 mg; 112 units of oxycodone 30 mg; and 30 units of Xanax 1 mg ......... 541863–541865

34. Patient JW paid cash for all of the 

above-listed prescriptions for controlled 

substances that she filled with the 

Respondent. 

35. Between February 26, 2018, and at 

least August 28, 2019, the Respondent 

filled at least 33 prescriptions for 

Patient CW for 30 units of methadone 5 

mg, 30–60 units of methadone 10 mg, 

90–120 units of hydromorphone 8 mg, 

30 units of Xanax 0.5 mg, 30 units of 

Xanax 1 mg, and 90 units of Xanax 2 

mg. These prescriptions were filled on 

or about the following specific 

occasions: 

Fill date Drug(s) dispensed Prescription Nos. 

2/26/2018 .......... 90 units of hydromorphone 8 mg ...................................................................................................... 535206 

3/26/2018 .......... 90 units of hydromorphone 8 mg ...................................................................................................... 535720 

4/23/2018 .......... 90 units of hydromorphone 8 mg ...................................................................................................... 536247 

5/21/2018 .......... 90 units of hydromorphone 8 mg ...................................................................................................... 536776 

7/24/2018 .......... 60 units of methadone 10 mg; 120 units of hydromorphone 8 mg; and 30 units of Xanax 1 mg ... 537446–537448 

8/24/2018 .......... 30 units of methadone 5 mg ............................................................................................................. 537818 

9/25/2018 .......... 30 units of methadone 10 mg; 120 units of hydromorphone 8 mg; and 90 units of Xanax 2 mg ... 538259; 538261; 538266 

10/23/2018 ........ 30 units of methadone 10 mg; and 120 units of hydromorphone 8 mg ........................................... 538675–538676 

10/24/2018 ........ 30 units of Xanax 1 mg ..................................................................................................................... 538714 

11/19/2018 ........ 30 units of methadone 10 mg; and 120 units of hydromorphone 8 mg ........................................... 539145–539146 

11/20/2018 ........ 30 units of Xanax 0.5 mg .................................................................................................................. 539154 

12/17/2018 ........ 30 units of methadone 10 mg; and 120 units of hydromorphone 8 mg ........................................... 539591–539592 

1/15/2019 .......... 30 units of methadone 5 mg; and 120 units of hydromorphone 8 mg ............................................. 540015–540016 

2/19/2019 .......... 120 units of hydromorphone 8 mg; and 30 units of Xanax 1 mg ..................................................... 540583; 540585 

3/19/2019 .......... 120 units of hydromorphone 8 mg; and 30 units of Xanax 1 mg ..................................................... 541065; 541069 

4/16/2019 .......... 120 units of hydromorphone 8 mg; and 30 units of Xanax 1 mg ..................................................... 541548–541549 


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*C Throughout the Chief ALJ’s description of both 

the Government’s Case and the Respondent’s Case, 

I have made some minor adjustments to the 

wording where noted for brevity and for clarity and 

to reflect more of my style. I agree with the Chief 

ALJ on the astute points that he made and I have 

left in the content. 

7 Gov’t Ex. 17. 

8 Dr. Schossow testified that she has practiced as 

a clinical pharmacist and a retail pharmacist. Tr. 

145. In her words, ‘‘a retail pharmacist does most 

of the actual dispensing of the medications into the 

bottles, versus a clinical pharmacist is more 

involved with the patient and the doctor, working 

more closely with them, usually offering 

recommendations on managing the patient.’’ Id. The 

witness testified that she practiced retail pharmacy 

for about twelve years. Id. 

9 Gov’t Ex. 17. 

10The witness testified that the Florida 

requirement for continuing education is limited to 

one hour every two years. Tr. 197. 

11This portion of the witness’s testimony was 

objected to as irrelevant by the Respondent’s 

counsel, and the tribunal subsequently sustained 

the objection. Thus, while no part of this statement 

will be considered to the detriment of the 

Respondent, it does present some potential insight 

into the mindset of the Government’s expert. Its 

consideration is limited to that narrow point. 

12 Dr. Schossow testified that she has been 

compensated for her professional work as an expert, 

including by DEA in this case. Tr. 530. She also 

testified that although thus far her expert opinion 

has been exclusively sought by DEA, she would be 

willing to ‘‘give [her] opinion to anybody who asks 

[her] regarding pharmacy.’’ Tr. 162–63. 

13Tr. 149. 

Fill date Drug(s) dispensed Prescription Nos. 

6/4/2019 ............ 120 units of hydromorphone 8 mg; and 30 units of Xanax 1 mg ..................................................... 542374–542375 

7/31/2019 .......... 120 units of hydromorphone 8 mg; and 30 units of Xanax 1 mg ..................................................... 543329–543330 

8/28/2019 .......... 120 units of hydromorphone 8 mg; and 30 units of Xanax 1 mg ..................................................... 543773–543774 

36. Patient CW paid cash for all of the 

above-listed prescriptions for controlled 

substances that she filled with the 

Respondent. 

The Government’s Case *C

In addition to its reliance on the 

agreed factual stipulations reached by 

the parties in this case, the Government 

presented its case through the testimony 

of a DEA Diversion Investigator and an 

expert pharmacy witness. 

Diversion Investigator 

The Government presented the 

testimony of a DEA Diversion 

Investigator (DI). DI testified that, as of 

the date of the hearing, he has been a 

DI for approximately three years and is 

currently stationed at the Miami field 

office. Tr. 19. The investigation that 

culminated in the present 

administrative charges was initiated by 

DI’s predecessor, DI 2. Tr. 22. Upon DI 

2’s retirement from DEA, DI assumed 

responsibility as the lead DEA 

investigator on the case and inherited 

both open and closed evidence requests, 

as well as the balance of the 

investigative case file. Tr. 22–23. 

According to DI, the Respondent 

became the focus of DEA’s attention 

after an on-site inspection by DEA in 

2015. Tr. 24. DI’s testimony was also 

used to authenticate a number of 

Government Exhibits, consisting of 

documents obtained during the course 

of the investigation. Tr. 31, 35, 38, 40– 

41, 46, 48–49, 62, 65, 67, 76, 79–80, 

109–10, 364. 

DI presented as an objective regulator 

and investigator with no discernable 

motive to fabricate or exaggerate. As a 

successor investigator, he demonstrated 

candor in teasing out which aspects of 

the investigation were initiated/ 

controlled by him, and which aspects 

were inherited. Where he was unsure of 

an answer, he presented a good-faith 

effort but made no attempt to supply a 

convenient contrivance. The testimony 

of this witness, viewed in toto, was 

sufficiently detailed, plausible, and 

internally consistent to be afforded full 

credibility in this case. 

Dr. Tracey Schossow, Pharm.D. 

The Government presented the expert 

testimony of Dr. Tracey Schossow. Dr. 

Schossow’s curriculum vitae (CV) 7

reflects that she received a Doctorate in 

Pharmacy in 2001, has practiced,8

managed, consulted, trained, and taught 

pharmacy for twenty-six years in a 

variety of settings, and even authored 

the pharmacy portion of a manual for a 

hospice company. Tr. 135, 155; Gov’t 

Ex. 17. In fact, the witness testified that 

her introduction to the pharmacy 

profession commenced with work as a 

pharmacy technician in her father’s 

independent pharmacy back in 1982. Tr. 

136. 

In the midst of a largely uneventful 

presentation, there arose a bizarre twist 

of events that bears special mention. 

During a cross-examination conducted 

by the Respondent’s (then) counsel, Dr. 

Schossow [testified] that she was 

familiar with the composition of the 

Florida Board of Pharmacy, and 

volunteered that ‘‘It’s made up of 

pharmacists. I sat on the Board one time 

so—a long time ago.’’ Tr. 455. Since 

neither Dr. Schossow’s CV,9 nor her 

direct testimony regarding her 

qualifications, reflected past 

employment as a Board member, [this 

testimony was unexpected. On cross 

examination, Respondent’s counsel 

followed up on this issue with Dr. 

Schossow, and they had the following 

exchange: 

Q: I understood you to say that you sat on 

the Board of Pharmacy for a period of time? 

Is that right? 

A: When I first graduated from pharmacy 

school, yes. I was—this was a long time ago. 

I don’t know if it was—I don’t remember the 

position, exactly. It wasn’t, like,—I wasn’t the 

head of the Board, or anything like that. But 

I did sit on the Board in the meetings. 

Q: Okay. And did you vote and participate 

in the process? 

A: I participated in the process, but I didn’t 

have any voting—I didn’t do any voting. 

Q: Okay. So, what you’re talking about is, 

maybe, internship-type position with the 

board of pharmacy? 

A: I don’t recall the exact title of it. It was 

not an intern position. I was a licensed 

pharmacist at the time. 

Q: All right. And so, this was, when? After 

you received your initial degree as a 

registered pharmacist, or during your Pharm 

D program? 

A: No, it was after I received my initial 

pharmacy degree back in ’94. 

Tr. 546–47. Dr. Schossow then 

confirmed that she ‘‘wasn’t sitting on 

the board’’ and ‘‘didn’t have a title like 

that,’’ but she did participate. Id. at 547. 

She continued, ‘‘It was a long time ago, 

so I do not recall the official, whatever 

I was doing at that time.’’ Id. As 

discussed in more detail below, this 

testimony was inconsistent and 

confusing. 

Dr. Schossow also testified that she 

could not recall particular sources that 

she reviewed prior to her testimony in 

this case, but stated that she is 

constantly reviewing a variety of 

information from legal sources, federal 

guidelines, as well as clinical data and 

studies to stay current on the applicable 

standard of care for Florida 

pharmacists.10 Tr. 152–53, 163; see also 

id. at 193. Dr. Schossow also 

volunteered that she ‘‘also had a lot of 

patients in the community arrested for 

opioid and other controlled substance 

fraud and abuse.’’ 11 Tr. 137. The 

witness testified that she has also served 

as a pharmacy expert reviewer in federal 

agency cases involving controlled 

substances 12 and has been recognized 

as an expert witness on multiple 

occasions in administrative enforcement 

cases. Tr. 145–47. Dr. Schossow was 

tendered 13 and, over the Respondent’s 


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14Throughout her testimony, the witness would 

refer to various Florida statutes that, according to 

her, inform her opinion on the standard of care for 

a Florida pharmacist. In evaluating the role of an 

expert witness in the pharmacy context, the Agency 

has held that a pharmacy expert is ‘‘not [expected 

to be] an expert in the details of state law, but she 

is required as a pharmacist to understand what 

conduct is outside of the usual course of 

professional practice in her state, whether that is 

derived from state law, mandatory training, 

standards of care or otherwise.’’ Suntree Pharmacy, 

85 FR 73,753, 73,772 (2020). 

15 During her testimony, the witness used the 

term ‘‘DUR’’ interchangeably to mean the process of 

a drug review, as well as for a finding made during 

the review that would warrant further review (i.e., 

a red flag); this was confusing and unhelpful. See, 

e.g., Tr. 187–88. 

16 It is Dr. Schossow’s view that a diversion red 

flag may only be resolved by a pharmacist, never 

a pharmacy technician. Tr. 200. 

17Tr. 446. 

18Tr. 198. 

19Patients JA, EA, SD, LH, DH, DK, JM, ST, JW, 

and CW. 

20 Dr. Schossow identified combinations of 

opioids and benzodiazepines that, when taken 

together, can potentially result in a dangerous 

suppression of the central nervous system. Tr. 204. 

21 Dr. Schossow testified that her opinion would 

not be altered by a brief temporal break such as two 

weeks between the in-conflict medications. Tr. 318. 22 Dr. Schossow testified that her opinion was not 

altered by the fact that the prescriptions in conflict 

were not dispensed on the same day. Tr. 324. 23 Dr. Schossow testified that her opinion was not 

altered by the fact that the prescriptions in conflict 

were dispensed several days apart. Tr. 338. 24E–FORCSE is the prescription drug monitoring 

program (PDMP or PMP) maintained by the State 

of Florida. 25The Government’s expert also referenced 

guidelines (CDC Guidelines) issued on March 18, 

2016 by the Centers for Disease Control and 

Prevention (CDC) regarding morphine equivalent 

dosages (MMEs). Tr. 205–06. The CDC Guidelines 

were the subject of official notice during the 

proceedings. ALJ Ex. 39. While the CDC Guidelines 

were the subject of some level of pre-hearing notice 

by the Government, ALJ Ex. 4 at 23, there was no 

specific notice that an MME at any particular level, 

standing on its own, constitutes a red flag requiring 

action by a pharmacy registrant. During her 

testimony, Dr. Schossow accepted the proposition 

that the CDC Guidelines were issued primarily to 

guide prescribers, not pharmacies. Tr. 503–04. 

26 During the hearing, Proposed Government 

Exhibit 16 was initially offered in the form of a 

compact disc and admitted with the condition that 

the Government provide a hard-copy version of the 

subset of pages that it seeks to rely upon. ALJ Ex. 

44. After the hearing, the Government discovered 

that the relevant information within Proposed 

Government Exhibit 16 was also contained within 

Government Exhibit 32, and subsequently withdrew 

Proposed Government Exhibit 16. ALJ Ex. 47. 

27Although the Respondent pharmacy’s notes did 

reflect that its personnel conducted a conversation 

with the prescriber, the Government’s expert held 

the view that the documentation was so lacking in 

detail that the applicable standard was not met. Tr. 

387–95. Dr. Schossow was steadfast in her opinion 

that the level of documentation was wanting, but 

was unable or unwilling to specify any sort of a 

generic standard as to what the level of 

documentation needs to be to pass muster. Id. 

objection, was accepted as an expert 

witness in the standard of care for 

Florida pharmacists and pharmacy 

practice in the State of Florida. Tr. 166– 

67. 

According to Dr. Schossow, the 

applicable standard of care for 

dispensing controlled substances in 

Florida requires a pharmacist to 

evaluate every prescription presented by 

a patient.14 Tr. 168–69. Dr. Schossow 

encapsulated her view of applicable 

statutes governing state corresponding 

responsibility in Florida as follows: 

[T]he responsibility of a [Florida] 

pharmacist is to ensure the safety and 

efficacy of the therapy for that person and 

also to protect that person in regards to safety 

for the patient and the community. It’s very 

clear. 

Tr. 171. Less helpfully, at another point 

in her testimony, the witness defined 

the applicable standard of care as 

‘‘[w]hat usually a normal pharmacist 

would do in a pharmacy or how they 

would practice the profession of 

pharmacy.’’ Tr. 181; see also id. at 336. 

According to the Government’s 

expert, in evaluating a prescription, a 

Florida pharmacist is required to 

perform a drug utilization review 

(DUR),15 which is a process by which a 

pharmacist analyzes a prescription to 

check for red flags signaling a potential 

diversion issue, and to ‘‘assure that the 

prescription is for a legitimate medical 

purpose.’’ Tr. 169; see id. at 189–90. Dr. 

Schossow defined a red flag as 

‘‘something on the prescription that 

alerts the pharmacist that the 

prescription may be being diverted or 

abused and that the pharmacist must do 

their due diligence to determine 

whether that red flag can be cleared or 

not.’’ Tr. 189–90. When a pharmacist 16

is faced with a red flag, the red flag must 

be addressed and documented. Tr. 189– 

90, 198. Documented findings can be 

recorded on the prescription itself, 

within a patient profile, or in a note 

section of a pharmacy software program. 

Tr. 177. The witness opined that a lack 

of documentation indicates that the 

required analysis of a red flag was not 

performed by the dispensing 

pharmacist. Tr. 199–200. The witness 

conceded that she did not know 

whether any of the red flags she 

identified were actually analyzed and 

resolved by the Respondent,17 but she 

made her opinion clear that a deficit in 

the adequacy of the documentation 

setting forth the pharmacist’s DUR 

analysis brings a dispensing event 

below the Florida minimum standard of 

care, and that the DUR analysis can be 

set forth on the prescription itself or in 

a pharmacy’s electronic records. Tr. 177, 

740. According to Dr. Schossow, the 

mere existence of a red flag, in and of 

itself, does not always prohibit a 

pharmacist from filing a prescription; 18

it was her view that upon sufficient 

documented analysis, all red flags are 

potentially resolvable. Tr. 237. The 

Government’s expert clarified early in 

her testimony that she was restricting 

her opinions to the minimum Florida 

standard of care, and not elucidating on 

best practices in the field of pharmacy. 

Tr. 175–76. 

The Government’s expert testified that 

she reviewed prescriptions and patient 

profiles corresponding to the Ten 

Patients 19 and determined that 

dispensing events depicted in those 

profiles and records presented 

numerous red flags, with no 

documented indications on the part of 

the Respondent of any attempts to 

resolve those red flags prior to filling the 

prescriptions in accordance with the 

standard of care for a Florida 

pharmacist. Tr. 431. One such red flag 

identified by the witness through the 

Respondent’s paperwork was present in 

dispensing events where controlled 

substances were filled in high-risk 

combinations 20 that significantly 

elevate the risk for such things as 

central nervous system (CNS)/ 

respiratory depression, overdose, coma, 

and death. Gov’t Exs. 6, 7, 9–11, 13, 14, 

22, 23, 25–27, 29; Tr. 215–16, 218–21; 

Stip. 33 (Patient JW); Tr. 268–69; Stip. 

19 (Patient EA); Tr. 287–91, 294–95; 

Stip. 21 (Patient SD); Tr. 309–12; Stip. 

25 (Patient DH); 21 Tr. 321–26; Stip. 27 

(Patient DK); 22 Tr. 330–32; Stip. 29 

(Patient JM); 23 Tr. 243–45; Stip. 35 

(Patient CW). According to Dr. 

Schossow, under the Florida standard of 

care, filling these prescriptions would 

require documented indicia that the 

pharmacist reviewed the patient’s 

history, reviewed the patient’s 

information on the Electronic-Florida 

Online Reporting of Controlled 

Substance Evaluation database (E– 

FORCSE),24 spoke with the doctor, 

spoke with the prescriber, inquired 

about the patient treatment plan, 

discussed function improvement of the 

patient, and discussed whether the 

patient had been apprised of the 

associated risks.25 Tr. 204, 213–14, 216. 

The witness explained that there was no 

indication in the Respondent’s records 

that the documentation requirement had 

been completed or addressed for the 

high-risk combination red flags that she 

identified. Gov’t Exs. 6, 7, 9–11, 13–15, 

22, 23, 25–27, 29, 32; 26 Tr. 240–41, 

424–25 (Patient JW); Tr. 286, 371–75 

(Patient EA); Tr. 295–300, 375–78 

(Patient SD); Tr. 319, 321, 385–88, 397– 

98, 408–09 (Patient DH); 27 Tr. 329–30, 


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28OSC/ISO Allegation 7.e charges that 

combination prescriptions between January 9, 2019 

and August 23, 2019 were dispensed by the 

Respondent to Patient JM without documented 

evidence that the identified combination red flag 

was resolved. ALJ Ex. 1 ¶ 7.e. 

29OSC/ISO Allegation 7.g charges that 

combination prescriptions between February 19, 

2019 and August 28, 2019 were dispensed by the 

Respondent to Patient CW without documented 

evidence that the identified combination red flag 

was resolved. ALJ Ex. 1 ¶ 7.g. 

30Tr. 281. 

31Certain controlled substances are prescribed to 

be taken scheduled, in order to maintain the 

medication at a certain level in the body 

consistently. Tr. 275–76. While other controlled 

substances are prescribed to address breakthrough 

pain, or episodic pain, on an as-needed basis. Tr. 

276–77. Here, Dr. Schossow testified that the 

Respondent was filling prescriptions where 

controlled substances that are usually prescribed for 

breakthrough pain were prescribed on a scheduled 

basis. Tr. 274–75. 

32The witness was unmoved by the fact that the 

prescription sig was marked ‘‘PRN,’’ signifying that 

the medication was to be taken on an ‘‘as needed’’ 

basis. Tr. 302–03. 

33Regarding Patient DH, Dr. Schossow’s opinion 

is that to resolve an identified dosing red flag 

within the standard of care, a Florida pharmacy 

registrant would be required to demonstrate 

documented ‘‘careful justification of why [the 

patient] would need so much [medicine] or the 

attempt of trying to lower it to a safer dose with the 

physician.’’ Tr. 409. [The Chief ALJ determined that 

the standard outlined by Dr. Schossow was too 

onerous to impose on pharmacists. However,] there 

is a sufficient lack of documentation in this case 

that it is not necessary to reach the issue of whether 

Dr. Schossow’s elevated standard of documentation 

delivered here meets or exceeds the required 

threshold. [Respondent’s failure to document any 

resolution of this red flag was outside the usual 

course of professional practice, and a violation of 

its corresponding responsibility.] 

34The witness defined therapeutic duplication as 

when two controlled substances that act 

pharmacologically the same are prescribed together. 

Tr. 335–36. 

35 [Omitted for clarity]. 

36Tr. 307. 

37 In one particular note for Patient LH, the 

Respondent wrote that the patient lived in Naples, 

Florida. Tr. 380; Gov’t Ex. 32 at 80. The witness 

testified that this type of notation is insufficient and 

that the standard of care requires communication 

and documentation regarding whether the patient is 

actually driving. Tr. 380. 

409–13 (Patient DK); Tr. 346–47, 425–30 

(Patient CW). Dr. Schossow’s testimony 

regarding the absence of documentation 

also extended to Patient JM. Tr. 338–39, 

413–16, 419–20; Gov’t Exs. 11, 15, 27, 

32. However, as highlighted in her 

testimony, the Respondent’s records did 

contain notes documenting combination 

medication discussions between the 

pharmacy and Patient JM. Tr. 414–418, 

471; Gov’t Ex. 32 at 69. Specifically, the 

pharmacy notes include, inter alia, the 

following entries: 

12/12/19 SPOKE TO MD OFFICE: PT HAS 

BIPOLAR SCHIZOPHRENIA/ANXIETY. MD 

IS AWARE OF COMBO DRUG (XANAX, 

TEMAZEPAM, HYDRO-MORPHONE, 

TIZANIDINE, MS CONTIN) NO SIGNS OF 

ABUSE. PT HAS BEEN ON MEDS SINCE 

2010. PT HAS BUILT UP TOLERANCE. 

12/16/19 SPOKE TO MD OFFICE: ABOUT 

COMBINATION OF OXYCO-DONE, MS 

CONTIN, XANAX, TIZANI-DINE, 

TEMAZEMAM. MD IS AWARE PT HAS 

BIPOLAR MORBIDITY. STATES MONITORS 

PT FOR ABUSE. NO SIGNS OF 

REPIRATORY DEPRESSION. PT HAS BEEN 

ON MEDS FOR OVER 5 YEARS. 

Gov’t Ex. 32 at 69. Similarly, a 

pharmacy note regarding Patient CW 

provides: 

12/18/19 SPOKE TO MD ABOUT 

COMBINATION OF HYDROMORPHONE/ 

ALPRAZOLAM. PT HAS NO SIGNS OF 

SIQUALE. NO SIGNS OF ABUSE PT HAS 

BEEN ON MEDS FOR SEVERAL YRS. OK TO 

FILL. . . . 

Id. at 13. To be sure, on their face, these 

highlighted pharmacy notes are 

temporally outside the Government’s 

allegations related to Patients JM 28 and 

CW,29 but they clearly do appear to 

contain analysis regarding the 

combination prescribing issue and 

coordination with the prescriber. These 

notes demonstrate that at some point the 

Respondent did commence 

documenting conversations with the 

prescribers on this issue, [which is a 

positive development that indicates an 

attempt by Respondent’s pharmacists to 

fulfill their corresponding responsibility 

and operate within the usual course of 

professional practice. However,] 

inasmuch as the documented 

resolutions are dated after the charged 

misconduct, they supply no defense to 

the registrant in this case. 

In reviewing the prescriptions that 

were filled by the Respondent, Dr. 

Schossow also identified anomalies in 

regard to dosages of controlled 

substance prescriptions that raised red 

flags. Specifically, the witness 

explained that certain prescriptions did 

not ‘‘make pharmacological sense’’ 30

because of the dosing combinations of 

long-acting and short-acting opioids.31

Gov’t Exs. 6–9, 11, 12; Tr. 274–76, 281– 

83; Stip. 19 (Patient EA); Tr. 296–97; 

Stip. 21 (Patient SD); Tr. 302–05; Stip. 

23 (Patient LH); 32 Tr. 315–16; Stip. 25 

(Patient DH); 33 Tr. 333–34; Stip. 29 

(Patient JM); Tr. 339–41; Stip. 31 

(Patient ST). And for at least one 

patient, Dr. Schossow testified that there 

were instances of therapeutic 

duplication, 34 which also presented a 

dosage-anomaly red flag. Gov’t Ex. 11; 

Tr. 335–38; Stip. 29 (Patient JM). The 

witness testified that to address a 

dosage-anomaly red flag, a Florida 

pharmacist acting within the standard of 

care is required to speak with the 

physician to discuss the potential 

dangers and the patient’s treatment 

plan, and then document the 

conversation.35 Tr. 284–855, 318, 336– 

37. Through her testimony, the witness 

explained that she saw no indication in 

her review of the Government exhibits 

that the Respondent resolved, 

addressed, or documented the dosageanomaly red flags. Gov’t Exs. 6–9, 11, 

12, 15, 22–25, 27, 28, 32; Tr. 286, 371– 

75 (Patient EA); Tr. 298–300, 375–78 

(Patient SD); Tr. 308, 378–80, 384 

(Patient LH); Tr. 319, 321, 385–88, 397– 

98, 408–09 (Patient DH); Tr. 338–39, 

413–16, 419–20 (Patient JM); Tr. 342– 

43, 420–23 (Patient ST). 

Dr. Schossow also testified that 

instances where customer-patients of 

the Respondent drove long distances to 

obtain and/or fill controlled substance 

prescriptions were red flags that must be 

addressed and resolved. Tr. 232–34; 

Gov’t Exs. 5, 8, 10, 12, 13, 21, 24, 26, 

28; Tr. 232–36 (Patient JW); Tr. 248–50 

(Patient JA); Tr. 305–06 (Patient LH); Tr. 

326–28 (Patient DK); Tr. 341–42 (Patient 

ST); ALJ Ex. 19, Attachs. A, C. [Dr. 

Schossow testified that] a patient 

driving long distances to fill a 

controlled substance prescription 

presents a red flag because of concerns 

‘‘for the safety of the patient’’ as they 

could potentially be driving under the 

influence of controlled substances. Tr. 

232–34. In order to address this longdistance red flag, a Florida pharmacist 

acting within the standard of care, at 

least according to Dr. Schossow, would 

need to question the patient on whether 

they were personally driving, question 

the prescriber on whether they 

‘‘discussed the dangers of the dosing of 

the medication in regards to operating a 

motor vehicle,’’ 36 and then document 

the conversation/resolution.37 Tr. 238– 

39; see also id. at 306–07, 328. [Omitted 

as superfluous. As discussed in more 

detail below, the Chief ALJ found that 

Dr. Schossow’s testimony regarding the 

distance red flag was not convincing. I 

agree, and I do not give any weight to 

this testimony in my Decision. I have 

omitted portions of the RD’s discussion 

of this red flag for brevity.] 

Cash payments for controlled 

substances were also identified by Dr. 

Schossow as a red flag of potential 

diversion. Tr. 222–23, 457; Gov’t Exs. 5– 

14, 21–29; Tr. 229–30; Stip. 34 (Patient 

JW); Tr. 242, 244; Stip. 18 (Patient JA); 

Tr. 269–70; Stip. 20 (Patient EA); Tr. 

296–97; Stip. 22 (Patient SD); Tr. 305; 

Stip. 24 (Patient LH); Tr. 313; Stip. 26 

(Patient DH); Tr. 326; Stip. 28 (Patient 

DK); Tr. 332–33; Stip. 30 (Patient JM); 

Tr. 341; Stip. 32 (Patient ST); Tr. 346; 

Stip. 36 (Patient CW). Dr. Schossow 

explained that an indication on a 


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38 During the course of his testimony on the issue, 

the Respondent’s owner testified that ‘‘cash’’ can 

mean currency, a credit card, or a check. Tr. 635. 

39The Government presented no evidence that 

any of the Ten Patients were or are drug diverters. 

This assumption played no role in the 

Government’s noticed theory of its case. ALJ Ex. 1. 

40According to Dr. Schossow, a notation that 

simply states that the patient does not have 

insurance is insufficient to meet the standard of 

care in Florida. Tr. 374. Dr. Schossow explained 

that even where a prescription contains such a 

notation, it is incumbent upon the pharmacist to 

contact the prescriber to ensure a true lack of 

insurance, Tr. 374, but conceded that ‘‘many’’ of the 

prescriptions she reviewed in this case did have an 

indication from the prescriber that the customerpatient was uninsured, Tr. 471. Thus, by Dr. 

Schossow’s view, even where the pharmacy has 

apparently determined that the customer-patient is 

without prescription insurance coverage and 

documented that conclusion on the relevant scrip, 

the additional step of contacting the prescriber and 

documenting the results of that conversation are 

required to meet the minimum standard of care in 

Florida. As discussed, infra, this makes no sense. 

41See, e.g., Gov’t Ex. 32 at 13 (pharmacy note 

entered outside the charged conduct period 

reflecting the Respondent’s conclusion that Patient 

CW paid cash because she did not have insurance). 

42 [Footnote omitted where text was deleted.] 

43 [Footnote omitted where text was deleted.] 

44 [Footnote omitted where text was deleted.] 

45 [Footnote omitted where text was deleted.] 

46 [Footnote omitted where text was deleted.] 

47 [Footnote omitted where text was deleted.] 

48 [Footnote omitted where text was deleted.] 

49 [Footnote omitted where text was deleted.] 

50 [Footnote omitted where text was deleted.] 

51Tr. 137. 

52Tr. 368. 

53Tr. 444–45. 

54See, e.g., Tr. 399–408. The witness volunteered 

that the pharmacy notes she was reviewing on the 

stand were not the same as the notes she reviewed 

prior to her testimony. Id. This anomaly was never 

cogently explained by the witness. [Omitted for 

brevity. I agree with the Chief ALJ that there was 

no ‘‘cognizable prejudice to the interests of justice 

or the Respondent’s case’’ from Dr. Schossow’s 

confusion about which notes she reviewed before 

the hearing, because Dr. Schossow was clear during 

her testimony about what materials she reviewed 

and how she formed her opinions.] 

55See, e.g., Tr. 243–44 (multiple attempts taken 

to get the witness to state that the paperwork she 

examined did not have any indication as to whether 

the customer-patients had insurance with 

prescription drug coverage); Tr. 291–93 (significant 

equivocation on whether identified red flags are 

resolvable, and if yes, how so); Tr. 448–49 

(significant equivocation on answering whether, 

during her analysis, she had identified violations 

beyond failure to document red flag resolutions); 

Tr. 451–52 (significant equivocation in addressing 

the straightforward question of whether she had 

ever read the footnotes, any of the footnotes, in a 

specified guidance document issued by the CDC). 

*D Throughout the Respondent’s case, I have 

made some minor adjustments to the wording 

where noted for brevity and for clarity and to reflect 

more of my style. See supra n. *C. 

56Resp’t Ex. 12. 

particular prescription of ‘‘cash’’ means 

that the price of the prescription was 

not ‘‘charged to an insurance company, 

or worker’s comp.’’ 38 Tr. 222–23. The 

Government’s expert explained that, in 

her opinion, if a patient did pay in 

‘‘cash’’ that she would assume the 

patient had insurance but was choosing 

not to utilize their insurance; a scheme 

she explained, in her experience, is 

practiced by drug diverters.39 Tr. 223– 

28. Dr. Schossow admitted that she 

could not know for certain whether a 

patient had insurance or not simply by 

seeing the notation ‘‘cash’’ on a 

prescription. Tr. 226. The witness also 

acknowledged that where a pharmacy is 

out of network, the customer patient can 

submit the insurance reimbursement 

claim to the insurer. Tr. 537. According 

to Dr. Schossow, in order to resolve a 

cash red flag, within the standard of 

care, a Florida pharmacist is required to 

ask the prescribing physician whether 

the patient has insurance and document 

the finding.40 Tr. 228–29, 239, 306. A 

notation by the pharmacy staff that a 

customer-patient did not have insurance 

coverage 41 was, in Dr. Schossow’s view, 

insufficient to resolve the red flag of 

cash payment. Tr. 367, 374, 428. Even 

a case where the registrant pharmacy 

documented that it was not contracted 

with the customer-patient’s insurance 

carrier was insufficient to satisfy the 

standard outlined by Dr. Schossow 

based on her expressed innate suspicion 

of a customer who would not, on that 

occasion, seek out a different pharmacy 

that accepted the prescription coverage 

benefit.42 Tr. 411. [Omitted for brevity. 

The Chief ALJ found that Dr. Shossow’s 

testimony about this red flag was not 

convincing and that her standard for 

resolving this red flag was too 

burdensome and illogical to set the 

minimum standard of care in Florida. 

The Chief ALJ did not sustain the 

Government’s allegations regarding this 

red flag, and the Government took 

Exception to this finding. As discussed 

below, I find that it is unnecessary for 

me to reach this issue because there is 

substantial other evidence on the record 

that demonstrates that Respondent’s 

registration is inconsistent with the 

public interest. 43 44 45 46 47 48 49 50

Overall, Dr. Schossow’s testimony, 

although not without its warts, was 

generally authoritative and amply 

supported by the admitted evidence of 

record. While her overall presentation 

was generally objective, her [testimony 

that she] ‘‘had a lot of patients in the 

community arrested for opioid and 

other controlled substance fraud and 

abuse,’’ 51 and her underlying 

assumption that customer-patients 

should be assumed to be abusers 52

(although she had no information that 

this may have been the case regarding 

any of the Ten Patients), 53 were 

certainly concerning aspects of her 

testimony. [It was also concerning that 

Dr. Schossow testified that] she had 

been a member of the Florida Board of 

Pharmacy and then denied that this was 

ever the case. [Omitted for brevity. I 

agree with the Chief ALJ that this 

testimony was confusing, but there is 

insufficient evidence on the record 

about how the Board operates and what 

role Dr. Schossow was referring to that 

would permit me to ascribe any level of 

intent to Dr. Schossow regarding this 

statement. Based on my review of the 

record, I did not discern any intent to 

mislead the Tribunal, but certainly at 

least her initial statement gave an 

incorrect impression and I consider this 

statement in the same manner as the 

Chief ALJ did below.] 

Dr. Schossow’s testimony also 

contained isolated occasions where she 

arguably presented as confusing,54

defensive, even bordering on evasive, 55

and the ‘‘on-the-Board’’/‘‘not-on-theBoard’’ feature was [confusing], but she 

has no objective stake in the outcome of 

the proceedings, and there is nothing 

present in the record or her testimony 

that would mortally undermine her 

credibility and reliability. On those 

points where her testimony was found 

reliable and persuasive in this RD, the 

witness provided sufficient, detailed, 

cogent support for her views. Of the two 

experts who testified in these 

proceedings, her shortcomings 

notwithstanding, she is the more 

reliable and persuasive, and where her 

testimony was at variance with the 

Respondent’s expert, it is Dr. 

Schossow’s opinion which will be 

relied upon. 

The Respondent’s Case *D

The Respondent’s case consisted of 

testimony from the Respondent’s owner 

and an expert witness. 

Dr. Daniel E. Buffington, Pharm.D. 

The Respondent presented the 

testimony of Dr. Daniel Buffington, 

Pharm.D. Dr. Buffington’s CV 56 reflects 

that he earned his Doctorate in 

Pharmacy in 1987, completed a 

pharmacy residency in 1988, and 

concluded a pharmacy fellowship in 

1989 that focused on pharmacy practice 

and clinical pharmacology. Tr. 792–94; 

Resp’t Ex. 12. The witness testified that 

he has held a faculty position at the 

University of South Florida, Colleges of 

Medicine and Pharmacy since the early 

1990s, along with various other 

academic appointments and positions 

where he has taught a myriad of topics 

regarding pharmacotherapy and clinical 

pharmacology. Tr. 792, 794–95. Dr. 

Buffington explained that, although he 

is not licensed as a consultant 


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57Tr. 793. 

58 Dr. Buffington explained that his work includes 

consulting with retail pharmacies regarding their 

compliance with relevant Florida law provisions. 

Tr. 816. 

59Tr. 799–800. 

60 During voir dire, the witness was combative 

and evasive even in answering straightforward 

questions regarding his qualifications. See, e.g., Tr. 

805–09. 

61Tr. 799. 

62The witness testified that in preparation for his 

testimony he reviewed relevant Florida 

administrative code sections. Tr. 815. In evaluating 

the role of an expert witness in the pharmacy 

context, the Agency has held that a pharmacy 

expert is ‘‘not [expected to be] an expert in the 

details of state law, but [ ]he is required as a 

pharmacist to understand what conduct is outside 

of the usual course of professional practice in [his] 

state, whether that is derived from state law, 

mandatory training, standards of care or otherwise.’’ 

Suntree Pharmacy, 85 FR 73,772. 

63 In fact, the Respondent’s expert communicated 

a certain hostility to even the concept of red flags, 

pointing out during his testimony that red flags is 

‘‘a colloquial term,’’ Tr. 832, and in the guidance 

issued by Florida and DEA ‘‘there are no definitions 

of red flags, nor is there any published requirement 

that guides pharmacy practice on what, and how, 

to document those,’’ Tr. 825. At another point in 

his testimony, the witness stated he would not 

document the resolution of a controlled substance 

red flag because he ‘‘can’t find a consistent 

definition of that colloquial term.’’ Tr. 936–37. This 

proposition [is inconsistent with] many years of 

Agency adjudication addressing red flags of 

potential diversion [supported by credible expert 

testimony] and longstanding acceptance of the term. 

See, e.g., Suntree Pharmacy, 85 FR 73,769 (‘‘When 

a pharmacist’s suspicions are aroused by a red flag, 

the pharmacist must question the prescription and, 

if unable to resolve the red flag, refuse to fill the 

prescription.’’) (collecting cases); Morning Star 

Pharmacy & Medical Supply 1, 85 FR 51,045, 

51,060 (2020) (same). 

64The witness was unpersuaded by the argument 

that without adequate documentation another 

pharmacist encountering the same customer-patient 

would be without knowledge of a red flag 

determination made by a predecessor pharmacist or 

be able to pass down information to a successor 

pharmacist. Tr. 960–61. 

pharmacist in Florida, 57 his pharmacy 

background has included some 

consultation, clinical research, and 

pharmacy work as both a clinical and 

retail pharmacist. Tr. 796–97. His 

current business, Clinical Pharmacology 

Services ‘‘is a licensed pharmacy [that] 

also provides direct patient 

consultation, manages clinical research 

trials, and provides drug information 

support for health systems, medical 

practices, but also forensics for law 

enforcement, government agencies.’’ 58

Tr. 796. The witness testified that he has 

also served as an expert in numerous 

state and federal cases and has 

participated on panels relative to 

Florida legislative initiatives regarding 

administrative code provisions. Tr. 814– 

15. Dr. Buffington was tendered 59 and, 

without objection from the Government, 

accepted 60 as an expert witness in 

Florida pharmacy practice under 

Florida and federal standards, and the 

standard of care for pharmacists 

practicing in the state of Florida.61 Tr. 

813. 

According to Dr. Buffington, under 

the applicable standard of care for 

dispensing controlled substances in 

Florida, a pharmacist is expected to 

assess every new and refill prescription 

presented to them by a patient.62 Tr. 

823. Dr. Buffington summarized his 

view of applicable statutes governing 

the standard in Florida as follows: 

[T]he pharmacist as the specialist in this 

area of pharmacology and drug-related issues 

is expected, per Florida Board of Pharmacy 

and regulations, to do [sic] on each new and 

refill prescription, to evaluate, prior to 

dispensing, seven key criterions that look at 

common drug-related problems. Some of 

those may be drug interactions or 

duplications in therapy, dosing, drug 

allegories, wide variety. 

Tr. 823. Regarding the issue of 

documentation, the witness holds the 

view that there is essentially no 

requirement that a pharmacist 

document any analysis employed for 

resolving any red flag issue that arises 

relative to potential controlled 

substance diversion so long as the 

medication is ultimately dispensed. 

According to Dr. Buffington, the Florida 

state standard of care is also apparently 

dependent upon whichever commercial 

software system any pharmacy elects to 

purchase and utilize. The colloquy 

between the Respondent’s counsel and 

its expert is [notable]: 

Q. Does the standard of care in Florida 

require that a pharmacist document, at all, 

resolution of any issues by the prospective 

drug utilization review? 

A. No, sir. It’s the pharmacist’s individual 

prerogative and up to their system. In some 

cases, their pharmacy software system may 

afford some of that by process. Others, there’s 

data entry fields. It doesn’t have to be solely 

contained in the pharmacy software. It can be 

in secondary software. It can be handwritten. It can be maintained in a variety of 

ways. They leave that up to the personal 

judgment and prerogative and systems at 

each pharmacy. 

Tr. 823–24. When asked to clarify if 

the standard really depends on 

something as subjective and unregulated 

as what commercial software is 

employed by individual pharmacies, the 

[Respondent’s expert testified]: 

No, sir. I’m saying it’s up to the pharmacist 

as to which method, or collective methods, 

they wish to document. There is no format. 

There is no content-specific requirements 

with which a pharmacist has to document 

the addressing of those issues. 

Tr. 824. By this view, a pharmacy that 

elects to purchase a substandard 

software system apparently can generate 

a lower standard of care than a 

pharmacy that acquires a more vigilant 

system. By this same reasoning, a 

pharmacy could even potentially escape 

regulatory scrutiny by the acquisition of 

a subpar software system. Suffice it to 

say that the notion that state and federal 

regulators intended to design a system 

that creates a perverse incentive to 

deploy bad software to dodge 

responsibility is unpersuasive. When 

asked again for clarification, the 

Respondent’s expert, after some 

[discussion] about whether DURs and 

red flags 63 are homonyms, stated his 

opinion: 

[T]here is no requirement for the 

documentation of red flags, or DURs, in the 

State of Florida. There is opportunity to 

document. There is a requirement, or a duty, 

to address those items. The—the—the DURs. 

There is no Florida-based, or DEA-based 

recognition for documenting red flags. 

Tr. 825. 

The Respondent’s expert later 

clarified that while processing a DUR, 

that even when a pharmacist encounters 

a potential red flag issue through its 

software, if ‘‘it didn’t need resolved, 

there’s no need to record it.’’ Tr. 913. 

Documentation, according to Dr. 

Buffington, is only required ‘‘[i]f there’s 

something to resolve.’’ Tr. 914. When 

asked if a heightened level of suspicion 

that supported a decision to decline to 

dispense would ever merit some level of 

documentation, Dr. Buffington 

[testified]: ‘‘Well, first of all, I’m going 

to work through whatever that question 

or suspicion is, and it’s not going to be 

documented—or, it’s not going to be 

dispensed.’’ Tr. 917 (emphasis 

supplied). Following this approach, a 

pharmacist can subjectively determine 

that there is no issue to be resolved, 

document nothing, and be within the 

Florida standard of care. And since 

nothing is documented, the only correct 

assumption available to regulators, 

according to the Respondent’s expert’s 

view, is that everything was correctly 

assessed and resolved. [Omitted.] Thus, 

according to Dr. Buffington, there is no 

requirement under the applicable 

standard of care to document any 

resolution regarding any indication of 

diversion on the part of any patient or 

prescriber, no matter how egregious or 

how potentially dangerous, so long as 

the decision was ultimately made to 

dispense. 

Dr. Buffington [also testified that the 

phrase] ‘‘if it wasn’t documented, it 

wasn’t done’’ has no application to a 

pharmacy’s obligation to document the 

resolution of red flags because there is 

no obligation to document the 

resolution of red flags.64 Tr. 825–26. [Dr. 


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65 Id. r. 64B16–27.831(2). 

66 Dr. Buffington’s opinion that there is no 

requirement for a Florida pharmacist to consult 

with prescribers regarding the existence of a clinical 

plan, tapering, or titration (Tr. 828) [is also not 

credible]. 

*EThe Chief ALJ’s interpretation that Florida law 

requires pharmacists to document the resolution of 

red flags is supported by a plain language reading 

of the various provisions of the Florida 

Administrative Code and by credible expert 

testimony about the importance of documentation 

in Florida. I agree with the Chief ALJ’s 

interpretation, and I agree with his conclusion that 

Respondent violated Florida law by failing to 

document the resolution of red flags. However, my 

Decision does not rely on any interpretation of 

Florida law, because, in failing to document the 

resolution of red flags, Respondent violated federal 

law in addition to state law. Dr. Schossow offered 

credible expert testimony that failing to document 

red flag resolution is outside the usual course of 

professional practice in Florida. Although Dr. 

Buffington offered conflicting testimony that 

documentation is not required in the usual course 

of professional practice, I agree with the Chief ALJ 

that Dr. Schossow’s testimony regarding 

documentation requirements was considerably 

more credible. Thus, as discussed in more detail 

infra, I find that Respondent repeatedly violated 

federal law by filling numerous prescriptions 

outside the usual course of professional practice 

without adequately addressing, resolving, or 

documenting red flags in violation of its 

corresponding responsibility. See 21 CFR 

1306.04(a) and 1306.06. Respondent’s violations of 

federal law serve as an independent basis for my 

conclusion that Respondent’s registration is 

inconsistent with the public interest and that 

revocation is the appropriate remedy in this case. 

67The witness reasoned that such occurrences 

can happen because ‘‘[y]ou build a therapeutic 

regimen that meets that patient’s specific needs and 

lifestyle.’’ Tr. 876. ‘‘[Y]ou don’t see that and assume 

that it’s somehow indicative of inappropriate 

patient care.’’ Tr. 878. 

Buffington testified that pharmacists are 

not obligated] to document the 

resolution of any controlled substance 

red flag because he ‘‘can’t find a 

consistent definition of that colloquial 

term.’’ Tr. 936–37; see also id. at 940, 

945. The witness suggested that 

requiring a level of documentation 

beyond this minimalist view would 

require the use of ‘‘court reporters in the 

pharmacy.’’ Tr. 939. [Omitted for 

brevity.] For, as Dr. Buffington reasoned, 

it is the pharmacist alone who exercises 

‘‘professional prerogative,’’ and as he, 

himself put it, ‘‘someone else not 

understanding the core facts of [his] job 

doesn’t make what [he’s] doing 

incorrect.’’ Tr. 915–16 

Dr. Buffington [offered an 

interpretation of Florida law that was 

not persuasive. Tr. 826–27, 924 

(discussing subsection (3)(a) of rule 

64B16–27.831 of the Florida 

Administrative Code (Florida Pharmacy 

Standards Statute or FPSS).] Subsection 

(3)(a) of the FPSS lists steps to be taken 

by a pharmacist before declining to 

dispense a controlled medication. Fla. 

Admin. Code Ann. r. 64B16– 

27.831(3)(a). The FPSS requires a 

pharmacist to reach out to the patient 

and prescriber, or check E–FORCSE in 

place of either (but not both) of those 

contacts prior to declining to dispense a 

controlled substance. Id. r. 64B16– 

27.831(3)(a), (b). [Although Dr. 

Buffington agrees that a pharmacist 

must document his decision to decline 

to fill a prescription, see Tr. 827, he 

does not believe that a Florida 

pharmacist has a] duty to evaluate the 

validity of the prescription or to 

document his/her analysis or findings 

[if the pharmacist ultimately fills the 

prescription.] There is no exposure so 

long as he/she dispenses the drugs. 

[This testimony is inconsistent with the] 

FPSS and other provisions of Florida 

law. The FPSS specifically instructs: 

There are circumstances that may cause a 

pharmacist to question the validity of a 

prescription for a controlled substance; 

however, a concern with the validity of a 

prescription does not mean the prescription 

shall not be filled. Rather, when a pharmacist 

is presented with a prescription for a 

controlled substance, the pharmacist shall 

attempt to determine the validity of the 

prescription and shall attempt to resolve any 

concerns about the validity of the 

prescription by exercising his or her 

independent professional judgment. 

Id. r. 64B16–27.831(2) (emphasis 

supplied). It is clear that in its 

description of ‘‘circumstances that may 

cause a pharmacist to question the 

validity of a prescription for a 

controlled substance,’’ the Florida 

legislature was referring to what has 

been ubiquitously referred to by DEA, 

the regulated community, and the 

industry, as a red flag of potential 

diversion. Upon encountering one of 

these, the FPSS directs pharmacy 

practitioners to consult with the 

prescribers, patients, and/or E–FORCSE. 

The opening section of the FPSS 

instructs that ‘‘[p]harmacists shall 

attempt to work with the patient and the 

prescriber to assist in determining the 

validity of the [controlled substance] 

prescription.’’ Id. r. 64B16–27.831. 

Thus, upon encountering a 

‘‘circumstance that may cause a 

pharmacist to question the validity of a 

prescription for a controlled 

substance’’ 65 (i.e., a red flag of potential 

diversion), a pharmacist must reach out 

to either the prescriber or the patient, 

and where appropriate, in place of one 

of those two sources (but not both) the 

pharmacist may resolve a red flag by 

utilizing E–FORCSE. Id. The Florida 

legislature has also directed that ‘‘[t]he 

pharmacist shall record any related 

information indicated by a licensed 

health care practitioner.’’ Fla. Admin. 

Code Ann. r. 64B16–27.800(2) (Florida 

Pharmacy Patient Record Statute or 

FPPRS). The FPPRS also directs 

pharmacists to create a record of 

‘‘[p]harmacist comments relevant to the 

individual’s drug therapy, including any 

other information peculiar to the 

specific patient or drug.’’ Id. r. 64B16– 

27.800(1)(f). Hence, contrary to Dr. 

Buffington’s view, under Florida law 

and the applicable standard of care, a 

pharmacist who encounters a red flag is 

required, before resolving the red flag 

[and filling the prescription], to contact 

the prescriber and/or patient and is 

required to document both of those 

interactions.66 *E

Contrary to Dr. Buffington’s testimony 

that [it should be assumed that a 

pharmacist has resolved any potential 

red flags if he decides to fill the 

prescription], the Agency has made it 

clear that it is unwilling to credit ‘‘[p]ost 

hoc written or oral justifications’’ for 

actions taken as a registrant that were 

not documented, George Pursley, M.D., 

85 FR 80,162, 80,171 n.28 (2020); see 

Lesly Pompy, M.D., 84 FR 57,749, 57,760 

(2019). In fact, the Agency has accepted 

the premise that ‘‘it would be reasonable 

to draw an adverse inference that a 

pharmacist failed to resolve a red flag 

(or flags) from the failure to document 

the resolution in any manner . . . .’’ 

Superior Pharmacy I and Superior 

Pharmacy II, 81 FR 31,310, 31,335 

(2016). [Omitted for brevity]. 

Dr. Buffington also testified that 

filling combination prescriptions of 

higher dosages of short-acting 

medications and lower dosages of longacting medications does not fall below 

the standard of care.67 Tr. 877. Likewise, 

the witness rejected medication 

combinations referred to as ‘‘cocktails’’ 

as a red flag, stating that ‘‘[e]very patient 

who has multiple drugs in their 

regiment is a cocktail [sic].’’ Tr. 955. 

The witness opined that simultaneously 

dispensing such combinations (either 

opioids and benzodiazepines, or 

opioids, benzodiazepines, and muscle 

relaxers) ‘‘[a]bsolutely [does] not’’ fall 

below the applicable standard of care 

for Florida pharmacists. Tr. 863–64. Dr. 

Buffington explained that the 

presentation of such controlled 

substance combinations is ‘‘not a 

potential issue, the fact that it may have 

been flagged in a DUR, unless the 

patient is experiencing complications.’’ 

Tr. 865. This view is not only 

inconsistent with the opinion of Dr. 

Schossow, but also the view of the 

Agency, which has sustained cocktail 

combinations as red flags of potential 

diversion requiring documented 

resolution. See, e.g., Suntree Pharmacy, 

85 FR 73,756 (acknowledging that DEA 

‘‘has long discussed cocktails’’ as a red 


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68Tr. 830, 862–64. 

69ALJ Ex. 39, Attach. B. 

70Also known as a boxed warning. 

71ALJ Ex. 39, Attach. C at 1. 

72Tr. 909. 

73 Dr. Buffington reasonably opined that requiring 

a pharmacy registrant to reach out to a physician’s 

office to investigate a patient’s insurance coverage 

is idiosyncratic because the insurance coverages are 

different. Tr. 834. 

flag issue). Furthermore, Dr. Schossow’s 

view of the appropriate uses of 

immediate-release and extended-release 

medications is more persuasive than Dr. 

Buffington’s summary dismissal of the 

issue. 

The witness was likewise dismissive 

in considering the applicability of the 

CDC Guidelines issued in 2016 

regarding controlled substance 

dispensing. Dr. Buffington testified that 

the CDC Guidelines had no impact on 

the standard of care for pharmacists 

practicing in Florida. Tr. 819, 907–08. 

According to the Respondent’s expert, 

the CDC Guidelines amount only to a 

‘‘recommendation to help educate 

physicians,’’ and a mere ‘‘guideline, or 

recommendation.’’ Tr. 820; see also id. 

at 903 (‘‘Typically all guidelines are 

recommendations, or instructional for— 

they’re not thresholds or limitations on 

practitioners.’’). 

[However,] the CDC Guidelines reveal 

considerable specificity in their 

guidance to prescribers (and by 

extension, to pharmacists [filling 

prescriber’s prescriptions]), including 

advisals to commence opioids at the 

‘‘lowest effective dosage,’’ preferences 

for immediate-release over extendedrelease opioids at the commencement of 

opioids as a pain treatment modality, 

specific guidance regarding MME levels 

exceeding 50, and a preference for 

‘‘[n]onpharmacologic therapy and 

nonopioid pharmacologic therapy’’ for 

chronic pain. ALJ Ex. 39, Attach. A at 

16. Although the issue in this case is 

whether a particular prescription raises 

a red flag of potential diversion, Dr. 

Buffington altered the subject into 

whether the CDC Guidelines imposed a 

‘‘hard stop, hard block, or change’’ on 

prescribers,68 which [is not relevant to 

the Government’s allegations. Although 

Dr. Buffington is correct that the CDC 

Guidelines do not impose a ‘‘hard stop,’’ 

the Guidelines issue clear guidance to 

medical professionals about prescribing 

high dosages of opioids:] 

Clinicians should use caution when 

prescribing opioids at any dosage, should 

carefully reassess evidence of individual 

benefits and risks when increasing dosage to 

≥ 50 morphine milligram equivalents (MME)/ 

day, and should avoid increasing dosage to 

≥ 90 MME/day or carefully justify a decision 

to titrate dosage to ≥ 90 MME/day. 

ALJ Ex. 39, Attach. A at 16. At another 

point in his testimony, Dr. Buffington 

allowed that the CDC Guidelines advise 

practitioners to ‘‘use caution if [they]’re 

getting to 90 [MME], or be very clear 

that [they] understand and have a 

rationale for doing that.’’ Tr. 908. 

Whatever be the limits of the finer 

points of the CDC’s guidance, to dismiss 

an encountered titration that exceeds 90 

MME/day as an insignificant non-issue 

to pharmacy practice is not a fair 

inference that can or should be drawn 

by the plain language of the CDC 

Guidelines. Neither is the subsequent 

policy clarification 69 (CDC 

Clarification) issued by the CDC 

particularly supportive of Dr. 

Buffington’s premise that it was issued 

to address ‘‘key areas where the [CDC] 

realized people, or courts, may be 

misrepresenting the [CDC G]uidelines as 

a fixed or regulatory threshold.’’ Tr. 

830–31. The principal focus of the CDC 

Clarification was focused on ensuring 

that practitioners did not read the CDC 

Guidelines as supporting dangerous, 

sudden, and drastic discontinuations of 

opioid therapy to the detriment of 

patients. ALJ Ex. 39, Attach. B at 1–2. 

There is nothing in the plain language 

of the document that runs counter to 

identifying a red flag of potential 

diversion under the appropriate 

circumstances based in some part on 

high opioid dosages. 

The witness was similarly dismissive 

in addressing a warning 70 issued by the 

U.S. Food and Drug Administration 

(FDA) concerning the extreme dangers 

posed by combining opioids and 

benzodiazepines (the Black Box 

Warning). ALJ Ex. 39, Attach. C. The 

Respondent’s expert acknowledged that 

a black box warning connotes a 

‘‘heightened level of warning,’’ that 

should inform a pharmacist’s decision 

making, but insisted (despite the FDA’s 

decision to issue the warning) that it 

contained no new information and was 

merely an advisal to prescribers that 

these ‘‘very low incident’’ complications 

could occur. Tr. 909. Although in its 

drug safety communication setting for 

the Black Box Warning, the FDA refers 

to black box warnings as its ‘‘strongest 

warnings,’’ 71 the Respondent’s expert 

[did not consider the warning to be 

notable, and further testified that ‘‘the 

combined use of the two [medications] 

presents no complication or problem for 

healthcare professionals specifically in 

chronic pain . . . .’’]. Tr. 909, 959. This 

view arguably stands in some tension 

with the plain language contained in the 

Black Box Warning: 

Health care professionals should limit 

prescribing opioid pain medicines with 

benzodiazepines or other CNS depressants 

only to patients for whom alternative 

treatment options are inadequate. If these 

medicines are prescribed together, limit the 

dosages and duration of each drug to the 

minimum possible while achieving the 

desired clinical effect. Warn patients and 

caregivers about the risks of slowed or 

difficult breathing and/or sedation, and the 

associated signs and symptoms. Avoid 

prescribing prescription opioid cough 

medicines for patients taking 

benzodiazepines or other CNS depressants, 

including alcohol. 

ALJ Ex. 39, Attach. C at 1 (emphasis 

supplied). Although Dr. Buffington 

reads the Black Box Warning as an 

authorization to continue to use (not 

limit) this combination,72 the FDA 

apparently holds the view that health 

care officials should limit the combined 

prescribing of opioids and 

benzodiazepines to situations where 

other treatment options are inadequate. 

Id. Notwithstanding this limitation 

(couched in directive, not passive 

language), Dr. Buffington’s position is 

apparently that the ‘‘avoid’’ aspect of 

the warning should be deemphasized 

over a recognition that the two 

medications can be prescribed together. 

In any event, the Government never 

argued that the combination is per se 

prohibited, but rather that the 

combination raises a dispensing red flag 

that requires documented resolution to 

meet the standard of care. [Relocated] 

In specifically addressing cash red 

flags, the Respondent’s expert opined 

that ‘‘the method of payment is 

somewhat irrelevant’’ and that the 

standard of care ‘‘[a]bsolutely [does] 

not’’ require pharmacists to investigate 

the rationale for a customer-patient 

utilizing cash payments or insurance. 

Tr. 833–34; see also id. at 953. Dr. 

Buffington reasoned that pharmacists 

‘‘have that capacity to understand that 

patients’ payment methods often ebb 

and flow based on [insurance] 

coverage. . . . There are just so many 

variables that there is no predictive 

validity, or use, of presuming cash 

payment to be a problem.’’ 73 Tr. 833. 

Regarding the position of the 

Government’s expert that a pharmacy is 

required to contact a prescriber to 

confirm prescription coverage details, 

Dr. Buffington persuasively testified that 

a ‘‘medical benefit does not always 

coincide with a drug-spend benefit.’’ Tr. 

834. While this perspective is 

reasonable, declaring cash as never a 

relevant consideration [is not balanced 

and not credible]. The view of the 

Respondent’s expert that cash is always 

patently irrelevant to the evaluation of 

dispensing events is in considerable 


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74 [Omitted.] 

75Tr. 873. 

76After repeatedly [testifying that distance was 

not] a potential red flag issue, the witness testified 

that he ‘‘already said it could’’ be a red flag. Tr. 952. 

At another point in his testimony, the witness, in 

response to a direct query of whether distance 

could ever be a red flag, [testified]: ‘‘It could, but 

I’ve already stated we already have methods for 

dealing with that, and I wouldn’t call it a red flag.’’ 

Id. at 954. [Omitted for brevity.] The inconsistencies 

further denigrated any ability to credit Dr. 

Buffington’s opinions. 

77 Dr. Buffington testified that, in addition to the 

Government Exhibits, he also reviewed Proposed 

Respondent Exhibits that were not offered or 

admitted during the course of the hearing. Tr. 845, 

880. 78The witness testified that this is ‘‘a patientspecific issue.’’ Tr. 852. This is another instance 

where the witness replaced the issue posed with 

one that [he preferred to discuss]. When asked 

about under-utilization, something that could 

potentially be a red flag of abuse requiring 

resolution, the witness substituted his analysis that 

the CDC Guidelines placed no hard cap on MME 

levels, Tr. 853–57, which was not among the 

Government’s theories. The issue in the case was 

never whether a prescriber can elect to use his/her 

professional judgment, but whether a particular 

dosage strength can raise a potential red flag 

requiring inquiry, resolution, and documentation. 

The witness’s responses on this issue were also (as 

many other answers were) seemingly dependent 

upon the limits of the commercial software 

purchased by an individual pharmacy, which, as 

discussed in detail, supra, cannot serve as a 

reasonable, objective yardstick for whether a DEA 

pharmacy registrant has met the applicable 

standard of care. 

79The witness defined therapeutic duplication as 

when two medications of the same class, or two 

medications with the same pharmacologic effect, 

are prescribed together. Tr. 854–55. 80 Dr. Buffington explained that when a 

pharmacist encounters a drug-drug interaction, they 

are ‘‘looking for predominantly metabolism, 

secondarily effects as to whether or not that 

potential for conflict is going to either create an 

adverse side-effect or potentially, some medications 

may bind to the other’’ rendering it therapeutically 

useless. Tr. 861. 

81This specific category was explained by the 

witness to typically be presented as a miss-fill on 

the part of the pharmacist or a scrivener’s error on 

the part of the prescriber. Tr. 868. 

82 Dr. Buffington differentiated between abuse 

and misuse by explaining that ‘‘abuse could have 

the ill intent to produce some effect . . . that that 

medication has,’’ while ‘‘[m]isuse may in fact be 

that the individual is not taking the medication 

properly, so poor compliance.’’ Tr. 870. 

83Regarding Patient JM, Dr. Buffington testified 

that the customer-patient receiving Restoril and 

Xanax at the same time ‘‘would not present a 

problem that needed resolved, unless, in fact, in the 

dialogue and counseling with that patient, you’ve 

identified a clinical concern where the patient is 

expressing they’re not getting therapeutic benefit or 

possibly too much therapeutic benefit.’’ Tr. 856. 

tension with the Agency’s view based 

on credible expert testimony. See, e.g., 

Suntree Pharmacy, 85 FR 73,757 n.13 

(sustaining ALJ’s finding based on 

credible expert testimony ‘‘that cash is 

a red flag in combination with other red 

flags’’); Pharmacy Doctors Enters., 83 FR 

10,876, 10,891 (2018) (same). As can 

fairly be stated about other aspects of 

Dr. Buffington’s presentation, he was 

inconsistent regarding this issue. At 

another point in his testimony the 

witness seemed to nominally retreat 

from this absolutist opinion and 

suggested that cash could indeed 

potentially be a red flag. Tr. 955. This 

was confusing. As discussed elsewhere 

in this recommended decision, although 

the rationale of the Government’s case 

for cash as a red flag in the present case 

(to wit, the pharmacy must call the 

doctor regarding pharmacy insurance 

coverage) was unpersuasive, [I also 

decline to credit Dr. Buffington’s 

testimony that cash payments are never 

a red flag.74 See infra for further 

discussion of cash payments. Omitted 

for brevity]. 

The Respondent’s expert similarly 

dismissed any considerations of long 

travel distances as a potential red flag. 

When asked whether distance could be 

a potential red flag, his response was 

‘‘[a]bsolutely not.’’ Tr. 948. Beyond his 

eminently valid point that a pharmacist 

possesses no capacity to limit the 

driving habits of its customer-patients 

beyond recommendations, 75 Dr. 

Buffington was unequivocal in his 

rejection of the whole concept, 

declaring: 

There’s no logical rationale, or 

supportable—and certainly no regulatory— 

oversight over that. You could live in the 

[Florida] Keys and fill in the [Florida] 

Panhandle. You could fill at a pharmacy you 

prefer, or have worked with, where you lived 

previously. One that’s—there are just so 

many variables, from your home, your office, 

your doctor’s office—it’s purely your choice 

as a consumer. There’s no predictive validity 

that where—in fact, you can fill out-of-state. 

There’s not a problem for your prescription. 

So, there is just no utility in attempting to 

use that as a metric. 

Tr. 834–35. The witness opined that 

‘‘distance is of no predictive value in 

and of itself . . . .’’ Tr. 949. [He 

testified that he was not obligated] to 

document a distance red flag, adding ‘‘I 

have no obligation to take someone 

else’s variable and write something 

down.’’ 76 Tr. 951. Certainly, Dr. 

Buffington’s broad denunciation of 

distance as a red flag is directly contrary 

to [prior Agency decisions based on 

credible expert testimony]. See, e.g., 

Heavenly Care Pharmacy, 85 FR 53,402, 

53,417 (2020) (recognizing based on 

credible expert testimony long distance 

as a valid red flag); Pharmacy Doctors 

Enters., 83 FR 10,885 (same); Hills 

Pharmacy, LLC, 81 FR 49,816, 49,839 

(2016); Holiday CVS, L.L.C., 77 FR 

62,316, 62,321–22 (2012) (same); E. 

Main St. Pharmacy, 75 FR 66,149, 

66,163–65 (2010) (same). [Omitted for 

brevity.] As was not uncommon 

throughout the course of his 

presentation, Dr. Buffington produced 

an answer favorable to the Respondent 

by changing the question. When asked 

if distance could support a diversion red 

flag (i.e., an issue to be resolved prior to 

dispensing), the witness answered the 

question of whether such an issue was 

potentially resolvable, which was a 

premise that comprised no part of the 

Government’s case. [Omitted for 

brevity.] Although the rationale 

employed by the Government’s expert 

(motor safety) was unpersuasive in this 

case, the categorical dismissal of 

distance as a red flag under all 

circumstances detracted from the 

reliability that should be afforded to Dr. 

Buffington’s testimony. 

The witness similarly transposed the 

issue of illogical medication dosing 

combinations as a red flag. When 

queried on the subject, Dr. Buffington 

[changed] the issue into whether such 

dosing variations between extendedrelease and short-acting medications 

were inappropriate under all 

circumstances, which was [not the 

Government’s or Dr. Schossow’s theory]. 

Tr. 877–81. The issue in the case is 

whether the Respondent pharmacy was 

presented with a red flag that required 

follow-up, resolution, and 

documentation. Like most red flags, the 

question presented may be (and often is) 

subject to resolution. Dr. Buffington’s 

view on the issue of illogical medication 

dosing is divergent from that of Dr. 

Schossow, but the Government expert’s 

testimony on this issue was better 

explained, more persuasive, less 

evasive, and more reliable. 

[The Chief ALJ questioned the 

credibility of Dr. Buffington’s testimony 

that he performs physical examinations 

on pharmacy customers. Tr. 920–21. I 

agree that this testimony was unusual, 

but I have omitted the discussion as it 

does not ultimately impact my 

Decision.] 

The Respondent’s expert testified that 

he reviewed the relevant documents 77

for the Ten Patients from the 

Respondent pharmacy and testified that 

the Respondent’s controlled substance 

dispensing did, in his opinion, meet the 

standard of care in Florida for each of 

the prescriptions at issue in this matter. 

Tr. 845, 850–51, 859, 881. Dr. 

Buffington testified that he saw no 

deviation from the standard of care on 

the part of the Respondent in terms of 

over-utilization and under-utilization,78

therapeutic duplication, 79 drug-disease 

interactions, drug-drug interactions,80

drug dosages or treatment,81 drugallergy interactions, and clinical abuse 

and misuse.82 Tr. 845, 854, 863, 865, 

868–69.83 Although it was never 


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84Tr. 866. 

85 Dr. Buffington restricts a pharmacist’s 

obligation to ‘‘doing a valid check on the legitimacy 

of the prescription in terms of having done your 

homework and understanding the prescriber, 

having done your homework and understanding the 

patient . . . .’’ Tr. 867. There was no clarification 

from the witness as to what objective steps could 

or must be invested in ‘‘understanding’’ the patient 

and prescriber, or what any of that means. At 

another point in his testimony, the Respondent’s 

expert explained his view that validating a 

prescription would include an evaluation of the 

scrip, the completeness of the scrip, the prescriber’s 

authority, and whatever evaluation steps are 

included in the pharmacy software. Tr. 909–10. 

When pressed upon the issue of whether risk plays 

a role in the assessment, Dr. Buffington stated that 

‘‘every medication has risk’’ and based his answer, 

not on whether a red flag is triggered by the level 

of risk, but whether a risk, standing alone, 

constitutes ‘‘a preclusion,’’ which he naturally 

answered in the negative. Tr. 911–12. The issue 

with red flags in this case, as alleged by the 

Government, never included a hard preclusion 

component, but only whether the evidence 

demonstrated unresolved red flags of potential 

diversion which remained unresolved and 

undocumented prior to dispensing. 

86 In responding to a hypothetical, the 

Respondent’s expert [testified] that even if newlyissued CDC guidelines indicated that a medication 

at a particular dosage level could result in physical 

harm to the patient, he would continue to dispense 

based on nothing more than the prescriber’s 

unexplained insistence. Tr. 905. 

entirely explained how he reached this 

supposition, Dr. Buffington testified that 

it was his understanding that each of the 

prescribers associated with the Ten 

Patients was a pain management 

specialist. Tr. 867. Whether this was the 

case or not, or how heavily this factor 

may have weighed into his metric, this 

assumption appears to have [impacted] 

his analysis. For each category, Dr. 

Buffington testified that a showing or 

‘‘hit’’ of one of these categories simply 

requires an evaluation on whether the 

patient is experiencing complications or 

side-effects, and the absence of 

complications or side-effects means the 

‘‘hit’’ does not rise to the level of a 

clinical problem. Tr. 855–58, 860, 862– 

63, 865, 870. The witness testified that 

‘‘[t]hese are categories that the Board of 

Pharmacy is saying you should evaluate 

these issues [sic] and determine in your 

professional judgment if there is 

something to avoid or resolve and that’s 

the issue.’’ Tr. 862. When Dr. Buffington 

was asked whether the presence of an 

opioid and a benzodiazepine would 

present a drug-drug interaction DUR, he 

replied in the following confusing way: 

No. Because those two are used routinely 

together. Now, could you—in other words 

there’s no certainty that that software system 

is going to flag the two of those—that’s 

something that the practitioner will 

understand. It may, based on the vendor who 

made the software or the pharmacy who 

added an additional manual edit to be part 

of that process, but none of these are hard 

stops with any regulatory oversight. 

Tr. 862. In specifically addressing 

duplicate therapy in regards to Patient 

JM, Dr. Buffington provided, ‘‘The mere 

presence of the two together do[es] not 

create the red flag. It’s as though 

someone is creating or propagating the 

fact that if the two appear, materialize 

in the same regiment that it is wrong. It 

is not wrong unless problems ensue 

. . . .’’ Tr. 968–69. The witness 

consistently alluded to a high level of 

deference and prerogative left, at least in 

his view, exclusively (and apparently 

un-reviewably) to the dispensing 

pharmacist, when he explained that for 

any of the categories, documentation is 

required only if an issue is identified 

(by the pharmacist). Tr. 866. 

As discussed, supra, a recurrent 

theme in the testimony of this witness 

was to eschew the issue at hand and 

substitute an issue he would prefer to 

address. At one point during his 

testimony, the witness was asked 

whether ‘‘patient questionnaires that 

were presented by [the Respondent] to 

new patrons . . . [is] something that 

[pharmacies are] required to maintain 

by any statute or regulation.’’ Tr. 851– 

52. Dr. Buffington’s answer was ‘‘No, 

just routine practice.’’ Tr. 852. 

Unanswered by the expert here is 

whether patient questionnaires are 

required to meet the applicable standard 

of care as subsumed by both federal and 

state statutes and regulations, and/or 

whether the ‘‘routine practice’’ 

employed by Florida pharmacies in his 

estimation comprises any portion of the 

applicable standard of care. Similarly, 

when asked whether there is a 

requirement for Florida pharmacists to 

document resolution of over-utilization, 

under-utilization, therapeutic 

duplication, and drug-disease 

contraindications, the witness’s answer 

again injected an intentional level of 

equivocation: 

Only if you in the course of, normal course 

of your practice identified there was an issue, 

a clinical presentation, a concern, something 

that might be hindering medication 

compliance and the likes, then, upon 

recognizing those, if it’s a concern during 

your evaluation, then you could take the 

steps to avoid and resolve the problem. 

Tr. 866. The framework of the witness’s 

answer here, like many of his answers, 

was unhelpful, and seemingly 

deliberately so. A red flag indicating a 

potential diversion issue is ‘‘a concern’’ 

or ‘‘an issue,’’ or even ‘‘something that 

might be hindering medication 

compliance and the likes.’’ 84 Thus, the 

interpretation that nothing is required of 

the pharmacist upon encountering a red 

flag creates an unhelpful level of a sort 

of plausible deniability. Another 

example of this is apparent in the 

witness’s explanation of subsection 

(1)(g) of rule 64B16–27.810 of the 

Florida Administrative Code (Florida 

DUR Statute), which requires the 

identification of ‘‘[c]linical abuse/ 

misuse.’’ Although the statute supplies 

no limitation regarding the nature of 

clinical abuse/misuse, the Respondent’s 

expert explained this aspect of the 

operation of the Florida DUR Statute in 

this circuitous manner: 

That means if you’ve identified as a 

practitioner that the patient is abusing or 

misusing the medication, and we state it that 

way for very specific reasons, abuse could 

have the ill intent to produce some effect, 

some main effect or side-effect, that the 

medication has. Misuse may in fact be that 

the individual is not taking the medication 

properly, so poor compliance. 

Tr. 869–70. When juxtaposed, Dr. 

Buffington’s dismissal of almost all red 

flags of potential diversion as nonissues 

with the pragmatic operation of his 

interpretation of the Florida DUR 

Statute is quite interesting. There are 

virtually no red flags that can or should 

motivate the pharmacist to resolve prior 

to dispensing a controlled substance (as 

opposed to declining to do so), so to the 

extent the pharmacist intends to fill the 

prescription, there is no need to contact 

the prescriber or discuss any issues with 

the patient.85 Thus, there is no real way 

(perhaps short of some extreme 

demonstration of intoxication or other 

drug-seeking behavior exhibited by a 

customer-patient which is observed and 

conveyed to the pharmacist by 

pharmacy staff, or other equally 

unlikely scenario) for the pharmacist to 

identify abuse or misuse. The 

pharmacist’s obligation under the 

Florida DUR Statute is [minimized to 

virtually no obligation, under Dr. 

Buffington’s view].86 Under an 

interpretation where there is no 

obligation to do anything beyond 

inexorably dispensing medications 

(with as substandard a software system 

as can be found), the pharmacy 

registrant [does not have a meaningful 

role of oversight]. [Omitted for brevity.] 

In opining that the Respondent met its 

corresponding responsibility, the 

witness stated that ‘‘corresponding 

responsibility is specific to that if either 

party, the prescriber, or the dispenser, 

knowingly fills a medication that is 

illegitimate; I saw no evidence that there 

was any illegitimate medications, 

prescriptions that were filled in this 

case.’’ Tr. 881. Dr. Buffington made it 

clear that the decisions made by the 

pharmacist, in his view, are not 

amenable to review by others. To the 

witness, a controlled substance 


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87Tr. 915. 

88The Respondent testified that in 2003 he 

worked as a clinical pharmacist at Jackson 

Memorial Hospital. Tr. 589. 

89Tr. 710–11. 

90Tr. 711. 

91 Dr. Howard testified that the Respondent 

pharmacy has been using RX30 software since 2010. 

Tr. 1169. 

prescription becomes invalid, 

potentially unfillable, only when there 

is a ‘‘[k]nowing that the patient was 

using the product inappropriately—they 

were abusing. Knowing that the patient 

was going to be handed the prescription 

but was misusing.’’ Tr. 914. 

Interestingly, Dr. Buffington explained 

that the concept of knowing is based 

purely on ‘‘professional prerogative,’’ 87

that the dispensing pharmacist is ‘‘the 

one that has to discern if [they] know, 

or have reason to know—not a third 

party who’s evaluating that.’’ Tr. 917. 

The witness’s standard strikes as an 

unreviewable judgment call on the part 

of the dispensing pharmacist. [Dr. 

Buffington appears to believe] that every 

pharmacy registrant is possessed of 

essentially un-regulatable, unreviewable 

authority. [This position is inconsistent 

with the] highly-regulated field such as 

pharmacy and the dispensing of 

controlled substances. 

When questioned on an objective 

component of the concept of knowing, 

Dr. Buffington explained that, in his 

opinion, ‘‘[t]he Florida Board of 

Pharmacy defines that.’’ Tr. 921. Dr. 

Buffington suggested at one point in his 

testimony that the state standard of care 

bears no correlation to the regulatory 

administration of a DEA registration. Tr. 

922–23. When pressed on whether his 

opinion would change to any extent if 

the Agency had interpreted knowing in 

a certain way, Dr. Buffington discounted 

DEA’s authority in this way: 

Well they don’t have—the DEA doesn’t 

have the training or the expertise, and has 

never provided a valid instrument that is 

predictively—with predictive valid— 

validity—that demonstrates the method they 

would use to discern that. 

Tr. 928. 

[The Chief ALJ found that Dr. 

Buffington was hostile to DEA as a 

regulator, based on Dr. Buffington’s 

testimony that he does not believe that 

DEA regulations or Agency decisions 

inform pharmacy practice in Florida, or 

that Agency decisions ‘‘even translate[] 

to something that is enforceable.’’ Tr. 

930, 947, 983. I agree with the Chief ALJ 

that this testimony is legally incorrect to 

the extent that it implies that DEA has 

no relevance to a pharmacist’s 

corresponding responsibility in 

dispensing controlled substances. 

Because of DEA’s role in ensuring that 

controlled substances are distributed 

only through lawful channels, and its 

authority to revoke or suspend DEA 

registrations, it is incumbent on 

pharmacies to be familiar with DEA 

decisions and create pharmacy policies 

that ensure that pharmacists are 

fulfilling their corresponding 

responsibility. See Suntree Pharmacy, 

85 FR 73,753, 73,770 (2020); see also 

S&S Pharmacy, Inc., 46 FR 13,051, 

13,052 (1981). DEA publishes final 

orders in administrative proceedings 

involving doctors, pharmacies, and 

other DEA registrants, which provide 

final adjudications on the public record 

of DEA’s expectations for current and 

prospective members of the registrant 

community regarding their obligations 

under the CSA, in particular how the 

provisions of the CSA are adjudicated in 

enforcement actions.] [Omitted for 

brevity.] 

Overall, even setting aside the 

multiple inconsistencies, evasiveness, 

and views he espoused that are directly 

contrary to the Agency’s prior decisions, 

Dr. Buffington’s expressed antagonism 

for the regulatory authority vested in 

DEA and the Administrator undermines 

the weight that can be attached to his 

presentation. While there is no question 

that the witness’s credentials were 

impressive, Dr. Buffington [presented as 

an advocate for Respondent rather than 

as an impartial expert]. That is not to 

say that Dr. Buffington is entirely 

unreliable. This witness is an 

experienced and well-credentialed 

professional. There were certainly 

aspects of his biographical information, 

the progress of his career, and even 

some testimony regarding dispensing in 

general that presented as sensible and 

consistent with the record. However, 

where Dr. Buffington’s views conflict 

with the views expressed by Dr. 

Schossow, at least where her views have 

been deemed reliable and wellsupported in this RD, it is her expert 

opinion that must be afforded greater 

weight. 

Dr. Aaron Howard, Pharm.D. 

The Respondent (while still 

represented by qualified counsel) 

presented the testimony of Dr. Aaron 

Howard, the owner and pharmacist-incharge (PIC) of the Respondent 

pharmacy. The witness (Dr. Howard, the 

Respondent’s owner, or the owner) 

testified that he received his Doctorate 

in Pharmacy in 2003 and has spent the 

vast majority of his career as a licensed 

pharmacist working as a retail 

pharmacist. Tr. 583–84. His experience 

consists of work in chain and 

independent pharmacies, work in a 

hospital pharmacy,88 as well as opening 

and establishing various pharmacies 

(including the Respondent pharmacy in 

2010). Tr. 584–89. 

The Respondent, doing business 

under the name ‘‘At Cost RX,’’ is an 

independent pharmacy and the witness 

explained that its business model was 

designed ‘‘to target patients who need 

prescription drugs who do not have 

insurance or are under insured.’’ Tr. 

589–90. Dr. Howard testified that the 

Respondent pharmacy operates a 

membership program wherein the 

majority of its customer-patients pay for 

their prescriptions in cash. Tr. 590–91. 

‘‘[T]hat’s [its] whole niche.’’ Tr. 591. 

According to Dr. Howard, upon paying 

a membership fee, a customer-patient 

can purchase medications at the 

Respondent pharmacy for prices below 

those found in chain pharmacies in the 

local area. Tr. 591. The discounted price 

is extended as a benefit of the 

membership. Id. The witness explained 

that the Respondent’s discounted price 

system and business model is designed 

to target ‘‘patients who are underserved 

or do[ ] not have insurance.’’ Tr. 1212. 

The ‘‘At Cost’’ name of the pharmacy is 

designed to convey the Respondent’s 

primary business objective of offering 

medications to its customer-patients at a 

discounted price. Tr. 1213. [However, 

there is] no evidence of record that any 

of the Ten Patients held memberships to 

this purported discount program, which 

renders the force of this evidence as 

only marginally relevant. While the 

Respondent employs multiple 

pharmacists, Dr. Howard testified that 

he is the owner and the only pharmacist 

in the organization that dispenses 

controlled substances. Tr. 605. 

Dr. Howard outlined the Respondent’s 

pre-dispensing processes, or drug 

utilization review (DUR). He testified 

that he is the person who conducts the 

DUR at the Respondent pharmacy, 89

that the procedure is conducted as the 

prescription is being processed, 90 and 

that these processes have been the 

subject of some level of evolution over 

time. Tr. 600. The owner testified that 

he places his initials on the prescription 

under review to signify that the DUR 

steps have been undertaken and 

completed. Tr. 735–37. Dr. Howard’s 

depiction of the Respondent’s DUR 

strikes as being strongly dependent 

upon queries generated by the 

commercial electronic software (RX30) 

utilized by the pharmacy.91 Tr. 607–10, 

711–13, 736, 758, 1201–02, 1213–14. 

The owner indicated that the RX30 


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92When pressed on the steps taken in the 

Respondent’s DUR protocol, the Respondent’s 

owner/PIC was either unable or unwilling to 

explain whether the steps occur in a defined order. 

Tr. 1192–95. There was arguably an evasive quality 

to the testimonial exchange with questions 

answered with questions and where a clear message 

was conveyed that the witness was unwilling to be 

locked into a set order of steps in the DUR process. 

Id. 

93After the initial check, the prescriber 

verification process is performed annually. Tr. 605– 

06. No documentation was offered to support this 

step. [Omitted for clarity]. 

94While Dr. Howard testified that he asks for a 

government photo ID to verify the identity of the 

customer-patient, he also volunteered that he does 

not know if this step is a state mandate. Tr. 599. 

95The majority of these notations consisted of a 

check mark and ‘‘PDMP’’ or ‘‘PMP.’’ 

96 Dr. Howard testified that the Respondent began 

utilizing questionnaires in 2015 and that copies of 

the questionnaires are maintained indefinitely at 

the pharmacy. Tr. 599–602, 1125. 

97Tr. 599–602, 1125. 

98ALJ Ex. 55 at 45. 

99Tr. 770. 

100At another point in his testimony, he testified 

that the last step was filling the prescription. Tr. 

1193. 

101No legal theory was ever offered by the 

Respondent to support this hypothetical concern of 

legal exposure for doing its job. 

assists him in identifying red flags of 

over-utilization/under-utilization, 

therapeutic duplication, and drugdisease contraindication. Tr. 712. When 

a patient presents at the Respondent 

pharmacy with a controlled substance 

prescription, Dr. Howard testified that 

there are a number of steps that he 

progresses through to verify the validity 

of the prescription. Tr. 596. However, he 

testified that there was no set order for 

the functions to be completed and 

memorialized on the prescription.92 Tr. 

770. As initially explained by the 

witness, where he is unfamiliar with the 

prescriber, the verification process 

begins with consulting websites 

maintained by DEA and the state of 

Florida to ensure that the prescriber’s 

state license and DEA registration are 

active and without discipline or 

restrictions.93 Tr. 596–97, 600–01. The 

owner testified that he also reviews the 

specialty of the prescriber. Tr. 601. 

The owner testified that he then 

converses with the customer-patient 

regarding ‘‘basic elements, how long 

they’ve been taking the medication, why 

they’re taking the medication, things of 

that nature.’’ Tr. 597; see id. at 737. To 

ensure that the presented patient is the 

patient for whom the prescription was 

written, the Respondent requires the 

presenting patient to show a 

government-issued photo identification 

card.94 Tr. 598–99, 737. The next step 

involves accessing E–FORCSE to 

ascertain when the patient last had a 

controlled substance prescription filled. 

Tr. 597, 736. The owner described the 

state E–FORCSE database as ‘‘a great 

tool’’ that he uses to look for evidence 

of patient doctor-shopping, duplicate or 

inappropriate therapy, as well as early 

refills, and that he notates the execution 

of a check of this system on the 

prescription itself.95 Tr. 611–13. If a 

customer-patient is accepted by the 

Respondent, Dr. Howard explained that 

he/she will fill out a questionnaire, 96

which may prompt additional 

questions/conversation with the patient. 

Tr. 598. Strangely, although the witness 

claims the questionnaires have been 

used by the pharmacy since 2015 and 

are maintained indefinitely, 97 these 

documents were not produced by the 

Respondent when it was served with 

two successive DEA investigative 

subpoenas requiring, inter alia, 

production of: 

[C]omplete medication or patient 

medication records/profiles that the 

pharmacy maintains which documents any 

and all prescriptions filled by the pharmacy; 

any and all additional records documenting 

the steps taken to avoid or resolve any issues 

with the prescriptions presented by [the 

named customer-patients] pursuant to the 

requirements of the Florida Statutes and 

Florida Administrative Code 64B16–27.800 

. . . and, any other documentation kept by 

the pharmacy in connection with the filling 

of prescriptions or providing medical 

treatment for these individuals, including but 

not limited to dispensing reports, billing 

records, [E–FORSCE] reports and medical 

records. 

Gov’t Ex. 2 at 1; see Gov’t Ex. 18 at 1. 

That the Respondent made a choice to 

hold these documents back from 

investigators, even in the face of a 

subpoena, does not further the strength 

of its position, or its efforts to rely on 

these items during the course of the 

hearing. In fact, the adverse inference 

sought by the Government in this case 98

is appropriately taken here. The Agency 

has found it appropriate to take an 

adverse inference where a party has 

made a ‘‘decision not to provide 

evidence within its control . . . .’’ 

Morning Star Pharmacy, 85 FR 51,063 

n.38; see Pharmacy Doctors Enters., 83 

FR 10,899. Accordingly, the decision to 

withhold the documents that were the 

subject of the subpoena gives rise to the 

inference (taken here) that the 

information therein would not be 

supportive of the Respondent’s case; 

that is, that there was either no helpful 

documentation in those papers, or that 

the documentation reflected therein 

would be detrimental to the 

Respondent’s case. 

Although the owner testified that the 

Respondent’s DUR protocol has no set 

order, 99 he also testified at one point 

that the last step in the verification 

process involves reaching out to the 

prescribing physician’s office.100 Tr. 

598. Although, according to the owner, 

he routinely reaches out to prescribers, 

he conceded that he does not document 

the substance of those conversations. Tr. 

602–03. He explained that because he is 

the only pharmacist at the Respondent 

pharmacy that dispenses controlled 

pain medication, he keeps this 

information in his head. Tr. 603–05. 

According to Dr. Howard, he discusses 

a wide range of information with the 

prescribing doctors, such as treatment 

plans, modifications, and red flags. Tr. 

616. When pressed on the issue of 

whether anomalous information 

received from the prescriber ever raises 

a concern that triggers a decision to 

decline dispensing, the owner would 

only go so far as to say ‘‘I have done that 

in the past,’’ but he readily admitted 

that he keeps no list or other 

documentation concerning the 

occasions where that has occurred. Tr. 

604–05. It is the owner’s estimation that 

he has only run into a single prescriber 

that he would place in the category of 

suspicious to the point where the 

Respondent pharmacy would decline to 

dispense on his controlled substance 

prescriptions. Tr. 605. In further 

explaining the decision not to document 

prescriber concerns or keep a list of 

suspicious prescribers, the witness 

offered the following: 

No, I don’t keep a list, you know, because 

that’s an independent judgment call. You 

know, you can’t—well, I’ve seen people 

who’ve gotten in trouble for saying I’m not 

going to fill this particular physician because 

of X, Y, Z. I don’t think that’s legal. I think 

you can subject yourself to legal 

ramifications, but my protocol, since I’m the 

only pharmacist there, if it’s something that 

I don’t agree with that has happened with 

that particular physician, I don’t fill it. I don’t 

keep a printout stating that I don’t fill these 

particular physicians. 

Tr. 604–05. Thus, the decision not to 

document or maintain a list of 

suspicious prescribers is based on the 

owner’s concern that by documenting 

his analysis or the result of the 

pharmacy’s regulatory obligation to 

exercise its corresponding responsibility 

(which he is legally obligated to do), he 

and/or his pharmacy would be 

vulnerable to some theoretical legal 

exposure.101 This theoretical legal 

concern seems to be in some tension 

with the rational and non-theoretical 

concern that by failing to document the 

exercise of the pharmacy’s 


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102Since no evidence was received regarding the 

significance of postal zip code digits, this process 

could not be the subject of any intelligent analysis 

on the issue of whether it rationally furthered the 

objective of identifying distance red flags 

concerning the customer-patients. 

103 [Omitted based on the Chief ALJ’s finding that 

the Government did not adequately prove that long 

distances traveled were a red flag in this case.] 

104The witness’s memory was refreshed with an 

excluded exhibit (Resp’t Ex. 1(ID) at 49) to relate the 

existence of a Patient JA questionnaire (and 

essentially read from it). Tr. 733–34. 

105See, e.g., Gov’t Ex. 5 at 11. 106As discussed, infra, the Respondent initially 

offered into the record a set of Proposed 

Respondent Exhibits (Resp’t Ex. 1(ID) at 41–90) that 

purportedly related to Patient JA. Although 

untimely, the Government’s timeliness objections 

were overruled to afford the Respondent the 

maximum level of due process. Tr. 642–60. 

However, other fundamental issues regarding 

inadequate foundation and reliability precluded the 

admission of the tendered evidence as being 

sufficiently reliable to be considered in this 

adjudication. See 5 U.S.C. 556(d). It is telling that 

after the anomalies regarding Respondent Exhibit 

1(ID) were discovered, the Respondent’s (then) 

counsel did not seek to offer the balance of the 

Proposed Respondent Exhibits that related to the 

nine other charged customer-patients. It is 

reasonable to assume that the unoffered documents 

suffered from the same reliability issues, but as they 

were not offered, such an assumption or further 

discussion is not required. Instead, the balance of 

those unoffered and outside-of-record (OOR) 

documents were used by the Respondent to refresh 

the recollection of the owner for each of the Ten 

Patients. 

107No attempt was made by the Respondent to 

seek to introduce any of the refreshing documents 

as past recollection recorded. See Fed. R. Evid. 

803(5). Ironically, on the last day of his testimony, 

when asked about whether he even remembered his 

testimony being refreshed on the previous day, the 

owner snapped ‘‘That was yesterday. I can’t 

remember. What—I guess what’s your question?’’ 

and ‘‘I don’t recall yesterday, but whatever —.’’ Tr. 

1189. Suffice it to say that announcing under oath 

that he has no recollection of events occurring on 

the previous day is singularly unhelpful to the 

credibility of a witness asking the tribunal and the 

Agency to credit his recollection of events that 

occurred months and years prior. 

108There was even a point during Dr. Howard’s 

testimony where his counsel forgot to employ the 

contrivance of having his recollection refreshed and 

the process devolved to the witness simply reading 

content verbatim from the OOR documents 

pertaining to Patient SD into the record. Tr. 1025– 

27. Suffice it to say that this did not enhance the 

credibility and force of his testimony, or the weight 

to be accorded to it. 

corresponding responsibility, the 

pharmacy would be subject to a 

sanction against its DEA registration. 

According to the owner, the RX30 is 

useful in checking for medication 

conflicts, allergies, and some treatment 

concerns, which, unlike the 

corresponding responsibility outcomes 

and analyses, Dr. Howard claims he 

does document. Tr. 613–15. Further, the 

RX30 system automatically prints out 

some drug-specific information and 

cautionary information for each patient. 

Tr. 618–19. The owner testified that, in 

addition to the RX30-generated patient 

information, he interacts with and 

counsels ‘‘each patient’’ regularly, 

inquiring about side effects, efficacy, 

and observing any overt signs of 

mobility limitations. Tr. 619–20. 

Regarding distance as a potential red 

flag, Dr. Howard testified that the extent 

of the Respondent’s distance-curiosity 

extends only to the zip code supplied by 

the patient-customer. Tr. 635. The 

witness provided the following 

elaboration on the subject: 

I look at the patient’s Florida ID and I look 

at the zip code. If it’s within the same threedigit zip code of our location, then there’s 

nothing for me to ask pertaining to the 

patient. If it doesn’t, then what I do is I 

inquire what’s the reason why they’re coming 

to our pharmacy . . . [, to ascertain t]he 

specific reason why they would travel to our 

pharmacy[.] Is it because of the prices? Is it 

because, you know – that’s pretty much it. 

Tr. 635–36; see also id. at 738, 1173–74. 

Thus, it appears that the Respondent 

looks at the customer-patient’s zip 

code,102 and if the distance is outside 

the three digits of the pharmacy’s 

location, the patient is asked whether it 

is the Respondent’s (presumably 

discounted) prices that has attracted the 

person to make the trip.103

Dr. Howard presented some more 

specific testimony concerning the Ten 

Patients that are the subject of the OSC/ 

ISO. He testified that he had some 

familiarity with Patient JA’s medical 

conditions. Tr. 714–15. According to Dr. 

Howard he spoke to this patient every 

month, and discussed his ailments and 

medications with Patient JA’s multiple 

treating physicians.104 Tr. 714–716, 739, 

750–51. The witness testified that 

through his review of a prescriber’s note 

on the prescriptions,105 he was aware 

that Patient JA had no insurance. Tr. 

752–54. His representation of some 

patient familiarity notwithstanding, 

beyond being led through some of the 

Government-supplied prescriptions, the 

only litigation vehicle apparently 

available to discuss Patient JA’s 

treatment was to have his (then) counsel 

repeatedly refresh his recollection by 

allowing him to peruse excluded/ 

inadmissible pharmacy patient records 

as he was testifying by VTC.106 Tr. 741– 

51, 755–57. Obviously, the weight that 

can be attached to testimony borne of 

the essentially ministerial act of a 

witness reading comments from 

documents that were insufficiently 

reliable to introduce into evidence is 

gravely diminished, but this evidentiary 

contrivance was endured at the hearing 

to afford the Respondent every possible 

measure of due process.107

Evidence was presented in like 

manner regarding his understanding of 

Patient EA. The Respondent’s owner 

recalled that the customer-patient was 

overweight, complained of leg pain, 

worked as a shutter installer, and that 

he spoke with him monthly. Tr. 762–63. 

He also recalled having conversations 

with Patient EA’s prescribing doctor. Tr. 

772. The remainder of the details were 

furnished by refreshing the owner’s 

recollection through Governmentfurnished prescriptions, OOR 

documents, and reviewing marks he 

testified that he had placed on 

dispensed prescriptions. Tr. 764–73, 

777–90, 999–1006. 

The testimony followed the same 

pattern regarding Patient SD. The 

witness testified that he conversed with 

this customer-patient monthly and 

communicated with the prescriber. Tr. 

1007, 1014. The owner again tracked 

along with the markings on the 

prescriptions as a guide to the DUR 

(which he presented as always being 

completed), he examined the 

prescriptions supplied by the 

Government in its exhibits, and 

refreshed his recollection with OOR 

documents as before.108 Tr. 1007–30. 

The same general mechanics were 

again applied by the Respondent in 

addressing charged prescriptions 

regarding Patient LH. The witness 

testified that he also had monthly 

interactions with Patient LH, that he 

was familiar with his prescribing 

physician, that the handwritten 

markings on the Government-furnished 

prescriptions signified that he employed 

every step of the Respondent’s DUR 

protocol, that he considered any and all 

red flags, and that he had them 

conclusively resolved by discussions 

with the customer-patient prior to 

dispensing. Tr. 1030–47. Regarding a 

drug-drug interaction flag that was 

presented in the OOR documents, and 

upon realizing that even the documents 

contained no articulated resolution, the 

witness [testified]: ‘‘Yeah. I assessed it 

in my mind. There’s no inter—there’s 

no issue with him taking that 

medication.’’ Tr. 1043. On the same red 

flag, when asked about how the issue 

was actually resolved, the witness 

merely added: ‘‘The [RX30] system flags 

it. I flagged it in my mind that that’s not 

a[n] issue.’’ Tr. 1044. Upon a third effort 

to attempt to help the witness explain 

how the red flag might have been 

analyzed and resolved, the owner 

became visibly impatient and said 

‘‘Well I don’t know how else to explain 

it.’’ Id. [Omitted for brevity.] The 

rationale here is apparently that because 

he dispensed the medicine he must 

have resolved whatever red flags may 

have been connected with the 

transaction. Either the witness was 


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109Tr. 1045. 

110 [Omitted for brevity.] 

111Even though this process had repeated itself 

numerous times, when asked by his counsel 

whether he had ‘‘an independent recollection of the 

flags that were raised and resolved with respect to 

the first set of prescriptions that [he had been 

asked] about with [Patient] DH,’’ he answered that 

he did. Tr. 1066. Thus, it would have appeared that 

the witness’s memory was not in need of refreshing. 

When asked about it, the witness then immediately 

said ‘‘No, I don’t recall.’’ Id. Like many other 

features of this witness’s testimony, this feature did 

not enhance the credibility of his presentation. This 

additional anomaly notwithstanding, the 

Respondent’s counsel was permitted to continue to 

refresh the owner’s recollection with excluded 

documentation to afford the Respondent the 

maximum margin of due process. 

112The witness testified that he did see a PMP 

anomaly regarding a new prescriber, raising a 

conflict that he purportedly resolved through 

conversations with the customer-patient and the 

prescriber, some details of which were 

memorialized in a July 31, 2019 handwritten note 

on the applicable prescription. Tr. 1163–64; Gov’t 

Ex. 29 at 5. 

being truthful and his analysis was 

really no cognizable analysis, or the red 

flag was never really considered before 

the medication was dispensed. Neither 

scenario furthers the Respondent’s 

interests in avoiding a registration 

sanction in this case. Even the 

subsequent leading, rehabilitation 

questions from the Respondent’s 

counsel about whether he believes he 

‘‘[w]ould [ ] have filled the prescription 

if [the red flag] had not been 

resolved’’ 109 [did not rehabilitate the 

witness on this issue]. 

The testimony of the Respondent’s 

owner regarding Patient DH followed 

the same general configuration. There 

was some testimony regarding the 

customer-patient’s diagnoses.110 Tr. 

1058. The witness’s memory also was 

refreshed 111 using a patient 

questionnaire that was also not offered 

or admitted into the record. Tr. 1059– 

64. At one point during the witness’s 

testimony about Patient DH he testified 

that he spoke to the prescriber to resolve 

a drug-drug red flag, then when pressed, 

retreated to the language of the 

refreshing document, and corrected his 

testimony to reflect that he only 

consulted with the patient on the issue. 

Tr. 1068–71. It is reasonable to infer that 

a recurring theme for this witness was 

to somehow ascertain the most 

advantageous answer, which often came 

from the refreshing documents. 

The testimony was very much the 

same with respect to Patient JM. The 

owner averred that he saw the patient 

monthly, that he spoke with her 

prescribers, and while on the stand he 

had his recollection refreshed with OOR 

documents. Tr. 1102–35. The 

recognition of marks on prescriptions 

regarding Patient JM again allowed him 

to assure the tribunal that all 

appropriate steps were taken. Tr. 1118– 

19, 1129–35. One aspect that was 

unique to the witness’s refreshed 

recollection regarding this patient is 

that, the testimony of the Government’s 

expert notwithstanding, the owner 

insisted that prescribing two different 

benzodiazepines simultaneously to one 

patient is ‘‘not a problem.’’ Tr. 1111. 

The owner dismissed the entire issue 

this way: ‘‘So I did hear previous 

testimony stating that that’s an issue, it’s 

absolutely incorrect.’’ Tr. 1111–12. 

Simultaneous prescribing of multiple 

opioids received the same treatment 

from the owner. When asked if this 

practice raised a red flag, his answer 

was ‘‘[a]bsolutely not.’’ Tr. 1112. He saw 

no red flags that required resolution. Tr. 

1116. 

The owner’s testimony regarding 

Patient JW was more of the same. He 

said he spoke to the patient once a 

month, spoke with his prescriber, and 

read off of a litany of OOR documents 

purportedly to tender a more refreshed 

recollection. Tr. 1139–50. Interestingly, 

the owner opined that the 

administration of methadone for pain is 

common. Tr. 1146. Whether through 

disinterest, witness fatigue, self-interest, 

or some other cause, when asked by 

counsel whether his testimony 

regarding the significance of the 

prescription annotations extended to all 

the prescriptions received in the record, 

the witness first said ‘‘No it wouldn’t,’’ 

but upon being pointedly re-asked the 

same question by the Respondent’s 

counsel, the witness then agreed that it 

would. Tr. 1148–49. This seeming 

recurrence of the witness’s willingness 

to say whatever answer he believed 

would be most helpful to his cause was 

not a credibility-enhancing feature of 

his presentation. Sworn testimony 

where a witness definitively responds 

yes and then upon being abruptly asked 

the same question a second time 

responds no hardly presents a model for 

reliable evidence. 

The same pattern persisted regarding 

the witness’s testimony concerning 

Patient CW. More refreshing that 

followed seemingly rote assurances that 

the customer-patient was seen monthly, 

and a blanket statement that no 

concerns regarding the dispensing 

events were encountered.112 Tr. 1151– 

64. Tellingly, when asked by the 

Respondent’s counsel whether the 

owner specifically recalled any physical 

observations regarding Patient CW, the 

witness replied: 

Well, yeah. I mean, I’ve been knowing her 

for probably since 2012, so I can’t remember 

like right off the top of my head, right now, 

as far as—I can’t remember right of the top 

of my head. I’m not sure. 

Tr. 1152. Thus, when first asked, the 

witness responded that he did recall 

some physical observations about the 

customer-patient, but then, apparently 

realizing that he might be called upon 

to relate some of those observations, 

reversed course and said he was not 

sure and could not remember them ‘‘off 

the top of [his] head.’’ Id. Prescribing 

multiple opioids simultaneously also 

was, in the opinion of the owner, 

undeserving of any particular 

heightened scrutiny. Tr. 1156. The 

witness’s view of disregarding the 

Government expert’s view regarding this 

red flag was merely that the patientcustomer had ‘‘been on pain 

management therapy for a very, very 

long time that I can remember . . . [for] 

a lot of different ailments . . . .’’ Id. 

Thus, the owner’s account presents a 

binary choice: Either there is no red flag 

inherent in prescribing multiple opioids 

and the Government’s expert is wrong, 

or the mere fact that the patient has 

been receiving medications in the face 

of a long-term unresolved red flag of 

potential diversion is completely 

dissipated by the fact that the 

dispensing (from the Respondent 

pharmacy) has been conducted in this 

manner for a long time. Neither scenario 

is particularly persuasive. The 

testimony of the Government’s expert 

regarding the validity of this multipleopioid red flag is persuasive, and the 

fact that a red flag was ignored for a 

sustained period does not deprive the 

red flag of its soundness. 

The presentation pattern was 

substantially repeated regarding Patient 

DK. Tr. 1078–1101. The witness did 

convey some seemingly 

contemporaneous memory about Patient 

DK, remembering some particulars 

about her treatment and about the fact 

that (according to the owner) a caretaker 

regularly dropped her off to retrieve her 

medications. Tr. 1086–88. But the 

Respondent resorted to the same 

recollection refreshing regarding the 

significant particulars of the dispensing 

events. One feature of the owner’s 

testimony regarding Patient DK was 

particularly telling. When directed to 

one of the Government-furnished 

prescriptions issued to this patient, the 

Respondent’s counsel invited his 

attention to what appeared to be a 

seemingly commendable notation on the 

prescription that purportedly 

synopsized a conversation between the 

owner and Patient DK concerning her 

diagnoses, weight loss, and pain 


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113The witness testified that the conversation 

with the customer-patient led to a resolved 

understanding of the prescriber’s decision to titrate 

the customer-patient’s medication downward. Tr. 

1097. 

114As it happens, these documents were not 

timely served on the tribunal or the Government, 

and the Government’s timeliness objections were 

overruled to afford the Respondent the maximum 

level of due process. Tr. 642–60. However, other 

fundamental issues regarding foundation and 

reliability precluded the admission of the tendered 

evidence as being sufficiently reliable to be 

considered in this adjudication. See 5 U.S.C. 556(d). 

While the procedural timeliness objection could be 

(and was) overlooked by the tribunal in an effort to 

ensure the Respondent was able to present its case, 

the inherent unreliability of the tendered 

documents (as discussed, infra) prevented receipt 

into the record. 

115See 5 U.S.C. 556(d). The untimely filing of the 

proposed evidence in the absence of any 

demonstration of good cause supplied good cause 

for the Government’s at-hearing authenticity 

objection. See 21 CFR 1316.59(c). 

level.113 Gov’t Ex. 26 at 17–18. After 

identifying his handwriting, the witness 

[offered testimony that devalued the 

importance of documentation]: 

Q. Dr. Howard, can you please tell the 

tribunal what was the intent and purpose of 

the note that you placed on this particular 

prescription? 

A. Basically, to document the 

conversations between the patients more. 

With this situation, what occurred is the 

patient had been in the hospital for probably 

about three weeks from a serious infection 

and what happened was is [that] the 

physician reduced the dosage for the patient 

based upon her weight loss. So I counseled 

the patient and explained to her the reason 

why the physician reduced her medication 

based upon that issue. So that was the reason 

why I documented it, it’s just an extra 

compliance step. This is something that 

pharmacists do all the time, never to—never 

to thought to this point where you would 

have to do things like this, but this is what 

we do. 

Q. I’m sorry, when you say you never 

thought you had to do things like this, what 

did you mean by this? 

A. Document to this extent. I mean it’s 

just—it’s absolutely absurd because you 

would be doing more documenting than 

dispensing medication if you go by some of 

the previous testimonies that I’ve heard, 

being a pharmacist. 

Q. Let me stop you there. . . . 

Tr. 1095–96 (emphasis supplied). When 

invited multiple times (by the tribunal 

and the Respondent’s counsel) to 

explain what he meant about the 

documentation being ‘‘absurd,’’ the 

Respondent’s owner stuck to his guns 

on the issue. Tr. 1098–1100. The owner 

asked the tribunal whether he had ever 

worked in a pharmacy, and upon 

procuring a negative response, he 

offered the following: 

Okay. So if you’ve ever worked in a 

pharmacy, you have a lot of patient 

interaction between yourself and the patient. 

And you have conversations every month. If 

you were to document every conversation, 

every incident that you have with a 

particular patient, you would not be able to 

fill prescriptions. 

Tr. 1098. When invited again to explain 

the part of the documentation obligation 

that he found ‘‘absurd,’’ the 

Respondent’s owner doubled down, 

stating: 

Well, I mean I think it’s absurd to the sense 

where from testimony that I’ve heard, 

previous testimony that I’ve heard on you 

call a physician every time you almost fill a 

prescription or if you know that particular 

patient, you know their illness. You’ve had 

interaction with that patient over the years. 

To call a physician, and you know the 

physician and you know the patient, on 

every prescription is absurd. 

Tr. 1099. The only testimony the 

Respondent’s owner ‘‘heard’’ during the 

hearing on this subject emanated from 

the Government’s expert witness, but to 

remove any ambiguity on that front, the 

witness clarified that the testimony he 

was referring to as ‘‘absurd’’ was ‘‘the 

expert witness for the DEA.’’ Tr. 1100. 

Thus, the Respondent’s owner was 

making it clear that the documentation 

requirements that underpin the standard 

of care are absurd in his view. [Omitted 

for brevity. I agree with the Chief ALJ 

that Respondent’s statements as do not 

instill confidence in me that he will be 

compliant with the law in the future.] 

At one point during the witness’s 

testimony, the Government conducted a 

voir dire regarding screen shots of RX30 

pages (the RX30 Screen Shots) regarding 

Patient JA that were purportedly 

generated in the ordinary course of 

business in the Respondent pharmacy at 

the time of the charged dispensing 

events.114 Resp’t Ex. 1(ID) at 55–90. 

Although the Government’s timeliness 

objections were overruled, the 

Respondent, as the proponent of the 

evidence,115 was ultimately 

unsuccessful in bearing its burden to 

establish admissibility. The 

Respondent’s theory for admission of 

the RX30 Screen Shots was founded on 

the proposition that each tendered page 

was a screen shot of information created 

and inputted into the RX30 at the time 

of the dispensing event. Tr. 664–69. Dr. 

Howard testified that he created and 

prepared every one of the documents 

within the RX30 Screen Shots. Tr. 669, 

686–88. At one point he testified that 

the data entries were made either by 

himself or the pharmacy staff. Tr. 665. 

He also (inconsistently) said that he 

inputted all data into the system 

himself. Tr. 688. However, the witness 

was unequivocal that the screen shots in 

question were made by him personally. 

Tr. 687–88. Yet, when Dr. Howard was 

asked to explain, if he truly made all the 

RX30 entries, why various RX30 screens 

contained the initials of pharmacy techs 

who work at his pharmacy, his answers 

were [inconsistent and confusing]. The 

witness first said that the tech initials 

could be explained by ‘‘[i]t could’ve 

been a different screen that I had to 

open up, or something like that.’’ Tr. 

686. After an offer by Dr. Howard to 

‘‘clarify so I can let you understand,’’ he 

explained the presence of various tech 

initials by saying, ‘‘That means that 

when I was logged into the system, I 

was logged in under just my initials.’’ 

Id. When asked why some of the initial 

fields were blank, the Respondent 

offered that this was ‘‘[b]ecause I was 

logged into my system.’’ Tr. 687. When 

pressed on this and given another 

opportunity to explain, the owner stated 

that the initials from various pharmacy 

technicians appeared on the screens on 

different pages 

[b]ecause I didn’t generate them all in one 

day. I didn’t sit there and go through these 

all in one day . . . . I just explained to you. 

Because when those would generate [sic], it 

was under that tech’s—I guess, that 

computer. 

Tr. 687. Whether the data was all 

inputted by Dr. Howard (as he said) or 

by Dr. Howard and pharmacy staff 

(which he also said), it is clear that this 

is yet another issue upon which Dr. 

Howard has provided inconsistent 

information under oath. Obviously, 

when taken together, none of these 

explanatory statements (made by a 

highly educated medical professional) 

made any sense whatsoever, raising the 

reasonable inference that he was being 

less than candid about the RX30 system, 

the identity of those who entered the 

data, and (most importantly) the 

integrity of the proffered evidence. 

Although the overwhelming majority 

of the tendered RX30 Screen Shots had 

a ‘‘Print’’ option at the bottom of the 

page, the owner at one point testified 

that the pages could not, in fact, be 

printed. Tr. 672. Dr. Howard then stated 

that the pages could be printed so long 

as the print feature is accessed through 

the DUR screen related to a specific 

dispensing event. Tr. 672. He then 

reversed himself and adhered to his 

initial position that the screen could not 

be printed out. Tr. 673. 

The majority of these pages contained 

options for a variety of actions, to wit: 

‘‘F1 Return,’’ ‘‘F3 Select,’’ ‘‘F5 Print,’’ 

‘‘F8 Delete,’’ and ‘‘F9 Help.’’ Resp’t Ex. 

1(ID) at 57–66, 68–90. Notwithstanding 

Dr. Howard’s assurance that the pages 

could not be printed, the majority of the 

software pages he tendered for the 


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116Notwithstanding his testimony that he 

inputted all the information into the RX30 system, 

the owner did not seem to understand much about 

how the system actually works; and his lack of 

understanding extended beyond cursors and 

printing. At another point in his testimony, Dr. 

Howard testified that he was unsure if the 

customer-patients were presented with counseling 

screens at the time of medication dispensing. Tr. 

758–59. When asked about it, he simply said ‘‘I’m 

not aware of how it works.’’ Tr. 758. Ultimately, he 

gave up on explaining whether the RX30 had such 

a feature, and volunteered that he provides a 

hardcopy paper counseling election sheet to each 

patient. Tr. 759. But when asked where such 

hardcopy counseling sheets are maintained at the 

pharmacy, he was unable to supply a coherent 

response. When asked if the counseling sheets are 

kept in a binder, his answer was: ‘‘Well, it’s not a 

binder. We keep it sort of—well, yeah, it’s a 

binder.’’ Tr. 760. The same confusion permeated the 

owner’s testimony about other systems that he 

would have been expected to be conversant in. 

When asked about whether and where patient 

questionnaires are maintained and for how long, he 

testified that they were stored at the pharmacy, and 

joked that they were maintained ‘‘[a]s long as we 

don’t lose them.’’ Tr. 601–03. Inasmuch as he 

testified that he is the owner, PIC, and exclusive 

controlled substance dispensing pharmacist, his 

general lack of awareness about the automation 

system utilized by his pharmacy, and even other 

filing systems used there, is surprising. Irrespective 

of whether the witness was being intentionally 

evasive, or genuinely lacks a basis for 

understanding the pharmacy systems (automated 

and manual) operating under the pharmacy he 

owns and supervises, this feature of his 

presentation was unhelpful in meeting the 

Government’s evidence. 

117Resp’t Ex. 1(ID) at 57. 118Tr. 1215. 

record clearly contained a print option 

for the operator on the screen. Page 67 

of the RX30 Screen Shots (Page 67) had 

no option to print, but unlike any of the 

other pages, this page had a ‘‘F4 Save’’ 

option, which was clearly highlighted. 

Id. at 67. It is not unreasonable to infer 

that the appearance of a ‘‘Save’’ option 

that was unique to a single page signals 

that as yet unsaved information was 

entered or altered into the database and 

that this changed information is now 

amenable to being saved. In the absence 

of any explanation by the owner (the 

purportedly most knowledgeable person 

at the hearing about the RX30 system) 

to the contrary, the preponderant 

evidence supports the proposition that 

Page 67 in the proffered exhibit depicts 

data that was altered or supplemented 

prior to the printing of the page, and not 

when the dispensing event occurred. 

Another feature that was remarkable 

about the RX30 Screen Shots is that, 

notwithstanding the Respondent’s 

admission theory that these documents 

represent unadulterated screen shots 

that merely and reliably depict 

information stored in the RX30 system, 

the cursor is lit up on different fields 

depending on the page. Id. at 57, 63, 66, 

68–90 (Intervention field), 58–62, 64–65 

(Outcome field), 67 (Reason for 

Intervention field), 56 (Patient name 

field), 55 (a listed diagnosis within the 

International Classification of Diseases 

(ICD) field). When asked why the cursor 

was resting in different fields depending 

on the page, the owner dismissively 

declared that he did not know, that he 

had ‘‘no clue,’’ that he had ‘‘no idea,’’ 

and that ‘‘[i]f you’re trying to imply that 

I changed things, you’re wrong.’’ Tr. 

675–78, 682–83. This was one of the 

points during the hearing where the 

witness’s voice and demeanor reflected 

increasing agitation and volume as the 

inquiry progressed. 

The witness insisted that he did not 

know where the cursor ordinarily 

populates and was unable to explain 

why it migrated to different places on 

the RX30 Screen Shots.116 Tr. 671. 

Additionally, when asked why one of 

the pages contained text that bore a date 

about three and a half years beyond the 

dispensing event date,117 the witness 

was unable to explain, but just kept 

repeating that he did not understand the 

question, and defensively asked ‘‘what 

are you trying to say?’’ Tr. 670–71, 679, 

681–82. 

Dr. Howard’s contradictory and 

illogical statements, coupled with his 

dismissive declarations that he has no 

clue and no idea about how his own 

software system operates and why a 

host of anomalies were present in the 

tendered RX30 Screen Shots, were and 

are simply unpersuasive and detracted 

profoundly, not only from the 

Respondent’s attempts to secure 

admission of the evidence, but more 

fundamentally from any credibility that 

could be accorded to the balance of his 

sworn testimony. 

The dynamic regarding the RX30 

notes is rendered worse by the fact that, 

as discussed, supra, these purportedly 

contemporaneously-created notes fit 

squarely within the parameters of the 

DEA’s multiple subpoena demands for: 

[C]omplete medication or patient 

medication records/profiles that the 

pharmacy maintains which documents any 

and all prescriptions filled by the pharmacy; 

any and all additional records documenting 

the steps taken to avoid or resolve any issues 

with the prescriptions presented by [the 

named customer-patients] pursuant to the 

requirements of the Florida Statutes and 

Florida Administrative Code 64B16–27.800 

. . . and, any other documentation kept by 

the pharmacy in connection with the filling 

of prescriptions or providing medical 

treatment for these individuals, including but 

not limited to dispensing reports, billing 

records, [E–FORSCE] reports and medical 

records. 

Gov’t Ex. 2 at 1; see Gov’t Ex. 18 at 

1. The Respondent’s owner [testified 

that he was confused by what was 

required]. Tr. 1206–07. The 

Respondent’s owner is and was a 

highly-educated, experienced registrant. 

The idea that this clear, directive 

language [was too confusing for him to 

comply with the subpoena was not 

credible]. Similarly unpersuasive was 

the Respondent’s argument that the 

owner was unobligated to comply with 

the Government’s multiple subpoenas 

because they were addressed to his 

counsel.118 Tr. 1208. The issue here was 

not a subpoena enforcement technicality 

being litigated in a United States District 

Court. See 5 U.S.C. 555(d). The 

Respondent is engaged in a dangerous, 

highly-regulated activity, and it and its 

(then) counsel well understood the 

documents the regulator was seeking. 

Likewise, the owner’s preliminary 

response to whether he produced the 

customer-patient questionnaires that 

evolved from ‘‘I think, at that time I 

think it was [produced], I believe so,’’ to 

a solid declaration that in the course of 

several seconds of testimony that he 

somehow became sure that the 

questionnaires were provided, was 

unconvincing to say the least. Tr. 1168– 

73. Similarly, when asked in what 

format the questionnaires were supplied 

to the Government, and if they were 

supplied in hard copy, the witness first 

said, ‘‘I’m not sure. I would assume. 

Yeah, they were in hard—well I don’t 

know if they were in hard copy, but I, 

I guess they were sent electronically.’’ 

Tr. 1172. This was shortly followed up 

by this more definitive declaration: 

‘‘Electronically. We produced them 

electronically.’’ Tr. 1173. This was 

immediately followed by the following 

statement: 

To be honest with you, I don’t 100% know. 

I know that we provided them to you. You 

know, whatever question that you’re trying to 

get at, I can tell you that we provided them 

to them, to you. Now the means that we 

provided it to you, I cannot remember, so I 

don’t want to sit here and say something that 

I did or didn’t do, when I totally don’t 

remember. I can tell you we scanned them. 

They were in a binder, we scanned them in, 

and those were provided to you. 

Id. [This testimony was inconsistent 

and not credible. Omitted for brevity.] 

The questionnaires and the RX30 notes 

were not produced when demanded. 

They were produced late and with 

anomalies in the RX30 notes that 

precluded a finding that they were 

reliable and may even possibly have 

been altered; and notwithstanding all 

that, the witness was still permitted to 

have his recollections refreshed by 

mostly reading the content of the 

unreliable, untimely-filed documents. 

The inconsistency of the owner’s 


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119Even beyond the words on the page of a sterile 

transcript (quite animated, even on their own in 

this case), the witness’s tone and volume during his 

testimony was sometimes elevated and presented 

on multiple occasions as impatient and even visibly 

angry. 

answers, the structure of the 

Respondent’s actions in subpoena 

(non)compliance, and the refreshing use 

of the documents essentially precluded 

reasonable reliance on these latediscovered items and ultimately hurt 

the credibility of the Respondent’s case. 

At another point in the owner’s 

testimony, when asked the basic, 

straightforward question as to whether 

he ‘‘would agree that there are red flags 

in pharmacy,’’ the witness supplied the 

following convoluted response: 

Well if you want to deem it as a red flag, 

if you want to use the term red flag, that will 

be considered a red flag, or, if you check the 

PMP and you see that this patient that 

probably has a valid prescription but they 

went to two other physicians the day before, 

that’s a red flag, for the same medication, 

those—if you wanna use the term red flag, 

that’s a red flag. 

Tr. 1182–83. While the witness did 

indicate that he would not dispense a 

prescription under the scenario his own 

reply created, his answer was 

[concerning in that he remains 

unwilling to acknowledge the 

importance, or even existence, of red 

flags. He dismissed the concept of a red 

flag] as a subjective exercise in whether 

the questioner (i.e., DEA) ‘‘want[s] to 

deem it as a red flag,’’ whereby anything 

‘‘will be considered a red flag.’’ Tr. 

1182. [Omitted for brevity. I agree with 

the Chief ALJ that these statements do 

not instill confidence in me that 

Respondent will be compliant with the 

law in the future.] 

The Respondent’s owner supplied 

another insightful window into his true 

amenability to regulatory oversight at 

another point in his testimony. This 

exchange commenced with an inquiry 

regarding whether the questionnaires 

used by the pharmacy had seen any 

level of modification over time. The 

owner impatiently replied that the 

documents were modified in format for 

‘‘[t]he same reason why we’re sitting 

here.’’ Tr. 1185. When asked to explain, 

the witness [testified]: 

All the documentation and things that we 

try to do to satisfy the DEA, it still does not 

matter, all the documentation, all the 

compliance that we’ve done, to show 

regulatory agencies we go over and beyond 

to try to, to make sure that we do our part, 

it did not matter. It did not matter. . . . I 

said it does not matter to the regulatory 

agencies. It does not matter as far as how 

much compliance the pharmacy does. We 

[changed the questionnaire] as a compliance 

issue to make sure that we’re trying to stay 

in compliance. We asked for guidance. We 

try our best to do what’s right. 

Tr. 1185–86. Thus, even in this case 

where the record shows that the 

Respondent’s documentation was 

inadequate [and outside the usual 

course of professional practice], the 

owner’s response is that he believes he 

has done enough and it does not matter 

what steps his pharmacy takes in the 

future. This is not the voice of a 

registrant seeking to come into 

compliance, but essentially one who is 

communicating that he is [frustrated] 

with the efforts already invested to try 

to meet the state standards for 

dispensing controlled substances. The 

owner’s mindset remained consistent 

when asked about why the 

Respondent’s patient questionnaires 

queried about distance. The witness did 

not indicate that distance could be an 

important red flag of potential 

diversion, but rather affirmed that the 

question was included ‘‘[b]ecause that’s 

one of the things that the DEA has been 

targeting, is patients traveling long 

distances.’’ Tr. 1218. [Omitted for 

brevity.] 

The witness was also unwilling to 

distance himself from Dr. Buffington’s 

opinions that DEA has virtually no 

legitimate role in regulating the 

dispensing of controlled substances, 

notwithstanding invitations by the 

tribunal to do so in the best interests of 

his case. Tr. 1222–24. [The witness 

maintained throughout the hearing] that 

every single prescription that is the 

subject of these proceedings was 

dispensed correctly and with adequate 

documentation. Tr. 1224. 

On the issue of credibility, 

Respondent’s owner, Dr. Howard, has 

the most at stake in these proceedings, 

as the DEA registration that is the 

subject of this litigation concerns his 

pharmacy. Even beyond that, the 

testimony of this witness was often 

evasive, internally inconsistent, 

defensive, implausible, and sometimes 

even objectively hostile in tone.119 As 

discussed in considerable detail, supra, 

during the course of his testimony, the 

witness [stated] that many of the efforts 

expended in the Respondent’s 

dispensing practices were not geared 

toward identifying and targeting 

potential diversion, but to avoid 

professional scrutiny from DEA. 

[Additionally], the fact that the 

Respondent’s owner declined to turn 

over subpoenaed documents until late 

in the proceedings, and sponsored 

documents that raised anomalies that 

were fatal to their reception into the 

record, further undermined his 

credibility, resulted in an adverse 

inference, and diluted the strength of 

his case. As discussed, supra, the 

Respondent’s owner [declined] to 

distance himself from the testimony of 

its expert witness that DEA [does not 

have a significant role] in regulating 

pharmacy practice. To be sure, there 

were certain historical and/or 

biographical features of this witness’s 

testimony that could be credited, but 

regrettably, the testimony presented by 

this witness cannot be afforded a 

positive credibility finding. 

Other facts necessary for a disposition 

of this case are set forth in the balance 

of this recommended decision. 

The Analysis 

The Government seeks revocation 

based on its contention that the 

Respondent, through its pharmacists 

and employees, has committed acts that 

would render its continued registration 

inconsistent with the public interest as 

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

gravamen of the Government’s 

allegations and evidence in this case 

focus on the Respondent’s alleged (1) 

dereliction in the exercise of its 

corresponding responsibility in 

dispensing of controlled substance 

prescriptions and (2) violations of 

federal and state laws relating to 

controlled substances. 

Public Interest Determination: The 

Standard 

Under 21 U.S.C. 824(a)(4), the Agency 

may revoke the COR of a registrant if the 

registrant ‘‘has committed such acts as 

would render [its] registration . . . 

inconsistent with the public interest.’’ 

21 U.S.C. 824(a)(4). Congress has 

circumscribed the definition of public 

interest in this context by directing 

consideration of the following factors: 

(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. 

(5) Such other conduct which may threaten 

the public health and safety. 

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

‘‘These factors are to be considered in 

the disjunctive.’’ Robert A. Leslie, M.D., 

68 FR 15,227, 15,230 (2003). Any one or 

a combination of factors may be relied 

upon, and when exercising authority as 

an impartial adjudicator, the Agency 

may properly give each factor whatever 

weight it deems appropriate in 


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120The Agency has consistently adhered to this 

policy in its adjudications. See, e.g., Ronald Lynch, 

M.D., 75 FR 78,745, 78,754 (2010) (holding that the 

respondent’s attempts to minimize misconduct 

undermined acceptance of responsibility); George 

Mathew, M.D., 75 FR 66,138, 66,140, 66,145, 66,148 

(2010); George C. Aycock, M.D., 74 FR 17,529, 

17,543 (2009); Krishna-Iyer, 74 FR 463; Steven M. 

Abbadessa, D.O., 74 FR 10,077, 10,078 (2009); Med. 

Shoppe-Jonesborough, 73 FR 387. 

121The record contains no recommendation from 

any state licensing board or professional 

disciplinary authority (Factor One). [Where the 

record contains no evidence of a recommendation 

by a state licensing board that absence does not 

weigh for or against revocation. See Roni Dreszer, 

M.D., 76 FR 19,434, 19,444 (2011) (‘‘The 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 the Respondent’s DEA certification 

is consistent with the public interest.’’).] The record 

likewise contains no evidence of a specific 

recommendation by competent state authority or 

any action from which its intent could be 

discerned. See Jeanne E. Germeil, M.D., 85 FR 

73,786, 73,799 (2020) (Agency recognizes that its 

prior final orders have considered this dichotomy 

of sources for Factor One consideration). The 

Agency has recognized that the failure by a state to 

affirmatively take action against a registrant ‘‘carries 

minimal to no weight under Factor One.’’ Id. 

Similarly, there is no record evidence of a 

conviction record relating to regulated activity 

(Factor Three). Even apart from the fact that the 

plain language of this factor does not appear to 

place emphasis on the absence of such a conviction 

record, the myriad of considerations that are 

factored into a decision to initiate, pursue, and 

dispose of criminal proceedings by federal, state, 

and local prosecution authorities lessen the logical 

impact of the absence of such a record. See Robert 

L. Dougherty, M.D., 76 FR 16,823, 16,833 n.13 

(2011); Dewey C. MacKay, M.D., 75 FR 49,956, 

49,973 (2010) (‘‘[W]hile a history of criminal 

convictions for offenses involving the distribution 

or dispensing of controlled substances is a highly 

relevant consideration, there are any number of 

reasons why a registrant may not have been 

convicted of such an offense, and thus, the absence 

of such a conviction is of considerably less 

consequence in the public interest inquiry.’’), aff’d, 

MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011); 

Ladapo O. Shyngle, M.D., 74 FR 6056, 6057 n.2 

(2009). The Agency has previously recognized the 

minimal impact of the absence of such a conviction 

in the Public Interest analysis. Germeil, 85 FR 

73,799. Therefore, the absence of criminal 

convictions militates neither for nor against the 

revocation sought by the Government. That the 

Government’s allegations and evidence fit squarely 

within the parameters of Factors Two and Four and 

do not raise ‘‘other conduct which may threaten the 

public health and safety,’’ 21 U.S.C. 823(f)(5) 

(Factor Five) (emphasis supplied), likewise 

militates neither for nor against the sanction sought 

by the Government in this case. 

122 JM Pharmacy Grp., Inc., 80 FR 28,667, 28,667 

n.2 (2015); Krishna-Iyer, 74 FR 462. 

determining whether a registrant’s COR 

should be revoked. Id.; see Morall v. 

DEA, 412 F.3d 165, 173–74 (D.C. Cir. 

2005). Moreover, the Agency is ‘‘not 

required to make findings as to all of the 

factors,’’ Hoxie v. DEA, 419 F.3d 477, 

482 (6th Cir. 2005) (citing Morall, 412 

F.3d at 173–74), and is not required to 

discuss consideration of each factor in 

equal detail, or even every factor in any 

given level of detail. Trawick v. DEA, 

861 F.2d 72, 76 (4th Cir. 1988) (holding 

that the Administrator’s obligation to 

explain the decision rationale may be 

satisfied even if only minimal 

consideration is given to the relevant 

factors, and that remand is required 

only when it is unclear whether the 

relevant factors were considered at all). 

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). 

In the adjudication of a revocation of 

a DEA COR, DEA has the burden of 

proving that the requirements for the 

revocation it seeks are satisfied. 21 CFR 

1301.44(e). Where the Government has 

met this burden by making a prima facie 

case for revocation of a registrant’s COR, 

the burden of production then shifts to 

the registrant to show that, given the 

totality of the facts and circumstances in 

the record, revoking the registrant’s COR 

would not be appropriate. Med. ShoppeJonesborough, 73 FR 364, 387 (2008). 

Further, ‘‘to rebut the Government’s 

prima facie case, [a 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 re-occurrence 

of similar acts.’’ Jeri Hassman, M.D., 75 

FR 8194, 8236 (2010); accord KrishnaIyer, 74 FR 464 n.8. 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. 

David A. Ruben, M.D., 78 FR 38,363, 

38,364, 38385 (2013). 

Normal hardships to the registrant, 

and even the surrounding community, 

which are attendant upon lack of 

registration, are not a relevant 

consideration. Heavenly Care 

Pharmacy, 85 FR 53,402, 53,420 (2020) 

(principle conclusively applied to 

pharmacy registrants); Linda Sue Cheek, 

M.D., 76 FR 66,972, 66,972–73 (2011); 

Gregory D. Owens, D.D.S., 74 FR 36,751, 

36,757 (2009). Further, the Agency’s 

conclusion that ‘‘past performance is the 

best predictor of future performance’’ 

has been sustained on review in the 

courts, Alra Labs., Inc. v. DEA, 54 F.3d 

450, 452 (7th Cir. 1995), as has the 

Agency’s consistent policy of strongly 

weighing whether a registrant who has 

committed acts inconsistent with the 

public interest has accepted 

responsibility and demonstrated that 

future misconduct will not occur. 

Hoxie, 419 F.3d at 483.120

Although the burden of proof at this 

administrative hearing is a 

preponderance-of-the-evidence 

standard, see Steadman v. SEC, 450 U.S. 

91, 100–03 (1981), the Agency’s 

ultimate factual findings will be 

sustained on review to the extent they 

are supported by ‘‘substantial 

evidence,’’ Hoxie, 419 F.3d at 481. 

While ‘‘the possibility of drawing two 

inconsistent conclusions from the 

evidence’’ does not limit the 

Administrator’s ability to find facts on 

either side of the contested issues in the 

case, Shatz v. U.S. Dep’t of Justice, 873 

F.2d 1089, 1092 (8th Cir. 1989) (citation 

omitted), all ‘‘important aspect[s] of the 

problem,’’ such as a respondent’s 

defense or explanation that runs counter 

to the Government’s evidence, must be 

considered, Wedgewood Vill. Pharmacy 

v. DEA, 509 F.3d 541, 549 (D.C. Cir. 

2007); see Humphreys v. DEA, 96 F.3d 

658, 663 (3d Cir. 1996). [Omitted for 

brevity.] 

[Omitted for brevity.] It is well settled 

that, because the Administrative Law 

Judge has had the opportunity to 

observe the demeanor and conduct of 

hearing witnesses, the factual findings 

set forth in this recommended decision 

are entitled to significant deference, see 

Universal Camera Corp. v. NLRB, 340 

U.S. 474, 496 (1951), and that this 

recommended decision constitutes an 

important part of the record that must 

be considered in the Agency’s final 

decision, see Morall, 412 F.3d at 179. 

However, any recommendations set 

forth herein regarding the exercise of 

discretion are by no means binding on 

the Administrator and do not limit the 

exercise of that discretion. See 5 U.S.C. 

557(b); River Forest Pharmacy, Inc. v. 

DEA, 501 F.2d 1202, 1206 (7th Cir. 

1974); Attorney General’s Manual on the 

Administrative Procedure Act 

§ 8(a)(1947). 

Factors Two and Four: The 

Respondent’s Experience Dispensing 

Controlled Substances and Compliance 

With Federal, State, and Local Law 

The Government has founded its 

theory for sanction exclusively on 

Public Interest Factors Two and Four, 

and it is to those two factors that the 

evidence of record relates.121

Applying the record evidence to 

Factor Two (experience in dispensing 

controlled substances) in accordance 

with Agency precedent,122 the 

Respondent is owned by Dr. Howard, 

and has been licensed in Florida since 

2010. Tr. 584. No evidence was 

introduced regarding the length of time 


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*FOmitted to reduce repetition with added text. 

See infra n. *H. 

*GOmitted to reduce repetition with added text. 

See infra n. *H. 

that the Respondent pharmacy has been 

in operation or any basis upon which to 

characterize its level of compliance 

prior to the allegations that form the 

basis of this litigation. 

The lion’s share of the evidence 

presented in this litigation is most 

readily considered under Factor Four 

(compliance with laws related to 

controlled substances). To effectuate the 

dual goals of conquering drug abuse and 

controlling both legitimate and 

illegitimate traffic in controlled 

substances, ‘‘Congress devised a closed 

regulatory system making it unlawful to 

manufacture, distribute, dispense, or 

possess any controlled substance except 

in a manner authorized by the CSA.’’ 

Gonzales v. Raich, 545 U.S. 1, 13 (2005). 

Under the regulations, ‘‘[t]he 

responsibility for the proper prescribing 

and dispensing of controlled substances 

is upon the prescribing practitioner, but 

a corresponding responsibility rests 

with the pharmacist who fills the 

prescription.’’ 21 CFR 1306.04(a). 

[Omitted.] *F

The pharmacy registrant’s 

responsibility under the regulations is 

not coextensive or identical to the 

duties imposed upon a prescriber, but 

rather, it is a corresponding one. 21 CFR 

1306.04(a). The regulation does not 

require the pharmacist to practice 

medicine; it instead imposes the 

responsibility to decline to dispense 

based upon an order that purports to be 

a prescription, but may not be, because 

evidence (either apparent on the 

prescription or attendant to the 

presentation of that scrip) would lead a 

reasonable pharmacist to suspect that 

the practitioner issued the prescription 

outside the scope of legitimate medical 

practice. E. Main St. Pharmacy, 75 FR 

66,149, 66,157 n.30 (2010). [Omitted.] *G

[According to the CSA’s 

implementing regulations, a lawful 

controlled substance order or 

prescription is one that is ‘‘issued for a 

legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice.’’ 21 CFR 1306.04(a). 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 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 a pharmacist violated her 

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 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 4730. When 

a pharmacist’s suspicions are aroused 

by a red flag, the pharmacist must 

question the prescription and, if unable 

to resolve the red flag, refuse to fill the 

prescription. Id.; Medicine ShoppeJonesborough, 300 F. App’x 409, 412 

(6th Cir. 2008) (‘‘When pharmacists’ 

suspicions are aroused as reasonable 

professionals, they must at least verify 

the prescription’s propriety, and if not 

satisfied by the answer they must refuse 

to dispense.’’). 

Finally, ‘‘[t]he corresponding 

responsibility to ensure the dispensing 

of valid prescriptions extends to the 

pharmacy itself.’’ Holiday CVS, 77 FR 

62,341 (citing Med. Shoppe— 

Jonesborough, 73 FR 384; United 

Prescription Servs., Inc., 72 FR 50,397, 

50,407–08 (2007); EZRX, L.L.C., 69 FR 

63,178, 63,181 (2004); Role of 

Authorized Agents in Communicating 

Controlled Substance Prescriptions to 

Pharmacies, 75 FR 61,613, 61,617 

(2010); Issuance of Multiple 

Prescriptions for Schedule II Controlled 

Substances, 72 FR 64,921, 64,924 (2007) 

(other citations omitted)). The DEA 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. 

EZRX, L.L.C., 69 FR 63,181; Plaza 

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

Similarly, ‘‘[k]nowledge obtained by the 

pharmacists and other employees acting 

within the scope of their employment 

may be imputed to the pharmacy itself.’’ 

Holiday CVS, 77 FR 62,341. 

In this matter, the Government did 

not allege that Respondent dispensed 

the subject prescriptions having actual 

knowledge that the prescriptions lacked 

a legitimate medical purpose. Instead, 

the Government alleged that 

Respondent violated the corresponding 

responsibility regulation for each of the 

patients at issue in this matter by filling 

prescriptions without addressing or 

resolving multiple red flags of abuse or 

diversion. Agency decisions have 

consistently found that prescriptions 

with the similar red flags at issue here 

were so suspicious as to support a 

finding that the pharmacists who filled 

them violated the Agency’s 

corresponding responsibility rule due to 

actual knowledge of, or willful 

blindness to, the prescriptions’ 

illegitimacy. 21 CFR 1306.04(a); see, 

e.g., Pharmacy Doctors Enterprises d/b/ 

a Zion Clinic Pharmacy, 83 FR 10,876, 

10,898, pet. for rev. denied, 789 F. 

App’x 724 (11th Cir. 2019) (long 

distances; pattern prescribing; 

customers with the same street address 

presenting the same prescriptions on the 

same day; drug cocktails; cash 


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*H The supplemented text in this section clarifies 

my analysis of a pharmacist’s corresponding 

responsibility under 21 CFR 1306.04(a). 

*IAs explained above, see supra n. *E, I agree 

with the Chief ALJ’s conclusion that Florida law 

requires pharmacists to document their attempts to 

address and resolve red flags. However, my 

Decision does not rely on any interpretation of 

Florida law, because, in failing to document the 

resolution of red flags, Respondent violated federal 

law in addition to state law. See 21 CFR 1306.04(a) 

and 1306.06. Respondent’s violations of federal law 

serve as an independent basis for my conclusion 

that Respondent’s registration is inconsistent with 

the public interest and that revocation is the 

appropriate remedy in this case. 

123As discussed, supra, the CSA authorizes the 

Agency to impose a sanction upon a finding that a 

registrant ‘‘has committed such acts as would 

render [its] registration under [21 U.S.C. 823] 

inconsistent with the public interest as determined 

under such section.’’ 21 U.S.C. 824(a)(4). Thus, for 

the Government to satisfy its prima facie burden, 

it must allege facts that, if sustained, would actually 

demonstrate that the registrant committed such acts 

as would render its registration inconsistent with 

the public interest. See id. Here, in a subset of 

allegations relating to the Ten Patients (the SheOpined Allegations), the Government does not 

allege actions, conduct, or omissions attributable to 

the Respondent, but rather conclusions or 

observations made by its own pharmacy expert. ALJ 

Ex. 1 ¶¶ 5, 6, 8, 9, 10, 11, 12, 13. The plain language 

of each of the She-Opined Allegations points 

merely to the fact that (at some unspecified point 

in time) the Government’s expert concluded that 

certain matters were true. Even if preponderantly 

established by the evidence, the fact that the 

Government’s expert held a point of view on a fact 

(in the past or at any time) cannot and does not 

constitute evidence (or, as more relevant here, an 

allegation) that the Respondent engaged in acts that 

are inconsistent with the public interest. However, 

while the drafting of the She-Opined Allegations is 

certainly suboptimal, it is clear that these issues 

were litigated by consent. See Farmacia Yani, 80 FR 

29,053, 29,059 (2015); Grider Drug #1 and Grider 

Drug #2, 77 FR 44,070, 44,078 n.23 (2012). The 

parties mutually understood that they were 

litigating the issue of whether the controlledsubstance dispensing issues set forth in a subset of 

those allegations depicted conduct that fell below 

the applicable standard. Additionally, this issue 

was not raised by the Respondent in its closing 

brief. See ALJ Ex. 54. This case raises no realistic 

notice issues, and the OSC/ISO language related to 

the opinions of the Government’s expert will be 

treated here as surplusage that does not impact the 

validity of the charges or the findings. Accordingly, 

based on the conduct of the parties at the hearing, 

as well as their post-hearing briefs, the She-Opined 

Allegations will be considered as if the underlying 

actions are alleged, not as if the conclusions of the 

Government’s expert (at some unspecified time) are 

the single issue (that is: As they were drafted and 

served on the Respondent and this tribunal). 

[Furthermore, it is noted that the OSC/ISO did 

include overarching acts or omissions in addition 

to the more-specific expert opinions. The OSC/ISO 

states that Respondent repeatedly filled 

prescriptions without addressing and resolving 

obvious red flags of drug abuse and diversion, 

which is conduct that constitutes ‘‘acts [that] would 

render its registration . . . inconsistent with the 

public interest’’ under the CSA. See, e.g., OSC, at 

2 (alleging that Respondent ‘‘repeatedly ignored 

obvious red flags of abuse or diversion and filled 

prescriptions without exercising its corresponding 

responsibility to ensure that prescriptions were 

issued for a legitimate medical purpose, in violation 

of federal and state law’’); id. at 8 (‘‘It is my 

preliminary finding that [Respondent] repeatedly 

dispensed controlled substances without attempting 

to address or resolve clear red flags of drug abuse 

or diversion, which is inconsistent with the public 

interest.’’). Therefore, although I agree with the 

Chief ALJ that the drafting could be improved, I 

Continued 

payments; early refills); Hills Pharmacy, 

81 FR 49,816, 49,836–39 (2016) 

(multiple customers presenting 

prescriptions written by the same 

prescriber for the same drugs in the 

same quantities; customers with the 

same last name and street address 

presenting similar prescriptions on the 

same day; long distances; drug 

cocktails); The Medicine Shoppe, 79 FR 

59,504, 59,507, 59,512–13 (2014) 

(unusually large quantity of a controlled 

substance; pattern prescribing; irregular 

dosing instructions; drug cocktails); 

Holiday CVS, 77 FR 62,316, 62,317–22 

(2012) (long distances; multiple 

customers presenting prescriptions 

written by the same prescriber for the 

same drugs in the same quantities; 

customers with the same last name and 

street address presenting virtually the 

same prescriptions within a short time 

span; payment by cash); East Main 

Street Pharmacy, 75 FR 66,149, 66,163– 

65 (2010) (long distances; lack of 

individualized therapy or dosing; drug 

cocktails; early fills/refills; other 

pharmacies’ refusals to fill the 

prescriptions). Here, the Government 

established the presence of red flags on 

the prescriptions that Respondent 

pharmacy filled.]*H

The Florida Administrative Code 

requires pharmacists to conduct a 

prospective drug use review for each 

‘‘new and refill prescription presented 

for dispensing’’ and identify, inter alia, 

‘‘[o]ver-utilization or under-utilization,’’ 

‘‘[t]herapeutic duplication,’’ ‘‘[d]rugdrug interactions,’’ and ‘‘[c]linical 

abuse/misuse.’’ Fla. Admin. Code Ann. 

r. 64B16–27.810(1) (Florida DUR 

Statute). Under the Florida DUR Statute, 

if such a matter is identified, ‘‘the 

pharmacist shall take appropriate steps 

to avoid or resolve the potential 

problems which shall, if necessary, 

include consultation with the 

prescriber.’’ Id. r. 64B16–27.810(2). A 

patient record system is required to be 

maintained in order to ‘‘provide for the 

immediate retrieval of information 

necessary for the dispensing pharmacist 

to identify previously dispensed drugs 

at the time a new or refill prescription 

is presented for dispensing.’’ Fla. 

Admin. Code Ann. r. 64B16–27.800(1). 

Significantly, within the patient record, 

a ‘‘pharmacist shall ensure that a 

reasonable effort is made to obtain, 

record and maintain’’ information 

including, inter alia, ‘‘[p]harmacist 

comments relevant to the individual’s 

drug therapy, including any other 

information peculiar to the specific 

patient or drug.’’ Id. In regard to 

controlled substance prescriptions, 

under the Florida Pharmacy Standards 

Statute, a pharmacist in Florida must 

‘‘exercise[e] sound professional 

judgment’’ in filling controlled 

substance prescriptions and ‘‘shall 

attempt to work with the patient and the 

prescriber to assist in determining the 

validity of the prescription.’’ Fla. 

Admin. Code Ann. r. 64B16–27.831. 

Specifically, ‘‘when a pharmacist is 

presented with a prescription for a 

controlled substance, the pharmacist 

shall attempt to determine the validity 

of the prescription and shall attempt to 

resolve any concerns about the validity 

of the prescription by exercising his or 

her independent professional 

judgment.’’ Id. r. 64B16–27.831(2). A 

valid prescription for a controlled 

substance is defined as one ‘‘based on 

a practitioner-patient relationship and 

when it has been issued for a legitimate 

medical purpose,’’ while an invalid 

prescription is one ‘‘the pharmacist 

knows or has reason to know that . . . 

was not issued for a legitimate medical 

purpose.’’ Id. r. 64B16–27.831(1)(a), (b). 

As discussed, supra, the concept of red 

flags is encapsulated in the FPSS as 

‘‘circumstances that may cause a 

pharmacist to question the validity of a 

prescription for a controlled substance.’’ 

Id. r. 64B16–27.831(2). Upon 

encountering a ‘‘circumstance that may 

cause a pharmacist to question the 

validity of a prescription for a 

controlled substance’’ (i.e., a red flag of 

potential diversion), a Florida 

pharmacist must reach out to either the 

prescriber or the patient; and where 

appropriate, in place of one of those two 

sources (but not both) the pharmacist 

may resolve a red flag by an E–FORCSE 

query. The Florida Pharmacy Patient 

Record Statute directs that ‘‘[t]he 

pharmacist shall record any related 

information indicated by a licensed 

health care practitioner.’’ Fla. Admin. 

Code Ann. r. 64B16–27.800(2). The 

FPPRS also directs pharmacists to create 

a record of ‘‘[p]harmacist comments 

relevant to the individual’s drug 

therapy, including any other 

information peculiar to the specific 

patient or drug.’’ Id. r. 64B16– 

27.800(1)(f). Accordingly the substance 

of the contacts initiated by a Florida 

pharmacist to resolve encountered red 

flags (which is required) must be 

documented.*I A failure to follow up on 

the red flags and the failure to document 

that follow-up falls below the applicable 

standard of care. 

Here,123 the Government has alleged 

and presented evidence that the 


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also agree with him that Respondent was 

adequately noticed of the allegations against it in 

this case.] 

124Additionally, the Agency has consistently 

sustained allegations that centered around 

unresolved high-risk combination red flags. See, 

e.g., Suntree Pharmacy, 85 FR 73,770; Pharmacy 

Doctors Enters., 83 FR 10,876, 10,898 (2018); E. 

Main St. Pharmacy, 75 FR 66,165. 

*JAs explained above, see supra ns. *E, *I, my 

Decision does not rely on any interpretation of 

Florida law. 

125As discussed elsewhere in this RD, the 

allegations centered on distance and cash red flags 

cannot be sustained based on the underlying 

rationale supplied by the Government’s expert. 

126ALJ Ex. 1 ¶ 7.d. 

127See Gregg & Son Distribs., 74 FR 17517, 17517 

n.1 (2009) (clarifying that ‘‘it is the Government’s 

obligation as part of its burden of proof and not the 

ALJ’s responsibility to sift through the records and 

highlight that information which is probative of the 

issues in the proceeding’’). 

128ALJ Ex. 1 ¶ 10.a. 

129ALJ Ex. 1 ¶ 10.b. 

130ALJ Ex. 1 ¶ 10.c. 

131ALJ Ex. 1 ¶ 10.f. 

*K The Chief ALJ did not sustain the 

Government’s improper dosing allegations related 

to Patients SD and LH. RD, at 78–79. The 

Government took Exception to this finding. Gov’t 

Exceptions, at 5–7. I find that it is unnecessary for 

me to reach this issue because there is substantial 

other evidence on the record that demonstrates that 

Respondent’s registration is inconsistent with the 

public interest. 

132ALJ Ex. 1 ¶ 10.d. 

133ALJ Ex. 1 ¶ 10.e. 

134See Gregg & Son Distributors, 74 FR 17,517 n.1 

(noting that ‘‘it is the Government’s obligation as 

part of its burden of proof . . . to sift through the 

records and highlight that information which is 

probative of the issues in the proceeding’’). 

Respondent pharmacy violated federal 

and state law relating to controlled 

substances and dispensed prescriptions 

in such a way that violated its 

corresponding responsibility to ensure 

that controlled substances are dispensed 

only upon an effective prescription by 

failing to recognize and resolve red flags 

of diversion prior to dispensing. See 21 

CFR 1306.04(a). Specifically, the 

Government alleges that the Respondent 

violated laws applicable to the 

dispensing of controlled substances by 

dispensing multiple controlled 

substances to the Ten Patients in the 

face of unresolved red flags indicating 

possible or even likely diversion. ALJ 

Ex. 1. The exact allegations charge that 

the Respondent ignored red flags based 

on: (1) High-risk combinations of 

controlled medications; (2) dosage 

anomalies; (3) cash payments; and (4) 

long distances between customers, 

prescribers, and the registrant 

pharmacy. 

The evidence of record demonstrates 

that on numerous occasions the 

Respondent pharmacy filled 

prescriptions in the face of unresolved 

high-risk combination red flags and 

dosage-anomaly red flags (i.e., illogical 

dosing combinations of long-acting and 

short-acting opioids, and therapeutic 

duplication). Gov’t Exs. 6–14, 22, 23, 

25–27, 29; Tr. 215–16, 218–21; Stip. 33 

(Patient JW); Tr. 268–69, 274–76, 281– 

83; Stip. 19 (Patient EA); Tr. 287–91, 

294–97; Stip. 21 (Patient SD); Tr. 302– 

05; Stip. 23 (Patient LH); Tr. 309–12, 

315–16; Stip. 25 (Patient DH); Tr. 321– 

26; Stip. 27 (Patient DK); Tr. 330–38; 

Stip. 29 (Patient JM); Tr. 339–41; Stip. 

31 (Patient ST); Tr. 243–45; Stip. 35 

(Patient CW). Dr. Schossow persuasively 

testified that these red flags require 

documented resolution in order for the 

Respondent pharmacy to comply with 

its corresponding responsibility.124 Tr. 

204, 213–14, 216, 284–855, 318, 336–37. 

However, such adequate documentation 

was not present here. Tr. 431; Gov’t Exs. 

6–15, 22–29, 32; Tr. 240–41, 424–25 

(Patient JW); Tr. 286, 371–75 (Patient 

EA); Tr. 295–300, 375–78 (Patient SD); 

Tr. 308, 378–80, 384 (Patient LH); Tr. 

319, 321, 385–88, 397–98, 408–09 

(Patient DH); Tr. 329–30, 409–13 

(Patient DK); Tr. 338–39, 413–16, 419– 

20 (Patient JM); Tr. 342–43, 420–23 

(Patient ST); Tr. 346–47, 425–30 (Patient 

CW). The Respondent’s countering 

argument that the relevant standard of 

care in Florida does not require 

documentation of the resolution of red 

flags is unsupported by the applicable 

statutes and unpersuasive on this 

record.*J In specifically addressing highrisk combinations of controlled 

substances and controlled substance 

prescriptions with dosage anomalies, 

the Respondent’s owner calmly and 

repeatedly explained that such 

occurrences did not raise any concern in 

his mind because such types of 

prescriptions are ‘‘common.’’ Tr. 1018, 

1025, 1056, 1087, 1112–13, 1131, 1146– 

47. The owner was firm in his belief that 

every prescription at issue was 

dispensed properly and that his 

documentation was adequate. Tr. 1224. 

The evidence of record demonstrates 

that the Respondent has neglected its 

corresponding responsibility imposed 

by the CSA and the Florida 

Administrative Code. See 21 CFR 

1306.04(a) (establishing corresponding 

responsibility under the Controlled 

Substances Act); Liddy’s Pharmacy, 76 

FR 48,895 (affirming that only lawful 

prescriptions may be dispensed); Fla. 

Admin. Code Ann. r. 64B16–27.831 

(establishing corresponding 

responsibility under Florida state law). 

The Respondent, through its PIC/owner, 

was derelict in executing its 

corresponding responsibility by 

dispensing in the face of an unresolved 

reason to believe that these 

prescriptions were not issued for a 

legitimate medical purpose in the usual 

course of professional practice. Cf. Med. 

Shoppe-Jonesborough, 73 FR 381 

(requiring a pharmacist to refuse to fill 

such prescriptions); Medic-Aid 

Pharmacy, 55 FR 30,044. By dispensing 

these prescriptions despite knowing that 

they were potentially dangerous and 

failing to investigate further, the 

Respondent pharmacy failed to follow 

its legal responsibilities. See Sun & Lake 

Pharmacy, 76 FR 24,530 (stating that a 

pharmacist may not ‘‘close his eyes and 

thereby avoid [actual] knowledge’’ of 

possible abuse or diversion) (quoting 

Bertolino, 55 FR 4730). 

[Omitted for clarity. The record 

evidence establishes that it was outside 

the usual course of professional practice 

for Respondent to dispense] the 

prescriptions detailed in the 

Government’s evidence and agreed 

stipulations without resolving the red 

flags presented and documenting that 

resolution.125 The red flags detailed 

above required the Respondent and its 

owner/PIC to question these 

prescriptions, and they did not. See 

Bertolino, 55 FR 4730 (requiring 

pharmacists to question prescriptions 

that present red flags for abuse or 

diversion). [Omitted for clarity.] 

The Government has presented 

uncontroverted evidence that the 

Respondent pharmacy dispensed 

multiple controlled substances in the 

face of multiple red flags of potential 

diversion. 

Accordingly, OSC/ISO Allegations 6, 

7.a, 7.b, 7.c, 7.e, 7.f, and 7.g (pertaining 

to high-risk combinations) are 

sustained. For the allegation pertaining 

to Patient SD,126 the record contains 

insufficient quantitative evidence to 

support the amount of alprazolam 

specified for the alleged amount of 

dispensing events.127 Accordingly, 

OSC/ISO Allegation 7.d is sustained in 

part to the extent that the charge alleges 

‘‘a quantity of alprazolam,’’ while the 

remaining alleged dosages/amounts 

within OSC/ISO Allegation 7.d are 

sustained as charged. 

The record contains sufficient 

quantitative evidence to preponderantly 

sustain the ratio dosage anomaly 

(illogical dosing combinations of longacting and short-acting opioids) 

allegations for Patients JM,128 ST,129

DH,130 and EA 131 as charged. 

Accordingly, OSC/ISO Allegations 10.a, 

10.b, 10.c, and 10.f are sustained. 

[Omitted.] *K 132 133 134

The Government alleges that on 

multiple occasions where the 

Respondent dispensed multiple 


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*LOmitted. The Government has taken Exception 

to the RD’s finding that allegation 13 was not 

sustained. Gov’t Exceptions, at 1–5. I agree with the 

Chief ALJ that Dr. Schossow’s method for resolving 

the red flag was logistically problematic. Still, I find 

that Dr. Schossow credibly testified that cash 

payments are a red flag that requires documented 

resolution. Ultimately, I find that it is unnecessary 

for me to reach this issue because there is 

substantial other evidence on the record that 

demonstrates that Respondent’s registration is 

inconsistent with the public interest. 

135The witness also allowed that the existence 

and resolution of a distance red flag could be 

different if the pharmacy and the prescriber were 

collocated in the same building. Tr. 238. But even 

where the dispenser and prescriber were located 

miles away, Dr. Schossow kept her focus on 

whether the patient-customer was doing the 

driving. Tr. 239. 

136See Gonzales v. Oregon, 546 U.S. 243, 270 

(2006) (the setting of medical standards is a 

function of the police powers of a state, whereas 

DEA’s authority under the CSA is limited to barring 

illicit drug dealing and trafficking as traditionally 

understood). 

137While OSC/ISO Allegation 8.e charges the 

Respondent with dispensing controlled substances 

to Patient EA in the face of long-distance red flags, 

the Government presented no evidence on this 

issue during the hearing and did not address the 

issue in its post-hearing brief. Therefore, the 

Government has apparently abandoned OSC/ISO 

Allegation 8.e. See George Pursley, M.D., 85 FR 

80,162, 80,181–82, 80,185 (2020) (finding the 

Government abandoned allegation by not 

addressing it within its post-hearing brief). 

138Again, see Gregg & Son Distributors, 74 FR 

17,517 n.1 (clarifying that ‘‘it is the Government’s 

obligation as part of its burden of proof and not the 

ALJ’s responsibility to sift through the records and 

highlight that information which is probative of the 

issues in the proceeding’’). 

139 Gov’t Ex. 1. 

140Stips. 1, 2. 

benzodiazepines (therapeutic 

duplication) to Patient JM, it failed to 

address or resolve this red flag in a way 

that would have been required to stay 

within the standard of care. Dr. 

Schossow’s expert opinion has been 

deemed persuasive on this issue. 

Accordingly, OSC/ISO Allegation 12 is 

sustained. 

Although Dr. Schossow’s expert 

opinion has been held generally 

reliable, her theory regarding the basis 

for the cash red flag (to wit, that 

[Respondent failed to adequately resolve 

the cash red flag], even where lack of 

insurance was specifically noted by the 

pharmacy staff) was too logically 

challenged to serve as a basis for 

sanction. Certainly the Agency has 

consistently sustained supported 

allegations that centered around 

unresolved cash red flags in the past. 

See, e.g., Suntree Pharmacy, 85 FR 

73770; Pharmacy Doctors Enters., 83 FR 

10,891; The Medicine Shoppe, 79 FR 

59,504, 59,507, 59,512–13 (2014); 

Holiday CVS, 77 FR 62,317–22. 

[Omitted for clarity.] As discussed 

elsewhere in this recommended 

decision, the red flag resolution 

proposed by the Government’s expert, to 

wit, that a dispenser-registrant is 

required in all cases to contact a 

prescriber-registrant to ascertain 

whether the customer-patient had 

prescription drug coverage (a subject 

within the exclusive purview of the 

pharmacy), does not further the goal of 

minimizing the risk of diversion. 

[Omitted.] *L

Further, it is beyond argument that 

there has been a long uncontradicted 

history of the Agency sustaining 

allegations relating to unresolved longdistance red flags. See, e.g., Heavenly 

Care Pharmacy, 85 FR 53,417; Suntree 

Pharmacy, 85 FR 73,770; Pharmacy 

Doctors Enters., 83 FR 10,885; Hills 

Pharmacy, 81 FR 49,839; Holiday CVS, 

77 FR 62,317–22; E. Main St. Pharmacy, 

75 FR 66,163–65. The basis of that 

history is rooted in expert testimony 

explaining the common-sense 

proposition that traveling a great 

distance to fill a prescription that could 

have been dispensed around the block 

from the customer-patient raises a 

reasonable suspicion that the customerpatient may have chosen the remotelylocated pharmacy for an improper 

purpose (e.g., to escape scrutiny from 

local, vigilant pharmacists, or to travel 

to a pharmacy believed to be less 

vigilant in its responsibilities). See, e.g., 

Holiday CVS, 77 FR 62,334. Under those 

circumstances, experts have testified 

that it is logical and required to explore 

and resolve the possibility that either 

the patient-customer is seeking to mask 

his/her diversion, or the pharmacy has 

been identified as an easy mark for 

improperly-authorized prescriptions. 

[Omitted for brevity.] 

This case presents a somewhat 

divergent issue. As discussed, supra, 

there is no genuine question that the 

distances between the customer-patient, 

the correlating prescriber, and the 

Respondent pharmacy are sufficiently 

lengthy as to objectively raise a red flag 

requiring pre-dispensing analysis and 

documentation. The fly in the ointment 

here is the primary rationale presented 

by Dr. Schossow as underlying the red 

flag. According to the Government’s 

expert, a remarkable travel distance 

raises a concern, not founded in 

concerns related to drug diversion, but 

rather because a customer-patient filling 

prescriptions for opioids and 

benzodiazepines presents ‘‘the risk for 

getting into a motor vehicle accident, 

[and] fractures, even death, [ ] could 

potentially occur.’’ Tr. 232 [However, 

the witness testified] that she had no 

information regarding whether any of 

the customers in question drove to the 

Respondent pharmacy. Tr. 545. In 

addressing a distance red flag related to 

one of the customer-patients, Dr. 

Schossow supplied the following 

opinion about why the red flag stood 

unresolved: 

[I]f you’re specifically talking about the red 

flag of distance, that would be asking the 

patient if he is actually driving a motor 

vehicle these distances while he’s on these 

medications, back and forth, this long 

distance. And that was not addressed in this 

[pharmacy] note. 

Tr. 380. Stated differently, if the 

Respondent had documented a 

representation by the customer-patient 

that someone drove him to the 

pharmacy the dispensing event would 

have met Dr. Schossow’s standard. Even 

when closely pressed on the issue, Dr. 

Schossow held her ground, explaining 

that to resolve a distance red flag, when 

encountered, would require no more 

than the pharmacist to procure a 

representation from the customerpatient that someone else was doing the 

driving to the pharmacy.135 Tr. 237–39. 

By the testimony of the Government’s 

expert, the long-distance red flags in 

this case were not founded in 

controlled-substance diversion (which 

is the focus of this proceeding and 

which circumscribe the hardline limits 

of this Agency’s jurisdiction); instead, 

the Government expert’s explanation of 

long-distance red flags related to general 

patient safety concerns. Dr. Schossow’s 

view paints safety with a broader brush 

than DEA’s statutory authority 

allows.136 Safer roads do not translate 

into lack of drug diversion, and more 

dangerous road conditions do not 

likewise translate into establishing the 

applicable dispensing standard for a 

DEA pharmacy registrant. This Agency 

is charged with administering the 

Controlled Substances Act, with no 

mandate to supervise highway and 

traffic safety. Accordingly, OSC/ISO 

Allegations 8.a, 8.b, 8.c, 8.d, 8.e,137 and 

8.f are not sustained. 

The Government further alleges that 

the Respondent filled prescriptions for 

alprazolam to Patients JW, EA, and SD 

in amounts that presented a red flag 

(because the dosages were 

pharmacologically illogical) without 

attempting to address the red flag. 

However, the Government presented no 

evidence that this occurred (nor did it 

address the issue in its post-hearing 

brief); 138 thus, it appears the 

Government has abandoned these 

allegations, see Pursley, 85 FR 80,181– 

82, 80,185. Accordingly, OSC/ISO 

Allegation 11 is not sustained. 

OSC/ISO Allegation 1 is sustained 

based on the evidence 139 and 

stipulations 140 of record. 


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*M For purposes of the imminent danger inquiry, 

my findings lead to the conclusion that Respondent 

has ‘‘fail[ed] . . . to maintain effective controls 

against diversion or otherwise comply with the 

obligations of a registrant’’ under the CSA. 21 

U.S.C. 824(d)(2). The substantial evidence that 

Respondent dispensed controlled substance 

prescriptions outside the usual course of the 

professional practice established ‘‘a substantial 

likelihood of an immediate threat that death, 

serious bodily harm, or abuse of a controlled 

substance . . . [would] occur in the absence of the 

immediate suspension’’ of Respondent’s 

registration.’’ Id. There was ample evidence 

introduced to establish that Respondent, without 

first resolving red flags, repeatedly dispensed 

combinations of medications that posed serious 

risks to patients. Thus, I find that at the time the 

Government issued the OSC/ISO, there was clear 

evidence of imminent danger. 

141See 21 CFR 1301.44(e). 

142This is only an evidentiary observation, not a 

point propounded by the Respondent regarding 

remedial steps. 

[Accordingly, I find that Respondent 

has operated outside the usual course of 

professional practice (in violation of 21 

CFR 1306.06 and Fla. Admin. Code 

Ann. r. 64B16–27.831 and in violation 

of its corresponding responsibility (in 

violation of 21 CFR 1306.04(a) and Fla. 

Admin. Code Ann. r. 64B16–27.831). I 

further find that the Government has 

made a prima facie case that the 

Respondent has committed acts which 

render its registration inconsistent with 

the public interest.] *M On consideration 

of the whole of the record, it is clear that 

Public Interest Factors Two and Four 

militate strongly in favor of the 

imposition of a registration sanction in 

this case. 

[Sanction] 

The evidence of record 

preponderantly establishes that the 

Respondent has committed acts which 

render its continued registration 

inconsistent with the public interest. 

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

Government has met its burden 141 in 

demonstrating that the revocation it 

seeks is authorized, to avoid sanction, it 

becomes incumbent upon the 

Respondent to demonstrate that given 

the totality of the facts and 

circumstances revocation is not 

warranted. See Med. ShoppeJonesborough, 73 FR 387. That is, upon 

the preponderant establishment of the 

Government’s prima facie case, the 

burden now shifts to the Respondent to 

show why it should continue to be 

entrusted with a DEA registration. See 

Kaniz F. Khan-Jaffery, M.D., 85 FR 

45,667, 45,689 (2020); Garrett Howard 

Smith, M.D., 83 FR 18,882, 18,910 

(2018). 

Although by no means the only 

requirement, in order to rebut the 

Government’s prima facie case, the 

Respondent must demonstrate both an 

unequivocal acceptance of 

responsibility and also a demonstrable 

plan of action to avoid similar conduct 

in the future. See Hassman, 75 FR 8236. 

While those two elements are key, the 

focus is, and must always be, rooted in 

a determination as to whether the 

Agency can have confidence that the 

Respondent can continue to be 

entrusted with the weighty and 

dangerous responsibilities of a 

registrant. Cf. Khan-Jaffery, M.D., 85 FR 

45,689; Smith, M.D., 83 FR 18,910. 

While analytical frameworks applied to 

prior Agency actions provide useful 

guidance and helpful structure, such 

tools cannot distract the Agency from its 

critical mission to keep the public safe 

by only issuing and maintaining CORs 

in cases where the public is adequately 

protected. The central issue is whether, 

based on the evidence of record, 

including the Respondent’s established 

misdeeds, the Agency can trust the 

Respondent with the authority to handle 

dangerous controlled substances. The 

Agency has provided the following 

framework for its analysis in this regard: 

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. A registrant’s candor 

during the investigation and hearing is an 

important factor in determining acceptance 

of responsibility and the appropriate 

sanction; as is whether the registrant’s 

acceptance of responsibility is unequivocal. 

Heavenly Care Pharmacy, 85 FR 53,420 

(internal citations omitted). 

Agency precedent is clear that a 

respondent must ‘‘unequivocally admit 

fault’’ as opposed to a ‘‘generalized 

acceptance of responsibility.’’ The 

Medicine Shoppe, 79 FR 59,510; see 

also Lon F. Alexander, M.D., 82 FR 

49,704, 49,728 (2017). To satisfy this 

burden, the respondent must show ‘‘true 

remorse’’ or an ‘‘acknowledgment of 

wrongdoing.’’ Michael S. Moore, M.D., 

76 FR 45,867, 45,877 (2011). The 

Agency has made it clear that 

unequivocal acceptance of 

responsibility is paramount for avoiding 

a sanction. Dougherty, 76 FR 16,834 

(citing Krishna-Iyer, 74 FR 464). This 

feature of the Agency’s interpretation of 

its statutory mandate on the exercise of 

its discretionary function under the CSA 

has been sustained on review. Jones 

Total Health Care Pharmacy, LLC v. 

DEA, 881 F.3d 823, 830–31 (11th Cir. 

2018); MacKay v. DEA, 664 F.3d 808, 

822 (10th Cir. 2011); Hoxie, 419 F.3d at 

483. 

For both prongs (acceptance of 

responsibility and remedial steps), the 

Respondent [did not present any 

evidence]. Arguably, as discussed, 

supra, at some point (outside the 

timeframe of the allegations) the 

evidence of record showed that the 

Respondent did appear to commence at 

least some documentation of some 

conversations with prescribers and 

patients.142 However, as discussed, 

supra, the Respondent’s owner made his 

view unflinchingly clear that the 

documentation level required to 

dispense within the standard applicable 

in the State of Florida is ‘‘absolutely 

absurd.’’ Tr. 1096. The Respondent’s 

owner, in the clearest terms possible, 

like the expert he called to meet the 

Government’s evidence, has 

demonstrated active hostility to 

applying this standard in the past, in the 

present, and in the future, as well as his 

amenability to Agency oversight. Thus, 

the Respondent accepts responsibility 

on no level, much less unequivocally. A 

change in this attitude is unlikely. The 

view of the Respondent’s owner/PIC is 

that no misconduct or deficits occurred, 

and to the extent that the Agency and 

its expert thinks otherwise, it is 

mistaken. 

While the transgressions alleged and 

proved here are certainly serious, it is 

arguable that an acceptance of 

responsibility, coupled with a 

thoughtful plan of remedial action on 

the part of the Respondent pharmacy, 

would have had the potential for a 

creditable case for lenity. The errant 

dispensing events that were sustained 

involved areas of prescribing and 

dispensing that may well have been 

amenable to a convincing case that the 

Respondent’s owner re-educated 

himself and now understood that 

follow-up and documentation are 

required to bring his pharmacy within 

the applicable standard. The 

Respondent pharmacy was clearly 

operating below an acceptable and safe 

standard, but it could not fairly be said 

that the pharmacy was a pill mill. On 

these facts, an unequivocal acceptance 

of responsibility and meaningful 

remedial steps could conceivably have 

supported a more moderate sanction. To 

the extent that the Respondent’s owner 

had expressed some level of contrition 

coupled with an expression of some 

understanding of why his pharmacy was 

operating below the applicable 

standard, it could have achieved much 

in empowering the Agency to exercise 

some measure of lenity as a matter of 

discretion. But in view of the present 

record, considering what could have 

been on a different record is of minimal 

utility. 


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143Hassman, 75 FR 8236. [Edited the footnoted 

sentence for clarity.] 

144As discussed, supra, the Respondent’s owner 

received multiple unsubtle entreaties from the 

tribunal to distance himself from his expert’s 

hostility to the exercise of regulatory authority by 

DEA, all of which were soundly declined. Tr. 1222– 

24. 

The Agency has frequently required 

unambiguous acceptance of 

responsibility and a remedial action 

plan as an essential component to avoid 

a sanction,143 and in this case it is clear 

that the Respondent’s owner, 

acknowledging no deficiencies, has no 

plan to conform his conduct 

whatsoever. In his view, he and his 

pharmacy did nothing wrong and would 

presumably make all the same choices 

if faced with the same facts tomorrow. 

The Agency is thus faced with a choice 

of imposing a registration sanction or 

imposing none and therein creating a 

virtual guarantee that it will be 

instituting new proceedings, charging 

the same conduct, on the day it issues 

its final order. On this point there is 

little room for logical, dispassionate 

dissent. Thus, in the face of a prima 

facie case, without the Respondent 

meeting the evidence with an 

acceptance of responsibility and 

proposing remedial measures geared 

toward avoiding future transgressions, 

the record supports the imposition of a 

sanction. 

Further, inasmuch as the evidence of 

record fails to demonstrate an 

unequivocal acceptance of 

responsibility, the issue of remedial 

steps becomes irrelevant. The Agency 

has consistently held that for either 

prong (acceptance of responsibility and 

remedial steps) to be considered in 

sanction amelioration, both prongs must 

have been established. Ajay S. Ahuja, 

M.D., 84 FR 5479, 5498 n.33 (2019); 

Jones Total Health Care Pharmacy, 

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

79,188, 79,202–03 (2016); Hassman, 75 

FR 8236. If one prong is absent, the 

other becomes irrelevant. Both or 

neither has been the rule for many 

years. The view of the Respondent’s 

owner that nothing is wrong with his 

pharmacy has virtually precluded him 

from establishing remedial steps of any 

kind. As noted, supra, there was some 

indication of a sporadic, mildly 

increased level of documentation 

beyond the temporal range of the 

allegations, but these were not even 

proffered as remedial steps. Thus, in 

view of the prima facie case established 

by the Government’s evidence, without 

the Respondent meeting the evidence 

with a convincing, unequivocal 

acceptance of responsibility and 

proposing thoughtful, concrete remedial 

measures geared toward avoiding future 

transgressions, the record supports the 

imposition of a sanction. That a 

sanction is supported does not end the 

inquiry, however. 

In determining whether and to what 

extent imposing a sanction is 

appropriate, consideration must also be 

given to the Agency’s interest in both 

specific and general deterrence and the 

egregiousness of the offenses established 

by the Government’s evidence. Ruben, 

78 FR 38,364, 38,385. The issue of the 

egregiousness of the offense favors 

revocation. The Respondent dispensed 

many controlled substances for over a 

year without any regard for its 

obligations to identify blatant red flags 

of potential diversion. There was no 

indication during the hearing that the 

Respondent’s owner did not understand 

his true obligations, only that he 

[resented those obligations.] The 

Respondent pharmacy [repeatedly 

dispensed controlled substances 

without appreciating that] further steps 

were required to resolve and document 

indications of potential diversion. 

Considerations of specific and general 

deterrence in this case militate in favor 

of revocation. Through the testimony of 

its owner, [it was clear that the 

Respondent did not feel that it had 

acted improperly, did not have a 

fulsome understanding of the 

requirements for operating in the usual 

course of professional practice, and did 

not believe that any actions the 

Respondent might take to curtail 

diversion would matter to DEA]. The 

Respondent’s owner and its expert 

witness [apparently believe] that DEA 

has no proper oversight role in the 

operation of the Respondent pharmacy 

and pharmacy practice in general.144

The Respondent’s owner [testified] that 

even the isolated instances of an 

increased level of documentation were 

effected, not in the interests of 

compliance with the applicable state 

standards, but to placate DEA. Tr. 1218– 

22, 1226–27. The Respondent’s owner is 

not amenable to supervision by 

regulatory authorities, including DEA. 

He believes he is and has been correct, 

and it can be confidently assumed that 

the absence of a registration sanction 

will result in the continuation of 

business as usual at his pharmacy. 

Thus, the interests of specific 

deterrence, even standing alone, 

motivate powerfully in favor of the 

revocation of the Respondent’s COR. 

The interests of general deterrence 

compel a like result. As the regulator in 

this field, the Agency bears the 

responsibility to deter similar 

misconduct on the part of others for the 

protection of the public at large. Ruben, 

78 FR 38,385. Where the record 

demonstrates that the Government has 

borne its burden and established that 

the Respondent has dispensed high 

numbers of controlled substances below 

the standard for over a year with no 

correction and no remorse, the 

unmistakable message to the regulated 

community would be that such conduct 

can be tried once (or more than once) 

with little or no consequence. Thus, on 

this record, the interests of general 

deterrence support the revocation 

sought by the Government. 

Another factor that weighs 

significantly in favor of the revocation 

sanction sought by the Government is 

the profound lack of candor 

demonstrated by the Respondent’s 

owner during his testimony and his 

actions during the investigation. In 

making the public interest 

determination, this Agency places great 

weight on a respondent’s candor both 

during an investigation and during a 

subsequent proceeding. Fred Samimi, 

M.D., 79 FR 18,698, 18,713 (2014); 

Robert F. Hunt, D.O., 75 FR 49,995, 

50,004 (2010). As discussed at length, 

supra, during the investigation in this 

matter, the Respondent declined to 

forward a large swath of material 

specifically subpoenaed by DEA 

investigators, and during the hearing 

there were marked and profound 

adverse issues regarding the credibility 

of the owner’s testimony. Hence, the 

issue of candor to the Agency, and 

candor to the tribunal, undermine the 

confidence that the Agency can have in 

the Respondent’s continuation as a DEA 

registrant. 

Accordingly, it is respectfully 

recommended that the Respondent’s 

DEA COR should be revoked, and any 

pending applications for renewal should 

be denied. 

Dated: April 7, 2021 

John H. Mulrooney, II 

Chief Administrative Law Judge 

The Respondent’s Exceptions 

On December 15, 2020, Respondent 

filed its exceptions to the 

Recommended Decision. DEA 

regulations require that Exceptions 

‘‘include a statement of supporting 

reasons for such exceptions, together 

with evidence of record (including 

specific and complete citations of the 

pages of the transcript and exhibits) and 

citations of the authorities relied upon.’’ 

21 CFR 1316.66. For the most part, 

Respondent’s Exceptions not only fail to 

comply with this regulatory 

requirement, but they also lack 

evidentiary support in the 

Administrative Record. Several of 


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*N In support of this argument, Respondent 

quotes from a West Virginia District Court order 

granting a pharmacy’s motion to dissolve an 

immediate suspension order. The district court 

found that the Government had not adequately 

supported its imminent danger finding, because it 

had not ‘‘demonstrat[ed] that actual or anticipated 

harm had occurred in patients.’’ Id. (citing Oakhill 

Hometown Pharmacy v. Uttam Dhillon, 2:19–cv– 

00716, at 9). Respondent’s reliance on this decision 

is misplaced, and it has no relevance to this 

proceeding. Respondent’s legal course of action on 

this matter would have been to challenge the ISO 

in court. The subject of this proceeding is the 

revocation of Respondent’s registration. I am 

finding in favor of revocation, and therefore, at the 

time that my order goes into effect, the immediate 

suspension will necessarily end. 

*O It is well-settled that because the 

Administrative Law Judge has had the opportunity 

to observe the demeanor and conduct of hearing 

witnesses, the factual findings set forth in this 

Recommended Decision are entitled to significant 

deference, Universal Camera Corp., 340 U.S. at 496, 

and that this Recommended Decision constitutes an 

important part of the record that must be 

considered in the Administrator’s decision. Morall, 

412 F.3d at 179. 

Respondent’s Exceptions also reflect a 

misunderstanding of the CSA and its 

implementing regulations. Additionally, 

some of Respondent’s Exceptions repeat 

arguments that were already raised in 

Respondent’s Posthearing Brief, or in 

prehearing or posthearing filings, and 

have been adequately addressed in the 

adopted Recommended Decision or in 

the Chief ALJ’s orders. Therefore, I 

reject Respondent’s Exceptions and 

adopt the Recommended Decision of the 

Chief ALJ as amended above. 

Exception A 

Respondent argues in its first 

Exception that the Government failed to 

demonstrate that Respondent’s 

prescribing ‘‘posed imminent harm to 

the public,’’ and that the Chief ALJ 

‘‘departed from established standard’’ 

by recommending that Respondent’s 

registration be revoked without any 

evidence of public harm. Resp 

Exceptions, at 2–3. However, 

Respondent does not cite legal authority 

for the proposition that I must find 

evidence of diversion or harm before I 

may suspend or revoke a registration. 

Agency Decisions have found that DEA 

has the authority to revoke a DEA 

registration in the absence of evidence 

of diversion if the registrant’s ‘‘practices 

. . . create a substantial risk of 

diversion’’ or even the ‘‘opportunity for 

diversion.’’ See, e.g., Garrett Howard 

Smith, M.D., 83 FR 18,882, 18,905 n.32 

(2018) (citing Dewey C. Mackay, M.D., 

75 FR 49,956, 49,974 n.35 (2010). 

Further, DEA has held that ‘‘[c]areless or 

negligent handling of controlled 

substances creates the opportunity for 

diversion and could justify revocation 

or denial.’’ Paul J. Caragine, Jr., 63 FR 

51,592, 51,601). 

As discussed in more detail above, 

DEA is authorized to revoke a 

registration upon a finding that the 

registrant’s registration is ‘‘inconsistent 

with the public interest,’’ based on a 

consideration of five enumerated 

factors, including the registrant’s 

‘‘experience dispensing . . . controlled 

substances’’ and the registrant’s 

‘‘[c]ompliance with applicable State, 

Federal, or local laws relating to 

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

In this case, I find that the Government 

has met its burden of proving that 

Respondent’s registration is inconsistent 

with the public interest by presenting 

evidence that Respondent repeatedly 

filled prescriptions that presented 

obvious and well-established red flags 

of drug abuse and diversion, in violation 

of federal and state law. Agency 

Decisions have consistently held that 

the repeated filling of prescriptions in 

violation of federal and state law 

constitutes acts that are inconsistent 

with the public interest, and establish 

grounds for DEA to revoke a 

registration. See, e.g., Suntree 

Pharmacy, 85 FR 73,776. 

Moreover, Respondent’s Exception 

conflates the legal standard for issuing 

an immediate suspension order under 

21 U.S.C. 824(d) with the legal standard 

for revoking a registration under 21 

U.S.C. 823(f). Before issuing an ISO, the 

Government must demonstrate that the 

registrant has ‘‘fail[ed] . . . to maintain 

effective controls against diversion or 

otherwise comply with the obligations 

of a registrant,’’ and that those failures 

have created a ‘‘substantial likelihood of 

an immediate threat that death, serious 

bodily harm, or abuse of a controlled 

substance . . . [would] occur in the 

absence of the immediate suspension’’ 

of Respondent’s registration.’’ 21 U.S.C. 

824(d) (emphasis added).*NAs 

discussed in more detail above, see 

supra n.*M, I find that at the time the 

Government issued the OSC/ISO, there 

was clear evidence of imminent danger. 

Exception B 

Respondent next takes exception to 

the Chief ALJ’s characterization of Dr. 

Schossow’s expert testimony. Resp 

Exceptions, at 4–6. Respondent argues 

that Dr. Schossow’s testimony should 

not be given any weight for several 

reasons. First, Respondent argues that 

Dr. Schossow cannot be trusted because 

she initially testified that she had sat on 

the Florida board of pharmacy in the 

1990s, and later confirmed that she had 

not. Second, Respondent argues that Dr. 

Schossow’s opinions were entitled to 

little weight because she did not speak 

to the physicians, pharmacists, and 

customers involved in Respondent’s 

dispensing, and she had never been to 

Respondent pharmacy. Respondent 

identifies several additional concerns 

with Dr. Schossow’s testimony, 

including that her opinions were 

illogical and based on speculation, that 

she did not identify any evidence that 

Respondent’s customers were abusing 

controlled substances, and that she did 

not have adequate information to 

conclude whether there was imminent 

danger or public harm. 

I agree with the Chief ALJ’s 

assessment of Dr. Schossow’s 

credibility,*O including his 

determination that Dr. Schossow’s 

misstatement about the Florida board of 

pharmacy was not material. See ALJ Ex. 

67 (Order Denying the Respondent’s 

Motion to Disqualify Expert Witness). I 

also find that Dr. Schossow reviewed 

sufficient materials to provide relevant 

opinions on Respondent’s compliance 

with the usual course of professional 

practice in Florida, and that her failure 

to speak to any of the involved 

pharmacists, physicians, or customers 

did not diminish the weight of her 

opinions. Dr. Schossow’s opinions 

primarily focused on Respondent’s 

failure to document a resolution of red 

flags of drug abuse and diversion. 

Respondent’s failure to document was 

sufficient evidence that Respondent’s 

dispensing was outside the usual course 

of professional practice, even without 

input from any of Respondent’s 

pharmacists or customers, or the 

prescribing physicians. 

Respondent’s additional concerns 

about the allegedly illogical and 

inconsistent nature of Dr. Schossow’s 

opinions are not adequately supported 

by citations to the record that would 

allow me to meaningfully respond. See 

21 CFR 1316.66. As stated above, I agree 

with the Chief ALJ’s credibility 

determinations and his analysis of Dr. 

Schossow’s opinions. I find that the 

Chief ALJ thoroughly and neutrally 

analyzed Dr. Schossow’s credibility and 

identified portions of her testimony that 

were illogical or internally inconsistent, 

and relied only on those portions that 

were logical and well-supported. 

Finally, as stated above, Respondent 

does not cite legal authority for the 

proposition that I must find evidence of 

diversion or harm before I may suspend 

or revoke a registration. It is therefore 

irrelevant to my Decision whether the 

Government’s expert believed that there 

was actual harm. 

Exception C 

Respondent next takes Exception to 

the Chief ALJ’s questions to 

Respondent’s representative, Dr. 


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*P See, e.g., Jayam Krishna-Iyer, 74 FR 459, 463 

(2009) (stating that ‘‘where a registrant has 

committed acts inconsistent with the public 

interest, the registrant must . . . demonstrate that 

[it] will not engage in future misconduct’’) (quoting 

Medicine Shoppe, 73 FR 364, 387 (2008)); see also 

Lisa Hamilton, N.P., 85 FR 71,465, 71,473 (2019) 

(observing, in determining that revocation was the 

appropriate remedy, that the respondent had 

‘‘demonstrated a general disdain for the charges 

against her and the situation in which she had 

found herself’’). 

*Q ALJ Ex. 36, at 2 (Order Denying the 

Respondent’s Motion to File a Second 

Supplemental Prehearing Statement) (citing 

Prehearing Ruling, at 2; 21 CFR 1316.55 (stating that 

a prehearing ruling issued in an administrative 

enforcement action ‘‘shall control the subsequent 

course of the hearing unless modified by a 

subsequent ruling’’)). 

*R Respondent disagrees with the Chief ALJ’s 

determination that it did not provide good cause for 

the late filing. Resp Exceptions, at 8. Respondent 

argues that ‘‘[t]here was good cause provided with 

the background setting of the pandemic that had 

caused the case to stay on hold for nearly a year,’’ 

and ‘‘[c]ounsel stated that there was no prejudice 

to the Government and that the pandemic and his 

recent notice of appearance in the case were the 

basis of the untimely Prehearing Statement.’’ Id. 

However, the Chief ALJ was aware of the 

pandemic’s impact on the litigation when he 

decided to exclude Respondent’s Second SPS, and 

he determined that Respondent had not provided 

good cause. Order Denying Respondent’s Motion, at 

2–3. 

*SAs the RD observes, Respondent could have 

sought to introduce the OOR documents into the 

record as past recollection recorded, but declined 

to do so. See RD, at 107 (citing Fed. R. Evid. 803(5)). 

Howard, about whether he agreed with 

certain testimony by Respondent’s 

expert, Dr. Buffington. Resp Exceptions, 

at 6–8. Respondent believes that the 

Chief ALJ’s questions to Dr. Howard 

misstated Dr. Buffington’s opinions and 

that they put Dr. Howard in the 

uncomfortable position of deciding 

whether to agree with Dr. Buffington’s 

opinions. Id. 

As discussed in more detail above, 

ALJs have authority to regulate the 

administrative hearing, which includes 

asking clarifying questions of counsel 

and witnesses and issuing evidentiary 

rulings. See supra n. *A (citing 5 U.S.C. 

556(c)(5); 21 CFR 1316.52(e)). In this 

case, the Chief ALJ was questioning Dr. 

Howard for Respondent’s benefit in an 

attempt to ascertain whether 

Respondent shared Dr. Buffington’s 

criticisms of—and hostility towards— 

DEA as a regulator. Respondent’s 

attitude towards DEA, and appreciation 

for the requirements for operating in the 

usual course of professional practice, 

are relevant to DEA’s determination as 

to Respondent’s likelihood of future 

compliance in determining whether a 

sanction is appropriate.*P I therefore 

find that the Chief ALJ properly 

exercised his discretionary authority to 

regulate the hearing and that 

Respondent’s Exception is without 

merit. 

Exception D 

Respondent next argues that the Chief 

ALJ improperly excluded Respondent’s 

Second Supplemental Prehearing 

Statement (hereinafter, Second SPS), 

which was filed approximately five 

months after the deadline set by the 

Prehearing Ruling. Resp Exceptions, at 

8–9. Respondent’s Second SPS was also 

not accompanied by a motion for good 

cause, which is a prerequisite for a latefiled prehearing statement.*Q The 

Government filed a Motion to Strike (see 

ALJ Ex. 34), and Respondent replied to 

that motion (see ALJ Ex. 35), arguing 

that there should be no prejudice to the 

Government from the late filing. The 

Chief ALJ determined that Respondent 

had not provided any rationale or good 

cause for its late filing.*R Order Denying 

Respondent’s Motion, at n. 3. As 

previously mentioned, the Chief ALJ has 

authority to regulate the hearing, which 

includes the authority to exclude 

evidence. 21 CFR 1316.52(e). I therefore 

defer to his decision to exclude 

Respondent’s Second SPS. 

I also find that there was no prejudice 

to the Respondent from the Chief ALJ’s 

denial of its Second SPS. The Second 

SPS did not notice any new witnesses 

or testimony; it simply noticed 

Respondent’s intention to amend ten of 

Respondent’s previously-disclosed 

exhibits. Respondent stated that the 

amended exhibits contained additional 

‘‘[drug utilization review] data.’’ See 

Second SPS, at 2. Although the Chief 

ALJ did not permit Respondent to 

amend these exhibits before the hearing, 

he allowed Respondent to attempt to 

authenticate the amended exhibits at the 

hearing ‘‘to afford the Respondent the 

maximum level of due process.’’ RD, at 

n. 106 (citing Tr. 642–60). Thus, the 

Chief ALJ essentially reversed his 

decision to deny the Second SPS by 

permitting the Respondent to offer the 

amended exhibits into evidence. 

In the RD, the Chief ALJ referred to 

the amended exhibits as the outside-ofrecord (OOR) documents. See RD, at n. 

106. Respondent attempted to admit one 

of the OOR documents at the hearing, 

but the Chief ALJ declined to admit it 

because there were ‘‘fundamental issues 

regarding inadequate foundation and 

reliability.’’ Id. Respondent did not offer 

the remaining OOR documents into the 

record after the first document was 

denied. Id. However, Respondent’s 

counsel repeatedly refreshed Dr. 

Howard’s recollection with the OOR 

documents, which gave Dr. Howard the 

opportunity to testify about any 

notations in the OOR documents that 

evidenced attempts by Respondent to 

conduct a drug utilization review. See 

supra Respondent’s Case, Summary of 

Dr. Howard’s Testimony.*S I find that 

Respondent was given ample 

opportunity at the hearing to provide 

the tribunal with all reliable evidence of 

its attempts to exercise due diligence 

efforts. 

Respondent further argues that the 

Chief ALJ’s decision to exclude the 

Second SPS was arbitrary in light of his 

decision to take official notice of an 

FDA black box warning that cautions 

against concurrent prescribing of 

opioids and benzodiazepines, which 

was not identified in the Government’s 

prehearing filings. Resp Exceptions, at 

8–9. However, on this issue, 

Respondent’s counsel did not object to 

the official notice and agreed that there 

was no serious notice issue. See ALJ Ex. 

39. I defer to the Chief ALJ’s decision to 

take official notice of this document, 

which was an exercise of his authority 

to regulate the hearing. As stated above, 

courts have uniformly held that judicial 

rulings issued during the course of 

litigation rarely constitute evidence of 

cognizable bias. Order Denying the 

Respondent’s Recusal Motions (citing 

Liteky v. United States, 510 U.S. 540, 

555 (1994), Hamm v. Members of Bd. of 

Regents, 708 F.2d 647, 651 (11th Cir. 

1983), Dewey C. Mackay, M.D., 75 FR 

49,956, 49,958–59 (2010)). Further, the 

contents of this document should not 

have been a surprise to Respondent, 

because this document is publicly 

available and widely known, and the 

Government had notified Respondent 

that its expert would testify about the 

dangers of prescribing opioids and 

benzodiazepines concurrently. See e.g., 

ALJ Ex. 4 (Gov’t Prehearing), at 20–21; 

see also OSC/ISO, at 3. 

Exception E 

Finally, Respondent argues that the 

Chief ALJ erred in finding that Dr. 

Howard’s hearing testimony suffered 

from diminished credibility. Resp 

Exceptions, at 9–11. In support of this 

argument, Respondent cites to only one 

page of the transcript, where the Chief 

ALJ faulted Dr. Howard for failing to 

remember testimony from the day 

before. Resp Exceptions, at 9 (citing Tr. 

53). Respondent’s Exception fails 

because it does not ‘‘include a statement 

of supporting reasons for such 

exceptions, together with evidence of 

record (including specific and complete 

citations of the pages of the transcript 

and exhibits) and citations of the 

authorities relied upon.’’ 21 CFR 

1316.66. Respondent’s Exception also 


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fails because, after reviewing the entire 

record, I find that the Chief ALJ 

thoroughly and accurately analyzed Dr. 

Howard’s credibility and his testimony, 

and I agree with his credibility findings. 

I therefore reject Respondent’s 

Exceptions and issue the following 

Order. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

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

824(a) and 21 U.S.C. 823(f), I hereby 

revoke DEA Certificate of Registration 

No. FA2125640 issued to AARRIC, Inc. 

Pursuant to 28 CFR 0.100(b) and the 

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

824(a) and 21 U.S.C. 823(f), I further 

hereby deny any pending applications 

for renewal or modification of this 

registration, as well as any other 

pending application of AARRIC, Inc. for 

additional registration in Florida. 

Pursuant to the authority vested in me 

by 21 U.S.C. 824(f), as well as 28 CFR 

0.100(b), I further order that any 

controlled substances seized pursuant to 

the Order of Immediate Suspension of 

Registration are forfeited to the United 

States. This Order is effective February 

18, 2022. 

Anne Milgram, 

Administrator. 

[FR Doc. 2022–00955 Filed 1–18–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

[OMB Number 1122–0001] 

Agency Information Collection 

Activities; Proposed eCollection 

eComments Requested; Extension of 

Currently Approved Collection 

AGENCY: Office on Violence Against 

Women, Department of Justice. 

ACTION: 30-Day notice. 

SUMMARY: The Department of Justice, 

Office on Violence Against Women 

(OVW) will be submitting the following 

information collection request to the 

Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. 

DATES: Comments are encouraged and 

will be accepted for 30 days until 

February 18, 2022. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

SUPPLEMENTARY INFORMATION: Written 

comments and suggestions from the 

public and affected agencies concerning 

the proposed collection of information 

are encouraged. Your comments should 

address one or more of the following 

four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(2) Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of This Information 

Collection 

(1) Type of Information Collection: 

Extension of a currently approved 

collection. 

(2) Title of the Form/Collection: 

Certification of Compliance with the 

Statutory Eligibility Requirements of the 

Violence Against Women Act as 

Amended. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Justice sponsoring the 

collection: Form Number: 1122–0001. 

U.S. Department of Justice, Office on 

Violence Against Women. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: The affected public includes 

STOP formula grantees (50 states, the 

District of Columbia and five territories 

(Guam, Puerto Rico, American Samoa, 

Virgin Islands, Northern Mariana 

Islands). The STOP Violence Against 

Women Formula Grant Program was 

authorized through the Violence Against 

Women Act of 1994 and reauthorized 

and amended in 2000, 2005, and 2013. 

The purpose of the STOP Formula Grant 

Program is to promote a coordinated, 

multi-disciplinary approach to 

improving the criminal justice system’s 

response to violence against women. It 

envisions a partnership among law 

enforcement, prosecution, courts, and 

victim advocacy organizations to 

enhance victim safety and hold 

offenders accountable for their crimes of 

violence against women. The 

Department of Justice’s Office on 

Violence Against Women (OVW) 

administers the STOP Formula Grant 

Program funds which must be 

distributed by STOP state 

administrators according to statutory 

formula (as amended in 2000, 2005 and 

2013). 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond/reply: It is estimated that it will 

take the approximately 56 respondents 

(state administrators from the STOP 

Formula Grant Program) less than one 

hour to complete a Certification of 

Compliance with the Statutory 

Eligibility Requirements of the Violence 

Against Women Act, as Amended. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: The total annual hour burden 

to complete the Certification is less than 

56 hours. 

If additional information is required 

contact: Melody Braswell, Deputy 

Clearance Officer, United States 

Department of Justice, Justice 

Management Division, Policy and 

Planning Staff, Two Constitution 

Square, 145 N Street NE, 3E, 405B, 

Washington, DC 20530. 

Dated: January 13, 2022. 

Melody Braswell, 

Department Clearance Officer, PRA U.S. 

Department of Justice. 

[FR Doc. 2022–00960 Filed 1–18–22; 8:45 am] 

BILLING CODE 4410–FX–P 

DEPARTMENT OF JUSTICE 

[OMB Number 1105–0080] 

Agency Information Collection 

Activities: Extension of a Currently 

Approved Collection: Annuity Broker 

Declaration Form 

ACTION: 60-Day notice of information 

collection under review. 

The Department of Justice (DOJ), Civil 

Division, will be submitting the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. 

The proposed information collection 

is published to obtain comments from 

the public and affected agencies. 

Comments are encouraged and will be 

accepted for 60 days until March 21, 

2022. 

If you have questions concerning the 

collection, please contact James G. 


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