Care Point Pharmacy, Inc.; Decision and Order, 40621-40627 [2021-16005]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40621-40627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16005]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Care Point Pharmacy, Inc.; Decision and Order

    On November 20, 2019, the Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause (hereinafter, OSC) to Care Point Pharmacy, Inc. 
(hereinafter, Registrant). Government's Request for Final Agency Action 
(hereinafter, RFAA) Exhibit (hereinafter, RFAAX) 1 (OSC). The OSC 
proposed to revoke Registrant's DEA Certificate of Registration Number 
BH9966904 (hereinafter, registration) and to deny any pending 
applications for renewal or modification of the registration, pursuant 
to 21 U.S.C. 824(a)(4) and 823(f), because Registrant's ``continued 
registration is inconsistent with the public interest.'' Id. (citing 21 
U.S.C. 824(a)(4) and 823(f)).
    The OSC alleged that Registrant is licensed as a community pharmacy 
in the State of Florida. Id. at 2. It further alleged that Ekaette 
Isemin is Registrant's sole corporate officer, and that she is licensed 
as a pharmacist in Florida. Id.
    The OSC alleged that ``[o]n six occasions, [Registrant] dispensed 
controlled substances to a DEA confidential source pursuant to 
fraudulent prescriptions, despite clear evidence of diversion.'' Id. at 
2. The OSC further alleged that ``[Registrant's] dispensing of 
controlled substances in the face of clear evidence of diversion 
violated federal and state law.'' Id. at 5 (citing 21 CFR 1306.06, 
1306.04(a); Fla. Stat. Sec. Sec.  893.04(2)(a), 465.016(1)(i), 
456.072(1)(m); Fla. Admin. Code. Ann. r. 64B16-27.831, 64B16-27.810).
    The OSC notified Registrant of its right to request a hearing on 
the allegations or to submit a written statement while waiving its 
right to a hearing, the procedures for electing either option, and the 
consequence of failing to elect either option. Id. at 5-6 (citing 21 
CFR 1301.43).
    In response to the OSC, Ekaette Isemin filed a timely request for 
an administrative hearing on Registrant's behalf, and requested that 
all future notices and mailings be mailed to her. RFAAX 2 (Request for 
Hearing). On December 26, 2019, the Chief Administrative Law Judge 
(hereinafter, Chief ALJ) established a schedule for the filing of 
prehearing statements. RFAAX 3 (Order for Prehearing Statements). The 
Government filed a timely prehearing statement on January 6, 2020,\1\ 
but Registrant failed to file any prehearing statement by the deadline. 
RFAAX 4 (Order Terminating Proceedings), at 1-2.
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    \1\ The Government notified Registrant in its prehearing 
statement that Registrant's DEA registration was subject to 
revocation on the additional ground that Registrant lacked authority 
to handle controlled substances in Florida, the state in which it is 
registered with the DEA. See 21 U.S.C. 824(a)(3). The Prehearing 
Statement was mailed to Ms. Isemin at the address that Ms. Isemin 
designated for future filings in her December 20, 2019 request for 
hearing. See RFAAX 2, at 2.
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    On January 21, 2020, the Chief ALJ issued an Order Directing 
Compliance and Postponing Prehearing Conference, which afforded 
Registrant until February 5, 2020, to file its prehearing statement and 
to show good cause for the delay. Id. at 2. The Order Directing 
Compliance and the Order for Prehearing Statements were sent to Ms. 
Isemin via first class mail, and neither document was returned as 
undeliverable. Id. Neither Registrant nor Ms. Isemin filed a showing of 
good cause for the delay or a prehearing statement by the deadline set 
forth in the Order Directing Compliance.\2\ Id. Therefore, the Chief 
ALJ determined that Registrant had ``effectively waived its right to a 
hearing,'' and he terminated the proceedings on February 6, 2020. 
Id.\3\ I agree with the Chief ALJ that Registrant waived its right to a 
hearing by failing to comply with the Chief ALJ's order.\4\
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    \2\ The Order Terminating Proceedings noted that Registrant was 
not currently represented by counsel and ``it appear[ed] that Ms. 
Isemin [was] appearing on the [Registrant's] behalf.'' RFAAX 4, at 1 
(citing 21 CFR 1316.50).
    \3\ In the Order Terminating Proceedings, the Chief ALJ stated 
that ``Agency precedent is clear that the unwillingness or inability 
of a party to comply with the directives of the [ALJ] may support an 
implied waiver of that party's right to a hearing.'' Id. (citing 
Robert M Brodkin, D.P.M, 77 FR 73,678, 73,679 (2012); Kamir Garces-
Mejias, M.D., 72 FR 54,931, 54,932 (2007); Andrew Desonia, M.D., 72 
FR 54,293, 54,294 (2007); Alan R. Schankman, M.D., 63 FR 45,260, 
45,260 (1998)).
    \4\ See 21 CFR 1301.43(d) (``If any person entitled to a hearing 
or to participate in a hearing pursuant to Sec.  1301.32 or 
Sec. Sec.  1301.34-1301.36 . . . files [a request for a hearing] and 
fails to appear at the hearing, such person shall be deemed to have 
waived the opportunity for a hearing or to participate in the 
hearing, unless such person shows good cause for such failure''); 
see also RFAAX 3, at 3-4 (notifying Registrant that ``[f]ailure to 
timely file a prehearing statement that complies with the directions 
provided [therein] may result in a sanction, including (but not 
limited to) a waiver of hearing and an implied withdrawal of a 
request for hearing'').
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    On February 19, 2020, the Government forwarded an RFAA, along with 
the evidentiary record for this matter, to my office. Having considered 
the record in its entirety, I find that the record establishes, by 
substantial evidence, that Registrant committed acts rendering its 
continued registration inconsistent with the public interest. 
Additionally, I find that Registrant lacks authority to handle 
controlled substances in the State of Florida, the state where it is 
registered with DEA. Accordingly, I conclude that the appropriate 
sanction is for Registrant's DEA registration to be revoked.

I. Findings of Fact

A. Registrant's DEA Registration

    Registrant is registered with DEA as a retail pharmacy in Schedules 
II through V under DEA registration number BH9966904, at the registered 
address of 1400 Hand Avenue, Suite 0, Ormond Beach, Florida 32174. 
RFAAX 5 (DEA Certificate of Registration). This registration expires on 
August 31, 2021. Id.

B. The Status of Registrant's State Authority

    Registrant was previously licensed as a community pharmacy in the 
State of Florida under license number PH22199. RFAAX 6 Appendix 
(hereinafter, App'x) B (Division of Corporations Printout), at 1. 
Registrant's sole corporate officer was Ekaette Isemin, id., who was 
previously registered as a pharmacist in Florida under license number 
PS28851. App'x A, at 1.
    On August 20, 2018, the Florida Department of Health (hereinafter, 
Florida DOH) ordered the emergency suspension of Ms. Isemin's pharmacy 
license, based on its determination that ``Ms. Isemin's continued 
practice as a pharmacist constitutes an immediate, serious danger to 
the health, safety, and welfare of the public . . . .'' Id. at 18. The 
order concluded that Ms. Isemin repeatedly violated state law over the 
course of approximately sixteen months by dispensing controlled 
substances to a

[[Page 40622]]

DEA Confidential Source (hereinafter, DEA CS), despite the DEA CS's 
repeated statements that he was diverting the controlled substances 
that Registrant dispensed. Id. at 14-18.
    Approximately sixteen months later, on December 12, 2019, the 
Florida DOH ordered the emergency suspension of Registrant's license to 
operate as a community pharmacy in Florida. App'x D (Order of Emergency 
Suspension of Permit). The suspension was primarily based on the fact 
that Registrant had continued to order and dispense controlled 
substances for approximately one year while Ms. Isemin's license was 
suspended. Id. at 9-10. The Florida DOH concluded that ``[Registrant's] 
continued operation as a community pharmacy presents an immediate, 
serious danger to the health, safety, and welfare of the public, and 
that this danger is likely to continue.'' Id. at 9. The Florida DOH 
noted that ``[r]estricting [Registrant's] permit would not adequately 
protect the public because any operation as a pharmacy would allow 
[Registrant] to continue engaging in the same illegal and dangerous 
conduct set forth above.'' Id.
    According to Florida's online records, of which I take official 
notice,\5\ Registrant's Florida pharmacy license is ``revoked.'' 
Therefore, I find that Registrant does not possess authority to handle 
controlled substances in Florida, the state in which Registrant is 
registered with DEA.
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    \5\ Under the Administrative Procedure Act, an agency ``may take 
official notice of facts at any stage in a proceeding--even in the 
final decision.'' United States Department of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), 
``[w]hen an agency decision rests on official notice of a material 
fact not appearing in the evidence in the record, a party is 
entitled, on timely request, to an opportunity to show the 
contrary.'' Accordingly, Registrant may dispute my finding by filing 
a properly supported motion for reconsideration of finding of fact 
within fifteen calendar days of the date of this Order. Any such 
motion and response shall be filed and served by email to the other 
party and to the Office of the Administrator, Drug Enforcement 
Administration, at [email protected].
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C. Government's Allegation That Registrant Dispensed Controlled 
Substances Unlawfully

    In its RFAA, the Government alleged that Registrant violated 
federal and state law by dispensing controlled substances to a DEA CS 
on six occasions in the face of clear evidence of diversion. OSC, at 2, 
5. To support this allegation, the Government submitted a declaration 
of the DEA Diversion Investigator (hereinafter, DI), who was assigned 
to the investigation of Registrant. RFAAX 6 (Declaration of DI). DI has 
been a DI for approximately 30 years and is currently assigned to the 
Orlando District Office of the Miami Field Division. Id. at 1. DI's 
declaration summarizes DEA's investigation, including the details of 
six undercover visits conducted by the DEA CS at Registrant between 
June 8, 2017, and March 6, 2018. In addition to DI's declaration, the 
Government submitted copies of controlled substance prescriptions that 
the DEA CS sought to fill at Registrant, along with the corresponding 
fill stickers. App'x E, I, M, Q, U, Y. The Government also submitted 
audio and video recordings of each undercover visit, as well as 
transcripts of the recordings. App'x F, G, J, K, N, O, R, S, V, W, ZA, 
AB (recordings); App'x H, L, P, T, X, ZC (transcripts).
1. The Undercover Visits
    The DEA CS visited Registrant in an undercover capacity on six 
separate occasions using the fake identity D.S. RFAAX 6, at 2. At each 
visit, the DEA CS sought to fill a prescription for controlled 
substances that had been issued to D.S.\6\ or to A.D., the fake 
identity of the CS's girlfriend. Id. at 2-8. DI's declaration states 
that each prescription that D.S. sought to fill at Registrant was 
``fraudulent and [] not valid.'' \7\ Id. At each recorded undercover 
visit, D.S. admitted that he had diverted, or intended to divert, the 
controlled substances that Registrant dispensed to him.
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    \6\ The DEA CS and D.S. are used interchangeably herein.
    \7\ DI's declaration does not provide factual support for the 
conclusion that the prescriptions were fraudulent and not valid. 
Presumably, these prescriptions were fraudulent and not valid 
because they were issued to fake identities. However, I do not find 
that it is necessary for me to determine whether the prescriptions 
were fraudulent or invalid, because Registrant clearly violated 
federal and state law by repeatedly dispensing controlled substances 
to D.S. with actual knowledge that D.S. intended to divert the 
controlled substances that Registrant dispensed, based on the 
recorded conversations. See infra II.A.2.
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a. June 8, 2017 Undercover Visit
    On June 8, 2017, the DEA CS visited Registrant in an undercover 
capacity, posing as D.S. Id. at 3. The DEA CS sought to fill a 
controlled substance prescription that had been issued to his 
girlfriend's fake identity, A.D., for one hundred eight-milligram 
tablets of hydromorphone.\8\ Id. at 3; App'x E (May 19, 2017 
Prescription).\9\ Prior to this visit, D.S. had filled hydromorphone 
prescriptions at Registrant, while acting in an undercover 
capacity.\10\ At this visit, D.S. told Ms. Isemin that he had given 
half of the hydromorphone prescription that he had previously filled at 
Registrant to his girlfriend, and some to a friend, so that he could 
afford Registrant's high prices. App'x H, at 1. D.S. told Ms. Isemin 
that he would be ``splitting these again,'' so that he could ``get 
ready for the next time [he] come[s].'' Id. at 2. Registrant dispensed 
one hundred eight-milligram tablets of hydromorphone to D.S. in 
exchange for $1,000 in cash.\11\ App'x E, at 2-4; RFAAX 6, at 3.
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    \8\ Hydromorphone is a Schedule II controlled substance. See 21 
CFR 1308.12(b)(1)(vii) (2017).
    \9\ The photocopy of the May 19, 2017 prescription is difficult 
to read. See App'x E, at 1. However, the fill sticker that was 
generated during this transaction shows the strength and quantity of 
hydromorphone that was dispensed, and it is consistent with DI's 
representation of the prescription that D.S. presented to Registrant 
at this visit. Compare App'x E, at 4 with GX 6, at 3.
    \10\ See App'x A, at 3 (stating that D.S. first filled a 
prescription at Registrant on December 12, 2016).
    \11\ The receipt from the transaction shows that Registrant 
charged D.S. $1,000.84, App'x E, at 2, 4, but D.S. paid Registrant 
$1,000 in cash. RFAAX 6, at 3.
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b. July 28, 2017 Undercover Visit
    The DEA CS visited Registrant again in an undercover capacity on 
July 28, 2017, posing as D.S. RFAAX 6, at 3-4. The DEA CS presented 
Registrant with a controlled substance prescription that had been 
issued to D.S. for one hundred eight-milligram tablets of 
hydromorphone. Id.\12\ At this visit, D.S. again admitted to Ms. Isemin 
that he was diverting some of the hydromorphone that Registrant 
dispensed to him. App'x L, at 5-6. He said that he only takes a few 
tablets himself, because they make him ``woozy,'' and he sells the rest 
to his employee. Id. at 6. D.S. told Ms. Isemin that he was going back 
to the doctor in a couple of weeks and he was ``gonna try to get him to 
up `em, so [he] [could] sell a few more.'' Id. at 6. Ms. Isemin advised 
D.S. not to obtain more than one hundred and thirty or one hundred and 
fifty tablets, because ``they are checking.'' \13\ Id.
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    \12\ The Government did not include a copy of the prescription 
that D.S. presented to Registrant on this date, but the Government 
provided a copy of the fill sticker, which is consistent with DI's 
representation of the prescription that D.S. presented to Registrant 
at this visit. Compare App'x I with RFAAX 6, at 3.
    \13\ Presumably, Ms. Isemin was referring to enforcement efforts 
by the state or federal government.
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    Registrant dispensed one hundred eight-milligram tablets of 
hydromorphone to D.S. at this visit and charged D.S. $1,000.84. App'x 
I; RFAAX 6, at 4. D.S. paid Registrant $1,020, and explained to Ms. 
Isemin that the extra money could cover what D.S owed

[[Page 40623]]

Registrant for the other prescriptions that Registrant had filled. 
RFAAX 6, at 4; App'x L, at 6. D.S. said, ``That way I don't owe you 
anything, cuz I don't want you to one day be like, Hey, this guy owes 
me, so I'm not going to fill you, I'll fill somebody else's.'' App'x L, 
at 6; App'x K, at 11:12:11-20.
c. October 17, 2017 Undercover Visit
    The DEA CS visited Registrant again in an undercover capacity on 
October 17, 2017, posing as D.S. RFAAX 6, at 4. The DEA CS presented 
Registrant with two controlled substance prescriptions--one that was 
issued to D.S. and one that was issued to A.D. Id. Each prescription 
was for one hundred and fifty eight-milligram tablets of hydromorphone. 
App'x M, at 1 (October 12, 2017 Prescriptions). At this visit, D.S. 
again admitted to Ms. Isemin that he was diverting some of the 
hydromorphone that Registrant dispensed to him. App'x P, at 2. Ms. 
Isemin warned D.S. not to get caught, and D.S. assured her that he 
would not. Id. D.S. told Ms. Isemin that they have ``a very short 
window of catching [him],'' because ``[t]hey'll be gone as fast as [he] 
get[s] them from [her], except for the ones [he] take[s].'' Id. 
Registrant dispensed three hundred eight-milligram tablets of 
hydromorphone to D.S. and charged D.S. $3,000. App'x M, at 3, 5. D.S. 
paid Registrant $3,020 in cash. RFAAX 6, at 5.
d. December 18, 2017 Undercover Visit
    The DEA CS visited Registrant in an undercover capacity again on 
December 18, 2017, posing as D.S. RFAAX 6, at 5. The DEA CS sought to 
fill two controlled substance prescriptions--one that was issued to 
D.S. and one that was issued to A.D. Id. Each prescription was for one 
hundred and fifty eight-milligram tablets of hydromorphone. App'x Q 
(December 15, 2017 Prescriptions). At this visit, Registrant dispensed 
three hundred eight-milligram tablets of hydromorphone to D.S. and 
charged D.S. $3,000. App'x Q at 3, 5. D.S. paid Registrant $3,200, 
explaining that the extra $200 was a ``Christmas bonus.'' App'x T, at 
2-3. D.S. said that he had fired the guy who had purchased the 
hydromorphone from him last time, but he found somebody else to buy the 
hydromorphone at higher prices. Id. at 2. Ms. Isemin asked D.S. if he 
was sure he wanted to give her a bonus, and he replied, ``I'm positive, 
Christmas bonus. . . . I'm making pretty good now, so we good.'' Id. at 
3.
e. January 23, 2018 Undercover Visit
    The DEA CS visited Registrant again in an undercover capacity on 
January 23, 2018, posing as D.S. RFAAX 6, at 6. The DEA CS presented 
Registrant with a controlled substance prescription issued to D.S. for 
one hundred and fifty eight-milligram tablets of hydromorphone. Id.; 
App'x U (January 22, 2018 Prescription). Ms. Isemin told D.S. that she 
did not have enough eight-milligram tablets to fill the prescription, 
so D.S. asked if she could provide four-milligram tablets. App'x X, at 
1-2. Ms. Isemin agreed, and dispensed two bottles of hydromorphone to 
D.S.--each containing a mixture of four and eight-milligram tablets. 
RFAAX 6, at 6. One bottle contained one hundred tablets and the other 
contained eighty-eight tablets. Id. The fill sticker generated by 
Registrant for this transaction falsely shows that Registrant dispensed 
one hundred and fifty eight-milligram tablets of hydromorphone to D.S. 
App'x U, at 3.
    Ms. Isemin again warned D.S. not to get caught by the police. App'x 
X, at 7. D.S. assured her that he is ``pretty good, all safe,'' when he 
sells the hydromorphone. Id. Ms. Isemin told D.S. that ``if they catch 
[the purchaser] they'll find out where he's getting it from.'' Id. D.S. 
laughed and told Ms. Isemin that they would not find out if he does not 
tell the purchaser where the tablets come from. Id. Ms. Isemin charged 
D.S. $1,410 for the prescription, but D.S. paid Ms. Isemin $1,500, 
explaining that ``[t]hat way [he] can just pick them up'' the next 
time, and joking that the extra money was so that Ms. Isemin did not 
``forget [him].'' Id. at 8. Ms. Isemin told D.S. that she would owe him 
nine tablets at the next visit. Id. at 6.
f. March 6, 2018 Undercover Visit
    The DEA CS visited Registrant in an undercover capacity again on 
March 6, 2018, posing as D.S. RFAAX 6 at 7. The DEA CS presented 
Registrant with a controlled substance prescription issued to D.S. for 
one hundred thirty-milligram tablets of oxycodone.\14\ Id.; App'x Y 
(March 5, 2018 Prescription). D.S. asked Ms. Isemin if she was going to 
get more tablets in stock, because the lack of stock was ``killing 
[his] business.'' App'x ZC, at 1-2. Ms. Isemin explained that she was 
trying to get more tablets in stock. Id. at 2. Registrant dispensed one 
hundred thirty-milligram tablets of oxycodone to D.S. and charged him 
$1,100 for the prescription, which D.S. paid in cash. RFAAX 6, at 7; 
App'x Y at 3.
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    \14\ Oxycodone is a Schedule II controlled substance. See 21 CFR 
1308.12(b)(1)(xiii) (2017).
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    Registrant also dispensed nine twenty-milligram tablets of 
oxycodone to D.S., although D.S. did not present a prescription for 
twenty-milligram tablets. RFAAX 6, at 8; App'x Z (Photograph of the 
Oxycodone Dispensed). Ms. Isemin confirmed that Registrant owed D.S. 
these tablets from a prior visit. App'x ZC, at 2. As discussed above, 
see supra I.C.1.e, Ms. Isemin had explained to D.S. at the previous 
visit on January 23, 2018, that she owed him nine tablets of 
hydromorphone, because she was unable to completely fill D.S.'s 
prescriptions for one hundred and fifty tablets of hydromorphone on 
that day. App'x X, at 6. At this visit, Ms. Isemin substituted nine 
tablets of oxycodone for nine tablets of hydromorphone, even though 
D.S.'s previous prescription had been for hydromorphone. There was no 
corresponding prescription for the nine tablets of oxycodone that Ms. 
Isemin dispensed to D.S.

II. Discussion

A. Registrant's Registration is Inconsistent With the Public Interest

    The Government alleged that Registrant's DEA registration should be 
revoked because Registrant committed acts that would render its 
registration inconsistent with the public interest as provided in 21 
U.S.C. 823(f). The Government's case centers on six recorded undercover 
visits, during which Registrant repeatedly dispensed controlled 
substances to a DEA CS, notwithstanding the CS's recurring statements 
that he was diverting the controlled substances that Registrant 
dispensed.
    Under the Controlled Substances Act (hereinafter, the CSA), ``[a] 
registration . . . to . . . dispense a controlled substance . . . may 
be suspended or revoked by the Attorney General upon a finding that the 
registrant . . . has committed such acts as would render his 
registration under section 823 of this title inconsistent with the 
public interest as determined under such section.'' 21 U.S.C. 
824(a)(4). In the case of a ``practitioner,'' which is defined in 21 
U.S.C. 802(21) to include a pharmacy, Congress directed the Attorney 
General to consider the following factors in making the public interest 
determination:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The [registrant]'s experience in dispensing . . . controlled 
substances.
    (3) The [registrant]'s conviction record under Federal or State 
laws relating to the . . . distribution[ ] or dispensing of controlled 
substances.

[[Page 40624]]

    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.
    21 U.S.C. 823(f). These factors are considered in the disjunctive. 
Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (2003).
    According to Agency decisions, I ``may rely on any one or a 
combination of factors and may give each factor the weight [I] deem[ ] 
appropriate in determining whether'' to revoke a registration. Id.; see 
also Jones Total Health Care Pharm., LLC v. Drug Enf't Admin., 881 F.3d 
823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi v. Drug Enf't Admin., 
841 F.3d 707, 711 (6th Cir. 2016); MacKay v. Drug Enf't Admin., 664 
F.3d 808, 816 (10th Cir. 2011); Volkman v. Drug Enf't Admin., 567 F.3d 
215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 
(6th Cir. 2005). Moreover, while I am required to consider each of the 
factors, I ``need not make explicit findings as to each one.'' MacKay, 
664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see also Hoxie, 419 
F.3d at 482. ``In short, . . . the Agency is not required to 
mechanically count up the factors and determine how many favor the 
Government and how many favor the registrant. Rather, it is an inquiry 
which focuses on protecting the public interest; what matters is the 
seriousness of the registrant's misconduct.'' Jayam Krishna-Iyer, M.D., 
74 FR 459, 462 (2009). Accordingly, findings under a single factor can 
support the revocation of a registration. MacKay, 664 F.3d at 821.
    The Government has the burden of proving that the requirements for 
revocation of a DEA registration in 21 U.S.C. 824(a) are satisfied. 21 
CFR 1301.44(e). When the Government has met its prima facie case, the 
burden then shifts to the registrant to show that revoking its 
registration would not be appropriate, given the totality of the facts 
and circumstances on the record. Med. Shoppe-Jonesborough, 73 FR 364, 
387 (2008).
    In this matter, while I have considered all of the factors, the 
Government's evidence in support of its prima facie case is most 
appropriately considered under Factors One, Two, and Four.\15\ I find 
that the Government has satisfied its prima facie burden of showing 
that Registrant's continued registration would be ``inconsistent with 
the public interest.'' 21 U.S.C. 824(a)(4).
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    \15\ As to Factor Three, although the record contains evidence 
that Registrant's sole corporate officer, Ms. Isemin, was arrested 
and charged with eight felony counts of drug trafficking, see App'x 
A, at 11; RFAAX 6 at 2, there is no evidence that Registrant has had 
a ``conviction record under Federal or State laws relating to the 
manufacture, distribution, or dispensing of controlled substances.'' 
21 U.S.C. 823(f)(3). However, as Agency cases have noted, there are 
a number of reasons why a person who has engaged in criminal 
misconduct may never have been convicted of an offense under this 
factor, let alone prosecuted for one. Dewey C. MacKay, M.D., 75 FR 
49,956, 49,973 (2010). Agency cases have therefore held that ``the 
absence of such a conviction is of considerably less consequence in 
the public interest inquiry'' and is therefore not dispositive. Id.; 
see also David D. Moon, D.O., 82 FR 19,385, 19,389 n.9 (finding that 
Factor Three was not dispositive where the registrant had been 
arrested for controlled substance-related charges, but there was no 
evidence of a conviction).
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1. Factor One--The Recommendation of the Appropriate State Licensing 
Board or Professional Disciplinary Authority
    In determining the public interest under Factor One, the 
``recommendation of the appropriate State licensing board or 
professional disciplinary authority . . . shall be considered.'' 21 
U.S.C. 823(f)(1). ``Two forms of recommendations appear in Agency 
decisions: (1) A recommendation to DEA directly from a state licensing 
board or professional disciplinary authority . . ., which explicitly 
addresses the granting or retention of a DEA COR; and (2) the 
appropriate state entity's action regarding the licensure under its 
jurisdiction on the same matter that is the basis for the DEA OSC.'' 
John O. Dimowo, 85 FR 15,800, 15,809 (2020); see also Kenneth Harold 
Bull, M.D., 78 FR 62,666, 62,672 (2013) (``DEA . . . thus considers 
disciplinary actions taken by a state board as relevant in the public 
interest determination when they result in a loss of state authority, 
or are based on findings establishing that a registrant diverted 
controlled substances . . . .'').
    Florida, the state in which Registrant is registered with DEA, 
immediately suspended Ms. Isemin's pharmacy license on August 20, 2018. 
See supra I.b. The suspension was primarily based on Registrant's 
unlawful dispensing of controlled substances to the DEA CS--the same 
misconduct that is at issue in this proceeding. Id. According to 
Florida's online records, Registrant's Florida pharmacy license has 
been ``revoked.'' Id. Because the ``appropriate State licensing board'' 
has revoked Registrant's state authority based on Registrant's unlawful 
dispensing of controlled substances, I find that Factor One weighs 
strongly in favor of revocation.\16\
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    \16\ Additionally, because Florida revoked Registrant's pharmacy 
license, I must revoke Registrant's DEA registration because 
Registrant is not ``authorized to dispense . . . controlled 
substances under the laws of the State in which [it] practices.'' 
See infra II.B (citing 21 U.S.C. 823(f)); see also Kenneth Harold 
Bull, 78 FR at 62,672 (noting in its Factor One analysis that where 
a state board takes action to restrict a practitioner's authority to 
dispense controlled substances, ``at a minimum, a practitioner's 
[DEA] registration must be limited to authorize the dispensing of 
only those controlled substances, which he can lawfully dispense 
under state law''); David W. Bailey, M.D., 81 FR 6045, 6046 n.2 
(2016) (``As for Factor One, while the State has not made a 
recommendation to the Agency, the State has revoked Respondent's 
medical license and thus, he no longer meets the CSA's requirement 
that he is authorized to dispense controlled substances in the State 
where he is registered.'').
---------------------------------------------------------------------------

2. Factors Two and Four--The Registrant's Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances
    In determining the public interest under Factors Two and Four, I am 
to consider evidence of Registrant's compliance (or non-compliance) 
with laws related to controlled substances and Registrant's experience 
dispensing controlled substances. The Government's case relies 
primarily on the actions of Registrant's sole corporate owner, Ms. 
Isemin. ``Agency precedent has consistently held that the registration 
of a pharmacy may be revoked as the result of the unlawful activity of 
the pharmacy's owners, majority shareholders, officers, managing 
pharmacist, or other key employee.'' Perry Cty. Food & Drug, 80 FR 
70,084, 70,109 (2015) (citing EZRX, LLC, 69 FR 63,178, 63,181 (1988); 
Plaza Pharmacy, 53 FR 36,910, 36,911 (1988)).
    The Government alleged that Registrant violated several federal and 
state laws related to controlled substances by dispensing controlled 
substances to a DEA CS in the face of clear evidence of diversion. OSC, 
at 2, 5 (citing violations of 21 CFR 1306.06 and 1306.04(a); Fla. Stat. 
Sec. Sec.  893.04(2)(a) and 465.016(1)(i); and Fla. Admin. Code. Ann. 
r. 64B16-27.831 and 64B16-27.810).\17\ The Government also alleged that 
Registrant violated federal and state law by dispensing a Schedule II 
controlled substance without a written prescription. Id. at 5 (citing 
21 U.S.C. 829(a); Fla. Stat. Sec.  465.015(2)(c); Fla. Stat. Sec.  
465.016(1)(i)).
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    \17\ The Government also alleged in the OSC that registrant 
violated Fla. Stat. Sec.  456.072(1)(m), which prevents the use of 
``trick[s] or scheme[s] in or related to the practice of a 
profession.'' OSC, at 3, 5. Because the Government did not reference 
this statute in the RFAA, or argue its applicability, I will not 
consider this allegation.
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(a) Violations of Federal Law

    According to the CSA's implementing regulations, a lawful 
controlled substance order or prescription is one that is ``issued for 
a legitimate medical

[[Page 40625]]

purpose by an individual practitioner acting in the usual course of his 
professional practice.'' 21 CFR1306.04(a). While the ``responsibility 
for the proper prescribing and dispensing of controlled substances is 
upon the prescribing practitioner, . . . a corresponding responsibility 
rests with the pharmacist who fills the prescription.'' Id. The 
regulations establish the parameters of the pharmacy's corresponding 
responsibility:

    An order purporting to be a prescription issued not in the usual 
course of professional treatment . . . is not a prescription within 
the meaning and intent of . . . 21 U.S.C. 829 . . . and the person 
knowingly filling such a purported prescription, as well as the 
person issuing it, shall be subject to the penalties provided for 
violations of the provisions of law relating to controlled 
substances.

    Id. ``The language in 21 CFR [Sec.  ] 1306.04 and relevant caselaw 
could not be more explicit. A pharmacist has his own responsibility to 
ensure that controlled substances are not dispensed for non-medical 
reasons.'' Ralph J. Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55 FR 
4729, 4730 (1990) (citing United States v. Hayes, 595 F.2d 258 (5th 
Cir. 1979), cert. denied, 444 U.S. 866 (1979); United States v. Henry, 
727 F.2d 1373 (5th Cir. 1984) (reversed on other grounds)). As the 
Supreme Court explained in the context of the CSA's requirement that 
schedule II controlled substances may be dispensed only by written 
prescription, ``the prescription requirement . . . ensures patients use 
controlled substances under the supervision of a doctor so as to 
prevent addiction and recreational abuse . . . [and] also bars doctors 
from peddling to patients who crave the drugs for those prohibited 
uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006).
    To prove that a pharmacist violated his corresponding 
responsibility, the Government must show that the pharmacist acted with 
the requisite degree of scienter. See 21 CFR 1306.04(a) (``[T]he person 
knowingly filling [a prescription issued not in the usual course of 
professional treatment] . . . shall be subject to the penalties 
provided for violations of the provisions of law relating to controlled 
substances.'') (emphasis added). DEA has also consistently interpreted 
the corresponding responsibility regulation such that ``[w]hen 
prescriptions are clearly not issued for legitimate medical purposes, a 
pharmacist may not intentionally close his eyes and thereby avoid 
[actual] knowledge of the real purpose of the prescription.'' 
Bertolino, 55 FR at 4730 (citations omitted); see also JM Pharmacy 
Group, Inc. d/b/a Pharmacia Nueva and Best Pharmacy Corp., 80 FR 
28,667, 28,670-72 (2015) (applying the standard of willful blindness in 
assessing whether a pharmacist acted with the requisite scienter). 
Pursuant to their corresponding responsibility, pharmacists must 
exercise ``common sense and professional judgment'' when filling a 
prescription issued by a physician. Bertolino, 55 FR at 4730.
    In this matter, the Government alleges that Registrant engaged in 
blatant drug dealing by dispensing controlled substances to a DEA CS, 
who ``exhibited clear and unambiguous signs of diversion.'' RFAA, at 
21. The Government asserts that in cases involving blatant drug 
dealing, ``this Agency has found that a pharmacy's registration [is] 
inconsistent with the public interest under Factors Two and Four, even 
without the benefit of any expert opinion.'' Id. at 20-21 (citing 
Lincoln Pharmacy, 75 FR 65,667, 65,668 (2010) (revoking respondent's 
registration and labeling its dispensing as ``blatant drug dealing,'' 
where a cooperating source told respondent's pharmacist that he was 
selling the dispensed drugs); S & S Pharmacy, Inc., d/b/a Platinum 
Pharmacy & Compounding, 78 FR 57,656, 57,660 (2013) (affirming 
immediate suspension of registration and labeling respondent's 
dispensing as a ``blatant drug deal,'' where respondent's pharmacist 
dispensed drugs pursuant to prescriptions that he knew were 
fictitious).
    I agree with the Government that this case involves blatant drug 
dealing, and I find that the Government has proven by substantial 
evidence that Registrant filled prescriptions for controlled substances 
that it knew were illegitimate, in violation of its corresponding 
responsibility under 21 CFR1306.04(a),\18\ and that Registrant filled 
these prescriptions outside the usual course of the professional 
practice of pharmacy in Florida, in violation of 21 CFR 1306.06.\19\ At 
each undercover visit, the DEA CS told Ms. Isemin that he was planning 
to divert, or already had diverted, the controlled substances that 
Registrant dispensed. See supra I.c.1. Ms. Isemin clearly understood 
that the DEA CS intended to divert the drugs, because she warned the 
DEA CS on several occasions not to get caught. Id. Ms. Isemin even 
accepted a cash tip from D.S. on several occasions, id., which further 
evidences her knowledge that she was engaging in blatant drug dealing. 
Respondent's flagrant violations of federal law weigh strongly against 
a finding that Registrant's continued registration is consistent with 
the public interest.
---------------------------------------------------------------------------

    \18\ See Ralph J. Bertolino Pharmacy, 55 FR at 4730 (noting that 
a pharmacist's corresponding responsibility requires him ``to ensure 
that controlled substances are not dispensed for non-medical 
reasons'') (internal citations omitted); S & S Pharmacy, Inc., 78 FR 
at 57,660 (finding that respondent violated 21 U.S.C. 841(a)(1) and 
21 CFR 1306.04 by exchanging controlled substances for cash, knowing 
that the prescriptions provided by the DEA's confidential source 
were fictitious).
    \19\ In relevant part, section 1306.06 provides that ``[a] 
prescription for a controlled substance may only be filled by a 
pharmacist, acting in the usual course of his professional 
practice.'' In order to prove a violation of this regulation, the 
Government must ``establish what the standards of pharmacy practice 
require, through either expert testimony or by reference to federal 
or state laws, pharmacy board or Agency regulations, or decisional 
law (whether of administrative bodies or the courts).'' Farmacia 
Yani, 80 FR 29,053, 29,062 (2015). I find below that the Government 
has proven by substantial evidence that Registrant violated several 
Florida laws related to the proper dispensing of controlled 
substances. See infra II.A.2.b.
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(b) Violations of State Law
    In addition to alleging that Registrant violated 21 CFR 1306.04(a) 
and 1306.06, the Government alleges that Registrant violated Florida 
state law by: (1) Failing to ``exercis[e] sound professional judgment'' 
and ``work with the patient and the prescriber to assist in determining 
the validity of the prescription''; \20\ (2) failing to review each 
prescription for potential problems, such as ``[o]ver utilization or 
under-utilization'' and ``[c]linical abuse/misuse,'' and failing to 
``take appropriate steps to avoid or resolve the potential problems''; 
\21\ and (3) dispensing Schedule II controlled substances to a patient 
``without first determining, in the exercise of her or his professional 
judgment, that the prescription is valid.'' \22\ The Government also 
alleges that Registrant violated Florida and federal law on March 6, 
2018, when it dispensed a Schedule II controlled substance without a 
written prescription of a practitioner.\23\
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    \20\ See Fla. Admin. Code. r. 64B16-27.831 (2015). This rule was 
amended in 2018, after the relevant misconduct in this case took 
place; however, there were no relevant, substantive modifications to 
this regulation in 2018.
    \21\ See Fla. Admin. Code. r. 64B16-27.810.
    \22\ See Fla. Stat. Sec.  893.04(2)(a) (2016). This statute was 
amended in 2018, after the relevant misconduct in this case took 
place; however, there were no relevant, substantive modifications to 
this regulation in 2018.
    \23\ See 21 U.S.C. 829(a); Fla. Stat. Sec.  465.015(2)(c) 
(prohibiting the dispensing of ``drugs as defined in [Fla. Stat. 
Sec.  ] 465.003(8) without first being furnished with a 
prescription''); see also Fla. Stat. Sec.  465.003(8) (defining 
``[m]edicinal drugs or drugs'' as ``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'') 
(internal quotations omitted).

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[[Page 40626]]

    I find that the Government has provided substantial evidence that 
Registrant violated these federal and state laws by dispensing 
controlled substances to the DEA CS on the six occasions outlined 
above. Ms. Isemin clearly did not ``exercise[e] sound professional 
judgment'' \24\ or ``work with the patient and the prescriber to assist 
in determining the validity of the prescription,'' as required by Fla. 
Admin. Code. r. 64B16-27.831.\25\ The DEA CS told Ms. Isemin that he 
intended to divert the controlled substances that she dispensed, and 
she simply warned him not to get caught. See supra I.c.1. Ms. Isemin 
also failed to identify and respond to factors that indicated a lack of 
``therapeutic appropriateness'' of the drugs dispensed, as outlined in 
Fla. Admin. Code. r. 64B16-27.810. Rather, Ms. Isemin knew that the 
controlled substances that Registrant dispensed would not be used for 
legitimate medical purposes, but she dispensed them anyway. In fact, 
the DEA CS told Ms. Isemin on one occasion that he does not take many 
of the pills himself because they make him ``woozy.'' See supra 
I.c.1.b. Finally, I found above that Registrant dispensed nine tablets 
of oxycodone, a Schedule II controlled substance, on March 6, 2018, 
without a written prescription of a practitioner. Id. Therefore, 
Registrant violated federal and state law. See 21 U.S.C. 829(a); Fla. 
Stat. Sec.  465.015(2)(c) (2016).
---------------------------------------------------------------------------

    \24\ In the emergency order suspending Ms. Isemin's state 
license, the Florida DOH concluded that Ms. Isemin ``lacks the good 
judgment needed to practice as a pharmacist in the State of 
Florida,'' because of her ``repeated failure to require patient 
identification from D.S. or to verify whether D.S.' prescriptions 
were valid prior to dispensing controlled substances; her continued 
sale of controlled substances to D.S., despite being informed on 
several occasions that he was selling them to unauthorized 
individuals; and her acceptance of a `bonus' for assisting D.S. in 
his illegal sale of controlled substances . . . .'' App'x A, at 12. 
The order also concluded that Ms. Isemin violated Fla. Stat. 
Sec. Sec.  893.04(1) and (2)(a), in part, because she ``[k]nowingly 
dispens[ed] controlled substances to a patient who stated he was 
selling the controlled substances to unauthorized persons.'' Id. at 
17.
    \25\ See also Fla. Stat. Sec.  893.04(2)(a) (prohibiting 
pharmacists from dispensing Schedule II controlled substances to a 
patient ``without first determining, in the exercise of her or his 
professional judgment, that the prescription is valid'').
---------------------------------------------------------------------------

    In light of Registrant's egregious conduct that has no resemblance 
to the professional practice of pharmacy, I conclude that Factors One, 
Two, and Four overwhelmingly demonstrate that Registrant ``has 
committed such acts as would render [its] registration . . . 
inconsistent with the public interest.'' 21 U.S.C. 824(a)(4). I further 
conclude that Registrant has not rebutted the Government's prima facie 
case.

B. Registrant Lacks Authority To Handle Controlled Substances

    The Government alternatively alleged that Registrant's DEA 
registration should be revoked because Registrant does not possess the 
requisite authority to dispense controlled substances in the State of 
Florida, where it is registered with DEA. RFAA, at 22.
    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized 
to suspend or revoke a registration issued under section 823 of the CSA 
``upon a finding that the registrant . . . has had his State license or 
registration suspended . . . [or] revoked . . . by competent State 
authority and is no longer authorized by State law to engage in the . . 
. dispensing of controlled substances.'' With respect to a 
practitioner, the Agency has long stated that the possession of 
authority to dispense controlled substances under the laws of the state 
in which the practitioner engages in professional practice is a 
fundamental condition for obtaining and maintaining a practitioner's 
registration. See, e.g., James L. Hooper, M.D., 76 FR 71,371 (2011), 
pet. for rev. denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh 
Blanton, M.D., 43 FR 27,616, 27,617 (1978).
    This rule derives from the text of two provisions of the CSA. 
First, Congress defined the term ``practitioner'' to mean ``a pharmacy 
. . . or other person licensed, registered, or otherwise permitted, by 
. . . the jurisdiction in which . . . [it] practices . . ., to 
distribute, dispense, . . . [or] administer . . . a controlled 
substance in the course of professional practice.'' 21 U.S.C. 802(21). 
Second, in setting the requirements for obtaining a practitioner's 
registration, Congress directed that ``[t]he Attorney General shall 
register practitioners . . . if the applicant is authorized to dispense 
. . . controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated 
that a practitioner possess state authority in order to be deemed a 
practitioner under the CSA, the Agency has repeatedly stated that 
revocation of a practitioner's registration is the appropriate sanction 
whenever it is no longer authorized to dispense controlled substances 
under the laws of the state in which she practices. See, e.g., James L. 
Hooper, M.D., 76 FR at 71,371-72; Sheran Arden Yeates, M.D., 71 FR 
39,130, 39,131 (2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 
(1993); Bobby Watts, M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh 
Blanton, M.D., 43 FR at 27,617.
    According to Florida statute, ``It is unlawful for any person to 
own, operate, maintain, open, establish, conduct, or have charge of . . 
. a pharmacy . . . [w]hich is not registered under the professions of 
[Chapter 465].'' Fla. Stat. Ann. Sec.  465.015(1)(a) (West, current 
with chapters from the 2021 First Regular Session of the Twenty-Seventh 
Legislature in effect through June 22, 2021). Further, ``It is unlawful 
for any person . . . [t]o fill, compound, or dispense prescriptions or 
to dispense medicinal drugs if such person does not hold an active 
license as a pharmacist in [Florida] . . . .'' Fla. Stat. Ann. Sec.  
465.015(2)(b).\26\ Accordingly, holding a permit issued by the Florida 
Board of Pharmacy is a prerequisite to operating a pharmacy and 
dispensing a controlled substance in Florida.
---------------------------------------------------------------------------

    \26\ See also Fla. Stat. Ann. Sec.  465.015(1)(b) (``It is 
unlawful for any person to own, operate, maintain, open, establish, 
conduct, or have charge of . . . a pharmacy . . . [i]n which a 
person not licensed as a pharmacist in this state . . . fills, 
compounds, or dispenses any prescription or dispenses medicinal 
drugs.)
---------------------------------------------------------------------------

    Here, the undisputed evidence in the record is that Registrant 
currently lacks authority to operate a pharmacy in Florida. As such, 
Registrant is not qualified to dispense controlled substances in 
Florida. Accordingly, I will order that Registrant's DEA registration 
be revoked.

III. Sanction

    Where, as here, the Government has met its prima facie burden of 
showing that Registrant's continued registration is inconsistent with 
the public interest, the burden shifts to the Registrant to show why it 
can be entrusted with a registration. Garrett Howard Smith, M.D., 83 FR 
18,882, 18,910 (2018) (collecting cases).
    The CSA authorizes the Attorney General to ``promulgate and enforce 
any rules, regulations, and procedures which he may deem necessary and 
appropriate for the efficient execution of his functions under this 
subchapter.'' 21 U.S.C. 871(b). This authority specifically relates 
``to `registration' and `control,' and `for the efficient execution of 
his functions' under the statute.'' Gonzales, 546 U.S. at 259. 
``Because `past performance is the best predictor of future 
performance, ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 
(7th Cir. 1995), [the Agency] has repeatedly held that where a 
registrant has committed acts inconsistent with the public interest, 
the registrant must

[[Page 40627]]

accept responsibility for [the registrant's] actions and demonstrate 
that [registrant] will not engage in future misconduct.''' Jayam 
Krishna-Iyer, 74 FR at 463 (quoting Med. Shoppe, 73 FR 364, 387 
(2008)); see also Samuel S. Jackson, 72 FR 23,848, 23,853 (2007); John 
H. Kennnedy, M.D., 71 FR 35,705, 35,709 (2006); Prince George Daniels, 
D.D.S., 60 FR 62,884, 62,887 (1995). The issue of trust is necessarily 
a fact-dependent determination based on the circumstances presented by 
the individual registrant; therefore, the Agency looks at factors, such 
as the acceptance of responsibility, and the credibility of that 
acceptance as it relates to the probability of repeat violations or 
behavior, and the nature of the misconduct that forms the basis for 
sanction, while also considering the Agency's interest in deterring 
similar acts. See Arvinder Singh, M.D., 81 FR 8247, 8248 (2016).
    Here the Registrant did not avail itself of the opportunity to 
refute the Government's case. In light of Registrant's egregious 
violations, which go to the heart of the CSA's purpose of 
``prevent[ing] addiction and recreational abuse'' of controlled 
substances,\27\ Registrant's silence weighs against the Registrant's 
continued registration. Zvi H. Perper, M.D., 77 FR at 64,142 (citing 
Med. Shoppe, 73 FR at 387); see also Jackson, 72 FR at 23,853.
---------------------------------------------------------------------------

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

    Accordingly, I find that the factors weigh in favor of revocation, 
and I shall order the sanctions that the Government requested, as 
contained in the Order below.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration 
BH9966904 issued to Care Point Pharmacy, Inc. Further, pursuant to 28 
CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I 
hereby deny any pending application of Care Point Pharmacy, Inc. to 
renew or modify this registration. This order is effective August 27, 
2021.

Anne Milgram,
Administrator.
[FR Doc. 2021-16005 Filed 7-27-21; 8:45 am]
BILLING CODE 4410-09-P