Notice2021-16005
Care Point Pharmacy, Inc.; Decision and Order
Primary source
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Published
July 28, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 86 Issue 142 (Wednesday, July 28, 2021)</title>
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[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40621-40627]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="/cdn-cgi/l/email-protection#66020307480702020948071212091408031f152602030748131502090c48010910"><span class="__cf_email__" data-cfemail="204445410e4144444f0e4154544f524e455953604445410e5553444f4a0e474f56">[email protected]</span></a>.
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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.
---------------------------------------------------------------------------
(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.
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\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.
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\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.)
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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.
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\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
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.