Cypress Creek Pharmacy, LLC; Order, 71927-71928 [2021-27486]
Download as PDF
Federal Register / Vol. 86, No. 241 / Monday, December 20, 2021 / Notices
Consequently, I find that the factors
weigh in favor of sanction and I shall
order the sanctions the Government
requested, as contained in the Order
below.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(f), I hereby deny the pending
application for a Certificate of
Registration, Control Number
W19097421C, submitted by Washington
Bryan, M.D., as well as any other
pending application of Washington
Bryan, M.D. for additional registration
in California. This Order is effective
January 19, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2021–27431 Filed 12–17–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
khammond on DSKJM1Z7X2PROD with NOTICES
Cypress Creek Pharmacy, LLC; Order
On October 18, 2019, a former
Assistant Administrator, Diversion
Control Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause to Cypress Creek Pharmacy, LLC
(hereinafter, Applicant), of Wesley
Chapel, Florida. Order to Show Cause
(hereinafter, OSC), at 1. The OSC
proposed the denial of Applicant’s
application for a DEA Certificate of
Registration because, according to the
OSC, Applicant’s registration with DEA
would be inconsistent with the public
interest. Id. (citing 21 U.S.C. 823(f) and
824(a)(4)).
In a Declaration dated August 3, 2021,
a Diversion Investigator (hereinafter, the
DI) assigned to the Tampa District
Office, Miami Field Division, stated that
on October 25, 2019, she met with
Applicant’s Registered Agent and
Manager at the DEA Tampa District
Office and ‘‘personally served him with
a copy of the [OSC].’’ Request for Final
Agency Action (hereinafter, RFAA),
Exhibit (hereinafter, RFAAX) B, at 1–2.
The DI also stated that since the service
of the OSC, she has ‘‘received no
communications from anyone acting on
behalf of [Applicant] regarding the
[OSC].’’ Id. at 2.
The Government filed a Request for
Final Agency Action (hereinafter,
RFAA) on September 3, 2021. In its
RFAA, the Government stated that
Applicant is without authority to handle
controlled substances in Florida,
because its state pharmacy license
VerDate Sep<11>2014
19:34 Dec 17, 2021
Jkt 256001
recently expired. RFAA, at 1. The
Government provided documentation
from the Florida Department of Health
to support this claim. See RFAAX B–1
and B–2. The Government then
requested that I deny Applicant’s
application for a DEA registration based
solely 1 on the ground that Applicant
lacks authority to handle controlled
substances in Florida, the state where
Applicant seeks a DEA registration.
RFAA, at 1 and 6. The Government did
not allege that Applicant lacked state
authority in the OSC. See generally
OSC.
Previous Agency decisions have
stated that the Government is not
required to issue an amended OSC to
notice an allegation of a registrant’s lack
of state authority that arises during the
pendency of a proceeding regarding a
DEA registration. Hatem M. Ataya, M.D.,
81 FR 8221, 8244 (2016). Additionally,
previous Agency decisions have stated
that because the possession of state
authority is a prerequisite for obtaining
and maintaining a registration, the issue
of state authority can be raised at any
stage of a proceeding, even sua sponte
by the Administrator. See id.; see also
Joe M. Morgan, D.O., 78 FR 61,961,
61,973–74 (2013). In those matters,
however, the registrant had a
meaningful opportunity, during at least
one stage in the proceeding, to refute the
Government’s claim that the registrant
lacked state authority. See, e.g., Ataya,
81 FR at 8245 (Administrator issued
order directing parties to address
whether registrant possessed state
authority); Lesly Pompy, M.D., 84 FR
57,749, 57,749–50 (2019) (notice
provided during administrative
hearing); Morgan, 78 FR at 61,973–74
(Government’s post-hearing Motion for
Summary Disposition provided
adequate notice).
Here, the Government cited to
Lawrence E. Stewart, M.D., 86 FR 15,257
(2021), to support the proposition that it
was not required to issue a new OSC
demonstrating lack of state authority.
RFAA, at 3–4. Although Stewart is
accurately quoted, it also supports the
notion that the Agency must give some
sort of notice and an opportunity to
contest the new allegations. In this case,
in spite of changing the grounds for
denial two years after issuance of the
OSC, the Government had not
demonstrated that it had given any such
opportunity to the Applicant.
Accordingly, on October 15, 2021, I
issued an Interim Order to Applicant
permitting it to submit a response
1 The Government appears to have abandoned its
public interest allegations in the RFAA, and
therefore, I am not considering them.
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
71927
addressing whether Applicant currently
holds state authority to handle
controlled substances in Florida within
fifteen calendar days from the date that
my office served the Order on
Applicant. Applicant sent an email in
reply to my Interim Order on October
20, 2021, stating, ‘‘I have closed the
pharmacy and wish to close out of all
matters dealing with the pharmacy and
the process of all licensure.’’ 2 Email
dated October 20, 2021. I have received
no further correspondence from
Applicant regarding the Government’s
allegations of its lack of state authority.
Because Applicant has presented no
evidence or statements related to its lack
of state authority, I consider the
evidence submitted by the Government
on the lack of state authority allegation
to be uncontested.
I make the following findings of fact
based on the record before me.
Findings of Fact
Applicant’s Application for a DEA
Registration
On or about September 6, 2018,
Applicant submitted an application for
a DEA Certificate of Registration as a
retail pharmacy in Schedules II through
V with a proposed registered address at
26829 Tanic Drive, Suite 101, Wesley
Chapel, Florida 33544. Applicant’s
application was assigned Control No.
W18097945A. RFAAX B, at 1.
The Status of Applicant’s State License
In her Declaration, the DI sated that
Applicant’s state pharmacy license
‘‘expired, without renewal, on February
28, 2021.’’ RFAAX B, at 2. The
Declaration noted that ‘‘that expiration
was automatically extended until June
30, 2021 as part of the State of Florida’s
COVID–19 response.’’ Id. at n.3.
According to Florida Department of
Health’s online records, of which I take
official notice, Applicant’s state
pharmacy registration PH31651 is
‘‘delinquent’’ 3 with a ‘‘license
expiration date’’ of February 28, 2021.4
2 In spite of Applicant’s statement regarding its
discontinuance of business, its application remains
pending and I will continue to assess the
application under 21 U.S.C. 823. See Lawrence E.
Stewart, M.D., 86 FR 15,257 (2021).
3 According to the state website, ‘‘delinquent’’
means ‘‘[t]he license practitioner who held a
CLEAR ACTIVE or CLEAR INACTIVE license, but
failed to renew the license by the expiration date.
The licensed practitioner is not authorized to
practice in the [S]tate of Florida.’’ https://mqainternet.doh.state.fl.us/MQASearchServices//
LicStatus.html#DELINQUENT.
4 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
E:\FR\FM\20DEN1.SGM
Continued
20DEN1
71928
Federal Register / Vol. 86, No. 241 / Monday, December 20, 2021 / Notices
Florida Department of Health’s License
Verification, Licensee Lookup, https://
mqa-internet.doh.state.fl.us/MQASearch
Services/Home (last visited date of
signature of this Order).
Accordingly, I find that Registrant
currently is not licensed to engage in the
practice of pharmacy in Florida, the
state in which Applicant applied for
registration with the DEA.
khammond on DSKJM1Z7X2PROD with NOTICES
Discussion
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 Controlled
Substances Act (hereinafter, CSA)
‘‘upon a finding that the registrant . . .
has had [its] 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 DEA has also long held
that the possession of authority to
dispense controlled substances under
the laws of the state in which a
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 he 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
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 shall be filed
with the Office of the Administrator and a copy
shall be served on the Government. In the event
Registrant files a motion, the Government shall
have fifteen calendar days to file a response. Any
such motion and response may be filed and served
by email (dea.addo.attorneys@dea.usdoj.gov).
VerDate Sep<11>2014
19:34 Dec 17, 2021
Jkt 256001
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 DEA has held repeatedly that
revocation of a practitioner’s registration
is the appropriate sanction whenever he
is no longer authorized to dispense
controlled substances under the laws of
the state in which he practices. See, e.g.,
James L. Hooper, 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, 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, either alone
or with another person or persons, a
pharmacy: (a) Which is not registered
under the provisions of this chapter.’’ 5
Fla. Stat. Ann. § 465.015(1). Further,
‘‘the practice of the profession of
pharmacy’’ definition ‘‘includes
compounding, dispensing, and
consulting concerning contents,
therapeutic values, and uses of any
medicinal drug 6 . . . .’’ Fla. Stat. Ann.
§ 465.003(13) (West, 2021).
Here, the undisputed evidence in the
record is that Applicant currently lacks
authority to operate a pharmacy in
Florida. As already discussed, a
pharmacy must be a licensed to
dispense a medicinal drug, including a
controlled substance, in Florida. Thus,
because Applicant lacks authority to
practice pharmacy in Florida and,
therefore, is not authorized to dispense
controlled substances in Florida,
Applicant is not eligible to receive a
DEA registration. Accordingly, I will
order that Applicant’s application for a
DEA registration be denied.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(f), I hereby order that the pending
application for a Certificate of
Registration, Control Number
W18097945A, submitted by Cypress
Creek Pharmacy, LLC is denied, as well
as any other pending application of
Cypress Creek Pharmacy, LLC for
5 The Government included an email from a
Florida Medical Quality Assurance Investigator
stating that ‘‘[p]harmacies are not allowed to
operate at all on a delinquent license.’’ RFAA B–
2, at 1 (emphasis in original). This statement is
supported by my analysis of Florida law.
6 ‘‘Medicinal Drugs’’ or ‘‘Drugs’’ means ‘‘those
substances or preparations commonly known as
‘prescription’ or ‘legend’ drugs which are required
by federal or state law to be dispensed only on a
prescription . . . .’’ Fla. Stat. Ann. § 465.003(8).
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
additional registration in Florida. This
Order is effective January 19, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2021–27486 Filed 12–17–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Employment and Training
Administration
Agency Information Collection
Activities; Comment Request; COVID–
19 Symptom Tracker for Students,
Emotional Wellness Form for Students,
and Student Vaccination Status and
Test Consent Form Collection
ACTION:
Notice.
The Department of Labor’s
(DOL) Employment and Training
Administration (ETA) is soliciting
comments concerning a proposed
extension for the authority to conduct
the information collection request (ICR)
titled, ‘‘COVID–19 Symptom Tracker for
Students, Emotional Wellness Form for
Students, and Student Vaccination
Status and Test Consent Form
Collection’’. This comment request is
part of continuing Departmental efforts
to reduce paperwork and respondent
burden in accordance with the
Paperwork Reduction Act of 1995
(PRA).
DATES: Consideration will be given to all
written comments received by February
18, 2022.
ADDRESSES: A copy of this ICR with
applicable supporting documentation,
including a description of the likely
respondents, proposed frequency of
response, and estimated total burden,
may be obtained free by contacting
Lawrence Lyford by telephone at 202–
693–3121 (this is not a toll-free
number), TTY 1–877–889–5627 (this is
not a toll-free number), or by email at
Lyford.Lawrence@dol.gov.
Submit written comments about, or
requests for a copy of, this ICR by mail
or courier to the U.S. Department of
Labor, Employment and Training
Administration, Office of Job Corps, 200
Constitution Avenue NW, Room N4459
Washington DC 20210; by email:
Lyford.Lawrence@dol.gov; or by fax
202–693–3113.
FOR FURTHER INFORMATION CONTACT:
Lawrence Lyford by telephone at 202–
693–3121 (this is not a toll-free number)
or by email at Lyford.Lawrence@dol.gov.
Authority: 44 U.S.C. 3506(c)(2)(A).
SUPPLEMENTARY INFORMATION: DOL, as
part of continuing efforts to reduce
SUMMARY:
E:\FR\FM\20DEN1.SGM
20DEN1
Agencies
[Federal Register Volume 86, Number 241 (Monday, December 20, 2021)]
[Notices]
[Pages 71927-71928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27486]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Cypress Creek Pharmacy, LLC; Order
On October 18, 2019, a former Assistant Administrator, Diversion
Control Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause to Cypress Creek Pharmacy,
LLC (hereinafter, Applicant), of Wesley Chapel, Florida. Order to Show
Cause (hereinafter, OSC), at 1. The OSC proposed the denial of
Applicant's application for a DEA Certificate of Registration because,
according to the OSC, Applicant's registration with DEA would be
inconsistent with the public interest. Id. (citing 21 U.S.C. 823(f) and
824(a)(4)).
In a Declaration dated August 3, 2021, a Diversion Investigator
(hereinafter, the DI) assigned to the Tampa District Office, Miami
Field Division, stated that on October 25, 2019, she met with
Applicant's Registered Agent and Manager at the DEA Tampa District
Office and ``personally served him with a copy of the [OSC].'' Request
for Final Agency Action (hereinafter, RFAA), Exhibit (hereinafter,
RFAAX) B, at 1-2. The DI also stated that since the service of the OSC,
she has ``received no communications from anyone acting on behalf of
[Applicant] regarding the [OSC].'' Id. at 2.
The Government filed a Request for Final Agency Action
(hereinafter, RFAA) on September 3, 2021. In its RFAA, the Government
stated that Applicant is without authority to handle controlled
substances in Florida, because its state pharmacy license recently
expired. RFAA, at 1. The Government provided documentation from the
Florida Department of Health to support this claim. See RFAAX B-1 and
B-2. The Government then requested that I deny Applicant's application
for a DEA registration based solely \1\ on the ground that Applicant
lacks authority to handle controlled substances in Florida, the state
where Applicant seeks a DEA registration. RFAA, at 1 and 6. The
Government did not allege that Applicant lacked state authority in the
OSC. See generally OSC.
---------------------------------------------------------------------------
\1\ The Government appears to have abandoned its public interest
allegations in the RFAA, and therefore, I am not considering them.
---------------------------------------------------------------------------
Previous Agency decisions have stated that the Government is not
required to issue an amended OSC to notice an allegation of a
registrant's lack of state authority that arises during the pendency of
a proceeding regarding a DEA registration. Hatem M. Ataya, M.D., 81 FR
8221, 8244 (2016). Additionally, previous Agency decisions have stated
that because the possession of state authority is a prerequisite for
obtaining and maintaining a registration, the issue of state authority
can be raised at any stage of a proceeding, even sua sponte by the
Administrator. See id.; see also Joe M. Morgan, D.O., 78 FR 61,961,
61,973-74 (2013). In those matters, however, the registrant had a
meaningful opportunity, during at least one stage in the proceeding, to
refute the Government's claim that the registrant lacked state
authority. See, e.g., Ataya, 81 FR at 8245 (Administrator issued order
directing parties to address whether registrant possessed state
authority); Lesly Pompy, M.D., 84 FR 57,749, 57,749-50 (2019) (notice
provided during administrative hearing); Morgan, 78 FR at 61,973-74
(Government's post-hearing Motion for Summary Disposition provided
adequate notice).
Here, the Government cited to Lawrence E. Stewart, M.D., 86 FR
15,257 (2021), to support the proposition that it was not required to
issue a new OSC demonstrating lack of state authority. RFAA, at 3-4.
Although Stewart is accurately quoted, it also supports the notion that
the Agency must give some sort of notice and an opportunity to contest
the new allegations. In this case, in spite of changing the grounds for
denial two years after issuance of the OSC, the Government had not
demonstrated that it had given any such opportunity to the Applicant.
Accordingly, on October 15, 2021, I issued an Interim Order to
Applicant permitting it to submit a response addressing whether
Applicant currently holds state authority to handle controlled
substances in Florida within fifteen calendar days from the date that
my office served the Order on Applicant. Applicant sent an email in
reply to my Interim Order on October 20, 2021, stating, ``I have closed
the pharmacy and wish to close out of all matters dealing with the
pharmacy and the process of all licensure.'' \2\ Email dated October
20, 2021. I have received no further correspondence from Applicant
regarding the Government's allegations of its lack of state authority.
---------------------------------------------------------------------------
\2\ In spite of Applicant's statement regarding its
discontinuance of business, its application remains pending and I
will continue to assess the application under 21 U.S.C. 823. See
Lawrence E. Stewart, M.D., 86 FR 15,257 (2021).
---------------------------------------------------------------------------
Because Applicant has presented no evidence or statements related
to its lack of state authority, I consider the evidence submitted by
the Government on the lack of state authority allegation to be
uncontested.
I make the following findings of fact based on the record before
me.
Findings of Fact
Applicant's Application for a DEA Registration
On or about September 6, 2018, Applicant submitted an application
for a DEA Certificate of Registration as a retail pharmacy in Schedules
II through V with a proposed registered address at 26829 Tanic Drive,
Suite 101, Wesley Chapel, Florida 33544. Applicant's application was
assigned Control No. W18097945A. RFAAX B, at 1.
The Status of Applicant's State License
In her Declaration, the DI sated that Applicant's state pharmacy
license ``expired, without renewal, on February 28, 2021.'' RFAAX B, at
2. The Declaration noted that ``that expiration was automatically
extended until June 30, 2021 as part of the State of Florida's COVID-19
response.'' Id. at n.3.
According to Florida Department of Health's online records, of
which I take official notice, Applicant's state pharmacy registration
PH31651 is ``delinquent'' \3\ with a ``license expiration date'' of
February 28, 2021.\4\
[[Page 71928]]
Florida Department of Health's License Verification, Licensee Lookup,
https://mqa-internet.doh.state.fl.us/MQASearchServices/Home (last
visited date of signature of this Order).
---------------------------------------------------------------------------
\3\ According to the state website, ``delinquent'' means ``[t]he
license practitioner who held a CLEAR ACTIVE or CLEAR INACTIVE
license, but failed to renew the license by the expiration date. The
licensed practitioner is not authorized to practice in the [S]tate
of Florida.'' https://mqa-internet.doh.state.fl.us/MQASearchServices//LicStatus.html#DELINQUENT.
\4\ 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 shall be filed with the Office of the Administrator and a
copy shall be served on the Government. In the event Registrant
files a motion, the Government shall have fifteen calendar days to
file a response. Any such motion and response may be filed and
served by email ([email protected]).
---------------------------------------------------------------------------
Accordingly, I find that Registrant currently is not licensed to
engage in the practice of pharmacy in Florida, the state in which
Applicant applied for registration with the DEA.
Discussion
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
Controlled Substances Act (hereinafter, CSA) ``upon a finding that the
registrant . . . has had [its] 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 DEA has also long
held that the possession of authority to dispense controlled substances
under the laws of the state in which a 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 he 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 DEA has held repeatedly that revocation
of a practitioner's registration is the appropriate sanction whenever
he is no longer authorized to dispense controlled substances under the
laws of the state in which he practices. See, e.g., James L. Hooper, 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, 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,
either alone or with another person or persons, a pharmacy: (a) Which
is not registered under the provisions of this chapter.'' \5\ Fla.
Stat. Ann. Sec. 465.015(1). Further, ``the practice of the profession
of pharmacy'' definition ``includes compounding, dispensing, and
consulting concerning contents, therapeutic values, and uses of any
medicinal drug \6\ . . . .'' Fla. Stat. Ann. Sec. 465.003(13) (West,
2021).
---------------------------------------------------------------------------
\5\ The Government included an email from a Florida Medical
Quality Assurance Investigator stating that ``[p]harmacies are not
allowed to operate at all on a delinquent license.'' RFAA B-2, at 1
(emphasis in original). This statement is supported by my analysis
of Florida law.
\6\ ``Medicinal Drugs'' or ``Drugs'' means ``those substances or
preparations commonly known as `prescription' or `legend' drugs
which are required by federal or state law to be dispensed only on a
prescription . . . .'' Fla. Stat. Ann. Sec. 465.003(8).
---------------------------------------------------------------------------
Here, the undisputed evidence in the record is that Applicant
currently lacks authority to operate a pharmacy in Florida. As already
discussed, a pharmacy must be a licensed to dispense a medicinal drug,
including a controlled substance, in Florida. Thus, because Applicant
lacks authority to practice pharmacy in Florida and, therefore, is not
authorized to dispense controlled substances in Florida, Applicant is
not eligible to receive a DEA registration. Accordingly, I will order
that Applicant's application for a DEA registration be denied.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(f), I hereby order that the pending application for a
Certificate of Registration, Control Number W18097945A, submitted by
Cypress Creek Pharmacy, LLC is denied, as well as any other pending
application of Cypress Creek Pharmacy, LLC for additional registration
in Florida. This Order is effective January 19, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2021-27486 Filed 12-17-21; 8:45 am]
BILLING CODE 4410-09-P