Ibem R. Borges, M.D.; Decision and Order, 23521-23523 [2016-09274]
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Rules of Practice and Procedure (19 CFR
210.8(b)).
FOR FURTHER INFORMATION CONTACT: Lisa
R. Barton, Secretary to the Commission,
U.S. International Trade Commission,
500 E Street SW., Washington, DC
20436, telephone (202) 205–2000. The
public version of the complaint can be
accessed on the Commission’s
Electronic Document Information
System (EDIS) at EDIS,1 and will be
available for inspection during official
business hours (8:45 a.m. to 5:15 p.m.)
in the Office of the Secretary, U.S.
International Trade Commission, 500 E
Street SW., Washington, DC 20436,
telephone (202) 205–2000.
General information concerning the
Commission may also be obtained by
accessing its Internet server at United
States International Trade Commission
(USITC) at USITC.2 The public record
for this investigation may be viewed on
the Commission’s Electronic Document
Information System (EDIS) at EDIS.3
Hearing-impaired persons are advised
that information on this matter can be
obtained by contacting the
Commission’s TDD terminal on (202)
205–1810.
SUPPLEMENTARY INFORMATION: The
Commission has received a complaint
and a submission pursuant to section
210.8(b) of the Commission’s Rules of
Practice and Procedure filed on behalf
of ResMed Corp; ResMed Inc. and
ResMed Ltd. on April 14, 2016. The
complaint alleges violations of section
337 of the Tariff Act of 1930 (19 U.S.C.
1337) in the importation into the United
States, the sale for importation, and the
sale within the United States after
importation of certain sleep-disordered
breathing treatment systems and
components thereof. The complaint
names as respondents BMC Medical Co.,
Ltd. of China; 3B Medical, Inc. of Lake
Wales, FL; and 3B Products, L.L.C. of
Lake Wales, FL. The complainant
requests that the Commission issue a
limited exclusion order, cease and
desist orders and impose a bond upon
respondents’ alleged infringing articles
during the 60-day Presidential review
period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other
interested parties, and members of the
public are invited to file comments, not
to exceed five (5) pages in length,
inclusive of attachments, on any public
interest issues raised by the complaint
or section 210.8(b) filing. Comments
1 Electronic Document Information System
(EDIS): https://edis.usitc.gov.
2 United States International Trade Commission
(USITC): https://edis.usitc.gov.
3 Electronic Document Information System
(EDIS): https://edis.usitc.gov.
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13:27 Apr 20, 2016
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should address whether issuance of the
relief specifically requested by the
complainant in this investigation would
affect the public health and welfare in
the United States, competitive
conditions in the United States
economy, the production of like or
directly competitive articles in the
United States, or United States
consumers.
In particular, the Commission is
interested in comments that:
(i) Explain how the articles
potentially subject to the requested
remedial orders are used in the United
States;
(ii) identify any public health, safety,
or welfare concerns in the United States
relating to the requested remedial
orders;
(iii) identify like or directly
competitive articles that complainant,
its licensees, or third parties make in the
United States which could replace the
subject articles if they were to be
excluded;
(iv) indicate whether complainant,
complainant’s licensees, and/or third
party suppliers have the capacity to
replace the volume of articles
potentially subject to the requested
exclusion order and/or a cease and
desist order within a commercially
reasonable time; and
(v) explain how the requested
remedial orders would impact United
States consumers.
Written submissions must be filed no
later than by close of business, eight
calendar days after the date of
publication of this notice in the Federal
Register. There will be further
opportunities for comment on the
public interest after the issuance of any
final initial determination in this
investigation.
Persons filing written submissions
must file the original document
electronically on or before the deadlines
stated above and submit 8 true paper
copies to the Office of the Secretary by
noon the next day pursuant to section
210.4(f) of the Commission’s Rules of
Practice and Procedure (19 CFR
210.4(f)). Submissions should refer to
the docket number (‘‘Docket No. 3140’’)
in a prominent place on the cover page
and/or the first page. (See Handbook for
Electronic Filing Procedures, Electronic
Filing Procedures 4). Persons with
questions regarding filing should
contact the Secretary (202–205–2000).
Any person desiring to submit a
document to the Commission in
confidence must request confidential
4 Handbook for Electronic Filing Procedures:
https://www.usitc.gov/secretary/fed_reg_notices/
rules/handbook_on_electronic_filing.pdf.
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treatment. All such requests should be
directed to the Secretary to the
Commission and must include a full
statement of the reasons why the
Commission should grant such
treatment. See 19 CFR 201.6. Documents
for which confidential treatment by the
Commission is properly sought will be
treated accordingly. All nonconfidential
written submissions will be available for
public inspection at the Office of the
Secretary and on EDIS.5
This action is taken under the
authority of section 337 of the Tariff Act
of 1930, as amended (19 U.S.C. 1337),
and of sections 201.10 and 210.8(c) of
the Commission’s Rules of Practice and
Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
Issued: April 15, 2016.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2016–09212 Filed 4–20–16; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Ibem R. Borges, M.D.; Decision and
Order
On October 14, 2015, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration (DEA), issued an Order
to Show Cause to Ibem R. Borges, M.D.
(Respondent), of Orlando, Florida. GX 1.
The Show Cause Order proposed the
revocation of Respondent’s DEA
Certificate of Registration BB3166053,
pursuant to which he is authorized to
dispense controlled substances in
schedules II though V as a practitioner,
and the denial of any application to
renew or modify this registration, as
well as any application for any other
DEA registration, on the ground that
Respondent does ‘‘not have authority to
handle controlled substances in Florida,
the State in which [he is] registered with
the DEA.’’ Id. at 1.
The Show Cause Order specifically
alleged that effective November 8, 2013,
the Florida Department of Health issued
an ‘‘Order of Emergency Restriction of
License’’ to Respondent, which
prohibits him from prescribing
controlled substances in schedules II
through IV. Id. The Show Cause Order
also alleged that Respondent ‘‘do[es] not
have a Florida dispensing license,
which is an additional license required
[by the State] before a physician is
authorized to order and directly
5 Electronic Document Information System
(EDIS): https://edis.usitc.gov.
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Federal Register / Vol. 81, No. 77 / Thursday, April 21, 2016 / Notices
dispense or administer controlled
substances.’’ Id. The Show Cause Order
thus alleged that Respondent ‘‘do[es]
not have authority in Florida to order,
dispense, prescribe or administer any
controlled substances in Schedules II
through IV,’’ and that the Agency ‘‘must
revoke [his] DEA registrations [sic]
based upon [his] lack of authority to
handle controlled substances in the
State of Florida for Schedules II through
IV.’’ Id. (citing 21 U.S.C. 802(21), 823(f)
and 824(a)(3)).
The Show Cause Order also notified
Respondent of his right to request a
hearing on the allegations or to submit
a written statement in lieu of a hearing,
the procedure for electing either option,
and the consequence for failing to elect
either option. Id. at 2 (citing 21 CFR
1301.43).
On October 22, 2015, a DEA Diversion
Investigator (DI) served the Order to
Show Cause by certified mail, return
receipt requested, addressed to
Respondent at his personal residence.
GX 3, at 1 (Declaration of DI). On
November 6, 2015, the DI received back
the USPS return receipt card; however,
while the card bore Respondent’s
signature, it was dated ‘‘2/29/15.’’ Id.;
see also GX 4, at 1. The DI then obtained
the USPS tracking record for the
delivery, which revealed that the Show
Cause Order was delivered on October
29, 2015. GX 3, at 1; GX 4, at 2.
On November 9, 2015, the DEA Office
of Administrative Law Judges received a
letter from an attorney stating that he
represented Respondent; the letter was
addressed to the Deputy Assistant
Administrator, care of the Hearing
Clerk, and used the mailing address of
the Office of Administrative Law Judges.
GXs 5 and 6. Thereafter, the Chief
Administrative Law Judge (CALJ) sent a
letter to Respondent’s attorney stating
that because the latter had not requested
a hearing, his Office was not authorized
to take any further action. GX 6.
The Government subsequently filed a
Request for Final Agency Action along
with various documents submitted as
the Investigative Record, including the
letter from Respondent’s attorney. Based
on Respondent’s failure to request a
hearing in his letter, I find that
Respondent has waived his right to a
hearing on the allegations of the Show
Cause Order. 21 CFR 1301.43(d).
However, I have treated the letter of
Respondent’s Counsel as his written
statement of position and made it a part
of the record. Id. § 1301.43(c). Having
considered the entire record, I issue this
Decision and Final Order, id.
§ 1301.43(e), and make the following
findings of fact.
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Findings
Respondent is the holder of DEA
Certificate of Registration BB3166053,
pursuant to which he is authorized to
dispense controlled substances in
schedules II through V, at the registered
address of Pain Free Clinic & More,
1800 W. Oakridge Rd., Orlando, Florida.
GX 2. Respondent’s registration does not
expire until July 31, 2016. Id.
On November 8, 2013, the Florida
Department of Health (DOH) issued an
Order of Emergency Restriction of
License (Order) to Respondent. The
Order restricted Respondent’s medical
license by prohibiting him from
prescribing any medications listed in
schedules II, III or IV, as set forth in
section 893.03 of the Florida Statutes.1
GX 8, at 28. In its Order, the DOH found
that Respondent: (1) ‘‘prescribed,
dispensed, administered, mixed or
otherwise prepared a legend drug, other
than in the course of his professional
practice’’ to an undercover officer, by
excessively and inappropriately
prescribing controlled substances; (2)
‘‘failed to keep legible medical records
that justif[ied] the course of treatment
of’’ the undercover officer, by ‘‘[f]ailing
to document a complete medical
history; and/or . . . [f]ailing to
document a complete physical
examination results’’; and (3) ‘‘failed to
comply with the applicable standards
for the use of controlled substances for
pain control.’’ GX 8, at 23–27 (citing Fla.
Stat. §§ 458.331(1)(q); 458.331(1)(m);
458.331(1)(nn) (2012–2013); Fla.
Admin. Code. r. 64B8–9.013(3)).
Under Florida law, physicians are
required to be registered as ‘‘a
dispensing practitioner’’ in order to
directly dispense a controlled
substance.2 Fla. Stat. § 465.0276. The
record includes a letter from the Florida
Department of Health which states that
Respondent is not registered as a
dispensing practitioner. GX 9.
A review of the Department of Health
Web site shows that while Respondent’s
license is in an active status, the
emergency prohibition against his
prescribing of any medications listed in
1 The factual basis of the DOH’s Order was
Respondent’s prescribing of oxycodone 30 mg and
morphine sulfate 30 mg to an undercover officer on
multiple occasions, ignoring ‘‘the most basic
standards for the use of controlled substances for
the treatment of pain as directed by the Board of
Medicine’s written standards found in Rule 64B8–
9.013 [of] the Florida Administrative Code.’’ GX 8,
at 18 (int. quotations omitted).
2 This provision, however, prohibits even a
properly registered practitioner from dispensing a
schedule II or III controlled substance except for in
limited situations. Fla. Stat. 465.027(1)(b).
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schedules II, III, or IV of Fla. Stat.
§ 893.03 remains in effect.3
Based on the above, I find that the
only authority Respondent currently
possesses under Florida law is the
authority to prescribe controlled
substances in schedule V.
In his written statement of position,
Respondent does not dispute this.
Indeed, he ‘‘recognizes that his DEA
registration for the prescription of
[s]chedules II, III, and IV [c]ontrolled
[s]ubstances is subject to revocation in
the immediate future.’’ GX 5, at 1.
However, he ‘‘reserves his right to
prescribe [s]chedule V [c]ontrolled
[s]ubstances.’’ Id. He further requests
that he be ‘‘permitted to retain and
renew his basic DEA registration and his
ability to prescribe Class V
pharmaceuticals as this would permit
him to renew or expand the scope of his
prescribing should he be acquitted of
the pending criminal charges and
otherwise fulfil [sic] the DEA
requirements for registration.’’ GX 5, at
1.
In addition to the foregoing, I take
official notice that court records from
the Osceola County Circuit Court
indicate that Respondent has been
charged with racketeering, conspiracy to
engage in racketeering, three counts of
trafficking oxycodone, and
manslaughter, and faces a jury trial on
June 6, 2016.
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, ‘‘upon a finding that
the registrant . . . has had his State
license . . . suspended [or] revoked
. . . by competent State authority and is
no longer authorized by State law to
engage in the . . . dispensing of
controlled substances.’’ Moreover,
Congress has defined ‘‘the term
‘practitioner’ [to] mean[] a . . .
physician . . . 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
3 Under the Administrative Procedure Act (APA),
an agency ‘‘may take official notice of facts at any
stage in a proceeding—even in the final decision.’’
U.S. Dept. of Justice, Attorney General’s Manual on
the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). In accordance
with the APA and DEA’s regulations, Respondent
is ‘‘entitled on timely request to an opportunity to
show to the contrary.’’ 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). To allow Respondent the
opportunity to refute the facts of which I take
official notice, Respondent may file a motion for
reconsideration within ten calendar days of service
of this order which shall commence on the date this
order is mailed.
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practice.’’ 21 U.S.C. 802(21). Likewise,
the CSA conditions the granting of a
practitioner’s application on his/her
possession of authority to dispense
controlled substances under state law.
See 21 U.S.C. 823(f) (‘‘The Attorney
General shall register practitioners . . .
to dispense . . . controlled substances
. . . if the applicant is authorized to
dispense . . . controlled substances
under the laws of the State in which he
practices.’’). Of further note, the CSA
defines the term ‘‘dispense’’ as meaning
‘‘to deliver a controlled substance to an
ultimate user . . . by, or pursuant to the
lawful order of, a practitioner.’’ Id.
§ 802(10) (emphasis added).
Thus, the Agency has repeatedly 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, 76 FR 71371 (2011),
pet. for rev. denied, 481 Fed Appx. 826
(4th Cir. 2012). And because a
practitioner’s authority under the CSA
is based on his/her authority to dispense
controlled substances under the laws of
the State in which he practices, the
Agency has further held that ‘‘to the
extent a practitioner is not authorized
under state law to dispense certain
categories or schedules of controlled
substances, he can no longer lawfully
dispense them under federal law.’’
Kenneth Harold Bull, 78 FR 62666,
62672 (2013).
In Bull, a case in which the
practitioner’s state board had prohibited
him from prescribing narcotics, the
Agency explained that ‘‘where a state
board takes such action, at a minimum,
a practitioner’s CSA registration must be
limited to authorize the dispensing of
only those controlled substances, which
he can lawfully dispense under state
law.’’ Id. at 62672. Here, the Florida
Department of Health has suspended
Respondent’s authority to prescribe any
medications listed in schedules II, III, or
IV of the Florida schedules of controlled
substances, and under Florida law,
Respondent is limited to prescribing
only those controlled substances in
schedule V.4 Accordingly, I will order
4 Have reviewed the schedules of controlled
substances under Florida law, I conclude that they
are coterminous with those of the CSA with the
exception of buprenorphine, which under Florida
law, is a schedule V controlled substance. While
buprenorphine was formerly a schedule V drug
under the CSA, in 2002, the drug was placed in
schedule III following the Department of Health and
Human Services’ reevaluation of the drug’s ‘‘abuse
potential and dependence profile in light of
numerous scientific studies and years of human
experience with [the] drug.’’ Schedules of
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that Respondent’s registration shall be
restricted to prohibit him from
dispensing controlled substances in
schedules II through IV and to authorize
only the prescribing of schedule V
controlled substances.
The conduct giving rise to the
criminal charges for racketeering
activity, unlawful distribution of
controlled prescription drugs, and
manslaughter related to drug overdose
deaths could serve as the basis for a
request for total revocation based on
public interest grounds (or, in the event
of a conviction, based upon a conviction
of a felony related to controlled
substances). 21 U.S.C. 824(a)(2) and (4).
The Order to Show Cause before me is
based solely upon Respondent’s lack of
state authority to handle certain
controlled substances. This Order is
constrained by the basis set forth in the
Order to Show Cause, and I will only
consider Respondent’s alleged criminal
conduct if and when he is served with
an Order to Show Cause why his
registration should not be revoked in
total based on public interest grounds,
and he is given the opportunity to
address that allegation.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824(a), as well as 28 CFR
0.100(b), I order that DEA Certificate of
Registration BB3166053, issued to Ibem
R. Borges, M.D., be, and it hereby is,
restricted to prohibit the dispensing of
controlled substance in schedules II
through IV and to authorize only the
prescribing of controlled substances in
schedule V of the Controlled Substances
Act (21 CFR 1308.15). This Order is
effective immediately.
Controlled Substances: Rescheduling of
Buprenorphine From Schedule V to Schedule III, 67
FR 62354 (2002) (final rule). Thus, this Agency has
determined that the drug ‘‘has a potential for abuse
less than the drugs or other substances in schedules
I and II,’’ that it ‘‘has a currently accepted medical
use in treatment in the United States,’’ and most
importantly, that ‘‘[a]buse of the drug . . . may lead
to moderate or low physical dependence or high
psychological dependence.’’ 21 U.S.C. 812(b)(3); see
also 67 FR at 62367.
Notably, Florida has adopted the same criteria for
placing a drug in its schedule III as the CSA uses,
see Fla. Stat. 893.03(3), and the State has
determined that Respondent’s ‘‘continued,
unrestricted practice of medicine poses an
immediate serious danger to the public health,
safety or welfare,’’ and concluded, inter alia, that
he cannot safely prescribe controlled substances in
schedule III. GX 8, at 20; see also id. at 28. I
therefore hold that notwithstanding that
buprenorphine remains a schedule V drug under
Florida law and that the scope of his federal
authority derives from his authority under state
law, the placement of the drug in schedule III of the
CSA precludes him from lawfully prescribing the
drug under his DEA registration.
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23523
Dated: April 5, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016–09274 Filed 4–20–16; 8:45 am]
BILLING CODE 4410–09–P
EXECUTIVE OFFICE OF THE
PRESIDENT
Office of National Drug Control Policy
Designation of Two Counties as High
Intensity Drug Trafficking Areas
Office of National Drug Control
Policy, Executive Office of the
President.
ACTION: Notice of HIDTA Designations.
AGENCY:
The Director of the Office of
National Drug Control Policy designated
two additional counties as High
Intensity Drug Trafficking Areas
(HIDTA) pursuant to 21 U.S.C. 1706.
The new counties are Austin and
Walker Counties in Texas as part of the
Houston HIDTA.
FOR FURTHER INFORMATION CONTACT:
Questions regarding this notice should
be directed to Michael K. Gottlieb,
Associate Director, Programs Office,
Office of National Drug Control Policy,
Executive Office of the President,
Washington, DC 20503; (202) 395–4868.
SUMMARY:
Dated: March 23, 2016.
Michael Passante,
Deputy General Counsel.
[FR Doc. 2016–09230 Filed 4–20–16; 8:45 am]
BILLING CODE 3280–F5–P
NATIONAL SCIENCE FOUNDATION
Notice of Permit Applications Received
Under the Antarctic Conservation Act
of 1978
National Science Foundation.
Notice of Permit Applications
Received under the Antarctic
Conservation Act of 1978, Public Law
95–541.
AGENCY:
ACTION:
The National Science
Foundation (NSF) is required to publish
a notice of permit applications received
to conduct activities regulated under the
Antarctic Conservation Act of 1978.
NSF has published regulations under
the Antarctic Conservation Act at Title
45 Part 670 of the Code of Federal
Regulations. This is the required notice
of permit applications received.
DATES: Interested parties are invited to
submit written data, comments, or
views with respect to this permit
application by May 23, 2016. This
SUMMARY:
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Agencies
[Federal Register Volume 81, Number 77 (Thursday, April 21, 2016)]
[Notices]
[Pages 23521-23523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09274]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Ibem R. Borges, M.D.; Decision and Order
On October 14, 2015, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Ibem R. Borges, M.D. (Respondent), of Orlando,
Florida. GX 1. The Show Cause Order proposed the revocation of
Respondent's DEA Certificate of Registration BB3166053, pursuant to
which he is authorized to dispense controlled substances in schedules
II though V as a practitioner, and the denial of any application to
renew or modify this registration, as well as any application for any
other DEA registration, on the ground that Respondent does ``not have
authority to handle controlled substances in Florida, the State in
which [he is] registered with the DEA.'' Id. at 1.
The Show Cause Order specifically alleged that effective November
8, 2013, the Florida Department of Health issued an ``Order of
Emergency Restriction of License'' to Respondent, which prohibits him
from prescribing controlled substances in schedules II through IV. Id.
The Show Cause Order also alleged that Respondent ``do[es] not have a
Florida dispensing license, which is an additional license required [by
the State] before a physician is authorized to order and directly
[[Page 23522]]
dispense or administer controlled substances.'' Id. The Show Cause
Order thus alleged that Respondent ``do[es] not have authority in
Florida to order, dispense, prescribe or administer any controlled
substances in Schedules II through IV,'' and that the Agency ``must
revoke [his] DEA registrations [sic] based upon [his] lack of authority
to handle controlled substances in the State of Florida for Schedules
II through IV.'' Id. (citing 21 U.S.C. 802(21), 823(f) and 824(a)(3)).
The Show Cause Order also notified Respondent of his right to
request a hearing on the allegations or to submit a written statement
in lieu of a hearing, the procedure for electing either option, and the
consequence for failing to elect either option. Id. at 2 (citing 21 CFR
1301.43).
On October 22, 2015, a DEA Diversion Investigator (DI) served the
Order to Show Cause by certified mail, return receipt requested,
addressed to Respondent at his personal residence. GX 3, at 1
(Declaration of DI). On November 6, 2015, the DI received back the USPS
return receipt card; however, while the card bore Respondent's
signature, it was dated ``2/29/15.'' Id.; see also GX 4, at 1. The DI
then obtained the USPS tracking record for the delivery, which revealed
that the Show Cause Order was delivered on October 29, 2015. GX 3, at
1; GX 4, at 2.
On November 9, 2015, the DEA Office of Administrative Law Judges
received a letter from an attorney stating that he represented
Respondent; the letter was addressed to the Deputy Assistant
Administrator, care of the Hearing Clerk, and used the mailing address
of the Office of Administrative Law Judges. GXs 5 and 6. Thereafter,
the Chief Administrative Law Judge (CALJ) sent a letter to Respondent's
attorney stating that because the latter had not requested a hearing,
his Office was not authorized to take any further action. GX 6.
The Government subsequently filed a Request for Final Agency Action
along with various documents submitted as the Investigative Record,
including the letter from Respondent's attorney. Based on Respondent's
failure to request a hearing in his letter, I find that Respondent has
waived his right to a hearing on the allegations of the Show Cause
Order. 21 CFR 1301.43(d). However, I have treated the letter of
Respondent's Counsel as his written statement of position and made it a
part of the record. Id. Sec. 1301.43(c). Having considered the entire
record, I issue this Decision and Final Order, id. Sec. 1301.43(e),
and make the following findings of fact.
Findings
Respondent is the holder of DEA Certificate of Registration
BB3166053, pursuant to which he is authorized to dispense controlled
substances in schedules II through V, at the registered address of Pain
Free Clinic & More, 1800 W. Oakridge Rd., Orlando, Florida. GX 2.
Respondent's registration does not expire until July 31, 2016. Id.
On November 8, 2013, the Florida Department of Health (DOH) issued
an Order of Emergency Restriction of License (Order) to Respondent. The
Order restricted Respondent's medical license by prohibiting him from
prescribing any medications listed in schedules II, III or IV, as set
forth in section 893.03 of the Florida Statutes.\1\ GX 8, at 28. In its
Order, the DOH found that Respondent: (1) ``prescribed, dispensed,
administered, mixed or otherwise prepared a legend drug, other than in
the course of his professional practice'' to an undercover officer, by
excessively and inappropriately prescribing controlled substances; (2)
``failed to keep legible medical records that justif[ied] the course of
treatment of'' the undercover officer, by ``[f]ailing to document a
complete medical history; and/or . . . [f]ailing to document a complete
physical examination results''; and (3) ``failed to comply with the
applicable standards for the use of controlled substances for pain
control.'' GX 8, at 23-27 (citing Fla. Stat. Sec. Sec. 458.331(1)(q);
458.331(1)(m); 458.331(1)(nn) (2012-2013); Fla. Admin. Code. r. 64B8-
9.013(3)).
---------------------------------------------------------------------------
\1\ The factual basis of the DOH's Order was Respondent's
prescribing of oxycodone 30 mg and morphine sulfate 30 mg to an
undercover officer on multiple occasions, ignoring ``the most basic
standards for the use of controlled substances for the treatment of
pain as directed by the Board of Medicine's written standards found
in Rule 64B8-9.013 [of] the Florida Administrative Code.'' GX 8, at
18 (int. quotations omitted).
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Under Florida law, physicians are required to be registered as ``a
dispensing practitioner'' in order to directly dispense a controlled
substance.\2\ Fla. Stat. Sec. 465.0276. The record includes a letter
from the Florida Department of Health which states that Respondent is
not registered as a dispensing practitioner. GX 9.
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\2\ This provision, however, prohibits even a properly
registered practitioner from dispensing a schedule II or III
controlled substance except for in limited situations. Fla. Stat.
465.027(1)(b).
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A review of the Department of Health Web site shows that while
Respondent's license is in an active status, the emergency prohibition
against his prescribing of any medications listed in schedules II, III,
or IV of Fla. Stat. Sec. 893.03 remains in effect.\3\
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\3\ Under the Administrative Procedure Act (APA), an agency
``may take official notice of facts at any stage in a proceeding--
even in the final decision.'' U.S. Dept. of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and
DEA's regulations, Respondent is ``entitled on timely request to an
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). To allow Respondent the opportunity to refute the
facts of which I take official notice, Respondent may file a motion
for reconsideration within ten calendar days of service of this
order which shall commence on the date this order is mailed.
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Based on the above, I find that the only authority Respondent
currently possesses under Florida law is the authority to prescribe
controlled substances in schedule V.
In his written statement of position, Respondent does not dispute
this. Indeed, he ``recognizes that his DEA registration for the
prescription of [s]chedules II, III, and IV [c]ontrolled [s]ubstances
is subject to revocation in the immediate future.'' GX 5, at 1.
However, he ``reserves his right to prescribe [s]chedule V [c]ontrolled
[s]ubstances.'' Id. He further requests that he be ``permitted to
retain and renew his basic DEA registration and his ability to
prescribe Class V pharmaceuticals as this would permit him to renew or
expand the scope of his prescribing should he be acquitted of the
pending criminal charges and otherwise fulfil [sic] the DEA
requirements for registration.'' GX 5, at 1.
In addition to the foregoing, I take official notice that court
records from the Osceola County Circuit Court indicate that Respondent
has been charged with racketeering, conspiracy to engage in
racketeering, three counts of trafficking oxycodone, and manslaughter,
and faces a jury trial on June 6, 2016.
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, ``upon a
finding that the registrant . . . has had his State license . . .
suspended [or] revoked . . . by competent State authority and is no
longer authorized by State law to engage in the . . . dispensing of
controlled substances.'' Moreover, Congress has defined ``the term
`practitioner' [to] mean[] a . . . physician . . . 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
[[Page 23523]]
practice.'' 21 U.S.C. 802(21). Likewise, the CSA conditions the
granting of a practitioner's application on his/her possession of
authority to dispense controlled substances under state law. See 21
U.S.C. 823(f) (``The Attorney General shall register practitioners . .
. to dispense . . . controlled substances . . . if the applicant is
authorized to dispense . . . controlled substances under the laws of
the State in which he practices.''). Of further note, the CSA defines
the term ``dispense'' as meaning ``to deliver a controlled substance to
an ultimate user . . . by, or pursuant to the lawful order of, a
practitioner.'' Id. Sec. 802(10) (emphasis added).
Thus, the Agency has repeatedly 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, 76 FR 71371 (2011), pet. for
rev. denied, 481 Fed Appx. 826 (4th Cir. 2012). And because a
practitioner's authority under the CSA is based on his/her authority to
dispense controlled substances under the laws of the State in which he
practices, the Agency has further held that ``to the extent a
practitioner is not authorized under state law to dispense certain
categories or schedules of controlled substances, he can no longer
lawfully dispense them under federal law.'' Kenneth Harold Bull, 78 FR
62666, 62672 (2013).
In Bull, a case in which the practitioner's state board had
prohibited him from prescribing narcotics, the Agency explained that
``where a state board takes such action, at a minimum, a practitioner's
CSA registration must be limited to authorize the dispensing of only
those controlled substances, which he can lawfully dispense under state
law.'' Id. at 62672. Here, the Florida Department of Health has
suspended Respondent's authority to prescribe any medications listed in
schedules II, III, or IV of the Florida schedules of controlled
substances, and under Florida law, Respondent is limited to prescribing
only those controlled substances in schedule V.\4\ Accordingly, I will
order that Respondent's registration shall be restricted to prohibit
him from dispensing controlled substances in schedules II through IV
and to authorize only the prescribing of schedule V controlled
substances.
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\4\ Have reviewed the schedules of controlled substances under
Florida law, I conclude that they are coterminous with those of the
CSA with the exception of buprenorphine, which under Florida law, is
a schedule V controlled substance. While buprenorphine was formerly
a schedule V drug under the CSA, in 2002, the drug was placed in
schedule III following the Department of Health and Human Services'
reevaluation of the drug's ``abuse potential and dependence profile
in light of numerous scientific studies and years of human
experience with [the] drug.'' Schedules of Controlled Substances:
Rescheduling of Buprenorphine From Schedule V to Schedule III, 67 FR
62354 (2002) (final rule). Thus, this Agency has determined that the
drug ``has a potential for abuse less than the drugs or other
substances in schedules I and II,'' that it ``has a currently
accepted medical use in treatment in the United States,'' and most
importantly, that ``[a]buse of the drug . . . may lead to moderate
or low physical dependence or high psychological dependence.'' 21
U.S.C. 812(b)(3); see also 67 FR at 62367.
Notably, Florida has adopted the same criteria for placing a
drug in its schedule III as the CSA uses, see Fla. Stat. 893.03(3),
and the State has determined that Respondent's ``continued,
unrestricted practice of medicine poses an immediate serious danger
to the public health, safety or welfare,'' and concluded, inter
alia, that he cannot safely prescribe controlled substances in
schedule III. GX 8, at 20; see also id. at 28. I therefore hold that
notwithstanding that buprenorphine remains a schedule V drug under
Florida law and that the scope of his federal authority derives from
his authority under state law, the placement of the drug in schedule
III of the CSA precludes him from lawfully prescribing the drug
under his DEA registration.
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The conduct giving rise to the criminal charges for racketeering
activity, unlawful distribution of controlled prescription drugs, and
manslaughter related to drug overdose deaths could serve as the basis
for a request for total revocation based on public interest grounds
(or, in the event of a conviction, based upon a conviction of a felony
related to controlled substances). 21 U.S.C. 824(a)(2) and (4). The
Order to Show Cause before me is based solely upon Respondent's lack of
state authority to handle certain controlled substances. This Order is
constrained by the basis set forth in the Order to Show Cause, and I
will only consider Respondent's alleged criminal conduct if and when he
is served with an Order to Show Cause why his registration should not
be revoked in total based on public interest grounds, and he is given
the opportunity to address that allegation.
Order
Pursuant to the authority vested in me by 21 U.S.C. 824(a), as well
as 28 CFR 0.100(b), I order that DEA Certificate of Registration
BB3166053, issued to Ibem R. Borges, M.D., be, and it hereby is,
restricted to prohibit the dispensing of controlled substance in
schedules II through IV and to authorize only the prescribing of
controlled substances in schedule V of the Controlled Substances Act
(21 CFR 1308.15). This Order is effective immediately.
Dated: April 5, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-09274 Filed 4-20-16; 8:45 am]
BILLING CODE 4410-09-P