81_FR_23598 81 FR 23521 - Ibem R. Borges, M.D.; Decision and Order

81 FR 23521 - Ibem R. Borges, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 77 (April 21, 2016)

Page Range23521-23523
FR Document2016-09274

Federal Register, Volume 81 Issue 77 (Thursday, April 21, 2016)
[Federal Register Volume 81, Number 77 (Thursday, April 21, 2016)]
[Notices]
[Pages 23521-23523]
From the Federal Register Online  [www.thefederalregister.org]
[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)).
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    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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



                                                                                Federal Register / Vol. 81, No. 77 / Thursday, April 21, 2016 / Notices                                                 23521

                                                  Rules of Practice and Procedure (19 CFR                 should address whether issuance of the                treatment. All such requests should be
                                                  210.8(b)).                                              relief specifically requested by the                  directed to the Secretary to the
                                                  FOR FURTHER INFORMATION CONTACT: Lisa                   complainant in this investigation would               Commission and must include a full
                                                  R. Barton, Secretary to the Commission,                 affect the public health and welfare in               statement of the reasons why the
                                                  U.S. International Trade Commission,                    the United States, competitive                        Commission should grant such
                                                  500 E Street SW., Washington, DC                        conditions in the United States                       treatment. See 19 CFR 201.6. Documents
                                                  20436, telephone (202) 205–2000. The                    economy, the production of like or                    for which confidential treatment by the
                                                  public version of the complaint can be                  directly competitive articles in the                  Commission is properly sought will be
                                                  accessed on the Commission’s                            United States, or United States                       treated accordingly. All nonconfidential
                                                  Electronic Document Information                         consumers.                                            written submissions will be available for
                                                  System (EDIS) at EDIS,1 and will be                        In particular, the Commission is                   public inspection at the Office of the
                                                  available for inspection during official                interested in comments that:                          Secretary and on EDIS.5
                                                  business hours (8:45 a.m. to 5:15 p.m.)                    (i) Explain how the articles                          This action is taken under the
                                                  in the Office of the Secretary, U.S.                    potentially subject to the requested                  authority of section 337 of the Tariff Act
                                                  International Trade Commission, 500 E                   remedial orders are used in the United                of 1930, as amended (19 U.S.C. 1337),
                                                  Street SW., Washington, DC 20436,                       States;                                               and of sections 201.10 and 210.8(c) of
                                                  telephone (202) 205–2000.                                  (ii) identify any public health, safety,           the Commission’s Rules of Practice and
                                                     General information concerning the                   or welfare concerns in the United States              Procedure (19 CFR 201.10, 210.8(c)).
                                                  Commission may also be obtained by                      relating to the requested remedial                      By order of the Commission.
                                                  accessing its Internet server at United                 orders;                                                 Issued: April 15, 2016.
                                                  States International Trade Commission                      (iii) identify like or directly                    Lisa R. Barton,
                                                  (USITC) at USITC.2 The public record                    competitive articles that complainant,                Secretary to the Commission.
                                                  for this investigation may be viewed on                 its licensees, or third parties make in the
                                                                                                                                                                [FR Doc. 2016–09212 Filed 4–20–16; 8:45 am]
                                                  the Commission’s Electronic Document                    United States which could replace the
                                                                                                                                                                BILLING CODE 7020–02–P
                                                  Information System (EDIS) at EDIS.3                     subject articles if they were to be
                                                  Hearing-impaired persons are advised                    excluded;
                                                  that information on this matter can be                     (iv) indicate whether complainant,
                                                                                                          complainant’s licensees, and/or third                 DEPARTMENT OF JUSTICE
                                                  obtained by contacting the
                                                  Commission’s TDD terminal on (202)                      party suppliers have the capacity to
                                                                                                                                                                Drug Enforcement Administration
                                                  205–1810.                                               replace the volume of articles
                                                  SUPPLEMENTARY INFORMATION: The                          potentially subject to the requested                  Ibem R. Borges, M.D.; Decision and
                                                  Commission has received a complaint                     exclusion order and/or a cease and                    Order
                                                  and a submission pursuant to section                    desist order within a commercially
                                                                                                          reasonable time; and                                     On October 14, 2015, the Deputy
                                                  210.8(b) of the Commission’s Rules of
                                                                                                             (v) explain how the requested                      Assistant Administrator, Office of
                                                  Practice and Procedure filed on behalf
                                                                                                          remedial orders would impact United                   Diversion Control, Drug Enforcement
                                                  of ResMed Corp; ResMed Inc. and                                                                               Administration (DEA), issued an Order
                                                  ResMed Ltd. on April 14, 2016. The                      States consumers.
                                                                                                             Written submissions must be filed no               to Show Cause to Ibem R. Borges, M.D.
                                                  complaint alleges violations of section                                                                       (Respondent), of Orlando, Florida. GX 1.
                                                  337 of the Tariff Act of 1930 (19 U.S.C.                later than by close of business, eight
                                                                                                          calendar days after the date of                       The Show Cause Order proposed the
                                                  1337) in the importation into the United                                                                      revocation of Respondent’s DEA
                                                  States, the sale for importation, and the               publication of this notice in the Federal
                                                                                                          Register. There will be further                       Certificate of Registration BB3166053,
                                                  sale within the United States after                                                                           pursuant to which he is authorized to
                                                  importation of certain sleep-disordered                 opportunities for comment on the
                                                                                                          public interest after the issuance of any             dispense controlled substances in
                                                  breathing treatment systems and                                                                               schedules II though V as a practitioner,
                                                  components thereof. The complaint                       final initial determination in this
                                                                                                          investigation.                                        and the denial of any application to
                                                  names as respondents BMC Medical Co.,                                                                         renew or modify this registration, as
                                                                                                             Persons filing written submissions
                                                  Ltd. of China; 3B Medical, Inc. of Lake                                                                       well as any application for any other
                                                                                                          must file the original document
                                                  Wales, FL; and 3B Products, L.L.C. of                                                                         DEA registration, on the ground that
                                                                                                          electronically on or before the deadlines
                                                  Lake Wales, FL. The complainant                                                                               Respondent does ‘‘not have authority to
                                                                                                          stated above and submit 8 true paper
                                                  requests that the Commission issue a                                                                          handle controlled substances in Florida,
                                                                                                          copies to the Office of the Secretary by
                                                  limited exclusion order, cease and                                                                            the State in which [he is] registered with
                                                                                                          noon the next day pursuant to section
                                                  desist orders and impose a bond upon                                                                          the DEA.’’ Id. at 1.
                                                                                                          210.4(f) of the Commission’s Rules of
                                                  respondents’ alleged infringing articles                                                                         The Show Cause Order specifically
                                                                                                          Practice and Procedure (19 CFR
                                                  during the 60-day Presidential review                                                                         alleged that effective November 8, 2013,
                                                                                                          210.4(f)). Submissions should refer to
                                                  period pursuant to 19 U.S.C. 1337(j).                                                                         the Florida Department of Health issued
                                                     Proposed respondents, other                          the docket number (‘‘Docket No. 3140’’)
                                                                                                          in a prominent place on the cover page                an ‘‘Order of Emergency Restriction of
                                                  interested parties, and members of the                                                                        License’’ to Respondent, which
                                                  public are invited to file comments, not                and/or the first page. (See Handbook for
                                                                                                          Electronic Filing Procedures, Electronic              prohibits him from prescribing
                                                  to exceed five (5) pages in length,                                                                           controlled substances in schedules II
                                                  inclusive of attachments, on any public                 Filing Procedures 4). Persons with
                                                                                                          questions regarding filing should                     through IV. Id. The Show Cause Order
                                                  interest issues raised by the complaint
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                                                                          contact the Secretary (202–205–2000).                 also alleged that Respondent ‘‘do[es] not
                                                  or section 210.8(b) filing. Comments                                                                          have a Florida dispensing license,
                                                                                                             Any person desiring to submit a
                                                    1 Electronic Document Information System              document to the Commission in                         which is an additional license required
                                                  (EDIS): http://edis.usitc.gov.                          confidence must request confidential                  [by the State] before a physician is
                                                    2 United States International Trade Commission                                                              authorized to order and directly
                                                  (USITC): http://edis.usitc.gov.                           4 Handbook for Electronic Filing Procedures:
                                                    3 Electronic Document Information System              http://www.usitc.gov/secretary/fed_reg_notices/         5 Electronic Document Information System

                                                  (EDIS): http://edis.usitc.gov.                          rules/handbook_on_electronic_filing.pdf.              (EDIS): http://edis.usitc.gov.



                                             VerDate Sep<11>2014   13:27 Apr 20, 2016   Jkt 238001   PO 00000   Frm 00066   Fmt 4703   Sfmt 4703   E:\FR\FM\21APN1.SGM   21APN1


                                                  23522                         Federal Register / Vol. 81, No. 77 / Thursday, April 21, 2016 / Notices

                                                  dispense or administer controlled                       Findings                                                schedules II, III, or IV of Fla. Stat.
                                                  substances.’’ Id. The Show Cause Order                                                                          § 893.03 remains in effect.3
                                                  thus alleged that Respondent ‘‘do[es]                      Respondent is the holder of DEA                         Based on the above, I find that the
                                                  not have authority in Florida to order,                 Certificate of Registration BB3166053,                  only authority Respondent currently
                                                  dispense, prescribe or administer any                   pursuant to which he is authorized to                   possesses under Florida law is the
                                                  controlled substances in Schedules II                   dispense controlled substances in                       authority to prescribe controlled
                                                  through IV,’’ and that the Agency ‘‘must                schedules II through V, at the registered               substances in schedule V.
                                                  revoke [his] DEA registrations [sic]                    address of Pain Free Clinic & More,                        In his written statement of position,
                                                  based upon [his] lack of authority to                   1800 W. Oakridge Rd., Orlando, Florida.                 Respondent does not dispute this.
                                                  handle controlled substances in the                     GX 2. Respondent’s registration does not                Indeed, he ‘‘recognizes that his DEA
                                                  State of Florida for Schedules II through               expire until July 31, 2016. Id.                         registration for the prescription of
                                                  IV.’’ Id. (citing 21 U.S.C. 802(21), 823(f)                On November 8, 2013, the Florida                     [s]chedules II, III, and IV [c]ontrolled
                                                  and 824(a)(3)).                                                                                                 [s]ubstances is subject to revocation in
                                                                                                          Department of Health (DOH) issued an
                                                     The Show Cause Order also notified                                                                           the immediate future.’’ GX 5, at 1.
                                                                                                          Order of Emergency Restriction of
                                                  Respondent of his right to request a                                                                            However, he ‘‘reserves his right to
                                                                                                          License (Order) to Respondent. The
                                                  hearing on the allegations or to submit                                                                         prescribe [s]chedule V [c]ontrolled
                                                                                                          Order restricted Respondent’s medical                   [s]ubstances.’’ Id. He further requests
                                                  a written statement in lieu of a hearing,               license by prohibiting him from
                                                  the procedure for electing either option,                                                                       that he be ‘‘permitted to retain and
                                                                                                          prescribing any medications listed in                   renew his basic DEA registration and his
                                                  and the consequence for failing to elect                schedules II, III or IV, as set forth in
                                                  either option. Id. at 2 (citing 21 CFR                                                                          ability to prescribe Class V
                                                                                                          section 893.03 of the Florida Statutes.1                pharmaceuticals as this would permit
                                                  1301.43).                                               GX 8, at 28. In its Order, the DOH found
                                                     On October 22, 2015, a DEA Diversion                                                                         him to renew or expand the scope of his
                                                                                                          that Respondent: (1) ‘‘prescribed,                      prescribing should he be acquitted of
                                                  Investigator (DI) served the Order to                   dispensed, administered, mixed or                       the pending criminal charges and
                                                  Show Cause by certified mail, return                    otherwise prepared a legend drug, other                 otherwise fulfil [sic] the DEA
                                                  receipt requested, addressed to                         than in the course of his professional                  requirements for registration.’’ GX 5, at
                                                  Respondent at his personal residence.                   practice’’ to an undercover officer, by                 1.
                                                  GX 3, at 1 (Declaration of DI). On                      excessively and inappropriately                            In addition to the foregoing, I take
                                                  November 6, 2015, the DI received back                  prescribing controlled substances; (2)                  official notice that court records from
                                                  the USPS return receipt card; however,                  ‘‘failed to keep legible medical records                the Osceola County Circuit Court
                                                  while the card bore Respondent’s                        that justif[ied] the course of treatment                indicate that Respondent has been
                                                  signature, it was dated ‘‘2/29/15.’’ Id.;               of’’ the undercover officer, by ‘‘[f]ailing             charged with racketeering, conspiracy to
                                                  see also GX 4, at 1. The DI then obtained               to document a complete medical                          engage in racketeering, three counts of
                                                  the USPS tracking record for the                                                                                trafficking oxycodone, and
                                                                                                          history; and/or . . . [f]ailing to
                                                  delivery, which revealed that the Show                                                                          manslaughter, and faces a jury trial on
                                                                                                          document a complete physical
                                                  Cause Order was delivered on October                                                                            June 6, 2016.
                                                                                                          examination results’’; and (3) ‘‘failed to
                                                  29, 2015. GX 3, at 1; GX 4, at 2.
                                                                                                          comply with the applicable standards                    Discussion
                                                     On November 9, 2015, the DEA Office                  for the use of controlled substances for
                                                  of Administrative Law Judges received a                                                                            Pursuant to 21 U.S.C. 824(a)(3), the
                                                                                                          pain control.’’ GX 8, at 23–27 (citing Fla.
                                                  letter from an attorney stating that he                                                                         Attorney General is authorized to
                                                                                                          Stat. §§ 458.331(1)(q); 458.331(1)(m);
                                                  represented Respondent; the letter was                                                                          suspend or revoke a registration issued
                                                                                                          458.331(1)(nn) (2012–2013); Fla.
                                                  addressed to the Deputy Assistant                                                                               under section 823, ‘‘upon a finding that
                                                                                                          Admin. Code. r. 64B8–9.013(3)).
                                                  Administrator, care of the Hearing                                                                              the registrant . . . has had his State
                                                  Clerk, and used the mailing address of                     Under Florida law, physicians are                    license . . . suspended [or] revoked
                                                  the Office of Administrative Law Judges.                required to be registered as ‘‘a                        . . . by competent State authority and is
                                                  GXs 5 and 6. Thereafter, the Chief                      dispensing practitioner’’ in order to                   no longer authorized by State law to
                                                  Administrative Law Judge (CALJ) sent a                  directly dispense a controlled                          engage in the . . . dispensing of
                                                  letter to Respondent’s attorney stating                 substance.2 Fla. Stat. § 465.0276. The                  controlled substances.’’ Moreover,
                                                  that because the latter had not requested               record includes a letter from the Florida               Congress has defined ‘‘the term
                                                  a hearing, his Office was not authorized                Department of Health which states that                  ‘practitioner’ [to] mean[] a . . .
                                                  to take any further action. GX 6.                       Respondent is not registered as a                       physician . . . or other person licensed,
                                                     The Government subsequently filed a                  dispensing practitioner. GX 9.                          registered or otherwise permitted, by
                                                  Request for Final Agency Action along                      A review of the Department of Health                 . . . the jurisdiction in which he
                                                  with various documents submitted as                     Web site shows that while Respondent’s                  practices . . . to distribute, dispense,
                                                  the Investigative Record, including the                 license is in an active status, the                     [or] administer . . . a controlled
                                                  letter from Respondent’s attorney. Based                emergency prohibition against his                       substance in the course of professional
                                                  on Respondent’s failure to request a                    prescribing of any medications listed in                   3 Under the Administrative Procedure Act (APA),
                                                  hearing in his letter, I find that
                                                                                                                                                                  an agency ‘‘may take official notice of facts at any
                                                  Respondent has waived his right to a                       1 The factual basis of the DOH’s Order was
                                                                                                                                                                  stage in a proceeding—even in the final decision.’’
                                                  hearing on the allegations of the Show                  Respondent’s prescribing of oxycodone 30 mg and         U.S. Dept. of Justice, Attorney General’s Manual on
                                                  Cause Order. 21 CFR 1301.43(d).                         morphine sulfate 30 mg to an undercover officer on      the Administrative Procedure Act 80 (1947) (Wm.
                                                  However, I have treated the letter of                   multiple occasions, ignoring ‘‘the most basic           W. Gaunt & Sons, Inc., Reprint 1979). In accordance
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                                                                                                          standards for the use of controlled substances for      with the APA and DEA’s regulations, Respondent
                                                  Respondent’s Counsel as his written                     the treatment of pain as directed by the Board of       is ‘‘entitled on timely request to an opportunity to
                                                  statement of position and made it a part                Medicine’s written standards found in Rule 64B8–        show to the contrary.’’ 5 U.S.C. 556(e); see also 21
                                                  of the record. Id. § 1301.43(c). Having                 9.013 [of] the Florida Administrative Code.’’ GX 8,     CFR 1316.59(e). To allow Respondent the
                                                  considered the entire record, I issue this              at 18 (int. quotations omitted).                        opportunity to refute the facts of which I take
                                                                                                             2 This provision, however, prohibits even a          official notice, Respondent may file a motion for
                                                  Decision and Final Order, id.                           properly registered practitioner from dispensing a      reconsideration within ten calendar days of service
                                                  § 1301.43(e), and make the following                    schedule II or III controlled substance except for in   of this order which shall commence on the date this
                                                  findings of fact.                                       limited situations. Fla. Stat. 465.027(1)(b).           order is mailed.



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                                                                                Federal Register / Vol. 81, No. 77 / Thursday, April 21, 2016 / Notices                                                    23523

                                                  practice.’’ 21 U.S.C. 802(21). Likewise,                that Respondent’s registration shall be                    Dated: April 5, 2016.
                                                  the CSA conditions the granting of a                    restricted to prohibit him from                          Chuck Rosenberg,
                                                  practitioner’s application on his/her                   dispensing controlled substances in                      Acting Administrator.
                                                  possession of authority to dispense                     schedules II through IV and to authorize                 [FR Doc. 2016–09274 Filed 4–20–16; 8:45 am]
                                                  controlled substances under state law.                  only the prescribing of schedule V                       BILLING CODE 4410–09–P
                                                  See 21 U.S.C. 823(f) (‘‘The Attorney                    controlled substances.
                                                  General shall register practitioners . . .
                                                                                                            The conduct giving rise to the
                                                  to dispense . . . controlled substances
                                                                                                          criminal charges for racketeering                        EXECUTIVE OFFICE OF THE
                                                  . . . if the applicant is authorized to
                                                                                                          activity, unlawful distribution of                       PRESIDENT
                                                  dispense . . . controlled substances
                                                  under the laws of the State in which he                 controlled prescription drugs, and
                                                                                                          manslaughter related to drug overdose                    Office of National Drug Control Policy
                                                  practices.’’). Of further note, the CSA
                                                  defines the term ‘‘dispense’’ as meaning                deaths could serve as the basis for a
                                                                                                                                                                   Designation of Two Counties as High
                                                  ‘‘to deliver a controlled substance to an               request for total revocation based on
                                                                                                                                                                   Intensity Drug Trafficking Areas
                                                  ultimate user . . . by, or pursuant to the              public interest grounds (or, in the event
                                                  lawful order of, a practitioner.’’ Id.                  of a conviction, based upon a conviction                 AGENCY:  Office of National Drug Control
                                                  § 802(10) (emphasis added).                             of a felony related to controlled                        Policy, Executive Office of the
                                                     Thus, the Agency has repeatedly held                 substances). 21 U.S.C. 824(a)(2) and (4).                President.
                                                  that the possession of authority to                     The Order to Show Cause before me is                     ACTION: Notice of HIDTA Designations.
                                                  dispense controlled substances under                    based solely upon Respondent’s lack of
                                                  the laws of the State in which a                        state authority to handle certain                        SUMMARY:   The Director of the Office of
                                                  practitioner engages in professional                    controlled substances. This Order is                     National Drug Control Policy designated
                                                  practice is a fundamental condition for                 constrained by the basis set forth in the                two additional counties as High
                                                  obtaining and maintaining a                             Order to Show Cause, and I will only                     Intensity Drug Trafficking Areas
                                                  practitioner’s registration. See, e.g.,                 consider Respondent’s alleged criminal                   (HIDTA) pursuant to 21 U.S.C. 1706.
                                                  James L. Hooper, 76 FR 71371 (2011),                    conduct if and when he is served with                    The new counties are Austin and
                                                  pet. for rev. denied, 481 Fed Appx. 826                 an Order to Show Cause why his                           Walker Counties in Texas as part of the
                                                  (4th Cir. 2012). And because a                          registration should not be revoked in                    Houston HIDTA.
                                                  practitioner’s authority under the CSA                  total based on public interest grounds,                  FOR FURTHER INFORMATION CONTACT:
                                                  is based on his/her authority to dispense               and he is given the opportunity to                       Questions regarding this notice should
                                                  controlled substances under the laws of                 address that allegation.                                 be directed to Michael K. Gottlieb,
                                                  the State in which he practices, the                                                                             Associate Director, Programs Office,
                                                  Agency has further held that ‘‘to the                   Order                                                    Office of National Drug Control Policy,
                                                  extent a practitioner is not authorized                                                                          Executive Office of the President,
                                                                                                             Pursuant to the authority vested in me
                                                  under state law to dispense certain                                                                              Washington, DC 20503; (202) 395–4868.
                                                                                                          by 21 U.S.C. 824(a), as well as 28 CFR
                                                  categories or schedules of controlled
                                                                                                          0.100(b), I order that DEA Certificate of                  Dated: March 23, 2016.
                                                  substances, he can no longer lawfully
                                                                                                          Registration BB3166053, issued to Ibem                   Michael Passante,
                                                  dispense them under federal law.’’
                                                                                                          R. Borges, M.D., be, and it hereby is,                   Deputy General Counsel.
                                                  Kenneth Harold Bull, 78 FR 62666,
                                                  62672 (2013).                                           restricted to prohibit the dispensing of                 [FR Doc. 2016–09230 Filed 4–20–16; 8:45 am]
                                                     In Bull, a case in which the                         controlled substance in schedules II                     BILLING CODE 3280–F5–P
                                                  practitioner’s state board had prohibited               through IV and to authorize only the
                                                  him from prescribing narcotics, the                     prescribing of controlled substances in
                                                  Agency explained that ‘‘where a state                   schedule V of the Controlled Substances
                                                                                                                                                                   NATIONAL SCIENCE FOUNDATION
                                                  board takes such action, at a minimum,                  Act (21 CFR 1308.15). This Order is
                                                  a practitioner’s CSA registration must be               effective immediately.                                   Notice of Permit Applications Received
                                                  limited to authorize the dispensing of                                                                           Under the Antarctic Conservation Act
                                                  only those controlled substances, which                 Controlled Substances: Rescheduling of                   of 1978
                                                                                                          Buprenorphine From Schedule V to Schedule III, 67
                                                  he can lawfully dispense under state                    FR 62354 (2002) (final rule). Thus, this Agency has
                                                  law.’’ Id. at 62672. Here, the Florida                                                                           AGENCY: National Science Foundation.
                                                                                                          determined that the drug ‘‘has a potential for abuse
                                                  Department of Health has suspended                      less than the drugs or other substances in schedules     ACTION: Notice of Permit Applications
                                                  Respondent’s authority to prescribe any                 I and II,’’ that it ‘‘has a currently accepted medical   Received under the Antarctic
                                                                                                          use in treatment in the United States,’’ and most        Conservation Act of 1978, Public Law
                                                  medications listed in schedules II, III, or             importantly, that ‘‘[a]buse of the drug . . . may lead
                                                  IV of the Florida schedules of controlled               to moderate or low physical dependence or high
                                                                                                                                                                   95–541.
                                                  substances, and under Florida law,                      psychological dependence.’’ 21 U.S.C. 812(b)(3); see
                                                                                                          also 67 FR at 62367.                                     SUMMARY:   The National Science
                                                  Respondent is limited to prescribing
                                                                                                             Notably, Florida has adopted the same criteria for    Foundation (NSF) is required to publish
                                                  only those controlled substances in
                                                                                                          placing a drug in its schedule III as the CSA uses,      a notice of permit applications received
                                                  schedule V.4 Accordingly, I will order                  see Fla. Stat. 893.03(3), and the State has              to conduct activities regulated under the
                                                                                                          determined that Respondent’s ‘‘continued,
                                                    4 Have reviewed the schedules of controlled           unrestricted practice of medicine poses an
                                                                                                                                                                   Antarctic Conservation Act of 1978.
                                                  substances under Florida law, I conclude that they      immediate serious danger to the public health,           NSF has published regulations under
                                                  are coterminous with those of the CSA with the          safety or welfare,’’ and concluded, inter alia, that     the Antarctic Conservation Act at Title
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                                                  exception of buprenorphine, which under Florida         he cannot safely prescribe controlled substances in      45 Part 670 of the Code of Federal
                                                  law, is a schedule V controlled substance. While        schedule III. GX 8, at 20; see also id. at 28. I
                                                  buprenorphine was formerly a schedule V drug            therefore hold that notwithstanding that
                                                                                                                                                                   Regulations. This is the required notice
                                                  under the CSA, in 2002, the drug was placed in          buprenorphine remains a schedule V drug under            of permit applications received.
                                                  schedule III following the Department of Health and     Florida law and that the scope of his federal            DATES: Interested parties are invited to
                                                  Human Services’ reevaluation of the drug’s ‘‘abuse      authority derives from his authority under state
                                                  potential and dependence profile in light of            law, the placement of the drug in schedule III of the
                                                                                                                                                                   submit written data, comments, or
                                                  numerous scientific studies and years of human          CSA precludes him from lawfully prescribing the          views with respect to this permit
                                                  experience with [the] drug.’’ Schedules of              drug under his DEA registration.                         application by May 23, 2016. This


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Document Created: 2016-04-21 01:17:46
Document Modified: 2016-04-21 01:17:46
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation81 FR 23521 

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