[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)).
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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).
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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