[Federal Register Volume 74, Number 22 (Wednesday, February 4, 2009)]
[Notices]
[Pages 6056-6059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-2331]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Ladapo O. Shyngle, M.D.; Denial of Application

    On April 15, 2008, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Ladapo O. Shyngle, M.D. (Respondent), of Tampa, Florida. 
The Show Cause Order proposed the denial of Respondent's pending 
application for a DEA Certificate of Registration as a practitioner, on 
the ground that his registration ``would be inconsistent with the 
public interest.'' Show Cause Order at 1.
    More specifically, the Show Cause Order alleged that Respondent had 
issued controlled-substance prescriptions to customers of an internet 
site who were located throughout the United States based on a 
questionnaire and/or telephone consultation, and that these 
prescriptions lacked ``a legitimate medical purpose'' and were issued 
``outside the usual course of professional practice, in violation of 21 
CFR 1306.04(a) and 21 U.S.C. 841(a)(1).'' Id. The Order further alleged 
that notwithstanding that his Florida medical license had expired on 
August 24, 2002, Respondent continued to issue prescriptions for 
controlled substances. Id. Relatedly, the Order alleged that Respondent 
had violated other state laws prohibiting the unauthorized practice of 
medicine by issuing prescriptions for controlled substances to 
residents of States where he was not licensed to practice. Id. at 1-2.
    On or about April 19, 2008, the Show Cause Order was served on 
Respondent by delivery to his residence. On May 14, 2008, Respondent 
requested a hearing on the allegations and the matter was placed on the 
docket of the Agency's Administrative Law Judges (ALJ).
    On the same date, Respondent also sought to withdraw his 
application, explaining that the State of Florida had criminally 
charged him with engaging in the unlicensed practice of medicine, that 
he intended ``to vigorously defend'' against this charge, and that in 
light of the pending proceeding, it was premature for the Agency to 
consider his application. On May 29, 2008, the Deputy Assistant 
Administrator denied Respondent's request, reasoning that ``the facts 
supporting the Order to Show Cause will not be affected by the outcome 
of the state prosecution'' and that Respondent ``intend[ed] to continue 
professional medical practice and * * * reapply for a * * * 
[r]egistration at the conclusion of the state criminal case.'' Letter 
from Joseph T. Rannazzisi to Respondent's Counsel (May 29, 2008).
    Thereafter, on July 9, 2008, Respondent withdrew his request for a 
hearing. The next day, the ALJ issued an order terminating the 
proceeding.
    Based on Respondent's letter withdrawing his request for a hearing, 
I conclude that Respondent has waived his right to a hearing. I 
therefore enter this Final Order without a hearing based on relevant 
material contained in the investigate file, see 21 CFR 1301.43, and 
make the following findings.

Findings

    On October 3, 2005, Respondent applied for a DEA Certificate of 
Registration as a practitioner which would authorize him to dispense 
controlled substances in schedules II through V, at the proposed 
location of 1493 Tampa Park Plaza, Tampa, Florida. Respondent 
previously held a practitioner's registration which was issued on 
December 11, 2000, and which expired on February 29, 2004.
    On August 24, 2000, the Florida Department of Health issued a 
``medical doctor restricted'' license to Respondent. The license 
expired, however, on August 24, 2002. Respondent did not obtain another 
medical license until September 16, 2005, when the Florida Department 
of Health issued him a ``medical doctor'' license. This license remains 
in effect until January 31, 2010. I further find that Respondent was 
not licensed in any other State when he committed the acts at issue 
here.
    In 2002, Respondent was hired by Kenneth Shobola, the owner of a 
Tampa, Florida medical clinic (the Kenaday Medical Clinic), to perform 
consultations on persons who were seeking prescriptions for controlled 
substances through Shobola's Web sites. While Respondent saw some walk-
in patients at the clinic, in an interview with DEA Investigators, he 
admitted that he saw only about five percent of the persons he 
prescribed to, and that his contact with most of the patients was 
limited to a telephone consultation which lasted five to ten minutes.
    Based on the consultations, Respondent would then typically issue a 
prescription for a schedule III controlled substance containing 
hydrocodone; Respondent also issued prescriptions for diazepam 
(Valium), a schedule IV controlled substance, 21 CFR 1308.14(c), and 
some non-controlled drugs. While the prescriptions were initially 
filled at F & B Pharmacy (another Tampa-based pharmacy which was 
operated by Olu Oyekoya), F & B eventually pulled out of the 
arrangement and all of the prescriptions were then filled by Ken Drugs, 
a pharmacy owned by Shobola.
    Respondent would perform up to twenty consultations a day for 
Shobola's clinic. According to computer records obtained by 
Investigators, Respondent issued over 3800 prescriptions which were 
filled by Shobola's pharmacy. Approximately seventy-five percent of the 
prescriptions were for hydrocodone, and between the original 
prescriptions and refills, Respondent authorized the dispensing of more 
than 500,000 dosage

[[Page 6057]]

units of the drug. Moreover, the prescriptions were issued to persons 
in forty-one different States.
    When asked by Investigators how he had established a doctor-patient 
relationship with the patients he did not see, Respondent maintained 
that he did so because he ``actually spoke to the patient on the 
phone,'' and that the Web site which arranged the consultations had the 
patient's medical records and ``the driver's license to identify the 
patient.'' Respondent admitted, however, that because of the number of 
``consults,'' ``seventy percent'' of the time he did not see a 
patient's medical records until after he had issued the prescription. 
Respondent also admitted that there were occasions when he never saw a 
patient's medical records. Respondent even admitted that ``we did do 
refills for patients'' who had not submitted records because ``the 
patient [was] already in the system, [and] we already kn[ew] about this 
patient.'' \1\
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    \1\ Respondent also acknowledged that a patient had to have a 
physical exam at some point and maintained that the clinic had hired 
either nurses or paramedics to perform physical exams on patients. 
Even if true, this does not aid Respondent for two reasons: (1) 
Respondent has not established the circumstances in which it may be 
lawful under the laws of the various States for a physician to rely 
on a physical examination performed by a nurse or paramedic, and (2) 
Respondent acknowledged that seventy percent of the time he did not 
see the records until after he prescribed. Respondent thus routinely 
prescribed without any independent assessment and verification of 
his patients' medical complaints.
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    Respondent further stated that he was ``not sure whether the law 
actually gives specific guidelines as to what constitutes the patient/
physician relationship because * * * when the laws were drawn there was 
no internet.'' When asked whether he was saying that he did not know if 
his prescribing was legal because he did not know the law, Respondent 
replied: ``No, what I'm saying is * * * I think the law the way it 
stands * * * makes a loophole available in terms of * * * what 
constitutes [the] patient/doctor relationship, when you * * * talk to 
the patient on the phone. * * * [T]hat is a leeway that's provided and 
that's what I had in mind when I got involved with * * * the whole 
thing.''
    Respondent acknowledged, however, that this method of prescribing 
``certainly'' opened the door to drug abuse and that ``providing 
medication through the internet has to provide safeguards to make sure 
that the patients are genuine, [that] they're not getting multiple 
drugs from different doctors and that * * * they actually have the 
problem that they're taking about.'' Moreover, Respondent stated to 
Investigators that ``the way we practiced * * * in Kennedy there's no 
way you could get all of those [illegitimate patients] out of the 
system * * * 100% of the time.'' Respondent further asserted that 
``there was a good proportion of people that actually needed help that 
got the help,'' but acknowledged that ``there were quite a few that 
[were] just doctor hopping or * * * shopping for medication.''
    As examples of Respondent's prescribing, the Government submitted 
copies of fourteen prescriptions which Respondent issued for such drugs 
as Norco (10/325 mg.), Lortab (10/500 mg.), Vicoprofen (7.5/200 mg.), 
and Vicodin (7.5/750 mg.), all of which are schedule III controlled 
substances containing hydrocodone. Most of the prescriptions were 
issued between October and December 2003, and were issued to patients 
in California, Massachusetts, Ohio, Oklahoma, Tennessee, Wisconsin, 
Washington (State), Mississippi, South Carolina, and Virginia.
    Respondent also prescribed controlled substances to a married 
couple (Mr. & Mrs. C.W.), who had used driver's licenses and medical 
records of friends and family members, as well as falsified medical 
records (including MRIs), in order to create multiple identities and 
obtain larger quantities of drugs such as hydrocodone and alprazolam. 
The C.Ws. both consumed and sold the drugs.

Discussion

    Section 303(f) of the Controlled Substances Act (CSA) provides that 
``[t]he Attorney General may deny an application for [a practitioner's] 
registration if he determines that the issuance of such registration 
would be inconsistent with the public interest.'' 21 U.S.C. 823(f). In 
making the public interest determination, the Act requires the 
consideration of the following factors:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing * * * controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

Id.

    [T]hese factors are * * * considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I may rely on any one or a 
combination of factors, and may give each factor the weight I deem 
appropriate in determining whether an application for a registration 
should be denied. Id. Moreover, I am ``not required to make findings as 
to all of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 
2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005).
    Having considered all the factors, I find that factors two and four 
provide ample support for the conclusion that granting Respondent's 
application for a registration would be ``inconsistent with the public 
interest.'' \2\ 21 U.S.C. 823(f). Respondent's application will 
therefore be denied.
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    \2\ I acknowledge that there is no evidence that the State of 
Florida has taken any action against Respondent's authority under 
State law to prescribe controlled substances. This Agency has long 
held, however, that a State's failure to take action against a 
practitioner's authority to dispense controlled substances is not 
dispositive in determining whether the granting of an application 
for registration would be consistent with the public interest. See 
Mortimer B. Levin, 55 FR 8209, 8210 (1990). I further note that 
Respondent alluded to his intention to vigorously contest a pending 
criminal charge based on his having engaged in the unlicensed 
practice of medicine. Under agency precedent, even if Respondent is 
acquitted of the charge(s), the judgment would not be dispositive in 
this proceeding, which focuses on the public interest. Edmund Chein, 
72 FR 6580, 6593 n.22 (2007).
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Factor Two and Four--Respondent's Experience in Dispensing Controlled 
Substances and Record of Compliance With Applicable Controlled 
Substance Laws

    Under a longstanding DEA regulation, a prescription for a 
controlled substance is not ``effective'' unless it is ``issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a). This 
regulation further provides that ``an order purporting to be a 
prescription issued not in the usual course of professional treatment * 
* * is not a prescription within the meaning and intent of [21 U.S.C. 
829] and * * * the person issuing it, shall be subject to the penalties 
provided for violations of the provisions of law relating to controlled 
substances.'' Id. As the Supreme Court recently explained, ``the 
prescription requirement * * * ensures patients use controlled 
substances under the supervision of a doctor so as to prevent addiction 
and recreational abuse. As a corollary, [it] also bars doctors from 
peddling to patients who crave the drugs for those prohibited uses.'' 
Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United States v. 
Moore, 423 U.S. 122, 135 (1975)).
    Under the CSA, it is fundamental that a practitioner must establish 
a bonafide

[[Page 6058]]

doctor-patient relationship in order to act ``in the usual course of * 
* * professional practice'' and to issue a prescription for a 
``legitimate medical purpose.'' Moore, 423 U.S. at 141-43. At the time 
of the events at issue here, the CSA generally looked to state law to 
determine whether a doctor and patient have established a bonafide 
doctor-patient relationship. See Kamir Garces-Mejias, 72 FR 54931, 
54935 (2007); United Prescription Services, Inc., 72 FR 50397, 50407 
(2007); Dispensing and Purchasing Controlled Substances Over the 
Internet, 66 FR at 21182-83.\3\
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    \3\ On October 15, 2008, the President signed into law the Ryan 
Haight Online Pharmacy Consumer Protection Act of 2008, Public Law 
110-425, 122 Stat. 4820 (2008). Section 2 of the Act prohibits the 
dispensing of a prescription controlled substance ``by means of the 
Internet without a valid prescription,'' and defines, in relevant 
part, ``[t]he term `valid prescription' [to] mean[] a prescription 
that is issued for a legitimate medical purpose in the usual course 
of professional practice by * * * a practitioner who has conducted 
at least 1 in-person medical evaluation of the patient.'' 122 Stat. 
4820. Section 2 further defines ``[t]he term `in-person medical 
evaluation' [to] mean[] a medical evaluation that is conducted with 
the patient in the physical presence of the practitioner, without 
regard to whether portions of the evaluation are conducted by other 
health professionals.'' Id. These provisions do not, however, apply 
to Respondent's conduct.
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    Moreover, shortly after the CSA's enactment, the Supreme Court 
explained that ``[i]n the case of a physician [the Act] contemplates 
that he is authorized by the State to practice medicine and to dispense 
drugs in connection with his professional practice.'' Moore, 423 U.S. 
at 140-41 (emphasis added). Accordingly, ``[a] physician who engages in 
the unauthorized practice of medicine'' under state laws ``is not a 
`practitioner acting in the usual course of * * * professional 
practice' '' under the CSA. United Prescription Services, 72 FR at 
50407 (quoting 21 CFR 1306.04(a)). This rule is supported by the plain 
meaning of the Act, which defines the ``[t]he term `practitioner' [to] 
mean[] a physician * * * licensed, registered, or otherwise permitted, 
by the United States or the jurisdiction in which he practices * * * to 
* * * dispense * * * a controlled substance,'' 21 U.S.C. 802(21), and 
``[t]he term `dispense' [to] mean[] to deliver a controlled substance 
to an ultimate user * * * by, or pursuant to the lawful order of, a 
practitioner.'' Id. section 802(10). See also id. section 823(f) (``The 
Attorney General shall register practitioners * * * to dispense * * * 
if the applicant is authorized to dispense * * * controlled substances 
under the laws of the State in which he practices.'').
    A controlled-substance prescription issued by a physician who lacks 
the license or other authority required to practice medicine within a 
State is therefore unlawful under the CSA. See 21 CFR 1306.04(a) (``An 
order purporting to be a prescription issued not in the usual course of 
professional treatment * * * is not a prescription within the meaning 
an intent of'' the CSA); Cf. 21 CFR 1306.03(a)(1) (``A prescription for 
a controlled substance may be issued only by an individual practitioner 
who is * * * [a]uthorized to prescribe controlled substances by the 
jurisdiction in which he is licensed to practice his profession[.]'').
    The investigative file establishes numerous instances in which 
Respondent violated the prescription requirement of Federal law as well 
as various state laws. As found above, Respondent's initial Florida 
medical license expired on August 24, 2002, and Respondent did not 
obtain a new Florida license until September 16, 2005. Thus, at the 
time Respondent prescribed controlled substances to many of the 
customers of the Kenaday Medical Clinic, he did not even have authority 
to prescribe under Florida law, let alone the laws of the forty other 
States where his patients resided. See Fla. Stat. Sec. Sec.  456.065 
(2003); 458.327(1)(a) (2003); see also, e.g., Cal. Bus. & Prof. Code 
section 2052(a) (2003) (prohibiting unlicensed practice of medicine); 
Cal. Health & Safety Code section 11352(a) (2003) (prohibiting 
furnishing of a controlled substance ``unless upon the written 
prescription of a physician * * * licensed to practice in this 
state''); Tenn. Comp. R. & Regs. 0880-2.16 (2003) (requiring license to 
``engage in the practice of medicine across state lines in this 
State'').
    As the California Court of Appeal has noted, the ``proscription of 
the unlicensed practice of medicine is neither an obscure nor an 
unusual state prohibition of which ignorance can reasonably be claimed, 
and certainly not by persons * * * who are licensed health care 
providers. Nor can such persons reasonably claim ignorance of the fact 
that authorization of a prescription pharmaceutical constitutes the 
practice of medicine.'' Hageseth v. Superior Court, 59 Cal. Rptr.3d 
385, 403 (Ct. App. 2007). In issuing thousands of prescriptions while 
lacking the authority to do so under the laws of both Florida and the 
States where the patients resided, Respondent acted outside of ``the 
usual course of * * * professional practice'' and thereby violated the 
prescription requirement of the CSA (as well as numerous state laws). 
See Moore, 423 U.S. at 140-41; United Prescription Services, 72 FR at 
50407; 21 CFR 1306.03.
    Respondent violated the CSA's prescription requirement for an 
additional reason because he did not establish a bonafide doctor-
patient relationship with the customers of the Web site. As Respondent 
admitted to the Investigators, with the possible exception of the small 
number of customers who appeared at the clinic, Respondent prescribed 
on the basis of a telephonic consultation and did not personally 
conduct a physical exam and take a medical history from the patients.
    In his interview with the Investigators, Respondent gave two 
justifications for his prescribing. First, Respondent maintained that 
the law did not provide specific guidelines that addressed what 
constitutes a valid doctor-patient relationship in the context of the 
internet, asserting that those laws were enacted when ``there was no 
internet,'' and that he acted within a loophole. Second, he maintained 
that the clinic had hired nurses or paramedics who visited the patients 
and performed physical exams on them.
    As for his first contention, at the time Respondent issued the 
prescriptions at issue here, numerous States had already adopted laws 
or regulations, or had issued policy statements, which made clear that 
Respondent's internet prescribing practices were illegal. See, e.g., 
Cal. Bus. & Prof. Code section 2242.1(a); Tenn. Comp. R. & Regs. 0880-
2.14(7) (2003) (``Prerequisites to Issuing Prescriptions''; prohibiting 
the prescribing or dispensing of ``any drug to any individual, whether 
in person or by electronic means or over the Internet or over telephone 
lines unless the physician, or his/her licensed supervisee pursuant to 
appropriate protocols or medical orders, has first done and 
appropriately documented, for the person to whom a prescription is to 
be issued or drugs dispensed * * * an appropriate history and physical 
examination''); Ohio Admin. Code 4731-11-09(A) (2003) (``Except in 
institutional settings, on call situations, cross coverage situations, 
situation involving new patients, protocol situations involving nurses 
practicing in accordance with standard care arrangements * * * a 
physician shall not prescribe, dispense, or otherwise provide, or cause 
to be provided, any controlled substance to a person who the physician 
has never personally physically examined and diagnosed.''); Oklahoma 
State Board of Medical Licensure and Supervision, Policy on Internet 
Prescribing (Ratified 01/25/01) (``Unprofessional conduct includes 
`prescribing * * * a drug * * * without sufficient examination and the

[[Page 6059]]

establishment of a valid physician/patient relationship' * * *. The 
members of the Oklahoma Medical Board have interpreted that a 
`sufficient examination' and `establishment of a valid physician/
patient relationship' cannot take place without an initial face to face 
encounter with the patient.'') (emphasis in original and quoting Okla. 
Stat. tit. 59, section 509-13).
    No more persuasive is Respondent's contention that his prescribings 
were lawful because the clinic used nurses or paramedics to perform 
physical examinations. Respondent did not provide any evidence to the 
Agency that the clinic's purported use of nurses to perform physical 
examinations was a lawful practice under the exceptions recognized by 
any State.\4\
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    \4\ Even if some States authorize a physician to prescribe in 
some circumstances based on a physical exam performed by a nurse, 
Respondent was required to comply with the law of every State in 
which his patients resided. In any event, Respondent did not 
establish that his prescribing was lawful under the law of any 
State.
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    Moreover, Respondent admitted to the Investigators that he 
routinely prescribed before he obtained medical records and in some 
cases he never reviewed records. Thus, even if some States allowed a 
physician to prescribe based on an exam performed by a nurse or 
paramedic in certain defined circumstances, a physical examination is a 
prerequisite to establishing a valid doctor-patient relationship. See 
Tenn. Comp R. & Regs 0880-2-.14(7). Generally, reviewing an examination 
conducted after the issuance of a prescription is not the usual course 
of professional practice.\5\ I thus conclude that Respondent lacked a 
legitimate medical purpose and acted outside of the usual course of 
professional practice in issuing the prescriptions.
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    \5\ It is acknowledged that the States generally allow a 
practitioner to issue a prescription in an emergency situation 
before conducting a physical exam. See 49 Pa. Code Sec.  16.92(a). 
Some States also allow a practitioner to issue a short term 
continuation prescription for a new patient prior to a patient's 
first appointment, in an order admitting a patient to a hospital, or 
for a patient of another physician for whom the prescriber is taking 
calls. Tenn. Comp. R. & Regs. 0880-2-.14(7)(b). None of these 
exceptions apply here.
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    Respondent's prescribing practices clearly resulted in the 
diversion of controlled substances. As Respondent acknowledged in the 
interview, ``there were quite a few [patients] that [were] just doctor 
hopping or * * * shopping for medication.'' \6\ Indeed, as the record 
establishes, Respondent prescribed to two people who used falsified 
records and the driver's licenses of other persons, to obtain such 
highly abused controlled substances as hydrocodone and alprazolam, 
which they both personally abused and sold to others. Given the 
thousands of prescriptions he issued in this manner, there were likely 
numerous other instances in which he prescribed to persons who were 
seeking the drugs for illicit purposes.
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    \6\ I reject as self-serving Respondent's assertion that he 
believed that ``a good proportion of [the] people [he prescribed to] 
actually needed help'' because their original doctors had become 
``weary'' of continuing to prescribe narcotics to them. Notably, 
Respondent did not identify a single instance in which he contacted 
the original physicians of the patients to even determine whether a 
patient had a legitimate medical condition which required the 
continued prescribing of a controlled substance. As Respondent 
himself recognized, internet prescribing invites ``doctor hopping'' 
and ``medication shopping'' by drug abusers and drug dealers. In 
short, as this Agency has found in the course of numerous 
investigations, the risk of diversion inherent in internet 
prescribing is extraordinary.
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    It is therefore clear that Respondent committed acts which 
establish that granting him a new registration would be ``inconsistent 
with the public interest.'' 21 U.S.C. 823(f).\7\ Respondent's 
application will therefore be denied.
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    \7\ In his request for a hearing, Respondent ``disagreed * * * 
that [the] prescriptions were issued without a legitimate medical 
purpose and outside the usual course of professional practice.'' 
While Respondent's counsel further represented that he did not 
intend to ``practic[e] medicine in any way related to an Internet 
pharmacy,'' Respondent has not satisfied the Agency's standard for 
obtaining a new registration, which requires that an applicant 
accept responsibility for his misconduct and acknowledge his 
wrongdoing. See, e.g., Medicine Shoppe--Jonesborough, 73 FR 364, 387 
(2008) (collecting cases), aff'd, Medicine Shoppe-Jonesborough v. 
DEA, slip op. at 9-10 (6th Cir. Nov. 13, 2008); Hoxie v. DEA, 419 
F.3d 477, 483 (6th Cir, 2005) (``admitting fault'' is ``properly 
consider[ed]'' by DEA to be an ``important factor[]'' in the public 
interest determination).
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Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well 
as 28 CFR 0.100(b) & 0.104, I order that the application of Ladapo O. 
Shyngle, M.D., for a DEA Certificate of Registration as a practitioner 
be, and it hereby is, denied. This order is effective March 6, 2009.

    Dated: January 27, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-2331 Filed 2-3-09; 8:45 am]
BILLING CODE 4410-09-P