Mohammed F. Abdel-Hameed, M.D.; Revocation of Registration, 61366-61370 [E9-28189]
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Federal Register / Vol. 74, No. 225 / Tuesday, November 24, 2009 / Notices
Effective Date: November 24,
2009.
FOR FURTHER INFORMATION CONTACT: Ben
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SUPPLEMENTARY INFORMATION:
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63924, in the second column, line
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Dated: October 21, 2009.
Larry Echo Hawk,
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[FR Doc. E9–28157 Filed 11–23–09; 8:45 am]
BILLING CODE 4310–W7–P
INTERNATIONAL BOUNDARY AND
WATER COMMISSION, UNITED
STATES AND MEXICO
United States Section; Notice of
Availability of Draft Environmental
Impact Statement, Flood Control
Improvements and Partial Levee
Relocation, Presidio Flood Control
Project, Presidio, TX
United States Section,
International Boundary and Water
Commission (USIBWC).
ACTION: Notice of Availability of Draft
Environmental Impact Statement.
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AGENCY:
SUMMARY: Pursuant to section 102(2)(c)
of the National Environmental Policy
Act (NEPA) of 1969, as amended, the
United States Section, International
Boundary and Water Commission
(USIBWC) has prepared a Draft
Environmental Impact Statement (Draft
EIS) for flood control improvements to
the Presidio Flood Control Project,
Presidio, Texas (Presidio FCP). The EIS
analyzes potential impacts of the No
Action Alternative and six action
alternatives under consideration. Sitespecific information is used to evaluate
environmental consequences that may
result from implementing improvements
in the upper, middle and lower reaches
of the Presidio FCP. The following
environmental resources are assessed in
the Draft EIS: Biological resources,
cultural resources, water resources, land
use, socioeconomic resources and
transportation, environmental health
issues (air quality, noise, public health,
and environmental hazards), and
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cumulative impacts. A public hearing
will be held in the City of Presidio to
receive comments on the Draft EIS from
interested organizations and individuals
through transcription by a certified
court reporter. Written comments may
be submitted at the public hearing, or
mailed to the USIBWC during the public
review period to the contact and address
below.
DATES: Written comments are requested
by January 12, 2010. The Draft EIS for
the Presidio Flood Control Project will
be available to agencies, organizations
and the general public on November 20,
2009. A copy of the Draft EIS will be
available for review at the City of
Presidio Library, 2440 O’Reilly Street,
Presidio, Texas 79845, and will also be
posted at the USIBWC Web site at
https://www.ibwc.gov. The USIBWC will
conduct a public hearing at the Presidio
Activities Center, 1200 East O’Reilly
Street, Presidio, Texas 79845, on
December 10, 2009, from 5 p.m. to 7
p.m. CST. The hearing date and location
will also be announced in local
newspapers two weeks prior to the
hearing date.
FOR FURTHER INFORMATION CONTACT: Mr.
Daniel Borunda, Environmental
Protection Specialist, Environmental
Management Division, USIBWC, 4171
North Mesa Street, C–100, El Paso,
Texas 79902 or e-mail:
danielborunda@ibwc.gov.
SUPPLEMENTARY INFORMATION: The Draft
EIS analyzes potential effects of the No
Action Alternative and flood control
improvement alternatives for the
Presidio FCP. The following six action
alternatives are under consideration: (1)
Retaining the current levee alignment,
repairing structural levee damage and
raising some levee segments as required
to ensure full protection from a 25-year
flood event; (2) 100-year flood
protection of the City of Presidio and
agricultural lands along the Presidio
FCP by raising the levee system along its
entire length and current alignment; (3)
raising the entire levee system for 100year flood protection, retaining current
levee alignment in the upper and
middle reaches of the Presidio FCP but
partially relocating approximately 3.4
miles of the levee in the lower reach; (4)
100-year flood protection of the City of
Presidio by raising the levee system in
the upper and middle reaches of the
Presidio FCP, in conjunction with a new
1.3-mile spur levee starting at mile 9.2
to connect the raised levee section to
elevated terrain south of the City of
Presidio; a 25-year flood protection
would be retained in the lower reach
along agricultural lands; (5) 100-year
flood protection of the City of Presidio
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by raising in place the levee system
along the upper and middle reaches of
the Presidio FCP, constructing a new
1.4-mile spur levee at mile 8.5, and
retaining the 25-year flood protection in
the lower reach; and (6) raising the levee
along the upstream sections of the levee
system to provide 100-year flood
protection to the City of Presidio and
retaining the 25-year flood protection of
agricultural lands in the lower reach, as
in the two previous alternatives, and
constructing a new 2.9-mile-long spur
levee in the middle reach, starting at
levee mile 7.3, along a railroad track.
Five copies of the Draft EIS for the
Presidio FCP have been filed with
USEPA, Region 6 Office of Federal
Activities, in accordance with 40 CFR
parts 1500–1508 and USIBWC
procedures. The public comment period
of the Draft EIS will end January 12,
2010.
Dated: November 18, 2009.
Pamela Barber,
Legal Counsel.
[FR Doc. E9–28136 Filed 11–23–09; 8:45 am]
BILLING CODE 7010–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Mohammed F. Abdel-Hameed, M.D.;
Revocation of Registration
On April 4, 2008, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Mohammed F. AbdelHameed, M.D. (Respondent), of
Orlando, Florida. The Show Cause
Order proposed the revocation of
Respondent’s DEA Certificate of
Registration, BA6015158, as a
practitioner, and proposed the denial of
any pending applications for
modification or renewal of the
registration, on the ground that
Respondent’s ‘‘continued registration is
inconsistent with the public interest’’ as
that term is defined in 21 U.S.C. 823(f)
and 824(a)(4). Show Cause Order at 1.
The Show Cause Order specifically
alleged that while Respondent is
licensed as a physician only in Florida,
he prescribed controlled substances for
internet customers ‘‘throughout the
United States from approximately June
2002, through September 2004, on the
basis of online questionnaires and/or
telephone consultations,’’ such that he
issued prescriptions ‘‘without a
legitimate medical purpose and outside
the usual course of professional
practice, in violation of 21 CFR
1306.04(a) and 21 U.S.C. 841(a)(1).’’ Id.
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at 1. The Show Cause Order further
alleged that Respondent’s writing of
controlled substance prescriptions
‘‘violated state laws that prohibit the
unauthorized practice of medicine,
including unlicensed, out-of-state
physicians issuing controlled substance
prescriptions to state residents’’ in such
States as California and Alabama. Id. at
1–2.
The Show Cause Order was served on
Respondent by FedEx to Respondent’s
last-known address on April 11, 2008;
on April 14, 2008, FedEx delivered the
Order. GX 2, at 2; GX 3. Because more
than 30 days have passed and neither
Respondent, nor any other person
purporting to represent him, has
requested a hearing, I find that
Respondent has waived his right to a
hearing. 21 CFR 1301.43(d). I therefore
enter this Decision and Final Order
based on relevant evidence contained in
the investigative file. See 21 CFR
1301.43(e), 1301.46.
Having considered the record in this
matter, I find that Respondent’s
continued registration is inconsistent
with the public interest. Accordingly,
Respondent’s registration will be
revoked and any pending applications
for renewal or modification will be
denied. I make the following findings.
Findings
Respondent is the holder of DEA
Certificate of Registration, BA6015158,
which authorizes him to dispense
controlled substances in schedules II
through V, as a practitioner, with a
registered location in Orlando, Florida.
Respondent’s registration does not
expire until June 30, 2010.
Respondent earned a Ph.D. in genetics
and an M.D. from the University of
California. In 1990, Respondent began
practicing medicine in the Orlando,
Florida area. Throughout the time at
issue in this proceeding, Respondent
was licensed as a physician in only the
State of Florida. GX 7, at 17; GX 10, at
2.
On November 4, 2004, two DEA
Diversion Investigators (DIs)
interviewed Respondent. GX 5, at 1. In
the interview, Respondent indicated
that sometime in late 2002, Ken
Shobola, the sole owner of Ken Drugs,
Inc. (‘‘Ken Drugs’’), contracted with him
to work as an internet prescribing
physician for Ken Drugs. Id.; GX 7, at
10. Respondent worked part-time—20
hours per week—for Ken Drugs/Kenady
Medical Clinic,1 for which he received
1 Kenady Medical Clinic, Inc., is a Florida
corporation incorporated by Kenneth Shobola in
April 2002. In the period under consideration in
this decision, Mr. Shobola was the president and
registered agent of the corporation. GX 7, at 16.
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a bi-weekly paycheck. GX 5, at 2.
Respondent handled both internetinitiated calls and some walk-in
patients. Id.
Respondent also indicated to the DIs
that he was operating under a Ken
Drugs/Kenady Medical Clinic policy
dated October 8, 2004, under which
internet prescribing physicians are not
expected to prescribe controlled
substances to internet clients until the
patients/clients are first seen by a
physician or a physician’s assistant. Id.
In September 2002, DEA, in
conjunction with other law enforcement
agencies, commenced a criminal
investigation of various web sites which
were believed to be engaged in the
distribution of controlled substances in
violation of federal law, as well as Ken
Drugs, Kennedee Group, Inc.,
pharmacist Kenneth Shobola, and
various physicians including
Respondent. GX 7, at 14. As part of the
investigation, on March 27, 2003,
investigators conducted a trash run at
the Ken Drugs pharmacy which was
located on Waters Avenue in Tampa,
Florida. Id. at 18. The investigators
found prescription labels bearing the
name ‘‘Dr. Fathi Hamid.’’ Id.
Subsequently, in June 2004,
Investigators obtained records from the
Kenady Medical Clinic, a Tampa-based
clinic owed by Shobola, which included
prescription records signed by ‘‘Hamid’’
and which bore Respondent’s DEA
registration number. Id. at 22.
As part of their investigation, DEA
and the cooperating agencies conducted
seventeen undercover purchases of
controlled substance prescriptions and
refills for hydrocodone, Xanax, and
Soma. Id. at 18–19. Whether the officers
initiated contact through https://
www.medsviaweb.com or by contacting
Ken Drugs directly, each purchase
included the payment of $120 or $125
for a telephonic consultation fee with a
purportedly licensed physician. Id. at
19. After payment of the fee, each
undercover officer talked by telephone
to an employee of Kenaday Group,2 who
advised the individual that he or she
would have to fax his/her medical
record accompanied by a photocopy of
his/her driver’s license. Id. Regardless of
whether the officer actually faxed in
his/her medical records, the employee
would notify the individual that a
doctor would soon be available for a
consultation, after which, according to
the employee, the prescribed controlled
substances would arrive via UPS or
2 Kennedee Group, Inc., a/k/a Kenaday Group, is
a Florida corporation incorporated by Kenneth
Shobola in September 2000. GX 7, at 16, 19. Mr.
Shobola was president of Kennedee Group. Id.
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FedEx. Id. On all but one of the buys,
the phone consultation was recorded
and transcribed. Id.
Throughout the undercover
purchases, officers dealt with one of
three physicians but not with
Respondent. See Id. In each instance,
the telephonic consultation lasted only
a few minutes. Id. at 19–20. In general,
the physicians inquired whether the
purchaser had faxed the requested
medical records to Kenaday Group, the
nature of the medical complaint, what
drugs or medications the purchaser had
taken in the past, and what medications
the purchaser currently desired. Id. at
20.
The officers, however, rarely faxed in
their medical records. Id. When they
did, the purchaser’s age conflicted with
the age given on the photocopied
driver’s license. Id. Nevertheless, on
each occasion, the physicians
prescribed schedule III controlled
substances containing hydrocodone,
which was expeditiously shipped and
delivered to the officer. Id. In no
instance was an undercover officer
required to obtain a physical
examination by a doctor associated with
Ken Drugs, Kenady Medical Clinic, or
Kenaday Group. Id.
On October 7, 2003, the Winchester,
Kentucky Police Department
interviewed E.C., who had used
eighteen names and seven addresses to
receive drug shipments from Ken Drugs.
Id. E.C. confessed that he was addicted
to hydrocodone and that his source for
controlled substances was Ken Drugs.
Id. According to E.C., he initially
consulted with one of the other three
doctors, who requested that he send
medical records. Id. at 20–21. Although
E.C. never sent the requested records,
Ken Drugs dispensed controlled
substances to him. Id. at 21.
On November 20, 2003, the Cabell
County, West Virginia Department of
Public Safety detained C.W. for traffic
violations. Id. In an interview, C.W.
stated that he and his wife had been
obtaining hydrocodone 7.5 mg. and 10
mg. tablets and Xanax 1 mg. and 2 mg.
tablets from Ken Drugs. Id. In order to
obtain a larger quantity of controlled
substances, C.W. and his wife submitted
to Ken Drugs the names, addresses,
drivers’ licenses, and medical records of
friends and relatives, as well as falsified
medical records including MRIs and test
results which were obtained from
internet sites. Id.
In June 2004, the law enforcement
agencies obtained records from Kenady
Medical Clinic corresponding to some of
the fictitious names given by Mr. and
Mrs. C.W. Id. at 22. Among these
records were prescriptions written by
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‘‘Fathi Hamid’’ under Respondent’s
DEA registration number. Id.
On September 21, 2004, a search
warrant was executed at the Ken Drugs
pharmacy on Habana Avenue in Tampa,
Florida. The Investigators obtained
computer records which showed that
between the dates of September 4, 2002,
and December 12, 2003, Respondent
had issued 992 controlled substance
prescriptions. Respondent issued these
prescriptions to residents of 38 States
and Puerto Rico.
More specifically, between April 2,
2003, and December 1, 2003,
Respondent wrote 147 prescriptions for
schedule III drugs containing
hydrocodone and 13 diazepam
prescriptions for residents of California.
Between April 2, 2003, and December 4,
2003, he wrote 54 prescriptions for
combination hydrocodone drugs for
residents of Georgia. Between April 4,
2003, and December 11, 2003, he wrote
24 prescriptions for combination
hydrocodone drugs for residents of
Texas. Between June 2, 2003, and
October 27, 2003, he wrote 21
prescriptions for combination
hydrocodone drugs for residents of
Alabama. Between April 4, 2003, and
December 5, 2003, he wrote nineteen
prescriptions for combination
hydrocodone drugs for residents of
North Carolina. Id.
Combination schedule III controlled
substances containing hydrocodone
heavily predominated in the 992
prescriptions Respondent wrote. As I
have noted in numerous other
decisions, the drugs are highly popular
drugs with abusers. See Southwood
Pharmaceuticals, Inc., 72 FR 36487,
36504 (2007) (noting 2004 survey of the
National Institute of Drug Abuse which
found that ‘‘9.3 percent of twelfth
graders reported using Vicodin, a brand
name Schedule III controlled substance
without a prescription in the previous
year’’); William R. Lockridge, 71 FR
77791, 77796 (2006) (noting that in
2002, the abuse of hydrocodone
products resulted in more than 27,000
emergency room visits).
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Discussion
Section 304(a) of the Controlled
Substances Act (CSA) provides that a
registration to ‘‘dispense a controlled
substance * * * may be suspended or
revoked by the Attorney General upon
a finding that the registrant * * * has
committed such acts as would render
his registration under section 823 of this
title inconsistent with the public
interest as determined under such
section.’’ 21 U.S.C. 824(a)(4). In making
the public interest determination, the
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CSA requires 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.
21 U.S.C. 823(f).
‘‘[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 I may give each factor the
weight I deem appropriate in
determining whether to revoke an
existing registration. Id. Moreover, I am
‘‘not required to make findings as to all
the factors.’’ Hoxie v. DEA, 419 F.3d
477, 482 (6th Cir. 2005); see also Morall
v. DEA, 412 F.3d 165, 173–74 (DC Cir.
2005).
Having considered all of the factors, I
acknowledge that the record contains no
evidence that the State of Florida has
taken action against Respondent’s
medical license (factor one) or that
Respondent has been convicted of an
offense related to controlled substances
(factor three).3 However, the record
contains substantial evidence that
Respondent’s experience in dispensing
controlled substances (factor two) and
his record of compliance with
applicable Federal and state laws (factor
four) is characterized by his repeated
violation of the CSA’s prescription
requirement, as well as his repeated
violation of state laws and regulations
prohibiting the unlicensed practice of
medicine and setting the standards for
prescribing controlled substances and
dangerous drugs. Accordingly, I
conclude that Respondent’s continued
registration would be inconsistent with
the public interest and will revoke his
registration.
3 This Agency has long held that a State’s failure
to take action against a practitioner’s authority to
dispense controlled substances is not dispositive in
determining whether the continuation of a
registration would be consistent with the public
interest. See Mortimer B. Levin, 55 FR 8209, 8210
(1990). The absence of a criminal conviction is
likewise not dispositive of the public interest
inquiry. See, e.g., Edmund Chein, 72 FR 6580, 6593
n.22 (2007).
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Factors Two and Four—Respondent’s
Experience in Dispensing Controlled
Substances and Record of Compliance
With Applicable Controlled Substance
Laws
The primary issue in this case is
whether the controlled-substance
prescriptions which Respondent wrote
in 2003, pursuant to his arrangement
with Ken Drugs/Kenady Medical Clinic,
were lawful prescriptions under the
CSA. 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.’’ Gonzalez v. Oregon, 546 U.S.
243, 274 (2006) (citing United States v.
Moore, 423 U.S. 122, 135, 143 (1975)).
Under the CSA, for a physician to act
‘‘in the usual course of * * *
professional practice’’ and to issue a
prescription for a ‘‘legitimate medical
purpose,’’ he or she must be authorized
to ‘‘practice medicine and to dispense
drugs in connection with his [or her]
professional practice,’’ and he or she
must also have established a bona fide
doctor-patient relationship with the
individual for whom the prescription is
written. Moore, 423 U.S. at 140–43. See
also Patrick W. Stodola, 74 FR 20727,
20731 (2009); Joseph Gaudio, 74 FR
10083, 10090 (2009). See also
Dispensing and Purchasing Controlled
Substances Over the Internet, 66 FR
21181 (2001).
A ‘‘physician who engages in the
unauthorized practice of medicine’’
under state laws—such as an out-ofstate physician who lacks the license to
prescribe to a State’s residents—‘‘is not
a practitioner acting in the usual course
of * * * professional practice’’ under
the CSA. United Prescription Services,
Inc., 72 FR 50397, 50407 (2007) (citing
21 CFR 1306.04(a)). This rule derives
directly from the text of the CSA which
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defines the term ‘‘practitioner’’ as ‘‘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). See also Moore, 423 U.S.
at 140–41 (‘‘In the case of a physician
[the CSA] contemplates that he is
authorized by the State to practice
medicine and to dispense drugs in
connecting with his professional
practice.’’) (emphasis added). A
controlled-substance prescription issued
by a physician who lacks the license or
authority required to practice medicine
within a State is therefore unlawful
under the CSA. See 21 CFR 1306.04(a).
As to the issue of a bona fide doctorpatient relationship, at the time of the
prescriptions at issue in this case, the
CSA generally looked to state law to
determine its elements.4 See Stodola, 74
FR at 20731; Kamir Garces-Mejias, 72
FR 54931, 54935 (2007); see also
Dispensing and Purchasing Controlled
Substances Over the Internet, 66 FR at
21182–83. As the DEA elaborated in the
2001 Guidance:
For purposes of state law, many state
authorities, with the endorsement of medical
societies, consider the existence of the
following four elements as an indication that
a legitimate doctor/patient relationship has
been established:
—A patient has a medical complaint;
—A medical history has been taken;
—A physical examination has been
performed; and
—Some logical connection exists between the
medical complaint, the medical history,
the physical examination, and the drug
prescribed.
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66 FR at 21182–83.
As found above, Respondent wrote
147 prescriptions for schedule III
controlled substances containing
hydrocodone and thirteen prescriptions
for diazepam for residents of California
between April 2, 2003, and December 1,
2003. These prescriptions were filled by
Ken Drugs pursuant to Respondent’s
4 On October 15, 2008, President Bush 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 ‘‘[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 ‘‘the 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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contractual arrangement with Ken
Drugs/Kenady Medical Clinic.
In 2000, California enacted a law
specifically prohibiting the prescribing
or dispensing of a dangerous drug ‘‘on
the Internet for delivery to any person
in [California], without an appropriate
prior examination and medical
indication therefore, except as
authorized by Section 2242.’’ Cal. Bus.
& Prof. Code § 2242.1.5 Moreover, in
2003, the Medical Board of California
expressly held that a ‘‘physician cannot
do a good faith prior examination based
on a history, a review of medical
records, responses to a questionnaire
and a telephone consultation with the
patient, without a physical examination
of the patient.’’ In re John Steven
Opsahl, M.D., Decision and Order, at 3
(Med Bd. Cal. 2003) (available by query
at https://publicdocs.medbd.ca.gov/pdl/
mbc.aspx). The California Board further
held that ‘‘[a] physician cannot
determine whether there is a medical
indication for prescription of a
dangerous drug without performing a
physical examination.’’ Id.
In addition, well before Respondent’s
issuance of the prescriptions, the
California Board had cited an out-ofstate physician for violating state law by
prescribing to state residents through
the internet. Citation Order, Carlos
Gustavo Levy (Nov. 30, 2001). As
Respondent did not hold a California
license, he clearly violated California
law and the CSA when he wrote
controlled-substance prescriptions for
California residents. Moreover, because
Respondent did not perform physical
examinations of the California residents,
his prescriptions were not issued in the
usual course of professional practice
and lacked a legitimate medical purpose
and thus violated the CSA for this
reason as well. See 21 CFR 1306.04(a).
Respondent wrote 54 prescriptions to
residents of Georgia for schedule III
controlled substances which contain
hydrocodone. Under Georgia law
(which was in effect when he issued the
prescriptions), an individual ‘‘who is
physically located in another state’’ and
who ‘‘through the use of any means,
including electronic * * * or other
means of telecommunication, through
which medical information or data is
transmitted, performs an act that is part
of a patient care service located in this
state * * * that would affect the
diagnosis or treatment of the patient’’ is
‘‘engaged in the practice of medicine’’ in
Georgia. Ga. Code Ann. § 43–34–31.1.
Such practice of medicine requires the
individual to have ‘‘a license to practice
medicine in [Georgia]’’ and subjects him
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61369
or her to ‘‘regulation by the board.’’ Id.
By issuing controlled substance
prescriptions to Georgia residents via
telephone and the internet without
having a Georgia license to practice
medicine, Respondent violated both
Georgia law and the CSA.
In addition, under the regulation of
the Georgia Composite State Board of
Medical Examiners, it is
‘‘unprofessional conduct’’ to
‘‘[p]rovid[e] treatment and/or
consultation recommendations via
electronic or other means unless the
licensee has performed a history and
physical examination of the patient
adequate to establish differential
diagnoses and identify underlying
conditions and or contraindications to
the treatment recommended.’’ Ga.
Comp. R. & Regs. 360–3–.02(6) (2002).
Respondent’s failure to perform a
physical examination on the Georgia
residents he prescribed to thus violated
Georgia law and the CSA for this reason
as well. See 21 CFR 1306.04(a).
Respondent wrote 24 prescriptions to
residents of Texas for schedule III
controlled substances containing
hydrocodone. Texas law provides that
individuals who are ‘‘physically located
in another jurisdiction but who, through
the use of any medium, including an
electronic medium, perform[ ] an act
that is part of a patient care service
initiated in [Texas] * * * and that
would affect the diagnosis or treatment
of the patient’’ are engaged in the
practice of medicine. Tex. Occup. Code
§ 151.056(a); see also Tex. Occup. Code
§ 155.001 (requiring a license to engage
in the practice of medicine). In order to
issue prescriptions for controlled
substances, such individuals must also
obtain a state registration to dispense
such drugs, which in turn requires them
to be licensed under the laws of Texas.
Tex. Health & Safety Code §§ 481.061(a)
& 481.063(d).
More specifically, Texas regulations
provide that ‘‘[p]hysicians who treat and
prescribe through the Internet are
practicing medicine and must possess
appropriate licensure in all jurisdictions
where patients reside.’’ Tex. Admin.
Code 174.4(c). Because Respondent was
not licensed to practice medicine in
Texas and did not hold a Texas
Controlled Substances Registration, his
prescriptions to the Texas residents
violated Texas law and the CSA. See
1306.04(a).
Respondent issued 21 prescriptions to
residents of Alabama for schedule III
controlled substances containing
hydrocodone. Notably, Alabama law
defines the practice of medicine to mean
‘‘[t]o diagnose, treat, correct, advise or
prescribe for any human disease,
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ailment, injury, infirmity, deformity,
pain or other condition, physical or
mental, real or imaginary, by any means
or instrumentality.’’ Ala. Code § 34–24–
50(1). Under Alabama law, ‘‘the practice
of medicine * * * across state lines’’ as
it applies to ‘‘[t]he rendering of
treatment to a patient located within
[Alabama] by a physician located
outside [Alabama] as a result of
transmission of individual patient data
by electronic or other means from this
state to such physician or his or her
agent’’ constitutes the ‘‘practice of
medicine,’’ such that ‘‘[n]o person shall
engage in the practice of medicine
* * * across state lines in [Alabama]’’
unless he or she has ‘‘been issued a
special purpose license to practice
medicine * * * across state lines.’’ Ala.
Code § 34–24–501 & 34–24–502(a). As
Respondent did not possess a special
purpose license from Alabama, his
prescribing over the internet to these
patients constituted violations of
Alabama law. In issuing these
controlled-substance prescriptions,
Respondent acted outside the usual
course of professional practice and
violated the CSA. See 21 CFR
1306.04(a).
Respondent wrote nineteen
prescriptions for schedule III drugs
containing hydrocodone to residents of
North Carolina. Under North Carolina
law prior to 2007, ‘‘prescribing
medication by use of the internet or a
toll-free number,’’ was ‘‘regarded as
practicing medicine’’ in North Carolina.
N.C. Gen. Stat. Ann. 90–18(b).6 As such,
it subjected a practitioner to North
Carolina law and the regulation of the
North Carolina Medical Board. Id. North
Carolina prohibits the practice of
medicine without the appropriate
license and registration and makes outof-state violators guilty of a ‘‘Class I
felony.’’ N.C. Gen. Stat. Ann. 90–18(a).
Respondent’s prescribing to North
Carolina residents via the internet
clearly violated North Carolina law.
Additionally, in February 2001, the
North Carolina Medical Board issued its
position statement, ‘‘Contact with
Patients Before Prescribing,’’ which
stated that ‘‘prescribing drugs to an
individual the prescriber has not
personally examined is inappropriate.’’
Contact with Patients before Prescribing,
at 1 (available at https://
www.ncmedboard.org/
position_statements/). The Board further
explained that ‘‘[o]rdinarily, this will
require that the physician personally
perform an appropriate history and
physical examination, make a diagnosis,
6 This provision was deleted, effective October 1,
2007, by S.L. 2007–346, section 23.
VerDate Nov<24>2008
15:15 Nov 23, 2009
Jkt 220001
and formulate a therapeutic plan, a part
of which might be a prescription.’’ Id.
As Respondent failed to perform
physical examinations of these patients,
his conduct was not in the usual course
of professional practice. He
consequently violated the CSA in
writing these prescriptions as well. See
21 CFR 1306.04(a).
As the foregoing demonstrates,
Respondent repeatedly violated state
laws and regulations prohibiting the
unlicensed practice of medicine and
establishing standards of medical
practice by prescribing controlled
substances to persons he never
physically examined and who resided
in States where he was not licensed to
practice and prescribe drugs. In issuing
the prescriptions, Respondent also acted
outside of ‘‘the usual course of
professional practice’’ and lacked ‘‘a
legitimate medical purpose’’ and thus
repeatedly violated the CSA. I therefore
conclude that Respondent has
committed acts which render his
continued registration ‘‘inconsistent
with the public interest.’’ 21 U.S.C.
824(a)(4). Accordingly, Respondent’s
registration will be revoked.
Order
Pursuant to the authority vested in me
by 21 U.S.C. §§ 823(f) and 824(a), as
well as 28 CFR 0.100(b) and 0.104, I
hereby order that DEA Certificate of
Registration, BA6015158, issued to
Mohammed F. Abdel-Hameed, M.D., be,
and it hereby is, revoked. I further order
that any pending application to renew
or modify the registration be, and it
hereby is, denied. This order is effective
December 24, 2009.
Dated: November 17, 2009
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9–28189 Filed 11–23–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 09–32]
Harrell E. Robinson, M.D.; Revocation
of Registration
On February 26, 2009, I, the Deputy
Administrator of the Drug Enforcement
Administration, issued an Order to
Show Cause and Immediate Suspension
of Registration to Harrell E. Robinson,
M.D. (Respondent), of Santa Ana,
California. The Order proposed the
revocation of Respondent’s DEA
Certificate of Registration, AR8613487,
which authorizes him to dispense
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
controlled substances in schedules II
through V as a practitioner, on the
ground that Respondent’s continued
registration is ‘‘inconsistent with the
public interest, as that term is defined
in 21 U.S.C. 823(f), 824(a)(4).’’ Show
Cause Order at 1. The Order also
proposed the denial of any pending
applications for renewal or modification
of Respondent’s registration. Id.
Specifically, the Show Cause Order
alleged that from February 2007 through
October 2008, Respondent ‘‘purchased
approximately 613,000 dosage units of
hydrocodone combination products and
unlawfully distributed these drugs to an
unregistered individual in exchange for
$10,000 per month * * * in violation of
21 U.S.C. 841(a)(1).’’ Id. In addition, the
Show Cause Order alleged that from
September 2007 through October 2008,
Respondent ‘‘purchased approximately
397,000 dosage units of hydrocodone
combination products using the DEA
registration numbers of two other
practitioners in violation of 21 U.S.C.
843(a)(2) and (3).’’ Id. at 2. Further,
Respondent allegedly then ‘‘distributed
these drugs to an unregistered
individual, in violation of 21 U.S.C.
841(a)(1).’’ Id.
Based on the above, I further
concluded that Respondent’s
‘‘continued registration while these
proceedings are pending constitutes an
imminent danger to the public health
and safety.’’ Show Cause Order at 2.
Consequently, pursuant to my authority
under 21 U.S.C. 824(d) and 21 CFR
1301.36(e), I immediately suspended
Respondent’s registration, with the
suspension to remain in effect until the
issuance of this Final Order. Id.
Respondent requested a hearing on
the allegations. The case was placed on
the docket of the Agency’s
Administrative Law Judges (ALJ) and a
hearing was scheduled for May 12,
2009. On April 9, 2009, the ALJ ordered
Respondent to file a prehearing
statement no later than May 4, 2009.
ALJ at 2 n.1; ALJ Ex. 3. The same day,
the ALJ’s law clerk faxed Respondent a
letter advising him of his right to
counsel. ALJ at 2 n.1; ALJ Ex. 4.
On May 1, Respondent requested an
extension of time to file his prehearing
statement, advising that he was
retaining counsel that afternoon. ALJ at
2 n.1. On May 4, the ALJ granted
Respondent an extension of time to May
7, noting that the hearing was set for
May 12 and that Respondent had not
asked for a postponement of the hearing.
Id.
On May 6, Respondent filed a request
to postpone the hearing; in response, the
ALJ’s law clerk ‘‘left a telephone
message for Respondent advising that
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[Federal Register Volume 74, Number 225 (Tuesday, November 24, 2009)]
[Notices]
[Pages 61366-61370]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28189]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Mohammed F. Abdel-Hameed, M.D.; Revocation of Registration
On April 4, 2008, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Mohammed F. Abdel-Hameed, M.D. (Respondent), of Orlando,
Florida. The Show Cause Order proposed the revocation of Respondent's
DEA Certificate of Registration, BA6015158, as a practitioner, and
proposed the denial of any pending applications for modification or
renewal of the registration, on the ground that Respondent's
``continued registration is inconsistent with the public interest'' as
that term is defined in 21 U.S.C. 823(f) and 824(a)(4). Show Cause
Order at 1.
The Show Cause Order specifically alleged that while Respondent is
licensed as a physician only in Florida, he prescribed controlled
substances for internet customers ``throughout the United States from
approximately June 2002, through September 2004, on the basis of online
questionnaires and/or telephone consultations,'' such that he issued
prescriptions ``without a legitimate medical purpose and outside the
usual course of professional practice, in violation of 21 CFR
1306.04(a) and 21 U.S.C. 841(a)(1).'' Id.
[[Page 61367]]
at 1. The Show Cause Order further alleged that Respondent's writing of
controlled substance prescriptions ``violated state laws that prohibit
the unauthorized practice of medicine, including unlicensed, out-of-
state physicians issuing controlled substance prescriptions to state
residents'' in such States as California and Alabama. Id. at 1-2.
The Show Cause Order was served on Respondent by FedEx to
Respondent's last-known address on April 11, 2008; on April 14, 2008,
FedEx delivered the Order. GX 2, at 2; GX 3. Because more than 30 days
have passed and neither Respondent, nor any other person purporting to
represent him, has requested a hearing, I find that Respondent has
waived his right to a hearing. 21 CFR 1301.43(d). I therefore enter
this Decision and Final Order based on relevant evidence contained in
the investigative file. See 21 CFR 1301.43(e), 1301.46.
Having considered the record in this matter, I find that
Respondent's continued registration is inconsistent with the public
interest. Accordingly, Respondent's registration will be revoked and
any pending applications for renewal or modification will be denied. I
make the following findings.
Findings
Respondent is the holder of DEA Certificate of Registration,
BA6015158, which authorizes him to dispense controlled substances in
schedules II through V, as a practitioner, with a registered location
in Orlando, Florida. Respondent's registration does not expire until
June 30, 2010.
Respondent earned a Ph.D. in genetics and an M.D. from the
University of California. In 1990, Respondent began practicing medicine
in the Orlando, Florida area. Throughout the time at issue in this
proceeding, Respondent was licensed as a physician in only the State of
Florida. GX 7, at 17; GX 10, at 2.
On November 4, 2004, two DEA Diversion Investigators (DIs)
interviewed Respondent. GX 5, at 1. In the interview, Respondent
indicated that sometime in late 2002, Ken Shobola, the sole owner of
Ken Drugs, Inc. (``Ken Drugs''), contracted with him to work as an
internet prescribing physician for Ken Drugs. Id.; GX 7, at 10.
Respondent worked part-time--20 hours per week--for Ken Drugs/Kenady
Medical Clinic,\1\ for which he received a bi-weekly paycheck. GX 5, at
2. Respondent handled both internet-initiated calls and some walk-in
patients. Id.
---------------------------------------------------------------------------
\1\ Kenady Medical Clinic, Inc., is a Florida corporation
incorporated by Kenneth Shobola in April 2002. In the period under
consideration in this decision, Mr. Shobola was the president and
registered agent of the corporation. GX 7, at 16.
---------------------------------------------------------------------------
Respondent also indicated to the DIs that he was operating under a
Ken Drugs/Kenady Medical Clinic policy dated October 8, 2004, under
which internet prescribing physicians are not expected to prescribe
controlled substances to internet clients until the patients/clients
are first seen by a physician or a physician's assistant. Id.
In September 2002, DEA, in conjunction with other law enforcement
agencies, commenced a criminal investigation of various web sites which
were believed to be engaged in the distribution of controlled
substances in violation of federal law, as well as Ken Drugs, Kennedee
Group, Inc., pharmacist Kenneth Shobola, and various physicians
including Respondent. GX 7, at 14. As part of the investigation, on
March 27, 2003, investigators conducted a trash run at the Ken Drugs
pharmacy which was located on Waters Avenue in Tampa, Florida. Id. at
18. The investigators found prescription labels bearing the name ``Dr.
Fathi Hamid.'' Id. Subsequently, in June 2004, Investigators obtained
records from the Kenady Medical Clinic, a Tampa-based clinic owed by
Shobola, which included prescription records signed by ``Hamid'' and
which bore Respondent's DEA registration number. Id. at 22.
As part of their investigation, DEA and the cooperating agencies
conducted seventeen undercover purchases of controlled substance
prescriptions and refills for hydrocodone, Xanax, and Soma. Id. at 18-
19. Whether the officers initiated contact through https://www.medsviaweb.com or by contacting Ken Drugs directly, each purchase
included the payment of $120 or $125 for a telephonic consultation fee
with a purportedly licensed physician. Id. at 19. After payment of the
fee, each undercover officer talked by telephone to an employee of
Kenaday Group,\2\ who advised the individual that he or she would have
to fax his/her medical record accompanied by a photocopy of his/her
driver's license. Id. Regardless of whether the officer actually faxed
in his/her medical records, the employee would notify the individual
that a doctor would soon be available for a consultation, after which,
according to the employee, the prescribed controlled substances would
arrive via UPS or FedEx. Id. On all but one of the buys, the phone
consultation was recorded and transcribed. Id.
---------------------------------------------------------------------------
\2\ Kennedee Group, Inc., a/k/a Kenaday Group, is a Florida
corporation incorporated by Kenneth Shobola in September 2000. GX 7,
at 16, 19. Mr. Shobola was president of Kennedee Group. Id.
---------------------------------------------------------------------------
Throughout the undercover purchases, officers dealt with one of
three physicians but not with Respondent. See Id. In each instance, the
telephonic consultation lasted only a few minutes. Id. at 19-20. In
general, the physicians inquired whether the purchaser had faxed the
requested medical records to Kenaday Group, the nature of the medical
complaint, what drugs or medications the purchaser had taken in the
past, and what medications the purchaser currently desired. Id. at 20.
The officers, however, rarely faxed in their medical records. Id.
When they did, the purchaser's age conflicted with the age given on the
photocopied driver's license. Id. Nevertheless, on each occasion, the
physicians prescribed schedule III controlled substances containing
hydrocodone, which was expeditiously shipped and delivered to the
officer. Id. In no instance was an undercover officer required to
obtain a physical examination by a doctor associated with Ken Drugs,
Kenady Medical Clinic, or Kenaday Group. Id.
On October 7, 2003, the Winchester, Kentucky Police Department
interviewed E.C., who had used eighteen names and seven addresses to
receive drug shipments from Ken Drugs. Id. E.C. confessed that he was
addicted to hydrocodone and that his source for controlled substances
was Ken Drugs. Id. According to E.C., he initially consulted with one
of the other three doctors, who requested that he send medical records.
Id. at 20-21. Although E.C. never sent the requested records, Ken Drugs
dispensed controlled substances to him. Id. at 21.
On November 20, 2003, the Cabell County, West Virginia Department
of Public Safety detained C.W. for traffic violations. Id. In an
interview, C.W. stated that he and his wife had been obtaining
hydrocodone 7.5 mg. and 10 mg. tablets and Xanax 1 mg. and 2 mg.
tablets from Ken Drugs. Id. In order to obtain a larger quantity of
controlled substances, C.W. and his wife submitted to Ken Drugs the
names, addresses, drivers' licenses, and medical records of friends and
relatives, as well as falsified medical records including MRIs and test
results which were obtained from internet sites. Id.
In June 2004, the law enforcement agencies obtained records from
Kenady Medical Clinic corresponding to some of the fictitious names
given by Mr. and Mrs. C.W. Id. at 22. Among these records were
prescriptions written by
[[Page 61368]]
``Fathi Hamid'' under Respondent's DEA registration number. Id.
On September 21, 2004, a search warrant was executed at the Ken
Drugs pharmacy on Habana Avenue in Tampa, Florida. The Investigators
obtained computer records which showed that between the dates of
September 4, 2002, and December 12, 2003, Respondent had issued 992
controlled substance prescriptions. Respondent issued these
prescriptions to residents of 38 States and Puerto Rico.
More specifically, between April 2, 2003, and December 1, 2003,
Respondent wrote 147 prescriptions for schedule III drugs containing
hydrocodone and 13 diazepam prescriptions for residents of California.
Between April 2, 2003, and December 4, 2003, he wrote 54 prescriptions
for combination hydrocodone drugs for residents of Georgia. Between
April 4, 2003, and December 11, 2003, he wrote 24 prescriptions for
combination hydrocodone drugs for residents of Texas. Between June 2,
2003, and October 27, 2003, he wrote 21 prescriptions for combination
hydrocodone drugs for residents of Alabama. Between April 4, 2003, and
December 5, 2003, he wrote nineteen prescriptions for combination
hydrocodone drugs for residents of North Carolina. Id.
Combination schedule III controlled substances containing
hydrocodone heavily predominated in the 992 prescriptions Respondent
wrote. As I have noted in numerous other decisions, the drugs are
highly popular drugs with abusers. See Southwood Pharmaceuticals, Inc.,
72 FR 36487, 36504 (2007) (noting 2004 survey of the National Institute
of Drug Abuse which found that ``9.3 percent of twelfth graders
reported using Vicodin, a brand name Schedule III controlled substance
without a prescription in the previous year''); William R. Lockridge,
71 FR 77791, 77796 (2006) (noting that in 2002, the abuse of
hydrocodone products resulted in more than 27,000 emergency room
visits).
Discussion
Section 304(a) of the Controlled Substances Act (CSA) provides that
a registration to ``dispense a controlled substance * * * may be
suspended or revoked by the Attorney General upon a finding that the
registrant * * * has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C.
824(a)(4). In making the public interest determination, the CSA
requires 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.
21 U.S.C. 823(f).
``[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 I may give each factor the weight I deem
appropriate in determining whether to revoke an existing registration.
Id. Moreover, I am ``not required to make findings as to all the
factors.'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also
Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 2005).
Having considered all of the factors, I acknowledge that the record
contains no evidence that the State of Florida has taken action against
Respondent's medical license (factor one) or that Respondent has been
convicted of an offense related to controlled substances (factor
three).\3\ However, the record contains substantial evidence that
Respondent's experience in dispensing controlled substances (factor
two) and his record of compliance with applicable Federal and state
laws (factor four) is characterized by his repeated violation of the
CSA's prescription requirement, as well as his repeated violation of
state laws and regulations prohibiting the unlicensed practice of
medicine and setting the standards for prescribing controlled
substances and dangerous drugs. Accordingly, I conclude that
Respondent's continued registration would be inconsistent with the
public interest and will revoke his registration.
---------------------------------------------------------------------------
\3\ This Agency has long held that a State's failure to take
action against a practitioner's authority to dispense controlled
substances is not dispositive in determining whether the
continuation of a registration would be consistent with the public
interest. See Mortimer B. Levin, 55 FR 8209, 8210 (1990). The
absence of a criminal conviction is likewise not dispositive of the
public interest inquiry. See, e.g., Edmund Chein, 72 FR 6580, 6593
n.22 (2007).
---------------------------------------------------------------------------
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Controlled
Substance Laws
The primary issue in this case is whether the controlled-substance
prescriptions which Respondent wrote in 2003, pursuant to his
arrangement with Ken Drugs/Kenady Medical Clinic, were lawful
prescriptions under the CSA. 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.'' Gonzalez v. Oregon, 546 U.S. 243, 274 (2006)
(citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)).
Under the CSA, for a physician to act ``in the usual course of * *
* professional practice'' and to issue a prescription for a
``legitimate medical purpose,'' he or she must be authorized to
``practice medicine and to dispense drugs in connection with his [or
her] professional practice,'' and he or she must also have established
a bona fide doctor-patient relationship with the individual for whom
the prescription is written. Moore, 423 U.S. at 140-43. See also
Patrick W. Stodola, 74 FR 20727, 20731 (2009); Joseph Gaudio, 74 FR
10083, 10090 (2009). See also Dispensing and Purchasing Controlled
Substances Over the Internet, 66 FR 21181 (2001).
A ``physician who engages in the unauthorized practice of
medicine'' under state laws--such as an out-of-state physician who
lacks the license to prescribe to a State's residents--``is not a
practitioner acting in the usual course of * * * professional
practice'' under the CSA. United Prescription Services, Inc., 72 FR
50397, 50407 (2007) (citing 21 CFR 1306.04(a)). This rule derives
directly from the text of the CSA which
[[Page 61369]]
defines the term ``practitioner'' as ``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). See also Moore, 423 U.S. at
140-41 (``In the case of a physician [the CSA] contemplates that he is
authorized by the State to practice medicine and to dispense drugs in
connecting with his professional practice.'') (emphasis added). A
controlled-substance prescription issued by a physician who lacks the
license or authority required to practice medicine within a State is
therefore unlawful under the CSA. See 21 CFR 1306.04(a).
As to the issue of a bona fide doctor-patient relationship, at the
time of the prescriptions at issue in this case, the CSA generally
looked to state law to determine its elements.\4\ See Stodola, 74 FR at
20731; Kamir Garces-Mejias, 72 FR 54931, 54935 (2007); see also
Dispensing and Purchasing Controlled Substances Over the Internet, 66
FR at 21182-83. As the DEA elaborated in the 2001 Guidance:
---------------------------------------------------------------------------
\4\ On October 15, 2008, President Bush 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 ``[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 ``the 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.
For purposes of state law, many state authorities, with the
endorsement of medical societies, consider the existence of the
following four elements as an indication that a legitimate doctor/
---------------------------------------------------------------------------
patient relationship has been established:
--A patient has a medical complaint;
--A medical history has been taken;
--A physical examination has been performed; and
--Some logical connection exists between the medical complaint, the
medical history, the physical examination, and the drug prescribed.
66 FR at 21182-83.
As found above, Respondent wrote 147 prescriptions for schedule III
controlled substances containing hydrocodone and thirteen prescriptions
for diazepam for residents of California between April 2, 2003, and
December 1, 2003. These prescriptions were filled by Ken Drugs pursuant
to Respondent's contractual arrangement with Ken Drugs/Kenady Medical
Clinic.
In 2000, California enacted a law specifically prohibiting the
prescribing or dispensing of a dangerous drug ``on the Internet for
delivery to any person in [California], without an appropriate prior
examination and medical indication therefore, except as authorized by
Section 2242.'' Cal. Bus. & Prof. Code Sec. 2242.1.\5\ Moreover, in
2003, the Medical Board of California expressly held that a ``physician
cannot do a good faith prior examination based on a history, a review
of medical records, responses to a questionnaire and a telephone
consultation with the patient, without a physical examination of the
patient.'' In re John Steven Opsahl, M.D., Decision and Order, at 3
(Med Bd. Cal. 2003) (available by query at https://publicdocs.medbd.ca.gov/pdl/mbc.aspx). The California Board further
held that ``[a] physician cannot determine whether there is a medical
indication for prescription of a dangerous drug without performing a
physical examination.'' Id.
---------------------------------------------------------------------------
\5\ This statute became effective on January 1, 2001.
---------------------------------------------------------------------------
In addition, well before Respondent's issuance of the
prescriptions, the California Board had cited an out-of-state physician
for violating state law by prescribing to state residents through the
internet. Citation Order, Carlos Gustavo Levy (Nov. 30, 2001). As
Respondent did not hold a California license, he clearly violated
California law and the CSA when he wrote controlled-substance
prescriptions for California residents. Moreover, because Respondent
did not perform physical examinations of the California residents, his
prescriptions were not issued in the usual course of professional
practice and lacked a legitimate medical purpose and thus violated the
CSA for this reason as well. See 21 CFR 1306.04(a).
Respondent wrote 54 prescriptions to residents of Georgia for
schedule III controlled substances which contain hydrocodone. Under
Georgia law (which was in effect when he issued the prescriptions), an
individual ``who is physically located in another state'' and who
``through the use of any means, including electronic * * * or other
means of telecommunication, through which medical information or data
is transmitted, performs an act that is part of a patient care service
located in this state * * * that would affect the diagnosis or
treatment of the patient'' is ``engaged in the practice of medicine''
in Georgia. Ga. Code Ann. Sec. 43-34-31.1. Such practice of medicine
requires the individual to have ``a license to practice medicine in
[Georgia]'' and subjects him or her to ``regulation by the board.'' Id.
By issuing controlled substance prescriptions to Georgia residents via
telephone and the internet without having a Georgia license to practice
medicine, Respondent violated both Georgia law and the CSA.
In addition, under the regulation of the Georgia Composite State
Board of Medical Examiners, it is ``unprofessional conduct'' to
``[p]rovid[e] treatment and/or consultation recommendations via
electronic or other means unless the licensee has performed a history
and physical examination of the patient adequate to establish
differential diagnoses and identify underlying conditions and or
contraindications to the treatment recommended.'' Ga. Comp. R. & Regs.
360-3-.02(6) (2002). Respondent's failure to perform a physical
examination on the Georgia residents he prescribed to thus violated
Georgia law and the CSA for this reason as well. See 21 CFR 1306.04(a).
Respondent wrote 24 prescriptions to residents of Texas for
schedule III controlled substances containing hydrocodone. Texas law
provides that individuals who are ``physically located in another
jurisdiction but who, through the use of any medium, including an
electronic medium, perform[ ] an act that is part of a patient care
service initiated in [Texas] * * * and that would affect the diagnosis
or treatment of the patient'' are engaged in the practice of medicine.
Tex. Occup. Code Sec. 151.056(a); see also Tex. Occup. Code Sec.
155.001 (requiring a license to engage in the practice of medicine). In
order to issue prescriptions for controlled substances, such
individuals must also obtain a state registration to dispense such
drugs, which in turn requires them to be licensed under the laws of
Texas. Tex. Health & Safety Code Sec. Sec. 481.061(a) & 481.063(d).
More specifically, Texas regulations provide that ``[p]hysicians
who treat and prescribe through the Internet are practicing medicine
and must possess appropriate licensure in all jurisdictions where
patients reside.'' Tex. Admin. Code 174.4(c). Because Respondent was
not licensed to practice medicine in Texas and did not hold a Texas
Controlled Substances Registration, his prescriptions to the Texas
residents violated Texas law and the CSA. See 1306.04(a).
Respondent issued 21 prescriptions to residents of Alabama for
schedule III controlled substances containing hydrocodone. Notably,
Alabama law defines the practice of medicine to mean ``[t]o diagnose,
treat, correct, advise or prescribe for any human disease,
[[Page 61370]]
ailment, injury, infirmity, deformity, pain or other condition,
physical or mental, real or imaginary, by any means or
instrumentality.'' Ala. Code Sec. 34-24-50(1). Under Alabama law,
``the practice of medicine * * * across state lines'' as it applies to
``[t]he rendering of treatment to a patient located within [Alabama] by
a physician located outside [Alabama] as a result of transmission of
individual patient data by electronic or other means from this state to
such physician or his or her agent'' constitutes the ``practice of
medicine,'' such that ``[n]o person shall engage in the practice of
medicine * * * across state lines in [Alabama]'' unless he or she has
``been issued a special purpose license to practice medicine * * *
across state lines.'' Ala. Code Sec. 34-24-501 & 34-24-502(a). As
Respondent did not possess a special purpose license from Alabama, his
prescribing over the internet to these patients constituted violations
of Alabama law. In issuing these controlled-substance prescriptions,
Respondent acted outside the usual course of professional practice and
violated the CSA. See 21 CFR 1306.04(a).
Respondent wrote nineteen prescriptions for schedule III drugs
containing hydrocodone to residents of North Carolina. Under North
Carolina law prior to 2007, ``prescribing medication by use of the
internet or a toll-free number,'' was ``regarded as practicing
medicine'' in North Carolina. N.C. Gen. Stat. Ann. 90-18(b).\6\ As
such, it subjected a practitioner to North Carolina law and the
regulation of the North Carolina Medical Board. Id. North Carolina
prohibits the practice of medicine without the appropriate license and
registration and makes out-of-state violators guilty of a ``Class I
felony.'' N.C. Gen. Stat. Ann. 90-18(a). Respondent's prescribing to
North Carolina residents via the internet clearly violated North
Carolina law.
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\6\ This provision was deleted, effective October 1, 2007, by
S.L. 2007-346, section 23.
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Additionally, in February 2001, the North Carolina Medical Board
issued its position statement, ``Contact with Patients Before
Prescribing,'' which stated that ``prescribing drugs to an individual
the prescriber has not personally examined is inappropriate.'' Contact
with Patients before Prescribing, at 1 (available at https://www.ncmedboard.org/position_statements/). The Board further explained
that ``[o]rdinarily, this will require that the physician personally
perform an appropriate history and physical examination, make a
diagnosis, and formulate a therapeutic plan, a part of which might be a
prescription.'' Id. As Respondent failed to perform physical
examinations of these patients, his conduct was not in the usual course
of professional practice. He consequently violated the CSA in writing
these prescriptions as well. See 21 CFR 1306.04(a).
As the foregoing demonstrates, Respondent repeatedly violated state
laws and regulations prohibiting the unlicensed practice of medicine
and establishing standards of medical practice by prescribing
controlled substances to persons he never physically examined and who
resided in States where he was not licensed to practice and prescribe
drugs. In issuing the prescriptions, Respondent also acted outside of
``the usual course of professional practice'' and lacked ``a legitimate
medical purpose'' and thus repeatedly violated the CSA. I therefore
conclude that Respondent has committed acts which render his continued
registration ``inconsistent with the public interest.'' 21 U.S.C.
824(a)(4). Accordingly, Respondent's registration will be revoked.
Order
Pursuant to the authority vested in me by 21 U.S.C. Sec. Sec.
823(f) and 824(a), as well as 28 CFR 0.100(b) and 0.104, I hereby order
that DEA Certificate of Registration, BA6015158, issued to Mohammed F.
Abdel-Hameed, M.D., be, and it hereby is, revoked. I further order that
any pending application to renew or modify the registration be, and it
hereby is, denied. This order is effective December 24, 2009.
Dated: November 17, 2009
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-28189 Filed 11-23-09; 8:45 am]
BILLING CODE 4410-09-P