[Federal Register: January 25, 2008 (Volume 73, Number 17)]
[
Notices]
[Page 4630-4633]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ja08-125]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Nasim F. Khan, M.D.; Denial of Application
On June 8, 2007, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Nasim F. Khan, M.D. (Respondent), of Houston, Texas. The
Show Cause Order proposed the denial of Respondent's pending
application for a DEA Certificate of Registration as a practitioner on
two grounds: (1) That she lacked authority under state law to handle
controlled substances, and (2) that her ``registration would be
inconsistent with the public interest.'' Show Cause Order at 1; see
also 21 U.S.C. 823(f).
The Show Cause Order specifically alleged that ``[o]n June 26,
2006, [Respondent's] Texas Controlled Substance Registration was
terminated,'' and that she was therefore ``not currently authorized by
the State of Texas to prescribe, dispense, or otherwise handle
controlled substances.'' Show Cause Order at 1. The Show Cause Order
further alleged that Respondent had committed acts inconsistent with
the public interest because she had ``allowed [her] DEA registration to
be used to dispense controlled substances for other than legitimate
medical purposes'' and had ``engage[ed] in self-prescribing of
controlled substances, in violation of the Texas Controlled Substances
Act.'' Id.
On June 15, 2007, the Show Cause Order, which also notified
Respondent of her right to request a hearing on the allegations, was
served on Respondent by Federal Express delivered to her residence.
Because: (1) More than thirty days have passed since service of the
Show Cause Order, and (2) neither Respondent, nor anyone purporting to
represent her, has requested a hearing, I conclude that Respondent has
waived her right to a hearing. See 21 CFR 1301.43(d). I therefore enter
this Final Order without a hearing based on relevant material contained
in the
[[Page 4631]]
investigative file, see id. 1301.43(e), and make the following
findings.
Findings
Respondent is a physician with a specialty in psychiatry and
pathology. Respondent previously held a DEA Certificate of Registration
as a practitioner at the registered location of Houston Medical Clinic,
10881 Richmond Ave., Apt. 412, Houston, Texas. In July 2004, DEA
Diversion Investigators with the Houston Field Division received
information that Respondent was prescribing promethazine with codeine
cough syrup, a schedule V controlled substance, see 21 CRR 1308.15(c),
to an individual who had been arrested three times by the Houston
Police Department for unlawfully possessing controlled substances.
In August 2005, DEA Diversion Investigators (DIs) received
information that two unlicensed individuals (F.K. and V.V.), who worked
at the Main Medical Clinic (which was located in Jacinto City, Texas),
were using Respondent's DEA registration to issue controlled-substance
prescriptions for drugs which included Lorcet 10/650 (a branded drug
combining hydrocodone and acetaminophen and a schedule III controlled
substance, see 21 CFR 1308.13(e), Xanax (alprazolam), a schedule IV
controlled substance, see id. 1308.14(c), and promethazine with codeine
cough syrup. Id. 1308.15(c). F.K. and V.V. charged $100 for each
prescription.
The DIs subsequently went to the clinic and interviewed several
people. While the DIs were told that Respondent had terminated her
employment at the clinic, they also obtained a stack of prescription
carbons. The copies indicated the patient's name, the name of a
controlled substance, and Respondent's DEA number. During other
interviews, the DIs determined that Respondent had seen only one or two
``patients'' each day, and that most of the clinic's ``patients'' were
seen by other people including several foreign graduate students who
were not licensed in any field of medical practice. The DIs also
confirmed that V.V. had sold a stack of prescriptions, which bore a
signature similar to Respondent's, for a large amount of cash.
Thereafter, on August 11, 2005, the DIs interviewed Respondent at
the location of a clinic (named the ``45 Clinic'') which she was
opening in Houston and for which she needed to change the address of
her registered location.\1\ During the interview, Respondent stated
that she had seen approximately forty patients a day at the Main
Medical Clinic and that the cost for a controlled-substance
prescription was $80 cash. Respondent further stated that at the
clinic, foreign graduate students worked under her supervision and
wrote the prescriptions which she then signed. Respondent also stated
that she had taken a continuing medical education class in pain
management and that the only controlled substances she prescribed were
Vicodin, Lorcet, and Lortab.\2\
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\1\ According to the investigative file, Respondent did not own
the clinic.
\2\ Respondent also stated that she prescribed Ritalin for her
child psychiatric patients who had Attention Deficit Disorder.
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In the course of the investigation, the DIs had previously
determined that Respondent had obtained controlled substances based on
117 prescriptions issued to her under her DEA number. During the
interview, Respondent denied that she had self-prescribed and claimed
that her son was also a physician and had prescribed the controlled
substances for her. Subsequently, the DIs searched the Texas Medical
Board's website and found that there was no listing for her son.
The DIs had also previously determined that between January 1,
2004, and August 11, 2005, Respondent had obtained approximately 474
twenty-five ml. bottles of schedule V cough medicines. When asked as to
why she had ordered the drugs, Respondent maintained that they were
small containers of cough syrup which she used when she was unable to
sleep.
While at Respondent's new clinic, the DIs interviewed V.V., the
same individual who had been implicated in selling controlled-substance
prescriptions at Respondent's former employer. V.V. told the
investigators that she had first met Respondent on that very day (when
she had purportedly interviewed for a position at the clinic) and that
her duties at Respondent's clinic would include scheduling
appointments, taking vital signs, and other duties performed by
receptionists.
Thereafter, on August 30, 2005, a registration technician changed
Respondent's registered location to the address of her new clinic.
Approximately three weeks later, on September 19, 2005, Respondent
notified a DI that V.V. was using her DEA number to write unauthorized
prescriptions for unknown individuals.
Later that day, two DIs interviewed Respondent at her residence.
Respondent told the DIs that she had terminated her employment at the
Main Medical Clinic because she suspected that its owner was involved
in illegal activities. Respondent stated that she had contacted DEA
because she had received information that the Corpus Christi, Texas
Police Department was looking for her regarding prescriptions she had
written. Respondent further stated that during the previous week, she
had gone to her new clinic and attempted to retrieve her prescriptions
but was told that the pads belonged to the clinic. Respondent added
that she had become concerned that someone was using her DEA number to
issue prescriptions without her consent. Because of the unauthorized
use of her number, Respondent then agreed to voluntarily surrender her
DEA registration. She also surrendered her state controlled-substances
registration.
On September 30, 2005, Respondent applied for a new registration
using the address of the 45 Clinic for her proposed registered
location. Several days later, two DIs went to Respondent's residence
and attempted to interview her. Upon opening the door, Respondent
started screaming at the DIs and stated that they should contact her
attorney. When one of the DIs asked Respondent for her attorney's phone
number, Respondent stated that she would get the number and slammed the
door. Several minutes later, Respondent opened the door, threw a piece
of paper at the DI, and stated in a loud voice that ``the White House
knew who her father was and that she was his daughter.'' After the DIs
told Respondent that they were there to speak to her about her
application, Respondent stated that ``there would be no trick or
treating here today.'' One of the DIs again asked Respondent whether
she had applied for a new registration. Respondent answered ``yes'' and
again slammed the door shut.
Thereafter, a local pharmacist notified DEA investigators that on
October 3 and 4, he had received two prescriptions which were written
under Respondent's DEA number. The pharmacist told the DIs that when he
had attempted to verify one the prescriptions, Respondent did not
return the call. Respondent, in a subsequent interview, denied issuing
the prescriptions.
On January 5, 2006, a detective with the Garland, Texas Police
Department notified one of the DIs that numerous prescriptions written
under Respondent's former DEA registration had been presented at a
local pharmacy. The prescriptions bore the name and address of the Main
Medical Clinic, Respondent's former employer.
[[Page 4632]]
Thereafter, on March 28, 2006, an official of the Texas Department
of Public Safety (DPS) notified a DI that the State intended to
terminate Respondent's state controlled-substances registration. The
state official further told the DI that Respondent's application had
been erroneously granted because at the time the application was
approved, the State was upgrading its computer system and was unable to
access her history.
Subsequently, on June 26, 2006, DPS terminated Respondent's state
controlled-substances registration on the ground that she was
prohibited under the State's rules for re-applying for a period of one
year following her surrendering of her state registration. I further
find that the State has not re-instated her controlled-substances
registration.
I also find that on August 24, 2007, Respondent entered into an
Agreed Order with the Texas Medical Board. Under the order, Respondent
voluntarily and permanently surrendered her medical license. According
to the Texas Medical Board's website, ``[t]he action was based on
[Respondent's] failure to meet the standard of care due [to] her non-
therapeutic prescription of controlled substances to four patients and
to herself.''
Discussion
Section 303(f) of the Controlled Substances Act provides that
``[t]he Attorney General shall register practitioners * * * to dispense
* * * controlled substances in schedule II, III, IV, or V, if the
applicant is authorized to dispense * * * controlled substances under
the laws of the State in which he practices.'' 21 U.S.C. 823(f).
Section 303(f) further provides that ``[t]he Attorney General may deny
an application for such registration if he determines that the issuance
of such registration would be inconsistent with the public interest.''
Id. 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 a registration should be
revoked.'' 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 (DC Cir. 2005).
In this case, I conclude that there are two independent grounds for
denying Respondent's application. First, Respondent is not currently
authorized under Texas law to handle controlled substances and thus
does not meet an essential requirement for a registration under the
CSA. Second, while it appears that Respondent will not be returning to
medical practice anytime soon, her experience in dispensing controlled
substances and her record of compliance with applicable laws make clear
that granting her a registration ``would be inconsistent with the
public interest.'' 21 U.S.C. 823(f).
Under the Controlled Substances Act (CSA), a practitioner must be
currently authorized to handle controlled substances in ``the
jurisdiction in which [she] practices'' in order to maintain a DEA
registration. See 21 U.S.C. 802(21) (``[t]he term `practitioner' means
a physician * * * licensed, registered, or otherwise permitted, by * *
* the jurisdiction in which he practices * * * to distribute, dispense,
[or] administer * * * a controlled substance in the course of
professional practice''). See also id. section 823(f) (``The Attorney
General shall register practitioners * * * if the applicant is
authorized to dispense * * * controlled substances under the laws of
the State in which he practices.''). Relatedly, DEA has repeatedly held
that the CSA requires the revocation of a registration issued to a
practitioner who no longer possesses authority under state law to
handle controlled substances. See Sheran Arden Yeates, 71 FR 39130,
39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby
Watts, 53 FR 11919, 11920 (1988). See also 21 U.S.C. 824(a)(3)
(authorizing the revocation of a registration ``upon a finding that the
registrant * * * has had his State license or registration suspended
[or] revoked * * * and is no longer authorized by State law to engage
in the * * * distribution [or] dispensing of controlled substances'').
Here, the investigative file establishes that Respondent's Texas
controlled-substances registration was terminated on June 26, 2006.
Moreover, there is no evidence that the State has issued a new
controlled substance registration to her, and the Agreed Order which
Respondent entered into with the Texas Medical Board suggests that the
State will not grant her a new controlled-substances registration any
time soon. Because Respondent is without authority to handle controlled
substances in Texas, the State in which she seeks a DEA registration,
she does not meet an essential prerequisite for a new DEA registration.
Accordingly, her application is denied on that basis. See 21 U.S.C.
823(f).
I further note that even if Respondent possessed a state
registration, the record would still support the denial of her
application on the ground that her registration would be ``inconsistent
with the public interest.'' 21 U.S.C. 823(f). As the State found,
Respondent has engaged in the non-therapeutic prescription of
controlled substances both to herself and others.
With respect to her self-prescribing, the record establishes that
Respondent issued to herself 117 prescriptions for narcotic-cough
syrups, which are schedule V controlled substances. The record further
establishes that Respondent's statements to investigators that the
prescriptions were issued to her by her son, and that her son was a
physician, were false.
Moreover, there is also substantial and disturbing evidence that
Respondent failed to exercise proper control over her prescriptions
pads and allowed unlicensed and un-registered individuals at the Main
Medical Clinic to write prescriptions under her DEA registration. This
conduct violates federal law and regulations, which require that a
prescription be ``issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of [her]
professional practice,'' 21 CFR 1306.04(a), and that each person
writing a prescription be ``[a]uthorized to prescribe controlled
substances by the jurisdiction in which he is licensed to practice his
profession and * * * [e]ither registered or exempted from
registration.'' Id. Sec. 1306.03(a). Accordingly, even if Respondent
held a state registration, her abysmal experience in dispensing
controlled substances and her record of non-compliance with federal and
state laws related to controlled substances would nonetheless require
the denial of her application.
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 Nasim F.
Khan, M.D., for
[[Page 4633]]
a DEA Certificate of Registration as a practitioner be, and it hereby
is, denied. This order is effective February 25, 2008.
Dated: January 17, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-1241 Filed 1-24-08; 8:45 am]
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