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 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. 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.

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.

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. § 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 a DEA Certificate of Registration as a practitioner be, and it hereby is, denied. This order is effective February 25, 2008.