[Federal Register Volume 76, Number 154 (Wednesday, August 10, 2011)]
[Notices]
[Pages 49506-49508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20284]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Jose Gonzalo Zavaleta, M.D.; Denial of Application

    On February 23, 2009, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause (Order) to Jose Gonzalo Zavaleta, M.D. (Applicant), of 
Pineville, Louisiana. The Order proposed the denial of Applicant's 
pending application for a DEA Certificate of Registration as a 
practitioner, on the ground that his registration would be 
``inconsistent with the public interest.'' Order at 1 (citing 21 U.S.C. 
823(f)).
    The Order alleged that Applicant voluntarily surrendered his DEA 
Certificate of Registration, BZ5998250, on March 26, 2008, after being 
charged with six counts of prescribing controlled substances beyond 
authority and accepted medical treatment, in violation of La. Rev. 
Stat. Ann. Sec.  40:971 (C)(1)(2008) (effective Aug. 15, 2006). Id. The 
Order further alleged that Applicant prescribed controlled substances 
to undercover agents with ``cursory or no medical examinations, and 
without a legitimate medical purpose in violation of 21 U.S.C. 
841(a)(1).'' Id. More specifically, the Order alleged that Applicant 
prescribed a total of 75 dosage units of hydrocodone (including Lortab 
and/or Lorcet), which are schedule III narcotics; 20 dosage units of 
Xanax, a schedule IV controlled substance; and six ounces of Phenergan 
with codeine, a schedule V narcotic cough syrup. Id. Finally, the Order 
that alleged ``[Applicant] facilitated the undercover officers' 
procurement of drugs by fraudulent means'' when he advised them to 
``provide false medical information'' to justify ``illegitimate 
prescriptions.'' Id. at 2.
    On March 2, 2009, the Order, which also notified Applicant of his 
right to either request a hearing on the allegations or to submit a 
written statement in lieu of a hearing, the procedures for doing so, 
and the consequence if he failed to do so, was served on Applicant by 
certified mail addressed to him at the address listed on his 
application. Id. at 2 (citing 21 CFR 1316.47; 21 CFR 1301.43). Since 
service of the Order, more than thirty days have now passed and neither 
Applicant, nor anyone purporting to represent him, has either requested 
a hearing or submitted a written statement in lieu of a hearing. See 21 
CFR 1301.43(b)-(d). Accordingly, I find that Applicant has waived his 
rights to a hearing or to submit a written statement. Id. 1301.43(d). I 
therefore issue this Decision and Final Order without a hearing based 
on relevant material contained in the investigative record submitted by 
the Government. I make the following findings.

Findings

    Applicant was previously the holder of DEA Certificate of 
Registration, BZ5998250, which authorized him to dispense controlled 
substances in schedules II through V as a practitioner at the 
registered location of 5629 Jackson Street Ext, Alexandria, Louisiana. 
Affidavit of Diversion Investigator (hereinafter, DI Aff.), at 1; 
Applicant Registration Information, at 1. However, on March 26, 2008, 
concurrent with Applicant's arrest on state drug charges (the 
circumstances of which are set forth below), he voluntarily surrendered 
his registration. DI Aff., at 1. Applicant's registration was then 
retired by DEA on March 27, 2008. Applicant Registration Information, 
at 1. On July 28, 2008, Applicant applied for a new DEA registration as 
a practitioner in schedules IV and V. Id.
    Applicant first came to the attention of law enforcement on January 
17, 2008, when Louisiana State Police received a call from a pharmacist 
that he had authorized prescriptions for ``excessive amounts of name 
brand narcotics with no generic substitutions allowed.'' DI Aff., at 2. 
Upon receipt of this information, an undercover state trooper (UC1) 
visited Applicant's clinic with audio/video recording equipment on 
January 23, 2008. Id. When Applicant asked UC1 ``why he was there,'' 
UC1 responded by requesting ``[h]ydrocodone pain pills.'' Id. UC1 
``initially denied that he was in pain but, after negotiating with 
[Applicant], he agreed to falsely state that he was suffering from a 
sexually transmitted disease,'' and Applicant recorded this false 
information in UC1's medical file. Id. Then, Applicant, without any 
physical examination to verify the claim of illness or symptoms, wrote 
prescriptions for 15 Lortab \1\ pills and an antibiotic. Id. The 
undercover agent paid $100 for the visit. Id.
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    \1\ Lortab, which is a combination drug containing hydrocodone 
and acetaminophen, is a schedule III controlled substance. 21 CFR 
1308.13(e)(iv).
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    Five days later, on January 28, 2008, UC1 returned to Applicant's 
clinic seeking additional ``pain pills.'' Id. However, Applicant denied 
his request for more pain pills ``because `big brother' was watching 
him.'' Id.
    Thereafter, on January 30, February 8, and February 28, 2008, a 
second state trooper (UC2) visited Applicant's clinic in an undercover 
capacity, while equipped with an audio/video recording device. Id. At 
UC2's first visit, Applicant issued her a prescription for 
hydrocodone,\2\ notwithstanding UC2's ``initially den[ying] she was in 
pain'' and ``later stat[ing] she was in pain in order to obtain a 
prescription for hydrocodone.'' Id. At her second visit on February 8, 
Applicant provided prescriptions for hydrocodone and Phenergan with 
codeine,\3\ the latter being a cough syrup, ``even though she had no 
cough or congestion and exhibited no such symptoms.'' Id. On UC2's 
third visit, she requested and obtained from Applicant, prescriptions 
for hydrocodone and Xanax.\4\ Id. To justify issuing the prescriptions, 
Applicant ``coached'' UC2 about what to say and recorded the coached 
statements in her medical file. Id. At the undercover visits, Applicant 
never ``require[d] any medical records nor did he conduct any physical 
examinations.'' Id.
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    \2\ Hydrocodone is typically combined with acetaminophen. In 
this formulation, it is a schedule III controlled substance. 21 CFR 
1308.13(e)(iv).
    \3\ Phenergan with codeine cough syrup consists of a combination 
of promethazine and codeine; it is a schedule V controlled 
substance. 21 CFR 1308.15(c).
    \4\ Xanax (alprazolam) is a schedule IV controlled substance; 21 
CFR 1308.14(c)(1).
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    On March 20, 2008, after a state court judge issued a warrant for 
Applicant's arrest, Louisiana State Police alerted DEA to the 
investigation and pending arrest. Id. Thereafter, on March 26, 2008, 
Applicant was arrested and charged with ``six counts of prescribing 
beyond authority and accepted medical treatment, a violation of 
Louisiana Revised Statute 40:971C(1).'' Id. at 3. Based on Applicant's 
arrest, a DEA Diversion Investigator asked for the voluntary surrender 
of his DEA

[[Page 49507]]

registration; Applicant agreed and signed a DEA-104, Voluntary 
Surrender of Controlled Substance Privileges. Id.
    Four months later, on July 28, 2008, Applicant submitted a DEA 
application for a new registration as a practitioner in schedules IV 
and V. Zavaleta Application Information at 1. On his application, 
Applicant stated that ``the medical board says there is no merit for 
any disciplinary action,'' he ``can continue working,'' and his 
``license is clear.'' Id. Applicant further stated that the State 
Police had yet to charge him and that the charges may be dropped. Id.

Discussion

    Section 303(f) of the Controlled Substances Act (CSA) provides that 
an application for a practitioner's registration may be denied upon a 
determination ``that the issuance of such registration would be 
inconsistent with the public interest.'' 21 U.S.C. 823(f). In making 
the public interest determination in the case of a practitioner, 
Congress directed that the following factors be considered:

    (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, 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 * * * to deny an application. 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) (citing 
Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 2005)).
    In this matter, while I have considered all of the factors, I 
conclude that it is not necessary to make findings with respect to 
factors one (the recommendation of the state licensing board), three 
(applicant's conviction record) and five (such other conduct which may 
threaten public health and safety). I find that the Government's 
evidence with respect to Applicant's experience in dispensing 
controlled substances (factor two) and his compliance with applicable 
Federal and State laws related to the distribution and dispensing of 
controlled substances (factor four) makes out a prima facie case that 
Applicant has committed acts which render his registration 
``inconsistent with the public interest.'' 21 U.S.C. 823(f), 824(a)(4). 
I will therefore order that his pending application for registration be 
denied.

Factors Two and Four--Applicant's Experience in Dispensing Controlled 
Substances and Compliance with Applicable Laws Related to Controlled 
Substances

    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 related to controlled 
substances.'' Id.; see also La. Rev. Stat. Ann. Sec.  40:961(33) (2008) 
(effective Aug. 15, 2004); \5\ La. Rev. Stat. Ann. Sec.  40:1238.2(A) 
(2008) (effective Aug. 15, 2006).\6\
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    \5\ Louisiana law defines the term ``prescription'' to mean ``a 
written request for a drug * * * issued by a licensed physician * * 
* for a legitimate medical purpose, for the purpose of correcting a 
physical, mental, or bodily ailment, and acting in good faith in the 
usual course of his professional practice.'' La. Rev. Stat. Ann. 
Sec.  40.961(33).
    \6\ This statute provides that:
     A prescription, in order to be effective in legalizing the 
possession of legend drugs, shall be issued for a legitimate medical 
purpose by one authorized to prescribe the use of such legend drugs. 
An order purporting to be a prescription issued to a drug abuser or 
habitual user of legend drugs, not in the course of professional 
treatment, is not a prescription within the meaning and intent of 
this Section. Any person who knows or should know that he or she is 
filling such a prescription or order to a drug abuser or habitual 
user of legend drugs, as well as the person issuing the 
prescription, may be charged with a violation of this Section.
    La. Rev. Stat. Ann. Sec.  40:1238.2(A).
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    As the Supreme Court recently explained, ``the [CSA's] prescription 
requirement * * * ensures patients use controlled substances under the 
supervision of a doctor so as to prevent addiction and recreational 
abuse. As a corollary, [it] also bars doctors from peddling to patients 
who crave the drugs for those prohibited uses.'' Gonzales v. Oregon, 
546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 
135, 143 (1975)); see also La. Rev. Stat. Ann. Sec.  40:1238.2(A) 
(2008) (effective Aug. 15, 2006).
    Under the CSA, it is fundamental that a practitioner must establish 
and maintain a bonafide doctor-patient relationship in order to act 
``in the usual course of * * * professional practice'' and to issue a 
prescription for a ``legitimate medical purpose.'' Laurence T. 
McKinney, 73 FR 43260, 43265 n.22 (2008); see also Moore, 423 U.S. at 
142-43 (noting that evidence established that physician ``exceeded the 
bounds of `professional practice,' '' when ``he gave inadequate 
physical examinations or none at all,'' ``ignored the results of the 
tests he did make,'' and ``took no precautions against * * * misuse and 
diversion''). The CSA generally looks to state law to determine whether 
a doctor and patient have established a bonafide doctor-patient 
relationship. See Kamir Garces-Mejias, 72 FR 54931, 54935 (2007); 
United Prescription Services, Inc., 72 FR 50397, 50407 (2007); but see 
21 U.S.C. 829(e)(2)(B) (providing Federal standard for prescribing over 
the Internet).
    Under the regulation of the Louisiana Board of Medical Examiners, 
in the treatment of ``intractable pain * * * a physician shall comply'' 
with the Louisiana Pain Rules, including the requirements that a 
physician perform an ``[e]valuation of the [p]atient'' and make a 
``[m]edical [d]iagnosis.'' La. Admin. Code tit. 46:XLV.6921(A) (2008). 
``Evaluation of the patient shall initially include relevant medical, 
pain, alcohol and substance abuse histories, an assessment of the 
impact of pain on the patient's physical and psychological functions, a 
review of previous diagnostics studies, previously utilized therapies, 
an assessment of coexisting illnesses, diseases, or conditions, and an 
appropriate physical examination.'' Id. (emphasis added); see also 
Armstrong v. La. State Bd. of Med. Examiners, 868 So. 2d 830, 840 
(La.App. 4 Cir. Feb. 18, 2004) (upholding two year suspension of 
physician's license; noting that when prescribing controlled substances 
for relief of non-malignant pain is '' unaccompanied by appropriate 
testing, diagnosis, oversight and monitoring * * * the physician falls 
below generally accepted standards of care''); Pastorek v. La. State 
Bd. of Med. Examiners, 4 So. 3d 833 (La.App. 4 Cir. Dec. 17, 2008). The 
Board's rules further require a ``medical diagnosis * * * be 
established and fully documented in the patient's medical record.'' La. 
Admin. Code tit. 46:XLV.6921(A)(2) (2008).
    Louisiana law further prohibits a physician from ``[a]ssist[ing] a 
patient or any other person in obtaining a controlled dangerous 
substance through

[[Page 49508]]

misrepresentation, fraud, forgery, deception, or subterfuge.'' La. Rev. 
Stat. Ann. Sec.  40:971.2 (2008) (effective Aug. 15, 2005). It is also 
unlawful for a physician to ``prescribe * * * legally controlled 
substances beyond his respective prescribing authority or for a purpose 
other than accepted medical treatment of disease, condition, or 
illness. Id., at Sec.  40:971(C)(1) (2008) (effective Sept. 9, 1988).
    As found above, on four occasions, Applicant prescribed drugs 
containing hydrocodone (including Lortab and/or Lorcet), which are 
schedule III narcotics; Xanax, a schedule IV controlled substance; and 
Phenergan with codeine, a schedule V narcotic cough syrup, to Louisiana 
State Troopers acting in undercover capacities. See DI Aff., at 2. 
Notably, Applicant issued these prescriptions without conducting a 
physical examination at any of the visits and the undercover agents 
received these prescriptions even though they did not demonstrate the 
conditions or symptoms that would justify the prescriptions. Id.
    Moreover, both undercover agents initially denied they were in 
pain, but Applicant assisted the agents in obtaining controlled 
substances by encouraging them to make false statements. See id. For 
example, while he denied being in pain, UC1 asked Applicant for 
``[h]ydrocodone pain pills,'' and then ``negotiate[ed]'' with Applicant 
to ``falsely state'' he had a sexually transmitted disease. Id. 
Likewise, Applicant also ``coached'' the second undercover agent on 
what to say to ``justify issuing the prescriptions and wrote her 
coached statements in a medical file.'' Id. Therefore, I conclude that 
Applicant failed to establish a physician-patient relationship, lacked 
a legitimate medical purpose, and acted outside of the usual course of 
professional practice in prescribing controlled substances to the 
undercover agents and thus violated Federal law. See 21 CFR 1306.04(a); 
21 U.S.C. 841(a)(1); see also Louisiana v. Moody, 393 So. 2d 1212, 1215 
(La. 1981) (holding that physician furnished prescriptions for ``other 
than a legitimate medical purpose'' based on evidence showing that 
prescriptions were issued in response to specific requests of patients 
and physician did not conduct physical examinations or take medical 
histories).
    I therefore hold that granting Applicant's application for a new 
registration ``would be inconsistent with the public interest.'' 21 
U.S.C. 823(f). Accordingly, I will order that Applicant's pending 
application be denied.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 
CFR 0.100(b), I order that the application of Jose Gonzalo Zavaleta, 
M.D., for a DEA Certificate of Registration as a practitioner be, and 
it hereby is, denied. This order is effective September 9, 2011.

    Dated: July 27, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-20284 Filed 8-9-11; 8:45 am]
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