[Federal Register Volume 67, Number 96 (Friday, May 17, 2002)]
[Notices]
[Pages 35137-35138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12357]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


James C. Womack, M.D.; Denial of Application

    On June 4, 2001, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause (OTSC) by certified mail to James C. Womack, M.D., 
notifying him of an opportunity to show cause as to why the DEA should 
not deny his application for DEA registration, pursuant to 21 U.S.C. 
823(f), for reason that Dr. Womack's registration would be inconsistent 
with the public interest. The OTSC also notified Dr. Womack that should 
no request for a hearing be filed within 30 days, his right to a 
hearing would be considered waived.
    The OTSC was sent to the address listed on Dr. Womack's application 
for registration. DEA received a postal return receipt indicating that 
an individual had signed on behalf of Dr. Womack June 15, 2001. No 
request for a hearing or any other response was received from Dr. 
Womack nor anyone purporting to represent him in this matter. 
Therefore, the Deputy Administrator, finding that (1) 30 days having 
passed since receipt of the OTSC, and (2) no request for a hearing 
having been received, concludes that Dr. Womack has waived his right to 
a hearing. Having considered the complete investigative file in this 
matter, the Deputy Administrator now enters his final order without a 
hearing pursuant to 21 CFR 1301.43(d) and (e) and 1301.46.
    The Deputy Administrator finds as follows. On November 14, 1985, 
Dr. Womack was granted a DEA Certificate of Registration as a 
practitioner in Schedules II through V.
    On July 28, 1989, the Texas State Board of Medical Examiners 
(Board) entered an Agreed Order based on a finding that Dr. Womack was 
an impaired and recovering physician. The Board suspended his medical 
license, stayed the suspension, and placed Dr. Womack on probation for 
ten years, subject to certain terms and conditions. Among the 
conditions imposed by the Board was a requirement that Dr. Womack 
surrender his DEA and Texas State controlled substance registrations. 
Accordingly, Dr. Womack surrendered his DEA Certificate of Registration 
on August 31, 1989, as well as his Texas State registration.
    Sometime in early 1990, the Board received information that Dr. 
Womack continued to issue prescriptions for controlled substances using 
the DEA registration of his father, also a licensed physician in the 
State of Texas. These prescriptions were not authorized by Dr. Womack's 
father. Subsequent investigation by DEA revealed that Dr. Womack had 
issued 701 prescriptions totaling 23,736 dosage units of controlled 
substances between the time of his surrender of his DEA and Texas State 
controlled substances registrations and September 5, 1990.
    On May 12, 1991, Dr. Womack submitted an application to DEA for 
registration as a practitioner that was denied. 58 FR 7,248 (1993). On 
May 9, 1994, Dr. Womack was issued a DEA Certificate of Registration as 
a practitioner in Schedules II through V.
    From February 1997 through January 1999, Dr. Womack was a 
supervising physician to a physician's assistant at a family practice 
clinic in Center, Texas, which was approximately 419 miles away from 
his primary practice in Brandera, Texas. During the time between April 
16, 1998, and May 14, 1998, Dr. Womack sought treatment for substance 
abuse at La Hacienda Treatment Center in Hunt, Texas. During the time 
of Dr. Womack's treatment, DEA received information that prescriptions 
for controlled substances were issued and filled under Dr. Womack's DEA 
registration number. Subsequent information received by DEA indicated 
that Dr. Womack's physician assistant called in the prescriptions using 
Dr. Womack's DEA registration number without Dr. Womack's 
authorization.
    On January 6, 1999, Dr. Womack was admitted to the emergency room 
at a hospital in San Antonio, Texas, and treated for chemical substance 
toxicity related to his abuse of alcohol and Soma, a non-controlled but 
addictive substance. On January 18, 1999, Dr. Womack again entered a 
program for the treatment of substance abuse, in the State of Oregon. 
As a result, Dr. Womack entered into an Agreed Order with the Board, in 
which Dr. Womack's medical license was suspended. The Board found, 
inter alia, that Dr. Womack failed to supervise the prescriptive 
authority of his physician assistant and failed to monitor the clinical 
responses to narcotic analgesia prescribed to a patient in September, 
1998. On August 28, 1999, the Board denied Dr. Womack's request to stay 
or lift the suspension based upon Dr. Womack's ``history of substance 
abuse, relapse, and depression.''
    On February 9, 1999, DEA investigators visited the family practice 
clinic in Center, Texas, and interviewed Dr. Womacks' physician 
assistant. DEA investigators found three triplicate prescription books, 
and one triplicate prescription book that contained ten blank pre-
signed prescription forms, all in Dr. Womack's name. As a result of the 
above-described activity, Dr. Womack surrendered his DEA registration 
on March 16, 1999.
    On March 31, 2000, the Board issued on Agreed Order staying the 
January 29, 1999, suspension of Dr. Womack's medical license, and 
placed Dr. Womack's medical license on probation for seven years 
subject to certain terms and conditions.
    Pursuant to 21 U.S.C. 823(f), the Administrator may deny an 
application for a DEA Certificate of Registration if he determined that 
granting the registration would be inconsistent with the public 
interest. Section 823(f) requires the following factors be considered 
in determining the public interest:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to 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.
    These factors are to be considered in the disjunctive; the 
Administrator may rely on any one or combination of factors and may 
give each factor the weight he deems appropriate in determining whether 
a registration should be revoked or an application for registration be 
denied, see Henry J. Schwartz, Jr., M.D., 54 FR 16,422 (1989).
    The Deputy Administrator finds with regard to factor one that, 
pursuant to the Agreed Order of the Texas State Board of Medical 
Examiners (Board) effective April 1, 2000, Dr. Womack's medical license 
was placed on seven year's probation, with extensive terms and 
conditions. Among the conditions is a requirement that Dr. Womack 
abstain from the consumption of alcohol, dangerous drugs, or controlled

[[Page 35138]]

substances unless prescribed by another physician for a legitimate and 
documented therapeutic purpose. Other relevant conditions are that Dr. 
Womack submit to random drug and alcohol screenings, that he attend 
Alcoholics Anonymous meetings at least four times a week, that he 
attend weekly meetings of a county or state medical society committee 
on physician health and rehabilitation, and that he continue to receive 
care and treatment from a psychiatrist at least once a month. The 
Deputy Administrator finds these and the other conditions of the Agreed 
Order to be evidence that the Board finds Dr. Womack could pose a 
substantial threat to the public health and safety, and further that 
Dr. Womack poses a significant threat of relapse.
    The Deputy Administrator finds with regard to factors two and four 
that the investigative file reveals Dr. Womack has a history of non-
compliance with applicable State and Federal laws relating to handling 
controlled substances. First, following the surrender of his DEA and 
Texas State controlled substances registrations, the Board found that 
Dr. Womack continued to issue prescriptions for controlled substances 
using the DEA registration of his father, also a licensed physician in 
the State of Texas, even though these prescription were not authorized 
by Dr. Womack's father. Subsequent investigation by DEA revealed that 
Dr. Womack had issued 701 prescriptions totaling 23,736 dosage units of 
controlled substances between the time of his surrender of his DEA and 
Texas State controlled substances registrations and September 5, 1990, 
in violation of 21 U.S.C. 843(a)(2) and 21 CFR 1306.03.
    Next, while Dr. Womack was acting as a supervising physician to a 
physician's assistant at a family practice clinic in Center, Texas, 
approximately 419 miles away from his primary practice in Banderra, 
Texas, Dr. Womack sought treatment for substance abuse at La Hacienda 
Treatment Center in Hunt, Texas. During the time of his treatment, DEA 
received information that prescriptions for controlled substances were 
issued and filled under Dr. Womack's DEA registration number. 
Subsequent information received by DEA indicated that Dr. Womack's 
physician assistant called in the prescriptions using Dr. Womack's DEA 
registration number without Dr. Womack's authorization. These 
prescriptions were issued in violation of 21 CFR 1306.03 and 1306.04 as 
a result of Dr. Womack's failure to adequately monitor and exercise 
control over his assistant. When DEA investigators visited the family 
practice clinic in Center, Texas, to interview the physician's 
assistant, the investigators found three triplicate prescription books, 
and one triplicate prescription book that contained ten blank pre-
signed prescription forms, all in Dr. Womack's name. As a result, Dr. 
Womack surrendered his DEA registration on March 16, 1999.
    With regard to factor three, the investigative file contains no 
evidence that Dr. Womack has any record of convictions under Federal or 
State laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    With regard to factor five, the Deputy Administrator finds that the 
investigative file reveals substantial evidence that Dr. Womack has, as 
the Board found in its Agreed Order, a ``history of substance abuse, 
relapse, and depression.'' The Deputy Administrator finds that 
insufficient time has passed since the effective date of the Agreed 
Order to determine whether Dr. Womack has been able to sufficiently 
overcome his problems so as not to pose a serious threat to the public 
health and safety. The Deputy Administrator notes that no 
countervailing evidence was presented, despite the opportunity to do 
so.
    Therefore, for the above-stated reasons, the Deputy Administrator 
concludes that it would be inconsistent with the public interest to 
grant Dr. Womack's application at this time.
    Accordingly, the Deputy Administrator of the Drug Enforcement 
Administration, pursuant to the authority vested in him by 21 U.S.C. 
823 and 824 and 28 CFR 0.100(b) and 0.104, hereby order that the 
application for a DEA Certificate of Registration submitted by James C. 
Womack, M.D., be, and it hereby is, denied. This order is effective 
June 17, 2002.

    Dated: May 6, 2002.
John B. Brown III,
Deputy Administrator.
[FR Doc. 02-12357 Filed 5-16-02; 8:45 am]
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