[Federal Register Volume 65, Number 24 (Friday, February 4, 2000)]
[Notices]
[Pages 5672-5675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2540]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 98-16]


Judy L. Henderson, D.V.M.; Grant of Restricted Registration

    On February 3, 1998, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Judy L. Henderson, D.V.M. (Respondent) of 
Corinth, Mississippi, notifying her of an opportunity to show cause as 
to why DEA should not deny her application for registration as a 
practitioner pursuant to 21 U.S.C. 823(f), for reason that her 
registration would be inconsistent with the public interest.
    By letter dated March 3, 1998, Respondent requested a hearing on 
the issues raised by the Order to Show Cause. Following prehearing 
procedures, a hearing was held in Memphis, Tennessee on November 18, 
1998, and April 20, 1999, before Administrative Law Judge Mary Ellen 
Bittner. At the hearing, the Government called witnesses and introduced 
documentary evidence and Respondent testified on her own behalf. After 
the hearing both parties submitted proposed findings of fact, 
conclusions of law and argument.
    On September 21, 1999, Judge Bittner issued her Opinion and 
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision 
(Opinion), recommending that Respondent's application for registration 
be granted limited to four specific substances and subject to two 
conditions. Neither party filed exceptions to Judge Bittner's Opinion, 
and on October 25, 1999, Judge Bittner transmitted the record of these 
proceedings to the Deputy Administrator.
    The Deputy Administrator has considered the record in its entirety, 
and pursuant to 21 CFR 1316.67, hereby issues his final order based 
upon findings of fact and conclusions of law as hereinafter set forth. 
The Deputy Administrator adopts the findings of fact and conclusions of 
law of the Administrative Law Judge in their entirety, and adopts with 
several modifications, as noted below, the conclusion and recommended 
decision of the Administrative Law Judge. His adoption is in no manner 
diminished by any recitation of facts, issues or conclusions herein, or 
of any failure to mention a matter of fact or law.
    The Deputy Administrator finds that Respondent is a veterinarian. 
At various times during her career she suffered from serious medical 
conditions which prevented her from practicing veterinary medicine.
    In March 1987, a local pharmacist advised the Mississippi Bureau of 
Narcotics (MBN) that Respondent had used prescriptions and DEA order 
forms to obtain a large amount of Demerol, a Schedule II narcotic 
controlled substance, from the pharmacy. A subsequent pharmacy survey 
revealed a total of six prescriptions and eight order forms written by 
Respondent. The prescriptions were for a total of 30 dosage units of 
Ionamin, a Schedule IV controlled substance, 30 dosage units of 
diazepam, a Schedule IV controlled substance, six ampules of Demerol, 
one ounce of liquid Demerol, and 20 dosage units of Mepergan Fortis, a 
Schedule II narcotic controlled substance. The Ionamin and diazepam 
prescriptions listed Respondent as the patient, the prescription for 
six ampules of Demerol listed the clinic where Respondent worked and 
had the notation ``clinic use only,'' the Mepergan Fortis prescription 
was made out to Respondent's then-husband, and the prescription for one 
ounce of Demerol was made out in a dog's name. Each of the order forms 
was for one 30 cc. vial of Demerol.
    On March 26, 1987, MBN agents interviewed Respondent who told the 
agents that she had obtained the various narcotics for her own use 
because she suffered from extremely painful medical conditions. The 
agents subsequently confirmed with Respondent's physician that he was 
treating Respondent for the medical conditions. However, the physician 
indicated that he did not know that Respondent was self-prescribing and 
that he would help her. No charges were filed against Respondent as a 
result of this investigation.
    Respondent testified at the hearing in this matter that she was 
treated with intravenous Demerol for a painful kidney disorder. 
Following surgery for this disorder, Respondent experienced withdrawal 
from the Demerol. Respondent testified that she was ashamed that she 
had become dependent on the Demerol and attempted to wean herself off 
by taking oral Demerol intended for the animals she treated. This 
attempt was unsuccessful and in fact Respondent was taking more Demerol 
than she had before her surgery. According to Respondent she then began 
injecting herself with Demerol. Finally, at or about the end of 
November 1997, Respondent entered a 28-day treatment program and 
stopped using controlled substances.

[[Page 5673]]

    As to the other prescriptions discovered during this investigation, 
Respondent testified that she purchased Ionamin to treat an obese dog, 
and that the Valium was for use in a clinic where she worked. 
Respondent further testified that she did not prescribe Mepergan Fortis 
for her then-husband, but that the prescription was for her then-
mother-in-law's dog, who Respondent was treating for cancer.
    The Government alleged that Respondent surrendered her DEA 
Certificate of Registration in 1987. However, the investigator who 
testified at the hearing indicated that she could not locate a copy of 
the surrender form. Respondent testified that at some point in 1987 the 
attorney for the Mississippi State Board of Veterinary Medicine 
(Veterinary Board) wrote to her recommending that she surrender her DEA 
registration, but that she did not respond to this letter since she was 
very ill and not working at the time. It was Respondent's recollection 
that she simply let her DEA registration expire. She testified that she 
still had the registration certificate in her possession the next time 
that she applied for a DEA registration. Judge Bittner found 
Respondent's testimony to be credible and therefore found that the 
evidence does not support a finding that Respondent's surrendered her 
DEA Certificate of Registration in 1987.
    Respondent was issued DEA Certificate of Registration BE2196687 on 
March 20, 1990.
    In October 1992, DEA was advised by Respondent's then-husband that 
Respondent was abusing controlled substances. A subsequent pharmacy 
survey did not reveal any controlled substance prescriptions issued by 
Respondent. DEA then contacted Respondent's drug distributor and 
discovered that Respondent had ordered 500 dosage units of lorazepam 2 
mg., a Schedule IV controlled substance, and 2200 dosage units of 
hydrocodone with APAP, a Schedule III controlled substance, between 
March 4 and October 19, 1992.
    A DEA investigator contacted two physician who had treated 
Respondent. One physician treated Respondent for painful medical 
conditions from 1989 until June 1992, and prescribed her Lortab 7.5 
mg., a Schedule III controlled substance. The other physician indicated 
that he treated Respondent from February 1987 until March 1991, also 
for painful medical conditions. There is no indication in the record 
whether this physician prescribed Respondent any controlled substances.
    On October 21, 1992, DEA agents met with Respondent at her home. 
Respondent told the agents that she had not been practicing veterinary 
medicine for a period of time because she was ill. She further told the 
agents that rather than filling the prescriptions that her physician 
issued to her, she was ordering the drugs using her DEA registration 
because it was less expensive to obtain the drugs that way. At this 
meeting, Respondent surrendered her DEA Certificate of Registration, 
order forms, and controlled substances in her possession.
    Respondent testified at the hearing that in 1990 she developed an 
extremely painful medical condition that rendered her unable to work. 
She acknowledged that she ordered controlled substances during this 
period, and that at one point she bought Demerol from a hospital 
pharmacy. Respondent further testified that her physician did not know 
that she was ordering hydrocodone, and that although she know that 
ordering the drug for herself was an unethical use of her DEA 
registration, she had not thought that it was criminal conduct. 
Respondent testified that she ultimately recovered from this illness 
following radical surgery.
    On March 1, 1996, Respondent executed an application for a new DEA 
Certificate of Registration. DEA sought a recommendation from the 
Veterinary Board as to whether this application should be granted. On 
June 10, 1996, the Veterinary Board responded, stating in pertinent 
part:

    While the granting or denial of [a DEA registration] is a 
determination to be made by your agency, the Mississippi Board of 
Veterinary Medicine cannot recommend unrestricted approval by your 
agency. While the Board is happy that [Respondent] has returned to 
practice, nevertheless, the Board feels that, at most, 
[Respondent's] purchases of controlled drugs should be limited to 
the purchase of euthanasia solutions and a limited number of 
purchases for anesthetics.

    As a result of this letter, Respondent wrote to the Veterinary 
Board asking for its approval for her to use ketamine, at the time a 
non-controlled substance; Socumb, brand name for a product containing 
sodium pentobarbital, a Schedule II non-narcotic controlled substance; 
Valium, brand name for a product containing diazepam; Sodium Pentothal, 
trade name for thiopental, a Schedule III non-narcotic controlled 
substance; phenobarbital, a Schedule IV controlled substance; 
testosterone, a Schedule III controlled substance; and Winstrol-V, 
Telazol, and Tussigon, all controlled substances. By letter to 
Respondent dated October 28, 1996, the Veterinary Board recommended 
that she use ketamine, Rompun, acepromazine (or other tranquilizers), 
gas anesthesia, lidocaine (for local use), Torbutral, and Sodium 
Pentothal as a pre-anesthetic. Rompun, acepromazine, and lidocaine are 
not controlled substances. Ketamine was previously noncontrolled but 
was placed in Schedule III effective August 12, 1999. Torbutral is a 
controlled substance.
    During the course of investigating Respondent's application for a 
DEA registration, DEA contacted the local sheriff. The local sheriff 
indicated that in 1993, Respondent was caught stealing ketamine from 
another veterinarian.
    In explaining why she stole the ketamine, Respondent testified that 
after her radical surgery, she went through a very bitter divorce and 
custody proceeding, that she ``lost everything,'' and that her ex-
husband made allegations about her to other veterinarians in the area 
that effectively prevented her from obtaining work. She further 
testified that her ex-husband was physically abusive and had threatened 
to kill her if she did not stop attempting to regain custody of their 
child. Respondent testified that upon the recommendation of a local 
police officer, she obtained a gun to protect herself from her ex-
husband. According to Respondent, she ultimately realized that she 
would not be able to shoot her ex-husband if threatened and instead 
decided to obtain ketamine to use as a chemical immobilizer. Respondent 
testified that shortly before stealing the ketamine, her ex-husband had 
attacked her with a hammer, resulting in her being admitted to an 
emergency room.
    Respondent testified that she stole ketamine from the other 
veterinarian twice. The first time, she took a total of two cc. of 
ketamine, but then decided that that would not be a sufficient quantity 
to subdue her ex-husband. Respondent testified that she then took a 
bottle that had held 10 cc. of ketamine and had about one cc. of the 
drug left in it, and she then added small quantities of ketamine that 
she took from other bottles, substituting saline in those bottles. 
Respondent acknowledged that what she did was wrong.
    The other veterinarian decided not to press charges against 
Respondent provided that Respondent seek treatment. As a result, 
Respondent entered a treatment program to be treated for depression and 
tested for ketamine. According to Respondent, she stayed in that 
program for two weeks and then went to a program that treated health 
care professionals where she stayed for three to four months. 
Thereafter she moved to an outpatient facility. Respondent testified 
that she spent a total of five months in treatment for clinical 
depression and hydrocodone

[[Page 5674]]

addiction. According to Respondent, her treatment ended in February 
1994. She testified that she has not taken any narcotic drug, except 
during surgery, since October 1993.
    On November 5, 1996, a DEA investigator asked Respondent to send 
information regarding her rehabilitation and aftercare treatment. 
According to the investigator, Respondent did not send any such 
information. Respondent acknowledged that the DEA investigator had 
asked her to provide records of her treatment, but that she had 
substantial difficulty obtaining these records from the facilities.
    Respondent testified that she eventually started her own veterinary 
practice, and that she was the only veterinarian in her town who was 
always available. According to Respondent, the majority of her practice 
is trauma emergency medicine, unlike other veterinarians.
    In June 1997, Respondent contacted the DEA investigator and advised 
that the only drug she was using at that time was Socumb. The 
investigator asked Respondent how she obtained the Socumb since she was 
not registered with DEA to handle controlled substances at that time. 
Respondent indicated that she received a partial bottle from another 
veterinarian. The DEA investigator contacted the other veterinarian who 
indicated that he provided the sodium pentobarbital to Respondent after 
Respondent showed him a letter from the Veterinary Board stating that 
she could use the drug. Respondent told the other veterinarian that she 
had an animal in distress, so he gave her 10 to 20 cc. to euthanize the 
animal.
    Respondent testified at the hearing that the dog she was treating 
had been poisoned, that the incident occurred late at night on a 
weekend, and that the dog was in intense pain. She contacted the other 
veterinarian who refused to put the dog to sleep himself, but offered 
to prescribe enough of the drug so Respondent could euthanize the dog. 
Respondent testified that because she was working under the other 
veterinarian she did not realize that she had done anything wrong. It 
is undisputed that after speaking to the DEA investigator, Respondent 
returned the remaining sodium pentobarbital to the other veterinarian.
    Respondent asserted that since she is the only veterinarian in the 
area who handles emergencies after hours, she needs a DEA registration 
in order to care for her patients. Respondent testified that she needs 
to use sodium pentobarbital, butorphanol, and Valium in her practice. 
The sodium pentobarbital would be used to euthanize animals, the 
butorphanol to relive pain in the animals, and the Valium to control 
seizures and treat sick cats that refuse to eat. According to 
Respondent, she would be willing to install security measures, maintain 
whatever records are required, and be subject to random drug testing.
    Respondent has acknowledged her mistakes. Respondent testified that 
she has ``suffered greatly because of this. And I expect to the rest of 
my life. This will be a great humiliation to me. But I truly--I truly 
don't believe it will ever happen again. I never have a desire to. I 
never had before these two instances and I never have since.''
    Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny an 
application for a DEA Certificate of Registration, if he determines 
that the registration would be inconsistent with the public interest. 
Section 823(f) requires that 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 
Deputy Administrator may rely on any one or a 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 denied. See Henry J. Schwarz, Jr., M.D., 54 FR 16422 
(1989).
    As to factor one, the Veterinary Board recommended that Respondent 
not be given an unrestricted registration, however the Veterinary Board 
did recommend that Respondent be authorized to handle thiopental and 
ketamine, Schedule III controlled substances, and butorphanol, a 
Schedule IV controlled substance. Although Respondent has indicated 
that she also needs to be able to use sodium pentobarbital for 
euthanasia, the Veterinary Board did not mention this substance in its 
June 10, 1996 letter. The Deputy Administrator agrees with Judge 
Bittner that while the Veterinary Board's recommendations are not 
dispositive, they certainly weigh in favor of at the very least 
granting Respondent a DEA registration restricted to certain 
substances.
    Regarding factor two, the evidence supports a finding that prior to 
1987, Respondent abused her DEA registration by issuing prescriptions 
and using DEA order forms to obtain controlled substances for her own 
use. In 1992, Respondent again used her DEA registration to obtain 
controlled substances for her own use. Respondent also handled sodium 
pentobarbital in 1997, when she was not authorized to do so.
    As to factor three, there is no evidence that Respondent has been 
convicted of any criminal charges relating to the manufacture, 
distribution or dispensing of controlled substances.
    Regarding factor four, Respondent's compliance with applicable laws 
relating to controlled substances, it is undisputed that Respondent 
used DEA order forms in violation of 21 U.S.C. 828(e) to obtain 
controlled substances for her own use. In addition, Respondent issued 
prescriptions to obtain Demerol for her own use in violation of 21 
U.S.C. 829 and 21 CFR 1306.04. The Deputy Administrator notes however 
that these violations occurred when Respondent was suffering from 
painful medical conditions and had become addicted to narcotic 
controlled substances. According to Respondent, these conditions are 
now under control, she has undergone treatment for her addiction, and 
she has not improperly obtained or personally used controlled 
substances, except as a result of surgery, since October 1993. As 
recently as 1997, Respondent handled sodium pentobarbital when she was 
not registered with DEA to do so in violation of 21 U.S.C. 841(a). 
While not condoning this violation, the Deputy Administrator does not 
find under the circumstances that this isolated incident warrants 
denying Respondent's application for registration.
    As to factor five, the Deputy Administrator is troubled by 
Respondent's theft of ketamine in 1993. Although ketamine was not a 
controlled substance at the time, her stated purpose of immobilizing 
her ex-husband with the drug raises serious concerns about her fitness 
to handle controlled substances. However, the Deputy Administrator 
notes that this incident occurred in 1993, that Respondent has since 
undergone extensive treatment for depression and drug addiction, that 
Respondent has acknowledged the wrongfulness of this behavior, and that 
there is no evidence

[[Page 5675]]

of any similar type behavior since that time.
    The Deputy Administrator also finds it relevant under this factor 
that Respondent was previously addicted to narcotic controlled 
substances. Respondent has acknowledged her past problems and appears 
to be remorseful. However, while Respondent asserts that she has 
undergone treatment and that she has not improperly used controlled 
substances since 1993, the Deputy Administrator is troubled by the lack 
of evidence in the record, other than Respondent's own testimony, 
regarding Respondent's treatment for her addiction. The record is also 
devoid of evidence of any continued monitoring of Respondent and any 
support network in place to help prevent a relapse.
    The Deputy Administrator agrees with Judge Bittner that the 
Government has presented a prima facie case for the denial of 
Respondent's application for registration based upon Respondent's use 
of her previous DEA registrations to obtain controlled substances for 
her own use, her abuse of controlled substance, her violation of laws 
relating to controlled substances, her handling of sodium pentobarbital 
in 1997 when not authorized to do so, and her theft of a non-controlled 
substance in 1993 to be used to temporarily immobilize her ex-husband. 
However, Judge Bittner found credible Respondent's testimony that she 
has not used controlled substances since 1993 except as prescribed 
lawfully by a physician. Judge Bittner also found credible Respondent's 
testimony regarding the circumstances surrounding her theft to ketamine 
in 1993 and her 1997 handling of sodium penotobarbital, and that she 
regrets her misconduct, is willing to accept restrictions on her 
registration, and will not abuse her registration or controlled 
substances in the future.
    Therefore, Judge Bittner concluded that it would not be 
inconsistent with the public interest to grant Respondent a DEA 
Certificate of Registration limited to the Schedule II controlled 
sodium pentobarbital, the Schedule III controlled substances ketamine 
and thiopental, and the Schedule IV controlled substance butorphanol 
subject to the following conditions:
    (1) Respondent shall maintain accurate records showing all 
purchases, administering and dispensing (including prescribing) of all 
controlled substances; and
    (2) Respondent shall submit copies of all such records to the 
Special Agent in Charge of DEA's New Orleans Office, or his designees, 
quarterly, for five years from the effective date of her registration.
    The Deputy Administrator agrees with Judge Bittner that it is not 
in the public interest to deny Respondent's application for 
registration and basically agrees with Judge Bittner's recommended 
restrictions. However, the Deputy Administrator is extremely reluctant 
to grant Respondent the authority to handle ketamine, the very 
substance she admitted stealing in 1993 to potentially use to 
incapacitate her ex-husband. Nonetheless, the Deputy Administrator will 
do so given that the Veterinary Board recommended that Respondent be 
authorized to handle ketamine and the recommendation of the appropriate 
state licensing authority is one of the factors to be considered by the 
Deputy Administrator in determining the public interest. The Deputy 
Administrator is also troubled by the lack of evidence in the record, 
other than Respondent's own testimony, regarding her treatment and 
rehabilitation. Consequently, the Deputy Administrator finds it 
necessary to have safeguards in place to be certain that Respondent 
does not abuse controlled substances once she is issued a limited 
registration.
    Therefore, the Deputy Administrator concludes that Respondent 
should be issued a DEA Certificate of Registration in Schedules II non-
narcotic, III and IV subject to the following restrictions for three 
years from the date of issuance of the DEA Certificate of Registration:
    (1) While Respondent shall be registered in Schedules II non-
narcotic, III and IV, she shall only handle sodium pentobarbital, 
ketamine, thiopental, and butorphanol.
    (2) Respondent shall send copies of records documenting all of her 
purchases of controlled substances to the Special Agent in Charge of 
the DEA New Orleans office, or her designee, on a quarterly basis.
    (3) Respondent shall submit, on a quarterly basis, a log of all of 
the controlled substances she has prescribed, administered, or 
dispensed during the previous quarter, to the Special Agent in Charge 
of the DEA New Orleans office, or his designee. The log shall include: 
the patient's name; the date that the controlled substance was 
prescribed, administered or dispensed; and the name, dosage and 
quantity of the controlled substance prescribed, administered or 
dispensed. If no controlled substances are prescribed, administered or 
dispensed during a given quarter, Respondent shall indicate that fact 
in writing, in lieu of submission of the log.
    (4) Respondent shall submit to random urinalysis, at her own 
expense, not less than one time per month. Within 30 days of the 
effective date of this order, Respondent shall notify the Special Agent 
in Charge of the DEA New Orleans office, or his designee, in writing, 
as to the identity of the laboratory or hospital that will be 
conducting the random urinalysis. Reports documenting the results of 
these tests shall be forwarded to the Special Agent in Charge of the 
DEA New Orleans office, or his designee.
    (5) Respondent shall consent to random, unannounced inspections 
without the need for an Administrative Inspection Warrant.
    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 orders that the 
application for registration submitted by Judy L. Henderson, D.V.M., 
be, and it hereby is, granted in Schedules II non-narcotics, III and 
IV, subject to the above described restrictions. This order is 
effective upon the issuance of the DEA Certificate of Registration, but 
no later than March 6, 2000.

    Dated: January 18, 2000.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 00-2540 Filed 2-3-00; 8:45 am]
BILLING CODE 4410-09-M