[Federal Register Volume 62, Number 52 (Tuesday, March 18, 1997)]
[Notices]
[Pages 12842-12847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6795]
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DEPARTMENT OF JUSTICE
[Docket No. 95-36]
Donald P. Tecca, M.D. Continuation of Registration With
Restrictions
On April 3, 1995, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Donald P. Tecca, M.D. (Respondent) of San Diego,
California, notifying him of an opportunity to show cause as to why DEA
should not revoke his DEA Certificate of Registration, AT1241847, and
deny any pending applications for renewal of such registration as a
practitioner under 21 U.S.C. 823(f), for reason that pursuant to 21
U.S.C. 824(a)(4), his continued registration would be inconsistent with
the public interest. The Order to Show Cause alleged, in essence, that:
(1) in June 1992, DEA received complaints from several area pharmacies
that Respondent was overprescribing controlled substances including
Vicodin and codeine, and in particular, one individual has received
1,640 dosage units of Tylenol No. 3 with codeine over a three month
period; and (2) on eight occasions between December 28, 1992 and May
25, 1993, Respondent prescribed controlled substances to undercover
officers for no legitimate medical reason.
By letter dated April 26, 1995, Respondent, through counsel, filed
a timely request for a hearing, and following prehearing procedures, a
hearing was held in San Diego, California on September 19 and 20, 1995,
before Administrative Law Judge Mary Ellen Bittner. At the hearing,
both parties called witnesses and introduced documentary evidence.
After the hearing, counsel for both parties submitted proposed findings
of fact, conclusions of law and argument. On June 21, 1996, Judge
Bittner issued her Opinion and Recommended Ruling, Findings of Fact,
Conclusion of Law and Decision, recommending that Respondent's DEA
registration be revoked, and any pending applications for registration
be denied. Respondent filed exceptions to Judge Bittner's Opinion and
Recommended Ruling, and thereafter, on August 6, 1996, the record of
these proceedings was transmitted to the Deputy Administrator.
The Acting Deputy Administrator has considered the record in its
entirety, and pursuant to 21 C.F.R. 1316.67, hereby issues his final
order based upon findings of fact and conclusions of law as hereinafter
set forth. The Acting Deputy Administrator adopts, except as noted, the
findings of fact and conclusions of law of the Administrative Law
Judge, but rejects the recommended ruling, for the reasons stated
below.
The Acting Deputy Administrator finds that Respondent graduated
from medical school in 1980, and in 1983, become board certified in
internal medicine. At the time of the hearing in this matter, he was on
the senior staff at three hospitals in San Diego, had consulting
privileges at a psychiatric hospital in San Diego, was the chief of the
Department of Medicine at one of the local hospitals, and maintained a
private practice in internal medicine.
In 1992, two local pharmacists made allegations to DEA that
Respondent may have been overprescribing controlled substances. While
the Order to Show Cause issued in this proceeding cited this alleged
overprescribing as evidence
[[Page 12843]]
that Respondent's continued registration would be inconsistent with the
public interest, no evidence was introduced at the hearing regarding
the validity of these allegations. Therefore, the Acting Deputy
Administrator has only considered the pharmacists' allegations as the
basis for the initiation of the investigation. Subsequently, state
undercover officers made 10 visits to Respondent's office between
December 1992 and July 1993 to attempt to obtain controlled substance
prescriptions from Respondent for no legitimate medical purpose.
The first visit occurred on December 28, 1992, when Special Agent
Roberts of the Bureau of Narcotic Enforcement (BNE) of the California
Department of Justice attempted to obtain a prescription for anabolic
steroids from Respondent. Before seeing Respondent, Agent Roberts
filled out a patient history form on which he did not indicate any
medical problems, and a nurse weighed him and took his blood pressure
and pulse. The transcript of this visit indicates that Respondent asked
Agent Roberts a series of medical history questions. Agent Roberts then
told Respondent that he was not seeing results at the gym, that he was
going to jail for a year and that he wanted to ``gain some size''.
Respondent indicated that it would probably not hurt Agent Roberts to
take anabolic steroids to put on muscle mass since he appeared healthy.
Then, in the agent's presence, Respondent telephoned a local pharmacist
seeking advice as to what to prescribe for this purpose. Respondent
testified that the pharmacist told him that Anadrol was used for that
purpose, but did not indicate that such use of the substance was
illegal or that it was a controlled substance. Following the
conversation with the pharmacist, Respondent told the agent, ``Anadrol
is what they use but it's not supposed to be prescribed for this
purpose.'' Respondent then consulted the 1991 edition of the
Physicians' Desk Reference, which did not indicate that Anadrol was a
controlled substance, to determine the proper dosage to prescribe.
Respondent told Agent Roberts that, ``I don't think there's anything
illegal about this, it's just frowned on because it's felt that the
risk outweighs the gain.'' Respondent warned Agent Roberts of the
possible side effects, advised him to discontinue taking the medication
if any of the side effects occurred, and told him to return in three
weeks for a blood test. Respondent then issued Agent Roberts a
prescription for 120 dosage units of Anadrol with no refills,
impressing upon him the need for follow-up care. Agent Roberts paid
$40.00 for the office visit.
At the follow-up visit on January 19, 1993, Agent Roberts had
gained a pound, his blood pressure had gone down, and he reported some
strength gains. The transcript of this visit indicates that Respondent
asked about various side effects, and Agent Roberts indicated that he
had not experienced any side effects. Respondent examined Agent Roberts
for possible liver enlargement and Respondent's nurse drew blood. Agent
Roberts asked Respondent for a prescription for Cylert, a Schedule IV
stimulant, because he felt that he was ``kind of dragging''. Agent
Roberts testified at the hearing that he asked for Cylert because it is
commonly taken by steroid users and because it was his understanding
that physicians who unlawfully prescribe controlled substances will
issue prescriptions for all types of controlled substances. Respondent
refused to give Agent Roberts a prescription for Cylert and suggested
aerobic activity instead. Respondent wrote Agent Roberts a prescription
for 100 dosage units of Anadrol with three refills, told him to return
in two months for a follow-up visit, and told him to call the office
for the results of the blood test. Agent Roberts paid $45.00 for the
office visit.
Sergeant Arvizu, then with the Medi-Cal Fraud Unit of the
Department of Health Services, went to Respondent's office on two
occasions, posing as Agent Roberts' girlfriend. Sergeant Arvizu had
never acted in an undercover capacity before and was instructed to ask
for Tylenol No. 3 with codeine (Tylenol No. 3), a Schedule III
controlled substance, without telling Respondent that anything was
wrong with her. There were no transcripts of these visits introduced
into evidence at the hearing.
On February 8, 1993, she entered Respondent's office, told the
receptionist that she was there for a check-up, filled out medical
history forms indicating as her chief complaint ``check-up'', and had
her weight, temperature and blood pressure taken. Sergeant Arvizu
testified that when Respondent asked her why she was there, she told
him that she was there for a check-up and that she wanted some Tylenol
No. 3. She testified that Respondent said ``sure'' and then asked some
medical history questions and checked her chest and back with a
stethoscope, checked her eyes, ears, throat, and neck, and reported
that she was in good health. Respondent testified that Sergeant Arvizu
stated that she wanted the Tylenol No. 3 to feel good and that implicit
in that request was that something was wrong with her. He testified
that he performed an extensive physical examination of Sergeant Arvizu
and found her to be very tense with quite a bit of muscle tenderness
and rigidity. At first, Respondent testified that Sergeant Arvizu
winced during the physical examination and told him that she had muscle
pain, but later testified that the finding of pain was based solely
upon his physical examination and her social history. Respondent's
medical chart for Sergeant Arvizu indicated ``Normal exam with muscle
tenderness-tension * * * Tylenol #3 for tension-muscle pain.'' Sergeant
Arvizu however testified that she never told Respondent that anything
was wrong with her and that there was no discussion during this visit
of any muscle pain or tenderness. Judge Bittner found Sergeant Arvizu
to be a credible witness and that she did not tell Respondent that she
was in pain. Respondent issued Sergeant Arvizu a prescription for 40
tablets of Tylenol No. 3, ``per pain'', with no refills.
Sergeant Arvizu returned to Respondent's office on February 22,
1993, and had her weight and blood pressure taken. She testified that
she told Respondent that she wanted another prescription for Tylenol
No. 3 because it made her feel good. Sergeant Arvizu further testified
that Respondent stated that ``this isn't really legitimate * * * it's
not really legal * * * you're putting me in a bind.'' Sergeant Arvizu
testified that there was then some discussion where Respondent said
that something had to be wrong with her and ``he made a suggestion
about a headache or a backache.'' Sergeant Arvizu also testified that
she told Respondent that she had used drugs in the past, but that
Respondent stated that he did not think that she was addicted to the
Tylenol No. 3, however she should only use it for emergencies.
Respondent testified that he conducted a brief physical examination on
this occasion. His notes of the visit indicate ``some muscle
tenderness'' in the neck and ``Tylenol #3 for tension Headaches--
may be useful to keep her off drugs and monitor usage.'' Respondent
further testified that there was no indication of any misuse of the
previous prescription for Tylenol No. 3. Respondent issued Sergeant
Arvizu a prescription for 48 tablets of Tylenol No. 3 with no refills,
``per pain'' and she paid the receptionist $20.00 for the visit.
Next, BNE Agent Ellis went to Respondent's office on two occasions
posing as a friend of Agent Roberts and seeking Winstrol, an anabolic
steroid. On his first visit on March 22, 1993, Agent Ellis filled out a
patient history
[[Page 12844]]
form indicating no medical problems, and then a nurse took his weight
and blood pressure, which was a little high. Agent Ellis then met with
Respondent and told Respondent that he was referred by his friend who
had gotten steroids from Respondent and that he wanted some Winstrol to
help him gain strength at the gym. Respondent indicated that he knew
who Agent Ellis was referring to, since he had only prescribed steroids
once before. Respondent then asked some medial history questions, took
Agent Ellis' blood pressure again, and stated that Winstrol is ``not
totally benign'' describing the various possible side effects.
Respondent told Agent Ellis that he needed to have a blood test for a
baseline, but Agent Ellis was reluctant to have blood drawn. Respondent
insisted that he could not give Agent Ellis the Winstrol without a
blood test, since the whole point of going to a doctor is so the doctor
can monitor the patient. Respondent issued Agent Ellis a prescription
for 60 dosage units of Winstrol and told him to come back for a follow-
up visit in a month. The transcript of this visit indicates that Agent
Ellis said, ``You know if I had a good supply of these we could make
lots of money,'' and Respondent replied, ``Well, I'm not interested in
that. Basically, you know, I'm not interested in making money; I'm just
interested that if I do a treatment, it's used properly.'' Agent Ellis
paid $65.00 for the visit.
Agent Ellis returned for his follow-up visit on April 26, 1993,
during which a nurse took his weight and blood pressure. Respondent
discussed the results of the blood test with Agent Ellis, asked if he
had experienced any side effects, to which Agent Ellis reported none,
checked Agent Ellis' liver, and gave Agent Ellis information about a
low-cholesterol diet. Respondent then indicated that he would give
Agent Ellis a refill of the prescription, but that next month he was
going to reduce the dosage. Agent Ellis then asked if he could pick up
a prescription for his friend, Agent Roberts. Respondent refused to
issue such a prescription and essentially told Agent Ellis that he
would not issue a prescription without seeing the patient. Respondent
gave Agent Ellis a prescription for 60 tablets of Winstrol and with no
refills, and Agent Ellis paid $39.00 for the office visit.
On May 3, 1993, Investigator Hutchison of the Medical Board of
California went to Respondent's office in an undercover capacity
seeking Vicodin, a Schedule III controlled substance. Investigator
Hutchison completed a patient history form on which she did not
indicate any medical complaints. A nurse took her weight and blood
pressure. Respondent asked Investigator Hutchison a series of medical
history questions and the investigator then asked for some Vicodin
explaining that she liked to take it when she went out with her friends
because she did not like alcohol. She told Respondent that Vicodin made
her feel relaxed and mellow. The transcript of this visit indicates
that Respondent stated on more than one occasion that this was a
strange request and that he had never had a request like this before.
Respondent warned Investigator Hutchison of the risks of addiction and
that such use could lead to abuse of other substances. Investigatory
Hutchison said that she used the Vicodin infrequently. Respondent told
Investigator Hutchison that if he gave her a small prescription she
would not become addicted, but that she should really reconsider using
the drug to relax since such use was not accepted in society.
Respondent also acknowledged that it was illegal for him to give her
the drug to feel good. Investigator Hutchison offered to tell
Respondent that she had a headache. Respondent issued Investigator
Hutchison a prescription for 30 tablets of Vicodin and charged her
$40.00 for the visit. Respondent testified that he knew that
Investigator Hutchison did not have a headache and that she was using
the Vicodin inappropriately, but that he issued her a trial
prescription to see how she would use the drug and then would try to
treat her inappropriate use the drug.
Investigator Hutchison returned to Respondent's office on June 28,
1993, and asked for another prescription for Vicodin. The transcript of
this visit indicates that Respondent repeatedly told Investigator
Hutchison that what she was doing was wrong. Respondent discussed the
dangers of addiction and that it was illegal for her to use the Vicodin
for her stated purpose.
Respondent attempted to discourage Investigator Hutchison from
continuing to use Vicodin the way she had been using it. Investigator
Hutchison offered several times to tell Respondent that she had
headaches or pain. Respondent refused to issue Investigator Hutchison a
prescription and did not charge her for this visit. Investigator
Hutchison testified that she believed that Respondent was trying to
establish a rapport with her and counseled her on the misuse of Vicodin
for illegal purposes.
Finally, BNE Agent Price made two undercover visits to Respondent
attempting to obtain prescriptions for Tylenol No. 3 without indicating
a medical reason for the substance. On May 25, 1993, Agent Price filled
out a patient history form indicating no medical problems. Agent Price
told Respondent that she had received Tylenol No. 3 about a year and a
half earlier following an appendectomy, and that she usually kept some
on hand. Agent Price told Respondent that she had no real pain, but
used the Tylenol No. 3 for relaxation. The transcript indicates that
Agent Price told Respondent that ``I work out at the gym a lot like
that. When I get home I just, once in awhile I might take a pill or
something.'' Agent Price further stated that it was ``not so much for
aches * * * it just kind of relaxes me.'' Respondent performed a brief
physical examination. Respondent told Agent Price that her request was
strange and he was not sure that he approved of her using Tylenol No. 3
for relaxation since it was a pain pill, but decided that he could give
her a few pills for emergencies. Respondent issued Agent Price a
prescription for 30 tablets for Tylenol No. 3 with one refill and she
paid $40.00 for the office visit. Respondent testified at the hearing
that he was confused by Agent Price's request because she did not
appear to be an addict since she was well-groomed and stated that she
only used a few pills, and he had never before had anyone request
Tylenol No. 3 for relaxation. Respondent further testified that he
interpreted Agent Price's use of the word ``relaxation'' to mean relief
from pain.
Agent Price returned to Respondent's office on July 26, 1993 and
told Respondent that she was not having any pains, that she wanted the
drug only for relaxation, and that she was just coming back for a
refill of the Tylenol No. 3 prescription. Respondent reiterated that
Tylenol No. 3 is used for pain and not relaxation, and that he did not
believe that Agent Price was using the medication for relief of pain.
Respondent expressed concern that Agent Price was becoming dependent on
the drug and refused to issue her another prescription. Respondent did
not charge Agent Price for the visit. On her chart for this visit,
Respondent wrote as his assessment, ``Drug Addiction (highly likely).''
A Special Agent with BNE testified at the hearing that he had asked
various knowledgeable sources, including manufacturers of anabolic
steroids, the Food and Drug Administration, and the American Medical
Association, whether the use of anabolic steroids to build muscle mass
is appropriate, and that all
[[Page 12845]]
of them replied in the negative. Anabolic steroids became controlled
substances under California law effective August 20, 1986, and
effective February 27, 1991, anabolic steroids became a Schedule III
controlled substance federally under the Controlled Substances Act.
Respondent testified that before prescribing Anadrol and Winstrol to
the undercover officers he consulted the 1991 edition of the
Physicians' Desk Reference, which did not indicate that they were
controlled substances.
The Director of Pharmacy Services at the psychiatric hospital where
Respondent had consulting privileges, testified that he monitors and
fills the prescriptions of doctors at the hospital and that he has
known Respondent for 10 years. He further testified that he had never
seen a prescription issued by Respondent for anabolic steroids and that
in his opinion, Respondent's use of Tylenol No. 3 and Vicodin is very
conservative and clinically appropriate. Three physicians, Respondent's
supervisor, an associate professor at the University of California San
Diego School of Medicine, and an internist in private practice, all
testified at the hearing that his prescribing of Vicodin and Tylenol
No. 3 to the undercover agents was medically appropriate, and that in
1992 and 1993, they were unaware that anabolic steroids were controlled
substances. One of the doctors testified that it is a common practice
to issue a trial prescription if a doctor is not sure whether a
substance is being misused. Respondent's supervisor at one of the
hospitals rated Respondent's medical abilities as a ten on a scale of
ten. Respondent also introduced into evidence a letter from a doctor
who has known Respondent for 11 years and considers him ``a most
knowledgeable, conscientious and ethical physician.'' This doctor also
stated in his letter that Respondent ``practiced at the standard of the
community'' in his prescribing of controlled substances to the
undercover officers. Respondent also introduced into evidence a letter
from a physician who has known Respondent for 11 years and shared an
office with him for four years, who stated that Respondent ``has
consistently demonstrated high quality medical care.'' Finally,
Respondent introduced a letter from a pharmacist who has known
Respondent for approximately 12 years and has filled hundreds of his
prescriptions. The pharmacist considers Respondent to be a ``very
conscientious, dedicated, and knowledgeable physician.''
Respondent testified at the hearing that he felt that he was
already conservative in his prescribing practices, but that as a result
of this experience he has become even more conservative. He stated that
he would never prescribe anabolic steroids again and that he has
learned that he must be very cautious in his prescribing of Schedule
III controlled substances.
Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy
Administrator may revoke a DEA Certificate of Registration and deny any
pending applications, if he determines that the continued registration
would be inconsistent with the public interest. Section 823(f) requires
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, 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 be denied. See Henry J. Schwarz, Jr., M.D., Docket No. 88-
42, 54 FR 16,422 (1989).
Regarding factor one, there is no evidence in the record of any
state action taken against Respondent's license to practice medicine.
Likewise, regarding factor three, there is no evidence that Respondent
has even been convicted under federal or state laws relating to the
manufacture, distribution, or dispensing of controlled substances.
As to factor, four, Respondent's experience in dispensing
controlled substances, the Administrative Law Judge found that
Respondent issued prescriptions to Sergeant Arvizu, Investigator
Hutchison and Agent Price for no legitimate purpose. Judge Bittner
found that ``Respondent prescribed Vicodin to Investigator Hutchison
despite knowing any saying that doing so was illegal because she had
not complained of any headache or other pain.'' Respondent testified
that he diagnosed Investigator Hutchison as inappropriately using
Vicodin; that he could have turned her away, but felt that his job was
not to just diagnose, but to treat the problem; and that he therefore
issued her a trial prescription on her first visit. Judge Bittner
specifically found that ``[a]' `trial prescription' of a controlled
substance just to see how a patient will use the substance * * * is too
likely to result in diversion and is not given for a legitimate medical
purpose. The same is true of prescribing a controlled substance just to
build a relationship with a patient.'' The Acting Deputy Administrator
agrees that a DEA registrant must be extremely careful in the
dispensing of controlled substances to protect against the diversion of
these dangerous substances. However, the Acting Deputy Administrator
does not adopt Judge Bittner's general proposition that trial
prescriptions are not issued for a legitimate medical purpose. The
Acting Deputy Administrator believes that every prescription must be
evaluated in light of the totality of the circumstances surrounding the
issuance of a prescription, and one of the physicians who testified in
this proceeding indicated that it is common practice to issue trial
prescriptions to see if a drug is being misused. But, the Acting Deputy
Administrator does find that in this case, Respondent's prescribing of
Vicodin to Investigator Hutchison during her first visit was extremely
questionable and was evidence of Respondent's lax prescribing
practices. Respondent admitted that he knew that Investigator Hutchison
was misusing Vicodin. Therefore, there was presumably no need to issue
a trial prescription.
Regarding Sergeant Arvizu, the Acting Deputy Administrator concurs
with Judge Bittner's conclusion that ``Respondent prescribe Tylenol No.
3 to Sergeant Arvizu although she said she was not in pain,'' and that
this prescribing was ``especially inappropriate'' since she had
indicated that she had a drug abuse problem in the past, and that
should have caused Respondent to be ``particularly suspicious of her
specific request for Tylenol No. 3.'' Respondent himself admitted at
the hearing that his experience with Sergeant Arvizu taught him that he
needs ``to be very cautious in prescribing Schedule III medications.''
The Acting Deputy Administrator concludes that Respondent's
issuance of a prescription to Agent Price was highly questionable given
that she told him that she used Tylenol No. 3 for relaxation and not
for pain. Respondent thought this was a strange request, but
nonetheless issued her a prescription for the drug to keep on hand for
[[Page 12846]]
emergencies. The Acting Deputy Administrator finds that this
prescribing is evidence of Respondent's lax practices.
Regarding Respondent's prescribing of anabolic steroids to the two
undercover agents, the Acting Deputy Administrator agrees with Judge
Bittner that there is no evidence in the record that Respondent knew
that these were controlled substances. In addition, the record shows
that Respondent advise the agents of the potential side effects from
taking the steroids; required that the agents submit to blood tests for
monitoring purposes; told the agents to return for follow-up visits;
checked for side effects during the follow-up visits; consulted with a
pharmacist regarding what substance to prescribe; and consulted the
Physicians' Desk Reference regarding the proper dosage to prescribe. As
will be discussed in the context of factor four, the prescribing of
steroids for the purpose of building muscle mass is not a legitimate
medical use, however it appears from the record that Respondent was
attempting to dispense the substances in a responsible fashion.
The Acting Deputy Administrator also finds it significant, that
Respondent refused one of the agent's invitations to go into the
business of selling anabolic steroids, stating that he was not
interested in making money, but in the proper management of the
medication; that Respondent refused to issue Agent Roberts a
prescription for Cylert; and that Respondent refused to give Agent
Ellis a prescription for his friend who was not present, stating that
he had to see the friend personally before he would issue a
prescription.
Judge Bittner concluded that, ``[a]though there is no direct
evidence that Respondent has done anything improper outside of the ten
undercover visits that took place as part of this investigation, what
occurred in those visits establishes that Respondent is lax about
prescribing controlled substances and that he is likely to prescribe
controlled substances for other than legitimate medical purposes in
other situations.''
The Acting Deputy Administrator concurs with Judge Bittner that
there is evidence in the record that, at least on some occasions,
Respondent was lax in this controlled substance prescribing practices.
However, there is also evidence in the record that other physicians and
pharmacists, who are in positions that enable them to observe and
evaluate Respondent's prescribing practices, find him to be
conscientious, knowledgeable, and ethical. In addition, Respondent
testified that this experience has caused him to ``become more
conservative''. Therefore, unlike Judge Bittner, the Acting Deputy
Administrator concludes that with proper training and monitoring, as
will be discussed below, it is unlikely that Respondent will prescribe
controlled substances for other than legitimate medical purposes in the
future.
Regarding factor four, there is evidence in the record that
Respondent prescribe control substances for no legitimate medical
purpose and therefore violated 21 U.S.C. Sec. 841(a), 21 C.F.R
Sec. 1306.04(a) and California Health and Safety Code Sec. 11153(a).
Respondent prescribed narcotic pain medication to three of the
undercover agents after they specifically told him that they were not
in pain. Investigator Hutchison was prescribed Vicodin after telling
Respondent that she used it to ``mellow out''. Sergeant Arvizu was
prescribed Tylenol No. 3 after telling Respondent that she takes it
``to feel good.'' Finally, Respondent prescribed Tylenol No. 3 to Agent
Price after she told him that she used it ``for relaxation and to
unwind''. DEA has previously revoked registrations based upon similar
conduct. See Mukand Lal Arora, M.D., 60 FR 4447 (1995) (practitioner's
DEA registration was revoked upon a finding that the practitioner
prescribed Vicodin to an undercover officer to mellow-out where the
undercover officer did not give an indication of any medical purpose
and denied any physical complaint.)
In addition, on four occasions, Respondent prescribed anabolic
steroids to undercover agents for no legitimate medical purpose. A BNE
Agent testified at the hearing before Judge Bittner that according to
various knowledgeable sources, including manufacturers of anabolic
steroids, the Food and Drug Administration, and the American Medical
Association, it is not proper medical practice to use anabolic steroids
to build muscle mass. DEA has previously held that the prescribing of
anabolic steroids for body enhancement is a violation of California
law, since it was not prescribed for a legitimate medical purpose. See
John W. Copeland, M.D., 59 FR 47,063 (1994).
The Administrative Law Judge concluded ``that the record as a whole
establishes that Respondent's continued registration would be
inconsistent with the public interest.'' Judge Bittner further
concluded that ``[u]ntil Respondent can demonstrate that he
acknowledges that his decisions were wrong and understands why and has
taken concrete steps to prevent it from happening again, allowing him
to dispense controlled substances presents to great a risk that
controlled substances will be diverted into illicit channels.''
Therefore, Judge Bittner recommended that Respondent's DEA registration
be revoked.
Respondent argues in his exceptions to Judge Bittner's Recommended
Ruling that the Government did not meet its burden of proof; that a
preponderance of the evidence shows that Respondent's continued
registration is consistent with the public interest; that Judge
Bittner's interpretation of the evidence was ``one-sided'' and
``unfair''; that a re-examination of the evidence refutes that
Respondent was lax in his prescribing practices or would be so in the
future; and that Respondent has accepted full responsibility for his
actions. In his exceptions, Respondent provided detailed citations to
the record in support of his arguments, and provided evidence of what
he has done since the hearing ``to avoid any similar incidents in the
future''. In addition, Respondent suggested an alternative resolution
to complete revocation, whereby certain restrictions would be placed on
his DEA registration.
The Acting Deputy Administrator has not considered the new
information in the exceptions submitted by Respondent that was not part
of the record derived from the hearing. Exceptions are a vehicle for
pointing out perceived errors in the recommended decision of the
Administrative Law Judge and not a vehicle for introducing evidence not
admitted through testimony and/or exhibits at the hearing. Respondent
could have filed a motion to reopen the record had he wanted this new
information considered.
However, the Acting Deputy Administrator has carefully considered
the entire record in this proceeding, including Respondent's exceptions
to Judge Bittner's recommended decision, and concludes that while the
Government established a prima facie case based upon Respondent's lax
prescribing of controlled substances to the undercover officers,
complete revocation of Respondent's registration is not necessary at
this time to protect the public interest. Evidence of Respondent's lax
prescribing practices appears to be limited to the prescriptions
provided to the undercover officers. Respondent testified at the
hearing that in hindsight he should not have prescribed some of the
substances to the undercover officers, and that he has become more
conservative in his prescribing practices. Therefore, the Acting Deputy
Administrator finds that Respondent's actions do not warrant complete
revocation of his DEA registration.
[[Page 12847]]
Nonetheless, a DEA registration carries with it the responsibility
to ensure that controlled substances are only prescribed for a
legitimate medical purpose thereby preventing the diversion of these
potentially dangerous substances from legitimate channels. Therefore,
the Acting Deputy Administrator concludes that some monitoring of
Respondent's controlled substance handling practices and some training
in the proper handling of controlled substance is necessary to protect
the public health and safety.
Thus, the Acting Deputy Administrator concludes that Respondent's
DEA registration should be continued subject to the following
conditions:
(1) For a period of two years from the effective date of this
order, Respondent shall be required to submit to the DEA San Diego
Field Division for review every three months, a log of his prescribing,
dispensing and administering of controlled substances. This log shall
include, at a minimum, the date of the prescribing, dispensing and
administering, the name of the patient, and the name, dosage and
quantity of the controlled substance prescribed, administered or
dispensed.
(2) Within three months of the effective date of this order,
Respondent shall provide to the DEA San Diego Field Division evidence
of the successful completion of at least 24 hours of training in the
proper handling of controlled substances.
Accordingly, the Acting Deputy Administrator of the Drug
Enforcement Administration, pursuant to the authority vested in him by
21 U.S.C. 823 and 824 and 28 C.F.R. 0.100(b) and 0.104, hereby orders
that DEA Certificate of Registration AT1241847, issued to Donald P.
Tecca, M.D., be continued, and any pending applications be granted,
subject to the above conditions. This order is effective April 17,
1997.
James S. Milford,
Acting Deputy Administrator.
Dated: March 4, 1997.
[FR Doc. 97-6795 Filed 3-17-97; 8:45 am]
BILLING CODE 4410-09-M
