12842 Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Notices

(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, the record

indicates that while Respondent

surrendered his state controlled

substances license in December 1992, it

ha since been reinstated with no

restrictions. In addition, it is unclear

exactly what action, if any, was taken by

the Texas State Board of Medical

Examiners regarding Respondent’s

license to practice medicine in that

state. However, it is undisputed that he

is currently licensed to practice

medicine in Texas.

As to Respondent’s experience in

dispensing controlled substances, it is

clear that Respondent prescribed

controlled substances to the undercover

agents for no legitimate medical reason.

The agents told Respondent that they

were cocaine users and that they needed

Tylenol with codeine and Valium to

help them come off their cocaine highs.

The Acting Deputy Administrator finds

that prescribing controlled substances

for this purpose is reprehensible, since

it fosters the continued illegal use of

cocaine.

Regarding factor three, Respondent

has been convicted of a controlled

substance related offense. DEA has

consistently held that a deferred

adjudication of guilt following a plea of

guilty is a conviction within the

meaning of the Controlled Substances

Act. See Harlan J. Borcherding, D.O., 60

FR 28,796 (1995); see also Clinton D.

Nutt, D.O., 55 FR 30,992 (1990) (where

plea was ‘‘nolo contendere’’ rather than

‘‘guilty’’). In his letter dated June 16,

1996, Respondent’s counsel eludes to an

entrapment defense to the charges

brought against Respondent. There is no

elaboration of this argument in

Respondent’s letter, and it is

nonetheless irrelevant to this

proceeding, since Respondent pled

guilty to the charges against him.

As to factor four, Respondent’s

conviction in state court for the

unlawful prescribing clearly shows that

Respondent failed to comply with the

applicable state law. In addition,

Respondent’s prescribing of controlled

substances to the undercover agents for

no legitimate medical purpose was in

violation of 21 U.S.C. 841(a)(1).

In June 16, 1996 letter, Respondent’s

counsel asserts that Respondent has

‘‘never had any trouble with the D.E.A.

prior to 1993 and he does need his

D.E.A. Certificate so that he may

practice normally again.’’ However,

other than counsel’s unsubstantiated

assertions, there is no documentation in

the record of Respondent’s fitness to

handle controlled substances.

The Acting Deputy Administrator

concludes that based upon the record

before him, Respondent’s registration

with DEA would be inconsistent with

the public interest. Respondent

prescribed highly abused substances for

no legitimate medical purpose to

purported users of cocaine. There is no

indication that Respondent can now be

trusted to responsibly handle 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 28 C.F.R. 0.100(b) and 0.104,

hereby orders that the application

submitted by Yu-To Hsu, M.D. for a

DEA Certificate of Registration be, and

it hereby is, denied. This order is

effective April 17, 1997.

Dated: March 10, 1997.

[FR Doc. 97–6793 Filed 3–17–97; 8:45 am]

BILLING CODE 4410–09–M

[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
Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Notices 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 MediCal 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
12844 Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Notices

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
Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Notices 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
12846 Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Notices

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. § 841(a), 21

C.F.R § 1306.04(a) and California Health

and Safety Code § 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 ‘‘onesided’’ and ‘‘unfair’’; that a reexamination 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.
Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Notices 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

[Docket No. 96–31]

Anne Lazar Thorn, M.D. Revocation of

Registration

On April 15, 1996, the Deputy

Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration (DEA) issued an Order

to Show Cause to Anne Lazar Thorn,

M.D. (Respondent), of Lafayette,

Louisiana, notifying her of an

opportunity to show cause as to why

DEA should not revoke her DEA

Certificate of Registration, AT6512152,

pursuant to 21 U.S.C. 824(a)(3), and

deny any pending applications for

renewal of such registration as a

practitioner pursuant to 21 U.S.C.

823(f), for reason that effective October

18, 1993, the Louisiana State Board of

Medical Examiners indefinitely

suspended her license to practice

medicine and as a result, she is not

currently authorized to handle

controlled substances in the State of

Louisiana.

By letter dated April 29, 1996,

Respondent, acting pro se, filed a timely

request for a hearing, and the matter was

docketed before Administrative Law

Judge Mary Ellen Bittner. On May 3,

1996, Judge Bittner issued an Order for

Prehearing Statements. On May 24,

1996, in lieu of filing such a statement,

the Government filed a Motion for

Summary Disposition and to Stay

Proceedings, asserting that ‘‘Respondent

is without state authorization to handle

controlled substances at this time.’’

Attached to the motion was a copy of

the Louisiana State Board of Medical

Examiner’s (Board) decision dated

October 18, 1993, indefinitely

suspending Respondent’s license to

practice medicine and a copy of a letter

from the Board notifying DEA that

Respondent’s license to practice

medicine in the State of Louisiana was

suspended.

On June 3, 1996, the Administrative

Law Judge received a letter from an

attorney indicating that he had been

retained to represent Respondent, and

on June 21, 1996, counsel for

Respondent filed a Memorandum in

Opposition to Government’s Motion for

Summary Disposition and Motion to

Stay Proceedings. Respondent did not

deny that she is currently without

authority to handle controlled

substances in the State of Louisiana.

However, she argued that 21 U.S.C.

824(a) provides for the Deputy

Administrator to use his discretion in

determining whether to revoke or

suspend a registration because of lack of

state authority to handle controlled

substances and that a hearing is

necessary to determine what action

should be taken against Respondent’s

registration. Respondent further argues

that this matter is not yet ripe for

determination since Respondent has not

‘‘had the opportunity to present her

evidence with supporting testimony

concerning her current fitness to

practice medicine, or the steps which

she is taking to seek the reinstatement

of her license to practice medicine in

the State of Louisiana.’’

On July 25, 1996, Judge Bittner issued

her Opinion and Recommended

Decision, finding that Respondent is not

currently authorized to handle

controlled substances in the State of

Louisiana; that she is bound by DEA’s

interpretation of the Controlled

Substances Act that, pursuant to 21

U.S.C. 823(f) and 802(21), a petitioner

may not hold a DEA registration without

state authority to handle controlled

substances; that since no material

question of fact is involved, a hearing is

not necessary; and that while the statue

provides for the revocation or

suspension, revocation is appropriate in

this case since there is no indication

that Respondent’s state license will be

reinstated any time soon. Accordingly,

Judge Bittner granted the Government’s

Motion for Summary Disposition and

recommended that the Respondent’s

DEA Certificate of Registration be

revoked.

On August 8, 1996, Respondent filed

with the Administrative Law Judge a

Motion for Reconsideration and/or to

Alter or Amend Judgment (Motion for

Reconsideration). Respondent argued

that the Board suspended her license

indefinitely, rather than revoking it

entirely, and that it would remain

suspended until further order of the

Board. Respondent asserted that the

only evidence before the Administrative

Law Judge in rendering her

recommended decision was the order of

the Board dated October 18, 1993 and

that ‘‘a great deal has transpired with

respect to Respondent’s license to

practice medicine and the steps she has

taken to have her license reinstated.’’

Respondent argued that she should be

given an opportunity for a hearing

regarding her DEA registration in order

to outline the steps she has taken to

have her state license reinstated, and

that the evidence which would have

been presented at a hearing would have

aided the Administrative Law Judge in

deciding whether to recommend

revocation or suspension of

Respondent’s registration. Respondent

contended that ‘‘the decision to

permanently revoke a physician’s

registration to distribute drugs is a

serious sanction, and is one which

should not be rendered without

considering all of the evidence in a

particular case.’’

Therefore, Respondent requested that

the Administrative Law Judge

reconsider her decision to deny

Respondent the opportunity for a

hearing, or in the alternative, that the

Administrative Law Judge alter her

recommendation from revocation to