Federal Register / Vol. 62, No. 65 / Friday, April 4, 1997 / Notices 16191

or any other reply was received by the

DEA from Dr. Demetrios or anyone

purporting to represent him in this

matter. Therefore, the Acting Deputy

Administrator, finding that: (1) Thirty

days have passed since the receipt of the

Order to Show Cause, and (2) no request

for a hearing having been received,

concludes that Dr. Demetrios is deemed

to have waived his hearing right. After

considering the relevant material from

the investigative file in this matter, the

Acting Deputy Administrator now

enters his final order without a hearing

pursuant to 21 CFR 1301.54(e) and

1301.57.

The Acting Deputy Administrator

finds that Dr. Demetrios is currently

registered with DEA in the State of

California. On June 3, 1993, he

submitted a renewal application for his

DEA registration indicating that he

wanted to change the address to a

location in Cumming, Georgia.

The Acting Deputy Administrator

further finds that on December 6, 1993,

the Composite State Board of Medical

Examiners for the State of Georgia

(Georgia Board) ordered the summary

suspension of Dr. Demetrios’ license to

practice medicine in the State of Georgia

‘‘based upon (his) repeated pattern of

inappropriate sexual conduct with his

patients.’’ Subsequently, on October 5,

1994, the Georgia Board accepted the

voluntary surrender of Dr. Demetrios’

Georgia medical license. Thereafter, on

May 30, 1995, the Medical Board of

California (California Board) filed an

Accusation proposing to revoke Dr.

Demetrios’ license to practice medicine

in the State of California based upon the

action of the Georgia Board, as well as

Dr. Demetrios’ conviction in a Georgia

state court on charges of rape, battery,

aggravated sexual battery, simple

battery, sexual battery, and sexual

assault by a practitioner of

psychotherapy against a patient. On

April 3, 1996, the California Board

entered a Default Decision revoking Dr.

Demetrios’ California medical license

effective May 3, 1996. The Acting

Deputy Administrator concludes that

Dr. Demetrios is not currently

authorized to handle controlled

substances in the State of California,

where he is currently registered with

DEA, nor in the State of Georgia, where

he is requesting modification of his DEA

registration.

The DEA does not have statutory

authority under the Controlled

Substances Act to issue or maintain a

registration if the applicant or registrant

is without state authority to handle

controlled substances in the state in

which he conducts his business. 21

U.S.C. 802(21), 823(f), and 824(a)(3).

This prerequisite has been consistently

upheld. See Dominick A. Ricci, M.D., 58

FR 51,104 (1993); James H. Nickens,

M.D. 57 FR 59,847 (1992); Roy E.

Hardman, M.D., 57 FR 49,195 (1992).

Here, it is clear that Dr. Demetrios is

neither currently authorized to practice

medicine nor to dispense controlled

substances in the States of Georgia and

California. Therefore, he is not entitled

to a DEA registration in either state.

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 CFR 0.100(b) and 0.104,

hereby orders that DEA Certificate of

Registration, BD1248029, previously

issued to Abbas Helim Demetrios, M.D.,

be, and it hereby is, revoked. The Acting

Deputy Administrator further orders

that any pending requests for renewal

and/or modification of such registration,

be, and they hereby are, denied. This

order is effective May 5, 1997.

Dated: March 24, 1997.

James S. Milford,

Acting Deputy Adminstrator.

[FR Doc. 97–8559 Filed 4–3–97; 8:45 am]

BILLING CODE 4410–09–M

[Docket No. 95–44]

Hagura Pharmacy; Denial of

Application

On May 23, 1995, the Deputy

Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration (DEA) issued an Order

to Show Cause to Hagura Pharmacy

(Respondent) of Philadelphia,

Pennsylvania, notifying it of an

opportunity to show cause as to why

DEA should not deny its application for

registration as a retail pharmacy under

21 U.S.C. 823(f), for reason that such

registration would be inconsistent with

the public interest.

By letter dated June 22, 1995, the

Respondent, through counsel, timely

filed a request for a hearing, and

following prehearing procedures, a

hearing was held in Philadelphia,

Pennsylvania on March 19, 1996, before

Administrative Law Judge Mary Ellen

Bittner. At the hearing, both parties

called a witness to testify and

introduced documentary evidence. After

the hearing, both parties submitted

proposed findings of fact, conclusions of

law and argument. On December 6,

1996, Judge Bittner issued her Opinion

and Recommended Ruling, Findings of

Fact, Conclusions of Law and Decision,

recommending that Respondent’s

application for a DEA Certificate of

Registration be denied. Neither party

filed exceptions to her Opinion and

Recommended Ruling and on January 9,

1997, Judge Bittner transmitted the

record of these proceedings to the

Acting Deputy Administrator.

The Acting 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 Acting

Deputy Administrator adopts, in full,

the Opinion and Recommended Ruling,

Findings of Fact, Conclusions of Law

and Decision of the Administrative Law

Judge. The Acting Deputy

Administrator’s adoption is in no

manner diminished by any recitation of

facts, issues and conclusions herein, or

of any failure to mention a matter of fact

or law.

The Acting Deputy Administrator

finds that Respondent pharmacy is

located in Philadelphia, Pennsylvania

and is owned and operated by Tahir

Abdullah, R.Ph., M.D. (hereinafter

referred to as Dr. Abdullah). Respondent

pharmacy is seeking registration with

DEA in order to handle controlled

substances.

Dr. Abdullah received his pharmacy

training in Pakistan and came to the

United States in 1973. From

approximately 1977 until 1985, Dr.

Abdullah owned another pharmacy,

also named Hagura Pharmacy, at

another location in Philadelphia,

Pennsylvania. In 1979, Dr. Abdullah’s

brother came to the United States and

worked at Hagura Pharmacy as a clerk.

Dr. Abdullah was the pharmacist-incharge at Hagura Pharmacy until

approximately 1981 when he began his

medical education outside of the United

States. Beginning in 1981, Dr.

Abdullah’s brother and the pharmacistin-charge handled the daily operations

of the pharmacy and Dr. Abdullah’s

wife paid the bills. In 1983, he returned

to the United States after the university

he was attending closed. While he was

in Philadelphia for the most part from

1983 through 1985, Dr. Abdullah only

occasionally went to Hagura Pharmacy

and was not involved in the daily

operations of the pharmacy.

In 1984, unbeknownst to Dr.

Abdullah, his brother attempted to

fraudulently assume ownership of

Hagura Pharmacy. However in this

proceeding, it is undisputed that Dr.

Abdullah remained the owner of Hagura

Pharmacy. In February 1985, Dr.

Abdullah decided to sell Hagura

Pharmacy to his brother-in-law and on

February 28, 1995, papers were filed

with the State Board of Pharmacy for a

change of ownership and listing the new

name of the pharmacy as Khawaja
16192 Federal Register / Vol. 62, No. 65 / Friday, April 4, 1997 / Notices

Pharmacy. A new DEA Certificate of

Registration was issued to Khawaja

Pharmacy. However, after only one

payment was made by Dr. Abdullah’s

brother-in-law, Khawaja Pharmacy was

closed and the inventory was

transferred to another local pharmacy in

mid-April 1985. Dr. Abdullah testified

at the hearing in this matter that he

arranged for the sale of Khawaja

Pharmacy. There is some question as to

whether Dr. Abdullah’s brother-in-law

was ever the actual owner of Khawaja

Pharmacy, however in light of the

findings below, the Acting Deputy

Administrator finds it unnecessary to

resolve this issue.

In 1985, DEA initiated an

investigation of the controlled substance

handling practices of Hagura Pharmacy

and Khawaja Pharmacy. This

investigation was initiated after DEA

had received a number of reports from

Hagura Pharmacy’s suppliers that the

pharmacy was purchasing an excessive

amount of Schedule II controlled

substances. On May 23, 1985, DEA

investigators attempted to serve an

administrative inspection warrant at

then-Khawaja Pharmacy. After

discovering that the pharmacy was

closed, the investigators contacted Dr.

Abdullah at the suggestion of the State

Board of Pharmacy. Dr. Abdullah and

the pharmacist-in-charge of Hagura

Pharmacy and Khawaja Pharmacy met

with the investigators at a building

where the controlled substance records

of the pharmacies were maintained. Dr.

Abdullah signed, as the owner of the

pharmacy, a receipt for the records

turned over to the investigators.

The investigators then conducted an

accountability audit of Schedule II

controlled substances using the records

supplied by Dr. Abdullah, as well as

information provided by Hagura

Pharmacy’s suppliers and the inventory

conducted by the pharmacist-in-charge

of Khawaja Pharmacy upon its closure.

The audit covered the period January 3,

1984 through April 17, 1985, and

revealed a shortage of 2,359 dosage

units of Ritalin 20 mg. and overages of

the other audited substances.

In conducting the audit, the

investigators noted that at least 85% of

the approximately 2,400 Schedule II

prescriptions filled during the audit

period were issued by one of three

doctors, all of whose offices were

located at least ten miles from Hagura

Pharmacy. The investigators

interviewed those doctors and showed

them copies of the prescriptions. Each

of the doctors stated that the names on

the prescriptions were not patients of

the doctor, that it was not the doctor’s

signature on the prescriptions, and that

no one from either Hagura Pharmacy or

Khawaja Pharmacy had ever telephoned

the doctor attempting to verify the

prescriptions. The investigators then

telephonically contacted the other

doctors whose prescriptions were found

in the pharmacies’ records to verify

their legitimacy. The investigators

determined that fraudulent

prescriptions found in the records of the

pharmacies accounted for 89% of the

approximately 174,000 dosage units of

the audited Schedule II substances

dispensed during the audit period, and

approximately 90% of the fraudulent

prescriptions were filled when the

pharmacy was operating under the

name Hagura Pharmacy. For purposes of

the audit, the investigators included the

fraudulent prescriptions in the total

amount of controlled substances

dispensed during the audit period.

However, if those prescriptions were

excluded, the results of the audit would

be significantly different, with the

shortage being larger and the overages

turning into shortages.

Dr. Abdullah graduated from medical

school in 1987, however as of the date

of the hearing he was not licensed to

practice medicine in the United States.

Dr. Abdullah testified that if

Respondent pharmacy is issued a DEA

Certificate of Registration, he will be the

managing pharmacist, and if he becomes

licensed to practice medicine in the

United States, he will close Respondent

pharmacy and surrender its DEA

registration.

The Government contends that

Respondent’s registration would be

inconsistent with the public interest

based upon the fact that Hagura

Pharmacy, while owned by Dr.

Abdullah, did not keep accurate

controlled substance dispensing records

as evidenced by the results of the

accountability audit and the significant

number of fraudulent prescriptions that

were filled by the pharmacy. The

Government also contends that

Respondent’s registration would not be

in the public interest because Dr.

Abdullah blames others for the

problems of Hagura Pharmacy, even

though he was the owner.

Respondent contends that although he

was the owner, he was not involved in

the daily operations of Hagura

Pharmacy from 1981 through 1985, and

therefore, was not involved in any

alleged wrongdoing. Respondent further

argues that any alleged wrongdoing

occurred prior to 1985 and therefore,

DEA’s proposed denial of its application

for registration is barred by the doctrine

of laches and/or principles of equity.

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 such

registration would be inconsistent with

the public interest. In determining the

public interest, the following factors are

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 that any state

licensing authority has taken any action

against Dr. Abdullah or any of his

pharmacies. As Judge Bittner noted

‘‘that although state licensure is a

prerequisite for a DEA registration, it is

not the only factor to be considered.’’

As to factor two, the Acting Deputy

Administrator finds that while DEA

registers pharmacies, a pharmacy can

only act through its officers and agents.

As Judge Bittner stated in her opinion,

‘‘[i]t is well settled that the Deputy

Administrator may revoke, suspend, or

deny a registration to a pharmacy ‘based

on the controlled substance handling

practices of the pharmacy’s owner,

majority shareholder, officer, managing

pharmacist or other key employee.’ ’’

Cumberland Prescription Center, Inc.,

52 FR 37,224 (1987). Therefore, in

determining Respondent’s experience in

dispensing controlled substances, the

Acting Deputy Administrator considers

the experience of Respondent’s owner/

pharmacist, Dr. Abdullah.

It is undisputed that Dr. Abdullah was

the owner of Hagura Pharmacy from

1977 until at least the end of February

1985. The DEA audit of Hagura

Pharmacy/Khawaja Pharmacy, covering

the period January 3, 1984 through

April 17, 1985, revealed that more than

2,400 fraudulent prescriptions were

filed by the pharmacy. Further

investigation revealed that three

doctors’ names appeared as the
Federal Register / Vol. 62, No. 65 / Friday, April 4, 1997 / Notices 16193

prescribing physicians on

approximately 85% of these

prescriptions and these doctors

indicated that the prescriptions were

forged and that no one from Hagura

Pharmacy had ever contacted them to

verify the legitimacy of the

prescriptions. Of the forged

prescriptions, 90% were filled prior to

February 28, 1985, while the pharmacy

was operating as Hagura Pharmacy with

Dr. Abdullah as the owner. Dr. Abdullah

contends that he should not be held

accountable for the forged prescriptions

that were filled at Hagura Pharmacy

since he was not actively involved in

the operation of the pharmacy at that

time.

Like Judge Bittner, the Acting Deputy

Administrator rejects Dr. Abdullah’s

contention. As the owner, he was

ultimately responsible for what

occurred at his pharmacy regardless of

whether he was involved in its daily

operation or not. It was Dr. Abdullah’s

responsibility to ensure that adequate

safeguards were in place to prevent the

diversion of controlled substances.

However, with Dr. Abdullah as the

owner, Hagura Pharmacy dispensed

thousands of dosage units of highly

abused Schedule II controlled

substances pursuant to fraudulent

prescriptions. The Acting Deputy

Administrator is troubled by Dr.

Abdullah’s continued assertions that he

should not be held accountable for the

improper dispensing that occurred at

Hagura Pharmacy. Dr. Abdullah’s failure

to accept responsibility, does not bode

well for Respondent’s future handling of

controlled substances.

Regarding factors three and four, there

is no evidence that Respondent or Dr.

Abdullah had ever been convicted

under state or Federal laws relating to

controlled substances. However, there is

evidence that Hagura Pharmacy, while

owned by Dr. Abdullah, failed to

comply with Federal laws relating to

controlled substances. Hagura Pharmacy

failed to maintain complete and

accurate records of controlled

substances in violation of 21 U.S.C. 827

and 21 CFR 1304.21, as evidenced by

the accountability audit results. In

addition, Hagura Pharmacy dispensed

controlled substances without a valid

prescription in violation of 21 U.S.C.

829 and 21 CFR 1306.04. Dr. Abdullah

again argues that he should not be held

accountable for Hagura Pharmacy’s

failure to comply with Federal laws

since he was not an active participant in

the operation of the pharmacy.

However, for the reasons discussed in

conjunction with factor two, the Acting

Deputy Administrator rejects this

argument.

As to factor five, Judge Bittner found

relevant ‘‘* * * Dr. Abdullah’s lack of

candor regarding the ownership of the

pharmacy. * * *’’ Dr. Abdullah

maintained that he was not the owner

of Khawaja Pharmacy and therefore

should not be held accountable for the

actions of that pharmacy. Judge Bittner

found this argument ‘‘at best

disingenuous’’ in light of the fact that

Dr. Abdullah arranged for the transfer of

the inventory to another pharmacy upon

Khawaja Pharmacy’s closure, an that his

brother-in-law had only made one

payment to Dr. Abdullah at the time the

pharmacy closed. But like Judge Bittner,

the Acting Deputy Administrator finds

it unnecessary to assess the impact of

this finding on the outcome of this

proceeding, since 90% of the fraudulent

prescriptions were filed by Hagura

Pharmacy while, without dispute, it was

owned by Dr. Abdullah.

Respondent asserts that the alleged

wrongdoing occurred more than ten

years ago and therefore the doctrine of

laches or other principles of equity

should preclude the denial of

Respondent’s application for

registration. DEA has consistently held

that while passage of time since the

wrongdoing is not, by itself, dispositive,

it is a consideration in assessing

whether Respondent’s registration

would be inconsistent with the public

interest. See Norman Alpert, M.D., 58

FR 67,420 (1993). In Alpert, the thenActing Administrator found significant,

‘‘Respondent’s recognition of the serious

abuse of his privileges as a DEA

registrant, and his sincere regret for his

actions.’’ Here however, Dr. Abdullah

maintains that he has done nothing

wrong and that he should not be held

accountable for the actions of Hagura

Pharmacy, even though he was its

owner.

Judge Bittner concluded that ‘‘[i]t is

clear from Dr. Abdullah’s suggestion

that he should not be held accountable

for the wrongdoing of his pharmacy

during his absence that he does not

appreciate or accept the responsibilities

that accompany owning a DEA

registrant. In addition, there is no

persuasive evidence in the record to

indicate that Dr. Abdullah would be a

more conscientious owner the second

time around.’’ The Acting Deputy

Administrator agrees. Dr. Abdullah has

exhibited a complete disregard for the

tremendous responsibilities that

accompany the issuance of a DEA

registration. Therefore, the Acting

Deputy Administrator concludes that it

would be inconsistent with the public

interest to grant Respondent pharmacy a

DEA registration.

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 CFR 0.100(b) and 0.104,

hereby orders that the application for

registration as a retail pharmacy

submitted by Hagura Pharmacy, be, and

it hereby is, denied. This order is

effective May 5, 1997.

Dated: March 27, 1997.

James S. Milford,

Acting Deputy Administrator.

[FR Doc. 97–8558 Filed 4–3–97; 8:45 am]

BILLING CODE 4410–09–M

Romeo J. Perez, M.D.; Revocation of

Registration

On July 31, 1996, the Deputy

Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration (DEA) issued an Order

to Show Cause to Romeo J. Perez, M.D.,

of St. Louis, Missouri, notifying him of

an opportunity to show cause as to why

DEA should not revoke his DEA

Certificate of Registration AP1596014,

and deny any pending applications for

renewal of such registration as a

practitioner pursuant to 21 U.S.C. 823(f)

and 824(a)(3), for reason that he is not

currently authorized to handle

controlled substances in the State of

Missouri. The order also notified Dr.

Perez that should no request for a

hearing be filed within 30 days, his

hearing right would be deemed waived.

The DEA received a signed receipt

indicating that the order was received

on August 2, 1996. No request for a

hearing or any other reply was received

by the DEA from Dr. Perez or anyone

purporting to represent him in this

matter. Therefore, the Acting Deputy

Administrator, finding that: (1) Thirty

days have passed since the receipt of the

Order to Show Cause, and (2) no request

for a hearing having been received,

concludes that Dr. Perez is deemed to

have waived his hearing right. After

considering the relevant material from

the investigative file in this matter, the

Acting Deputy Administrator now

enters his final order without a hearing

pursuant to 21 CFR 1301.54(e) and

1301.57.

The Acting Deputy Administrator

finds that, by order effective August 24,

1994, the State Board of Healing Arts,

State of Missouri (Board) revoked Dr.

Perez’ license to practice medicine. The

Board further ordered that Dr. Perez

shall not apply for reinstatement of his

license for at least two years and one

day from the effective date. The Acting

Deputy Administrator finds that there is