46512 Federal Register / Vol. 62, No. 170 / Wednesday, September 3, 1997 / Notices

4. Meeting schedule through June, 1998

FURTHER MATTERS TO BE CONSIDERED:

(Closed to the Public 1:30 PM)

1. Finance Project in Venezuela

2. Finance Project in Jamaica

3. Finance Project in India

4. Finance and Insurance Project in

Bangladesh

5. Investment Fund in the Middle East

& North Africa

6. Investment Fund in the West Bank,

Gaza and Jordan

7. Investment Fund in Africa

8. Pending Major Projects

9. Proposed FY 1999 Budget and

Allocation of Retained Earnings

10. Approval of June 10, 1997 Minutes

(Closed Portion)

CONTACT PERSON FOR INFORMATION:

Information on the meeting may be

obtained from Connie M. Downs at (202)

336–8438.

Dated: August 29, 1997.

Connie M. Downs,

OPIC Corporate Secretary.

[FR Doc. 97–23447 Filed 8–29–97; 11:24 am]

BILLING CODE 3210–01–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Manufacturer Of Controlled

Substances; Notice of Application

Pursuant to Section 1301.33 of Title

21 of the Code of Federal Regulations

(CFR), this is notice that on June 6,

1997, Arenol Corporation, 189 Meister

Avenue, Somerville, New Jersey 08876,

made application by renewal to the

Drug Enforcement Administration

(DEA) for registration as a bulk

manufacturer of the basic classes of

controlled substances listed below:

Drug Schedule

N-Ethylamphetamine (1475) ......... I

Difenoxin (9168) ........................... I

Amphetamine (1100) .................... II

Methamphetamine (1105) ............ II

The firm plans to manufacture the

listed controlled substances to produce

pharmaceutical products for its

customers.

Any other such applicant and any

person who is presently registered with

DEA to manufacture such substances

may file comments or objections to the

issuance of the proposed registration.

Any such comments or objections

may be addressed, in quintuplicate, to

the Deputy Assistant Administrator,

Office of Diversion Control, Drug

Enforcement Administration, United

States Department of Justice,

Washington, D.C. 20537, Attention: DEA

Federal Register Representative (CCR),

and must be filed no later than (60 days

from publication.

Dated: August 20, 1997.

John H. King,

Deputy Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration.

[FR Doc. 97–23310 Filed 9–2–97; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

West End Drugs, Inc. Revocation of

Registration

On May 28, 1997, the Acting Deputy

Administrator of the Drug Enforcement

Administration (DEA) issued an Order

to Show Cause to West End Drugs, Inc.,

(West End Drugs) of Nashville,

Tennessee, proposing to revoke its DEA

Certificate of Registration AH5042077,

and to deny any pending applications

for registration as a retail pharmacy for

reason that its continued registration

would be inconsistent with the public

interest pursuant to 21 U.S.C. 823(f) and

824(a)(4). Additionally, citing his

preliminary finding that the continued

registration of West End Drugs posed an

imminent danger to the public health

and safety, the Acting Deputy

Administrator ordered the immediate

suspension of DEA Certificate of

Registration AH5042077 during the

pendency of these proceedings pursuant

to 21 U.S.C. 824(d). The Order to Show

Cause also notified West End Drugs that

should no request for a hearing be filed

within 30 days of receipt, its hearing

right would be deemed waived.

The Order to Show Cause/Immediate

Suspension of Registration was

personally served on Henry Birdsong,

the owner and pharmacist of West End

Drugs, on May 29, 1997. No request for

a hearing or any other reply was

received by the DEA from West End

Drugs or anyone purporting to represent

it in this matter. Therefore, the Acting

Deputy Administrator, finding that (1)

30 days have passed since the receipt of

the Order to Show Cause, and (2) no

request for a hearing having been

received, concludes that West End

Drugs is deemed to have waived its

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

1301.43 (d) and (e) and 1301.46.

The Acting Deputy Administrator

finds that in January 1997, the

Tennessee Board of Pharmacy (Board)

was contacted by a local drug

wholesaler regarding large purchases by

West End Drugs of diazepam 10 mg., a

Schedule IV controlled substance, and

Guiatuss AC syrup and Cheratussin AC

syrup, both Schedule V controlled

substances. As a result of this

information, investigators of the Board

and the Tennessee Bureau of

Investigation conducted random

surveillance of West End Drugs on the

day, or day after the pharmacy had

received orders of diazepam 10 mg. The

investigators noticed certain vehicles

arriving at the pharmacy that were

registered to individuals with criminal

histories, including some with arrests

and convictions for fraudulently

obtaining controlled substances.

On March 4, 1997, a Board

investigator conducted an inspection of

the pharmacy. The inspection revealed

that the majority of the prescriptions in

the pharmacy’s files were for controlled

substances, and that the majority of the

prescriptions for diazepam were written

by one of three doctors. During this

inspection, Mr. Birdsong informed the

investigator that the pharmacy fills

approximately 40 to 45 prescriptions

per day and that some individuals pick

up prescriptions for other people.

According to investigators familiar with

the dispensing practices of community

pharmacies in the area, West End Drugs’

filling of 40 to 45 prescriptions per day

is well below the average of pharmacies

similar to West End Drugs which fill

100 or more prescriptions per day.

As part of the investigations, the local

wholesaler compared West End Drugs’

purchases of dizaepam 10 mg.,

Cheratussin AC syrup, and Guiatuss AC

syrup to purchases by its other

customers for the period March 1, 1996

to February 28, 1997. West End Drugs

was the largest purchaser of diazepam

10 mg., purchasing 138,000 tablets. The

second and third largest purchasers

bought 25,000 tablets and 15,500 tablets

respectively, during the same time

period. West End Drugs was also the

number one purchaser of Cheratussin

AC syrup buying from the wholesaler

3,112 four ounce bottles. The number

two purchaser during this time period

bought 447 four ounce bottles, and the

number three purchaser bought 175 four

ounce bottles. Finally, West End Drugs

was the largest purchaser of Guiatuss

AC syrup buying 1,046 four ounce

bottles. For the same time period, the

second and third largest purchasers

bought 223 and 142 four ounce bottles,

respectively.
Federal Register / Vol. 62, No. 170 / Wednesday, September 3, 1997 / Notices 46513

In March 1997, DEA joined the

investigation of West End Drugs, and on

April 16, 1997, a search warrant and

administrative inspection warrant were

executed at the pharmacy. During the

search, records of controlled substances

dispensed by West End Drugs were

seized. The records were analyzed for

the period March 10, 1997 through

April 16, 1997, and revealed that at least

639 controlled substance prescriptions

filled by West End Drugs were either not

issued by the physician whose name

appeared on the prescription or a

fictitious name was used as the issuing

physician.

For example, investigators identified

approximately 106 controlled substance

prescriptions during this time period

that were allegedly written by Dr. John

Reynolds and were filled by West End

Drugs. These prescriptions bore a DEA

registration number that was later

determined to be a fraudulent number.

The prescriptions included 5

prescriptions for acetaminophen with

codeine #4, totaling 500 dosage units; 23

prescriptions for diazepam 10 mg.,

totaling 2,300 dosage units; 5

prescriptions for Fastin, totaling 300

dosage units; 3 prescriptions for Lorcet

Plus, totaling 300 dosage units; and 67

prescriptions for Lortab 7.5/500 mg.,

totaling 6,700 dosage units.

During the execution of the search

warrant on April 16, 1997, the

pharmacy received a telephone call

from an individual identifying herself as

an employee of Dr. Reynolds and

advising Mr. Birdsong that she was

calling in prescriptions for 12 new

patients. These prescriptions included

approximately 1,200 dosage units of

Lortab 7.5 mg., and approximately 600

dosage units of diazepam 10 mg., and

were to be picked up the following day

by another individual.

Mr. Birdsong informed the

investigators that he never verified the

prescriptions issued by Dr. John

Reynolds, but that Dr. Reynolds worked

at Vanderbilt Medical Center. However,

the investigators later contacted

Vanderbilt Medical Center and were

advised that no Dr. John Reynolds

worked there. Further investigation

revealed that only two Dr. John

Reynolds were registered with DEA in

Tennessee. One had retired from

practice in December 1996, and the

other, a dentist, advised investigators

that he had not called in any

prescriptions to West End Pharmacy on

April 16, 1997, and that he rarely called

in prescriptions for Lortab and never for

such large amounts.

On April 17, 1997, the individual

arrived at the pharmacy and picked up

the medication dispensed pursuant to

the prescriptions called in the previous

day. As she was leaving the pharmacy,

she was questioned by investigators and

admitted that since approximately July

1996, she had been calling in 10 to 12

fictitious prescriptions to West End

Drugs every week using the name of Dr.

John Reynolds. She further stated that

prior to July 1996, her sister had called

in prescriptions to West End Drugs

using the fictitious name of Dr. John

Reynolds.

During execution of the search

warrant, the investigators noted

controlled substance prescriptions

allegedly issued by Dr. Charles

McGinnis. When asked about these

prescriptions, Mr. Birdsong stated that

Dr. McGinnis sends prescriptions to the

pharmacy by courier. Mr. Birdsong fills

the prescriptions and the courier then

returns and pays cash for the

medication. A review of the

prescriptions seized from the pharmacy

revealed that between March 10, 1997

and April 16, 1997, West End Drugs

filled approximately 199 controlled

substance prescriptions allegedly

written by Dr. Charles McGinnis. These

prescriptions included 51 prescriptions

for acetaminophen with codeine #4,

totaling 4,590 dosage units; 15

prescriptions for diazepam 10 mg.,

totaling 1,355 dosage units; 65

prescriptions for Lortab, totaling 2,492

dosage units; and 63 prescriptions for

Valium 10 mg., totaling 5,670 dosage

units. Investigators later contacted the

office of Dr. Charles McGinnis and were

advised that Dr. McGinnis had not

authorized any prescriptions since

suffering a stroke in December 1996.

The investigators also noted

approximately 300 controlled substance

prescriptions allegedly authorized by

Dr. George Herda that were filled by

West End Drugs. These prescriptions

included 56 prescriptions for

acetaminophen with codeine #4,

totaling 5,040 dosage units; 113

prescriptions for diazepam 10 mg.,

totaling 10,120 dosage units; 58

prescriptions for Lortab 10 mg., totaling

2,320 dosage units; 59 prescriptions for

Lortab 7.5/500 mg., totaling 2,360

dosage units; 3 prescriptions for Tylenol

with codeine #4, totaling 270 dosage

units; and 10 prescriptions for Valium

10 mg., totaling 900 dosage units.

Investigators contacted Dr. Herda who

indicated that he had not authorized

these prescriptions.

While the investigators were in West

end Drugs on April 17, 1997, waiting for

the individual to pick up the

prescriptions allegedly authorized by

Dr. Reynolds, the pharmacy received a

telephone call from an individual

identifying himself as Dr. Herda and

calling in prescriptions for hydrocodone

and Tylenol with codeine. Mr. Birdsong

expressed reluctance to fill the

prescriptions stating that he did not

know the individual. The individual

replied that he has had an arrangement

with West End Drugs for over two years.

Ultimately, at the direction of the

investigators, Mr. Birdsong filled the

prescriptions. Later that day, the

investigators stopped an individual

leaving West end Drugs with the filled

prescriptions for hydrocodone and

Tylenol with codeine. The individual

admitted that another individual had

asked him to pick up the prescriptions;

that that individual had called in

prescriptions to West end Drugs on at

least 12 other occasions; and that the

individual had used the names

‘‘McGinnis’’ and ‘‘Herda’’ to call in the

prescriptions.

On April 16, 1997, Mr. Birdsong

voluntarily provided a written

statement. Specifically, Mr. Birdsong

stated that, ‘‘I had my doubts that the

prescriptions containing the

physicians[’] names of McGinnis,

Reynolds and Herda were not written

for legitimate medical purposes but I

did not follow up on my doubts.’’

On April 18, 1997, the investigators

were informed by the local wholesaler

that West End Drugs had placed an

order for 1,000 diazepam 10 mg. and

500 diaxepam 5 mg. to be picked up that

day. Later that day, a local police officer

observed a female leave West End Drugs

having difficulty walking. The

individual got into her vehicle and was

later stopped by the officer who

discovered a vial with 65 hydrocodone

tablets. The label indicated that the

prescriptions had been authorized by

Dr. Teresa Cook and had been filled at

West End Drugs. Mr. Birdsong was later

questioned about the hydrocodone and

he admitted that he had filled the

prescription. He stated that Dr. Cook

was new in the area and gave the officer

a telephone number for Dr. Cook which

turned out to be a pager number.

Further investigation revealed that there

is no Dr. Teresa Cook registered with the

State of Tennessee or with DEA to

practice medicine or handle controlled

substances in Tennessee, nor was there

anyone listed by that name in the local

telephone directory.

A subsequent review of the

prescriptions seized from West End

Drugs during execution of the search

warrant revealed approximately 34

controlled substance prescriptions

allegedly issued by Dr. Teresa Cook

between March 10, 1997 and April 16,

1997, which were filled by West End

Drugs. These prescriptions included 22

prescriptions for Lortab 5 mg., totaling
46514 Federal Register / Vol. 62, No. 170 / Wednesday, September 3, 1997 / Notices

1,495 dosage units; 7 prescriptions for

Valium 10 mg., totaling 240 dosage

units; and 4 prescriptions for Vicodin,

totaling 255 dosage units.

Subsequently, on April 22, 1997, a

second search warrant was executed at

West End Drugs. During the search, a

DEA investigator observed Mr. Birdsong

filling a prescription for Lortab 10 mg.

which appeared to have been altered

from 20 to 30 tablets. The investigator

contacted the physician who signed the

prescription. The physician indicated

that he had issued the prescription to

the patient, but for 20 dosage units, not

30.

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 or 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 factors one and three, there

is no evidence in the record that the

State of Tennessee has taken any action

against the pharmacy license of West

End Drugs, or that the pharmacy or its

owner has been convicted of any offense

relating to controlled substances.

However, in considering factors two and

four, West End Drugs’ experience in

dispensing controlled substances and its

compliance with applicable laws

relating to controlled substances, the

Acting Deputy Administrator finds that

there is more than ample evidence to

support the revocation of the

pharmacy’s DEA Certificate of

Registration.

Between March 10 and April 16,

1997, West End Drugs filled over 600

controlled substance prescriptions that

were either not issued by the physician

whose name appeared on the

prescription or a fictitious name was

used as the issuing physician. Mr.

Birdsong admitted that he did not verify

these prescriptions with the physicians

who allegedly issued them, and further

admitted that he had his doubts that

most of these prescriptions were

legitimate. Two individuals who were

questioned during the investigation after

picking up multiple prescriptions from

West and Drugs admitted that the

prescriptions were not valid. In

addition, Mr. Birdsong was observed

filling a prescription where the quantity

prescribed had been altered.

In light of the above, the Acting

Deputy administrator finds that Mr.

Birdsong violated 21 CFR 1306.04,

which provides that,

A prescription for a controlled substance to

be effective must be issued for a legitimate

medical purpose by an individual

practitioner acting in the usual course of his

professional practice. The responsibility for

the proper prescribing and dispensing of

controlled substances is on the prescribing

practitioner, but a corresponding

responsibility rests with the pharmacist who

fills the prescription. . . .

West End Drugs and Mr. Birdsong

clearly abrogated its corresponding

responsibility. Mr. Birdsong admitted

that he had his doubts about the

legitimacy of these prescriptions, yet he

filled them anyway without verifying

their legitimacy. As a result, thousands

of dosage units of controlled substances

were diverted into the illicit market.

The Acting Deputy administrator

finds that based upon the foregoing, the

continued registration of West End

Drugs would be inconsistent with the

public interest. No evidence of

explanation or mitigating circumstances

has been offered on behalf of West End

Drugs. Therefore, the Acting Deputy

Administrator concludes that its

registration must be revoked.

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 AH5042077, previously

issued to West End Drugs, Inc., be, and

it hereby is revoked. The Acting Deputy

Administrator further orders that any

pending applications for renewal of

such registration, be, and they hereby

are denied. This order is effective

immediately.

When the order to Show Cause/

Immediate Suspension was served on

West End Drugs, Inc., all controlled

substances possessed by the pharmacy

under the authority of its thensuspended registration were placed

under seal and removed for safekeeping.

Title 21 U.S.C. 824(f) provides that no

disposition may be made of such

controlled substances under seal until

all appeals have been concluded or until

the time for taking an appeal has

elapsed. Accordingly, those controlled

substances shall remain under seal until

October 3, 1997, or until any appeal of

this order has been concluded. At that

time, all such controlled substances

shall be forfeited to the United States

and shall be disposed of pursuant to 21

U.S.C. 881(e).

Dated: August 27, 1997.

James S. Milford,

Acting Deputy Administrator.

[FR Doc. 97–23309 Filed 9–2–97; 8:45 am]

BILLING CODE 4410–09–M

NATIONAL ARCHIVES AND RECORDS

ADMINISTRATION

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: National Archives and Records

Administration (NARA).

ACTION: Notice.

SUMMARY: NARA is giving public notice

that the agency proposes to request

extension of two currently approved

information collections used in the

National Historical Publications and

Records Commission (NHPRC)’s grant

program for subvention of part of the

costs of manufacturing and distributing

volumes published by NHPRCsupported documentary editorial

projects. One collection is a grant

application prepared by university and

other non-profit presses applying for a

subvention grant. The other collection is

is a sales report made by a non-profit

press which has received a subvention

grant from the NHPRC. The public is

invited to comment on the proposed

information collections pursuant to the

Paperwork Reduction Act of 1995.

DATES: Written comments must be

received on or before November 3, 1997

to be assured of consideration.

ADDRESSES: Comments should be sent

to: Paperwork Reduction Act Comments

(NHP), Room 3200, National Archives

and Records Administration, 8601

Adelphi Rd, College Park, MD 20740–

6001; or faxed to 301–713–6913; or

electronically mailed to

tamee.fechhelm@arch2.nara.gov.

FOR FURTHER INFORMATION CONTACT:

Requests for additional information or

copies of the proposed information