[Federal Register Volume 62, Number 170 (Wednesday, September 3, 1997)]
[Notices]
[Pages 46512-46514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23309]
-----------------------------------------------------------------------
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.
[[Page 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
[[Page 46514]]
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 then-suspended 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