[Federal Register Volume 60, Number 66 (Thursday, April 6, 1995)]
[Notices]
[Pages 17574-17577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8402]



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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 93-51]


Frank's Corner Pharmacy; Revocation of Registration

    On June 4, 1993, the Deputy Assistant Administrator (then 
Director), Office of Diversion Control, Drug Enforcement Administration 
(DEA), issued an Order to Show Cause to Frank's Corner Pharmacy 
(Respondent), of Detroit, Michigan, proposing to revoke its DEA 
Certificate of Registration, BF1175466, and deny any pending 
applications for renewal of such registration. The statutory basis for 
the Order to Show Cause was that Respondent's continued registration 
would be inconsistent with the public interest pursuant to 21 U.S.C. 
823(f) and 824(a)(4).
    On July 23, 1993, Respondent, through counsel, requested a hearing 
on the issues raised in the Order to Show Cause and the matter was 
docketed before Administrative Law Judge Paul A. Tenney. Following 
prehearing procedures, a hearing was held in Detroit, Michigan on May 3 
and 4, 1994. On August 29, 1994, Judge Tenney issued his Findings of 
Fact, Conclusions of Law and Recommended Ruling 
[[Page 17575]] recommending that Respondent's registration be suspended 
for a period not exceeding six months. The Government filed exceptions 
to Judge Tenney's opinion on September 19, 1994. Respondent filed its 
exceptions to Judge Tenney's opinion and its response to the 
Government's exceptions on September 30, 1994, and filed corrections to 
those exceptions on October 11, 1994.
    On October 14, 1994, the administrative law judge transmitted the 
record of these proceedings, including the exceptions, to the Deputy 
Administrator. The Deputy Administrator has considered the record in 
its entirety and hereby issues his final order pursuant to 21 CFR 
1316.67, based upon the findings of fact and conclusions of law as set 
forth herein.
    The administrative law judge found that, in September 1986, Alvin 
Goldstein, R.Ph (Mr. Goldstein), a pharmacist licensed by the State of 
Michigan, became a 50% stockholder owner of Respondent, a pharmacy 
licensed and operated in the State of Michigan. From September 1987 
onward, Respondent's principal stockholder and operator has been Mr. 
Goldstein.
    On October 5, 1989, the Michigan Board of Pharmacy (the Board) 
filed an administrative complaint charging Respondent and Mr. Goldstein 
with violations of Michigan regulations pertaining to controlled 
substance recordkeeping and shortages of controlled substances based 
upon an audit conducted by the Board on June 29, 1988. The Board's 
initial order was appealed to the Michigan Circuit Court for the County 
of Oakland where it was affirmed in part, and reversed in part, on 
January 14, 1994. The circuit court affirmed the Board's order to the 
extent it found that Respondent and Mr. Goldstein: (1) Were responsible 
for shortages of controlled substances (including Darvocet, Tylenol 
with codeine #4, and Valium); (2) were negligent in the practice of 
pharmacy; (3) were incompetent under applicable Michigan State law 
based upon a 14% shortage of Darvocet; (4) failed to comply with a 
state administrative subpoena by not supplying the state investigators 
with records required to be kept pursuant to Michigan law; and (5) 
failed to produce drug utilization reports as required under Michigan 
law.
    The circuit court remanded the case back to the Board which issued 
its Amended Final Order on Remand on April 22, 1994. The amended order 
suspended Respondent's controlled substances license for a period of 
three months. Mr. Goldstein was ordered to pay a $5,000 fine and placed 
on probation for one year and Respondent pharmacy also was placed on 
probation for one year.
    On February 28, 1991, DEA conducted an audit of four controlled 
substances covering the period June 6, 1990 through February 28, 1991, 
following reports of excessive purchases of controlled substances by 
Respondent from local drug distributors. The audit revealed a shortage 
of 1,870 dosage units of Valium 10 milligram tablets.
    Respondent's computer dispensing records for the period covering 
February 2, 1990 through February 7, 1991, revealed that 78 entries 
lacked corresponding paper prescriptions which should have been 
retained by Respondent. Mr. Goldstein subsequently found, and produced 
at the hearing, a number of prescriptions which he maintained had been 
accidentally placed at his home with other prescriptions for non-
controlled substances. Judge Tenney found that Mr. Goldstein was 
responsible for the unaccounted prescriptions.
    In addition, the investigation revealed that Respondent dispensed a 
combination of glutethimide (brand name ``Doriden'') and Tylenol #4, a 
combination known to have a high abuse potential and which typically is 
not prescribed for a legitimate medical purpose. Mr. Goldstein 
testified that he did not agree with manufacturers' guidelines with 
respect to glutethimide because new studies may refute those 
guidelines. He also testified that he did not receive any information 
from the State of Michigan, the DEA or any other source notifying him 
that glutethimide in combination with Tylenol #4 is dangerous or should 
not be prescribed in excess of seven dosage units.
    Judge Tenney found that Mr. Goldstein knew or should have known of 
the dangers of combining the controlled substances and chose to ``shut 
his eyes'' while filling prescriptions. He further found that the 
prescriptions were not issued in the usual course of professional 
treatment.
    On several occasions Respondent dispensed two prescriptions of the 
same or similar controlled substance to the same individual within days 
of dispensing the original prescription. The prescriptions in question 
typically were issued by different physicians. In one such example, a 
physician issued an individual a prescription for 30 dosage units of 
Tylenol #3 on January 24, 1990, which was dispensed by Respondent on 
January 25, 1990. On January 29, 1990, a second physician issued a 30 
dosage unit prescription for Tylenol #4 to the same individual, which 
was dispensed by Respondent on the same date-four days after the 
initial prescription was dispensed.
    This patter continued approximately every two months through 
February 1991, with the individual obtaining two or more prescriptions 
for Tylenol #3 and #4, from a combination of four physicians, which 
Respondent would subsequently dispense within days of each 
prescription. At the hearing on this matter, Mr. Goldstein testified 
that he had contacted each of the prescribing physicians who indicated 
that, although the individual was a drug addict, Mr. Goldstein should 
not be concerned about the prescriptions.
    Prescriptins written for two other individuals were filled under 
similar circumstances. Respondent received a prescription issued to one 
individual for 30 dosage units of Tylenol #3 on June 4, 1990, which was 
dispensed the same day. Respondent then dispensed another prescription 
for Tylenol #3 written to the same person by a second physician on June 
7, 1990. Under the instructions of the first prescription, this 
individual should not have finished the prescription for seven days. 
Respondent dispensed the second prescription only three days after the 
first.
    On January 10, 1990, a third individual was issued a prescription 
for 30 dosage units of Tylenol #4 with one refill. This prescription 
was dispensed by Respondent on January 15, 1990. Two days later, 
Respondent dispensed a second prescription for 30 dosage units of 
Tylenol #4 to the individual based on the prescription of a different 
physician. Throughout 1990, this individual received two prescriptions 
for Tylenol # approximately every two months, from two different 
physicians. The prescriptions were dispensed by Respondent within days 
of each other. One physician informed Mr. Goldstein that this 
individual was a codeine addict.
    The DEA investigator, who testified at the hearing, placed some 
reliance on the number of days set forth in Respondent's computer 
records as to the amount of days that should pass prior to refilling 
prescriptions. In response, Mr. Goldstein testified that his computer 
record of the number of days that should pass prior to refiling a 
prescription is an arbitrary number and does not represent the number 
of days that should pass before a prescription is refilled. Judge 
Tenney, while accepting Mr. Goldstein's explanation of the numbers, 
found that the practice of dispensing prescriptions for the same 
controlled substances to one patient, from several doctors, over an 
excessive [[Page 17576]] period of time to be in violation of 21 CFR 
1306.04.
    The computer printout of prescriptions from Respondent obtained 
through the audit revealed that one individual was dispensed 40 Tylenol 
#3 tablets two times on January 17, 1990, based on one prescription. On 
April 5, 1990, a ``double entry'' also was noted for a prescription for 
Valium to the same person. Mr. Goldstein testified that the individual 
required two separate identification numbers for insurance billing 
purposes, so that Respondent could bill the insurance carrier for the 
cost of the prescription and Medicaid for the co-payment. Mr. Goldstein 
offered the same explanation for the ``double dispensing' of Tylenol #3 
to another individual on November 26, 1990.
    The administrative law judge also found persuasive evidence of 
other recordkeeping and dispensing violations, including dispensing a 
prescription without a DEA registration number on the prescription; 
dispensing three refills of Tylenol #3 to an individual without 
authorization from the prescribing physician; and dispensing a 
prescription that was not signed by the issuing physician.
    Judge Tenney noted several possible mitigating factors. First, 
Respondent is located in a low social economic area where many patients 
are Medicaid recipients. Second, Mr. Goldstein's contentions that he 
was not informed that glutethimide had been reclassified from a 
Schedule III to a Schedule II controlled substance, nor was he put on 
notice as to any potential danger concerning glutethimide. Third, Mr. 
Goldstein testified, as evidence toward his care in dispensing 
controlled substances, that he would confiscate prescriptions that he 
felt were not legitimate.
    In determining whether Respondent's continued registration by DEA 
would be inconsistent with public interest, as that term is used under 
21 U.S.C. 823 and 824, the Deputy Administrator considers the following 
factors set forth in 21 U.S.C. 823(f):
    (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; and
    (5) Such other conduct which may threaten public health and safety.
    The Deputy Administrator is not required to make findings with 
respect to each of the above enumerated factors, but, instead, has the 
discretion to give each factor the weight he deems appropriate, 
depending on the facts and circumstances of each case. See, Henry J. 
Schwartz, Jr., M.D., 54 16422 (1989).
    The administrative law judge found that the Government had met its 
burden of proof with respect to factors (1), (2), (4), and (5) as set 
forth under 21 U.S.C. 823(f). Factor (1) was met based upon the 
Michigan Board of Pharmacy proceedings taken against Respondent and Mr. 
Goldstein. The ultimate findings established significant shortages for 
several controlled substances pursuant to an audit completed in 1989, 
and also encompassed other recordkeeping violations.
    Judge Tenney found that the DEA had met its burden of proof with 
respect to Factor (2) based upon indications from Respondent's records 
that Respondent had dispensed unauthorized prescriptions as reflected 
in the fact that Respondent could not account for 19 paper copies of 
prescriptions. Additionally, Respondent, on numerous occasions, 
dispensed a prescription refill before the prior prescription could 
have been completely consumed by the patient, as determined by the 
prescribing physician's directions or based on the estimates Respondent 
had placed in its dispensing records, and that on many occasions the 
original and the refills were issued by different physicians. Judge 
Tenney noted that a pharmacy may be found in violation of the public 
interest where the pharmacy dispensed controlled substances before the 
prior expiration period had expired and based upon evidence that the 
pharmacy had accepted many prescriptions from various physicians for 
the same substance and patient. See Ralph J. Bertolino's Pharmacy, 55 
FR 4729 (1990). Additionally, where Respondent knowingly dispensed 
these refills to individuals who were characterized by their physicians 
as ``addicts'', Respondent's actions pose a threat to public health and 
safety.
    The administrative law judge found factor (4) was met by evidence 
that Respondent dispensed a prescription without a physician's 
signature and dispensed another prescription without a DEA registration 
number in violation of 21 CFR 1306.04(a). Further, the shortages in 
Respondent's controlled substance inventory, as revealed by the DEA 
audit, constitute a violation of 21 U.S.C. 842(a)(5).
    Finally, concerning factor (5), and with regard to Mr. Goldstein's 
testimony that the glutethimide and Tylenol prescriptions were 
``legal'' and therefore he was not concerned about dispensing 
combinations of these drugs, Judge Tenney found that a pharmacy has a 
responsibility, with respect to controlled substances, to do more than 
merely fill prescriptions as written by a physician. A pharmacy is 
obligated to refuse to fill a prescription if it knows, or has reason 
to know that the prescription was not written for a legitimate medical 
purpose. Medic-Aid Pharmacy, 55 FR 30043 (1989). Indications that a 
prescription is not for legitimate medical use include filling 
prescriptions for customers who received controlled substances in 
quantities far exceeding those recommended by the Physician's Desk 
Reference, too frequently and for excessive periods of time. Id. 
Verification of the prescription with the prescribing doctor is not 
necessarily enough. See United States v. Hayes, 595 F. 2d 258, 260 (5th 
Cir. 1989). Judge Tenney found that Mr. Goldstein purposely ignored 
suspicious prescribing practices by dispensing prescriptions clearly 
not issued for a legitimate medical purpose by presuming that the 
prescriptions were legal because the physicians' signatures did not 
appear to be forged.
    Judge Tenney recommended that Respondent's registration be 
suspended for a period not to exceed six months. He based this 
recommendation on the fact that the Michigan Board of Pharmacy 
previously had suspended Respondent's license for three months and had 
placed Mr. Goldstein on probation for a year and ordered payment of a 
fine of $5,000, and, therefore, had exacted ``full and fair 
retribution'' for Respondent's actions. Charles A. Buscema, M.D., 59 FR 
42857 (1994).
    The Deputy Administrator has carefully reviewed the entire record 
and adopts all of the administrative law judge's findings of fact, with 
the exception of the following: (1) Mr. Goldstein's testimony 
concerning the arbitrary nature of his computer records pertaining to 
the number of days that should pass before a prescription is refilled; 
(2) Mr. Goldstein's testimony regarding instances of creating double 
computer entries for each dispensed prescription as his method of 
accounting for insurance billing purposes. The Deputy Administrator 
also concurs with Judge Tenney's conclusion that the Government has met 
its burden with respect to public [[Page 17577]] interest factors (1), 
(2), (4), and (5) under 21 U.S.C. 823(f).
    The Deputy Administrator, concurring with the Government's 
exceptions, does not agree with Judge Tenney's finding that 
Respondent's location in a low socio-economic area constitutes a 
mitigating factor for Respondent's numerous violations of the laws and 
regulations relating to controlled substances. The Deputy Administrator 
similarly rejects as a mitigating factor, Respondent's plea of good 
faith ignorance in that he was not actually informed of the 
reclassification of glutethimide from a Schedule III to a Schedule II 
controlled substance.
    The Deputy Administrator disagrees with, and declines to follow, 
Judge Tenney's proposed suspension of Respondent's registration. Judge 
Tenney's reliance on Buscema is not applicable to the facts in the 
instant case. In Buscema, Judge Tenney found that Respondent's actions 
in failing to account for the disposition of Schedule II controlled 
substances and his subsequent guilty plea to a felony charge of 
falsifying records concerning controlled substances, occurred over a 
limited period of time and was motivated by his desire to protect his 
wife, an employee of his office and a subsequently rehabilitated drug 
addict suspected of diverting the missing drugs for her own use. In 
finding that the State of New York had exacted ``full and fair'' 
retribution and recommending that Dr. Buscema's registration not be 
revoked, Judge Tenney found, and the Deputy Administrator concurred, 
that Dr. Buscema had served his probationary sentence, had been 
discharged from probation two and one-half years early and had accepted 
responsibility for his conduct and failures regarding his wife's 
chemical dependency.
    The Deputy Administrator finds that the leniency exercised in 
Buscema should not similarly be extended to Respondent in this 
proceeding. Respondent's numerous recordkeeping violations have 
resulted in the diversion of large quantities of controlled substances 
to a number of individuals, including drug addicts. Further, these 
violations were ongoing while previous violations by the State of 
Michigan were being appealed, and, therefore, the State of Michigan 
cannot be found to have exacted its ``retribution'' against Respondent 
for violations which it never had the opportunity to address. 
Additionally, as noted in Judge Tenney's thorough Findings of Fact, 
even aside from the numerous recordkeeping violations, Respondent also 
diverted large amounts of Tylenol with codeine and glutethimide for no 
legitimate medical purpose. Finally, contrary to Dr. Buscema's 
acceptance of responsibility for his actions, Mr. Goldstein, owner of 
Respondent pharmacy, continues to deny any misconduct, including those 
State violations upheld on appeal.
    The Deputy Administrator finds merit in all of the Government's 
exceptions, and further finds that Respondent's ongoing violations of 
Federal and State controlled substance rules and regulations strongly 
indicate that his continued registration with DEA would not be 
consistent with the public interest.
    Accordingly, the 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, BF1175466, issued to Frank's Corner 
Pharmacy, be and it hereby is, revoked, and that any pending 
applications for registration be denied.

    This order is effective May 8, 1995.

    Dated: March 30, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-8402 Filed 4-5-95; 8:45 am]
BILLING CODE 4410-09-M