[Federal Register Volume 59, Number 171 (Tuesday, September 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21830]
[[Page Unknown]]
[Federal Register: September 6, 1994]
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DEPARTMENT OF JUSTICE
[Docket No. 93-44]
Dellmar Pharmacy #4; Revocation of Registration
On April 8, 1993, the Deputy Assistant Administrator (then
Director), Office of Diversion Control, Drug Enforcement Administration
(DEA), directed an Order to Show Cause to Dellmar Pharmacy #4
(Respondent), proposing to revoke its DEA Certificate of Registration,
AD0931407, as a retail pharmacy under 21 U.S.C. 824(a)(4), and to deny
any pending applications under 21 U.S.C. 823(f). The Order to Show
Cause alleged that the continued registration of the Respondent would
be inconsistent with the public interest.
The Respondent, by counsel, requested a hearing on the issues
raised in the Order to Show Cause. The matter was docketed before
Administrative Law Judge Mary Ellen Bittner. Following prehearing
procedures, a hearing was held in San Antonio, Texas on October 28,
1993.
On May 27, 1994, Judge Bittner issued her opinion and recommended
ruling, findings of fact, conclusions of law and decision in which she
recommended that the Respondent's registration be revoked. Respondent
filed exceptions to this opinion, and on June 27, 1994, the
administrative law judge transmitted the record of the proceedings to
the Deputy Administrator.
The Deputy Administrator has considered the record in its entirety
and, pursuant to 21 CFR 1316.67, enters his final order in this matter,
based on findings of fact and conclusions of law as hereinafter set
forth.
The administrative law judge found that in 1990, the DEA and the
State of Texas began a joint investigation of Respondent based upon a
complaint that a customer was receiving controlled substances without a
physician's authorization. Investigators acquired a patient profile
printout of pharmacy records for this customer, and determined from the
listed physician that he had not prescribed the medication indicated.
Investigators commenced an audit of the controlled substances which
revealed shortages of Fastin, Dalmane, and flurazepam, all Schedule IV
controlled substances. Investigators then requested a physician profile
printout of pharmacy records which revealed that prescriptions had been
filled for several other customers which also were erroneously
attributed to this same physician. Subsequently, Respondent's owner and
pharmacist-in-charge, Mr. Jesus Garcia, admitted that he had filled or
refilled prescriptions for a number of customers without a physician's
authorization. The audit revealed that Respondent had filled 218
controlled substance prescriptions and refilled 58 others without a
physician's authorization.
The administrative law judge found that statements given to
investigators by Respondent's customers indicated that customers were
told to call Respondent when they needed anything, and that they would
be issued controlled substances via prescriptions attributed to various
doctors and filled under various patient names and addresses.
Statements from the physicians involved revealed that although they may
have treated the customers indicated with various courses of drugs,
they often had neither issued these patients prescriptions for the
controlled substances, nor did they authorize the frequency of
prescribing attributed to them. These prescriptions included a wide
variety of Schedule III and IV controlled substances.
The administrative law judge found that on May 29, 1991, Mr. Garcia
was indicted in Bexar County, Texas, on a charge of furnishing a
fraudulent prescription to a state investigator. Upon his plea of
guilty, he was sentenced to four years deferred adjudication and
probation.
The administrative law judge further found that on April 29, 1992,
the Texas Pharmacy Board suspended Mr. Garcia's license for two years,
probating all but 90 days of that period, ordered that the pharmacy pay
a $3,000 fine, and required that Mr. Garcia pass a Texas Pharmacy
Jurisprudence examination before resuming the practice of pharmacy.
Under 21 U.S.C. 824(a)(4), and pursuant to 21 U.S.C. 823(f), ``[i]n
determining the public interest, the following factors shall 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.''
It is well established that these factors are to be considered in
the disjunctive, i.e., the Deputy Administrator may properly rely on
any one or a combination of factors, and give each factor the weight he
deems appropriate. Henry J. Schwarz, Jr., M.D., 54 FR 16422 (1989).
Of the stated factors, the administrative law judge found that all
were relevant and that there was a statutory basis for revocation based
on findings that Respondent engaged in a definite and clear pattern of
furnishing huge quantities of controlled substances and other
prescription medication to customers without physician authorization,
and that Respondent was unable to account for substantial quantities of
controlled substances. Respondent offered as evidence statements made
by some of the physicians that they had actually treated some of the
customers, and argued that there was a potential that the physician
records failed to reflect authorization of certain prescriptions. Judge
Bittner found this to be speculative and insufficient to counter the
overwhelming evidence that Respondent's behavior was egregious and a
total abrogation of its obligations as a DEA registrant. The
administrative law judge concluded that Respondent's continued
registration would not be in the public interest.
Respondent filed exceptions to the opinion and recommended ruling
of the administrative law judge asserting that the administrative law
judge failed to consider that Mr. Garcia cooperated with authorities in
the criminal proceeding brought against him and, as a result, he was
given the least possible punishment. Furthermore, he asserted that the
administrative law judge failed to consider as evidence of future
conduct, the fact that Mr. Garcia cooperated fully with DEA and State
officials and Mr. Garcia was in compliance with this probation.
Finally, Respondent argued that it has suffered enough revocation of
its DEA registration would be devastating to Mr. Garcia and the low
income community it services.
The Deputy Administrator finds that the administrative law judge
has fully considered the facts and circumstances surrounding Mr.
Garcia's guilty plea, which however, were outweighed by the
Respondent's recent pattern of fraudulent activity which led to the
diversion of large quantities of controlled substances. The Deputy
Administrator adopts the findings of fact, conclusions of law, and
recommended ruling of Administrative Law Judge Bittner in its entirety.
Based on the foregoing, the Deputy Administrator concludes that the
Respondent's continued registration would not be in 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 (59 FR 23637), hereby orders
that DEA Certificate of Registration, AD0931407, issued to Dellmar
Pharmacy #4, be and it hereby is, revoked; and that any pending
applications, be, and they hereby are, denied. This order is effective
October 6, 1994.
Dated: August 30, 1994.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 94-21830 Filed 9-2-94; 8:45 am]
BILLING CODE 4410-09-M