[Federal Register Volume 63, Number 20 (Friday, January 30, 1998)]
[Notices]
[Pages 4668-4672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2374]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 95-49]
Singer-Andreini Pharmacy, Inc., Revocation of Registration
On June 13, 1995, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to singers-Andreini Pharmacy, Inc. (Respondent) of
West New York, New Jersey, notifying the pharmacy of an opportunity to
show cause as to why DEA should not revoke its DEA Certificate of
Registration, AS0666757, and deny any pending applications for renewal
of such registration as a retail pharmacy under 21 U.S.C 823(f), for
reason that the pharmacy's continued registration would be inconsistent
with the public interest pursuant to 21 U.S.C. 824(a)(4).
On July 10, 1995, Respondent filed a timely request for a hearing,
and following prehearing procedures, a hearing was held in New York,
New York on June 11 and 12, 1996, before Administrative Law Judge Mary
Ellen Bittner. At the hearing, both parties called witnesses to testify
and introduced documentary evidence. After the hearing, Government
counsel submitted proposed findings of fact, conclusions of law and
argument, and counsel for Respondent submitted a closing argument
summation. On October 23, 1997, Judge Bittner issued her Opinion and
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision,
recommending that Respondent's DEA Certificate of Registration be
revoked. Neither party
[[Page 4669]]
filed exceptions to her decision, and on December 12, 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, and his 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 Harry Richman is a
registered pharmacist who has been involved with Respondent pharmacy
for over 30 years. Mr. Richman has jointly owned Respondent with the
Andreini family for a number of years, and during all relevant times to
this case has been the pharmacist-in-charge, responsible for the day-
to-day operation of the pharmacy.
In 1983, DEA conducted an inspection of Respondent after it
received a report from a distributor that Respondent had purchased more
than 88,000 dosage units of Tranxene, a Schedule IV controlled
substance, between April 1, 1982 and February 15, 1983. As part of the
inspection, DEA conducted an accountability audit covering the period
April 1, 1982 to February 15, 1983, which revealed that Respondent
could not account for approximately 4,000 dosage units of various
strengths of Tranxene. This shortage was most likely understated since
DEA used a zero beginning balance in conducting the audit, and as a
result, Respondent was not held accountable for any Tranxene that it
may have had on hand at the beginning of the audit period. In addition
to the audit results, the inspection revealed the following violations
of Federal regulations: numerous prescriptions lacked the patients'
addresses, issuance dates and dates filled; several Schedule II
prescriptions were not maintained separately from other controlled
substance prescriptions; and several Schedule III through V
prescriptions were refilled more than six months after the issuance
date of the prescription. In a letter to DEA dated July 1, 1983,
Respondent indicated that it would correct the alleged violations,
however it did not mention the shortage of Tranxene.
In July 1985, the New Jersey Division of Consumer Affairs conducted
a routine Board of Pharmacy inspection of Respondent. This inspection
noted a number of deficiencies including: (1) A total of 177 outdated
medications were found in the active stock inventory; (2) 12
medications were improperly stored; (3) stock shelves were extremely
dirty and in some places liquid medications had spilled on the shelves
and dried making it difficult to remove some containers; (4) Respondent
failed to dispense generic alternatives for some brand name medications
pursuant to state and Medicaid requirements; (5) patient addresses were
missing from the Exempt Narcotic Register; (6) patient addresses were
not written on some controlled substance prescriptions; (7) DEA numbers
were not written on some controlled substance prescriptions; (8)
Schedule IV controlled substance prescriptions were filed with other
prescriptions for legend drugs without being marked with the required
red letter ``C''; (9) prescriptions received over the telephone failed
to include the physician's address, the patient's address and/or the
physician's DEA number; and (10) Respondent dispensed 13 oral emergency
prescriptions for Schedule II substances without subsequently obtaining
written prescriptions for these dispensations. As a result of this
inspection, by letter dated March 6, 1987, the New Jersey Board of
Pharmacy offered Respondent ``the opportunity to settle this matter and
avoid the initiation of formal disciplinary proceedings'' by paying a
civil penalty of $5,175.00. There is no evidence in the record to
indicate whether Respondent paid this penalty.
On March 19, 1986, another Board of Pharmacy inspection was
conducted of Respondent. This inspection revealed that Respondent: (1)
Maintained 32 outdated medications in the active inventory; (2) failed
to dispense formulary alternatives for popular brand name medications;
(3) dispensed six emergency telephone prescriptions for Schedule II
substances without subsequently obtaining a written prescription; and
(4) dispensed Schedule II substances pursuant to nine prescriptions
that did not include the patients' addresses. Like with the prior state
inspection, by letter dated May 23, 1988, Respondent was offered the
opportunity to avoid formal disciplinary proceedings by paying a
$750.00 civil penalty. Again, there is no evidence in the record to
indicate whether Respondent paid this penalty.
Subsequently, DEA was contacted by a postal employee who indicated
that in September 1990 he had injured his arm at work. According to the
employee, the postmaster encouraged him not to seek medical attention,
and instead told the employee that he would get the employee any drug
he wanted. The employee stated that he told the postmaster that he
wanted Darvocet, a Schedule IV controlled substance, and that
ultimately he was given an unlabeled vial containing approximately 10
to 12 pills inscribed ``Darvocet N-100.'' DEA then interviewed the
postmaster, who at first denied that he was involved in distributing
controlled substances, but later admitted that he had obtained the
Darvocet for the employee from Mr. Richman at Respondent without a
physician's prescription for the medication. At the hearing in this
matter, Mr. Richman asked, ``how could anybody accuse me of that when
there's no label on the bottle?''
DEA then conducted another inspection of Respondent in October
1990. As part of this inspection, DEA audited Respondent's handling of
Darvocet and its generic equivalent, and various strengths of Dilaudid,
a Schedule II controlled substance. The audit covered the period July 1
to October 30, 1990, and revealed a shortage of over 1,000 dosage units
of Darvocet N-100, and over 300 dosage units of Dilaudid 4 mg. The
shortage of Dilaudid was most likely understated since DEA used a zero
beginning balance in conducting the audit, and as a result, Respondent
was not held accountable for any Dilaudid 4 mg. that it may have had on
hand at the beginning of the audit period. In addition to the audit
discrepancies, the inspection of Respondent's records revealed other
violations of controlled substance related regulations during the audit
period. Respondent refilled some controlled substance prescriptions
more than six months after the original prescription was issued and
refilled some controlled substance prescriptions more than five times.
On numerous occasions, Respondent dispensed controlled substances
pursuant to prescriptions which did not bear a DEA number for the
prescribing practitioner and dispend controlled substances on several
occasions pursuant to prescriptions which contained incorrect DEA
numbers. In addition, Respondent filled a Darvocet prescription even
though the patient's address was not on the prescription, and
Respondent failed to maintain some receiving records, including a copy
of a DEA official order form.
Subsequent to this inspection, DEA investigators interviewed two
physicians who had purportedly issued
[[Page 4670]]
controlled substance prescriptions that were found in Respondent's
records. In one instance, the prescription found in the pharmacy was
dated May 31, 1990, however the dispensing log indicated that it was
dated October 9, 1990. The physician told the investigators that while
he had a patient by that name, a check of his records indicated that he
had written a prescription for that patient on May 31, 1990, but had
not authorized a prescription for the patient in October 1990. The
investigators interviewed the second physician regarding a prescription
that appeared to be either a photocopy and/or a forgery. The physician
indicated that he had not seen the patient listed on the prescription
on the date the prescription was supposedly issued; that he did not
issue the prescription; and that he did not write the numeral ``8'' the
way it looked on the prescription.
On July 20, 1992, DEA again inspected Respondent pharmacy and
conducted an accountability audit covering the period October 30, 1990
to July 20, 1992, of the same controlled substances audited in October
1990. This audit revealed total shortages of over 8,000 dosage units.
In addition, a review of Respondent's records during this period
revealed that on a number of occasions, Respondent's dispensing logs
did not list the prescribing physician's DEA number; a number of
controlled substance telephone prescriptions did not contain required
information such as the prescribing physician's DEA number, patient
addresses, dates, physician's addresses, the number of authorized
refills, or a stamped red ``C'' denoting that the prescription was for
a controlled substance. Also, this inspection revealed that Respondent
dispensed Schedule II controlled substances on numerous occasions
pursuant to telephone prescriptions without subsequently obtaining any
written prescriptions for these dispensations, and that several
Schedule II prescriptions were found in the same files as prescriptions
for Schedule III and IV substances. Further, the inspection revealed a
prescription for a Schedule IV controlled substance that was refilled
12 times. The review of the records also revealed that several Schedule
II order forms were missing from Respondent's files.
Following the inspection, DEA investigators interviewed several
physicians who purportedly issued controlled substance prescriptions
that were found in Respondent's files. One physician was asked about
two prescriptions that appeared to be photocopies. The physician
checked his records and determined that he did have a patient by the
name listed on the prescriptions, but that he did not issue photocopied
prescriptions. A second physician was asked about a prescription that
had pertinent information such as the patient's name and address, the
date, and part of the doctor's name covered with correction fluid, and
other information written over those portions of the prescription. The
physician stated that while she did have a patient by the name listed
on the prescription, she had not seen the patient on the date noted on
the prescription. Another physician was interviewed about a
prescription where the date was covered with correction fluid and
January 23, 1991 was written over it. The physician stated that he had
treated that patient on May 26, 1990, but not on January 23, 1991. A
DEA investigator testified that if the prescription is held up to the
light, it appears that the original date under the correction fluid is
May 26, 1990. A fourth physician was interviewed about a prescription
for 25 Percocet, a Schedule II controlled substance. The physician
indicated that she did not have a patient by the name listed on the
prescription and that she would not issue a Percocet prescription
unless a patient had undergone surgery. The investigators interviewed
another physician about a telephone prescription for Darvocet
Respondent's records of this prescription did not indicate the
patient's or physician's address, the physician's DEA number, nor any
indication as to whether refills were authorized. Nonetheless,
Respondent's records showed that this prescription was refilled twice.
The physician indicated that he did not have a patient by the name
indicated on the prescription. Finally, a physician was interviewed
about a prescription that she had purportedly issued for an individual
for 40 dosage units of Percocet. It appeared that there was correction
fluid on the prescription and that the quantity authorized had been
altered from 10 to 40 dosage units. After checking her records, the
physician confirmed that she had issued a prescription for the
individual on the date listed, however she had only authorized 10
dosage units.
During the course of the investigation, DEA investigators
interviewed a former employee of Respondent who alleged that the clerk/
bookkeeper at Respondent would divert controlled substances from orders
received at Respondent, then telephone the distributor telling it that
it had forgotten to ship whatever she had taken, and then sell or trade
the drugs. The former employee also told the investigators that when
Mr. Richman would leave Respondent for whatever reason, he would leave
a pharmacy intern in charge of the pharmacy, and that the pharmacy
interns would divert controlled substances and distribute them without
a prescription. At the hearing, Mr. Richman characterized the former
employee as a ``disgruntled person'' who understood very little
English.
The former employee's daughter had worked at Respondent as a clerk
and she also was interviewed by the investigators. She stated that she
saw Mr. Richman give controlled substances to customers without a
prescription; that Mr. Richman's employees and friends took controlled
substances from Respondent; and that she saw Mr. Richman and pharmacy
interns exchange controlled substances for food with an individual who
worked at a local food store. At the hearing, Mr. Richman testified
that the former employee's daughter, ``never, never worked the drug
counter. * * * So she couldn't hear anything and she didn't have enough
intelligence to sense anything.'' The former employee's son told the
investigators that he sometimes ran errands for Respondent and that he
has seen the owner of the business next door to Respondent go into
Respondent's dispensing area and take medication. At the hearing, Mr.
Richman testified that the son never worked for him and that ``he was a
special ed student.''
On February 10, 1994, DEA investigators conducted another
inspection of Respondent during which Respondent's prescription files
were seized. Upon reviewing Respondent's records, the investigators
determined that a number of prescriptions and 134 daily dispensing logs
had not been provided by Respondent. Consequently, the investigators
returned to Respondent on two other occasions in order to obtain from
Respondent's computer the dispensing information necessary to conduct
an accountability audit. DEA then conducted an audit of certain
Schedule II controlled substances for the period May 4, 1993 through
February 10, 1994, and of certain Schedule III through V controlled
substances for the period May 7, 1993 to February 10, 1994. The audits
revealed discrepancies in Respondent's recordkeeping, including a
shortage of 3,351 dosage units of Fiorinal with codeine #3, a Schedule
III controlled substance.
In addition to the audit results, the 1994 inspection revealed
other violations of Federal regulations relating to controlled
substances. A review of
[[Page 4671]]
Respondent's dispensing logs disclosed a number of instances where an
invalid DEA number was listed for the prescribing physician, and a
number of occasions where Respondent dispensed Schedule II controlled
substances pursuant to telephone prescriptions without subsequently
obtaining any written prescriptions for these dispensations. A review
of Respondent's prescription files revealed numerous prescriptions that
did not contain required information such as the physician's name, the
physician's DEA number, the patient's name, the patient's address, and/
or the date issued. In addition, approximately 13 Schedule II
controlled substance prescriptions were filed with prescriptions for
Schedule III and IV substances instead of separately. Also, while
conducting the inspection of Respondent, a DEA investigator observed a
note taped to the wall in the dispensing area that appeared to be an
``IOU'' for Demerol, A Schedule II controlled substance, and Klonopin,
a Schedule IV controlled substance. When asked about the note, Mr.
Richman replied that another area pharmacy had loaned him the drugs,
however the investigator found no order form or other record of this
controlled substance transfer.
After reviewing records seized during the 1994 inspection, DEA
sought to verify three controlled substance prescriptions found in
Respondent's files that had purportedly been written by physicians
working at a local hospital. The hospital's records indicated that none
of these prescriptions were authorized, however the DEA investigator
did not contact the physicians who purportedly issued the prescriptions
to determine whether they had authorized them. In addition, the DEA
investigator interviewed four physicians about a total of nine
controlled substance prescriptions that were purportedly issued by them
and found in Respondent's files. The physicians all indicated that they
did not authorize the prescriptions attributed to them.
At the hearing in this matter, Mr. Richman did not offer any
explanation for the audit discrepancies or recordkeeping violations
discovered during the various inspections of Respondent. Respondent
testified that no one at Respondent pharmacy ever forged a
prescription. In addition, Mr. Richman testified that ``[a]nytime we
get a narcotic that's of a tremendous amount and quantity and we don't
know who the patient is, especially from out of town New York, which we
don't even fill, we always call a doctor.'' Further, Mr. Richman
testified that the prescriptions with correction fluid found at
Respondent were probably first brought to another pharmacy and not
filled for some reason.
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 of 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 F.R.
16,422 (1989).
As a preliminary matter, Respondent argues that its registration
should not be revoked because most of the Government's case is based on
hearsay and is therefore unreliable. The Acting Deputy Administrator
disagree with Respondent's contention. ``. . .[H]earsay is both
admissible, and may, standing by itself, constitute substantial
evidence in support of an administrative decision.'' Klinestiver v.
Drug Enforcement Administration, 606 F.2d 1128 (D.C. Cir. 1979).
Regarding factor one, there is evidence in the record that the New
Jersey Board of Pharmacy conducted inspections of Respondent in 1985
and 1986, both of which revealed numerous violations. In both instances
the Board of Pharmacy offered Respondent the opportunity to pay civil
penalties in order to avoid formal disciplinary action, however, there
is no evidence in the record whether Respondent even paid these fines.
There is also no evidence in the record to suggest that the Board of
Pharmacy has restricted Respondent's pharmacy permit or Mr. Richman's
license to practice pharmacy. But as Judge Bittner notes, ``sate
licensure is a necessary but not sufficient condition for DEA
registration.'' Therefore, the fact that Respondent currently possesses
and unrestricted state license is not dispositive of the issue of
whether or not to revoke its DEA registration.
Factors two and four, Respondent's experience in dispensing
controlled substances and its compliance with applicable laws and
regulations relating to controlled substances, are extremely relevant
in this proceeding. The record clearly establishes Respondent's long
history of failure to comply with the laws and regulations relating to
the dispensing of controlled substances. The state conducted
inspections of Respondent in 1985 and 1986 and DEA conducted
inspections, which included accountability audits, in 1983, 1990, and
1994. Each of these inspections revealed numerous recordkeeping
deficiencies.
The state inspections revealed a number of violations of state
requirements relating to controlled substances. The DEA inspections
revealed Respondent's failure to keep complete and accurate records of
its handling of controlled substances as required by 21 U.S.C. 827 and
21 CFR 1304.21, and as evidenced by the various audit results. In
addition, Respondent dispensed controlled substances pursuant to both
oral and written prescriptions found in its files that did not contain
information required by 21 CFR 1306.05(a), such as the physician's DEA
registration number, the patient's address, and/or the date of
issuance. Also, oral prescriptions for Schedule II controlled
substances were dispensed without subsequently obtaining a written
prescription for the dispensation in violation of 21 CFR 1306.11, and
Schedule II prescriptions were intermingled in Respondent's files with
Schedule III and IV controlled substance prescriptions in violation of
21 CFR 1304.04(h)(1). Further, Respondent refilled substance
prescriptions more than five times, and in some instances, more than
six months after the original prescription was issued, both in
violation of 21 CFR 1306.22(a).
In addition, Respondent dispensed controlled substances without a
valid prescription in violating of 21 U.S.C. 829, as evidenced by the
Darvocet given to the postal employee in 1990. The Acting Deputy
Administrator further finds that the physician interviews conducted by
DEA establish that Respondent dispensed controlled substances without a
physician's authorization. As Judge Bittner notes, ``although the
evidence as to
[[Page 4672]]
unauthorized dispensing is hearsay, Respondent offered no contraditory
evidence.'' The Acting Deputy Administrator concurs with Judge
Bittner's conclusion that ``although it is possible that some of the
physicians interviewed by investigators may have been mistaken, it
strains credulity past the breaking point to find that all were.''
Further, there is evidence in the record that Respondent dispensed
controlled substances pursuant to prescriptions that appeared on their
face to be forged and/or altered, and therefore not valid. Respondent
argues that the Government did not prove that anyone at Respondent
forged the prescriptions. The Acting Deputy Administrator finds that
Respondent is correct, however the mere fact that Respondent dispensed
controlled substances pursuant to clearly forged and/or altered
prescriptions is evidence of Respondent's violation of its
corresponding responsibility, as set forth in 21 CFR 1306.04, for the
proper prescribing and dispensing of controlled substances.
Other violations noted during these inspections were: failure to
maintain all its records of receipt, including DEA order forms, as
required by 21 CFR 1304.04 and 21 CFR 1305.13; failure to maintain
records in a readily retrievable manner as require by 21 CFR
1304.04(h)(2), and as evidenced by its inability to provide its
dispensing records during the 1994 inspection; failure to use a DEA
order form when transferring Schedule II controlled substances between
registrants as required by 21 CFR 1305.03, and as evidence by the
``IOU'' for Demerol found at the pharmacy during the 1994 inspection.
The Acting Deputy Administrator concurs with Judge Bittner's
conclusion that ``Respondent has presented no evidence explaining its
extraordinary history of noncompliance, nor did Mr. Richman provide any
basis for me to conclude that Respondent would be more mindful of and
compliant with applicable law and regulations in the future.'' Of
particular concern to the Acting Deputy Administrator is that many of
the same violations were discovered during each of the inspections.
There is no evidence of any effort on Respondent's part to correct the
deficiencies after each inspection. This cavalier attitude towards
compliance with the Controlled Substances Act and its implementing
regulations is extremely troubling. The Acting Deputy Administrator
finds that these factors weigh in favor of a conclusion that
Respondents continued registration would not be in the public interest.
Regarding factor three, there is no evidence that Respondent or Mr.
Richman has ever been convicted under state or Federal laws relating to
controlled substances. As to factor five, the Acting Deputy
Administrator agrees with Judge Bittner and Government counsel that Mr.
Richman's ``recalcitrant'' attitude evidences that he ``is either
unwilling or unable to accept the responsibility inherent in a DEA
registration.
Judge Bittner concluded ``that the record as a whole establishes
that Respondent's registration with the DEA would be inconsistent with
the public interest,'' and therefore recommended that its registration
be revoked. The Acting Deputy Administrator agrees. Respondent's
continued failure to abide by the laws and regulations in place to
prevent the diversion of controlled substances clearly justifies the
revocation of its DEA Certificate of 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 DEA Certificate of Registration AS0666757, previously issued to
Singers-Andreini Pharmacy, Inc., be, and it hereby is, revoked. The
Acting Deputy Administrator further orders that any pending
applications for the renewal of such registration, be, and they hereby
are, denied. This order is effective March 2, 1998.
Dated: January 20, 1998.
Peter F. Gruden,
Acting Deputy Administrator.
[FR Doc. 98-2374 Filed 1-29-98; 8:45 am]
BILLING CODE 4410-09-M