[Federal Register Volume 62, Number 13 (Tuesday, January 21, 1997)]
[Notices]
[Pages 3056-3064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1385]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 94-54]
Rocco's Pharmacy; Revocation of Registration
On May 23, 1994, the then-Director, Office of Diversion Control,
Drug Enforcement Administration (DEA), issued an Order to Show Cause to
Rocco's Pharmacy (Respondent) of Bristol, Pennsylvania, notifying the
pharmacy of an opportunity to show cause as to why DEA should not
revoke its DEA Certificate of Registration, AR8587125, and deny any
pending applications for 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 5, 1994, the Respondent, through counsel, filed a timely
request for a hearing, and following prehearing procedures, a hearing
was held in Philadelphia, Pennsylvania on March 22, 1995, before
Administrative Law Judge Mary Ellen Bittner. At the hearing, both
parties called witnesses to testify, and introduced documentary
evidence.
Following the hearing, but before post-hearing briefs were filed,
on April 10, 1995, Respondent filed a Motion to Reopen the Record to
Permit Testimony Regarding the Accuracy of the Pill Count (Motion to
Reopen the Record), a Motion to Permit Oral Argument at the Conclusion
of the Briefing Schedule (Motion for Oral Argument), and a Motion to
Admit Character Reference Testimony into the Record. On April 19, 1995,
the Government filed a Motion in Opposition to Respondent's Motion to
Reopen the Record to Permit Testimony Regarding the Accuracy of the
Pill Count, and on April 24, 1995, the Government filed a Motion in
Opposition to Respondent's Motion to Permit Oral Argument. On May 10,
1995, the Administrative Law Judge issued a Memorandum to Counsel and
Ruling on Motions granting Respondent's Motion to Admit Character
Reference Testimony into the Record, and denying Respondent's Motion to
Reopen the Record and Motion for Oral Argument.
Subsequently, both parties filed proposed findings of fact,
conclusions of law and argument. Then on June 20, 1995, Respondent
filed a Motion for Disqualification of Chief Administrative Law Judge
Mary Ellen Bittner and Memorandum of Law in Support of Motion (Motion
for Disqualification). On March 26, 1996, Judge Bittner issued her
Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law
and Decision, denying Respondent's Motion for Disqualification and
recommending that Respondent's DEA Certificate of Registration be
revoked. Thereafter, on April 18, 1996, Respondent filed its Exceptions
to Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law
and Decision of the Administrative Law Judge, and on April 30, 1996,
the record of these proceedings was transmitted to the Deputy
Administrator.
Subsequently, on May 9, 1996, Respondent submitted a Motion for
Leave to File Supplemental Exceptions as well as Supplemental
Exceptions to Opinion and Recommended Rulings, Findings of Fact,
Conclusions of Law and Decision of the Administrative Law Judge. Judge
Bittner forwarded these filings to the Deputy Administrator on May 9,
1996. By letter dated May 10, 1996, the then-Deputy Administrator
accepted for consideration Respondent's Supplemental Exceptions and
provided the Government an opportunity to file a response to these
exceptions. The Government filed its Response to
[[Page 3057]]
Respondent's Supplemental Exceptions on May 20, 1996.
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, except as specifically
noted below, the Findings of Fact, Conclusions of Law and Recommended
Ruling 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 James Rocco, Jr. has been a
registered pharmacist since 1965, and has owned Respondent pharmacy
since 1976. In August 1989, a confidential informant indicated to the
Bristol Township Pennsylvania Police Department (Bristol P.D.) that an
individual named Ozzie Willis was his source for pharmaceutical drugs
and that Mr. Willis was obtaining controlled substances from Respondent
without a prescription. Subsequently, Mr. Willis, while under
surveillance, obtained controlled substances from Respondent without
presenting a prescription and then gave the drugs to the confidential
informant in exchange for money. Mr. Willis was then arrested in April
1990. At the time of his arrest, Mr. Willis' car was searched,
revealing two empty prescription vials indicating that they had been
filled with Percocet, a Scheduled II controlled substance, at another
pharmacy, an envelope with 31 Tylenol with codeine #4 (Tylenol #4), a
Schedule III controlled substance, a vial from another pharmacy
containing 27 Percocet tablets and several loose pills.
Prior to 1990, Ozzie Willis had been found guilty in 1984 and 1986
of the unlawful sale of controlled substances. At the time of his
arrest in April 1990, Mr. Willis agreed to cooperate in an
investigation of Respondent. Mr. Willis was told that the Bristol P.D.
could not promise him anything in exchange for his cooperation, but
would testify on his behalf in any proceedings regarding his recent
arrest. As part of his agreement with the Bristol P.D., Ozzie Willis
was not to purchase controlled substances elsewhere or to go into
Respondent pharmacy except when under police surveillance.
Consequently, Mr. Willis, while under surveillance, went to
Respondent pharmacy on 15 occasions between April 30 and June 29, 1990
attempting to obtain controlled substances. On each occasion, Mr.
Willis was equipped with a recording device and he and his car were
thoroughly searched before he entered Respondent. He was under constant
police surveillance from the time of the search until he entered the
pharmacy and again from the time he left until he was searched again.
He was not given advance notice of when an attempted controlled buy
would occur.
Mr. Willis' first attempted buy was on April 30, 1990, when he went
into Respondent with $40.00 and a prescription vial for prescription
number 377809 dated April 18, 1989 for Ozzie Willis. Mr. Willis came
out of Respondent with 90 tablets of Tylenol #4 in the prescription
vial he brought into the pharmacy. The transcript of this visit
reflects that Ozzie Willis stated, ``* * * so this is 40 here for a
hundred for today, Social Security check come in I'll pay you 40 right?
I didn't bother you last week remember that?'' to which Mr. Rocco
replied, ``Yea, O.K.'' Mr. Rocco testified that he dispensed Tylenol #4
to Ozzie Willis pursuant to a telephone prescription from Dr. N.
However, Dr. N testified at Mr. Rocco's subsequent criminal trial that
while Ozzie Willis had previously been a patient of his, he no longer
practiced in the area; he had last treated Ozzie Willis in August 1986;
and had not authorized the April 30, 1990 prescription.
Ozzie Willis returned to Respondent on May 3, 1990. While Mr.
Willis did not obtain any controlled substances on this occasion the
transcript indicates that Mr. Willis asked for Percocet and Mr. Rocco
replied, ``* * * I'll tell you what, I'll get a script tonight from a
doctor, pick it up tomorrow * * *.'' Mr. Rocco testified at both his
criminal trial and at the hearing before Judge Bittner that he would
say anything to Mr. Willis to get him to leave the pharmacy because he
was rude and obnoxious.
Mr. Willis went back to Respondent pharmacy the next day, May 4,
1990, and came out of Respondent with 30 Percocet tablets in a bottled
marked UNI-ACE, a nonprescription pain reliever. Respondent introduced
into evidence at the hearing a copy of a prescription for a J.C. dated
May 2, 1990 for Percocet, and a copy of a receipt dated May 4, 1990
made out to Ozzie Willis listing two prescriptions for J.C. The
transcript of this visit indicates that Ozzie Willis paid Mrs. Rocco
$30.00, however there was no mention of J.C. and his prescriptions. Mr.
Rocco testified at the hearing that he sold UNI-ACE to Ozzie Willis on
May 4, 1990. However, there is nothing on the receipt introduced into
evidence by Respondent indicating such a sale.
Ozzie Willis returned to Respondent on May 7, 1990. According to
the Bristol police detective who testified at the hearing, Mr. Willis
was given $40.00 and the same prescription bottle used on April 30,
1990. Mr. Willis came out of Respondent with 101 Tylenol #4 in the
prescription bottle. A receipt introduced into evidence by Respondent
indicated that Ozzie Willis picked up a prescription for S.C. and paid
$40.00 on his account. Mr. Rocco testified at the criminal trial that
he did not provide Tylenol #4 to Ozzie Willis on May 7, 1990.
According to the transcript, on May 9, 1990, Ozzie Willis went to
Respondent and asked Mrs. Rocco to ``* * * ask Rocco if I can, can get
some more Percs one day next week, either that or either Placidyls.''
Ozzie Willis did not obtain any controlled substances on this occasion.
Mr. Willis returned to Respondent pharmacy on May 16, 1990 with
$40.00 and the prescription bottle used on April 30, 1990. He came out
of Respondent without the $40.00 and with 100 Tylenol #4 in the
prescription bottle. Respondent introduced into evidence a copy of
call-in prescription number 409233 from Dr. N for Ozzie Willis for 100
APAP with codeine 60 mg. and a copy of a receipt dated May 16, 1990,
indicating that Ozzie Willis paid $20.00 for ``Rx 409233'' and $20.00
for lottery tickets. According to the transcript of this visit, Ozzie
Willis told Mr. Rocco, ``* * * I really need them Percs * * *. I done
got part of the guy's money.'' Mr. Rocco replied, ``* * * I just got a
script from that doctor, thought I'd get you 30 and that would be it.
Thirty I got.'' Mr. Rocco told Ozzie Willis to check back with him in
two weeks.
On May 18, 1990, Mr. Willis went to Respondent and asked Mr. Rocco
if he had obtained ``the script from that other doctor,'' to which Mr.
Rocco replied, ``No, not til the end of the month.'' Mr. Rocco
testified that he assumed that at the time of this conversation that
Ozzie Willis was showing him a bottle for a prescription that could not
be filled until the following week.
Ozzie Willis returned to Respondent on May 24, 1990 with $100.00
and emerged with $60.00 and a prescription vial bearing prescription
number 410166, indicating that Dr. N was the prescriber, and containing
30 Placidyl, a Schedule IV controlled substance. Respondent placed into
evidence a copy of such a call-in prescription. The doctor testified at
Mr. Rocco's criminal trial and denied ever having called in any of the
prescriptions in question to Respondent.
On May 30, 1990, another controlled buy was attempted, but Ozzie
Willis did not obtain any controlled substances.
[[Page 3058]]
While in the pharmacy, Mr. Willis told Mr. Rocco, ``I thought you said
Percocet, on the first.'' Mr. Rocco replied, ``I'll let you know when I
get that * * * from the doctor.''
On June 4, 1990, Ozzie Willis visited Respondent and asked Mr.
Rocco, ``* * * did you see that doctor?'' to which Mr. Rocco replied,
``No, not yet.'' Mr. Willis then asked, ``You don't know when?'' and
ultimately Mr. Rocco responded, ``Thursday morning, come in and see me
then.''
Ozzie Willis then went to Respondent on June 7, 1990, with $60.00
and when he exited the pharmacy, he had a white plastic bottle marked
``Pfeiffer 3+weight loss supplement'' which contained 100 Tylenol #4.
The transcript indicates that Mrs. Rocco refers to a $40.00 charge.
Respondent introduced into evidence a copy of a call-in prescription
number 411301 from Dr. N for Ozzie Wills for 100 APAP with codeine 60
mg. and copy of a receipt dated June 7, 1990 indicating that Ozzie
Willis paid $40.00 on account, including $20.00 for prescription number
411301. Again, Dr. N testified earlier that he had not called not
called in any of the prescriptions for Ozzie Willis during the time
period in question.
While in Respondent on June 12, 1990, Ozzie Willis said to Mrs.
Rocco, ``He [apparently referring to Mr. Rocco] told me I could get
Percocets the first of this month.'' Mrs. Rocco then told Mr. Willis to
call Mr. Rocco the next day.
Ozzie Willis telephoned Respondent on June 13, 1990. During the
conversation, Mr. Willis told Mr. Rocco, ``I was in yesterday and Mrs.
Rocco told me to call you this morning about the Percocets I was
supposed to get the first of the month.'' Mr. Rocco replied, ``yea, if
I can get the script.'' Mr. Rocco indicated that the doctor was in the
hospital and Ozzie Willis then asked, ``You got any idea when, cause I
got people, got three guys waiting for them.'' Mr. Rocco responded,
``it probably won't be till the end of the month, he's supposed to be
back the 25th, to work.'' Mr. Willis then asked if he could get some
``4's'' next week, apparently referring to Tylenol #4. Mr. Rocco
replied, ``Yea, next week's fine.''
On June 20, 1990, Mr. Willis visited Respondent but did not obtain
any controlled substances. During the conversation there was some
discussion of whether Mr. Willis could ``get these this week.'' Mr.
Rocco said, ``No sooner than Thursday,'' and then asked Mr. Willis,
``You gonna hold it or not?'' Mr. Willis responded affirmatively, and
Mr. Rocco said, ``Yea cause it goes by days, everything's finally
computerized, you can't, you know * * *.''
According to the transcript, on June 28, 1990 Ozzie Willis asked
Mr. Rocco, ``Did the doctor, you tell me the 25th * * *'' and Mr. Rocco
replied, ``yea, tomorrow morning come back * * *.'' According to
Respondent's prescription log book, Ozzie Willis picked up two
prescriptions for non-controlled substances for S.C.
On June 29, 1990, Ozzie Willis went into Respondent with $60.00 and
returned with $30.00 and 30 Percocet in a small unlabeled box in a
brown bag. Mr. Rocco testified that he did not dispense Percocet to
Ozzie Willis on this occasion and that he never provided medication to
Ozzie Willis, or to anyone else, in other than a properly labeled
container. There was no prescription for Percocet for Ozzie Willis
dated June 29, 1990 found at Respondent pharmacy.
Subsequent to the completion of the investigation, it was learned
that Ozzie Willis was in Respondent on several occasions when he was
not under surveillance by the Bristol P.D., and that he obtained
controlled substances from other pharmacies between April 30 and June
29, 1990, both in violation of his agreement with the Bristol P.D. In
addition, evidence was introduced into the record which indicated that
both before and after the dates of the investigation, Ozzie Willis
obtained controlled substances from other pharmacies pursuant to
doctors' prescriptions.
Mr. Rocco testified that he had known Ozzie Willis for
approximately 6-7 years before the investigation; that Mr. Willis was a
very rude person; that he never came into the pharmacy as frequently as
he did between April 30 and June 29, 1990; and that Ozzie Willis'
prescriptions indicated that the medication was for back pain and
perhaps arthritis. Mr. Rocco testified that because Ozzie Willis was so
loud and obnoxious when he was in Respondent, Mr. Rocco would say
anything and agree with Mr. Willis in order to get him out of the
store. However, Mr. Rocco testified that he never provided Ozzie Willis
with controlled substances except pursuant to what Mr. Rocco believed
to be a proper prescription.
On July 23, 1990, a search warrant was executed at Respondent
pharmacy by a number of officers of the Bristol P.D., an agent of the
Pennsylvania Bureau of Narcotics Investigation (BNI), and an assistant
district attorney. Given the number of people in Respondent during the
execution of the warrant, it was very crowded and chaotic. Respondent's
records pertaining to controlled substances, as well as its computer,
were seized. No biennial inventory was found. Mr. and Mrs. Rocco
cooperated with the search and showed the officers the various
locations where the controlled substances and controlled substance
records were kept. The BNI agent conducted a count of the Schedule II
controlled substances on hand, however Mr. Rocco testified that it was
not done under his ``direct supervision'' because he was getting things
for the other officers.
Subsequent to the execution of the search warrant, a DEA
investigator conducted an accountability audit of Respondent's handling
of Percocet and its generic equivalents for the period May 1, 1989
through July 23, 1990. Since Respondent did not have a biennial
inventory, the investigator first used a zero initial inventory figure
for May 1, 1989. However, after reviewing Respondent's records, the
investigator determined that while Respondent had not received any
Percocet or its generic equivalents between May 1, and May 28, 1990
(the date of its first record of receipt), it had dispensed 1,708
dosage units. Therefore, the investigator used 1,708 as the initial
inventory figure on the premise that Respondent could not have
dispensed what it did not have. In its post-hearing filings, Respondent
argued that the investigator's premise was incorrect because it
contended that Respondent's first receipt of Percocet was May 25, 1990
and not May 28, 1990, and that it had dispensed 278 dosage units
between May 25 and May 27, 1990. The Acting Deputy Administrator
concludes that the investigator's interpretation of the records was
correct. Pursuant to 21 CFR 1305.09(e), a purchaser of controlled
substances (in this instance Respondent) is required to indicate the
date of receipt of Schedule II controlled substances on the appropriate
copy of the order form. Respondent introduced into evidence a copy of
the order form signed by Mr. Rocco which indicates that the Percocet
was received on May 28. It is possible that Respondent is confused and
that May 25 is the date the Percocet was shipped by the wholesaler, but
it was not the date received. Accordingly, the Acting Deputy
Administrator finds that the initial inventory figure of 1,708 was
proper.
Respondent's records, as well as summaries from the wholesaler,
indicated that Respondent received 27,000 dosage units of Percocet and
its generic equivalents during the audit period. Therefore, Respondent
was accountable for 28,708 dosage units.
The DEA investigator did not conduct the closing inventory, but
used the
[[Page 3059]]
figure provided to her by the BNI agent who conducted the count of
drugs on hand during the execution of the search warrant. The BNI agent
testified at the hearing that it was unusual to conduct a pill count
during execution of a warrant and both Mr. and Mrs. Rocco testified
that it was chaotic with so many people in the store. However, the BNI
agent repeatedly asked both Mr. and Mrs. Rocco where all of the
Schedule II controlled substances were located. The BNI agent testified
that in conducting the count, she used a pill counter, but since that
is not very reliable, she verified the count by hand. Mrs. Rocco stated
that she did not see the agent doing a hand count. However, as noted
above, it was very crowded and chaotic in the store.
During questioning at the hearing regarding her notes of the pill
count, the BNI agent stated that she would not know which specific
types of generic equivalents of Percocet she counted since she listed
everything under Percocet, specifying each bottle by the manufacturer,
not the name of the substance, However, the BNI agent testified that
she counted all of the Percocet and generic equivalents shown to her by
the Roccos. The BNI agent concluded that Respondent had 2,657 dosage
units of Percocet and its generic equivalents on hand on July 23, 1990.
Respondent argues that the closing inventory is inaccurate since
the BNI agent's notes do not reflect the generic manufacturers for
oxycet and roxicet and therefore those substances were not counted.
Both Mr. and Mrs. Rocco testified that they believed that throughout
1990, Respondent always maintained some oxycet and roxicet. Order forms
introduced into evidence by Respondent indicate that both oxycet and
roxicet were purchased during the audit period. However the Acting
Deputy Administrator agrees with the Administrative Law Judge that
Respondent offered no definitive evidence that oxycet and roxicet were
on hand on July 23, 1990, and given Respondent's overall dispensing
pattern of Percocet it would not be unreasonable to find that there
might not have been any on hand on that date.
In its Supplemental Exceptions, Respondent also argues that the
closing inventory figure in the computation chart is inaccurate due to
a mathematical error. Respondent contends that the BNI agent's notes
indicate that the closing figure should have been 4,248 dosage units
rather than 2,657, since the BNI agent failed to add in 1,591 which was
noted as ``Perc Gen'' in her notes. The Acting Deputy Administrator
finds that this argument is without merit. As the Government asserts,
``Perc Gen'' is most likely referring to Percodan, not Percocet. This
assertion is supported by the BNI agent's working papers which were put
into evidence by Respondent where a listing of the controlled
substances counted indicates 1,591 next to ``Percodan''. Therefore, the
Acting Deputy Administrator finds that the closing inventory figure
used by the DEA investigator in conducting the audit of Percocet and
its generic equivalents was correct.
To determine how much Percocet and its generic equivalent were sold
by Respondent during the audit period, the DEA investigator looked at
both Respondent's prescription records, as well as reports required to
be filed with the BNI regarding all Schedule II prescriptions
dispensed. In reviewing the records, it was revealed that during the
audit period, 21 prescriptions found at Respondent pharmacy were not
listed in the BNI reports, and 21 different prescriptions listed in the
reports were not found in Respondent's records. In arriving at the
sales figure for the audit, the DEA investigator included all of these
prescriptions in the total amount dispensed. In its Motion to Reopen
the Record, Respondent argued that the sales figure was inaccurate
since the DEA investigator did not look at Respondent's Schedule III-V
prescription files to see if any prescriptions for Percocet or its
generic equivalent were misfiled. The Acting Deputy Administrator finds
this argument to be without merit since the DEA investigator testified
at both the criminal trial and the hearing before Judge Bittner that
she reviewed all of the prescription files, including Schedules III-V,
to look for prescriptions for Percocet or its generic equivalent.
The audit revealed that Respondent could not account for 2,167
dosage units of Percocet and its generic equivalent.
The DEA investigator testified that during the course of her review
of the records seized during execution of the search warrant, she found
only one prescription for Ozzie Willis. It was dated May 24, 1990 for
Placidyl and indicated that it had been called in by Dr. N. As noted
above, Dr. N previously testified that he did not authorize this
prescription. In addition, the investigator's review of the BNI reports
filed by Respondent did not reveal any prescriptions listed for Ozzie
Willis.
As a result of the investigation, criminal charges were brought
against Mr. Rocco. Neither party submitted direct evidence regarding
these charges and/or their disposition. However, it appears based upon
Respondent's assertions in its post-hearing filing and statements made
by the DEA investigator that testified in these proceedings, that Mr.
Rocco was charged with seven counts of dispensing controlled substances
without a prescription; that the jury was hung on six of those counts
and found Mr. Rocco not guilty of the seventh; that rather than retry
Mr. Rocco, he was accepted into an Accelerated Rehabilitation
Disposition program in March 1992; and pursuant to that program, all
charges against Mr. Rocco were dropped in March 1994.
Respondent introduced into evidence a number of character
references from various members of his community, all stating that they
had known Mr. Rocco for many years and attesting to his personal and
professional integrity, his professional expertise and his concern for
his customers.
On April 10, 1996, after the hearing was concluded but prior to the
filing of post-hearing briefs, Respondent submitted its Motion to
Reopen the Record, Motion for Oral Argument, and Motion to Admit
Character Reference Testimony into the Record. The Government did not
oppose Respondent's Motion regarding character reference testimony, and
on May 10, 1995, Judge Bittner granted this motion and received
Respondent's character reference letters into evidence.
In its Motion to Reopen the Record, Respondent argues that it was
prejudiced by the Government's failure to comply with the Prehearing
Ruling issued by the Administrative Law Judge. Respondent argues that
the Prehearing Ruling ordered the Government to advise Respondent in
writing of the documents that were used as the basis for the pill count
and the preparation of the computation chart, and that Respondent did
not receive a copy of the BNI agent's notes regarding her pill count
taken during the execution of the search warrant on July 23, 1990,
until the hearing in this matter. In support of its Motion, Respondent
also argues that the BNI agent was uncertain about generic equivalents
of Percocet; that the DEA investigator's starting inventory of 1,708
dosage units of Percocet was incorrect because it failed to account for
a shipment Respondent received on May 25, 1989; that the sales figure
on the computation chart was incorrect because it failed to take into
account six misfiled prescriptions; that the closing inventory must
have been inaccurate because Respondent dispensed more generic
oxycodone with APAP between the date of the closing inventory and its
next shipment than it would have had
[[Page 3060]]
on hand according to the inventory; that the circumstances in which the
closing inventory was taken were unfair to Respondent; that its May
1991 inventory showed a surplus; and that reopening the record to
permit Respondent to adduce new evidence is required in the interests
of justice and would not unduly burden the Government or waste judicial
resources.
In denying Respondent's motion, Judge Bittner found that ``[t]here
is no indication that [the DEA investigator] relied on any documents
(the BNI agent) drafted in preparing the computation chart.'' Judge
Bittner therefore found ``no merit to Respondent's contention that the
Government failed to comply with the prehearing ruling.'' Judge Bittner
also found that Respondent's argument that it dispensed more generic
form of Percocet than the closing inventory plus subsequent receipts is
``untenable'' inasmuch as the BNI agent's notes are ambiguous regarding
whether her figures referred to Percocet or its generic equivalents.
Further, in rejecting Respondent's Motion to Reopen the Record, Judge
Bittner found that there was no showing that Respondent could not have
found the allegedly misfiled prescriptions earlier, and that an order
form in evidence as a Respondent exhibit, correctly shows that May 28,
1989 was the date Respondent first received Percocet or its generic
equivalent after May 1, 1989.
As the Government correctly asserts in its Opposition to
Respondent's Motion to Reopen the Record, neither the DEA regulations
nor the Administrative Procedure Act provide for the submission of
additional evidence after the hearing has been concluded and the record
closed. The Deputy Administrator has previously held that he has
discretionary authority to request that a record be reopened to receive
newly discovered evidence on the basis that a final order must be
issued based upon a full and fair record. See Robert M. Golden, M.D.,
61 FR 24,808 (1996). In Golden, the Deputy Administrator concluded
that, ``to prevail on such a motion, the moving party must who that the
evidence sought to be introduced (1) was previously unavailable and (2)
would be material and relevant to the matters in dispute.''
Respondent was on notice as of May 23, 1994, the date of the Order
to Show Cause that Respondent's failure to keep complete and accurate
records regarding controlled substances would be an issue in this case.
By October 1994, Respondent was provided a copy of the audit
computation chart. Other than the BNI agent's notes regarding the pill
count, there is no evidence in Respondent's motion that other
information was previously unavailable.
Regarding the closing inventory, Respondent contends that the
Government did not comply with the Prehearing Ruling since it failed to
turn over the BNI agent's notes regarding the pill count in advance of
the hearing. Judge Bittner disagreed with this contention, seemingly
confining her order to those documents relied upon by the DEA
investigator in preparing the computation chart. Since the Acting
Deputy Administrator was not a party to the prehearing discussions, it
is difficult to know what was actually agreed to regarding the
underlying documents to the computation chart. However, a plain reading
of Judge Bittner's Prehearing Ruling appears to support Respondent's
contention. The Prehearing Ruling orders the Government counsel to
advise counsel for Respondent ``in writing what documents was used as
the basis for the inventory count on July 23, 1990, and the subsequent
preparation of the computation chart.'' Therefore, the Acting Deputy
Administrator disagrees with the Administrative Law Judge that the
Government did not violate the Prehearing Ruling.
However, the Acting Deputy Administrator does not find that the
Government's failure to turn over the notes was intentional, since
Government counsel asserts that she was not aware of the notes herself
and apparently mistakenly thought, as did the Administrative Law Judge,
that she only needed to turn over what the Government witness relied
upon in preparing the computation chart. The DEA investigator testified
that in obtaining the closing inventory figure she relied upon the
verbal representation of the BNI agent.
Respondent argued that its failure to obtain the BNI agent's notes
prior to the hearing put it at an unfair disadvantage and the record
should be reopened. The Acting Deputy Administrator disagrees. First,
the only aspect of the audit that the notes pertain to is the closing
inventory. Therefore, the failure to turn over the notes regarding the
pill count does not give rise to the entire audit being reopened.
Respondent was clearly on notice regarding the other parts of the
audit, and had ample opportunity to prepare for the hearing. Second,
Respondent argues that the notes of the pill count indicate that the
BNI agent did not count oxycet and roxicet and therefore the closing
inventory figure is incorrect. The transcript of the hearing clearly
indicates that Respondent thoroughly questioned the BNI agent as to
whether she counted all of the percocet and its generic equivalents.
Respondent also questioned both Mr. and Mrs. Rocco regarding its stock
of the substances, and introduced into evidence copies of orders forms
indicating the purchase of the substances during the audit period.
Consequently, the Acting Deputy Administrator finds that Respondent
was not prejudiced by not being provided the BNI agent's notes in
advance of the hearing. Therefore, while not agreeing with the
Administrative Law Judge regarding whether there was a violation of the
Prehearing Ruling, the Acting Deputy Administrator does agree with her
denial of the motion to reopen the record. Respondent did not present
any evidence that, other than the BNI agent's notes, the evidence was
previously unavailable. Further, Respondent was not prejudiced by not
receiving the notes earlier since it had the opportunity to not only
question the BNI agent about the pill count, but also introduced other
evidence in the record regarding oxycet and roxicet.
In its Motion for Oral Argument, Respondent argued that oral
argument after filing of the briefs would effectively summarize
testimony from the criminal proceeding which is in evidence in this
proceeding; that it would facilitate the Administrative Law Judge's
understanding of the parties' positions; and that it would not
substantially prejudice the Government. In denying Respondent's Motion,
Judge Bittner stated that she was ``not persuaded * * * that oral
argument would significantly assist [her] in preparing a decision in
this proceeding * * *.'' She further stated that her denial of the
motion is ``without prejudice to Respondent's right to raise in its
posthearing brief the issues it intended to argue orally.''
As the Government correctly notes, there is nothing in the
regulations governing these proceedings that provides for oral argument
following the filing of briefs. Consequently, the Acting Deputy
Administrator finds that it is in the Administrative Law Judge's
discretion whether or not to permit oral argument.
On June 20, 1995, Respondent filed a Motion for Disqualification of
the Chief Administrative Law Judge. Respondent contends that the
``Judge in this case has exhibited open and obvious favoritism to the
Government which not only shatters the appearance of impartiality, but
in fact demonstrates actual pro-Government bias * * *.'' Respondent
argues that the Administrative Law Judge's admonishment of Respondent's
counsel for failing to request a subpoena more in advance of the
proceeding is
[[Page 3061]]
evidence of their bias. The Acting Deputy Administrator concludes that
any statement made regarding the timing of the subpoena of the BNI
agent is irrelevant to his decision in this matter. The BNI agent
ultimately appeared and testified at the hearing, and this final order
is based upon the testimony and documentary evidence introduced at the
hearing.
Respondent argues that the Administrative Law Judge's bias is
exhibited by her mischaracterization of her own Prehearing Ruling by
finding that the Government did not violate the Ruling by failing to
turn over the BNI agent's notes regarding the pill count to
Respondent's counsel. While, the Acting Deputy Administrator has
already found that it appears that the Administrative Law Judge did
mischaracterize her Prehearing Ruling, such a mischaracterization in no
way warrants disqualification. The regulations governing these
proceedings provide for the filing of exceptions when a party disagrees
with a finding, conclusion and/or ruling of the Administrative Law
Judge. Respondent availed himself of this opportunity, and the Acting
Deputy Administrator concurs with Respondent's contention that the
Prehearing Ruling was mischaracterized. However, as previously
discussed, the discovery of the BNI agent's notes was not significant
enough to reopen the record since the notes only affected the closing
inventory, and Respondent questioned the BNI agent about the closing
inventory at the hearing.
Respondent further argues that the Administrative Law Judge was
biased in her ruling denying Respondent's Motion to Reopen the Record,
as evidenced by her acceptance of the DEA investigator's interpretation
of when controlled substances were first received by Respondent after
May 1, 1989, without allowing Respondent an opportunity to introduce
evidence to rebut the interpretation. The Acting Deputy Administrator
finds no evidence of bias in this ruling since he concurs with Judge
Bittner's conclusion. First, since Respondent was on notice of the
computation chart well in advance of the hearing, it had more than
ample opportunity to prepare for this aspect of the audit. Respondent's
lack of preparation does not warrant reopening the record. Second, even
if Respondent had been allowed to present evidence regarding the
initial inventory after the record had been closed, the Acting Deputy
Administrator's conclusion would not change. Respondent's own order
form signed by Mr. Rocco demonstrates that Respondent received the
controlled substances in question on May 28, 1989.
Respondent also argues that the Administrative Law Judge's denial
of Respondent's Motion for Oral Argument evidences Judge Bittner's bias
in that ``the Government enjoyed an effective veto power.'' Respondent
contends that Judge Bittner's denial of this motion is ``difficult to
rationalize on any basis other than the fact that the Government
opposed it.'' As stated previously, the regulations do not provide for
oral argument following submission of the briefs, therefore, to grant
such a request would be extraordinary. Consequently, the Acting Deputy
Administrator does not find Judge Bittner's denial of Respondent's
motion unreasonable since as she stated, she was ``not persuaded at
this time that oral argument would significantly assist [her] in
preparing a decision in this proceeding * * *.''
Finally, Respondent argues that ``the very structure of
Administrative Law Judges inherently raises suspicions about their
capacity for judicial independence.'' As Judge Bittner noted in her
opinion, ``the Supreme Court of the United States and various United
States Courts of Appeals have found that the Administrative Procedure
Act 5 U.S.C. 551 et. seq., safeguards the procedural and substantive
due process rights of parties to administrative proceedings and the
independence of the Administrative Law Judges who hear them.'' See,
e.g., Butz v. Economou, 438 U.S. 478, 513-15 (1978); Nash v. Califano,
613 F.2d 10, 14-16 (2d Cir. 1980).
The Acting Deputy Administrator concludes that other than her
mischaracterization of the Prehearing Ruling, Judge Bittner's rulings
in this matter have been correct based upon a careful consideration of
the evidence and the laws and regulations governing these proceedings.
The Acting Deputy Administrator is not persuaded by Respondent's
arguments that the Administrative Law Judge has exhibited pro-
Government bias in this matter. Accordingly, Respondent's Motion for
Disqualification was properly denied.
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 and
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. Schwartz, Jr., M.D., Docket No.
88-42, 54 FR 16.422 (1989).
Regarding factor one, there is no evidence in the record that any
action has been taken by any state agency against either Respondent
pharmacy or Mr. Rocco, therefore, this factor is not relevant in
determining the public interest in this case. Respondent argues in his
exceptions that the Administrative Law Judge should have considered
this lack of state action in Respondent's favor in rendering her
recommendation. The Acting Deputy Administrator concludes that this
factor should be given no weight since there is no evidence in the
record that a hearing was conducted by a state agency and no action was
taken or that the state agency formally reviewed the evidence and
declined to take action.
Regarding factor two, Respondent's experience in dispensing
controlled substances, Mr. Rocco has been a practicing pharmacist for
over 30 years. It has introduced letters into evidence form various
members of the community attesting to Mr. Rocco's professionalism and
value to the community. While the other evidence in the record
regarding this factor covers a relatively small portion of Mr. Rocco's
30 years as a pharmacist, his dispensing to Ozzie Willis and the
results of the audit covering an approximately 14 month period of time
raise serious concerns regarding Respondent's continued registration.
Respondent contends that Mr. Rocco only dispensed controlled
substances to Ozzie Willis pursuant to what he believed to be valid
prescriptions. Respondent argues that either Dr. N authorized the
prescription or Mr. Willis called the prescriptions into the pharmacy
since he knew Dr. N's DEA registration number. However, the Acting
Deputy Administrator, like Judge Bittner, does not credit this
explanation
[[Page 3062]]
for the drugs provided on April 30, May 16, May 24, and June 7, 1990.
Dr. N testified in Mr. Rocco's criminal proceeding that he did not
authorize any of these prescriptions, and other than the May 24th
prescription for Placidyl, none of these prescriptions were found in
Respondent's records seized during execution of the search warrant.
On the other occasions, May 4, May 7, and June 29, 1990, when Ozzie
Willis came out of Respondent pharmacy with controlled substances,
Respondent argues that Mr. Willis had had an opportunity to plant the
drugs. While Respondent argues in its exceptions that Mr. Willis might
have had a motive to plant incriminating evidence on Respondent's
premises, the Acting Deputy Administrator finds that this argument is
speculative. The transcripts of Mr. Willis' visits, as well as the fact
that no evidence was presented that anyone saw Ozzie Willis planting
and/or retrieving the drugs belie such a theory. As Judge Bittner noted
in her opinion, ``on May 3 Mr. Rocco told Mr. Willis that he would
obtain a prescription that night; on subsequent visits Mr. Rocco
repeatedly said he would see a doctor and/or obtain a prescription, on
June 13 Mr. Rocco said that the doctor in question was hospitalized
until June 25, and on June 28 Mr. Rocco told Mr. Willis to come back
the next day.'' Therefore, the Acting Deputy Administrator agrees with
Judge Bittner that ``it is reasonable to infer * * * that on May 4 and
June 29 Mr. Rocco carried out his previously stated intention to
provide Percocet to Mr. Willis'' rather than that the drugs were
planted.
Respondent argues that the fact that no Percocet prescriptions for
Ozzie Willis were found at Respondent pharmacy supports the theory that
Mr. Rocco was only talking about obtaining a prescription from a doctor
to get Ozzie Willis out of the pharmacy. However, the Acting Deputy
Administrator finds that nothing in the transcript of Mr. Willis'
visits indicates that a prescription would be written in Ozzie Willis'
name, but just that Mr. Rocco needed to obtain a prescription from a
doctor before he could give Mr. Willis any Percocet.
Regarding the May 7th visit, Respondent argues that Ozzie Willis
had an opportunity to plant the Tylenol #4 obtained on that occasion.
Again, the Acting Deputy Administrator finds this argument to be
speculative. Mr Willis was not given advance notice when he would be
sent into the pharmacy, and there was no evidence presented that anyone
saw Mr. Willis planting and/or retrieving the drugs.
Respondent contends that he only dispensed controlled substances in
properly labeled containers, but that Ozzie Willis switched the
controlled substances into the other containers. The Acting Deputy
Administrator finds this argument also to be speculative. Since Mr.
Willis was searched and under surveillance going into the pharmacy and
after coming out of the pharmacy, he would have had to switch
containers in the store. Like with the theory that Mr. Willis planted
drugs, there is no evidence in the record that anyone saw Ozzie Willis
switching containers while in the pharmacy. In addition, on May 24,
1990, Mr. Willis emerged from Respondent with Placidyl in a properly
labeled container even though the prescription was not authorized by
Dr. N. If as Respondent argues, Mr. Willis was switching containers, it
would follow that he would have switched the container on this occasion
also.
The Acting Deputy Administrator finds the transcripts of
conversations between the Roccos and Mr. Willis of considerable
significance in evaluating Respondent's experience in dispensing
controlled substances. On May 3, 1990, Ozzie Willis asked for Percocet,
and Mr. Rocco replied, ``I'll tell you what, I'll get a script tonight
from a doctor, pick it up tomorrow * * *.'' The next day, Ozzie Willis
came out of Respondent pharmacy with 30 Percocet tablets in a UNI-ACE
bottle.
On May 9, 1990, Ozzie Willis asked Mrs. Rocco to ``ask Rocco if I
can, can get some more Percs one day next week, either that or either
Placidyls.'' (emphasis added). The Acting Deputy Administrator finds it
noteworthy that since no Percocet prescriptions for Ozzie Willis were
found at Respondent pharmacy, why would Mr. Willis ask for ``more
Percs'', unless he had been dispensed the Percocets without a valid
prescription.
Ozzie Willis told Mr. Rocco on May 16, 1990, ``* * * I really need
them Percs * * * I done got part of the guy's money.'' Mr. Rocco
replied, ``* * * I just got a script from that doctor, thought I'd get
you 30 and that would be it. Thirty I got.'' Mr. Rocco told Mr. Willis
to come back in two weeks. The Acting Deputy Administrator finds
significant that two weeks before this visit, on May 4th, Ozzie Willis
came out of Respondent's pharmacy with 30 Percocet after being told the
day before that Mr. Rocco would get a prescription from a doctor.
On May 18, 1990, Ozzie Willis asked Mr. Rocco, ``* * * you get the
script from that other doctor?'' Mr. Rocco replied, ``No, not til the
end of the month.'' On May 30, 1990, Mr. Rocco stated, ``I'll let you
know when I get that.'' Then on June 4, 1990, Mr. Willis asked Mr.
Rocco, ``did you see that doctor?'' Mr. Rocco replied, ``no, not yet *
* *. Thursday morning, come in and see me then.'' During a telephone
conversation on June 13, 1990, Mr. Willis asked about ``the Percocets I
was supposed to get the first of the month.'' Mr. Rocco replied,
``Yeah, not this month though.'' Mr. Willis then stated, ``last month
you told me, the first of June,'' to which Mr. Rocco answered, ``* * *
if I can get the script * * * but I haven't got the script.'' Mr. Rocco
went on to explain that the doctor went into the hospital. Mr. Willis
asked, ``You got any idea when, cause I got people, got three guys
waiting for them.'' Mr. Willis replied, ``* * * it probably won't be
till the end of the month he's supposed to be back the 25th, to work.''
Then on June 28, 1990, Mr. Willis asked about the doctor and Mr.
Rocco stated, ``Yea, tomorrow morning come back.'' On June 29th Ozzie
Willis came out of Respondent pharmacy with 30 Percocet in a small
unlabeled box in a brown bag.
The Acting Deputy Administrator concludes that these transcripts
show that Ozzie Willis and Mr. Rocco were discussing the dispensing of
Percocet to Mr. Willis without a valid prescription.
Respondent contends that Ozzie Willis was unreliable and dishonest;
that he wrongly stated that Respondent was his source of controlled
substances; and that the entire investigation was tainted because Ozzie
Willis violated his agreement with the Bristol P.D. by going to
Respondent when he was not under surveillance and by continuing to
obtain controlled substances from other sources during the
investigation. The Acting Deputy Administrator finds that given the
criminal trial testimony and printouts from various pharmacies admitted
into evidence in this proceeding, as well as the contents of Ozzie
Willis' car at the time of his arrest on April 30, 1990, it is clear
that Mr. Willis was obtaining controlled substances from places other
than Respondent pharmacy. The Acting Deputy Administrator also finds
that Ozzie Willis clearly violated his cooperation agreement with the
Bristol P.D. and was convicted two times previously of offenses
relating to drugs. However, the Acting Deputy Administrator concludes
that regardless of these facts, the evidence is clear that Ozzie Willis
obtained controlled substances from Respondent without a valid
prescription.
[[Page 3063]]
Respondent's inability to account for over 2,000 dosage units of
Percocet and its generic equivalents over an approximately 14 month
period of time is of serious concern to the Acting Deputy Administrator
in evaluating Respondent's experience in dispensing controlled
substances.
Regarding factor three, other than Respondent's assertions in its
post-hearing filing, there is virtually no evidence in the record
regarding this factor, However, it appears that criminal charges
against Mr. Rocco were ultimately dismissed after his successful
participation in an Accelerated Rehabilitation Disposition program.
Therefore, since there is no evidence of a conviction regarding
controlled substances, the Acting Deputy Administrator concurs with
Judge Bittner's finding that this factor does not weigh against
Respondent's continued registration.
As to factor four, the Acting Deputy Administrator concurs with
Judge Bittner's conclusion that ``Respondent's failure to comply with
state law and the Controlled Substances Act and its implementing
regulations weigh in favor of a finding that its continued registration
would not be in the public interest.'' Respondent's dispensing of
controlled substances without a valid prescription to Ozzie Willis was
in violation of 21 U.S.C. 829 and 21 CFR 1306.11 and 1306.21 Further,
his dispensing of some of these substances in improperly labeled
containers violated 21 CFR 1306.14 and 1306.24.
In addition, the review of Respondent's records seized during the
execution of the search warrant on July 23, 1990 revealed recordkeeping
violations, First, Respondent failed to comply with state law as
evidenced by the reports it filed with BNI regarding its dispensing
which did not indicate 21 prescriptions which were found in
Respondent's files. Second, Respondent violates 21 U.S.C. 827 and 21
CFR 1304.04 as evidenced by the 21 prescriptions noted on the BNI
reports that were not found in Respondent's records seized from the
pharmacy. Respondent also violated 21 CFR 1304.13, by failing to
maintain a biennial inventory. Finally, Respondent violated 21 U.S.C.
827 and 21 CFR 1304.21, by failing to maintain complete and accurate
records of controlled substances as evidenced by the shortage of
Percocet revealed by the DEA accountability audit.
Respondent argued in its exceptions that in assessing Respondent's
compliance with applicable state and Federal laws and regulations, the
Administrative Law Judge's decision ``was heavily dependent on her
interpretation of the meaning of audiotaped conversations,'' and that
``she relied entirely on typed transcripts'' rather than listening to
the tapes themselves. The transcripts of the conversations are all that
are in evidence in this proceeding, and there is no indication in the
transcript of the hearing in this matter that Respondent objected to
their admission into evidence. Therefore, the Acting Deputy
Administrator finds that the Administrative Law Judge did not err in
relying on these transcripts in rendering her recommended decision.
Respondent also argues that the Administrative Law Judge improperly
relied upon hearsay testimony of Dr. N that he did not authorize the
call-in prescriptions in question in this proceeding and that Judge
Bittner erred in finding that Dr.N had no motivation to lie, and in
ignoring the possibility that Ozzie Willis, knowing Dr. N's DEA number
could have called the prescriptions in to Respondent's pharmacy. The
Acting Deputy Administrator has considered these arguments and is not
persuaded by them, particularly since only one of these prescriptions
was found in Respondent's records seized during execution of the search
warrant.
The Acting Deputy Administrator does however concur with
Respondent's exception regarding the Administrative Law Judge's
reliance as evidence of unlawful dispensing on the discovery of a
prescription profile in Ozzie Willis' name spelled backwards. There is
no evidence in the record regarding this profile other than the fact
that it was discovered and therefore the Acting Deputy Administrator
does not rely upon it as evidence of unlawful dispensing of controlled
substances and Respondent pharmacy.
Respondent also argues that the Administrative Law Judge ignored
the prescription for J.C. for Percocet dated May 2, 1990 which was
picked up by Ozzie Willis on May 4th. However, the Acting Deputy
Administrator notes that on May 3, 1990, Mr. Rocco told Ozzie Willis
that he'd get a prescription from a doctor that night and for Mr.
Willis to pick up the Percocet the next day. Therefore, the Acting
Deputy Administrator concurs with the Administrative Law Judge's
finding that Respondent dispensed Percocet on May 4, 1990 without a
valid prescription.
Respondent also argues that the audit was improperly based on
hearsay statements from an employee of Respondent's wholesaler. First,
the Acting Deputy Administrator finds that hearsay is clearly
admissible in administrative proceedings. See Klinestiver v. Drug
Enforcement Administration, 606 F.2d 1128 (D.C. Cir. 1979). Second, in
conducting the audit, the DEA investigator sought information from the
wholesaler to verify Respondent's own records which it is required to
maintain pursuant to the Controlled Substances Act.
The Acting Deputy Administrator finds the Respondent clearly
violated both state and Federal laws and regulations relating to
controlled substances and therefore factor four is highly relevant in
determining whether Respondent's continued registration is in the
public interest.
Regarding factor five, the Acting Deputy Administrator concurs with
the Administrative Law Judge's finding that ``Mr. Rocco's apparent
dishonesty and refusal to accept responsibility for his misconduct does
not augur well for his future responsibility if permitted to retain his
DEA registration.'' In a previous case, the Administrator found that a
pharmacist's ``refusal to acknowledge the impropriety of his dispensing
practices * * * give[s] rise to the inference that [he] is not likely
to act more responsibly in the future.'' Medic-Aid Pharmacy, 55, FR
30,043 (1990). Like Judge Bittner, the Acting Deputy Administrator has
considered Respondent's character references, however they do not
outweigh the evidence of Respondent's improper dispensing and
recordkeeping. Consequently, this factor weighs against Respondent's
continued registration.
The Acting Deputy Administrator agrees with Judge Bittner, that
based upon a careful consideration of the factors enumerated in 21
U.S.C. 823(f), the record as a whole establishes that Respondent's
continued registration would be inconsistent with the public interest.
Respondent pharmacy's dispensing of controlled substances without a
valid prescription, the shortage of Percocet and its generic
equivalents revealed by the accountability audit, its violations of
applicable laws and regulations, and Mr. Rocco's continued denials of
any wrongdoing whatsoever support such a conclusion. Therefore, the
Acting Deputy Administrator concludes that revocation of Respondent's
DEA Certificate of Registration is an appropriate remedy.
Respondent asserts in its exceptions that the Administrative Law
Judge improperly focused on the same misconduct in her analysis of
three of the five factors. The Acting Deputy Administrator concludes
that there is no merit to this argument, finding that there is nothing
in the statute that
[[Page 3064]]
precludes the same behavior from being considered under multiple
factors. DEA has consistently considered the same conduct under more
than one factor. See Robert M. Golden, M.D., 61 FR 24,808 (1996);
Herman E. Walker, Jr., M.D., 60 FR 52,705 (1995).
Respondent, in its post-hearing filings further argues that DEA's
failure to initiate administrative proceedings against Respondent's DEA
Certificate of Registration sooner or to immediately suspend
Respondent's registration pursuant to 21 U.S.C. 824(d), ``is
inconsistent with a contention that continued registration would
violate the public interest.'' The Acting Deputy Administrator finds no
merit to this argument. First, an immediate suspension of a
registration pursuant to 21 U.S.C. 824(d) can only be utilized by DEA
when a finding has been made ``that there is an imminent danger to the
public health or safety.'' Since a registration is immediately
suspended without first providing an opportunity for a hearing, clearly
Congress did not intend this tool to be used in every instance where
DEA alleges that continued registration would be inconsistent with the
public interest. Therefore, the Acting Deputy Administrator rejects
Respondent's contention that, ``* * * rather than put this case on the
fast track, the DEA put it on a slow track which belies any contention
about threats to the public interest.''
Second, as to DEA's failure to initiate proceedings sooner, the
Acting Deputy Administrator finds that while passage of time, alone is
not dispositive, it is a consideration in assessing whether
Respondent's continued registration is inconsistent with the public
interest. See Norman Alpert, M.D., 58 FR 67,420 (1993). However, in
Alpert, the then-Acting Administrator found significant, ``Respondent's
recognition of the serious abuse of his privileges as a DEA registrant,
and his sincere regret for his actions.'' In this case, Mr. Rocco
continues to deny that the pharmacy has misused its DEA registration.
Therefore, the Acting Deputy Administrator concludes that the fact that
DEA did not initiate proceedings sooner is outweighed by Respondent's
continued denial of wrongdoing.
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 AR8587125, issued to Rocco's Pharmacy,
be, and it hereby is, revoked and any pending applications for renewal
of such registration, be, and they hereby are, denied. This order is
effective February 20, 1997.
Dated: January 14, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-1385 Filed 1-17-97; 8:45 am]
BILLING CODE 4410-09-M