[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