[Federal Register Volume 73, Number 1 (Wednesday, January 2, 2008)]
[Notices]
[Pages 364-388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-25342]



[[Page 363]]

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Part V





Department of Justice





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Drug Enforcement Administration



Medicine Shoppe--Jonesborough; Revocation of Registration; Notice

  Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / 
Notices  

[[Page 364]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 03-21]


Medicine Shoppe--Jonesborough; Revocation of Registration

    On March 14, 2003, the Deputy Assistant Administrator, Office of 
Diversion Control, issued an Order to Show Cause to the Medicine 
Shoppe--Jonesborough (Respondent) of Jonesborough, Tennessee. The Show 
Cause Order proposed the revocation of Respondent's DEA Certificate of 
Registration, BM3913781, as a retail pharmacy, and the denial of any 
pending application for renewal of its registration, on the ground that 
its continued registration would be ``inconsistent with the public 
interest.'' Show Cause Order at 1 (citing 21 U.S.C. 823(f)).
    The Show Cause Order specifically alleged that a DEA investigation 
had determined that between 1990 and 1995, Royce E. Blackmon, Jr., a 
physician located in Butler, Tennessee, had ``issued numerous 
controlled substance prescriptions for no legitimate medical reason.'' 
Id. The Show Cause Order alleged that in December 1995, DEA 
investigators visited Respondent and determined that it had filled 947 
of the controlled-substance prescriptions issued by Dr. Blackmon. Id. 
at 1-2. The Show Cause Order further alleged that on October 29, 1997, 
DEA investigators returned to Respondent and subsequently determined 
that Respondent had filled an additional 3,100 controlled-substance 
prescriptions issued by Dr. Blackmon. Id. at 2. Relatedly, the Show 
Cause Order alleged that on October 6, 1997, Blackmon entered into an 
Agreed Order with the Tennessee Board of Medical Examiners which 
revoked his state medical license. Id. at 2.
    The Show Cause Order next alleged that between May 1996 and 
December 1997, Respondent filled 124 prescriptions issued by Edmond 
Watts, a veterinarian practicing in Johnson City, Tennessee, 
notwithstanding that Watts' DEA registration and state veterinary 
license had expired on May 31, 1996, and February 29, 1996, 
respectively. Id. at 2. The Show Cause Order further alleged that 
``[m]any of these prescriptions were issued to persons using several 
aliases and false addresses,'' and that Watts was ultimately indicted 
and pled guilty to two state-law counts of obtaining prescription drugs 
by fraud. Id. at 2-3.
    The Show Cause Order next alleged that on March 9, 1998, DEA 
investigators returned to Respondent to review its controlled-substance 
records and to conduct an accountability audit. Id. at 3. The Show 
Cause Order alleged that Mr. Jeff Street, Respondent's owner and 
pharmacist, told DEA investigators that ``the pharmacy's computer could 
not process prescription information at that time,'' and that the 
investigators ``would have to wait until the following morning'' to 
obtain the information. Id. The Show Cause Order further alleged 
``[t]hat the following morning, Mr. Street informed investigators that 
the pharmacy's computer [had] `crashed' and its data had been lost.'' 
Id. at 3. The Show Cause Order thus alleged that Respondent violated 21 
U.S.C. 827(a)(3), as well as 21 CFR 1304.04 and 1304.21. Id.
    Next, the Show Cause Order alleged that on December 14, 1999, DEA 
audited Respondent's handling of twenty-nine controlled substances 
during the period of January 11, 1999, to December 14, 1999. Id. The 
Show Cause Order alleged that the audit found that Respondent had an 
overage of 29,656 dosage units of diazepam, a schedule IV controlled 
substance, and a shortage of 3,453 dosage units of combination 
hydrocodone drugs, which are schedule III controlled substances. Id.
    Relatedly, the Show Cause Order alleged that on April 10, 2001, and 
April 2, 2002, DEA had performed additional audits of Respondent's 
handling of various controlled substances and that each audit had found 
both overages and shortages. Id. at 3-4. More specifically, the Show 
Cause Order alleged that the April 2002 audit found that Respondent was 
short 4,505 tablets of some higher-strength combination hydrocodone/
acetaminophen products and had overages of 2,273 lower-strength 
hydrocodone/acetaminophen products. Id. at 4. The Show Cause Order 
further alleged that the April 2002 audit found both ``shortages and 
overages of between 500 and 1,000 tablets.'' Id.
    Finally, the Show Cause Order alleged that in analyzing 
Respondent's records for the period 2001 through 2002, DEA had 
determined that ``many patients received in excess of 2,000 dosage 
units of hydrocodone, often from several physicians.'' Id. The Show 
Cause Order thus alleged that ``[u]nder regulation, a pharmacy has a 
corresponding liability to ensure that every prescription [it] 
dispense[s] is for a legitimate medical purpose,'' and that ``[t]here 
is no indication that [Respondent] took steps to corroborate the 
necessity of these large amounts of controlled substances.'' Id. at 4-
5.
    Respondent, through its counsel, timely requested a hearing on the 
allegations. The matter was assigned to Administrative Law Judge (ALJ) 
Gail Randall, who conducted a hearing in Knoxville, Tennessee, on July 
27-29, 2004, and in Greenville, Tennessee, on May 24, 2005. At the 
hearing, both the Government and Respondent called witnesses to testify 
and introduced both testimonial and documentary evidence into the 
record. Following the hearing, both parties filed briefs containing 
their proposed findings of fact and conclusions of law.
    On June 9, 2006, the ALJ filed her recommended decision. In her 
decision, the ALJ found that while there was a factual ``dispute 
regarding the exact numbers involved in the three DEA audits, the 
record clearly shows that [the] audits and inventories of * * * 
Respondent revealed substantial shortages and overages of the 
controlled substances investigated.'' ALJ at 69. The ALJ rejected, 
however, the Government's contention that Respondent had failed ``on 
multiple occasions'' to comply with ``its corresponding responsibility 
to ensure that dispensed prescriptions for controlled substances were 
issued by the physician for a legitimate medical purpose and in the 
usual course of professional practice.'' Gov. Proposed Findings at 10; 
see also ALJ at 72.
    While noting that ``the patient profiles did not contain any 
documents demonstrating that Respondent's pharmacists made any 
telephone calls to verify suspect prescriptions,'' the ALJ credited the 
testimony of Respondent's owner that he had called the doctors whose 
prescriptions were suspicious ``on many occasions'' to ``verify the 
prescriptions prior to filling them.'' ALJ at 72; see also id. at 75 
(noting that ``Mr. Street's credible testimony concerning his personal 
knowledge of his customers [and] the actions he took to coordinate his 
dispensing with the patients' health care providers * * * dispelled 
many of [the] concerns'' expressed by the Government's expert 
witnesses). While the ALJ also found Respondent's filling of 
prescriptions issued by a veterinarian during 1996 and 1997 
``bothersome,'' she further reasoned that the datedness of the conduct 
and ``the lack of any more recent evidence of similar carelessness'' 
did not support the revocation of Respondent's registration. Id. at 78. 
The ALJ thus recommended that Respondent be allowed to maintain its 
registration subject to the condition that it undergo an annual audit 
by an independent auditor at its own expense for a period of three 
years from the date of the issuance of this Final Order. Id. at 78.

[[Page 365]]

    The Government filed exceptions to the ALJ's recommended decision. 
While asserting that it was not arguing ``the minutiae of the specific 
findings, or the issue of the credibility * * * of seriatim statements 
of Respondent's pharmacist owner,'' the Government's principal 
exception was that ``Respondent's entire defense consistently produced 
explanations for every fact that the Government proved,'' and that 
``for every patient that the Government showed * * * was receiving 
excessive amounts of controlled substances, Respondent had a recitation 
as to the medical condition . . . which would . . . justify [the] 
dispensing'' and the avoidance of liability under 21 CFR 1306.04. Gov. 
Exceptions at 1-2. The Government further argued that Respondent's 
owner ``had months . . . to prepare a self-serving testimonial defense 
by acquiring and reviewing medical records after [the] presentation of 
the Government's case,'' and that Respondent did not have access to 
these records ``at the time the prescriptions were presented.'' Id. at 
2. The Government thus contended that ``by accepting'' the testimony of 
Respondent's owner, ``the ALJ effectively negated the expert testimony 
of the two health care professionals who testified on behalf of the 
Government.'' Id. The Government also argued that Respondent's lack of 
accountability in its handling of controlled substances warranted the 
revocation of its registration.\1\ Id.
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    \1\ I also note Respondent's response to the Government's 
exceptions and have considered the arguments raised therein.
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    Thereafter, the record was forwarded to me for final agency action. 
In her decision, the ALJ decision found that Respondent had ``last 
renewed [its] registration on January 3, 2000, and [that] the 
registration was due to expire on January 31, 2003.'' ALJ at 3. Under 
DEA precedent, ``[i]f a registrant has not submitted a timely renewal 
application prior to the expiration date, then the registration number 
expires and there is nothing to revoke.'' Ronald J. Riegel, 63 FR 
67132, 67133 (1998). Because ``it appear[ed] that Respondent's 
registration had expired before the . . . proceeding was even 
initiated,'' the case was remanded to the ALJ to determine whether 
Respondent had submitted a timely renewal application in accordance 
with DEA's regulations and the Administrative Procedure Act (APA). See 
Order Remanding for Further Proceedings at 1-2; see also 5 U.S.C. 
558(c) (``[w]hen [a] licensee has made timely and sufficient 
application for a renewal or a new license in accordance with agency 
rules, a license with reference to an activity of a continuing nature 
does not expire until the application has been finally determined by 
the agency'').
    Thereafter, the ALJ conducted further proceedings in accordance 
with my remand order. Those proceedings determined that Respondent had 
submitted a renewal application prior to the January 31, 2003 
expiration of its registration and had paid the appropriate fee. 
However, Respondent's owner was told that its registration had not been 
renewed pending ``administrative review.'' Affidavit of Jeffrey Street 
at 1. According to the Government, Respondent's registration was 
renewed, but ``for unknown reasons,'' the Agency's Registrant 
Information Consolidated System ``did not record the renewal timely 
submitted for the 2003-2006 period,'' Gov. Resp. to the Registration 
Issue on Remand at 2, and ``did not advance the expiration date from 
January 31, 2003 to January 31, 2006.'' Affidavit of Richard Boyd, 
Chief of Registration and Program Support Section, at 1. Apparently, 
the new registration which was issued to Respondent in January 2003, 
simply used the same January 31, 2003 expiration date of the previous 
registration. See id.
    I therefore find that in January 2003, Respondent made a timely and 
sufficient application for a new registration. I further hold that 
because the registration which the Agency issued in January 2003 did 
not extend the expiration date of the registration, but rather, only 
re-instituted the January 31, 2003 expiration date of the existing 
registration, the Agency did not make a final determination on the 
application and Respondent therefore has maintained a valid 
registration throughout these proceedings.\2\ See 5 U.S.C. 558(c). 
Accordingly, there is jurisdiction to determine whether Respondent's 
registration should be revoked and its pending application should be 
denied.
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    \2\ The Government contends that Respondent's ``registration 
actually expired on January 31, 2006,'' and that ``Respondent was 
obligated to continue to file renewal applications during the 
duration of the show cause process.'' Gov. Resp. to the Registration 
Issue (ALJ Ex. 14) at 2. While I reject the Government's contention, 
even if Respondent's registration had, in fact, been renewed with a 
new expiration date of January 31, 2006, there is no evidence that 
the Agency ever notified it of this fact. Respondent cannot be 
faulted for failing to file an application to renew a registration 
when the Government never informed it of the new expiration date.
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    Having considered the record as a whole including the ALJ's 
recommended decision, I hereby issue this Decision and Final Order. As 
explained below, I adopt in part and reject in part the ALJ's findings 
of fact and conclusions of law. More specifically, while the ALJ 
rejected the entirety of the Government's allegations that Respondent 
dispensed controlled substances to numerous patients in violation of 
its corresponding responsibility under federal law, as ultimate 
factfinder, I conclude that the Government has proved by a 
preponderance of the evidence that Respondent unlawfully dispensed 
controlled substances to numerous persons. I also conclude that 
Respondent violated federal law and DEA regulations by failing to 
maintain complete and accurate records. Based on my findings and 
Respondent's (and its owner's) failure to acknowledge their misconduct, 
I concluded that revocation of its registration is necessary to protect 
the public interest. I make the following findings.

Findings of Fact

    Respondent is a pharmacy which is located in Jonesborough, 
Tennessee. Respondent has been registered as a retail pharmacy since 
February 1994, and as found above, currently holds DEA Certificate of 
Registration, BM3913781, which remains valid pending the issuance of 
this Final Order. See Gov. Ex. 1. Respondent is owned by Mr. Jeffrey 
Street, who has been a licensed pharmacist since 1984. Tr. May 24, 2005 
at 75.\3\
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    \3\ All citations to the transcript which do not include a date 
refer to the testimony taken on July 27-29, 2004.
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The Investigation of Respondent

    Sometime in 1995, DEA investigators received information from the 
Tennessee Bureau of Investigation and the First Judicial District Drug 
Task Force that Dr. Royce Blackmon, a Butler, Tennessee based 
physician, was writing prescriptions for drugs containing hydrocodone, 
a schedule III controlled substance, see 21 CFR 1308.13(e), and for 
Dilaudid (hydromorphone), a schedule II controlled substance, id. 
1308.12(b), without a legitimate medical purpose. Tr. 22. As part of 
the investigation, DEA investigators interviewed some of Dr. Blackmon's 
``patients'' and determined that Blackmon would frequently write 
prescriptions ``without even seeing the patient.'' Id. at 24.\4\ Dr. 
Blackmon's staff would then tell the ``patients'' to bring the 
prescriptions to Respondent for filling. Id. Moreover, the 
investigation determined that both Dr. Blackmon's

[[Page 366]]

wife and his daughter were drug addicts, that Dr. Blackmon prescribed 
both Dilaudid and hydrocodone drugs for his daughter, and that Mr. 
Street filled some of the daughter's prescriptions. Id. at 53 & 86.
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    \4\ DEA investigators were, however, unable to obtain Blackmon's 
medical records. Tr. 56.
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    As part of the investigation, DEA conducted a prescription review 
of approximately 15 to 20 pharmacies including Respondent, which were 
located in the areas of Johnson City, Bristol, Kingsport and 
Jonesborough. Id. at 26. In either November or December 1995, DEA 
investigators visited Respondent and found that it had dispensed 
approximately 950 prescriptions which had been issued by Dr. Blackmon. 
Id. at 27; see also id. at 181. Most of the other area pharmacies had 
stopped filling Blackmon's prescriptions, id. at 26, but some continued 
to do so. May 24, 2005 Tr. at 9-10.
    In October 1997, DEA investigators returned to Respondent to 
determine whether Respondent had continued to fill Blackmon's 
prescriptions since the previous visit. Tr. at 182. The investigators 
found that Respondent had filled more than 3,000 of Blackmon's 
prescriptions, all of which were for controlled substances. Id. at 183.
    Mr. Richards, a private investigator retained by Respondent, 
testified, however, that he had interviewed Mr. James Backers, a 
pharmacist who had worked as a relief pharmacist for Respondent during 
the last three months of 1996, as well as in 1997 and 1998. May 24, 
2005 Tr. at 69. According to Mr. Richards, Mr. Backers told him that 
``because he had heard rumors that some . . . drugstores weren't 
filling Dr. Blackmon's prescriptions anymore'' he visited Blackmon at 
his office. Id. at 11. Mr. Richards testified that Mr. Backers stated 
that Blackmon ``was very nice to him, showed him his records, showed 
him that he was making referrals to specialists, [and] doing tests.'' 
Id. Moreover, Dr. Blackmon ``was writing not only pain medication, but 
other maintenance drugs, as well.'' Id. Mr. Backers told Mr. Street 
about his visit. Id. He also continued to fill Blackmon's prescriptions 
although he would call his office if one did not ``look right.'' Id.\5\
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    \5\ It is questionable whether Mr. Backers' hearsay statements 
are reliable because Mr. Richards obtained them in anticipation of 
this litigation. I assume without deciding that the statements meet 
the APA's standard that evidence must be ``reliable'' and 
``substantial,'' 5 U.S.C. 556(d), because I conclude that the 
appropriate analysis of whether Respondent dispensed controlled 
substances in violation of federal law should focus on the actual 
prescriptions it filled.
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The Audits

    In March 1998, a DI returned to Respondent with the intention of 
auditing its handling of controlled substances and presented an 
Administrative Inspection Warrant to Mr. Street. Tr. at 185-87. The DI 
asked Mr. Street to provide the pharmacy's purchase, dispensing and 
distribution records,\6\ id. at 187-88; these are records which a 
pharmacy is required under regulation to maintain for two years. Id. at 
189. Mr. Street assisted in conducting a closing inventory and provided 
the pharmacy's invoices for the drugs being audited. Because preparing 
the drug usage reports required accessing data in Respondent's computer 
and Mr. Street was to teach a class that night, Mr. Street printed out 
only two drug usage reports (one for Dilaudid and one for Lortab 5) and 
requested that he be allowed to print out the remaining reports in the 
morning. Tr. 192; May 5, 2005 Tr. at 117.\7\ When the DI arrived at the 
pharmacy the next morning, Mr. Street reported that ``his computer had 
crashed and he'd lost all [of] his prescription data.'' Tr. 192. Mr. 
Street further told the DI that his computer's hard drive had failed. 
May 24, 2005 Tr. at 121.
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    \6\ Under DEA regulations, a pharmacy is required to maintain 
records for a minimum of two years and the records must document the 
purchase and receipt, dispensing, and distribution through 
destruction, loss, theft or a transfer between registrants of 
controlled substances. Tr. 190-91; see also 21 CFR 1304.22(c). 
Moreover, records pertaining to schedule II controlled substances 
must be ``maintained separately from all other records of the 
pharmacy,'' with the prescriptions ``maintained in a separate 
prescription file.'' 21 CFR 1304.04(h)(1). With respect to schedule 
III through V controlled substances, a pharmacy's records must be 
``maintained separately from all other records of the pharmacy or in 
such form that the information required is readily retrievable from 
[the] ordinary business records of the pharmacy'' with prescription 
records ``maintained either in a separate prescription file for 
controlled substances in Schedules III, IV, and V only or in such 
form that they are readily retrievable from the other records of the 
pharmacy.'' See also 21 CFR 1304; Tr. 193.
    \7\ There is conflicting evidence as to when the DI obtained 
Respondent's backup tape. The DI testified that Mr. Street gave him 
the backup tape (which was stored in his files and not the 
pharmacy's computer) before leaving on the day that he showed up to 
conduct the audit. Tr. 192. Mr. Street testified that upon the DI's 
arrival the next morning, he assured the DI that ``everything's 
going to be okay because I've got a good backup tape,'' to which the 
DI responded ``Show it to me.'' May 24, 2005 Tr. at 121. According 
to Mr. Street, he then pulled the tape out of the computer's 
``external drive'' and the DI took possession of it. Id. at 121.
    I also note that Mr. Street testified that he ran a backup tape 
``every night.'' May 24, 2005 Tr. at 120. Mr. Street did not testify 
that the backup tapes were re-used, and given the absence of such 
testimony, it is perplexing that Mr. Street did not have a more 
current backup tape available. The ALJ did not, however, reconcile 
her findings with this testimony.
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    According to Mr. Street, several days later the DI returned to the 
pharmacy with the backup tape. Upon loading the tape into the computer, 
there were no records on it. Respondent then loaded another backup 
tape, which he had last used in either October or November and the tape 
loaded up right away. Id. at 122. Because several months of records 
were missing, the DI determined that an audit could not be conducted. 
Tr. 193. The ALJ specifically credited the DI's testimony that while he 
had inspected fifty to seventy-five pharmacies, this was the only time 
a pharmacy had been unable to produce the required records. ALJ at 10 
(citing Tr. 194).
    In December 1999, the DI obtained another administrative warrant 
and returned to Respondent to conduct an audit.\8\ GX 6, Tr. 195. Mr. 
Street provided the DI with a copy of Respondent's biennial inventory 
which had been taken on January 11, 1999. GX 5. According to Mr. 
Street, under the rules of the Tennessee Board of Pharmacy, a 
pharmacist is allowed to estimate the number of pills in an open bottle 
in conducting an inventory of schedule III through V controlled 
substances. May 24, 2005 Tr. 149.
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    \8\ The DI was accompanied by another DI and an investigator 
from the Tennessee Board. Tr. 198.
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    Another DI and a state investigator conducted a closing inventory 
of Respondent's controlled substances. Tr. 198. Mr. Street signed the 
closing inventory thereby attesting to its accuracy. Id. at 199. 
According to the DI, the audit ``look[ed] . . . at all the records of 
purchase, all records of distribution'' including the prescription 
records, as well as various DEA forms for reporting theft, loss and 
destruction of controlled substances, and other forms that document the 
movement of controlled substances between the beginning and end dates 
of the audit. Id. at 201. For each audited drug, the DI added up the 
amount of Respondent's purchases during the audit period and added them 
to the opening inventory; the DI then added the total amount of each 
drug dispensed (and or distributed) to the ending inventory and 
compared the two figures. Id.
    While the two numbers should equal each other, the DEA audit found 
that there were both numerous shortages and overages. GX 8. Some of the 
discrepancies involved substantial quantities in absolute terms. The 
ALJ found credible Mr. Street's testimony that the Government's audit 
contained eleven errors because four drug usages reports had been left 
out,\9\ that one of

[[Page 367]]

the five diazepam drug usage reports provided to DEA overlapped with 
another report resulting in an overage of 30,000 tablets of 
diazepam,\10\ that the DI had used ``some inaccurate beginning counts . 
. . off of our inventory,'' and that the DI had failed to include drugs 
Respondent had reported stolen. May 24, 2005 Tr. 125.\11\
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    \9\ In his testimony, Mr. Street did not specifically identify 
which drug usage reports had been left out. Respondent also did not 
submit the DEA-106s into evidence.
    To make clear for future cases, to successfully challenge an 
audit, a registrant must specifically identify the error which it 
claims was made. For example, if it claims that the Government left 
out a drug usage report, it must specifically identify the report 
and show how its exclusion affected the results. The generalized 
testimony which Mr. Street typically gave is wholly insufficient to 
demonstrate that the audit results were erroneous. I conclude, 
however, that there is no need for a remand on this issue because 
even Mr. Street's audits found numerous discrepancies.
    \10\ As discussed below, it is a registrant's responsibility to 
maintain accurate records. The fact that the audit may have showed 
an overage of diazepam because the dispensings were recorded on 
multiple drug usage reports is therefore further evidence of 
Respondent's poor recordkeeping practices.
    \11\ At the hearing, the DI acknowledged that he erred when he 
recorded the beginning inventory figure for hydrocodone/
acetaminophen 10/650 from Respondent's January 11, 1999 inventory 
onto his spreadsheet. More specifically, the DI wrote that the 
pharmacy had on hand 330 tablets rather than 33. Tr. 219.
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    There is, however, no dispute that Respondent was short 800 tablets 
of hydrocodone/acetaminophen \12\ (5/500) and more than 380 tablets of 
Lortab (7.5/500), a brand name drug which also contains hydrocodone and 
acetaminophen. Compare ALJ Attachments A and B. Respondent was also 
short 200 tablets of Dilaudid (hydromorphone) 4 mg. and 193 tablets of 
generic hydromorphone 4 mg. Id. Respondent was also short 485 tablets 
of acetaminophen/codeine (300/60). Id.
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    \12\ Through out this decision, the term ``apap'' is used as an 
abbreviation for acetaminophen.
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    Furthermore, according to Respondent's audit, the pharmacy was 
short 589 tablets of hydrocodone/apap (7.5/500) and 704 tablets of 
Diazepam 10 mg. Id. at Attachment B. Moreover, Respondent's audit found 
substantial overages in multiple drugs include hydrocodone/apap 7.5/750 
(740 tablets), hydrocodone/apap 10/650 (438 tablets), Lortab 5/500 (189 
tablets), and apap/codeine 300/30 (369 tablets). Id. While it is not 
uncommon that a pharmacy will have small shortages or overages (of less 
than fifty dosage units), Tr. 72-73, the shortages and overages found 
during the 1999 audit are not trifling amounts.
    On April 10, 2001, DEA investigators returned to Respondent to 
conduct another audit. For the closing counts, the DIs took an 
inventory of the drugs being audited which Mr. Street verified. GX 10. 
For most of the drugs being audited, the DIs used the inventory taken 
during the December 14, 1999 audit for the beginning counts.\13\ Here 
again, the Government found several substantial shortages of 
hydrocodone/apap drugs and numerous overages. See GX 11.
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    \13\ For several schedule II drugs (Oxycontin and Methadone) 
which had not been previously audited, the DIs used for the 
beginning count the inventory which Respondent took on May 10, 2000. 
GX 11.
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    Mr. Street also disputed the accuracy of this audit and testified 
that he found that it had eight errors. May 24, 2005 Tr 128. More 
specifically, Mr. Street testified that the several drug usage reports 
and purchase invoices were left out. Id. He also asserted that the 
diazepam was again over-accounted for. Id.
    Mr. Street again conducted his own audit and found that Respondent 
had substantial shortages in numerous drugs. See ALJ 15, Resp. Ex. 3. 
With respect to generic hydrocodone/apap drugs, Respondent was short 
171 tablets of 5/500 strength, 656 tablets of 7.5/500, and 657 tablets 
of 10/500; Respondent was also short 196 tablets of Lortab 10. Resp. 
Ex. 3. As for diazepam, Respondent was short 312 tablets of 5 mg. 
strength and 554 tablets of 10 mg. strength. See id. Respondent was 
also short 152 tablets of methadone 40 mg. (a schedule II drug, 21 CFR 
1308.12(c)), and 166 tablets of acetaminophen and codeine 4. 
See Resp. Ex. 3 at 2.
    On April 30, 2002, the DIs returned to Respondent and conducted an 
audit which covered the period between the April 10, 2001 and the date 
of their visit. GX 13. The DIs used the closing inventory counts from 
the 2001 audit for the beginning count and took an inventory of the 
drugs on hand for the closing count, which Mr. Street verified. See id.
    Even though the DIs audited only twelve drugs, they again found 
several substantial shortages and overages, see GX 14, and Mr. Street 
disputed the accuracy of the audit. May 24, 2005 Tr. at 129 & 137. More 
specifically, Mr. Street testified that the DEA audit did not include 
three drug usage reports and that apparently, the amounts from some 
invoices were not properly counted. Id. at 129.
    Once again, Mr. Street's audit found substantial shortages and 
overages. See Resp. Ex. 4. Specifically, Respondent was short 498 
tablets of diazepam 10mg., 754 tablets of hydrocodone/apap 7.5/500, and 
910 tablets of hydrocodone/apap 10/500. Resp. Ex. 4. Respondent also 
had overages of 442 units of hydrocodone/apap 7.5/650 and 364 units of 
hydrocodone/apap 10/650.
    With respect to the 2001 audit, the ALJ found that Mr. Street 
``credibly stated that he attributed such discrepancies to human 
error.'' ALJ 15. More specifically, Mr. Street testified that ``it 
could have been simply [that] the person was supposed to have gotten 
the generic and we accidentally pulled the name brand off the shelf.'' 
May 24, 2005 Tr. at 142-43. Mr. Street further testified that there 
were ``four different'' strengths of combination hydrocodone drugs 
``all on the shelf together[,] and it could have been just simply the 
fact that we just pulled the wrong one off the shelf.'' Id. at 143. The 
ALJ also credited Mr. Street's testimony that ``there was no deliberate 
diversion of drugs.'' ALJ at 15 (May 24, 2005 Tr. at 143).
    As for Mr. Street's contention that his pharmacy may have confused 
branded and generic drugs when it filled prescriptions, it would have 
been easy enough to prove this by showing the existence of 
corresponding overages and shortages in the respective drugs. Mr. 
Street did not, however, offer any evidence from his own audits to this 
effect.\14\
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    \14\ For example, even if DEA did not audit a branded drug of 
the same strength as a generic drug that it audited, Mr. Street 
could have done so.
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    Mr. Street's contention that he and other pharmacy personnel may 
have mistakenly filled a prescription with a drug of a different 
strength than that prescribed by his customers' physicians is alarming. 
Under federal regulations, drug manufacturers and distributors are 
required to label the containers that they use to distribute their 
drugs. 21 CFR Pt. 201. Manufacturers are also required to imprint each 
dosage unit ``with a code imprint that, in conjunction with the 
product's size, shape and color, permits the unique identification of 
the drug product and the manufacturer * * * of the product.'' 21 CFR 
206.10(a). Moreover, ``[i]dentification of the drug product requires 
identification of its active ingredients and its dosage strength.'' Id. 
In short, a pharmacist should know the strength of a drug he is 
dispensing based on both the container's labeling and the imprint on 
the dosage unit and make sure that he has dispensed the correct 
strength of a drug. Indeed, dispensing controlled substances of the 
wrong strength can have serious consequences for the health of 
patients.
    As for Mr. Street's testimony that ``there was no deliberate 
diversion'' of the drugs his pharmacy was short of, this is pure 
speculation. Respondent offered no evidence that it had

[[Page 368]]

investigated its employees to determine whether any of them could be 
diverting the missing drugs. In short, Mr. Street does not know whether 
or not his pharmacy's employees could have been diverting drugs.
    Respondent also introduced into evidence the affidavit of Mr. 
Timothy Mitchell Pierce, a lawyer and registered pharmacist. Resp. Ex. 
6. Mr. Pierce reviewed various documents in the case, medical records, 
and interviewed Mr. Street. Mr. Pierce, who was presumably testifying 
as an expert, opined that ``the alleged overages and shortages of 
controlled substances as described in the Order to Show Cause are not 
due to deliberate diversion,'' and ``are more likely due to DEA audit 
errors, acceptable human error by [Respondent's] personnel and theft by 
person(s) not associated with'' Respondent. Id. at 4.
    I reject the conclusions of Mr. Pierce for several reasons. First, 
while Mr. Pierce has been a registered pharmacist and stated that he 
has practiced in retail pharmacy settings, his affidavit does not 
establish how many years of actual pharmacy practice he has, that he 
has remained active in pharmacy practice,\15\ and that he has any 
experience in conducting audits.
---------------------------------------------------------------------------

    \15\ Indeed, it appears that Mr. Pierce has not practiced as a 
pharmacist in a substantial time because he graduated from a 
Tennessee law school in 1992, is licensed as a lawyer in Tennessee, 
but holds a Louisiana pharmacy license.
---------------------------------------------------------------------------

    Second, Mr. Pierce's affidavit typically did not address the 
shortages which Mr. Street's own audits found. For example, in 
discussing the December 1999 audit, Mr. Pierce discussed only the 
shortage of one drug (hydrocodone/apap 7.5/500). RX 6, at 4-5. Mr. 
Pierce's affidavit ignores that Respondent was short 800 tablets of 
hydrocodone/apap 5/500, 380 tablets of Lortab (7.5/500), 200 tablets of 
Dilaudid 4 mg., 193 tablets of generic hydromorphone 4 mg., 485 tablets 
of acetaminophen/codeine (300/60), and 704 tablets of diazepam 10 mg. 
See id. Similarly, with respect to the April 2001 audits, Mr. Pierce's 
affidavit ignores the shortages of 312 tablets of diazepam 5 mg. and 
554 tablets of diazepam 10 mg. See id. at 5-6. The affidavit also 
offers nothing but speculation regarding the shortages of hydrocodone/
apap.\16\
---------------------------------------------------------------------------

    \16\ With respect to the April 2002 audits and the diazepam 
shortages, Mr. Pierce's affidavit responds to the allegations of the 
Show Cause Order. The Show Cause Order, however, only sets the 
parameters of the proceeding and does not constitute evidence.
---------------------------------------------------------------------------

    Finally, with respect to the April 2002 audits, Mr. Pierce's 
affidavit does not even acknowledge the figures for the hydrocodone 
shortages per Mr. Street's own audit (754 tablets of hydrocodone/apap 
7.5/500 and 910 tablets of hydrocodone/apap 10/500). See id. at 8. Mr. 
Pierce then opined that the shortages and overages ``were probably 
due'' to ``inadvertently'' dispensing the wrong strength of drug. Id. 
Mr. Pierce also opined that a name brand drug could have been 
``dispensed for a generic brand drug or vice versa,'' and noted that 
``[t]he name brand drugs were not audited and thus cannot be 
compared.'' Id. Again, Mr. Pierce's opinion amounts to pure 
speculation. His testimony is therefore rejected.

The Evidence Regarding Respondent's Dispensings

    The ALJ found that during 1997, Respondent ``filled over 124 
controlled substance prescriptions written by Edmond Watts,'' a 
veterinarian who had allowed both his DEA registration and state 
veterinary license to expire without renewing them, ALJ at 17 (citing 
Tr. 37-38, 41-42), and was therefore without authority to prescribe 
controlled substances. According to the credited testimony of a DEA 
supervisory diversion investigator, a pharmacist is required to 
periodically check with the appropriate state licensing authority to 
ensure that a practitioner holds a current license. Id. (citing Tr. 
61).
    Normally, veterinarians purchase the controlled substances they 
dispense directly from wholesale distributors and dispense the drugs 
directly to the owner of the animal. Tr. 88. Indeed, under DEA 
regulations, ``[a] prescription may not be issued in order for an 
individual practitioner to obtain controlled substances for supplying 
the individual practitioner for the purpose of general dispensing to 
patients.'' 21 CFR 1306.04(b).
    Watts wrote the prescriptions, which were for drugs containing 
hydrocodone, in the names of fictitious patients,\17\ Tr. 40, and had 
his brother present them to Respondent for filling. Id. at 62-63. 
Moreover, Watts' brother was presenting the prescriptions ``almost 
every day [or] every other day.'' Id. at 62. The drugs were then 
personally used by Veterinarian Watts. Id. at 40. Eventually, Watts was 
convicted of a controlled-substances related felony. Id. at 42.
---------------------------------------------------------------------------

    \17\ Watts also wrote prescriptions ``in the name of his sister-
in-law.'' Tr. 41. Watt's sister-in-law ``was interviewed and 
indicated [that] she never received that medication.'' Id.
---------------------------------------------------------------------------

    With respect to the prescriptions issued by Watts, Respondent put 
on the testimony of Mr. Richards, a private investigator it had 
retained. Mr. Richards testified that Watts told him that he had 
``deceived'' Street, and ``didn't tell him [Street]'' about his 
licensure status. May 24, 2005 Tr. at 14. There is, however, no 
evidence that Mr. Street had asked Watts whether he had a valid DEA 
registration and state license prior to the incident in summer of 1997 
when state investigators showed up at Respondent and inquired about 
Watts' prescriptions. Id.
    Moreover, Mr. Richards testified that ``all of the prescriptions 
that Dr. Watts wrote that Jeff filled for any kind of pain drugs 
contained acetaminophen. And that would alert a pharmacist to the fact 
that it was probably for an animal, because acetaminophen is toxic to 
certain animals.'' Id. at 16. Contrary to Mr. Richard's testimony, the 
fact that ``acetaminophen is toxic to certain animals'' points to the 
exact opposite conclusion--that the drugs were not being prescribed to 
treat animals for a ``legitimate medical purpose'' and that Watts was 
not acting in the ``usual course of his professional practice.'' 21 CFR 
1306.04(a).
    DEA investigators also found that Respondent was filling large 
amounts of prescriptions for schedule III drugs containing hydrocodone 
that were written by a dentist, J. Michael Haws. ALJ at 19 (citing Tr. 
34-35, GX 15I). According to a DEA diversion group supervisor, Dr. Haws 
``was prescribing to almost all of his patients, and even though the 
amounts weren't that large, the frequency was. [The patients] were 
going to him almost every other day and requiring additional 
prescriptions.'' Tr. 35. Ultimately, the state dental board placed Dr. 
Haws on probation for three years, and following the issuance of an 
Order to Show Cause, Haws voluntarily agreed to restrictions on his DEA 
registration. Id. at 37.
    On cross-examination, the DEA investigator acknowledged that Haws 
did a lot of extractions and that it would not be unusual for a dentist 
to prescribe pain medication after doing this procedure. Id. at 59. 
However, on re-direct examination, the investigator testified that in 
his experience, dentists who performed extractions treat acute pain 
which ``lasts for a short period of time'' and that dentists do not 
``normally'' treat chronic pain. Id. at 87-88. The investigator further 
explained that the frequency of the prescriptions issued by Haws and 
filled by Respondent was not consistent with the treatment of acute 
pain, but rather, with the treatment of chronic pain. Id. at 87-88.
    DEA investigators also determined that Respondent was filling a 
large number of prescriptions issued by Dr. Frank Varney for 
benzodiazepines (such as Valium or diazepam), which are

[[Page 369]]

schedule IV controlled substances. Tr. 28, 31-33, see 21 CFR 
1308.14(c)). According to the supervisory investigator, in 1994, the 
state board put Dr. Varney on probation and required that he attend a 
course on prescribing controlled substances. Tr. 33. Before the state 
board action, Dr. Varney was writing prescriptions for schedule II 
narcotic prescriptions; after the board action, he turned to writing 
the benzodiazepine prescriptions. Id. at 33-34. Respondent filled 
``over 7000'' prescriptions written by Dr. Varney, most of which were 
for benzodiazepines. Id.\18\
---------------------------------------------------------------------------

    \18\ Mr. Richards testified that between 1997 to 1999, a 
competitor pharmacy ``filled 1,886 controlled substance 
prescriptions for Dr. Varney'' and ``Jonesborough Drug filled 25,861 
hard copies during the same period.'' May 24, 2005 Tr. 32. Even if 
Mr. Richard's testimony regarding the prescriptions filled by 
Jonesborough Drug was meant to refer to controlled-substance 
prescriptions, the testimony is not relevant to the issue of whether 
Respondent filled unlawful prescriptions.
---------------------------------------------------------------------------

The Prescription Traces

    The Government introduced into evidence prescriptions traces for 
twenty-five customers of Respondent. See Gov. Ex. 15 (A-Y). For each 
customer, the traces indicated the name and strength of the controlled 
substance, the quantity dispensed, the prescription number, the date of 
the original prescription, and the name of the prescribing 
practitioners. The Government also put on two expert witnesses, Dr. 
John Mulder, a physician with a specialty in family practice who is 
board certified in hospice and palliative medicine, GX 16, and Dr. 
James Ferrell, a pharmacist with forty-one years of experience and the 
former director of the Tennessee State Board of Pharmacy. Tr. 271, GX 
17.
    With respect to several of the traces, either one or both of the 
Government's experts testified that Respondent's dispensings were not 
improper. With respect to Customer M.B. (GX 15-A), Dr. Mulder opined 
that his review found ``no significant deviation from what could be 
expected to be a standard of care for prescribing these medications. In 
other words, the quantities over a period of time could be consistent 
with an acceptable medical reason.'' Tr. 499.
    With respect to patient D.C. 2 (GX 15-C), Dr. Mulder ``found 
nothing that would be outside of a legitimate medical reason for the 
dispensing of these particular amounts and types of medications.'' Id. 
at 507. As for Government Exhibit 15-E, a trace which listed a male 
(D.E.) and female (J.E.) who used the same address, Dr. Mulder stated 
that ``[t]he amounts of medicine prescribed began to skirt the upper 
limit of acceptable, but [they] never actually surpassed it in terms of 
the number of pills dispensed within a given month.'' Id. at 509. Dr. 
Mulder further explained that ``it is conceivable that someone with a 
particular pain problem could be dispensed this amount of medication 
longitudinally, so I did not have a particular problem with this 
particular chart.'' Id. at 509-10.
    Dr. Mulder also found that the prescriptions for patient B.R. (GX 
15-O) ``could have been . . . for legitimate medical purposes,'' Tr. 
528, that Respondent had properly dispensed to patient W.B. (GX 15-P), 
Tr. 530, and that Respondent ``probably met'' the standard in 
dispensing to patient R.S. (GX 15-S). Tr. 533. Finally, with respect to 
patient W.T. (GX 15-W), Dr. Ferrell noted that while ``[t]he dosages 
are really high . . . [w]hen your patients have cancer and they're 
dying, we do see . . . dosages of controlled substances [that] are 
really high.'' Tr. 359. Dr. Ferrell thus concluded that the 
prescriptions ``could be legitimate.'' Id. at 359-60.
    The remaining traces did, however, raise substantial questions 
regarding the legitimacy of the prescriptions Respondent filled. Set 
forth below is a discussion of the evidence regarding Respondent's 
dispensings to those patients which the Government's experts concluded 
(at least initially) did not satisfy the ``corresponding 
responsibility'' under Federal law.

Patient D.C. 1.

    This trace showed that Respondent dispensed to D.C. numerous 
prescriptions for Lorcet, a branded drug combining hydrocodone and 
acetaminophen, which were issued by J. Michael Haws, a dentist. See GX 
15-B, at 1-2. Between June 24, 1997, and September 29, 1997, Respondent 
filled twenty-nine controlled substance prescriptions for narcotics; 
twenty-eight of the prescriptions were for hydrocodone and 
acetaminophen, and one of the prescriptions was for Percodan, a 
schedule II controlled substance which contains oxycodone and aspirin. 
See 21 CFR 1308.12(b). The prescriptions were typically issued every 
three to four days. See GX 15-B, at 1-2. Furthermore, during both July 
and August, the controlled substances dispensed by Respondent contained 
140,400 mg. of acetaminophen or approximately 4529 mg. per day. 
Moreover, on July 8, 1997, one day after Respondent filled a 
prescription for twenty-four Vicodin ES tablets, which was issued by 
Dentist Haws, it filled a prescription for sixty Lorcet 10/650 tablets 
issued by another practitioner, Dr. Caudle. Id. at 2.
    With respect to the prescriptions Dentist Haws issued to D.C., Dr. 
Ferrrell observed: ``that's a lot of times, a lot of dental problems 
right there. At some point in time, you've got to wonder * * * why he's 
seeing the dentist so often and why he's having so much dental 
problems.'' Tr. 289. Dr. Ferrell further explained that dentists 
usually treat acute pain and that ``after maybe a month or two and I 
continued to see those things * * * I would ask the dentist to supply 
me some type of reason for why the prescriptions kept going on for such 
a long period of time.'' Id. at 290.
    Relatedly, Dr. Mulder opined ``that the prescriptions over a 
longitudinal basis for this narcotic in this dose were being prescribed 
by a dentist who is not a physician which heightens the level of 
concern about this particular prescription.'' Id. at 504. Dr. Mulder 
also testified that the drugs Respondent dispensed contained 
acetaminophen, and that there is a ``safe limit'' as to the amount of 
acetaminophen an individual can take during a day without ``developing 
a toxic state,'' which is ``four grams a day.'' Id. at 500. Dr. Mulder 
further testified that ``[t]he number of pills dispensed to this 
individual were above the acceptable limit'' and could lead to serious 
illness if the patient was actually taking the drugs. Id. at 500-01.
    In his testimony, Mr. Street acknowledged that the prescriptions 
``slightly exceed[ed]'' the safe limit for acetaminophen ``on two 
separate months.'' May 25, 2005 Tr. at 79. Mr. Street testified that 
D.C. ``required a lot of dental work,'' and that because he was a 
patient ``that Dr. Haws [was] treating over a long period of time, we 
kept in touch with the dentist office. And it was easy to do, because 
the dentist office is right there in town. And kept in touch with 
either Dr. Haws or his receptionist * * * Ms. Williams, to verify that 
they were, you know, requiring ongoing treatment.'' Id. The ALJ 
credited this testimony, see ALJ at 35, and many of the prescriptions 
issued by Dentist Haws appear to have been called in to Respondent.\19\ 
See GX 15-B.

[[Page 370]]

None of the prescriptions, however, include a notation that the 
dispensing pharmacist had questioned Dentist Haws about D.C.'s 
continuing need for the drugs. See Id.
---------------------------------------------------------------------------

    \19\ The ALJ also found that ``Mr. Street had counseled [D.C. 1] 
not to take additional over-the-counter acetaminophen during this 
time.'' ALJ at 35 (citing Resp. Ex. 1, at 1). Mr. Street did not, 
however, testify to this under oath and the document which contains 
this statement was not sworn. It is also notable that Mr. Street and 
his counsel had approximately ten months from the time the 
Government rested until the hearing reconvened and thus they had 
ample time to prepare for his testimony. ALJ at 2. Because Mr. 
Street could have testified to this but chose not to, I give no 
weight to this statement.
---------------------------------------------------------------------------

Patient E.C.

    Government Exhibit 15-D shows that on several occasions, Respondent 
dispensed to E.C. prescriptions for combination hydrocodone and 
acetaminophen products issued by different doctors within a short 
period of other similar prescriptions. For example, on October 24, 
1997, Respondent dispensed a prescription for 20 Lortab 7.5/500 issued 
by Dr. Hussain; the next day, it dispensed a prescription for 25 
hydrocodone/apap 5/500 issued by Dr. Wiles. See GX 15-D at 1. Three 
days later (on October 28), Respondent dispensed another 30 tablets of 
Lortab 5/500 issued by Dr. Wiles. Id. Dr. Ferrell specifically noted 
that upon receiving such prescriptions, a pharmacist should call the 
prescriber and ask if he was ``aware that the patient had gotten Lortab 
the day before.'' Tr. 296.
    The trace also showed that Respondent had filled multiple 
prescriptions for sixty tablets of alprazolam 5 mg. issued by Dr. 
Hussain, as well as multiple prescriptions for diazepam 5 mg. issued by 
Dr. Slonaker. GX 15-D. In several instances, Respondent filled the 
prescriptions only days apart. See Id. at 1 (10/26/99 Rx for 60 
alprazolam and 10/27/99 Rx for 60 diazepam; 11/20/99 Rx for 60 
alprazolam and 11/23/99 Rx for 60 diazepam). Id. at 1. Both drugs are 
schedule IV depressants, see 21 CFR 1308.14(c), and according to Dr. 
Ferrell ``have a synergistic effect'' when taken together. Tr. 297. Dr. 
Ferrell further noted that the trace showed that the patient was 
simultaneously receiving multiple controlled substances for pain (from 
Dr. Slonaker) such as hydrocodone/apap 7.5/500 and hydrocodone/apap 10/
500, Id. at 298, and that the pharmacy should have questioned this. Id. 
at 300; GX 15-D at 2. Relatedly, Dr. Mulder testified that ``[it] is 
generally considered not appropriate to be mixing different short-
acting analgesic medications at the same time'' such as E.C. was 
receiving, and that the pharmacist should have contacted the physician. 
Tr. 508. None of the prescriptions indicated that Respondent had 
contacted the prescriber. See GX 15-D.
    Mr. Street testified that ``I'd talk to Dr. Slonaker about this 
before, because he does this for many of his patients'' and that ``he 
likes to prescribe a stronger pain med for severe pain, and a weaker 
pain med * * * for mild to moderate pain.'' May 24, 2005 Tr. 81-82. Mr. 
Street also testified that E.C. had been a patient since Respondent 
opened, that he had ``chronic back problems'' and ``has seizures'' 
related to a fall he had in November 1997. Id. at 81. Mr. Street, 
however, offered no testimony regarding Respondent's frequent (and 
sometimes nearly simultaneous) dispensings of the alprazolam and 
diazepam prescriptions which were written by different doctors.
    Respondent also introduced into evidence the affidavit of Joseph 
Montgomery, a physician with thirty years of experience. See RX 5. Dr. 
Montgomery reviewed the medical records of most of the patients 
identified in the traces. Dr. Montgomery opined that it was ``probably 
* * * medically justified'' for E.C. ``to receive the degree of pain 
medications prescribed.'' RX 5, Ex. A. at 2. Dr. Montgomery offered no 
opinion, however, as to whether the prescriptions Respondent repeatedly 
filled for alprazolam and diazepam were issued for a legitimate medical 
purpose. See Id.

Patient S.F.

    The prescription trace for S.F. shows that beginning in January 
1996 and ending in April 1997, Respondent filled approximately 126 
prescriptions issued by Dr. Blackmon which were primarily for Dilaudid 
(schedule II) and Lorcet 10/650 (schedule III). GX 15-F. Dr. Ferrell 
noted that in 1996, Respondent filled approximately 47 hydrocodone/apap 
prescriptions for a total of 3,915 dosage units and 35 Dilaudid 
prescriptions for 3,090 dosage units. Tr. 306. Dr. Ferrell further 
explained that this amounted to ten tablets a day of hydrocodone and 
eight tablets a day of Dilaudid, ``which is real heavy usage of * * * 
the two opioids.'' Id. Moreover, in the first three-and-a-half months 
of 1997, Respondent filled 23 prescriptions totaling 2,070 dosage units 
of hydrocodone and 16 prescriptions totaling 1,454 dosage units of 
Dilaudid. Id. This amounted to approximately 17 tablets a day of 
hydrocodone and 12 tablets a day of Dilaudid. Id. Dr. Ferrell also 
noted that Respondent had filled a prescription for Buprenex, a 
narcotic agonist-antagonist which can cause acute withdrawal symptoms 
in patients taking Dilaudid, an opioid agonist. Id. at 307.
    Dr. Ferrell further noted that the Buprenex prescriptions contained 
no notation that Respondent had contacted the prescriber. Id. at 308. 
Dr. Ferrell added that based upon the dosages being prescribed, S.F. 
was ``at least physically dependent'' on the opioids and that he would 
have ``probably refuse[d] to fill his prescriptions.'' Id.
    Dr. Mulder added that the quantities of dosage units of 
hydrocodone/acetaminophen drugs ``were twice the acceptable limits'' 
and ``would be potentially toxic.'' Id. at 511. He further testified 
that a pharmacist has an obligation ``not to dispense medication 
knowingly harmful to the patient'' and ``to contact the physician to 
let him know that the prescriptions were exceeding acceptable norms.'' 
Id. Dr. Mulder also noted that Respondent was dispensing ``two 
different narcotics simultaneously in relatively large quantities.'' 
Id.
    The ALJ found credible Mr. Street's testimony that S.F. had ``three 
major back surgeries'' and had difficulty walking. ALJ 40. The ALJ also 
found credible Mr. Street's testimony that he ``had to make frequent 
phone calls about him, because he was always wanting his medications 
early, or he would * * * bring a prescription in that was * * * too 
frequent, too close to the other one he brought in.'' May 24, 2005 Tr. 
85. Mr. Street maintained, however, that Dr. Blackmon ``was monitoring 
him closely,'' and that while Dr. Blackmon acknowledged that ``he was 
giving [S.F.] a high amount of narcotics, he felt [S.F.] needed these 
just so * * * he could function in every day life.'' Id.
    The ALJ also found credible Mr. Street's testimony that while he 
provided early refills of S.F.'s prescription, he never did so without 
verifying it with Dr. Blackmon and then ``document[ed] the transaction 
in the computer.'' ALJ at 40 (citing May 24, 2005 Tr. at 85-86). 
Respondent did not, however, produce any printouts of this 
documentation (or for any other instance in which he claimed to have 
contacted a prescriber) and testified on cross-examination that he did 
not know if the ``specific notes for each specific patient'' could even 
be printed out. May 24, 2005 Tr. at 154.
    As for the filling of the Buprenex, the ALJ credited Mr. Street's 
testimony that the drug's package insert ``gives no interactions or 
contraindications to ingestion with hydrocodone.'' ALJ at 40. The ALJ 
also credited Mr. Street's testimony that ``[t]he only precaution 
regarding Buprenex and hydrocodone is that the combination may 
`increase * * * drowsiness.''' Id. at 40-41 (citing May 24, 2005 Tr. 
87).
    Respondent, however, offered no testimony in response to Dr. 
Mulder's testimony that Respondent was filling prescriptions for 
combination hydrocodone/acetaminophen at quantities that exceeded 
acceptable safe

[[Page 371]]

limits.\20\ Furthermore, I take official notice of the package insert 
for Buprenex.\21\ Under the section captioned ``Use in Narcotic-
Dependent Patients,'' the insert states: ``Because of the narcotic 
antagonist activity of Buprenex, use in the physically dependent 
individual may result in withdrawal effects.'' Buprenex Injectable 
Package Insert, at 1. I therefore reject the ALJ's finding crediting 
Mr. Street's testimony on the issue. I further find that at the time 
Respondent filled the Buprenex prescription, it had filled more than 
sixty prescriptions issued to S.F. for both Dilaudid (hydromorphone) 
and combination hydrocodone drugs, both of which are narcotics. See GX 
15-F, at 1 & 3; see also 21 CFR 1300.01(b)(30); Id. 1308.12(b)(1); Id. 
1308.13(e).
---------------------------------------------------------------------------

    \20\ Neither Mr. Street nor his expert witness, Dr. Montgomery, 
offered any evidence to refute this testimony. See RX 5, at 3-4. 
Moreover, while Dr. Montgomery stated that ``the records showed that 
Jeff Street called Dr. Blackmon's office regarding the quantity of 
pain medicine and Soma that [S.F.] received,'' RX 5, at 5, Dr. 
Montgomery offered no opinion as to why it was appropriate to 
dispense either quantities of drugs that are potentially toxic or 
multiple opiates. See id. at 4-5.
    \21\ In accordance with the Administrative Procedure Act (APA), 
an agency ``may take official notice of facts at any stage in a 
proceeding--even in the final decision.'' U.S. Dept. of Justice, 
Attorney General's Manual on the Administrative Procedure Act 80 
(1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). In accordance with 
the APA and DEA's regulations, Respondent is ``entitled on timely 
request to an opportunity to show to the contrary.'' 5 U.S.C. Sec.  
556(e); see also 21 CFR 1316.59(e). To allow Respondent the 
opportunity to refute the facts of which I take official notice, 
Respondent may file a motion for reconsideration within fifteen days 
of service of this order which shall commence with the mailing of 
the order.
---------------------------------------------------------------------------

Patient B.J.

    This trace showed that twenty-one different physicians had 
prescribed controlled substances to B.J. The prescriptions were for 
multiple schedule IV benzodiazepines including alprazolam, lorazepam, 
clonazepam, temazepam, and triazolam; multiple schedule III narcotics 
including combination hydrocodone/apap, Fiorinal with Codeine,\22\ and 
propoxyphene/apap, some schedule II endocet (oxycodone with 
acetaminophen), and four prescriptions for Stadol (butorphanol), a 
schedule IV drug (21 CFR 1308.14(f)), which is a mixed agonist/
antagonist but which has opioid antagonist properties. Tr. 548.
---------------------------------------------------------------------------

    \22\ A branded drug containing butalbital, aspirin, caffeine and 
codeine phosphate.
---------------------------------------------------------------------------

    The trace showed that Respondent repeatedly filled alprazolam and 
lorazepam prescriptions which were issued by different physicians for 
B.J. and that in multiple instances the prescriptions were filled 
within several days of each other. See GX 15-G at 1 (Compare Dr. 
Greenwood Rx for 60 alprazolam on 5/24/99 with Dr. Varney Rx for 90 
lorazepam on 5/25/99; Greenwood Rx for 45 alprazolam on 6/23/99 with 
Varney Rx for 90 lorazepam on 6/21/99; Greenwood Rx for 60 alprazolam 
on 10/26/99 with Varney Rx for 90 lorazepam on 11/1/99; Greenwood Rx 
for 60 alprazolam on 11/30/99 with Varney Rx for 90 lorazepam on 11/29/
99).\23\ The trace also showed multiple instances in which Respondent 
filled prescriptions for schedule III narcotics such as generic 
Fiorinal with Codeine and propoxyphene--which again were issued by 
different doctors--within a short time of each dispensing. Moreover, 
the trace showed numerous instances in which Respondent filled 
prescriptions for hydrocodone/apap issued by six practitioners. Id. at 
8.
---------------------------------------------------------------------------

    \23\ There were also similar instances on February 9 and 15, 
1999; March 6 and 11, 1999; April 27, 29, 30 and May 1, 1999, in 
which Respondent filled prescriptions for these drugs which were 
issued by these two doctors for B.J. See GX 15-G, at 2. There were 
also many instances in which the prescriptions were presented within 
a week to two weeks of each other but were for large quantities.
---------------------------------------------------------------------------

    Finally, the trace showed that Respondent filled prescriptions for 
Stadol on April 19 and 24, 1999, September 30, 1999, and November 6, 
1999. Id. at 1-2. Respondent, however, was also filling prescriptions 
for narcotics contemporaneously with its Stadol dispensings. See Id.
    In his testimony, Dr. Ferrell explained that ``[a] pharmacist is 
basically the gatekeeper of the medical delivery system.'' Tr. 310. 
After noting the numerous instances in which Respondent filled 
prescriptions for different benzodiazepines which were issued by 
different doctors and the large quantities of these drugs it dispensed, 
Id. at 312, Dr. Ferrell explained that a pharmacist must contact the 
prescriber, ask him if he is ``familiar with the fact [that] the 
patient'' is on another drug of the same class, and ask if he really 
wants the patient to receive the drug. Id. at 313. Dr. Ferrell also 
found problematic Respondent's filling of the prescriptions for 
hydrocodone/apap which were written by six different practitioners. Id. 
at 315.
    Dr. Mulder found problematic Respondent's filling of ``simultaneous 
prescription[s] of narcotic analgesics'' and noted that ``there were 
six different narcotics being * * * dispensed simultaneously by a 
number of different physicians.'' Id. at 512-13. Dr. Mulder further 
found that ``[t]he number of pills dispensed * * * exceeded the 
acceptable safe limits and would have been toxic to the patient.'' Id. 
at 513.
    Dr. Mulder also explained that prescribing an agonist/antagonist 
such as Stadol ``at the same time that you're giving an agonist * * * 
precipitate[s] a withdrawal reaction [in] the patients.'' Id. Dr. 
Mulder further explained that Stadol and narcotic agonist drugs 
``cannot be given simultaneously and they were given simultaneously in 
this particular patient.'' Id. at 513-514. According to Dr. Mulder, 
Respondent ``should not have filled'' the Stadol prescriptions. Id. at 
514. Respondent also should have notified the physician that ``he 
cannot fill'' the prescription because of the ``potential medical 
problems'' that can occur ``by dispensing these two medications 
together'' and also that the ``numbers of pills are too much.'' Id.
    Finally, with respect to Respondent's dispensing of multiple 
benzodiazepines, Dr. Mulder opined that ``the patient was receiving as 
many as three different benzodiazepines as the same time [and] [t]here 
[is] no medical indication for it whatsoever.'' Tr. 515. Dr. Mulder 
further explained that ``to dispense'' these prescriptions was 
``problematic,'' because ``the combined effect'' of the drugs ``could 
be devastating for the patient.'' Id.
    Mr. Street testified that B.J. had ``a lot of medical problems'' 
including chronic pain, chronic headaches, chronic kidney problems and 
numerous hospital stays. May 24, 2005 Tr. 87. Mr. Street also testified 
that B.J. had seen four different primary care physicians because the 
first two she saw had closed their practices or Tenncare had required 
her to change doctors. Id. at 88. Mr. Street further stated that B.J. 
``didn't see [the physicians] at the same time.'' Id.
    Mr. Street also testified that B.J. ``is a mental health patient,'' 
and that she went to a mental health group practice which had ``five or 
six doctors.'' Id. Mr. Street maintained that B.J. would not 
necessarily see the same doctor at each appointment. Id.
    As for the three different benzodiazepines, Mr. Street testified 
that Dr. Varney was her primary care physician and was prescribing her 
one benzodiazepine for tension because she had headaches and another 
for sleep. Id. at 89. Moreover, a physician at the mental health group 
was prescribing alprazolam to her for anxiety. Id. The ALJ further 
credited Mr. Street's testimony that he had called both Dr. Varney and 
the mental health group and that ``[t]hey were both aware they were 
both prescribing at the same time.'' Id. See also ALJ at 43. The ALJ 
also credited Mr. Street's testimony that he documented this in his 
computer. Id. Mr. Street did not, however, testify as to

[[Page 372]]

when he first called the respective physicians.
    Moreover, Mr. Street did not address why Respondent, between March 
and October 1999, repeatedly filled prescriptions for propoxyphene/apap 
and butalbital with codeine, which were continually issued by Drs. 
Gastineau and Varney respectively.\24\ See GX 15-G, at 1-2. Nor did he 
offer any testimony as to why Respondent filled the four Stadol 
prescriptions when it was also dispensing narcotics to B.J.\25\ 
Moreover, while Dr. Montgomery's affidavit concluded that B.J. ``is an 
unfortunate patient who has multiple medical/dental producing pain 
syndromes which were appropriately treated,'' the affidavit does not 
address the prescribings of narcotics by Drs. Varney and Gastineau. RX 
5, at 11. Nor did it address the medical appropriateness of the 
simultaneous prescribing of alprazolam and lorazepam by Drs. Greenwood 
and Varney. See Id.
---------------------------------------------------------------------------

    \24\ Dr. Gastineau was also a family and internal medicine 
practitioner and practiced in Elizabethon, Tennessee; Dr. Varney was 
not a member of Dr. Gastineau's group and practiced in Jonesborough. 
See GX 15-G, at 38 & 71.
    \25\ As explained at footnote 19, Respondent submitted an 
exhibit entitled ``Comparison/Analysis of Patients in Exhibit 15.'' 
RX 1. With respect to B.J., the documents states that ``MD OK'd 
Stadol, but not with other meds. Drug literature says can be given 
with a narcotic, and to use caution when doing so.'' RX 1, at 3. The 
ALJ did not rely on this statement and the exhibit was not sworn. As 
stated above, because Mr. Street could have testified to this (and 
been subject to cross-examination) but did not, I conclude that the 
statements in this document are entitled to no weight.
---------------------------------------------------------------------------

Patient W.L.

    The prescriptions for W.L. indicate that between December 21, 1995, 
and February 15, 1997, Respondent filled 239 controlled substances 
prescriptions (including refills) issued by Dr. Blackmon for such drugs 
as Buprenex, Diazepam, Lortab 7.5/500, generic hydrocodone/apap 10/650, 
and Tussionex Pennkinetic Suspension (hydrocodone with 
chlorpheniramine) oral solution. See GX 15-H. In 1996, Respondent made 
163 dispensings of Buprenex totaling 5,380 dosage units for 
``approximately 14 units a day,'' thirty-one dispensings of 
hydrocodone/apap totaling 2550 dosage units, and twenty-two dispensings 
of diazepam totaling 1530 dosage units. Tr. 317; see also GX 15-H, at 
1-4.\26\
---------------------------------------------------------------------------

    \26\ Some of the refills may have dispensed in the first week of 
January of the next year.
---------------------------------------------------------------------------

    Dr. Ferrell re-iterated that ``Buprenex is a narcotic antagonist'' 
and ``has many drug interactions'' including ``respiratory and 
cardiovascular bouts * * * in patients receiving therapeutic doses of 
diazepam.'' Id. Dr. Ferrrell stated that he ``probably would not have 
filled the prescription.'' Id. at 318.
    Relatedly, Dr. Mulder testified that Respondent did not comply with 
its corresponding responsibility under federal law for three reasons. 
Tr. 515-16. Specifically, Dr. Mulder noted: (1) That ``the number [of] 
pills dispensed * * * would have been toxic if taken as prescribed''; 
(2) ``the simultaneous prescription of two or more analgesic 
medications''; and (3) ``the combination of * * * agonist and the 
antagonist, agonist medications which are contraindicated to be given 
together.'' Id. at 516. Dr. Mulder concluded that Respondent should 
have notified the physician that the medications prescribed were 
contraindicated and that it should not have filled the prescriptions. 
Id.
    The ALJ credited Mr. Street's testimony that W.L. was disabled and 
had chronic back pain. ALJ at 43. (citing May 24, 2005 Tr. at 90). On 
the issue of the interaction of Buprenex and diazepam, Mr. Street 
testified that ``the only thing the package insert says about combining 
the two drugs is that there have been reports of respiratory problems 
when Diazepam is given with Buprenex.'' May 24, 2005 Tr. at 90. Mr. 
Street further added that the insert then ``tells the physician to 
proceed with caution if you're going to administer the two drugs.'' Id. 
The ALJ also credited Mr. Street's testimony that while W.L. was 
receiving ``a pretty heavy dose of narcotics, * * * we stayed [in] 
contact with Dr. Blackmon's office; and Dr. Blackmon * * * said he was 
monitoring him close,'' and needed the high doses ``for his medical 
condition.'' Id. at 90-91; ALJ at 44.
    According to the Buprenex package insert (which I have taken 
official notice of), ``[t]here have been reports of respiratory and 
cardiovascular collapse in patients who receive therapeutic dose of 
diazepam and Buprenex,'' and ``[p]articular care should be taken when 
Buprenex is used in combination with central nervous system depressant 
drugs.'' Buprenex Package Insert at 1. The package insert further 
states, however, that ``[p]atients receiving Buprenex in the presence 
of other narcotic analgesics [and] benzodiazepines * * * may exhibit 
increased CNS depression. When such combined therapy is contemplated, 
it is particularly important that the dose of one or both agents be 
reduced.'' Id. (emphasis added).
    The prescription traces indicate, however, that Dr. Blackmon's 
prescriptions did not reduce the dosing of the Buprenex, the diazepam, 
or the hydrocodone/apap and Tussionex. For example, while in January 
1996, Blackmon twice prescribed only thirty Lortab, on February 7, he 
issued a prescription for sixty Lortab (7.5/500) with one refill, and 
on February 21, he issued a prescription for ninety hydrocodone/apap 
(10/650) with two refills. Blackmon proceeded to prescribe ninety 
Lortab in various strengths with refills until February 1997. See GX 
15-H, at 1. Moreover, while Blackmon initially prescribed only thirty 
tablets of diazepam, approximately two weeks later, he issued a 
prescription for sixty tablets with one refill. See Id. Two weeks 
later, Blackmon issued another prescription for sixty diazepam with one 
refill. See Id. Three weeks later, Blackmon increased the diazepam 
prescriptions to ninety tablets with one refill, and similar 
prescriptions were issued on approximately a monthly basis until 
Blackmon's prescription writing ended. See Id.
    Moreover, the trace indicates that Blackmon increased the quantity 
and number of refills of Buprenex notwithstanding that he was also 
prescribing the other drugs. See id. Thus, the evidence indicates that 
Blackmon did not reduce the dosing of either the Buprenex or the other 
drugs as called for in the Buprenex warnings but actually increased 
them.\27\ Respondent nonetheless filled the prescriptions.
---------------------------------------------------------------------------

    \27\ Dr. Montgomery's affidavit does not discuss W.L. See RX 5.
---------------------------------------------------------------------------

Patient A.L.

    This trace indicated that between August 23, 1997, and January 12, 
1998, Respondent filled twenty-four prescriptions for Angela L. (who 
was married to Rex L., GX 15-J) which were issued by Dentist Haws. Most 
of the prescriptions were for either Lorcet 10/650 or Lortab 10/500. 
See GX 15-I. Respondent also filled three prescriptions Dentist Haws 
issued for Tussionex Pennkinetic Suspension, a combination of 
hydrocodone and chlorpheniramine which is prescribed for cough and 
upper respiratory symptoms. The original prescription was dated 9/11/
97, and the trace indicates that Respondent also dispensed two re-
fills. GX 15-I. The trace also showed that Respondent filled other 
prescriptions for Lortab which were issued by a Dr. Caudle/Caudill.
    Based on the stickers that had been attached to the original 
prescriptions, Dr. Ferrell noted that some of the prescriptions were 
issued to Rex L. but were apparently dispensed to Angela L. See id. at 
4; Tr. 320-21. Dr. Ferrell

[[Page 373]]

stated that this should not have occurred. Id. at 321. Dr. Mulder 
testified that the number of pills dispensed would have been ``toxic if 
taken the way they were prescribed and dispensed.'' Id. at 517. He 
further explained that the pharmacist should have ``[a]dvised the 
patient as to the * * * problem * * * and notified the physician that 
an excess amount of pills were prescribed.'' Id. at 518.
    Mr. Street testified that Angela L. was a typical patient of 
Dentist Haws because she had a ``low income,'' ``no insurance'' and 
``needed a lot of work.'' May 24, 2005, Tr. 91. He also testified that 
``as with all his patients that he was treating over a long period of 
time, we stayed in contact'' with Dr. Haws and ``verified that they 
were still getting treatment.'' Id. The ALJ credited this testimony. 
ALJ at 45. Mr. Street further testified that while Angela L.'s 
prescriptions may have exceeded the acetaminophen limits ``slightly,'' 
this happened in only one month and she was getting ``lots of dental 
work done.'' May 24, 2005 Tr. 91.
    In discussing Respondent's dispensings to Rex L., Mr. Street 
testified that he had discovered that a ``relief pharmacist'' had 
filled a prescription for Tussionex, which Mr. Street caught ``when 
[he] came back to work.'' May 24, 2005, Tr. 93. Mr. Street then 
testified:

    And I alerted Dr. Haws to the fact that * * * it's not within 
your usual course of practice to prescribe Tussionex. And so * * * I 
explained to him why. I said, ``That's--basically, that's not a pain 
syrup, that's a cough syrup, and that's not within your usual course 
of practice.'' And after that, he ceased doing that. I've never seen 
him do it again.

Id. According to the trace for Rex L., Respondent filled or refilled 
Tussionex prescriptions issued by Dr. Haws on August 1, 4, and 29, 
1997. See GX 15-J, at 2, 5 & 13.
    The trace for Angela L. shows, however, that Respondent filled a 
Tussionex prescription which Dr. Haws issued on September 11, 1997, 
after Mr. Street claimed to have called Haws. See GX 15-I, at 1. 
Moreover, Respondent refilled this prescription twice. See id. Mr. 
Street offered no explanation as to why these prescriptions and the 
refills were also not outside the usual course of Dr. Haws' 
professional practice. See May 24, 2005 Tr. at 91. Nor did he explain 
why Respondent filled the prescriptions. See id.

Patient R.L.

    This trace showed that Respondent dispensed numerous prescriptions 
for diazepam and combination hydrocodone products (primarily Lorcet 10/
650) between February 27, 1996, and April 15, 1997. See GX 15-J. 
According to Dr. Ferrell, in 1996, Respondent filled 53 prescriptions 
(with refills) written by Dr. Blackmon totaling 3,180 dosage units of 
combination hydrocodone/apap, and twenty-one prescriptions totaling 
1,200 dosage units of diazepam. Tr. 323.
    Rex L. also received numerous prescriptions from Dentist Haws for 
combination hydrocodone drugs and the two prescriptions for 720 ml. of 
Tussionex. Regarding the Tussionex, Dr. Ferrell testified that not only 
is it ``unusual to see a dentist write for cough syrup,'' but these 
prescriptions were for a very large quantity and he could not ``think 
of any reason why a prescription for [720 ml.] of Tussionex'' would be 
necessary. Id. at 324-25. According to Dr. Ferrell, ``the usual 
dosage'' of Tussionex ``is 5 milliliters every 12 hours,'' so that 720 
ml. provides 144 dosage units. Id. at 325.\28\
---------------------------------------------------------------------------

    \28\ Dr. Ferrrell testified that if a patient took the usual 
dosage of five ml. twice a day, 144 dosage units would last 36 days. 
Id. at 326. This appears to be a math error as 144 dosage units, if 
taken twice a day, should last 72 days.
---------------------------------------------------------------------------

    The stickers attached to the actual hard copy prescriptions show 
that on August 1, 1997, Respondent dispensed to Rex. L. 720 ml. of 
Tussionex, and that three days later, it dispensed to him an additional 
360 ml. GX 15-J, at 13. Furthermore, on August 29, 1997, Respondent 
dispensed to Rex L. an additional prescription for 720 ml. of Tussionex 
based on Dr. Haws' authorization. Id. at 5. Dr. Ferrell further noted 
that Dr. Haws' Tussionex prescriptions did not appear to include 
specific directions as to how the drug should be taken. Tr. 326; see 
also GX 15-J, at 5 & 13.
    Regarding Rex L., Dr. Mulder testified that the quantities of pills 
Respondent dispensed ``could have been toxic if taken as prescribed.'' 
Tr. 519. Dr. Mulder further noted that there was evidence that Rex L. 
was ``Doctor Shopping,'' a practice in which drug abusers and 
prescription drug-dealers ``will go from physician to physician to 
present the same story to'' each doctor so as to ``amass their 
quantities of medications.'' Id. at 520-21.
    According to the trace, on November 10, 14, and 18, 1997, 
Respondent filled prescriptions which Rex L. obtained from Dentist Haws 
for 24 Lorcet (10/650). GX 15-J, at 2. Thereafter, on November 22, 
Respondent filled a prescription Rex L. obtained from Dr. Egidio for 
another 60 Lorcet. Next, on November 29, Respondent filled a 
prescription Rex L. obtained from Dr. Caudill for 90 Lortab 10/500; 
Respondent then refilled this prescription twice. See id.
    This was followed by a December 5 dispensing of a prescription for 
240 ml. of Tussionex issued by Dr. Caudell,\29\ dispensings on December 
9 and 12 of prescriptions for 20 and 24 Lorcet issued by Dentist Haws, 
a December 17 dispensing of a prescription for 100 tablets of MS Contin 
100 mg. (a schedule II drug containing morphine) issued by Dr. Caudle, 
and a December 23 dispensing of a prescription for 65 Dilaudid 4 mg. 
issued by Dr. Egidio. See id. These were followed by dispensings of 24 
Lorcet tablets on December 31, 1997, and January 5, 1998, pursuant to 
prescriptions issued by Dentist Haws, followed by a January 9 
dispensing of a prescription for 240 ml. of Tussionex issued by Dr. 
Caudill, and additional prescriptions for Lorcet issued by Dentist 
Haws. See id.
---------------------------------------------------------------------------

    \29\ It is not clear whether this is a misspelling of Dr. 
Caudill's name.
---------------------------------------------------------------------------

    The ALJ found credible Mr. Street's testimony that Rex L. suffered 
from ``extreme chronic pain'' and that Respondent contacted Dr. 
Blackmon who informed him that ``he needed this dose for his chronic 
pain.'' May 24, 2005, Tr. 92; see also ALJ at 46. The ALJ also found 
that Mr. Street was aware that patients may develop a tolerance and 
require larger doses of pain medication. ALJ at 46.
    Regarding the Tussionex, the ALJ found credible Mr. Street's 
testimony ``that the prescription * * * was filled by a relief 
pharmacist.'' ALJ at 46 (citing May 24, 2005 Tr. at 93. The ALJ also 
found credible Mr. Street's testimony that he called Dr. Haws and 
discussed that the prescriptions ``would not normally be within the 
usual course of a dentist's practice,'' and ``that, after the phone 
call, he did not see anymore Tussionex prescriptions issued by Dr. 
Haws.'' Id. (Citing May 24, 2005 at 93). For the reasons stated in the 
discussion regarding Angela L., I reject the ALJ's credibility finding 
regarding Mr. Street's phone call.
    In his testimony, Mr. Street did not specify which of the three 
Tussionex prescriptions issued by Dr. Haws for Rex L. were filled by 
the relief pharmacist. Nor did he testify as to which of these 
prescriptions prompted his phone call to Haws. See May 24, 2005 Tr. 93.
    Moreover, Mr. Street offered no testimony responding to Dr. 
Mulder's opinion that Rex L. was engaged in doctor shopping. More 
specifically, Mr. Street did not testify at all as to why his pharmacy 
filled the prescriptions that

[[Page 374]]

Rex L. presented from multiple practitioners between November 1997 and 
January 1998.\30\ See id. at 92-93.
---------------------------------------------------------------------------

    \30\ Again I note that in Respondent Exhibit 1, there is a 
notation that ``MDs (Caudill and Egidio) were contacted to make sure 
both were aware patient was seeing each. Both had agreed to see 
patient since Caudill was semi-retired.'' RX 1, at 4. As explained 
previously, I decline to give any weight to this document. I further 
note that even if Mr. Street contacted both doctors, his statement 
says nothing about whether he notified each of them as to what drug 
the other doctor (as well as Dr. Haws) was prescribing.
---------------------------------------------------------------------------

Patient K.P.

    This trace showed that Respondent filled prescriptions K.P. had 
received from ``some 22 different prescribers.'' \31\ Tr. 328. Most of 
the prescriptions were for combination hydrocodone/acetaminophen in 
various strengths. See GX 15-K. There were, however, also prescriptions 
for alprazolam, propoxyphene/apap, Tussionex, Fiorinal with Codeine, 
and phentermine. See id.
---------------------------------------------------------------------------

    \31\ There actually appear to have been 26 different 
prescribers. See GX 15-K.
---------------------------------------------------------------------------

    Dr. Ferrell noted that between April 20, 2001, and April 19, 2002, 
Respondent dispensed to K.P. 58 prescriptions for combination 
hydrocodone/apap products totaling 2,355 dosage units. Tr. 328. 
According to Dr. Ferrell, Respondent ``absolutely should have called'' 
the prescribers ``on each case.'' Id. at 329. Dr. Ferrell opined that 
K.P. was a ``doctor shopper.'' Id. at 330.
    Dr. Mulder likewise identified ``the number[] of physicians for 
whom prescriptions were being filled over a relatively short period of 
time,'' and that the ``quantity of pills * * * exceeded * * * 
acceptable limits.'' Tr. 522. Dr. Mulder further testified that 
Respondent ``[h]ad a responsibility not to fill prescriptions for more 
pills than what would be considered safe and acceptable'' and to 
``notify * * * the physicians that the patient was receiving the same 
prescription from multiple physicians over the same period of time.'' 
Id. at 522-23.
    Regarding K.P., Mr. Street testified that she had complications 
from neck surgery. May 24, 2005 Tr. at 94. He further testified that 
``over the course of time [K.P.] had to see five different primary care 
physicians'' either because the physician closed his/her practice or 
Tenncare moved her to a different physician. Id. Mr. Street added that 
K.P. had ``seen neurosurgeons'' and they had ``referred her to a pain 
management doctor who * * * was writing her pain meds.'' Id. Mr. Street 
further added that ``[t]hey were both aware that they were prescribing 
them at the same time.'' Id. Finally, Mr. Street added that during the 
April 2001 to April 2002 period, K.P. ``had to see seven emergency room 
doctors,'' and added that this was ``not surprising, considering * * * 
she had the two major surgeries [and] all the complications.'' Id.
    While the ALJ credited this testimony, Mr. Street did not identify 
the names of the doctors by their practice areas. Nor, other than in 
his vague testimony that the neurosurgeons (Drs. Wiles and Vaught) and 
the pain management doctor (Dr. Smyth) were each aware of the other's 
prescribing, did Mr. Street testify as to his pharmacy having contacted 
any of the other prescribers, such as the orthopedic surgeons (Drs. 
Beaver and J. Williams) and the emergency room physicians she was also 
seeing in the same time frame. Moreover, while Dr. Mongtomery opined 
that there was medical justification for K.P. to have received 
``tremendous amounts of narcotics,'' his affidavit does not address the 
issue of doctor shopping. RX 5, at 12.

Patient P.P.

    The prescription trace indicated that Respondent filled 
prescriptions for P.P. that were issued by eleven different 
prescribers. See GX 15-L. Dr. Ferrell specifically noted that during 
February 2002, P.P. obtained prescriptions for hydrocodone/apap from 
Doctors Goulding, Smyth, Haws and Pelletier for a total of 79 dosage 
units.\32\ Tr. 331. Dr. Ferrell further concluded that ``if 
[Respondent] was telling the different physicians about [the] history 
of this patient, [it] probably could have cancelled their 
prescriptions.'' Id. at 332.
---------------------------------------------------------------------------

    \32\ The prescriptions were dated between February 14, 2002, and 
February 25, 2002. GX 15-L, at 2.
---------------------------------------------------------------------------

    There is also evidence that during the fall of 1999, Respondent 
filled prescriptions for narcotics that were issued in close proximity 
to other prescriptions for either the same or similar narcotics and 
that P.P. was engaged in doctor shopping. For example, on October 4, 
1999, Respondent dispensed an original prescription for 60 hydrocodone/
apap (5/500) that was issued by Dr. Lynch; Respondent dispensed refills 
of the prescription on both October 15 and 25, 1999. GX 15-L, at 1. On 
October 18, 1999, Respondent dispensed two prescriptions issued by Dr. 
Wyche: one for 30 hydrocodone/apap (5/500), and one for 48 
propoxyphene/apap. Id. Moreover, on November 17, 1999, Respondent 
dispensed a prescription for 36 propoxyphene/apap issued by Dr. Wyche, 
and on November 18, Respondent dispensed a prescription for 48 
hydrocodone/apap, which was also issued by Dr. Wyche.\33\ Id.
---------------------------------------------------------------------------

    \33\ On November 5 and 10, 1999, Respondent also dispensed a 
prescription and refill which Dr. Wyche wrote for 180 ml. of 
acetaminophen with codeine elixir. GX 15-L, at 1.
---------------------------------------------------------------------------

    Dr. Mulder testified that Respondent had not met its corresponding 
responsibility in its dispensings to P.P. for several reasons. In 
support of his conclusion, Dr. Mulder cited ``the numbers of 
prescriptions that were [being] dispensed within each given month, the 
combination of two or more narcotics at the same time, and [that] 
multiple physicians [were] writing prescriptions for this patient.'' 
Tr. 523-24. Dr. Mulder also observed that K.P. (GX 15-K) ``had the same 
address as'' P.P., and ``there was a very significant amount of 
narcotics going into this household every day.'' Id. at 524. Dr. Mulder 
further explained that in his experience, it is ``highly unusual that 
you would have two family members with medical problems that would 
require the same level of prescribing within each individual month.'' 
Id.
    Dr. Mulder also testified that he would have contacted law 
enforcement officials regarding what ``may be going on in that 
particular household.'' Id. at 525. Finally, Dr. Mulder testified that 
a pharmacist should not ``fill what is inappropriate from a dosage 
perspective,'' and that a pharmacist should ``notify the physicians 
that the patients are receiving multiple prescriptions from multiple 
physicians for the same thing.'' Id. at 524.
    Mr. Street testified that P.P. was K.P.'s husband and that he was 
another ``chronic pain patient.'' May 24, 2005 Tr. at 95-96. Mr. Street 
further testified that P.P. mainly saw Dr. Tochev, a primary care 
physician, and Dr. Tanner, who was also in the same group. Id. at 96.
    Mr. Street added that Dr. Tochev referred P.P. to a pain management 
group, which started writing prescriptions for pain meds for him. Id. 
Mr. Street then testified that ``we contacted pain management about 
that, and Dr. Tochev, and neither one * * * [was] aware the other one 
was prescribing. Well, after we contacted them, pain management cease 
to write [P P.] any more pain meds.'' Id.
    Concluding his testimony regarding P.P., Mr. Street stated that 
``he had seen ER doctors a couple of times; he had seen a dentist a 
couple of times.'' Id. Mr. Street then explained that ``if you knew the 
doctors in the area like I do, it shouldn't present a problem.'' Id.
    Notably, Mr. Street offered no testimony regarding the multiple

[[Page 375]]

prescriptions his pharmacy filled that were issued by Drs. Wyche and 
Lynch. P.P. saw these doctors two years before he saw Dr. Tochev, the 
physician who referred P.P. to the pain management specialist.\34\ See 
GX 15-L, at 16-17. Moreover, of the doctors who prescribed to P.P. 
during the period when Dr. Tochev was also treating P.P., only Dr. 
Smyth's prescriptions indicate a specialty of pain management, and the 
trace suggests that P.P. saw Dr. Smyth on at least two occasions. Id. 
at 4.
---------------------------------------------------------------------------

    \34\ Neither Dr. Wyche nor Dr. Lynch presents him/ herself as a 
pain management specialist. See GX15-L, at 16-17. Dr. Wyche's 
scripts indicate that he has a ``FAMILY PRACTICE,'' and Dr. Lynch's 
scripts contain no indication of a specialty. Id.
---------------------------------------------------------------------------

    On February 20, 2002, Dr. Smyth wrote P.P. a prescription for 30 
hydrocodone/apap (5/500) with one refill. Id. at 8. Respondent filled 
the initial prescription the same day and the refill on March 19, 2002. 
Id. at 2. Moreover, the next day, Respondent also filled a prescription 
issued by Dr. Haws for 24 hydrocodone/apap 7.5/500. Id. This was 
followed by a February 25, 2002 dispensing of 14 tablets of 
hydrocodone/apap 5/500 pursuant to a prescription of Dr. Pelletier, and 
the dispensing of a March 5, 2002 prescription by Dr. Haws for another 
40 tablets of hydrocodone/apap 7.5/500. Id.
    Two days later on March 7, 2002, Respondent filled a prescription 
for 60 tablets of hydrocodone/apap 7.5/500 which P.P. obtained from Dr. 
Tochev; on March 25, Respondent refilled the prescription. Id. at 2. 
Thereafter, on March 27, 2002, Dr. Tochev issued another prescription 
for 60 hydrocodone/apap 7.5/500; Respondent filled the prescription the 
same day. Id.
    Finally, on April 2, 2002, Respondent dispensed another 
prescription for 62 hydrocodone/apap 7.5/500 which was issued by Dr. 
Smyth, the pain management doctor who according to Mr. Street, had 
stopped writing prescriptions after being informed that Dr. Tochev was 
also writing prescriptions for the same drug. Id.; May 24, 2005 Tr. 96. 
Furthermore, Government Exhibit 15-L also contains a copy of a 
prescription for methadone (a schedule II drug, 21 CFR 1308.12(c)) 
which Dr. Smyth issued on April 25, 2002; attached to the prescription 
is the sticker that is created upon the dispensing of a drug which 
includes the Rx number, name of the drug, the quantity and patient 
instructions, and price. See GX 15-L, at 3-4. I thus find that on April 
25, 2002, Respondent also dispensed 62 tablets of methadone to P.P.
    In his testimony, Mr. Street did not specify the date that he 
contacted the pain management doctor and Dr. Tochev regarding the fact 
that both doctors were writing prescriptions for narcotic pain 
medications. Perhaps at some point he did. The fact remains, however, 
that Respondent filled multiple prescriptions for hydrocodone that were 
being issued by multiple doctors within the same time period.
    For example, Respondent refilled a Dr. Smyth issued prescription on 
March 19, notwithstanding that on March 7, it had filled Dr. Tochev's 
prescription. On March 25, it refilled Dr. Tochev's prescription even 
though it had refilled Dr. Smyth's prescriptions six days earlier. 
Then, two days later, it filled another prescription by Dr. Tochev; 
less than a week later, it filled another prescription from Dr. Smyth. 
Finally, Respondent also filled prescriptions issued by Dentist Haws 
during the same period it was filling the prescriptions from Dr. Smith, 
Tochev, and two other physicians (Goulding and Pelletier).\35\
---------------------------------------------------------------------------

    \35\ Regarding P.P., Dr. Montgomery stated that ``[t]his patient 
has a tremendous pain syndrome due to documented medical and trauma 
etiologies. It is my opinion that this patient was appropriately 
treated and the large numbers of pain medicines were reasonable 
care.'' RX 5, at 12. Again, Dr. Montgomery's statement does not 
address whether it was appropriate for Respondent to fill multiple 
prescriptions from multiple doctors within the same time frame.
---------------------------------------------------------------------------

Patient S.P.

    This trace shows numerous instances in which Respondent filled 
prescriptions that were issued contemporaneously by multiple providers 
for either the same or similar drugs. These included narcotic pain 
medicines such as combination hydrocodone/apap, codeine/apap, and 
propxyphene/apap, as well as benzodiazepines such as clonazepam and 
temazepam. GX 15-M, at 1-2.
    Dr. Ferrell noted that S.P. has seen multiple physicians (fourteen 
by his count), and noted various instances in which ``two pain 
relievers of * * * essentially the same type characteristics'' were 
prescribed by different doctors a day apart. Tr. at 333 & 335. Dr. 
Ferrell specifically noted that on February 8, 1999, Respondent filled 
a prescription for 40 tablets of acetaminophen with codeine  3 
which was issued by Dr. Varney; the next day, Respondent filled a 
prescription for 30 propoxyphene with acetaminophen which was issued by 
Dr. Huddleston. Tr. 333. Similarly, on August 13, 1997, Respondent 
filled a prescription for 30 acetaminophen with codeine  3 
which was issued by Dr. Sykes; the next day, Respondent filled a 
prescription for 60 propoxyphene with acetaminophen which was issued by 
Dr. Varney. Id. Dr. Mulder likewise noted that Respondent had violated 
its corresponding responsibility based on its having dispensed 
excessive quantities of pills, ``two or more narcotics at the same 
time, and [the] numbers of physicians * * * for whom prescriptions were 
being filled.'' Id. at 526.
    The trace also shows that on January 14, 1999, Respondent dispensed 
25 tablets of acetaminophen with codeine  3 issued by Dr. 
Huddleston; on January 19, it dispensed another 20 tablets of the same 
drug issued by Dr. Varney. GX 15-M, at 2. On January 21, Respondent 
then dispensed 60 tablets of hydrocodone/apap 5/500 issued by Dr. 
Anderson, and on January 25, it dispensed another 25 tablets of 
acetaminophen with codeine  3 issued by Dr. Huddleston. Id. 
This was followed by a January 27 dispensing of 30 propoxyphene with 
acetaminophen, and a January 29 dispensing of acetaminophen with 
codeine  3, both of which were authorized by Dr. Varney. Id. 
The trace also shows that in April and May 1999, Respondent filled 
numerous prescriptions for narcotic pain medicines that were issued by 
Drs. Varney, Huddleston, and Hudson. Id.
    Finally, the trace also shows numerous instances in which 
Respondent dispensed temazepam prescriptions issued by Dr. Varney and, 
sometimes within a day, dispensed clonazepam prescriptions issued by 
Dr. Shah. See id. at 2. Both of these drugs are benzodiazepines. As Dr. 
Mulder earlier testified, taking multiple benzodiazepines has 
synergistic effects and could be devastating to the patient. Tr. 515.
    The ALJ found credible Mr. Street's testimony that S.P. had knee 
surgeries, hip surgeries, rotator cuff surgeries, and a partial 
amputation of her leg. ALJ at 49 (citing May 24, 2005 Tr. at 96). Mr. 
Street also testified that while it seemed like she had seen 15 
different doctors, five of the doctors practice in the same orthopedic 
group and three of the doctors practice in the mental health group. May 
24, 2005 Tr. at 97. Mr. Street also testified that Dr. Varney was ``her 
primary care physician'' and that he ``likes to write two different 
pain meds * * * one for severe pain and one for milder pain.'' Id. Mr. 
Street also stated that Dr. Varney had referred S.P. to the orthopedic 
group, which ``was prescribing her some more pain meds for acute 
pain,'' and he had ``stayed in contact with'' the doctors who ``thought 
it was okay.'' Id. at 98.
    The Government did not rebut Mr. Street's testimony on these 
points, and upon reviewing the prescriptions, it appears that some of 
the doctors were in the same group. Mr. Street, however,

[[Page 376]]

offered no testimony regarding Respondent's numerous dispensings of 
benzodiazepine prescriptions by Dr. Varney (S.P.'s family 
practitioner), and Dr. Shaw. Moreover, while Dr. Montgomery opined that 
S.P. was ``a difficult patient who received a lot of multiple narcotics 
and it was reasonable to treat her in this fashion,'' RX 5, at 12, he 
offered no opinion as to whether it was reasonable for her to receive 
multiple benzodiazepines simultaneously.

Patient J.P.

    This trace showed that Respondent dispensed multiple narcotic pain 
medicines including Darvocet (propoxyophene/apap), Lortab (hydrocodone/
apap 5/500), Tylenol with codeine  4, and Stadol spray; 
benzodiazepines including diazepam and temazepam; Pondimin 
(fenfluramine, a schedule IV drug, 21 CFR 1308.14(d)); and phentermine, 
a schedule IV stimulant (21 CFR 1308.14(e)). See GX 15-N. Most of the 
drugs were prescribed by Dr. Varney, although the Lortab was prescribed 
by Dr. Johnson, who issued fourteen prescriptions of the drug to J.P. 
throughout 1999. See id. Moreover, the trace shows that Dr. Varney 
would issue as many as four to five prescriptions for different 
controlled substances at a time. See id.
    Dr. Ferrell testified that he did not ``understand why a doctor 
would prescribe two drugs like [Tylenol with Codeine and propoxyphene/
apap] at the same time.'' Tr. 336. Dr. Ferrell noted that Darvocet and 
Tylenol  3 provide ``about the same in relief of pain.'' Id. 
at 338. Dr. Ferrell also found problematic the prescribing of Stadol at 
the same time that Darvocet and Tylenol with codeine were being 
dispensed and noted that this happened repeatedly. Id. at 337.
    Dr. Mulder testified while ``[t]he actual quantities of pills 
looked at in an isolated manner were not * * * of that much concern,'' 
J.P. ``was prescribed seven different addicting medications 
simultaneously.'' Id. at 527. Dr. Mulder further explained that J.P. 
``had stimulants and depressants, she had analgesics and anxiolytics 
and this is a whole host of different sorts of addicting medications.'' 
Id. Continuing, Dr. Mulder added that ``[a]t the very least, it would 
have warranted a discussion with the physician [to] help me understand 
what's going on here so I feel comfortable about these ying-yang sorts 
of things I'm doing with this patient's pharmacologic regime.'' Id.
    Mr. Street testified that he ``remember[ed] talking to Dr. Varney'' 
about the five or six different controlled substances he was 
prescribing. According to Mr. Street's testimony, Varney was 
prescribing two drugs for pain pills. May 24, 2005 Tr. 98-99. The ALJ 
found credible Mr. Street's testimony that J.P. weighed 350 to 400 
pounds and that Dr. Varney wrote her prescriptions for scheduled diet 
drugs to treat obesity. ALJ at 50 (citing id.). Moreover, Varney also 
``prescribed her something for sleep [and a] muscle relaxer.'' May 24, 
2005 Tr. 99.
    As for the Stadol, Mr. Street acknowledged that it was an agonist-
antagonist which might cause ``withdrawal problems.'' Id. Mr. Street 
testified, however, that the warning in the Stadol insert applies only 
to a person who ``is severely dependent on narcotics.'' Id. at 100. Mr. 
Street further testified that he talked with a physician, who he did 
not identify, about the use of Stadol and was told its use would not 
pose a problem unless the patient was ``a street addict.'' Id. Mr. 
Street also testified that he asked this physician about whether it was 
appropriate to prescribe the drug if a patient was ``getting two or 
three pain pills a day.'' Id. According to Mr. Street, the physician 
told him that it would not be a problem as long as the drug was used 
``on an acute'' or an ``as needed basis,'' and that he instructed the 
patient not to take their ``pain pill * * * in the same time period.'' 
Id.
    The ALJ found this testimony credible and the Government did not 
rebut it. Mr. Street, however, offered no testimony as to why 
Respondent also filled the prescriptions for Lortab that were issued by 
Dr. Johnson during the same period it was also filling the 
prescriptions issued by Dr. Varney for the three opiates (Stadol, 
Darvocet and Tylenol 3).\36\
---------------------------------------------------------------------------

    \36\ While Dr. Montgomery opined that treating J.P. with 
narcotics was medically justified, his affidavit does not address 
whether it was appropriate for multiple physicians to be 
simultaneously prescribing opiates to her. RX 5, at 12-13.
---------------------------------------------------------------------------

Patient A.S.

    This trace showed that between April 25, 2001, and March 12, 2002, 
Respondent filled prescriptions which A.S. obtained for various 
strengths of combination hydrocodone/apap products from eight different 
practitioners. GX 15-Q. Dr. Ferrell specifically noted that there were 
seventeen different prescriptions totaling 369 dosage units. Tr. 343-
44.
    Dr. Mulder testified, however, that ``the number of pills were 
acceptable,'' and that ``[t]he only disturbing thing about this was the 
use of the number of different physicians for filling these 
prescriptions.'' Id. at 531. Dr. Mulder further testified that, under 
these circumstances, ``[i]t would have been appropriate for the 
pharmacist to have notified the multiplicity of physicians that a 
number of different prescriptions were being received for this narcotic 
so that they could concentrate that in one place.'' Id. Dr. Mulder did 
not, testify, however, that doing so was required for Mr. Street to 
comply with his corresponding responsibility given the limited number 
of pills being dispensed. See id.
    Moreover, the ALJ found credible Mr. Street's testimony that A.S. 
had to switch her primary care physician multiple times because a 
physician closed her practice. ALJ 53. Furthermore, several of the 
prescriptions were for small amounts and were issued by her dentist and 
emergency room physicians. Id. Mr. Street thus testified that this did 
not ``throw up any red flags.'' May 24, 2005 Tr. at 104; see also ALJ 
at 53. The Government did not offer any evidence rebutting Mr. Streets' 
testimony or demonstrate through other evidence that it was 
implausible.

Patient R.S.

    This trace showed that R.S. had received prescriptions from nine 
different prescribers. See GX 15-R, at 1-4. According to the trace, in 
1999, Respondent filled thirty one prescriptions for alprazolam, 
nineteen prescriptions for clonazepam, two prescriptions for diazepam, 
and one prescription for lorazepam. See id. at 1-3.
    The alprazolam prescriptions were issued by Drs. Lynch, Wiley, and 
Niner; the clonazepam prescriptions were written by Dr. Wiley. See id. 
Most significantly, the trace showed that both Drs. Lynch and Wiley 
were writing alprazolam prescriptions during the same time period. More 
specifically, Dr. Lynch wrote prescriptions for 100 alprazolam which 
Respondent filled on January 5, February 11 and 24, March 11 and 15, 
April 15 and 26, May 13, June 4 and 28, August 11, September 7 and 13, 
October 4, November 24, and December 6, 1999. Id. Dr. Wiley wrote 
prescriptions for 60 alprazolam which Respondent filled on January 27, 
February 4 and 22, March 13 and 31, April 6 and 22, May 10 and 29, June 
15, July 5 and 22, August 9, and September 3, 1999. Id. Dr. Niner also 
wrote an alprazolam prescription on September 25, 1999. Id. at 2.
    Dr. Lynch was R.S.'s primary care physician. May 24, 2005 Tr. 105; 
see also id. at 8. Dr. Wiley was a psychiatrist. Id. at 26. These 
physicians

[[Page 377]]

had offices in different cities and did not practice together.
    Respondent also filled numerous prescriptions for combination 
hydrocodone/apap and oxycodone/apap drugs which were written by Dentist 
Haws and Dr. Lynch; most of the prescriptions were filled only days 
apart. Id. at 1-2. Specifically, on May 5, 1999, Respondent dispensed a 
prescription for 60 Lortab 10/500 issued by Dr. Lynch. Id. at 1. 
Moreover, pursuant to prescriptions issued by Dr. Haws, on May 12 and 
18, 1999, Respondent dispensed two prescriptions for the schedule II 
drug Endocet (oxycodone/apap 5/325), and on May 21 and June 8, 1999, it 
dispensed two prescriptions for Percocet (also oxycodone/apap). Id. at 
2. Furthermore, on June 1, 1999, Respondent dispensed a prescription 
issued by Dr. Lynch for 60 Lortab 10/500; on June 12, it refilled the 
prescription. Id.
    During February through April 2002, there were again repeated 
instances in which Respondent dispensed prescriptions for combination 
hydrocodone/apap products which were issued by Drs. Lynch and Haws only 
days apart. Id. at 4. More specifically, Respondent dispensed 
prescriptions issued by Dr. Lynch for 60 hydrocodone/apap 10/650 on 
February 2, 14, and 26, March 7, 16, 21, and 29, and April 5, 9, and 
22. Id. As for Dr. Haws' prescriptions, Respondent dispensed 24 
hydrocodone/apap (typically 10/650) on February 21, March 13 and 14, 
and April 24 and 26, and prescriptions for 12 hydrocodone/apap on March 
18 and April 8. Id.
    Both Dr. Ferrell and Mulder found Respondent's dispensings of both 
the benzodiazepine and narcotics to be in violation of Respondent's 
corresponding responsibility. Tr. 347 & 532. Dr. Ferrell testified that 
there ``[s]hould have been some coordination between the two 
prescribers.'' Id. at 347. Dr. Mulder noted that the number of pills 
being dispensed ``exceeded safe, acceptable'' limits and that 
Respondent should have notified the physicians ``that multiple 
prescriptions were being written.'' Id. at 532.
    Mr. Street testified that R.S. had been wounded in a robbery 
attempt and had ``extreme chronic pain'' in his shoulder and upper 
back. May 24, 2005 Tr. 104-05. Mr. Street further testified he was 
seeing both a primary care doctor and was ``a mental health patient.'' 
Id. at 105. Continuing, Mr. Street testified:

    There was a question about similar drugs being prescribed 
together. That was his mental health doctor that started that. He 
was prescribing benzodiazepines; namely alprazolam for anxiety and 
clonazepam for depression. So we called the doctor and he told me 
the reason he was prescribing those. Now, later on his primary care 
doctor, Dr. Lynch, started prescribing him alprazolam exclusively 
for anxiety, but he continued to get the clonazepam from his mental 
health doctor for the depression.

Id.

    As for the multiple narcotic prescriptions, Mr. Street testified 
that ``Dr. Lynch was prescribing Lortab for his chronic pain * * * due 
to the gunshot wound he had years ago. And at the same time he started 
seeing Dr. Haws. And Dr. Haws * * * more or less just pulled all of his 
teeth and made him a * * * complete partial--complete full plate.'' Id. 
at 105-06. Continuing, Mr. Street testified that ``[w]e made contact 
with both doctor and dentist to make them aware that both were 
prescribing.'' Id. at 106. According to Mr. Street, Dr. Lynch stated 
that she was prescribing for chronic pain and ``realize[d] the need for 
acute pain * * * when he sees Dr. Haws,'' and thus Dr. Lynch approved 
the prescription as did Dr. Haws. Id. The ALJ found Mr. Street's 
testimony credible.
    There is evidence corroborating Mr. Street's testimony that he 
called Dr. Lynch ``regarding narcotic prescriptions.'' RX 5, at 14 
(affidavit of Dr. Montgomery). In his testimony, however, Mr. Street 
did not explain why for eight months, his pharmacy repeatedly dispensed 
alprazolam prescriptions that were being issued by both Drs. Lynch and 
Wiley, many of which were filled only days apart. Relatedly, Dr. 
Montgomery's affidavit does not address why it would be medically 
appropriate for two physicians to be simultaneously prescribing 
alprazolam to a patient.

Patient J.S.

    Both Drs. Ferrell and Mulder identified Respondent's simultaneous 
dispensings of pentazocine/naloxone and acetaminophen with codeine 
 3 as problematic because pentazocine/naloxone ``is a narcotic 
antagonist,'' Tr. 351, and acetaminophen with codeine  3 is a 
narcotic agonist. Id.; see also id. at 534; GX 15-T. Mr. Street 
testified, however, that the antagonist part of pentazocine/naloxone 
(naloxone) ``is not active when you take it by mouth or orally.'' May 
24, 2005 Tr. 107. The ALJ found this testimony to be credible and the 
Government offered no evidence to rebut it.

Patient H.T.

    This trace showed multiple instances in which Respondent dispensed 
three different narcotic pain medications either on the same day or 
within only a couple of days of dispensing the other narcotic drugs. 
For example, on April 19, 1999, Respondent dispensed 100 acetaminophen 
with codeine  3, 100 propoxyphene/apap, and 100 hydrocodone/
apap 7.5/500. GX 15-U at 2. This pattern of dispensing was repeated on 
May 10-12, July 2, August 10, October 6, October 28-29, and November 
23. Id. at 1-2. Most of the prescriptions were written by a single 
physician, Dr. Hartsell, although a Dr. Sibley wrote several of the 
hydrocodone prescriptions. Id. In addition, on January 20, 1999, 
Respondent filled a prescription issued by Dr. Huddleston for 30 
hydrocodone/apap 7.5/500; on January 23, it filled a prescription 
issued by Dr. Hartsell for 100 hydrocodone/apap 5/500; and on January 
27, it filled a prescription issued by Dr. Sibley for 50 hydrocodone/
apap 7.5/500. Id. at 2.
    Moreover, between April 10, 2001, and April 5, 2002, Respondent 
dispensed 23 prescriptions for combination hydrocodone/apap totaling 
2,440 tablets. Id. at 4. The prescriptions were issued by five 
different doctors including Drs. Hartsell and Sibley. Id.
    Dr. Ferrell testified that Respondent did not comply with its 
corresponding responsibility because it should have closely monitored 
the patient and communicated with the various prescribers to make them 
aware of the multiple prescriptions and the large number of dosage 
units being prescribed. Tr. 353-55. Dr. Mulder testified that 
Respondent did not comply with its corresponding responsibility because 
of the ``[l]arge numbers of pills being dispensed on a monthly basis of 
multiple narcotics,'' and that ``[i]n some cases, three different 
narcotics [were] being dispensed within a couple of days of one another 
and this was a repetitive pattern, month after month.'' Id. at 535-36. 
Dr. Mulder also noted that there were ``multiple physicians prescribing 
these medications.'' Id. at 536. Dr. Mulder added that the pharmacy 
should have ``notif[ied] the physicians that multiple prescriptions 
were coming in from this patient, not fill unsafe amounts of these 
medications, [and] notify the patient that it's inappropriate to take 
[the] medications together.'' Id.
    Mr. Street testified that H.T. ``had a host of medical conditions'' 
including ``severe chronic lung problems,'' as well as ``severe chronic 
pain in the knees, and lower back.'' May 24, 2005 Tr. 108. Mr. Street 
further testified that H.T. was seeing both Dr. Hartsell, who was her 
primary care physician, and Dr. Sibley, who was her internal medicine 
doctor,

[[Page 378]]

and that Dr. May ``practice[d] in the same group'' as Dr. Sibley. Id.
    Mr. Street added that Dr. Hartsell's prescribing of propoxyphene 
and Tylenol 3 and Dr. Sibley's simultaneous prescribing of 
Lortab ``thr[ew] up a red flag.'' Id. at 109. Mr. Street then testified 
to having called both doctors who ``confirmed they were both treating 
her.'' Id. Mr. Street added that both doctors ``were aware they were 
both giving her meds[,] one for milder pain, one was for more severe 
pain.'' Id. Mr. Street further testified that H.T. also had to see some 
specialists who wrote her prescriptions for acute pain. Id. Finally, 
Mr. Street testified that he documented his contacts with Drs. Sibley 
and Hartsell in the computer and that both had ``okayed'' the 
prescribings. Id. The ALJ found Mr. Street's testimony credible and the 
Government produced no evidence to rebut it.

Patient W.T.

    This trace shows that Respondent dispensed prescriptions for W.T. 
that were written by fifteen different physicians for such drugs as 
alprazolam, Endocet 325 (a combination of oxycodone and acetaminophen), 
generic oxycodone with acetaminophen (5/500), various strengths of 
hydrocodone/apap, and propoxyphene-hcl 65 mg. See GX 15-V, at 1-3. The 
trace also shows that Respondent repeatedly dispensed prescriptions for 
both propoxyphene and oxycodone throughout the same time period, and 
that in some instances, did so on the same day. See id. at 1. Regarding 
these prescriptions, Dr. Ferrell testified that ``it's unusual to see a 
patient who's taking Oxycodone and also taking Propoxyphene.'' Tr. 356-
57.
    Most significantly, the trace shows that Respondent dispensed two 
separate prescriptions on a single day, each being for 300 tablets of 
schedule II drugs containing oxycodone which were issued under the name 
of Dr. Donovan. See GX 15-V, at 1. More specifically, on July 31, 1997, 
Respondent dispensed to W.T. 300 tablets of oxycodone/apap 5/500 
pursuant to prescription number 2003283, and 300 tablets of Endocet 325 
pursuant to prescription number 2003284. See id. at 1 & 21.
    Regarding one of these dispensings, Dr. Ferrell testified that 300 
tablets of oxycodone/apap ``is an unusual quantity'' and ``would be 
more than a month's supply.'' Tr. 357. On this day, however, Respondent 
dispensed to W.T a total of 600 tablets of drugs containing 
oxycodone.\37\ While Dr. Donovan had previously prescribed both Endocet 
and generic oxycodone/apap to W.T., the prescriptions had never 
exceeded 100 tablets and he had never prescribed both drugs at the same 
time.
---------------------------------------------------------------------------

    \37\ According to Dr. Montgomery's review of W.T.'s medical 
records, a progress note prepared on the same day stated that ``she 
has become dependent upon Xanax and Darvocet.'' RX 5, at 17. Dr. 
Montgomery did not specify the name of the doctor who prepared this 
note. However, at the beginning of this paragraph, Dr. Montgomery 
noted that ``[f]urther records indicate that this patient was 
followed by HG Barbarito, MD, at the medical group in Johnson 
City,'' and Mr. Street testified that Drs. Donovan and Barbarito 
were in the same group. May 24, 2005 Tr. 110. Notably, the affidavit 
does not address whether it was appropriate for Respondent to 
dispense this quantity of drugs (600 dosage units) or to dispense 
prescriptions for these drugs that were being issued in the same 
timeframe by multiple prescribers.
---------------------------------------------------------------------------

    Moreover, on August 14, only fourteen days after dispensing 600 
tablets of oxycodone, Respondent dispensed another 40 tablets of 
Endocet 325, and six days later, on August 20, it dispensed another 100 
tablets of oxycodone/apap 5/500. See GX 15-V, at 21-22. Finally, the 
trace also shows that Respondent dispensed to W.T. several 
prescriptions for Endocet 325 that were written by Dr. Haynes during 
the same period in which it was filling Dr. Donovan's prescriptions for 
the same drug. See id. at 1. Drs. Donovan and Haynes did not practice 
in the same group. See id. at 22.
    Dr. Mulder concluded that Respondent violated its corresponding 
responsibility because of the ``very large quantities of pills being 
dispensed on a monthly basis.'' Tr. 537. He also noted that there were 
``multiple analgesic agents,'' and that there were ``multiple numbers 
of physician[s] on a monthly basis.'' Id.
    Regarding W.T., Mr. Street testified that she had ``started off 
seeing a Dr. Donovan and a Dr. Barbarito, who was in the same group,'' 
and then ``had to switch to a Dr. Steffner.'' May 24, 2005 Tr. 110. Mr. 
Street further testified that W.T. had seen ``numerous specialists 
because of surger[ies] she's had'' on various body parts including her 
hand, shoulder, and gall bladder. Id. Mr. Street added that W.T.'s 
``primary care doctor was the one that was prescribing the bulk of her 
pain meds,'' and that she also had ``chronic abdominal pain.'' Id. Mr. 
Street testified that W.T.'s primary care physician had ``prescribed 
her a stronger pain med for severe pain, and a weaker pain med for less 
severe or milder pain.'' Id.
    Notably, at no time in his testimony did Mr. Street state that 
either he or any other of Respondent's pharmacists had contacted any of 
the doctors who prescribed to W.T. to verify the legitimacy of the 
prescriptions. Mr. Street likewise offered no testimony regarding his 
pharmacy's dispensing of 600 dosage units of schedule II drugs 
containing oxycodone on a single day. Nor did he testify as to why 
Respondent filled prescriptions for drugs containing oxycodone that 
were issued by Drs. Donovan and Haynes, who did not practice together, 
within the same timeframe.

Patient B.W.

    Respondent dispensed numerous prescriptions issued by Dr. Blackmon 
for Lortab 7.5/500 and Valium (diazepam) between May 1996 and March 
1997, when Dr. Blackmon's prescriptions ended. GX 15-X at 1-3. Also, 
between February 16 and November 11, 1999, Respondent filled each month 
prescriptions issued by Dr. Egidio for several controlled substances 
including Oxycontin 20 mg., Lortab 7.5/500, and alprazolam 0.5 mg. Id. 
at 2. All but the first two Oxycontin prescriptions were for 60 
tablets; most of the Lortab prescriptions were for 90 tablets. Id. The 
trace further showed that between April 19, 2001, and April 9, 2002, 
Respondent dispensed thirteen prescriptions issued by Dr. Egidio for 
Oxycontin 40 mg. Id. at 3. The first five of the prescriptions were for 
60 tablets; the remaining eight prescriptions were for 90 tablets. Id.
    Dr. Ferrell noted that Dr. Blackmon had prescribed 1,621 dosage 
units of hydrocodone and 1,300 dosage units of diazepam and that both 
quantities were ``high.'' Tr. 361. He also noted that several of Dr. 
Egidio's prescriptions for Oxycontin gave ``PRN'' as the direction for 
taking the drug, id; this term means to take as needed. Id. Oxycontin 
is, however, typically taken on a scheduled basis. Id. While Dr. 
Ferrell concluded that Respondent violated its corresponding 
responsibility in dispensing the prescriptions issued by Dr. Blackmon, 
he concluded that Respondent's dispensings of Dr. Egidio's 
prescriptions were not improper even though they contained the 
erroneous directions for taking the Oxycontin. Id. at 362.
    Relatedly, Dr. Mulder concluded that Respondent had not met its 
corresponding responsibility because ``the number of pills being 
dispensed within a given month * * * exceeded safe limits.'' Id. at 
540. Dr. Mulder further testified that the pharmacist should have told 
the patient that ``he cannot fill those'' prescriptions and notified 
the doctor. Id.
    Mr. Street testified that B.W. had degenerative disk disease and 
chronic pain in the lower back. May 24, 2005 Tr. 111-12. Mr. Street 
testified that Dr. Blackmon's prescribing of hydrocodone

[[Page 379]]

and diazepam was standard treatment. Id. at 112. He further testified 
that Dr. Blackmon had been called and ``verified what he was treating 
[B.W.] for when we called him.'' Id. Mr. Street was thus ``certain that 
her meds were for a legitimate medical purpose.'' Id. Finally, Mr. 
Street testified that ``we called Dr. Egidio * * * when [B.W.] started 
seeing him, and confirmed the diagnosis and treatment[,] so all her 
meds were given for a legitimate medical purpose.'' Id. The ALJ found 
Mr. Street's testimony credible and the Government offered no evidence 
to rebut it.

Patient J.Y.

    Most of the prescriptions listed on this trace were written by Drs. 
Blackmon and Haws. See GX-15Y. Between August 16, 1996 and March 3, 
1997, Dr. Blackmon issued and Respondent dispensed eleven prescriptions 
for combination hydrocodone/apap drugs and five for diazepam. Id. at 2.
    Moreover, between April 7 and December 1, 1997, Dr. Haws issued, 
and Respondent dispensed, seventeen prescriptions for various strengths 
of hydrocodone/apap products and one prescription for Percodan, a 
schedule II drug which contains oxycodone and aspirin. See id. at 2; 
see also 21 CFR 1308.12(b)(1). There is then a gap in the trace until 
March 30, 1999, when Respondent recommenced dispensing prescriptions 
issued by Dr. Haws for combination hydrocodone/apap. GX15-Y, at 2. 
Between March 30 and November 22, 1999, Respondent dispensed a total of 
20 such prescriptions. Id. Moreover, between June 29, 2001, and 
February 18, 2002, Respondent dispensed another five prescriptions 
issued by Dr. Haws to J.Y. for combination hydrocodone/apap drugs. Id. 
at 1.
    Regarding Dr. Haws' prescriptions, Dr. Ferrell testified that 
``[y]ou've got to wonder what point in time was he actually having 
dental problems,'' and that ``[i]n that long of a treatment, I would 
have had to have some kind of documentation on what's wrong with the 
patient.'' Tr. 363. Dr. Ferrell further testified that Respondent 
``should have verified that [the] patient had a legitimate need for a 
controlled substance for that long a period of time.'' Id. at 364.
    While Dr. Mulder found that the prescriptions issued by Dr. 
Blackmon ``could have been dispensed for legitimate purposes,'' he 
further explained that ``in [his] experience, to have prolonged dental 
pain that requires narcotics over that length or period of time is 
somewhat problematic.'' Id. at 541. Dr. Mulder added that ``this is 
unusual for dentists to be prescribing [analgesic medications] for an 
ongoing period of time,'' and that ``[f]or dentists to prescribe, it's 
usually short-term, episodic, due to acute pain * * * or for operative 
issues and not for long-term chronic pain problems.'' Id. at 542. Dr. 
Mulder further testified that it ``would be quite unusual'' for a 
dentist to be ``qualified to treat chronic pain,'' id. at 543, and that 
the dentist should have been called and asked what type of treatment 
the patient was undergoing. Id. at 542.
    On re-direct examination, Dr. Mulder testified that ``[t]here's 
obviously a finite limit to how many teeth you can pull out.'' Tr. 563-
64. Dr. Mulder then testified, however, that ``the repetitive 
prescription, month after month after month, it just seemed * * * with 
that particular file, I--it probably--I couldn't state that it violated 
standards. It just seemed a little unusual to have that many sequential 
prescriptions from a dentist for the same patient.'' Id. at 564.
    Mr. Street testified that J.Y. ``was another typical Dr. Haws 
patient'' who had ``low income, no insurance,'' and needed much work. 
May 24, 2005 Tr. 112. Mr. Street further testified that ``we stayed in 
contact with * * * Dr. Haws'' office * * * frequently to confirm that 
they were still getting treatment * * * on a regular basis[,]'' and 
asked ``[i]s this patient still getting work done?'' Id. Mr. Street 
then testified that ``they would confirm that, and that would be 
documented in the computer.'' Id. at 112-13. Here, again, the ALJ found 
this testimony credible, see ALJ at 62, and the Government offered no 
evidence to rebut it.\38\
---------------------------------------------------------------------------

    \38\ While Dr. Montgomery could not review J.Y.'s medical record 
because they were ``not available,'' he then stated that ``Dr. Haws 
is a dentist and I probably can surmise the patient was having 
significant dental problems given the number of prescriptions that 
are recorded.'' RX 5, at 18. Dr. Montgomery's statement is nothing 
more than speculation.
---------------------------------------------------------------------------

Respondent's Other Evidence

    As previously stated, Respondent elicited extensive testimony on a 
variety of factual issues from Mr. Richards, a private investigator it 
hired following the initiation of this proceeding. Beyond the testimony 
that has been discussed above, Mr. Richards also testified about 
interviews he conducted with some of the physicians, some employees of 
both the physicians and Mr. Street, and some of the patients whose 
prescriptions were discussed above.
    All of this testimony was, of course, hearsay, and while hearsay is 
admissible in these proceedings, it must still be ``reliable, 
probative, and substantial.'' 5 U.S.C. 556(d). As for the reliability 
of this evidence, when asked by the ALJ whether he found the people he 
interviewed to be credible, Mr. Richards attempted to bolster their 
credibility by asserting that ``they didn't have a dog in the fight,'' 
\39\ but then added ``whether they were 100% credible, who the heck 
knows.'' May 24, 2005 Tr. 72. Moreover, it is undisputed that these 
statements were gathered during the course of, and for the very purpose 
of being used in, this litigation. The statements which Mr. Richards 
testified to were generally not sworn and were made by their various 
declarants long after the underlying events. Furthermore, the record 
does not reflect what preliminary discussions occurred between Mr. 
Richards and the declarants and the extent to which the declarants 
needed to have their memories refreshed or may have been prompted by 
suggestive interviewing techniques. Finally, the statements were 
generally vague as to dates of the underlying events and lack probative 
force.
---------------------------------------------------------------------------

    \39\ The evidence suggests, however, that Drs. Blackmon, Egidio, 
and Slonaker had previously been investigated by various law 
enforcement and licensing authorities including DEA. Tr. 60; May 24, 
2005 Tr. 56-58. Furthermore, those patients who were having their 
illegitimate prescriptions filled by Respondent clearly had ``a dog 
in the fight.''
---------------------------------------------------------------------------

    With regard to the prescribers that he interviewed, Mr. Richards 
testified that Dr. Blackmon stated that Mr. Street ``called many times 
checking on patients and prescriptions that he wrote.'' Id. at 19. Dr. 
Blackmon's statement does not discuss any specific conversations or 
prescriptions and thus, even if I held that it was reliable, lacks 
probative value. To similar effect is Mr. Richard's testimony regarding 
the statements of Dr. Lynch and Dr. Slonaker. Id. at 21-22; id. at 24.
    Mr. Richards also testified that Dr. Hartsell stated to him that:

    [m]y file on Ms. [H.T.] reflects that Jeff or someone in his 
pharmacy called and verified one of her Lorazepam prescriptions. Her 
file shows that on July 19, 2001, * * * the Medicine Shoppe called 
and said that she was trying to have an Ativan prescription filled a 
little early. I had cut her dosage down on Ativan, but since she was 
out of the drug she must have been doubling up.

    Id. at 20-21. The prescription trace for H.T. indicates, however, 
that the actual prescription was telephoned in to Respondent. See GX 
15-U, at 15. Thus, Dr. Hartsell's statement does not accurately reflect 
the circumstances surrounding the filling of the prescriptions. And 
given all of the prescriptions that Dr. Hartsell wrote for

[[Page 380]]

H.T., that he frequently wrote prescriptions for as many as three 
different opiates at a time,\40\ and that Mr. Street testified that 
both Drs. Hartsell and Sibley were aware that each was prescribing 
opiates to H.T. at the same time and that each doctor ``okayed it,'' 
May 24, 2005 Tr. 109, it is perplexing that Dr. Hartsell did not relate 
that H.T.'s file contained a note that he had received a phone call 
from Mr. Street or his employees regarding the prescriptions being 
issued by Dr. Sibley and thus corroborating Mr. Street's testimony.\41\
---------------------------------------------------------------------------

    \40\ The drugs were hydrocodone/apap, apap/codeine  4, 
and propoxyphene/apap. See GX 15U at 1-2.
    \41\ Mr. Richards also testified that Dr. Egidio had stated that 
Mr. Street had called him regarding four specific patients, R.S., 
B.R., D.C., and B.W. Id. at 19. With respect to three of the 
patients (D.C., B.R. and R.S.), the Government's experts did not 
find Mr. Street's dispensing to be improper. Finally, because I 
conclude that the Government did not prove that Respondent's 
dispensings to B.W. were unlawful, I need not decide whether Mr. 
Richard's testimony should be given any weight.

    Mr. Richard's testimony regarding the interviews he conducted with 
the employees of various doctors was also typically lacking in 
probative force. For example, Mr. Richards testified that an employee 
of a clinic ``said that she talks frequently to people in Jeff's 
pharmacy.'' May 24, 2005 Tr. at 22. Likewise, Mr. Richards also 
testified that an employee of a neurology group had told him that she 
had worked for the group ``for three years, and during that period Jeff 
has called my office questioning prescriptions written by physicians in 
our group.'' Id. at 23.\42\ Again, neither this testimony--nor the 
other hearsay statements of various doctors' employees--addresses any 
of the specific prescriptions at issue in this proceeding.
---------------------------------------------------------------------------

    \42\ Mr. Richards further testified that during his interview of 
Ms. Timbs, ``she was shown a copy of a prescription'' that was 
written by one of the physicians who practiced with her employer, 
Doctor's Care. May 24, 2005 Tr. 22. Mr. Richards went on to testify 
that ``Mr. Street felt the prescription was suspicious and called 
Doctors Care,'' which told him that the physician had not prescribed 
Xanax, but only Triamcinolone Cream. Id. Notably, Mr. Richards did 
not testify that Ms. Timbs told him that she recalled Mr. Street's 
phone call or the circumstances surrounding the prescription. See 
id.
---------------------------------------------------------------------------

    Mr. Richards also testified as to interviews he conducted of 
several employees of Mr. Street. According to Mr. Richards, these 
employees generally stated that they had seen Mr. Street call 
physicians to verify prescriptions. However, none of these statements 
relate to any specific patient or prescription. See id. at 25-26; 27-
30. Mr. Richards further testified that these employees had told him 
Mr. Street ``called doctors anytime he had a prescription that he was 
not certain about, and that he documented it in his computer.'' \43\ 
Id. at 28.
---------------------------------------------------------------------------

    \43\ Given this, it is perplexing that Mr. Street did not 
produce any printouts from his computer to support his claims of 
having called the physicians who issued the many suspicious 
prescriptions which he filled, and that he testified that he did not 
even know if he could print this information. See May 24, 2005 Tr. 
154.
---------------------------------------------------------------------------

    According to Mr. Richards, a pharmacy technician who worked for Mr. 
Street ``was aware of several instances where Mr. Street reported 
customers to the police for forged prescriptions.'' Id. at 30. Mr. 
Richards subsequently testified that he had talked with a retired 
detective regarding various police reports involving Respondent. 
According to Mr. Richards, Mr. Street reported incidents of suspected 
prescription fraud to the police on January 16 and September 13, 2001, 
and February 11 and April 5, 2002. Id. at 71-72. The actual incident 
reports were not, however, introduced into evidence and Mr. Richards 
testified only to the date, time and drug involved and not the 
underlying circumstances of each incident. See id.
    Mr. Richards also testified that he had interviewed many of the 
patients whose prescriptions were discussed above. While the patients 
typically related to Mr. Richards that Mr. Street had never refilled 
their medications early and had counseled them regarding the addictive 
nature of their drugs, only two of the patients related that Mr. Street 
had called a particular physician. See May 24, 2005 Tr. at 45-46 
(statement of W.L. that Mr. Street had called Dr. Blackmon many times); 
id. at 50 (B.W.'s statement that she was aware that Mr. Street called 
Dr. Egidio but not specifying the date). Because Mr. Street 
specifically testified that he called Dr. Blackmon regarding W.L.'s 
prescriptions, id. at 90-91, and Dr. Egidio regarding B.W.'s 
prescriptions, id. at 112, and the ALJ credited Mr. Street's testimony 
in each instance, it is unnecessary to decide whether to give either of 
these statements any weight.

Discussion

    Section 304(a) of the Controlled Substance Act provides that ``[a] 
registration * * * to * * * dispense a controlled substance * * * may 
be suspended or revoked by the Attorney General upon a finding that the 
registrant * * * has committed such acts as would render his 
registration under section 823 of this title inconsistent with the 
public interest as determined under such section.'' 21 U.S.C. 824(a). 
In determining the public interest, the Act directs that the Attorney 
General consider the following factors:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing * * * 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.

Id. section 823(f).

    ``[T]hese factors are * * * considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or 
a combination of factors, and may give each factor the weight [I] 
deem[] appropriate in determining whether a registration should be 
revoked.'' Id. Moreover, case law establishes that I am ``not required 
to make findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d 
477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74 
(D.C. Cir. 2005). Finally, where the Government has made out its prima 
facie case, the burden shifts to the Respondent to show why its 
continued registration would be consistent with the public interest. 
See, e.g., Theodore Neujahr, 65 FR 5680, 5682 (2000); Service Pharmacy, 
Inc., 61 FR 10791, 10795 (1996).
    In this case, having considered all of the factors, I conclude that 
the Government's evidence with respect to factors two and four 
establishes a prima facie case that Respondent's continued registration 
is ``inconsistent with the public interest,'' 21 U.S.C. 823(f), and 
that Respondent failed to refute this showing. Accordingly, 
Respondent's registration will be revoked and its pending application 
for renewal of its registration will be denied.

Factor Two--Respondent's Experience in Dispensing Controlled Substances

    Under DEA's regulation, a prescription for a controlled substance 
is unlawful unless it has been ``issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of his 
professional practice.'' 21 CFR 1306.04(a). The regulation further 
provides that while ``[t]he responsibility for the proper prescribing 
and dispensing of controlled substances is upon the prescribing 
practitioner, * * * a corresponding responsibility rests with the 
pharmacist who fills the prescription.'' Id. (emphasis added). 
Continuing, the

[[Page 381]]

regulation states that ``the person knowingly filling such a purported 
prescription, as well as the person issuing it, [is] subject to the 
penalties provided for violations of the provisions of law relating to 
controlled substances.'' Id.
    DEA has consistently interpreted this provision as prohibiting a 
pharmacist from filling a prescription for a controlled substance when 
he either ``knows or has reason to know that the prescription was not 
written for a legitimate medical purpose.'' Medic-Aid Pharmacy, 55 FR 
30043, 30044 (1990); see also Frank's Corner Pharmacy, 60 FR 17574, 
17576 (1995); Ralph J. Bertolino, 55 FR 4729, 4730 (1990); United 
States v. Seelig, 622 F.2d 207, 213 (6th Cir. 1980). This Agency has 
further held that ``[w]hen prescriptions are clearly not issued for 
legitimate medical purposes, a pharmacist may not intentionally close 
his eyes and thereby avoid [actual] knowledge of the real purpose of 
the prescription.'' Bertolino, 55 FR at 4730 (citations omitted).\44\
---------------------------------------------------------------------------

    \44\ As the Supreme Court recently explained, ``the prescription 
requirement * * * ensures patients use controlled substances under 
the supervision of a doctor so as to prevent addiction and 
recreational abuse. As a corollary, [it] also bars doctors from 
peddling to patients who crave the drugs for those prohibited 
uses.'' Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United 
States v. Moore, 423 U.S. 122, 135 (1975)).
---------------------------------------------------------------------------

    Accordingly, when a customer presents a suspicious prescription, at 
a minimum, a pharmacist has a duty to verify the prescription with the 
prescriber. Moreover, even if a prescriber tells a pharmacist that a 
prescription has been issued for a legitimate medical purpose, a 
pharmacist cannot ignore evidence which provides reason to believe that 
the prescription has not been issued for a legitimate medical purpose 
or that the prescriber is acting outside of the usual course of his or 
her professional practice.
    The ALJ found that Respondent's dispensed ``over 124 controlled 
substance prescriptions'' which were written by Dr. Watts, a 
veterinarian, and which were presented by Dr. Watts' brother even 
though they were written in the names of fictitious patients. ALJ at 
17. The drugs were then diverted to Dr. Watts, who personally abused 
the drugs. During the period in which Respondent filled these 
prescriptions, Dr. Watts did not hold a DEA registration or a state 
license as he had allowed both to expire. See United Prescription 
Services, Inc., 72 FR 50397, 50407(2007) (``A controlled-substance 
prescription issued by a physician who lacks the license necessary to 
practice medicine within a State is * * * unlawful under the CSA.''); 
United States v. Moore, 423 U.S. 122, 140-41 (1975) (``In the case of a 
physician, [the CSA] contemplates that he is authorized by the State to 
practice medicine and to dispense drugs in connections with his 
professional practice.'').\45\
---------------------------------------------------------------------------

    \45\ A pharmacy has a duty to periodically check to see that a 
practitioner retains the authority to practice medicine and dispense 
a controlled substance. As the ALJ recognized, failure to do so 
could threaten public health and safety because there is usually a 
good reason for why a practitioner has lost his or her state license 
and DEA registration. In light of the other evidence regarding 
Respondent's filling of Dr. Watts' prescriptions, I need not decide 
whether it also violated this duty.
---------------------------------------------------------------------------

    Moreover, the prescriptions were being presented ``almost every day 
[or] every other day,'' Tr. 62, and were for drugs which contain 
hydrocodone. As Respondent's own witness testified, ``all of the 
prescriptions that Dr. Watts wrote that [Mr. Street] filled for any 
kind of pain drugs contained acetaminophen,'' a drug which ``is toxic 
to certain animals.'' May 24, 2005 Tr. 16.
    While the ALJ did not consider this evidence in her analysis of 
whether Respondent dispensed controlled substances in violation of the 
prescription requirement,\46\ she nonetheless noted that ``the pattern 
of Dr. Watts' brother bringing these prescriptions to the Respondent 
for filling, and the fact that the prescriptions were written in other 
people's names, should have caused Mr. Street to investigate the 
prescriptions prior to dispensing the medications.'' ALJ at 76. The ALJ 
also noted that ``[s]uch conduct by the Respondent's main pharmacist 
could threaten the public health and safety, for such conduct [by Dr. 
Watts] easily could have indicated diversion of controlled substances. 
Yet Mr. Street filled these prescriptions without further 
investigation.'' Id. at 76-77.
---------------------------------------------------------------------------

    \46\ The ALJ considered the evidence regarding Respondent's 
filling of Dr. Watts' prescriptions only under factor five. ALJ at 
76. This evidence is, however, also highly relevant in the 
consideration of Respondent's experience in dispensing controlled 
substances.
---------------------------------------------------------------------------

    I agree. There was ample evidence available to Mr. Street (and 
Respondent) to question the legitimacy of the prescriptions even if Mr. 
Street was unaware that Dr. Watts no longer held a DEA registration and 
a state license. Beyond the testimony that veterinarians usually 
purchase the controlled substances they dispense directly from 
wholesale distributors and dispense the drugs directly to an animal's 
owner, the repeated appearance of Dr. Watts' brother at Respondent to 
present prescriptions which were issued in other persons' names and 
pick up the drugs was highly suspicious and should have prompted Mr. 
Street to question the legitimacy of the prescriptions. Finally, Dr. 
Watts was writing prescriptions that according to Mr. Richards, were 
for pain drugs which ``contained acetaminophen'' and ``acetaminophen is 
toxic to certain animals.'' This should have alerted Mr. Street to the 
fact that Dr. Watts' prescriptions were not being issued for a 
``legitimate medical purpose'' and that Watts was not acting in the 
``usual course of his professional practice.'' 21 CFR 1306.04(a). I 
thus conclude that Mr. Street (and his pharmacy) had reason to know 
that these prescriptions were unlawful under federal law and that he 
repeatedly violated his corresponding responsibility when he filled 
them.\47\
---------------------------------------------------------------------------

    \47\ The Show Cause Order also alleged that Dr. Blackmon 
``issued numerous controlled substance prescriptions for no 
legitimate medical reason'' and that Respondent filled large numbers 
of these prescriptions. Show Cause Order at 1-2. While the 
Government appears to rely on the fact that some of Blackmon's 
patients traveled great distances to have their prescriptions filled 
at Respondent, some other area pharmacies continued to fill 
Blackmon's prescription.
    The record does not establish, however, how many of Dr. 
Blackmon's patients were traveling great distances to fill their 
prescriptions at Respondent. Moreover, with respect to J.Y., one of 
Blackmon's patients whose prescriptions were entered into evidence, 
the Government's own experts testified that Respondent's dispensings 
were not improper. I thus conclude that the appropriate resolution 
of whether Respondent was unlawfully dispensing prescriptions should 
focus on the evidence of its actual dispensings as indicated in the 
traces and not on the Government's generalized assertions.
---------------------------------------------------------------------------

The Prescription Traces

    As explained above, the Government also introduced into evidence 
twenty-five prescription traces which it contends show that Mr. Street 
and Respondent repeatedly dispensed controlled substances in violation 
of federal law. While noting that the traces and the Government's 
expert testimony suggest that the Government had ``met its burden of 
proof,'' the ALJ then concluded that ``Respondent presented evidence 
that demonstrated that Dr. Mulder and Dr. Ferrell did not have the 
complete picture of the Respondent's dispensing practices from the 
selected prescription traces.'' ALJ at 75. In support of her 
conclusion, the ALJ specifically noted ``Mr. Street's credible 
testimony concerning his personal knowledge of his customers, the 
actions he took to coordinate his dispensings with the patients' health 
care providers,'' and the testimony of Mr. Richards. Id. The ALJ thus 
rejected the entirety of the Government's prescription trace evidence.

[[Page 382]]

    While I agree that the Government failed to prove that Respondent 
unlawfully dispensed control substances to a number of the patients, in 
other instances the ALJ ignored relevant evidence. More specifically, 
with respect to multiple patients, the ALJ ignored clear evidence of 
doctor shopping for which Mr. Street had no explanation. She also 
ignored several instances in which Mr. Street's testimony failed to 
address the Government experts' testimony, as well as instances in 
which his testimony was inconsistent with other evidence.
    As found above, either one or both of the Government's experts 
concluded that Respondent did not violate its corresponding 
responsibility in the dispensings it made to the following patients: 
M.B. (GX 15-A); D.C. 2 (GX 15-C), D.E. & J.E. (GX 15-E), B.R. (GX 15-
O); W.B. (GX 15-P), R.S. (GX 15-S), and W.T. (GX 15-W). Based on my 
findings with respect to J.S. (GX 15-T), I also conclude that the 
Government did not prove by a preponderance of the evidence that 
Respondent unlawfully dispensed controlled substances to him.
    With respect to patient A.S., to whom Respondent dispensed a total 
of 369 dosage units of combination hydrocodone/apap drugs over a ten-
and-a-half month period pursuant to prescriptions issued by eight 
different prescribers, Dr. Mulder testified only that ``[i]t would have 
been appropriate for [Respondent] to have notified'' the various 
physicians that it was receiving a number of different prescriptions 
``for this narcotic so that they could concentrate that in one place.'' 
Tr. 531. Dr. Mulder did not testify that Respondent's failure to notify 
the physicians was a breach of its corresponding responsibility. 
Moreover, the ALJ credited Mr. Street's testimony that A.S. had to 
switch her primary care physicians because they closed their practices 
and had also gone to the emergency room. The Government did not rebut 
this testimony. I therefore conclude that Respondent's dispensings to 
A.S. did not violate federal law.
    With respect to patient B.W., Drs. Ferrell and Mulder respectively 
concluded that Dr. Blackmon's hydrocodone/apap (7.5/500) prescriptions 
were high and ``exceeded safe limits.'' Tr. 540. These dispensings 
averaged, however, only 170 tablets per month and less than six tablets 
per day and were thus substantially under the four gram level at which 
acetaminophen causes toxicity. Finally, the ALJ found credible Mr. 
Street's testimony that he had verified the prescriptions with Dr. 
Blackmon and the Government offered no evidence to rebut his 
contention. I therefore conclude that Respondent's dispensings to B.W. 
did not violate federal law.
    Next, both patients D.C. (GX 15-B) and J.Y. (GX 15-Y) received 
large numbers of prescriptions from Dr. Haws, a dentist. As found 
above, on re-direct examination regarding J.Y., Dr. Mulder testified 
that ``[t]here's obviously a finite limit to how many teeth you can 
pull out.'' Tr. 563-64. Continuing, Dr. Mulder testified that ``the 
repetitive prescription, month after month after month, it just seemed 
* * * with that particular file, I--it probably--I couldn't state that 
it violated standards. It just seemed a little unusual to have that 
many sequential prescriptions from a dentist for the same patient.'' 
Id. at 564.
    Based on Dr. Mulder's testimony, I conclude that the Government has 
not proved that Respondent violated federal law in its dispensings to 
J.Y. Furthermore, because Respondent's dispensings to D.C., fit the 
same pattern, I also conclude that the Government has not proved that 
Respondent violated federal law in its dispensings to D.C.
    The evidence pertaining to the remaining patients does, however, 
establish that Respondent repeatedly dispensed controlled substances in 
violation of federal law. In particular, the record shows that 
Respondent repeatedly filled prescriptions presented by persons who 
were clearly engaged in doctor shopping. Moreover, the evidence shows 
that Respondent also filled prescriptions which could have been toxic 
if taken in the prescribed amounts or were for drugs which were 
contraindicated for the patient.
    It is true that in some instances, Mr. Street testified that he had 
contacted a patient's prescribers and that they were ``okay'' with the 
fact that the other doctor was also prescribing. While the ALJ credited 
this dubious testimony, I need not reject her credibility findings in 
toto to conclude that the Government proved its case with respect to 
the remaining patients because there were numerous dispensings for 
which Mr. Street offered no explanation at all. Indeed, there is even 
evidence that Respondent filled prescriptions which Mr. Street himself 
acknowledged were outside of the course of the practitioner's 
professional practice and did so after Mr. Street claimed to have 
notified the prescriber that the prescriptions for that drug were 
unlawful.
    For example, Respondent repeatedly dispensed to Patient E.C. 
alprazolam prescriptions issued by Dr. Hussain and diazepam 
prescriptions issued by Dr. Slonaker. GX 15-D. In several instances, 
the prescriptions were dispensed only days apart and the Government's 
experts testified that these drugs ``have a synergistic effect'' when 
taken together, Tr. 297, and that taking these drugs in combination 
could have devastating effects. Id. 515. Moreover, Respondent also 
dispensed to E.C. three prescriptions for hydrocodone/apap that were 
issued by Dr. Hussain (who wrote two of the Rxs) and Dr. Wiles within a 
four-day period; the first two of these prescriptions were filled on 
consecutive days.
    Mr. Street testified only as to why Respondent had also filled the 
prescriptions which Dr. Slonaker simultaneously issued for two 
combination hydrocodone/apap drugs. He offered no testimony to explain 
why Respondent dispensed the hydrocodone prescriptions issued by Drs. 
Hussain and Wiles and the benzodiazepine prescriptions issued by Drs. 
Hussain and Slonaker. I thus conclude that Respondent repeatedly 
violated federal law in dispensing these prescriptions to E.C.
    With respect to patient S.F., the Government's evidence showed that 
Respondent simultaneously dispensed extraordinary quantities of Lorcet, 
a combination hydrocodone/apap 10/650 drug, and Dilaudid, a schedule II 
controlled substance, based on prescriptions which were written by Dr. 
Blackmon. More specifically, Dr. Ferrell testified that S.F. was 
receiving approximately 17 tablets a day of Lorcet and 12 tablets a day 
of Dilaudid. Tr. 306. Dr. Ferrell further noted that S.F. was 
``physically dependent'' on the drugs. Id. at 308. Moreover, Respondent 
was dispensing Lorcet in amounts which, as Dr. Mulder testified, 
clearly exceeded ``acceptable limits'' and ``would be potentially 
toxic.'' \48\ Id. at 511. The trace also showed that Respondent 
dispensed a prescription for Buprenex, a drug which can cause acute 
withdrawal symptoms in patients taking Dilaudid and other opiates. Tr. 
307.
---------------------------------------------------------------------------

    \48\ Although Dr. Mulder testified that the dosages of 
hydrocodone/apap products was twice the acceptable limits, when 
Respondent was dispensing an average of 17 tablets a day, the amount 
was nearly three times the acceptable limit.
    While there was testimony that patients can develop a tolerance 
to opiates, see RX 5, at 5, Respondent offered no evidence as to why 
it would be appropriate to continue to prescribe combination 
hydrocodone drugs at this level when other stronger opiates, which 
do not contain acetaminophen, are available. In any event, I do not 
rely solely on the quantity of the hydrocodone/apap prescriptions, 
but rather on all the evidence related to S.F. in concluding that 
Respondent should not have filled the prescriptions.
---------------------------------------------------------------------------

    Mr. Street testified that he contacted Dr. Blackmon frequently 
because S.F. ``was always wanting his medications

[[Page 383]]

early,'' and was presenting prescriptions ``too close to'' the other 
prescriptions ``he brought in.'' May 24, 2005 Tr. 85. He also asserted 
that Dr. Blackmon was ``monitoring him closely,'' and that Blackmon 
told him that S.F. needed large amounts of narcotics to ``function.'' 
Id. Mr. Street offered no evidence to refute the testimony of Dr. 
Mulder--who is a pain management specialist--that the level of drugs 
being prescribed by Blackmon was potentially toxic. Consistent with the 
testimony of Dr. Mulder that a pharmacist has an obligation ``not to 
dispense medication knowingly harmful to the patient,'' I conclude that 
contacting Dr. Blackmon was not enough and that Mr. Street had an 
affirmative obligation to refuse to dispense these drugs to S.F.
    The quantities of drugs which Dr. Blackmon was prescribing were 
extraordinary, greatly exceeded acceptable levels of acetaminophen, and 
were potentially toxic. Moreover, that S.F. was ``always wanting his 
medications early'' and presenting prescriptions ``too close to'' other 
prescriptions he had brought in were telltale signs that he was either 
a drug abuser or selling the drugs to others.
    Dr. Blackmon's issuance of the Buprenex prescription provided a 
further reason why Mr. Street should have questioned the legitimacy of 
the prescriptions and stopped filling them. Mr. Street justified 
dispensing this drug on the ground that ``[t]he only precaution 
regarding Buprenex and hydrocodone is that the combination may increase 
drowsiness,'' May 24, 2005 Tr. at 87 (emphasis added). Mr. Street's 
testimony is false. As found above, under the caption ``Use in 
Narcotic-Dependent Patients,'' the package insert clearly states that: 
``[b]ecause of the narcotic antagonist activity of Buprenex, use in the 
physically dependent individual may result in withdrawal effects.'' 
Given the prescriptions Dr. Blackmon was writing and S.F.'s conduct 
which indicated--as Dr. Ferrell observed--that he was physically 
dependent, I conclude that Mr. Street had reason to know that Dr. 
Blackmon was not writing prescriptions for legitimate medical purposes. 
Respondent therefore violated federal law by filling these 
prescriptions.\49\
---------------------------------------------------------------------------

    \49\ Under the CSA, it does not matter whether S.F. was 
physically dependent on the drugs or was selling them on the street.
---------------------------------------------------------------------------

    Patient B.J. obtained controlled-substance prescriptions (which 
Respondent filled) from twenty-one different prescribers for five 
different benzodiazepines, three different schedule III narcotics 
(hydrocodone/apap, propoxyphene/apap, and Fiorinal with codeine), 
Endocet, a schedule II drug, and Stadol. GX 15-G. More specifically, 
the evidence showed that Respondent repeatedly dispensed multiple 
prescriptions issued by Dr. Greenwood for alprazolam and Dr. Varney for 
lorazepam for a period of six months. The trace also showed that in 
multiple instances, Respondent dispensed schedule III narcotics such as 
Fiorinal with codeine and propoxyphene which were issued by different 
doctors within the same timeframe. Id.
    Mr. Street testified that he called both Dr. Varney and Dr. 
Greenwood's practice group and that ``[t]hey were both aware they were 
both prescribing at the same time.'' May 24, 2005 Tr. 89. Mr. Street 
did not, however, testify as to why, between March and October 1999, 
his pharmacy repeatedly filled prescriptions for propoxyphene/apap, 
which were written by Dr. Gastineau, and Fiorinal (butalbital) with 
codeine, which were written by Dr. Varney. Here again, the evidence 
establishes that Mr. Street and Respondent failed to comply with their 
corresponding responsibility under federal law.
    The evidence regarding W.L. showed that Dr. Blackmon prescribed, 
and Respondent dispensed, 239 controlled substance prescriptions in a 
fourteen-month period. In 1996, Respondent made 163 dispensings 
(totaling 5,380 dosage units) of Buprenex, thirty-one dispensings of 
hydrocodone/apap (totaling 2550 dosage units), and twenty-two 
dispensings of diazepam (totaling 1530 dosage units). Furthermore, the 
Buprenex package insert warns that ``[p]articular care should be taken 
when Buprenex is used in combination with central nervous system 
depressant drugs,'' that ``[p]atients receiving Buprenex in the 
presence of other narcotic analgesics [and] benzodiazepines * * * may 
exhibit increased CNS depression,'' and that ``[w]hen such combined 
therapy is contemplated, it is particularly important that the dose of 
one or both agents be reduced.'' (emphasis added).
    Blackmon did not, however, reduce the dosing of the Buprenex, the 
hydrocodone, or the diazepam. Rather, he prescribed to W.L. 
increasingly large amounts of the three drugs and Respondent filled 
these prescriptions.
    The ALJ credited Mr. Street's testimony that ``the only thing the 
package insert says about combining the two drugs of respiratory 
problems when Diazepam is given with Buprenex'' and that the physician 
should ``proceed with caution if you're going to administer the two 
drugs.'' ALJ at 43. Mr. Street's testimony did not accurately reflect 
the entire scope of the Buprenex warnings,\50\ which clearly showed 
that Blackmon's prescriptions were improper.
---------------------------------------------------------------------------

    \50\ I therefore also reject the ALJ's credibility finding.
---------------------------------------------------------------------------

    As the testimony established, a pharmacist is responsible for 
knowing how a drug will interact with other drugs his patient is 
taking. Tr. 280-81; see also Tennessee Bd. of Pharmacy R. 1140-
3.01(3)(a). I thus adopt Dr. Mulder's conclusion that the prescriptions 
should not have been filled. Tr. 516. I further conclude that Mr. 
Street and Respondent failed to comply with their corresponding 
responsibility under federal law in the dispensings to W.L.
    The evidence regarding Angela L. showed that she had received 
numerous prescriptions from a dentist, Michael Haws. While most of the 
prescriptions were for combination hydrocodone/apap drugs, on September 
11, 1997, Respondent also dispensed a prescription (which was also 
issued by Haws) for Tussionex Pennkinetic Suspension, a combination of 
hydrocodone and chlorpheniramine. Respondent also dispensed two refills 
of the Tussionex to Angela L.
    As found above, Respondent had previously made three dispensings of 
large quantities of Tussionex (which again was prescribed by Dr. Haws) 
to Rex L., who was Angela's spouse. Regarding Respondent's dispensings 
of Tussionex to Rex L., Dr. Ferrell testified that it is ``unusual to 
see a dentist write for cough syrup.'' Tr. 325. Responding to this 
testimony, Mr. Street explained that ``this was filled by a relief 
pharmacist,'' and that when he ``came back to work'' and caught it, he 
then ``alerted Dr. Haws to the fact that * * * it's not within your 
usual course of practice to prescribe Tussionex.'' May 24, 2005 Tr. at 
93. Mr. Street then testified that ``he [Haws] ceased doing that[,]'' 
and ``I've never seen him do it again.'' Id.
    While Mr. Street's testimony did not specify which of the 
dispensings to Rex L. had prompted him to contact Dr. Haws, the 
evidence clearly shows that Respondent dispensed Tussionex to Angela L. 
pursuant to prescriptions issued by Dr. Haws on three occasions after 
the dispensings it made to her husband. Based on Mr. Street's testimony 
that prescribing Tussionex was outside of the course of Dr. Haws's 
professional practice, I also conclude that the Tussionex prescriptions 
which Haws wrote, and Respondent filled for Angela L., were also 
outside of the

[[Page 384]]

course of his professional practice. Mr. Street offered no explanation 
as to why his pharmacy filled these prescriptions. I thus conclude that 
Mr. Street and Respondent violated federal law in dispensing them.\51\
---------------------------------------------------------------------------

    \51\ I also reject the ALJ's finding that Mr. Street credibly 
testified that following his phone call to Dr. Haws, Respondent did 
not receive any more Tussionex prescriptions that were issued by Dr. 
Haws.
---------------------------------------------------------------------------

    Relatedly, the Tussionex prescriptions issued to Rex L. were for 
very large quantities. As the evidence showed, on August 1, 1997, 
Respondent dispensed to Rex L. 720 ml. of this drug; three days later, 
it dispensed to him another 360 ml. Moreover, on August 29, 1997, 
Respondent dispensed to Rex L. another 720 ml. of the drug. Dr. Ferrell 
testified that ``the usual dosage'' of this drug ``is 5 milliliters 
every 12 hours,'' (approximately 300 ml. for a thirty day period) and 
that he could not ``think of any reason why a prescription for'' 720 
ml. would be necessary. Tr. 324-25.
    Dr. Mulder also noted the evidence that Rex L. was engaged in 
doctor shopping. As found above, between November 10, 1997 and January 
9, 1998, Respondent filled numerous prescriptions for opiates which 
included Lorcet, Lortab, Tussionex, MS Contin, and Dilaudid. The 
prescriptions were written by three different doctors (Drs. Haws, 
Caudill, and Egidio), and most of them were dispensed only days apart.
    While the ALJ found credible Mr. Street's testimony that a relief 
pharmacist filled the Tussionex prescription that was issued by Dr. 
Haws, ALJ at 46, the evidence shows that Respondent made a total of 
three dispensings of this drug pursuant to prescriptions by Dr. Haws. 
Moreover, even if a relief pharmacist made all three dispensings, 
Respondent is still properly charged with violating its corresponding 
responsibility. Moreover, Mr. Street did not testify as to why his 
pharmacy filled the prescriptions that Rex L. presented for opiates 
from Drs. Haws, Caudill, and Egidio. I thus conclude that Mr. Street 
and Respondent violated their corresponding responsibility in making 
these dispensings.
    The evidence showed that K.P. (GX 15-K) received prescriptions from 
more than two dozen prescribers which were dispensed by Respondent. 
Most of the prescriptions were for combination hydrocodone/apap drugs, 
although she also obtained prescriptions for several other controlled 
substances. Between April 20, 2001, and April 19, 2002, Respondent 
dispensed to K.P. 58 prescriptions for a total of 2,355 dosage units of 
combination hydrocodone/apap drugs. Both Drs. Ferrrell and Mulder 
concluded that K.P. was a doctor shopper.\52\
---------------------------------------------------------------------------

    \52\ This Agency is well familiar with ``doctor shopping.'' 
Expert testimony is not essential to prove that a person engaged in 
it. Rather, ``doctor shopping'' can be proved based solely on 
documentary evidence.
---------------------------------------------------------------------------

    The ALJ credited Mr. Street's testimony that K.P. had seen five 
different primary care physicians either because the physicians closed 
their practices or the State's Tenncare program had moved her to a 
different physician. The ALJ also credited Mr. Street's testimony that 
K.P. had seen neurosurgeons who referred her to a pain management 
specialist (Dr. Smyth), who also proceeded to prescribe narcotics for 
her, and that both were ``aware that they were prescribing them at the 
same time.'' \53\ ALJ at 47 (citing May 24, 2005 Tr. 94). Finally, the 
ALJ credited Mr. Street's testimony that K.P. had seen seven emergency 
room doctors because of complications she had from major surgeries.
---------------------------------------------------------------------------

    \53\ The implication of Mr. Street's testimony was that the 
doctors agreed that K.P. could receive narcotics from multiple 
physicians in different practices. K.P.'s pain management specialist 
was also Dr. Smyth, the same doctor who Mr. Street, in testifying 
about P.P. (K.P.'s husband), claimed had stopped writing 
prescriptions for narcotics upon being notified by Mr. Street that 
he was also receiving ``pain meds'' from his primary care physician. 
May 24, 2005 Tr. at 96.
---------------------------------------------------------------------------

    Notably, two of the physicians K.P. obtained prescriptions from 
were orthopedic surgeons (Drs. Beaver and J. Williams) and Mr. Street 
offered no testimony that he had contacted them to verify their 
prescriptions and make them aware that K.P. was also obtaining 
prescriptions from Dr. Wiles (the neurosurgeon). Nor did he testify 
that he contacted Dr. Wiles to inform him that K.P. was obtaining 
prescriptions from Drs. Beaver and Williams. Accordingly, I conclude 
that Mr. Street and Respondent violated their corresponding 
responsibility under federal law in dispensing to K.P.
    Patient P.P. (GX 15-L), who was K.P.'s husband, obtained 
prescriptions from eleven prescribers which were dispensed by 
Respondent. The evidence showed that during the same period in which it 
was dispensing hydrocodone/apap prescriptions written by Dr. Lynch, it 
was also dispensing prescriptions for hydrocodone/apap, propoxyphene/
apap, and codeine/apap which were written by Dr. Wyche. The trace also 
showed that between June 2001 and April 2002, Respondent dispensed to 
P.P. prescriptions for hydrocodone/apap which she obtained from seven 
different doctors.
    In his testimony, Dr. Mulder concluded that Respondent had failed 
to comply with its corresponding responsibility because of the number 
of prescriptions that were being dispensed each month, the dispensing 
of multiple narcotics at the same time, and that multiple physicians 
were prescribing to P.P. Dr. Ferrell also noted the prescribing by 
multiple physicians. Finally, Dr. Mulder noted that K.P. and P.P. lived 
at the same address and that it is ``highly unusual'' for two family 
members to have ``medical problems that * * * required the same level 
of prescribing within each * * * month.'' Tr. 524.
    Mr. Street testified that P.P. was mainly seen by Drs. Tochev and 
Tanner, who were his primary care physicians, and that Dr. Tochev 
referred P.P. to a pain management group, which started prescribing 
pain medications for him. Mr. Street further testified that ``we 
contacted'' the pain management group and Dr. Tochev, and that 
``neither one * * * were [sic] aware [that] the other one was 
prescribing.'' May 24, 2005 Tr. at 96. Mr. Street added that ``after we 
contacted them, pain management cease[d] to write any more pain meds'' 
for P.P. Id. As for the other evidence of doctor shopping, Mr. Street 
explained that P.P. had seen dentists and emergency room doctors a 
couple of times and that ``if you knew the doctors in the area like I 
do, it shouldn't present a problem.'' Id. Mr. Street did not testify 
that his pharmacy called any of these other prescribers and the fair 
inference to be drawn from this testimony is that Mr. Street did not 
call either the dentists or the emergency rooms before filling the 
prescriptions.\54\
---------------------------------------------------------------------------

    \54\ In rejecting the Government's evidence, the ALJ also relied 
on Mr. Street's ``knowledge of [his customer's] medical history and 
treatments.'' ALJ at 74. While acknowledging that ``Mr. Street 
reviewed medical records in preparation for this hearing,'' the ALJ 
credited his testimony because it ``demonstrated a more generic 
knowledge of each patient's situation, [and] not a prompted, 
detailed knowledge that would come from reviewing and attempting to 
memorize patients' medical conditions.'' ALJ at 74 n.12. The ALJ 
thus concluded that Mr. Street's testimony was ``a credible 
rendition'' of what he knew about his customers ``at the time he 
dispensed the controlled substances.'' Id.
    Even assuming that Mr. Street would recall the medical 
conditions of these twenty-five patients out of the 17,000 patients 
he testified Respondent had, and crediting Mr. Street's testimony, 
see May 24, 2005 Tr. 95, a pharmacist's knowledge of a customer's 
medical conditions does not excuse him from his duty to verify the 
legitimacy of prescriptions when there is reason to suspect that the 
customer is engaged in doctor shopping. Nor does it excuse a 
pharmacist from his responsibility not to dispense drugs that are 
either being prescribed in quantities which would be toxic to the 
patient if taken as directed, or contraindicated because of other 
drugs a patient is taking or the patient's medical conditions.

---------------------------------------------------------------------------

[[Page 385]]

    Mr. Street offered no testimony as to why his pharmacy filled 
(sometimes only days apart) the multiple narcotic prescriptions that 
were issued by Drs. Lynch and Wyche during October and November 1999. 
Moreover, his testimony that he contacted P.P.'s pain management doctor 
(Dr. Smyth) to inform him that Dr. Tochev was still prescribing and 
that Dr. Smyth stopped writing is not consistent with the evidence. 
While Mr. Street did not specify the date that he contacted Dr. Smyth, 
the evidence shows that his pharmacy filled multiple prescriptions for 
hydrocodone/apap drugs that were issued by both Drs. Smyth and Tochev 
between February and April 2002. Indeed, the evidence shows that Dr. 
Smyth issued, and Respondent filled, a prescription for hydrocodone/
apap nearly six weeks after P.P. presented the first prescription he 
obtained from Dr. Smyth, and only a week after it had filled two 
additional prescriptions for the same drug that were issued by Dr. 
Tochev. Moreover, three weeks later, Respondent filled a prescription 
for methadone which was also issued by Dr. Smyth.
    In short, the evidence does not support Mr. Street's testimony. 
Moreover, his statement to the effect that his dispensings of 
prescriptions issued by dentists and emergency room physicians should 
not present a problem if you know the doctors ``like I do,'' is a non-
explanation. Even if a pharmacist knows the practice specialty of a 
prescriber, he must still verify the legitimacy of a prescription when 
a person is repeatedly presenting prescriptions for the same drug from 
other prescribers and doing so at frequent intervals. Consistent with 
the testimony of Drs. Ferrell and Mulder, I thus conclude that Mr. 
Street and Respondent violated their corresponding responsibility under 
federal law in dispensing to P.P.
    S.P. (GX 15-M) was another patient who presented prescriptions from 
numerous providers. While most of the testimony focused on narcotic 
prescriptions, the evidence also showed that in numerous instances, 
Respondent dispensed to S.P. temazepam prescriptions issued by Dr. 
Varney and clonazepam prescriptions issued by Dr. Shah. In some 
instances, the dispensings occurred only a day (or a couple of days) 
apart. Both of these drugs are benzodiazepines, and as Dr. Mulder 
testified, taking multiple benzodiazepines has a synergistic effect and 
can be devastating to the patient.
    Mr. Street offered no testimony regarding Respondent's dispensings 
of these drugs. I therefore conclude that Mr. Street did not contact 
either prescriber to verify the legitimacy of the prescriptions and to 
inform them that S.P. was presenting prescriptions from the other 
physician for another benzodiazepine. Accordingly, I also conclude that 
Mr. Street and Respondent did not comply with their corresponding 
responsibility under federal law in dispensing these prescriptions to 
S.P.
    The evidence regarding patient J.P. (GX 15-N) showed that 
Respondent was dispensing to her multiple opiates (Stadol, Darvocet 
(propoxyphene/apap) and Tylenol 3 (codeine/apap)), as well as 
benzodiazepines and schedule IV drugs such as fenfluramine and 
phentermine based on prescriptions issued by Dr. Varney. Moreover, for 
nearly a year, Respondent repeatedly dispensed to J.P. hydrocodone/apap 
(for a total of 14 Rxs) that were issued by Dr. Johnson at the same 
time that it was dispensing the prescriptions issued by Dr. Varney.
    Dr. Mulder noted that J.P. was receiving ``seven different 
addicting medications simultaneously,'' which included ``stimulants and 
depressants,'' and ``analgesics and anxiolytics.'' Tr. 527. Dr. Ferrell 
also noted that Darvocet and Tylenol  3 provide ``about the 
same'' level of pain relief and did not understand why a physician 
would simultaneously prescribe them. Id. at 336-38.
    While Mr. Street testified that he called Dr. Varney regarding his 
prescribing to J.P. and that there were legitimate medical purposes for 
this regime, May 24, 2005 Tr. 99, Mr. Street offered no evidence that 
refuted Dr. Ferrell's testimony on the simultaneous prescribing of 
Darvocet and Tylenol  3. Moreover, Mr. Street offered no 
testimony as to why Respondent repeatedly dispensed the Darvocet and 
Tylenol  3 prescriptions issued by Dr. Varney during the same 
period in which it also dispensed the fourteen Lortab prescriptions 
that were issued by Dr. Johnson.
    I therefore conclude that Mr. Street and Respondent did not verify 
the legitimacy of the Lortab prescriptions with Dr. Johnson and inform 
him that J.P. was receiving multiple opiates. I further conclude that 
Mr. Street and Respondent violated federal law in dispensing the Lortab 
prescriptions to J.P. when it was also dispensing the Darvocet and 
Tylenol  3 prescriptions issued by Dr. Varney.
    The evidence regarding R.S. (GX 15-R) showed that during 1999, 
Respondent dispensed to him 30 prescriptions for alprazolam, 19 
prescriptions for clonazepam, two prescriptions for diazepam, and one 
prescription for lorazepam. Most significantly, for approximately eight 
months, Respondent dispensed prescriptions for 100 tablets of 
alprazolam which were written by Dr. Lynch (R.S.'s primary care 
physician), while it was also dispensing prescriptions for 60 tablets 
of alprazolam which were written by Dr. Wiley (R.S.'s psychiatrist). 
Dr. Wiley also prescribed clonazepam, another benzodiazepine, 
throughout 1999. Both Drs. Ferrell and Mulder found that Respondent's 
dispensing of the drugs was a violation of its corresponding 
responsibility.
    Mr. Street's justification for the dispensings was that Dr. Wiley 
had started prescribing the benzodiazepines, ``namely alprazolam for 
anxiety and clonazepam for depression,'' and that ``we called the 
doctor and he told me the reason he was prescribing those.'' May 24, 
2005 Tr. at 105. Mr. Street then explained that ``later on [R.S.'s] 
primary care doctor, Dr. Lynch, started prescribing him alprazolam 
exclusively for anxiety, but he continued to get the clonazepam from 
his mental health doctor for the depression.'' Id.
    Mr. Street's testimony suggests that after Dr. Lynch began 
prescribing alprazolam, R.S. received only clonazepam from Dr. Wiley. 
But as explained above, for approximately eight months, Respondent 
repeatedly dispensed alprazolam to R.S. pursuant to prescriptions 
written by both doctors and many of the dispensings occurred only days 
apart. Mr. Street offered no explanation for why his pharmacy did so. I 
thus conclude that Mr. Street and Respondent violated federal law in 
dispensing the alprazolam prescriptions to R.S.
    The evidence shows that Respondent dispensed prescriptions for W.T. 
(GX 15-V) that were written by fourteen different prescribers for such 
drugs as alprazolam, Endocet 325, generic oxycodone with acetaminophen, 
various strengths of hydrocodone/apap, and propoxyphene-hcl. Most 
significantly, on a single day, Respondent dispensed to W.T. two 
separate 300-count prescriptions purportedly written by Dr. Donovan for 
schedule II drugs containing oxycodone and acetaminophen, Endocet 325 
and generic oxycodone/apap 5/500. This, as Dr. Ferrell explained, was 
``an unusual quantity.'' Tr. 357. Indeed, while Dr. Donovan had 
previously prescribed these drugs to W.T., the prescriptions had never 
exceeded 100 tablets and he had never prescribed both drugs at the same 
time.

[[Page 386]]

    Moreover, during the same period, Respondent was also 
simultaneously dispensing propoxyphene prescriptions written by Dr. 
Donovan. Finally, Respondent also dispensed three prescriptions for 
Endocet 325 written by Dr. Haynes during the same period in which it 
was dispensing Dr. Donovan's prescriptions for drugs containing 
oxycodone. Dr. Haynes and Donovan did not practice together.
    While Mr. Street testified as to the various doctors that W.T. had 
seen and her medical conditions, at no time did he state that either he 
or his employees had contacted any of W.T's doctors to verify the 
legitimacy of the prescriptions. See May 25, 2005 Tr. at 110. Mr. 
Street likewise offered no testimony as to why Respondent dispensed 600 
dosage units of oxycodone on a single day or as to why Respondent 
filled prescriptions for oxycodone that W.T. had presented from Drs. 
Donovan and Haynes in the same time frame. I thus conclude that Mr. 
Street and Respondent failed to comply with their corresponding 
responsibility under federal law when they dispensed to W.T. 600 units 
of oxycodone on a single day and the oxycodone prescriptions that were 
written by Drs. Haynes and Donovan during the same period.\55\
---------------------------------------------------------------------------

    \55\ In light of the abundant evidence of Respondent's unlawful 
dispensings, it is unnecessary to make any legal conclusions 
regarding Respondent's dispensing to Patient H.T, (GX 15-U), who 
received numerous prescriptions for three different narcotic pain 
medicines from two prescribers. The ALJ credited Mr. Street's 
testimony that he had contacted each prescriber, that each was aware 
that the other was prescribing as well, and that they both 
``okayed'' H.T.'s receipt of the prescriptions.
    Putting aside that Dr. Hartsell's statement to Mr. Richards made 
no mention of Mr. Street ever having called him to discuss the fact 
that H.T. was also presenting prescriptions for hydrocodone/apap 
from another physician, May 24, 2005 Tr. at 20-21, the notion that a 
competent physician would willingly continue to prescribe highly 
abused drugs knowing that her patient was also receiving similar 
drugs from another prescriber stretches the limits of plausibility. 
While the Government's experts testified that the prescribing of 
controlled substances should be coordinated between a patient's 
physicians so that only one physician is prescribing, neither 
definitively stated that it is a violation of standards of medical 
practice for two physicians to be doing so. See, e.g., Tr. 570.
---------------------------------------------------------------------------

    Accordingly, having reviewed all of the evidence, I conclude that 
in numerous instances, Respondent violated federal law in dispensing 
controlled substances. In so holding, I acknowledge that pharmacists do 
not practice medicine. But requiring a pharmacist to identify doctor 
shopping does not require him to practice medicine.
    In his affidavit, Dr. Montgomery opined that the prescribing 
physician ``is the primary responsible party for drug selection and 
quantity based upon the physician's assessment of the patient.'' RX 5, 
at 6. While acknowledging--in his words--that ``[t]here are a few 
occasions when it would appear that [Respondent] fell short of what I 
would consider optimal pharmacy recognition of a potential drug abuser 
profile,'' Dr. Montgomery then asserted that ``the physicians who 
prescribed the patients controlled substances were more responsible for 
any abuse than the pharmacy filling said prescriptions.'' Id.
    Respondent's attempt to deflect responsibility for its unlawful 
dispensings is unavailing. Under the Tennessee Board of Pharmacy's 
Standards of Practice, a pharmacist is required to review ``a patient's 
record prior to dispensing each * * * prescription order.'' GX 21, at 2 
(Rule 1140-3.01(3)(a)). As part of this review, the pharmacist is 
further required to evaluate the prescription for, inter alia, ``over-
utilization,'' ``therapeutic duplication,'' ``drug-drug interactions,'' 
``incorrect drug dosage or duration of drug treatment,'' and ``clinical 
abuse/misuse.'' Id. Holding Mr. Street and his pharmacy accountable for 
dispensing prescriptions when there was reason to believe those 
prescriptions were not issued for legitimate medical purposes (because 
those prescriptions were contraindicated to other drugs a patient was 
taking or the drugs were being prescribed in amounts that would be 
potentially toxic if taken as directed) thus does no more than require 
him to comply with the duties imposed on him as a pharmacist under the 
State of Tennessee's regulations.
    Contrary to Dr. Montgomery's opinion, this case is not simply about 
a few dispensings which ``fell short of * * * optimal pharmacy 
recognition of a potential drug abuser.'' RX 5, at 6. Rather, it is 
about the numerous instances in which Respondent and Mr. Street 
unlawfully dispensed a controlled substance under federal law by 
ignoring evidence which provided reason to believe that the 
prescription was illegitimate. Bertolino, 55 FR at 4730 (citations 
omitted). Accordingly, Mr. Street and Respondent are responsible for 
the numerous unlawful dispensings found above including those which 
were made to Dr. Watts.
    Furthermore, many of the dispensings cannot be attributed to mere 
oversight, but rather, are flagrant violations of federal law because 
they involved repeated dispensings to persons who were clearly engaged 
in doctor shopping and went on for months on end. Moreover, the 
quantities and combinations of drugs dispensed (including the 
interactions which would occur if the drugs were actually taken) also 
support the conclusion that the violations were flagrant. Accordingly, 
notwithstanding the evidence that Respondent had 17,000 patients, May 
24, 2005 Tr. 95, I conclude that Respondent's experience in dispensing 
controlled substances warrants a finding that its continued 
registration is inconsistent with the public interest.\56\ This finding 
provides reason alone to revoke Respondent's registration.
---------------------------------------------------------------------------

    \56\ The fundamental question under the CSA is whether 
Respondent ``has committed acts as would render [its] registration 
inconsistent with the public interest.'' 21 U.S.C. Sec.  824(a)(4). 
No amount of legitimate dispensings can render Respondent's flagrant 
violations ``consistent with the public interest.''
---------------------------------------------------------------------------

Factor Four--Respondent's Compliance With Applicable Laws

    As found above, Respondent repeatedly violated DEA regulations and 
federal law in its dispensings of controlled substances. That analysis 
is incorporated herein and will not be repeated.
    Respondent also failed to comply with federal law and DEA 
regulations by failing to maintain ``a complete and accurate record of 
each [controlled] substance [it] received, sold, delivered, or 
otherwise disposed of.'' 21 U.S.C. 827(a); see also 21 CFR 1304.21(a). 
While the ALJ credited Mr. Street's testimony regarding the 1998 
computer ``crash,'' the fact remains that significant discrepancies 
were found during each of the three audits that were subsequently 
conducted. Moreover, while Mr. Street challenged the accuracy of each 
of these audits and presented his own figures, even his audits found 
that his pharmacy had substantial shortages in multiple drugs.
    For example, according to Mr. Street's December 1999 audit, his 
pharmacy was short 800 tablets of generic hydrocodone/apap 5/500, 589 
tablets of generic hydrocodone/apap 7.5/500, 380 tablets of Lortab 7.5/
500, 485 tablets of acetaminophen with codeine 300/60, 704 tablets of 
diazepam 10mg., 200 tablets of Dilaudid (hydromorphone) 4 mg., and 193 
tablets of generic hydromorphone 4 mg. There were also numerous 
overages. These discrepancies are especially noteworthy as the audit 
period used Respondent's January 11, 1999 inventory as the beginning 
date and covered only an eleventh-month period.
    As for Mr. Street's assertion that the DEA audit was in error 
because Respondent's diazepam dispensings were recorded on multiple 
drug usage

[[Page 387]]

reports, under federal law it is Respondent's responsibility to 
maintain accurate dispensing records. Respondent's failure to do so 
further supports the conclusion that its recordkeeping is not in 
compliance with federal law.
    Mr. Street's April 2001 audit found shortages of 657 tablets of 
generic hydrocodone/apap 10/500, 656 tablets of generic hydrocodone/
apap 7.5/500, 171 tablets of generic hydrocodone/apap 5/500, and 196 
tablets of Lortab 10. Respondent was also short 312 tablets of diazepam 
5 mg. and 554 tablets of diazepam 10 mg., 166 tablets of acetaminophen 
with codeine  4, and 152 tablets of methadone 40 mg.
    Finally, while the April 2002 audit involved only twelve drugs and 
covered a period of a little more than a year, once again even Mr. 
Street's figures showed substantial discrepancies. More specifically, 
Respondent was short 498 tablets of diazepam 10 mg., 754 tablets of 
generic hydrocodone/apap (7.5/500), and 910 tablets of generic 
hydrocodone/apap (10/500).
    While the ALJ reasoned that these discrepancies ``only represented 
2% of the Respondent's business,'' ALJ at 70, they are nonetheless 
substantial and occurred at each of the three audits. Moreover, having 
conducted his own audit following the April 2001 DEA visit, Mr. Street 
was clearly aware that Respondent had serious recordkeeping problems. 
Yet substantial discrepancies were still found during the subsequent 
audit even though only twelve drugs were audited. Moreover, at the 
hearing, Mr. Street offered no evidence to show that he and Respondent 
had taken corrective action to prevent similar discrepancies from 
occurring in the future.\57\ I therefore also find that Respondent's 
failure to maintain complete and accurate records of its handling of 
controlled substances supports an adverse finding under this factor. 
This factor thus further supports the conclusion that Respondent's 
registration is ``inconsistent with the public interest.'' 21 U.S.C. 
823(f).\58\
---------------------------------------------------------------------------

    \57\ I place no weight on the statements of Mr. Pierce and Mr. 
Street that there was no deliberate diversion of drugs. As found 
above, Mr. Pierce's affidavit frequently did not even address the 
shortages that Mr. Street's audits found. Moreover, Mr. Street did 
not testify that he had investigated any of his employees to 
determine whether they may have been diverting. Instead, he 
attributed the discrepancies to human error. As for Mr. Street's 
assertion that ``if we could have audited both name brand and 
generic'' versions of a drug, ``they might have balanced out 
there,'' May 24, 2005 Tr. 144, Mr. Street was not prevented from 
doing exactly that in his own audits. Mr. Street's testimony that 
the discrepancies are the result of human error is as much 
speculation as his assertion that there was no deliberate diversion. 
In fact, no one knows.
    \58\ I acknowledge that the state board has not taken any action 
against Mr. Street or Respondent and that neither Mr. Street nor his 
pharmacy has been convicted of a crime. My findings regarding 
Respondent's dispensing and recordkeeping violations, however, 
greatly outweigh these factors.
---------------------------------------------------------------------------

Sanction

    As found above, Respondent's numerous violations pertaining to its 
dispensing practices and its failure to maintain complete and accurate 
records establish a prima facie case that its continued registration is 
``inconsistent with the public interest'' and that its registration 
should therefore be revoked. Id. Where the Government has made out its 
prima facie case, the burden shifts to the Respondent to show why its 
continued registration would nonetheless be consistent with the public 
interest. See, e.g., Theodore Neujahr, 65 FR 5680, 5682 (2000); Service 
Pharmacy, Inc., 61 FR10791, 10795 (1996).
    In discussing the appropriate sanction, the ALJ relied largely on 
her conclusion that the Government had failed to prove that Respondent 
had improperly dispensed controlled substances. While the ALJ noted Mr. 
Street's ``bothersome'' conduct in filling the prescriptions which Dr. 
Watts (the veterinarian) wrote for his personal use, she further 
reasoned that this conduct had occurred in 1996-97, and that ``the lack 
of any more recent evidence of similar carelessness,'' does not now 
support revoking Respondent's registration. ALJ at 78.
    Respondent's dispensing violations were not, however, limited to 
what the ALJ found. Rather, the violations include numerous instances 
in which it flagrantly violated federal law and regulations by: (1) 
Dispensing controlled substances to persons clearly engaged in doctor 
shopping, (2) dispensing controlled substances which were 
contraindicated to other controlled substances it was also dispensing 
to the same patient, (3) dispensing controlled substances that were 
outside of the scope of the prescriber's professional practice, and (4) 
dispensing various controlled substances in quantities that clearly 
were excessive and would, with respect to some of the drugs, be toxic 
if they were taken as prescribed. Moreover, the record contains 
evidence--specifically, the unlawful dispensings Respondent made to 
K.P. and P.P.--which occurred shortly before this proceeding was 
commenced.
    In Respondent's favor, there is some evidence that Mr. Street 
reported four forged prescriptions to the police.\59\ Respondent did 
not, however, submit the actual reports that were filed and the 
circumstances surrounding these incidents were not established. 
Moreover, I conclude that the harm to public health and safety caused 
by Respondent's unlawful dispensings was far greater than the benefits 
that may have resulted from his reporting of the fraudulent 
prescriptions.
---------------------------------------------------------------------------

    \59\ The ALJ also reasoned that ``Mr. Street's assistance to the 
DEA during its audit and his provision to the DEA of all the 
information and documentation it requested'' was ``a factor to be 
weighed.'' ALJ at 70. Mr. Street had, however, been served with a 
warrant prior to each audit. See GXs 4, 6, 9, and 12. Mr. Street's 
assistance during the audits is thus entitled to only slight weight.
---------------------------------------------------------------------------

    Most significantly, under Agency precedent, where the Government 
has proved that a registrant has committed acts inconsistent with the 
public interest, a registrant must ```present[] sufficient mitigating 
evidence to assure the Administrator that [it] can be entrusted with 
the responsibility carried by such a registration.''' Samuel S. 
Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 
21932 (1988)). Moreover, because ``past performance is the best 
predictor of future performance,'' ALRA Labs., Inc., v. DEA, 54 F.3d 
450, 452 (7th Cir. 1995), this Agency has repeatedly held that where a 
registrant has committed acts inconsistent with the public interest, 
the registrant must accept responsibility for its actions and 
demonstrate that it will not engage in future misconduct. See Jackson, 
72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); Prince 
George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. DEA, 419 
F.3d at 483 (``admitting fault'' is ``properly consider[ed]'' by DEA to 
be an ``important factor[]'' in the public interest determination).
    Here, Respondent has not even acknowledged that it has serious 
recordkeeping problems, let alone that it committed numerous violations 
of federal law in dispensing controlled substances. Relatedly, 
Respondent has presented no evidence that it has reformed its shoddy 
recordkeeping practices and its abysmal dispensing practices.\60\ 
Accordingly, it has not rebutted the Government's prima facie showing 
that its continued registration ``is inconsistent with the public 
interest.'' 21 U.S.C. 823(f). I therefore conclude that revocation of 
its registration is essential to protect the public interest.
---------------------------------------------------------------------------

    \60\ As Respondent's own expert acknowledged, its recognition of 
drug abusers ``fell short of * * * optimal.'' RX 5-6. Yet Respondent 
does not even admit that it has a problem.

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[[Page 388]]

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 
824(a), as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA 
Certificate of Registration, BM3913781, issued to the Medicine Shoppe--
Jonesborough, be, and it hereby is, revoked. I further order that any 
pending application of Respondent for renewal or modification of its 
registration be, and it hereby is, denied. This order is effective 
February 1, 2008.

    Dated: December 13, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-25342 Filed 12-31-07; 8:45 am]
BILLING CODE 4410-09-P