[Federal Register Volume 75, Number 207 (Wednesday, October 27, 2010)]
[Notices]
[Pages 66149-66165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27096]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 09-48]


East Main Street Pharmacy; Affirmance of Suspension Order

    On April 23, 2009, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to East Main Street Pharmacy (``Respondent''), of Columbus, 
Ohio. The Show Cause Order proposed the revocation of Respondent's DEA 
Certificate of Registration, BE5902615, as a retail pharmacy, as well 
as the denial of any pending applications to renew or modify its 
registration, ``for reason that [Respondent's] continued registration 
is inconsistent with the public interest, as that term is used in 21 
U.S.C. 823(f) and 824(a)(4).'' ALJ Ex. 1, at 1. More specifically, the 
Order alleged that Respondent had violated its corresponding 
responsibility under Federal regulations to not fill unlawful 
prescriptions. Id. at 2 (citing 21 CFR 1306.04(a)).
    The Show Cause Order alleged that Respondent was owned by Eugene H. 
Fletcher, Respondent's sole pharmacist, and that from ``September 2005 
through February 2006'' it ``filled 6,619 controlled substance 
prescriptions'' including 4,979 prescriptions issued by Dr. Paul 
Volkman of Portsmouth, Ohio. Id. at 1. The Show Cause Order further 
alleged that on February 10, 2006, DEA had immediately suspended 
Volkman's registration and that the Agency subsequently found that he 
had ```repeatedly violated Federal law by prescribing controlled 
substances without a legitimate medical purpose and outside the course 
of professional practice.''' Id. (citing Paul H. Volkman, 73 FR 30630, 
30642 (2008)). The Order also alleged that ``Dr. Volkman directed his 
patients to have their prescriptions filled at'' Respondent, who 
``filled them mostly in exchange for cash,'' and that ``[n]inety-eight 
percent of Dr. Volkman's patients that filled their prescriptions at 
[Respondent] did not reside in the Columbus area.'' Id. Relatedly, the 
Order alleged that some of Volkman's patients travelled from Portsmouth 
and Chillicothe, Ohio to Respondent, a distance of 92 and 45 miles, 
respectively; that one of Volkman's patients had travelled from South 
Central Kentucky to Respondent to obtain his prescriptions, that many 
of Volkman's patients were obtaining prescriptions from other 
physicians, and that several of these persons died of overdoses. Id. at 
2.
    The Show Cause Order further alleged that Respondent ``filled 
prescriptions for combinations of controlled substances and the non-
controlled, but highly addictive drug carisoprodal [sic] (Soma), under 
circumstances indicating that the prescriptions were issued outside the 
usual course of professional practice.'' Id. at 2. More specifically, 
the Order alleged that Respondent filled for numerous patients of 
Volkman, ``large quantity prescriptions'' for a benzodiazepine, two 
narcotic pain medications, and Soma, and that ``[t]hese drug 
combinations are generally known in the medical and pharmacy profession 
as being favored by drug-seeking individuals.'' Id. The Order also 
alleged that Respondent ``filled several of the above combination 
prescriptions when the patients should have had two to three weeks' 
supply of medication from a previous prescription'' and it either ``did 
not recognize, or ignored these indicators of drug diversion and 
abuse.'' Id.
    Finally, the Order alleged that, with regard to Dr. Volkman's 
prescriptions, Mr. Fletcher had told a DEA Investigator ``that it was 
`not [his] job to question a physician.' '' Id. Based on the above, the 
Order alleged that Respondent ``knew, or should have known that [the] 
controlled substance prescriptions it filled for patients of Dr. 
Volkman were for no legitimate medical purpose.'' Id.
    By letter of May 20, 2009, counsel for Respondent timely requested 
a hearing.\1\ ALJ Ex. 2, at 1. The matter was then placed on the docket 
of the Agency's Administrative Law Judges (ALJs), and an ALJ proceeded 
to conduct pre-hearing procedures.
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    \1\ Therein, Respondent denied the allegations maintaining that 
``Mr. Fletcher, based on his experience, training, and expertise, 
reasonably believed that all prescriptions filled were for a 
legitimate medical purpose'' and that he ``frequently exercised 
independent judgment to determine if the prescriptions were for 
legitimate medical purposes, and often refused to fill prescriptions 
written by licensed medical doctors, including Dr. Volkman.'' ALJ 
Ex. 2, at 2.
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    On May 26, 2009, the ALJ issued an Order for Pre-Hearing 
Statements. ALJ Ex. 14. The ALJ's order directed the parties to prepare 
a written statement, to be filed with the Hearing Clerk and served on 
opposing counsel, disclosing the ``names and addresses of all witnesses 
whose testimony is to be presented.'' Id. at 2. The ALJ further ordered 
the parties to provide a:

[b]rief summary of the testimony of each witness, with the 
Government to indicate clearly each and every act, omission or 
occurrence upon which it relies in seeking to revoke Respondent's 
DEA Certificate of Registration, and the Respondent to indicate 
clearly each and every matter as to which it intends to introduce 
evidence in opposition thereto. The summaries are to state what the 
testimony will be, rather than merely listing the areas to be 
covered. The parties are reminded that testimony not disclosed in 
the prehearing statements or pursuant to subsequent filing is likely 
to be excluded at the hearing.

Id.
    On July 31, 2009, the ALJ conducted a pre-hearing conference call 
with the parties and also issued a Prehearing Ruling. See ALJ Ex. 3. In 
her Prehearing Ruling, the ALJ ordered that ``[i]f either party chooses 
to amend its witness list, it must file a supplement to its Prehearing 
Statement, noting any changes. The names of additional witnesses must 
be listed, along with a summary of the proposed testimony.'' Id. at 2. 
The ALJ further ``reminded'' the parties ``that testimony not 
summarized in prehearing statements or

[[Page 66150]]

supplements thereto may be excluded at the hearing.'' Id.
    Pursuant to my authority under 21 U.S.C. 824(d), on November 10, 
2009, I further ordered that Respondent's registration be suspended 
immediately because its ``continued registration * * * constitutes an 
imminent danger to the public health and safety.'' ALJ Ex. 8, at 1. The 
Immediate Suspension Order incorporated by reference the allegations of 
the Order to Show Cause and cited the additional allegations that 
Respondent had recently filled more prescriptions for controlled 
substances for two persons who were travelling substantial distances to 
obtain the drugs. Id. at 1-2.
    More specifically, the Immediate Suspension Order alleged that on 
October 2, 2009, L.D.C., a resident of Portsmouth, Ohio obtained from a 
physician practicing in Wheelersburg, Ohio, prescriptions for 90 
tablets of oxycodone 30 mg. and 60 tablets of carisoprodol (a non-
controlled but highly abused drug which metabolizes into meprobamate, a 
Schedule IV depressant), and that she then travelled ``approximately 
100 miles from Wheelersburg to Columbus'' and filled the prescriptions 
at Respondent. Id. at 2. The Order alleged that the next morning, 
L.D.C. ``was found dead at her residence * * * with a prescription vial 
identifying [Respondent] as the dispensing pharmacy and several 
scattered oxycodone tablets * * * next to her body,'' and that the 
Coroner's Office had preliminarily determined that she ``died from the 
* * * `probable toxic effects of drugs (oxycodone, carisoprodol and 
others).' '' Id.
    The Immediate Suspension Order also alleged that on various dates 
including July 3, September 1, and October 1, 2009, Respondent had 
filled various prescriptions for oxycodone issued to S.J.P., of 
Waverly, Ohio. Id. The Order alleged that Waverly, Ohio is 
``approximately 64 miles from Columbus'' and that the prescriptions 
were issued by physicians who practiced ``in Lees [sic] Summit, 
Missouri,'' as well as in Dayton and Portsmouth, Ohio, which are 78 and 
92 miles, respectively, from Respondent. Id.
    The Order thus alleged that Respondent ``knew or should have known 
that the above dispensed controlled substances were likely to be 
diverted or used for other than legitimate medical purposes'' and that 
``[b]y dispensing such prescriptions, [Respondent] failed to fulfill 
its corresponding responsibility for the proper dispensing of 
controlled substances.'' Id. at 3. Based on the above, I concluded that 
there was a ``substantial likelihood that [Respondent] will continue to 
violate its corresponding responsibility to properly dispense 
controlled substances'' and that Respondent's continued registration 
during the pendency of the proceeding ``would constitute an imminent 
danger to the public health and safety.'' Id. I, therefore, ordered 
that Respondent's registration be suspended.
    On November 18-19, 2009, as well as on March 23-25, 2010, the ALJ 
conducted a hearing in Columbus, Ohio.\2\ At the hearing, both parties 
elicited testimony from witnesses and submitted documentary evidence 
into the record. Following the hearing, both parties filed briefs 
containing their proposed findings of fact, conclusions of law, and 
argument.
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    \2\ On February 4, 2010, the Government filed a motion in limine 
to exclude the testimony of various witnesses for Respondent on the 
ground that their names and an adequate summary of their testimony 
had not been previously disclosed as required by the ALJ's Order for 
Pre-Hearing Statements. ALJ Ex. 20. At the hearing on March 23, the 
Government renewed its motion. The ALJ found that Respondent's 
Counsel had violated her Order because ``the Summary of Witnesses 
[sic] testimonies was not provided by the deadlines, and the summary 
that was provided is topical in nature, and not specific'' and did 
not provide ``full disclosure of proposed witness testimony.'' Tr. 
786-87. While deeming ``such conduct abhorrent'' and acknowledging 
that the Government's Motion ``in all [of] parameters should be 
granted,'' she nonetheless allowed Respondent to call all of its 
witnesses even though the Government was ``being prejudiced'' by the 
inadequacy of the disclosure. Id. at 786-88. This was because the 
ALJ understood that she has ``a responsibility to develop a 
record.'' Id. at 787.
     The ALJ's comments reflect a clear misunderstanding of her 
role. Proceedings under sections 303 and 304 of the Controlled 
Substances Act are adversarial and not inquisitorial in nature. As 
such, it is not the ALJ's role but rather that of the parties to 
develop the record; the ALJ's role is to ensure that the parties do 
so in accordance with the Agency's rules of procedure and the 
Administrative Procedure Act and that the proceeding is conducted 
with due regard for the Respondent's rights under the Due Process 
Clause.
     Equally troubling is the ALJ's failure to resolve the issues 
raised by the Government's motion prior to the second phase of the 
hearing, which did not reconvene until March 23, 2010. Notably, 
Respondent filed its response to the Government's motion and its 
second supplemental pre-hearing statement on February 12, 2010; 
surely, at some point during this nearly six-week-long period and 
prior to the hearing, the ALJ could have ruled on the motion and 
issued an appropriate order.
    However, while I find the ALJ's delay in handling the motion and 
her ruling disturbing, much (if not most) of the evidence presented 
in this matter (including that presented by the Government) is not 
probative of the issue of whether Respondent violated 21 CFR 
1306.04(a). Moreover, many of Respondent's witnesses testified as to 
the character/reputation of its owner; while disclosure regarding 
these witnesses should have been more detailed, the prejudice to the 
Government was minimal.
    As to the remaining witnesses, only three of them (Mark Aalyson, 
Catherine Smith, and Carisa Cole) offered any testimony that is 
arguably relevant to, and probative of, the central issue. Notably, 
in its post-hearing brief, the Government does not contend that it 
was prejudiced by inadequate disclosure of the testimony of these 
witnesses. I therefore conclude that Government has not preserved 
its objection.
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    On May 18, 2010, the ALJ issued her Recommended Decision. Applying 
the public interest factors, see 21 U.S.C. 823(f), the ALJ concluded 
that the ``record demonstrates that it is against the public interest 
for the Respondent to retain its controlled substances registration'' 
and recommended that ``Respondent's registration be revoked and any 
pending applications for renewal be denied.'' ALJ at 54.
    Under the first factor--the recommendation of the appropriate State 
licensing board or professional disciplinary authority--the ALJ found 
that ``the Ohio Board of Pharmacy has not made a recommendation in this 
proceeding.'' Id. at 45. The ALJ further found, however, that on March 
5, 2009, the Board had fined Mr. Fletcher and placed his license on 
probation because he ``did not ensure, on three separate occasions, 
that a qualified person was at * * * Respondent to receive deliveries 
of controlled substances,'' which ``were left at unsecure locations 
pending his arrival at the Respondent. '' Id. The ALJ concluded that 
this ``security violation weighs in favor of revocation'' of 
Respondent's registration. Id.
    As to the second factor--Respondent's experience in dispensing 
controlled substances--the ALJ found that ``Respondent ignored numerous 
`red flags' when dispensing controlled substances to Dr. Volkman's 
patients.'' Id. at 46. In particular, the ALJ relied on the testimony 
and report of the Government's Expert that various patients of Volkman:

(1) were driving long distances to have their prescriptions filled, 
(2) were receiving large volumes of controlled substances in the 
highest strength in each prescription, (3) were not receiving 
individualized therapy, for 75% of these patients received the same 
four drug `cocktail,' (4) were paying large amounts of cash for 
their prescriptions, and (5) were receiving multiple narcotic pain 
killers on the same day.

Id.
    Noting Agency precedent 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 prescriptions,' '' id. at 47 (quoting Ralph J. 
Bertolino, 55 FR 4729, 4730 (1990)), the ALJ concluded that Respondent 
``clos[ed] a blind eye to these obvious red flags,'' and accordingly, 
``was not taking seriously its corresponding responsibility for these 
prescriptions'' to

[[Page 66151]]

these patients. Id. (citing 21 CFR 1306.04(a)).
    The ALJ also noted that ``[m]any of Dr. Volkman's patients had told 
[Respondent's owner] that other pharmacies would not fill Dr. Volkman's 
prescriptions'' and yet Respondent's owner did not call these other 
pharmacies to ask why. Id. She also noted that Respondent had an 
``unconventional'' relationship with Volkman in that Volkman referred 
his patients to Respondent, that Mr. Fletcher and Volkman's office 
would coordinate keeping Respondent ``open late in the evenings'' so 
that Volkman's patients could fill their controlled substance 
prescriptions, and that it ``kept large quantities of controlled 
substances on hand to fill these large prescriptions.'' Id. at 48. 
Relatedly, the ALJ found that one of Volkman's patients credibly 
testified that she had filled prescriptions at Respondent ``while 
exhibiting `high' behavior such as slurred speech, stumbling walk, and 
probably `drooling.' '' Id. at 49.
    The ALJ further found that ``a number of Dr. Volkman's patients 
died from drug overdoses after having prescriptions filled at the 
Respondent'' and that while ``these patients were often drug addicts 
who did not take the prescription drugs in the manner prescribed,'' the 
quantities Respondent dispensed ``provided these patients with the 
means to ingest such quantities as to cause an overdose death.'' Id. at 
47. The ALJ also found that the quantities Respondent dispensed were 
large enough not only to support various Volkman patients' ``own 
addiction, but to also sell the extra controlled substances to provide 
the income needed for the next prescriptions, or to sponsor someone 
else in their quest for the drugs needed to feed their addiction.'' Id. 
at 48.
    While noting that Respondent's owner had called Dr. Volkman ``to 
verify his legitimacy,'' as well as ``a local attorney to inquire about 
Dr. Volkman's reputation in the community,'' that he had called other 
prescribing physicians to verify prescriptions, and that he required 
customers to show identification prior to dispensing controlled 
substances and had no security issues beyond those for which he was 
cited by the Ohio Board, the ALJ concluded that ``Respondent's failure 
to react to the `red flags' raised by the conduct of Dr. Volkman's 
patients and the dispensing patterns the Respondent used for these 
patients weigh in favor of revocation.'' Id. at 49-50.
    As to the third factor--Respondent's conviction record under 
Federal or State laws relating to the manufacture, distribution, or 
dispensing of controlled substances--the ALJ found that the record 
``contains no evidence of a conviction of * * * Respondent or Mr. 
Fletcher related to the dispensing of controlled substances.'' ALJ at 
50.
    As to the fourth factor--Respondent's compliance with applicable 
State, Federal, or local laws relating to controlled substances--the 
ALJ found that ``Respondent violated recordkeeping requirements by 
failing to have readily retrievable biennial inventories'' and thus 
violated 21 U.S.C. 827(a)(1) and 21 CFR 1304.11(c). Id. The ALJ also 
found that ``Mr. Fletcher failed to do drug utilization reviews prior 
to dispensing controlled substances.'' Id. at 51.
    Next, the ALJ found that ``in 2008 and 2009, [Mr. Fletcher] 
conducted searches on the OARRS \3\ database'' for ``individuals who 
had predeceased the search'' and thus ``violat[ed] the requirement that 
he only search this database for current customers.'' Id. She also 
found that ``Respondent's banking conduct related to its dispensing 
business violated bank structuring laws and regulations'' because ``Mr. 
Fletcher made deposits just short of $10,000, thus avoiding the 
reporting requirement of the Bank Secrecy Act.'' Id.
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    \3\ Ohio Automated Rx Reporting System. The law allowing the 
Ohio Board of Pharmacy (BOP) to develop its prescription monitoring 
program (OARRS) became effective May 18, 2005; the rules 
implementing the law went into effect on January 1, 2006. GX 18, at 
2 (Ohio Automated Rx Reporting System Handbook). These rules require 
every pharmacy (including out-of-State pharmacies) that ``services 
outpatients and dispenses to an Ohio residence any controlled 
substance or any product containing tramadol or carisoprodol'' ``to 
submit the dispensing information to the BOP.'' Id.
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    Finally, the ALJ reiterated her previous findings that Respondent 
had ignored the ``red flags'' indicating that Dr. Volkman's 
prescriptions were illegal. Id. Noting ``the lack of individual 
therapy, the quantities and strength of the medications, and the other 
behavior patterns demonstrated by'' the Volkman patients, the ALJ 
concluded that Respondent had ``adequate evidence to determine that the 
prescriptions were not written for a legitimate medical purpose,'' and 
that its violation of its ``corresponding responsibility weights 
greatly in favor of revocation in this matter.'' Id. at 51-52.
    As for the fifth factor--such other conduct which may threaten the 
public health and safety--the ALJ noted that Mr. Fletcher did not 
testify in the proceeding. Id. at 52. While she acknowledged the 
settled case law that notwithstanding the Fifth Amendment privilege, an 
adverse inference may be drawn in a civil matter based on a party's 
failure to testify, the ALJ nevertheless declined to ``draw an adverse 
inference'' even though she found Mr. Fletcher's ``inconsistent 
handling of controlled substances'' to be ``most troubling.'' Id. 
(citing, inter alia, Baxter v. Palmigiano, 425 U.S. 308, 318 (1976)). 
More specifically, the ALJ observed that Mr. Fletcher ``clearly knew 
the questions to ask when dispensing controlled substances to a 
customer'' but that ``in six months he filled over 4,900 prescriptions 
without seeming to consistently engage in such conversations with Dr. 
Volkman's patients'' and that, even ``when they demonstrated their 
addictive behavior before him, he filled [their] prescriptions 
anyway.'' Id. The ALJ concluded that this conduct was ``adverse to the 
public health'' and supported revocation. Id. at 53. The ALJ further 
noted that Mr. Fletcher had failed to provide assurances that he will 
not engage in future misconduct. Id. (citing numerous Agency cases).\4\
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    \4\ Based on the testimony of Respondent's character witnesses 
(which included some of his customers), the ALJ concluded that this 
``evidence demonstrates that the Respondent acts responsively in 
many of his dealings with others.'' ALJ at 54. The ALJ concluded, 
however, this evidence does ``not negate the fact that at least 
between September 2005 and February of 2006, Mr. Fletcher chose to 
turn a blind eye to the conduct of Dr. Volkman's patients and to 
dispense controlled substances irresponsibly.'' Id.
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    The ALJ thus concluded that the Government had ``met its burden of 
proof'' and demonstrated that Respondent's continued registration is 
inconsistent with ``the public interest.'' Id. at 54. She therefore 
recommended that ``Respondent's registration be revoked and [that] any 
pending applications for renewal be denied.'' Id.
    On June 17, 2010, Respondent timely filed Exceptions to the ALJ's 
Decision; its Exceptions have been considered in my review of this 
matter. Having reviewed the record in its entirety, I agree with the 
ALJ's ultimate finding that Respondent's continued registration is 
inconsistent with the public interest. However, because Respondent's 
registration has expired and it has not filed a renewal application, 
there is neither a registration to revoke nor a renewal application to 
deny.
    As noted above, Respondent's registration was suspended prior to 
the hearing pursuant to my authority under 21 U.S.C. 824(d). I, 
therefore, conclude that this case is not moot and uphold the 
suspension order. As the ultimate finder of fact, I make the following 
findings.

[[Page 66152]]

Findings

    Respondent previously held DEA Certificate of Registration, 
BE5902615, under which it was authorized to dispense controlled 
substance in Schedules II through V at the registered location of 1336 
East Main Street, Columbus, Ohio 43205. GXs 1 & 2. Respondent last 
renewed its registration on August 27, 2007; its registration expired 
on August 31, 2010. Id. According to the records of the Agency, of 
which I take official notice, Respondent has not filed a renewal 
application.\5\
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    \5\ 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). In accordance with the Administrative Procedure Act and 
DEA's regulation, Respondent is ``entitled on timely request to an 
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21 
CFR 1316.59(e). Accordingly, Respondent may file a motion for 
reconsideration of this fact within fifteen days of service of this 
Order which shall commence with the mailing of the Order.
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    Respondent is owned by Eugene H. Fletcher, who is also its sole 
pharmacist.\6\ ALJ Ex. 3, at 2. Respondent sells only prescription 
pharmaceuticals. Tr. 863.
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    \6\ Mr. Fletcher additionally owns and operates a dumpster 
business and owns and manages both commercial and residential rental 
properties. Id. at 866, 1598.
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    In 2003, Dr. Paul Volkman, a physician who was unable to obtain 
malpractice insurance because of several large malpractice settlements 
and judgments, commenced working at a Portsmouth, Ohio pain clinic 
owned by one Denise Huffman. GX 6, at 2. As previously found by the 
Agency (and as upheld by the United States Court of Appeals for the 
Sixth Circuit), Volkman frequently prescribed large quantities of 
multiple controlled substances including narcotics containing oxycodone 
\7\ and hydrocodone,\8\ benzodiazepines such as Xanax (alprazolam) and 
Valium (diazepam),\9\ as well as the currently non-controlled drug Soma 
(carisoprodol) which is nonetheless popular with drug abusers, without 
a legitimate medical purpose and outside of the usual course of 
professional practice. GX 6, at 2-3; Paul H. Volkman, 73 FR 30630, 
30633-34, 30639 (2008), pet. for rev. denied, Volkman v. DEA, 567 F.3d 
1215 (6th Cir. 2009). In plain English, the record in the Agency 
proceeding involving Dr. Volkman conclusively established that he was a 
drug dealer.
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    \7\ Oxycodone is a schedule II controlled substance. 21 CFR 
1308.12(b)(1)(xiii).
    \8\ Hydrocodone, when combined with another non-narcotic 
therapeutic ingredient such as acetaminophen, is a schedule III 
controlled substance. 21 CFR 1308.13(e)(1).
    \9\ Alprazolam and diazepam are benzodiazepines and are schedule 
IV depressants. 21 CFR 1308.14(c).
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    On September 9, 2005 (several months after DEA executed a search 
warrant at Huffman's clinic), Volkman left the clinic; three days 
later, he started seeing patients out of his residence at 1310 Center 
St. in Portsmouth.\10\ GX 6, at 4; 73 FR at 30635. However, Volkman's 
patients encountered problems filling his prescriptions. GX 39, at 1. 
D.S., one of Volkman's patients, helped Volkman by going on the 
Internet to search for pharmacies that would fill his prescriptions; 
according to D.S., she would call and ask the pharmacists if they 
``would fill prescriptions for oxycodone 30 mg., hydrocodone 10 mg., 
Xanax 2mg., [and] Soma 350 mg., and if they had the drugs on hand.'' 
\11\ Id. While the pharmacists at other pharmacies ``either said they 
did not have the medications in stock or would not fill prescriptions 
for Dr. Volkman,'' Mr. Fletcher said that he had the ``drugs in stock'' 
and that ``he would fill the prescriptions.'' Id. at 2.
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    \10\ According to a Diversion Investigator (DI), Volkman started 
writing prescriptions out of his residence on September 12, 2005. GX 
9, at 9.
    \11\ It is acknowledged that D.S.'s affidavit stated that in 
September 2005, she had started taking people to Respondent to fill 
prescriptions. GX 39, at 3. D.S. further stated that she had taken 
her friend C.R. to Respondent to fill prescriptions and that C.R. 
overdosed and died the same day as her first trip to Respondent. Id. 
at 5. Subsequently, the Government acknowledged that C.R. had died 
on March 9, 2004. Letter of Government Counsel to ALJ, at 1. (May 
10, 2010).
     Notwithstanding D.S.'s misrepresentation, there is substantial 
circumstantial evidence establishing the relationship between 
Respondent and Volkman. I therefor find credible D.S.'s statement 
regarding how she found Respondent.
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    Thereafter, D.S. posted a notice on a bulletin board in Volkman's 
office which provided Respondent's name, address, and phone number. 
Id.; see also GX 15. Directions were also provided from Volkman's 
residence to Respondent.\12\ See GX 15, at 1, 2, 4, 5. Moreover, when, 
in October 2005, Volkman moved to Chillicothe, Ohio, he posted similar 
notices with directions to Respondent. The distance from Volkman's 
Portsmouth residence to Respondent was approximately 94 miles, see GX 
15, at 2; the distance from his Chillicothe office to Respondent was 56 
miles. GX 9, at 23.
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    \12\ In October 2005, the Portsmouth Police executed a search 
warrant at Volkman's residence. GX 6, at 4. While no charges were 
filed, Volkman was issued a condemnation notice. Id. Shortly 
thereafter, Volkman moved to Chillicothe, Ohio. Id.
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    According to Dr. Volkman's former security guard, ``Volkman 
instructed his employees to send all his patients to [Respondent] to 
have their prescriptions filled.'' GX 22, at 2; see also GX 23, at 1. 
Moreover, ``just about every day, a call was made from [Volkman's] 
clinic to [Respondent] or from the [Respondent] to the clinic'' during 
which Mr. Fletcher was told when Volkman's ``last patient had been 
seen'' so that he would know how late to keep the pharmacy open to fill 
the prescriptions Volkman issued. GX 22, at 2. At times, patients would 
show up at Respondent and fill their prescriptions as late as midnight. 
GX 24, at 3; see also GX 23, at 2 (L.W. relating that she filled 
prescriptions at Respondent as late as 9 or 10 p.m.). Volkman's ex-
security guard stated that the patients ``did not appear to be in 
pain'' and that he believed that ``about 60% of [them] were pill 
patients and not pain patients.'' GX 22, at 3. See also GX 24, at 6 
(affidavit of A.S.; ``[t]here were some legitimate patients, but most 
of Dr. Volkman's patients were not legitimate. They were going to Dr. 
Volkman and [Respondent] for drugs to abuse and to sell.''); GX 9, at 
11 (photographs of patients waiting to see Volkman taken on date 
Portsmouth P.D. executed search warrant at his practice).
    As part of the investigation, DEA Diversion Investigators (DIs) 
obtained data from the Agency's ARCOS system showing Respondent's 
purchases of oxycodone and hydrocodone combination drugs; these drugs 
are Schedule II and III narcotics, respectively. Tr. 533-34. The 
oxycodone data showed that in 2004, Respondent had purchased 96,000 
dosage units. GX 9, at 33. However, during 2005, Respondent purchased 
495,000 dosage units; of this amount, approximately 400,000 dosage 
units were purchased between September and December. Id. Likewise, in 
2004, Respondent purchased 88,000 dosage units of hydrocodone. Id. at 
34. In 2005, Respondent purchased 328,000 dosage units; of this amount, 
more than 200,000 were purchased between September and December.\13\ 
Id. While in 2004, Respondent was only the 300th largest pharmacy 
purchaser of oxycodone in Ohio; in 2005, it was the eleventh largest 
purchaser, and in 2006, it was the seventh largest. Id.
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    \13\ The data also showed that in 2006, Respondent purchased 
820,000 dosage units of oxycodone and 224,000 dosage units of 
hydrocodone. GX 9, at 33-34.
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    On February 10, 2006, a search warrant was executed at Respondent 
and its dispensing records were seized.\14\ Tr. 523. The records showed 
that between September 1, 2005 and February 10, 2006, Respondent 
dispensed a total of 6,619 controlled-

[[Page 66153]]

substance prescriptions; 4,979 of the prescriptions (75%) had been 
issued by Dr. Volkman.\15\ GX 9, at 62. Corresponding with Mr. 
Fletcher's agreeing to fill Volkman's prescriptions, Respondent 
experienced multi-fold increases in the amounts of prescriptions it 
filled for oxycodone, hydrocodone, diazepam and alprazolam. Tr. 526; GX 
9, at 29.
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    \14\ On the same day, a search warrant was also executed at Dr. 
Volkman's Chillicothe office and his registration was suspended. GX 
9, at 13.
    \15\ During this period, Respondent filled a total of 5,206 
prescriptions issued by Volkman. GX 9, at 24, 28.
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    Nearly ninety-nine percent of the persons who obtained controlled-
substance prescriptions from Volkman and filled them at Respondent did 
not live in Columbus, Ohio. GX 9, at 24; Tr. 522. Approximately half of 
the patients were from Kentucky, with some of the patients driving 
three to four hours to obtain the drugs; \16\ many other patients were 
from the Portsmouth, Ohio area.\17\ See GX 14; Tr. 571-72. From 
Portsmouth to Respondent there were 40 other pharmacies along the 
route. GX 34, at 2. Moreover, the dispensing records showed that 87 
percent of Respondent's customers paid cash for their prescriptions; by 
contrast, according to the Government's Expert, ``the national average 
of cash paying customers for prescriptions [was] 11.4% in 2005 and 10% 
in 2006.'' \18\ GX 20, at 2; Tr. 534-35. Only five percent of the 
customers paid with insurance, and eight percent paid with a 
combination of insurance and cash. Tr. 534-35; GX 9, at 41.
---------------------------------------------------------------------------

    \16\ Several persons drove to Respondent from Paintsville, 
Kentucky, a distance of 182 miles; according to a DI, there were 96 
pharmacies enroute. GX 34, at 3.
    \17\ According to the testimony of Lisa Roberts, R.N., who works 
for the Portsmouth Health Department and who is a member of the Ohio 
Department of Health Poison Action Group, Tr. 26, Scioto County 
(where Portsmouth is located) ``showed a 360 percent increase in 
unintentional prescription drug overdoses'' from 1999 to 2009. Id. 
at 32. In a Community Health Assessment she prepared for the City of 
Portsmouth, Ms. Roberts wrote that ``Scioto County has long been the 
target of lucrative `Pill Mills' [which] prescribe powerful 
prescription drugs to individuals without proof of chronic pain.'' 
GX 8, at 6. Continuing, Ms. Roberts noted that ``[m]any people have 
become addicted as a result of these establishments'' and that 
``much of the pills distributed there end up being illegally 
diverted to the public, including [to] high school students.'' Id. 
She also noted that ``[p]eople come from other states as well to 
patronize these establishments.'' Id. Ms. Roberts testified that she 
``knew people that went to [Dr. Volkman] to get drugs to sell,'' as 
well as about the practice of sponsoring, by which an abuser or drug 
dealer recruits another person and fronts the person the money 
needed to pay for a doctor visit and to fill the prescriptions; the 
sponsor then receives half the pills back which can then be sold. 
Tr. 43, 62-63. See also Tr. 264, 266, 276, 283.
    \18\ Payment information was taken from the seized 
prescriptions. Tr. 570.
---------------------------------------------------------------------------

    L.W., a resident of Quincy, Kentucky, and A.S., a resident of 
Portsmouth, were among those persons who obtained controlled-substance 
prescriptions from Volkman and filled them at Respondent. See GXs 23 & 
24; Tr. 272. On October 10, 2005, L.W. filled at Respondent 
prescriptions for 270 tablets of oxycodone 30 mg., 240 tablets of 
hydrocodone/apap (10/500),\19\ 90 tablets of alprazolam 2 mg. (generic 
for Xanax), and 180 tablets of carisoprodol 350 mg. GX 12, at 2. On 
November 7, L.W. obtained from Respondent an additional 270 tablets of 
oxycodone 30 mg., 240 hydrocodone 10/500, 90 alprazolam 2 mg., and 240 
tablets of carisoprodol; on December 6, she obtained the same four 
drugs and quantities, the sole difference being that she received only 
180 oxycodone 30 mg. Id. Finally, on February 3, 2006, L.W. obtained 
from Respondent 360 tablets of oxycodone 30 mg., 360 tablets of 
hydrocodone 10/325, 90 tablets of alprazolam 2 mg., and 240 
carisoprodol. Id.
---------------------------------------------------------------------------

    \19\ Apap is the abbreviation for acetaminophen.
---------------------------------------------------------------------------

    In an affidavit, L.W. stated that while she initially needed to 
take pain medication following two accidents, the last of which 
occurred in February 2004, at the time she was seeing Dr. Volkman and 
filling the prescriptions at Respondent, she was both selling the drugs 
and taking them ``to get high.'' GX 23, at 4. She stated that on those 
occasions when she spoke with Mr. Fletcher at Respondent, he ``never 
asked me about my medical condition but would just make small talk.'' 
Id.\20\ She further stated that she ``was high on drugs several times 
when having prescriptions filled at [Respondent] and at times was high 
when [she] spoke with'' Mr. Fletcher. Id. at 3-4. L.W. further stated 
that on her last visit to Respondent, she was ``so high'' that her 
``slurred speech and unsteady walk would have been very noticeable'' 
and that her ``head was hanging down and [she] was probably drooling.'' 
Id. at 4.
---------------------------------------------------------------------------

    \20\ Cf. GX 22, at 3 (affidavit of Delbert Evans, Dr. Volkman's 
security guard; ``Some calls by Eugene were to speak with Dr. 
Volkman but the majority of the calls were to determine how late he 
should stay open to fill Dr. Volkman's prescriptions.'').
---------------------------------------------------------------------------

    Respondent filled A.S.'s prescriptions, which she obtained from Dr. 
Volkman, for oxycodone, hydrocodone, diazepam, alprazolam, and 
carisoprodol on seven occasions between September 13, 2005 and February 
1, 2006. GX 12, at 1. More specifically, on September 13, Respondent 
dispensed to her 240 oxycodone 30 mg., 180 hydrocodone/apap 10/650, 90 
diazepam 10 mg., and 90 carisoprodol 350 mg. Id. Respondent made 
additional dispensings of Volkman's prescriptions as follows: On 
October 10, 330 oxycodone 30 mg., 240 hydrocodone 10/500, 90 alprazolam 
2 mg., and 180 carisoprodol 350 mg.;\21\ on November 8, 165 oxycodone 
30 mg., 120 hydrocodone, 45 alprazolam, and 90 carisoprodol; on 
December 2, 180 oxycodone 5 mg., 240 hydrocodone, 90 alprazolam, and 
180 carisoprodol; on December 20, 90 oxycodone 5 mg., 120 hydrocodone, 
45 alprazolam, and 90 carisoprodol; on January 2, 2006, 240 oxycodone 
15 mg., 240 hydrocodone, 90 alprazolam, and 180 carisoprodol; and on 
February 1, 240 oxycodone 30 mg., 240 hydrocodone, 90 alprazolam, and 
180 carisoprodol. Id.
---------------------------------------------------------------------------

    \21\ After this date, each of the hydrocodone dispensings was 
for the 10 mg. strength (which is the strongest formulation); the 
alprazolam dispensings were for the 2 mg. strength, and the 
carisoprodol was for the 350 mg. strength. See GX 12, at 1.
---------------------------------------------------------------------------

    A.S. testified at the hearing. While the ALJ found portions of her 
testimony not credible because ``she became vague, and contradicted 
herself,'' ALJ at 23 n.6, the ALJ found credible her testimony that her 
sister-in-law told her about Dr. Volkman and sponsored her by giving 
her the money to pay for her office visit and to fill the prescriptions 
she obtained. Id. at 22 n.5; Tr. 264. The ALJ further found credible 
A.S.'s testimony that she gave her sister-in-law ``half of the pills,'' 
which her sister-in-law then sold to raise money to sponsor someone 
else. ALJ at 22 & n.5. (citing Tr. 266, 276, 283.) A.S. testified that 
her sister-in-law ``would take several people to the doctor'' and that 
they would go to Respondent to fill the prescriptions. Tr. 283. A.S.'s 
sister-in-law would pay for everything and receive ``half [of] the 
medication.'' Id. A.S. testified that Volkman gave her combination 
prescriptions and that Volkman's office told her to go to Respondent, 
which was a two-hour drive (one-way) from Portsmouth. Id. at 274-75. 
A.S. also admitted that she was addicted to oxycodone and had been at 
the time she obtained prescriptions from Dr. Volkman and filled them at 
Respondent.\22\ Id. at 253 & 336.
---------------------------------------------------------------------------

    \22\ On cross-examination, A.S. admitted that she never told Mr. 
Fletcher that she was addicted or that she was giving half of her 
drugs to her sister-in-law. Tr. 312. However, one would hardly 
expect a drug abuser or diverter to tell a pharmacist why she was 
seeking the drugs. A.S. also testified on cross-examination that she 
presented valid prescriptions to Mr. Fletcher. Id. at 314. However, 
Respondent's counsel did not clarify what he meant by the term 
``valid,'' which can mean one of several things such as that the 
prescriptions were not fraudulent or forged, that they were issued 
for a legitimate medical purpose, or that they were in proper form 
and contained the required information.
     A.S. also testified that she had been in constant pain since a 
1996 car accident, that she was in pain when she testified in this 
proceeding, and that she had pain at the level of an eight on the 
scale of one to ten. Id. at 258-60.

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

[[Page 66154]]

    S.L.J. was a confidential informant for the Portsmouth Police 
Department (PPD). GX 4, at 744. On September 16, 2005, the PPD sent 
S.L.J. to see Dr. Volkman and to obtain controlled- substance 
prescriptions. Id. Dr. Volkman wrote her prescriptions for oxycodone 30 
mg. and Percocet,\23\ which S.L.J. turned over to the police. Id. On 
September 26, S.L.J., who was an addict, returned to Dr. Volkman's 
office on her own initiative and without the PPD's knowledge; she 
obtained prescriptions for 135 tablets of Percocet 5/325 mg. and 135 
tablets of oxycodone 30 mg. Id. at 745-46. The same day, S.L.J. filled 
those prescriptions at Respondent. Id. at 746. On September 29, 2005, 
S.L.J. was found dead; the coroner determined that the cause of death 
was ``multiple drug intoxication.'' Id. The Government did not, 
however, submit the coroner's report or a police report and thus did 
not establish that Respondent dispensed the drugs on which S.L.J. 
overdosed.\24\
---------------------------------------------------------------------------

    \23\ Percocet is a brand-name product containing oxycodone and 
acetaminophen and is a schedule II controlled substance. ALJ Ex. 5, 
at 1.
    \24\ While I previously found in the Volkman decision that 
S.L.J. had died of multiple drug intoxication and had both oxycodone 
and alprazolam in her system, see 73 FR 30636 n.23, Respondent was 
not a party to that proceeding. The Government was thus required to 
prove this fact anew, which it failed to do because the DI testified 
that he was unsure of, and did not recall the cause of S.L.J.'s 
death. Accordingly, I conclude that the Government has not proved 
that S.L.J.'s death was caused by the prescriptions she filled at 
Respondent.
---------------------------------------------------------------------------

    E.R. lived in Grayson, Kentucky and went to Dr. Volkman at his 
Chillicothe, Ohio clinic on just one occasion. GX 4, at 749 & 750; Tr. 
407. He had planned to obtain prescriptions for controlled substances, 
fill them, and then sell the drugs on the street to get out of debt. 
Tr. 405-07, 409-10. E.R., who had heard from friends that Volkman would 
write large-volume controlled-substance prescriptions, drove for 
several hours with a friend to see Volkman. Id. at 406, 410. E.R. 
obtained from Volkman prescriptions for 240 oxycodone 30 mg., 240 
hydrocodone/apap 10/500, 90 alprazolam 2 mg., and 90 Soma 350 mg. Id. 
at 408; GX 4, at 750. The following day, E.R. drove with his wife to 
Respondent and filled the prescriptions. Id. at 409-12.
    Immediately after he obtained the drugs, E.R. entered his car and 
proceeded to crush and snort two oxycodone tablets. Id. at 412. On the 
return trip, ``he also took a couple of Xanax.'' Id. Following a stop 
at the local WalMart, E.R. and wife went to see a friend who sold 
controlled substances and E.R. offered to sell him some of the 
hydrocodone. Id. at 413. However, the drug dealer was having a domestic 
dispute so E.R. and his wife returned to their home. Id.
    Later that evening, the drug dealer came to E.R.'s house and 
``partied with'' E.R. for several hours. Id. The following morning, 
E.R. was found dead. Id. at 413-14. However, once again, the Government 
did not introduce into evidence the coroner's report or a police report 
and thus has not established in this case that E.R. overdosed on the 
drugs he obtained at Respondent.
    The evidence also showed that in October 2005, and shortly after 
Respondent started dispensing the Volkman prescriptions, Mr. Fletcher 
phoned Robin Padolik, who was then employed as an Automated Clearing 
House Coordinator for the Commerce National Bank (CNB), where he held 
various accounts. GX 25, at 1, 3. According to Ms. Padolik, beginning 
around September 2005, CNB personnel began noticing an increase in the 
amounts of Mr. Fletcher's cash deposits and placed him on CNB's ``Watch 
List.'' Id. The same month, Mr. Fletcher's transfers to his outside 
accounts became more frequent, and in mid-October, Mr. Fletched called 
and asked Ms. Padolik ``at what point the bank would be required to 
file a form when he made a cash deposit; how a deposit would [be] 
process[ed]''; and, if making deposits into two ``separate accounts 
[would] prevent a form submission.'' Id. at 3. Ms. Padolik specifically 
related that on October 13, 2005, Mr. Fletcher called and asked whether 
``if he deposited $6,000 in one account and $4,000 in another 
account,'' the bank would be required ``to submit `that report.' '' Id. 
Based on Mr. Fletcher's question, Ms. Padolik, who had been trained in 
the Bank Secrecy Act and the recognition of money-laundering, concluded 
that Mr. Fletcher ``apparently knew [that] the threshold for reporting 
was any amount over $10,000, but did not know the name of the form the 
bank was required to file.'' Id. Ms. Padolik ducked Mr. Fletcher's 
question. Id.
    On October 18, Mr. Fletcher called Ms. Padolik and asked if 
``account deposit amounts were associated with the Taxpayer 
Identification Number (TIN).'' Id. at 4. He also asked ``how he could 
change his TIN'' for the accounts he maintained for Respondent and for 
his other business ventures. Id. Ms. Padolik again ducked Mr. 
Fletcher's questions and reported him to Andrew Reardon, CNB's 
Compliance Manager. Id.
    As Ms. Padolik testified, ``it was really a big red flag when he 
started asking questions about dollar amounts * * * so it looked like 
he was really fishing for information on how he can [sic] get around 
BSA reporting.'' Tr. 167. Ms. Padolik explained that ``[d]eposit 
structuring * * * is a break-up of cash deposits that are turned into 
other financial transactions * * * it's cash that is taken from its 
criminal origin and passed through the system with many transactions * 
* * Structuring is a way to take cash from an illegal source and make 
it look more legal by passing it through the financial system.'' Tr. 
157-58.
    Ms. Padolik specifically identified six transactions by Mr. 
Fletcher which raised her suspicion that he was engaged in structuring 
to avoid the bank's filing of a Currency Transaction Report (CTR). GX 
25, at 4; see also Tr. 166; 31 CFR 103.11. These included deposits of 
$9,900 on October 11, a check for $41,000 issued to an investment 
company on October 15, a deposit of $9,980 on October 17, a deposit of 
$8,380 on October 18, a deposit of $9,950 on October 19, and a deposit 
of $9,900 on October 20, 2005. GX 25, at 4. Following a review of his 
transactions by the CNB's High Risk Committee, the Bank concluded that 
Mr. Fletcher had engaged in structuring in violation of Federal banking 
regulations and closed his accounts. Tr. 207-08; GX 28.\25\ A DI 
further found that Mr. Fletcher's ``net profit from dispensing for Dr. 
Volkman [was] almost $500,000.'' Tr. 620.
---------------------------------------------------------------------------

    \25\ To refute this evidence, Respondent put on the testimony of 
his accountant, who maintained that Mr. Fletcher ``more than 
likely'' was of ``low sophistication'' in regards to banking 
regulations. Tr. 1602. However, I find credible Ms. Padolik's 
testimony (both at the hearing and in her affidavit) regarding the 
questions Mr. Fletcher asked regarding the bank's reporting 
obligations and conclude that he clearly knew what he was doing and 
was engaged in structuring.
---------------------------------------------------------------------------

    DEA Investigators interviewed Mr. Fletcher regarding the Volkman 
prescriptions on two occasions, February 10, 2006 and November 27, 
2007. Tr. 600. According to the DI who conducted the latter interview, 
Mr. Fletcher said that ``he had questions about'' Dr. Volkman. Id. at 
606. Mr. Fletcher maintained that he had called Dr. Volkman, who told 
him that ``he did an MRI, and blood tests.'' \26\ Id. Mr. Fletcher also 
maintained that Volkman's prescriptions were valid because ``the 
physician was licensed in Ohio and [the prescription] was written to 
the person

[[Page 66155]]

presenting'' it. Id. He stated the prescriptions were not forged. Id.
---------------------------------------------------------------------------

    \26\ There was also testimony that Volkman's patients complained 
to Respondent's employees of having to pay extra for drug tests. Tr. 
1265-67; 1713-14.
---------------------------------------------------------------------------

    However, twice in the interview, Mr. Fletcher admitted that his 
customers had told him that ```other pharmacists would not fill Dr. 
Volkman's prescriptions.''' Id. at 622 & 624. The DI then asked Mr. 
Fletcher if he had ``call[ed] the other pharmacists and asked them why 
they were not filling Dr. Volkman's scripts.'' Id. at 622. Mr. Fletcher 
answered: ``I don't communicate with other pharmacists.'' Id.
    The DI also asked Mr. Fletcher if he ever felt that Dr. Volkman's 
patients were addicted to drugs; Mr. Fletcher answered that it was 
```hard to say.' '' Id. at 606. Mr. Fletcher told the DI that sometimes 
Dr. Volkman's patients would ask him to sell them extra pills; Mr. 
Fletcher stated that he had refused to do so. Id. He also stated that 
he did ``not get into'' the ``personal life'' of his customers to 
determine their medical conditions. GX 9, at 69.
    When the DI asked Mr. Fletcher about his ``corresponding 
responsibility,'' he acknowledged that a physician must prescribe ``for 
a legitimate ailment, and [that] the dose must be correct.'' GX 9, at 
68. However, Mr. Fletcher maintained that ``what to prescribe and the 
quantities'' was for the physician to decide and that it was ``not his 
job to question a physician.'' Id. He further asserted that he did not 
find it suspicious that the customers were traveling long distances, 
paying cash, obtaining combinations of controlled substances, and that 
other pharmacies had refused to fill the prescriptions. Id. at 69.
    The Government introduced evidence showing that Respondent's 
purchases and dispensings of controlled substances were substantially 
greater than that of a single CVS pharmacy which was located 1.6 miles 
from it. GX 9, at 30-39. It also introduced evidence comparing the 
prices Respondent and four other independent pharmacies (two of which 
were located in Columbus, two of which were located in Portsmouth) paid 
their suppliers for various controlled substances as well as what they 
charged their customers; the Government asserts that this evidence 
shows that these four pharmacies sold controlled substances at an 
average price 37% cheaper than that charged by Respondent. GX 9, at 55-
56.
    It is obvious, however, that neither strand of evidence rises to 
the level of substantial evidence because neither is based on a 
statistically valid sample. Indeed, to compare Respondent's controlled-
substance dispensings to that of a single CVS located 1.6 miles away 
ignores that the two stores may serve communities with substantially 
different demographics such as the age of the residents and the 
presence of competitors. So too, comparing Respondent's prices with 
those charged by four other pharmacies (out of likely thousands of 
pharmacies in the State of Ohio including hundreds of independents) and 
which do not even appear to have been selected at random, is manifestly 
inadequate to prove that Respondent charged more because it was selling 
to an illicit market.
    The Government also put on extensive evidence to the effect that 
Respondent was located in a bad/high-crime neighborhood and that Mr. 
Fletcher carried a gun while at his business. As for the character of 
Respondent's neighborhood, the principal issue in this case was whether 
Respondent was dispensing controlled-substance prescriptions which it 
either knew or had reason to know lacked a legitimate medical purpose 
and were issued outside of the usual course of professional practice. 
See ALJ Ex. 1, at 1-2 (citing 21 CFR 1306.04(a)). Whether Respondent is 
located in a bad neighborhood is of no relevance in determining whether 
Mr. Fletcher violated his corresponding responsibility under the CSA. 
While there is evidence (discussed below) that Respondent and Mr. 
Fletcher were found by the Ohio Board of Pharmacy to have violated 
State law because he was not present on three occasions when controlled 
substances were delivered and the drugs were not properly stored, GX 
16, at 2, presumably, this would have been a violation even if 
Respondent had been located in the safest neighborhood in the State of 
Ohio. So too, the evidence that Mr. Fletcher carried a gun is entirely 
irrelevant.\27\
---------------------------------------------------------------------------

    \27\ The Government also introduced evidence showing that Mr. 
Fletcher had violated the Ohio Board of Pharmacy's Acceptable Use 
Policy for the OARRS, because he obtained prescription information 
on two persons who had died. Tr. 930-31, 1803, 1808; GX 42, at 1. 
According to the Government's Expert, this violated the Board's 
policy because a pharmacy can only obtain information on a current 
customer. Tr. at 930-31. Notably, the Government's Expert did not 
testify that this conduct violated any State law or regulation.
    While this may be an improper use of the database and a 
violation of the Board's policy, the matter is best left to the 
Board to resolve.
---------------------------------------------------------------------------

Evidence Regarding Respondent's Practices After February 10, 2006

    The Government also obtained data from OARRS, the Ohio prescription 
monitoring program, showing controlled-substance prescriptions that 
were issued by Florida-based physicians and filled by Respondent. Tr. 
476; GXs 10 & 11. The Government submitted a spreadsheet showing more 
than fifty prescriptions for drugs such as oxycodone in 15 mg. and 30 
mg. strength and alprazolam, which Respondent filled between September 
4, 2007 and September 2, 2008. See GX 10. At least seventeen of the 
persons listed as having filled prescriptions at Respondent were 
residents of Kentucky; several individuals filled multiple 
prescriptions for oxycodone on the same day. See id. For example, on 
April 25, 2008, A.B., a resident of Denton, Kentucky (143 miles from 
Respondent), filled prescriptions for 180 oxycodone 30 mg., 120 
oxycodone 15 mg., and 90 alprazolam 2 mg.; on July 23, 2008, C.W., a 
resident of Ashland, Kentucky (123 miles from Respondent), filled 
prescriptions for 240 oxycodone 30 mg., 60 oxycodone 15 mg., and also 
60 alprazolam 2 mg.; and on August 11, 2008, N.W., a resident of 
Flatwoods, Kentucky (118 miles from Respondent), filled prescriptions 
for 240 oxycodone 30 mg., 90 oxycodone 15 mg., and also 60 alprazolam 2 
mg. GX 10, at 1-2. Moreover, on August 25, 2008, C.L. filled 
prescriptions for 90 diazepam 10 mg. and 60 alprazolam 2 mg.\28\ Id. at 
1.
---------------------------------------------------------------------------

    \28\ On March 20, 2009, the Ohio Board of Pharmacy sent a notice 
to pharmacists explaining that it had observed ``a significant 
volume of prescriptions from physicians in Florida'' who were 
prescribing oxycodone, Xanax, Percocet and Soma for residents of 
Ohio and Kentucky who were ``generally 20-55 years old and usually 
pay cash.'' GX 17. The Board further explained that ``[i]n many of 
these cases, we are wondering how the term `legitimate medical 
purpose' applies when a patient who is supposedly in severe pain can 
ride to Florida and back to receive treatment when we have excellent 
facilities in Ohio.'' Id. The Board requested pharmacists who had 
``already filled such prescriptions'' to contact one of its Agents 
because the Board believed that ``this may be a coordinated effort 
to obtain drugs and we are trying to develop a list of the people 
involved.'' Id.
    There was also evidence that because of the effectiveness of the 
State of Kentucky's prescription monitoring program, drug dealers 
were sponsoring people to go to South Florida to obtain controlled-
substance prescriptions and that some of these individuals would 
fill the prescriptions in Ohio. Tr. 429-34.
---------------------------------------------------------------------------

Additional Evidence Regarding Patient Deaths

    The Government also introduced evidence regarding two additional 
persons, L.D.C. and B.A., who obtained controlled substances from 
Respondent and died the following day. Both deaths occurred in the fall 
of 2009.
    L.D.C., who was 34 years old at the time of her death, lived in 
West Portsmouth, Ohio. GX 29. On October 2, 2009, L.D.C. obtained 
prescriptions from Dr. Georgescu of Wheelersburg, Ohio for 90 tablets 
of oxycodone 30 mg. (90 dosage units) and 60 tablets of

[[Page 66156]]

carisoprodol which she then filled at Respondent. GX 32, at 1, 4; GX 
29, at 2; Tr. 629. These were the first and last prescriptions she 
filled at Respondent. GX 32, at 1.
    According to the report filed by the Scioto Sheriff's Office, on 
October 3, L.D.C.'s boyfriend found her lying on the floor of the 
master bedroom near the footboard of their bed with blood coming from 
her nose and mouth. Id. On arriving at the scene, a Deputy Sheriff 
observed ``38 white pills laying beside her and a pill bottle labeled 
oxycodone 30 mg. [which] was prescribed on October 2, 2009 and filled 
at'' Respondent. GX 29, at 2. The officer also found that ``on a 
dresser next to her [were] 10 oblong pills scored GG/2/4/9 and a pill 
bottle labeled Soma 350 mg. with 48 pills in it.'' Id. He also ``saw a 
silver spoon with white residue on it and a needle with no cap on it.'' 
Id. at 4. A second officer made the same observations and reported that 
the pills labeled GG/2/4/9 were ``believed to be Xanax.'' Id. at 5.
    Thereafter, an autopsy was performed on L.D.C. On November 30, 
2009, the Coroner issued her Opinion that the cause of L.D.C.'s death 
was the ``[t]oxic effects of drugs'' including ``oxycodone, oxymorphone 
and others.'' GX 37, at 1. According to the toxicology report, 
oxycodone, oxymorphone, carisoprodol, and meprobamate were found in her 
blood. Id. at 2; GX 31.
    On November 4, 2009, B.A., ``a recovering drug addict'' and 
resident of Morehead, Kentucky, ``went to a doctor in Portsmouth[,] 
Ohio'' and obtained four controlled-substance prescriptions, which he 
then filled at Respondent the same day. GX 38, at 1 & 7. The 
prescriptions were for 60 tablets of Roxicodone 30 mg. (oxycodone), 120 
tablets of oxycodone 15 mg., 180 tablets of Roxicodone 30 mg. 
(oxycodone), and 30 alprazolam 1 mg. Id. at 7.
    B.A. ``went to bed at around 2300-2400 on Thursday November 4[,] 
2009 and was high when he went to bed.'' Id. at 1. He was ``found 
deceased the next morning by his room-mate.'' Id.
    The next morning, a Detective went to B.A.'s trailer and 
interviewed B.A.'s roommate L.R., who reported that B.A. ``appeared to 
be a little high last night before he went to bed'' but because B.A. 
``had not been home all day yesterday * * * he did not know exactly 
what all [B.A.] had done.'' Id. at 4. L.R. further stated that B.A. 
``really didn't seem right,'' that he had been in the bathroom ``for a 
long time,'' that when B.A. went to bed, he was ``snoring really loud'' 
but that when L.R. got up to use the bathroom at about 3:30 a.m., B.A. 
was no longer snoring. Id. at 5.
    The Detective obtained L.R.'s consent to search the premises and 
found a key on B.A.'s car key ring which fit a safe in B.A.'s bedroom. 
Id. at 5. The Detective opened the safe and found six pill bottles, 
including the four prescriptions which B.A. had filled the day before 
at Respondent. Id. at 5-6.
    With respect to these four prescriptions, the Detective found that 
there were no tablets left in the bottle which had contained 60 
Roxicodone 30 mg., there were only fifty-two tablets left in the bottle 
which had contained 120 oxycodone 15 mg., there were only nineteen 
tablets left in the bottle which had contained 180 Roxicodone 30 mg., 
and there were only eight tablets left of the thirty alprazolam. Id. at 
7.
    The Detective also interviewed two persons who had accompanied B.A. 
on his trip to the doctor's office and to Respondent. Id. They stated 
that when B.A. emerged from the doctor's office, he had a `` `mapquest' 
printout'' with directions to Respondent; B.A. told them that the 
doctor's staff had said to fill his prescriptions at Respondent. Id. at 
8.
    Following L.D.C.'s death, Investigators conducted surveillance of 
Respondent during which they observed the license plates of its 
customers to determine where they were coming from. Tr. 592. One of the 
plates was traced to S.P., a resident of Waverly, Ohio. Tr. 593; GX 33. 
The Investigators then obtained an OARRS report on S.P. and prepared a 
spreadsheet listing the prescriptions she filled by date between 
November 6, 2007 and October 30, 2009, the dispensing pharmacy, and the 
prescriber. GX 33.
    The report showed that S.P. had obtained oxycodone from Respondent 
on eighteen occasions during this period using prescriptions she had 
obtained from seven different doctors. See GX 33. Moreover, according 
to the OARRS report, the doctors were located in Waverly, Beavercreek, 
Dayton, Wheelersburg and Portsmouth; two of the Portsmouth doctors 
practiced at different clinics.\29\ Id.
---------------------------------------------------------------------------

    \29\ However, Drs. J.C. and M.G. appeared to have practiced at 
the same Portsmouth address. See GX 33, at 2; GX 38, at 7-8. There 
is, however, no evidence that J.C. and M.G. were at the clinic in 
the same time period.
    In the Immediate Suspension Order, the Government alleged that 
Dr. M.F. was in Lee's Summit, Missouri. ALJ Ex. 8, at 2. On cross-
examination, the DI conceded that the prescription issued by Dr. 
M.F. had indicated that he was in Wheelersburg, Ohio. Tr. 701.
    During cross-examination of the DI, Respondent's counsel also 
suggested that Dr. P.C. was not practicing in Dayton but rather in 
Portsmouth when he wrote the prescriptions for S.P. Id. at 629-31. 
However, the DI said he did not have information that Dr. P.C. was 
practicing in Portsmouth and Respondent produced no evidence 
establishing this as a fact. Id. at 631.
---------------------------------------------------------------------------

    The prescriptions included ones for oxycodone issued by the 
following doctors: (1) On November 6 and December 4, 2007, as well as 
on January 9 and February 14, 2008, by Dr. B.B. of Waverly, Ohio; (2) 
on May 20, June 13 and 23, July 11, August 12, 2008 and January 6, 
2009, by Dr. D.B. of Beavercreek, Ohio; (3) on September 10, October 1 
and 27, and November 27, 2009, by Dr. M.G. of Portsmouth (Medical 
Solutions, L.L.C.); (4) on July 3, 2009, by Dr. J.D. of a different 
Portsmouth clinic (Complete Pain Management, L.L.C.); (5) on September 
1, 2009, by Dr. P.C. of Dayton; (6) on October 1, 2009, by Dr. M.F. of 
Wheelersburg; and (7) on October 30, 2009, by Dr. J.C. of Portsmouth. 
See GX 33. The OARRS Report also contained controlled-substance 
prescriptions written by additional doctors which S.P. filled at other 
pharmacies. See id.
    On November 6, 2009, DEA Investigators conducted an administrative 
inspection of Respondent. Tr. 610, 692. Investigators requested that 
Mr. Fletcher provide Respondent's biennial inventory of its controlled 
substances, but Respondent was unable to do so. Id. at 693-94. The lead 
DI further testified that Mr. Fletcher stated that he was unaware of 
the requirement of maintaining a biennial inventory. Id. at 694.

The Government's Expert Witness

    The Government called Donald Sullivan, R.Ph. and PhD, as its expert 
witness. Dr. Sullivan, who holds active pharmacist licenses in Ohio and 
Florida, obtained a B.S. in Pharmacy from The Ohio State University, as 
well as both an M.S. and PhD in Pharmaceutical Administration, also 
from The Ohio State University. GX 19, at 1; Tr. 922. Between 1997 and 
2006, Dr. Sullivan was an Associate Professor of Pharmacy Practice at 
Ohio Northern University. GX 19, at 1; Tr. 920. Thereafter, Dr. 
Sullivan was appointed to the rank of Full Professor and has been 
Chairman of the Department of Pharmacy at Ohio Northern University for 
the last four years. Tr. 920.
    During graduate school, Dr. Sullivan worked as a Registered 
Pharmacist at both retail and mail order pharmacies. GX 19, at 2; Tr. 
934. He testified that he has worked at ``several different 
independents in the central Ohio area'' and that he currently works 
part-time as a pharmacist for North Central Mental Health. Id. at 934-
35. Dr. Sullivan was offered and accepted as an ``expert witness * * * 
on standard pharmacy

[[Page 66157]]

practice and standards for dispensing controlled substances.'' Id. at 
938.
    Dr. Sullivan testified that the curriculum at pharmacy college 
includes courses in pharmacology and therapeutics, which cover ``the 
actual pharmacology and pathophysiology of drug abuse,'' as well as in 
pharmacy law, which covers the subject of prescription drug abuse and 
prescription drug fraud. Id. at 925. He testified that the American 
Council of Pharmaceutical Education, which accredits schools of 
pharmacy, requires that these subject areas ``be taught.'' Id. at 925-
26. Dr. Sullivan has taught pharmacy law since his time as a teaching 
assistant in graduate school; in addition to his teaching at Ohio 
Northern University, he also teaches pharmacy law in continuing 
education programs and in review classes for the NAPLEX exam. Id. at 
933.
    Dr. Sullivan testified that under both Ohio and Federal law, there 
``is corresponding responsibility between the physician and the 
pharmacist.'' Tr. 939. He further explained that ``[a] lot of 
pharmacists think that just because the physician wrote it, I have to 
fill it.'' Id. However, Dr. Sullivan stated that [t]here is nothing in 
Ohio law that says you have to fill any prescription.'' Id. at 939-40. 
He then explained that ``one of the first things we try to get the 
students and pharmacist to understand is that under Ohio law, and 
federal law * * * 50 percent of the responsibility falls on the 
pharmacy, the pharmacist, 50 percent falls on the physician. Don't just 
fill it because the doctor wrote it.'' Id.
    Similarly, in his report, Dr. Sullivan, after discussing the CSA's 
prescription requirement (21 CFR 1306.04(a)), explained that:

    The State of Ohio has similar language in its laws and 
regulations. Ohio Law states that: The pharmacist who fills any 
prescription has a corresponding responsibility with the physician 
to make sure that the prescription has been issued for a Legitimate 
Medical Purpose. The responsibility to ensure that a prescription is 
for a legitimate medical purpose in the usual course of a 
prescriber's professional practice is equal for both the physician 
and pharmacist. (Fifty percent of this responsibility is on the 
pharmacist and 50% is on the physician). The argument that ``Just 
because a physician wrote the prescription, I can legally fill it'' 
is no excuse.

GX 20, at 1 \30\ (emphasis in original).
---------------------------------------------------------------------------

    \30\ While the Ohio courts may have interpreted State law as 
described above, as explained below, Dr. Sullivan's testimony that 
Federal law allocates fifty percent of the responsibility to the 
physician and fifty percent to the pharmacist is not a correct 
statement of the law, which has been amply explained in numerous 
decisions of the Federal courts and this Agency. To make clear, 
Federal law does not apportion the responsibility for dispensing 
unlawful prescriptions between a prescribing practitioner and a 
pharmacist. Rather, Federal law imposes separate and independent 
duties on the prescriber and the pharmacist.

    More specifically, the prescriber must act within the usual course 
of professional practice and have a legitimate medical purpose to 
lawfully issue a controlled-substance prescription. 21 CFR 1306.04(a). 
As the Supreme Court and numerous Federal courts have made plain, to 
lawfully prescribe a controlled substance the physician must act ``in 
accordance with a standard of medical practice generally recognized and 
accepted in the United States.'' United States v. Moore, 423 U.S. 122, 
138-39 (1975); see also United States v. Smith, 573 F.3d 639, 647-48 
(8th Cir. 2009); United States v. Merrill, 513 F.3d 1293, 1306 (11th 
Cir. 2008).
    By contrast, a ``pharmacist is not required to * * * practice 
medicine.'' United States v. Hayes, 595 F.2d 258, 261 (5th. Cir 1979). 
``What is required of [a pharmacist] is the responsibility not to fill 
an order that purports to be a prescription but is not a prescription 
within the meaning of the statute because he knows [or has reason to 
know] that the issuing practitioner issued it outside the scope of 
medical practice.'' Id. at 261. As the Fifth Circuit has further 
explained, ``a pharmacist can know that prescriptions are issued for no 
legitimate medical purpose without his needing to know anything about 
medical science.'' Id at 261 n.6; see also United States v. Henry, 727 
F.2d 1373, 1379 (5th Cir. 1984) (applying ``reason to believe'' 
standard to pharmacist); United States v. Seeling, 622 F.2d 207, 213 
(6th Cir. 1980) (upholding use of deliberate ignorance instruction in 
prosecution of pharmacist).
    However, Dr. Sullivan's statements that: (1) A pharmacist is not 
required to fill any prescription, and (2) it is not an excuse that 
because a doctor wrote the prescription, it can be legally filled, are 
consistent with Federal law.
    More importantly, Dr. Sullivan testified that a pharmacist is 
``[a]bsolutely'' taught to question the legality of a prescription. Tr. 
940. As examples of prescriptions he had refused to fill, Dr. Sullivan 
noted an instance where a physician had written for a combination of a 
narcotic, a benzodiazepine, a muscle relaxant, and a sleeping pill; 
there were ``similar doses for everybody, [with] no individualization 
of therapy''; and ``maximum doses for everyone.'' Id. at 940-41. Dr. 
Sullivan further testified that when he called the physician to 
determine what was wrong with the patients, ``so we could document 
whether it is for a legitimate purpose,'' the physician never provided 
a ``good answer'' and he ``stopped filling prescriptions for these 
patients.'' Id. at 941.
    Continuing, Dr. Sullivan explained that ``[m]ore is required'' from 
a pharmacist than merely verifying the prescription with the doctor and 
that ``[i]t is still [a pharmacist's] professional judgment to make the 
call * * * is it for a legitimate purpose or not?'' Id. at 942. Dr. 
Sullivan emphasized that ``just because the physician tells [a 
pharmacist] that, yes, it is for a legitimate medical purpose * * * 
[the pharmacist] still ha[s] that 50 percent corresponding liability to 
make [his] own judgment, is that for a legitimate medical purpose or 
not.'' Id.
    Dr. Sullivan testified that there are ``red flags'' which 
pharmacists need to recognize and consider before they dispense a 
prescription. Tr. 936. As examples, he testified that pharmacists are 
``required to do drug utilization review on every prescription * * * 
before it is dispensed in the pharmacy'' to determine whether ``doses * 
* * are too high, duplicate therapy, potential use or misabuse [sic], 
[and prescriptions are] being filled too soon.'' \31\ Id. Additional 
red flags include ``[m]aximum doses being seen for every single 
patient, lack of individuation of therapy, certain patterns from 
physicians of potential abuse of seeing the same types of controlled 
substances over, and over, and over, again.'' Id. at 937. Moreover, 
other red flags involve ``drug interactions [such as] [t]wo drugs being 
used for the same thing, three drugs being used for the same thing, 
three drugs in different classes[ ] that can cause the same side 
effects, such as respiratory [depression] where you might see a 
benzodiazepine, a muscle relaxer, and a narcotic pain killer.'' Id. at 
937.
---------------------------------------------------------------------------

    \31\ According to Dr. Sullivan, as part of the prospective drug 
utilization review, a pharmacist is required to check a patient's 
profile for the following: ``(a) over-utilization or under-
utilization[;] (b) therapeutic duplication[;] (c) drug-disease state 
contraindications[;] (d) drug-drug interactions[;] (e) incorrect 
drug dose or duration of treatment[;] (f) drug-allergy 
interaction[;] (g) abuse/misuse[;] (h) inappropriate duration of 
treatment[; and] (i) documented good/nutritional supplements-drug 
interactions.'' GX 20, at 3-4 (emphasis in original).
---------------------------------------------------------------------------

    On cross-examination, Dr. Sullivan explained that ``[t]here is no 
permanent physical checklist. [A pharmacist] should look for several 
different things, such as number of drugs being prescribed, quantities, 
types of drugs, patient profile, what is going on with that patient's 
drug therapy in the past, because you have to do prospective DUR. Where 
the patient lives, where they are coming from, and even method of 
payment.'' Id. at 993.
    Dr. Sullivan further testified that it is ``[a]bsolutely'' 
important that pharmacists communicate with one another. Tr. 950-51. 
Dr. Sullivan explained that a pharmacist readily ``develop[s] a pretty 
quick informal network among the pharmacists * * * within a five to ten 
mile radius'' of his store because of the need to transfer 
prescriptions and that these informal networks also host such 
discussion as whether there is suspicious prescribing going on in 
various parts of the State. Id. at 951-52. Continuing, he testified 
that if a pharmacist is presented with a

[[Page 66158]]

prescription which another pharmacy had refused to fill, ``there had 
better be a lot of documentation, a lot of conversation with the 
physician, and a very, very good explanation * * * professionally as to 
why that patient needs that prescription filled'' before the pharmacist 
``risk[s] [his] license and fill[s] that prescription.'' Id. at 953.
    Dr. Sullivan explained that were a patient to tell him that another 
pharmacy had refused to fill the prescription, he would first call that 
pharmacist and ask why he refused to fill the prescription and why he 
suspected that the prescription was not ``for a legitimate medical 
purpose.'' Id. Dr. Sullivan also explained that it was ``[a]bsolutely'' 
important that a pharmacist maintain an open line of communication with 
a prescribing physician. Id. at 954.
    Dr. Sullivan reviewed the prescriptions issued to fifty-five 
patients by Dr. Volkman which were filled by Respondent between 
September 13, 2005 and February 9, 2006. Id. at 948, 991, 1011; GX 
20.\32\ He subsequently prepared a report which was submitted into the 
record. GX 20.
---------------------------------------------------------------------------

    \32\ While the ALJ found that ``Dr. Sullivan was provided 55 
prescriptions,'' ALJ at 30, his subsequent testimony made clear that 
he had actually reviewed hundreds of prescriptions. Tr. 1011 
(``There were 55 patients, there were hundreds of prescriptions that 
I looked at.'').
    Respondent's Counsel also took issue with Dr. Sullivan's 
statement that he had reviewed a ``random'' sample. See Tr. 992 
(``So you would agree with me that this isn't really a random 
sample, wouldn't you?''). Dr. Sullivan testified that the sample 
represented ten percent of the prescriptions seized from Respondent 
by DEA and that the selection of that ten percent was ``based on a 
statistical formula'' that he obtained from a statistics Web site 
and had later validated, but he did not include the formula in his 
report. Id. at 992.
    However, it is immaterial whether the sample Dr. Sullivan 
reviewed was randomly selected as Mr. Fletcher's obligation under 21 
CFR 1306.04(a) applies to every prescription he dispensed.
---------------------------------------------------------------------------

    At the outset of his report, Dr. Sullivan observed that ``all these 
patients were from extreme southern Ohio and northern Kentucky'' and 
were ``driving 2+ hours to Columbus to have their prescriptions 
filled.'' Id. at 1. Dr. Sullivan noted that the customers ``would have 
bypassed [dozens of other] pharmacies en route to Columbus.'' Id.; Tr. 
960. Dr. Sullivan opined that ``[t]his would be a major red flag to any 
pharmacist'' and that ``a reasonable pharmacist would seriously 
question why these patients were driving such a long distance to have 
their prescriptions filled.'' GX 20, at 1. At the hearing, Dr. Sullivan 
further explained that according to the Shearing Report, which ``looks 
at why consumers shop at certain community pharmacies,'' in ``at least 
28 out of the last 30 years, the number one reason is proximity to 
where they live.'' Tr. 959. Dr. Sullivan thus observed that ``[t]his 
pattern of patients traveling long distances from the location of their 
home and physician is extremely unusual and very suspicious.'' GX 20, 
at 2.
    In addition, Dr. Sullivan noted that forty of the fifty-five 
patients (73%) had paid cash for their prescriptions'' and that ``the 
national average of cash paying customers for prescriptions [was] 11.4% 
in 2005 and 10% in 2006.'' \33\ Id. Explaining that ``profit margins on 
cash prescriptions are 30% higher than insurance prescriptions for 
brand-name[] drugs and 100% to 500% higher than insurance prescriptions 
for generics,'' he concluded that this ``is an obvious example of a 
pharmacy profiting from drugs that are most likely being abused or 
diverted for sale on the street'' and that ``[a]ny reasonable 
pharmacist knows that a patient that wants to pay cash for a large 
quantity of controlled substances is immediately suspect.'' Id.
---------------------------------------------------------------------------

    \33\ The ALJ found that Dr. Sullivan ``credibly'' testified that 
``nationwide[ ] only 10% of prescriptions [are] paid for in cash.'' 
ALJ at 31 (citing Tr. 961). Dr. Sullivan further testified that IMS 
Health, ``the number one data collection firm for basically all 
prescription drug prescribing, dispensing, and pricing,'' was the 
source of this data. Tr. 961.
---------------------------------------------------------------------------

    In his report, Dr. Sullivan stated that in all of his ``years of 
practice and teaching, I have never seen such an abuse of controlled 
substances dispensing by one pharmacy, especially in schedule II 
controlled substances.'' \34\ GX 20, at 1. Dr. Sullivan also found 
``extremely surprising the volume of controlled substances this one 
doctor [wrote], especially for schedule II drugs.'' GX 20, at 1-2. 
According to Dr. Sullivan, this ``should have been a major red flag for 
any reasonable pharmacist that this physician is nothing more than a 
controlled substance prescription mill for patients who are diverting 
and abusing narcotic drugs.'' Id. at 2.
---------------------------------------------------------------------------

    \34\ In his testimony, Dr. Sullivan elaborated that he had 
``almost never seen'' cases where physicians were ``abusing the 
prescribing of controlled substances'' by issuing prescriptions for 
schedule II drugs and that most cases typically involved schedule 
III and IV drugs. Tr. 955-56. On cross-examination, Dr. Sullivan 
admitted that he had probably not filled a pain medication 
prescription in approximately twelve years, id. at 977, and that 
this report represented his first determination that ``a pharmacy is 
abusing controlled substances.'' Id. at 990. However, he had 
previously filled ``probably 1,000'' prescriptions for oxycodone and 
thousands of prescriptions for alprazolam. Id. at 980-981.
---------------------------------------------------------------------------

    Dr. Sullivan further observed that ``75% of the [Volkman] patients 
received the same four drug cocktail, which included a benzodiazepine, 
two narcotic pain killers and Soma (a muscle relaxer known to be highly 
abused).'' Id. at 3. According to Dr. Sullivan, ``[i]t is well known in 
the pharmacy profession [that] the combination of a benzodiazepine, 
narcotic pain killer, and Soma [is] being used by patients abusing 
prescription drugs.'' Id. Dr. Sullivan then noted that Dr. Volkman 
``took this to another level by prescribing two narcotic pain killers 
at the same time.'' Id.
    In his testimony, Dr. Sullivan explained that pharmacists refer to 
the combination of ``the benzodiazepine, the narcotic * * * pain 
killer, and the sleeping pill'' as ``[t]he triple,'' and that when Soma 
(carisoprodol) is added, the combination is known as the ``homerun.'' 
Tr. 956. Noting that Volkman was issuing duplicate prescriptions for 
schedule II narcotics, Dr. Sullivan testified that he had never seen 
two schedule II narcotics prescribed together other than for treatment 
of cancer or hospice patients. Id. at 956-57, 1027-28.\35\ He further 
observed that ``41 of the 55 [patients] (75%) received two narcotic 
pain killers on the same day,'' and that this happened ``68 different 
times for these 41 patients.'' GX 20, at 3. He then reiterated that 
``[t]o have two schedule II controlled substances, or two narcotics, a 
schedule II, and a schedule III * * * like * * * a Vicodin * * * or a 
Lortab * * * combined together * * * was something [he] had never seen 
to this extent before these prescriptions.'' Id. at 957.
---------------------------------------------------------------------------

    \35\ When asked on cross-examination if he knew what break-
through pain is and whether he was aware that Dr. Volkman 
``practiced pain break-through type treatment,'' Dr. Sullivan 
explained that there is no such separate specialty in pain 
management and that this ``is when a patient is on a dose of 
medication, and they are having flare-ups in pain, then another drug 
is given to help on a temporary acute basis to take care of that 
pain flare.'' Tr. 1027. He further stated that such treatment 
regimens were sometimes seen ``in hospice patients and cancer 
patients.'' Id. at 1028. Respondent did not establish that Volkman 
was legitimately prescribing multiple drugs for this purpose.
---------------------------------------------------------------------------

    Noting that a pharmacist's primary obligation is to take care of 
the patient, Dr. Sullivan stated that if he saw two prescriptions for 
two narcotic pain killers for one patient, he would worry about the 
potential central nervous system (CNS) effects or ``the respiratory 
depression that might occur with this patient.'' Id. at 957. Observing 
that ``a lot of these drugs'' have a ``synergistic effect on 
respiratory depression,'' he explained that ``[i]t is not two narcotics 
equal twice the respiratory depression, it is one plus one equals three 
or four times the respiratory depression.'' Id. Moreover, when a 
benzodiazepine and a muscle relaxant are added ``on top of that,'' 
there is a concern as to whether ``the patient

[[Page 66159]]

[is] going to be able to safely take these medications together.'' Id. 
He then testified that looking at the quantities, doses, and that 
multiple drugs were being prescribed for a single patient, he would ask 
himself ``how could this possibly be for a legitimate medical 
purpose.'' Tr. 958.
    In his report, Dr. Sullivan further noted that there were three 
patients who ``received three narcotic pain killers on the same day'' 
and that ``[t]here is no logical reason why the patient would be on two 
or three narcotic pain killers at the same time.'' GX 20, at 3. 
Continuing, he explained that this is ``a major red flag'' which is 
strongly suggestive of abuse and that ``[n]o reasonable pharmacist 
would fill two or three of these prescriptions on the same day.'' Id. 
See also id. at 5 (discussing M.C., who on the same day received 
prescriptions for Percocet 10/325, Norco 10/325,\36\ and oxycodone 30 
mg.).
---------------------------------------------------------------------------

    \36\ Norco is a brand name drug containing hydrocodone 
bitartrate and acetaminophen, and a schedule III controlled 
substance pursuant to 21 CFR 1308.13(e)(1). ALJ Ex. 5, at 2.
---------------------------------------------------------------------------

    With regard to the narcotic pain killers Respondent dispensed, Dr. 
Sullivan explained that the ``normal dose of oxycodone'' is ``5 mg. to 
10 mg. every four hours,'' but that ``80% of the patients in the sample 
were prescribed 15 mg. to 60 mg. every two or three hours.'' GX 20, at 
4. Dr. Sullivan explained that ``a reasonable pharmacist would 
recognize this as a problem and a marker of drug abuse and addiction.'' 
Id.
    As to the prescriptions for schedule III hydrocodone/apap drugs, 
Dr. Sullivan noted that ``100% (89/89) were for the highest strength 
available, which is 10 mg. of hydrocodone.'' Id. Observing that it was 
``clinically impossible that all the patients in the sample would 
always need the highest possible dose of hydrocodone with 
acetaminophen,'' Dr. Sullivan thus concluded that there was ``no 
individualization of dosing based on pain in these patients, which 
should have been a major red flag for any pharmacist.'' Id. Moreover, 
``[a]ny pharmacist would have known that this was a problem and a 
strong indicator of a doctor operating a controlled substance 
prescribing mill.'' Id.\37\
---------------------------------------------------------------------------

    \37\ Dr. Sullivan also observed that ``[m]any of the narcotic 
prescriptions had the words `severe LBP' on them,'' which ``most 
likely stands for `Severe Low Back Pain.' '' GX 20, at 5. Explaining 
that ``[l]ower back pain is viewed in the medical field as the 
`biggest scam to obtain controlled substances' because it is the 
hardest to disprove due to the lack of definitive clinical 
measures,'' he reported that ``[i]t is very unusual that all these 
patients had the same diagnosis and they all had to be on the 
maximum doses of these controlled substances including Soma.'' Id.
---------------------------------------------------------------------------

    With respect to the Xanax (alprazolam) prescriptions, ``one of the 
most highly abused benzodiazepines on the market'' and a drug ``in high 
demand on the street,'' Dr. Sullivan observed that all sixty 
prescriptions were for the maximum strength of the drug. Id. Moreover, 
ninety-three percent of the prescriptions ``exceeded the FDA approved 
maximum daily dosage of 4 mg. per day'' and thirty-two percent 
``exceeded the FDA approved dosing schedule of three times a day.'' Id. 
At the hearing, Dr. Sullivan explained that Xanax 2 mg. is generally 
only prescribed to patients with post-traumatic stress disorder. Tr. 
970.
    Again, Dr. Sullivan noted that there was ``no individualization of 
therapy'' and that ``[e]very patient was prescribed the same strength 
at extremely high doses.'' GX 20, at 4. He further opined that ``[a]ny 
pharmacist would have known that this was a problem and a strong 
indicator of a doctor operating a controlled substance prescribing 
mill.'' Id.
    With regard to the Valium (diazepam), which is also ``a highly 
abused benzodiazepine in high demand on the street,'' Dr. Sullivan 
noted that all of the forty-two prescriptions he reviewed were for the 
highest strength available, 10 mg. GX 20, at 4. He then noted that 
Patient K.D. ``was prescribed Valium 20 mg. at bedtime, twice the 
maximum dose,'' and ``[a]t least 50% of the prescriptions were written 
for a maximum dose of four times daily.'' Id. at 5. Dr. Sullivan again 
explained that ``[a]ny pharmacist would have known that this was a 
problem and a strong indicator of a doctor operating a controlled 
substance prescribing mill.'' Id.
    After noting that over the period of September 2005 through January 
2006, Dr. Volkman ``seemed to be writ[ing] larger doses and higher 
quantities as time went on'' and that this was ``definitely a sign of 
drug abuse'' which ``a reasonable pharmacist \38\ would have caught,'' 
Dr. Sullivan discussed ``a few of the most blatant examples of abuse 
and diversion.'' Id. These included instances in which Respondent 
provided early refills such as for L.B., who on December 28, 2005, 
received a Xanax prescription two weeks early; and S.K., who, on 
September 13, 2005, received a prescription for 240 tablets of 
oxycodone 15 mg., with eight tablets to be taken per day (thus being a 
thirty-day supply), and who, one week later, obtained an additional 168 
tablets of the same drug. Id. at 5-6. Moreover, M.P. filled two 
prescriptions for Percocet 5/325 on the same day, and L.A.T. filled two 
prescriptions for oxycodone on the same day. Id. at 6.
---------------------------------------------------------------------------

    \38\ On cross-examination Dr. Sullivan elaborated that ``a 
reasonable pharmacist'' is ``[a] pharmacist who looks out for the 
best interest of their patients, takes care of their patients, 
within the legal requirements of the law.'' Tr. 1025.
---------------------------------------------------------------------------

    Dr. Sullivan further observed that J.C. had received a prescription 
for 720 tablets of oxycodone 15 mg. with a dosing of two tablets every 
two hours (or twenty-four tablets per day), as well as for twelve 
tablets per day of hydrocodone/apap 10 mg./325 mg.; according to Dr. 
Sullivan, ``[n]o patient could take this much narcotic in one day and 
not overdose.'' Id. at 5. He also noted that M.C. had received three 
different narcotics on the same day including 180 Percocet 10/325, 180 
Norco 10/325, and 240 oxycodone 30 mg., and observed that ``[a]t these 
doses[,] this patient [was] taking 300 mg. of oxycodone per day along 
with 60 mg. of hydrocodone'' and that ``[n]o patient could take this 
much narcotic in one day and not overdose.'' Id. Finally, with respect 
to J.C. (a resident of Grayson, Ky.) and M.C. (a resident of Flatwoods, 
Ky.), Dr. Sullivan explained that ``[a] reasonable pharmacist would 
notice [the amounts being taken] as a problem'' and that the amounts 
were a marker of drug abuse or diversion such that a reasonable 
pharmacist would not have filled the prescriptions. Id.
    Dr. Sullivan concluded his report as follows:

    A pharmacist might act in the best interest of the patient and 
fill an occasion[al] prescription for a high dose or large quantity. 
However, the evidence presented above is overwhelming and shows a 
pattern of dispensing controlled substances to patients who are 
known drug abusers \39\ or are diverting prescription drugs for 
illegal purposes. There are dozens of patients with the same drugs 
on their profile[s] and all at maximum doses and beyond. There is no 
medically sound reason why patients should be treated with two or 
three drugs in the same class for the same thing as these patients 
are. Any reasonable pharmacist would notice this as a problem very 
quickly and easily. In addition, these drugs when combined cause CNS 
(central nervous system) depression and can easily lead to overdose. 
Any reasonable pharmacist would recognize this danger and would not 
dispense these medications (duplicate therapy) together. These are 
all textbook examples of drug abuse and/or drug diversion. Any 
reasonable pharmacist would quickly recognize this based on their 
education and training. In all my years of practicing and teaching, 
I have never seen such an abuse of controlled substance

[[Page 66160]]

dispensing by one pharmacy, especially in schedule II controlled 
substances.
---------------------------------------------------------------------------

    \39\ On cross-examination, Dr. Sullivan clarified that he 
described the patients as ``known drug abusers'' because ``[t]hat is 
my professional opinion based on what I saw in the prescriptions.'' 
Tr. 1032-33.

---------------------------------------------------------------------------
Id. at 6.

    On cross-examination, Dr. Sullivan conceded that he ``would not 
have turn[ed] away every one of'' the customers whose prescriptions 
were reviewed in his report but that after he had ``seen a pattern,'' 
he ``would have started to make phone calls and then started to not 
fill them.'' Tr. 1009. Moreover, ``based on the large quantities'' and 
``the safety of the patient,'' there were some prescriptions, including 
those ``for three narcotic pain killers'' that he ``would not have 
filled'' at all. Id. at 1010. Dr. Sullivan further explained that in 
determining which prescriptions he would have filled, he would ``had to 
have looked at the patient history, and [considered] the conversation 
of the physician.'' Id. at 1011. Clarifying his testimony, Dr. Sullivan 
explained that while it might have required time to detect a pattern 
with respect to some of the prescriptions, others should not have been 
filled at all ``just looking blatantly at the doses, the combinations, 
that would have been, definitely, harmful to that patient, taking those 
drugs in those doses.'' Id. at 1012-13. Dr. Sullivan then explained 
that part of the reason for his equivocation with respect to whether he 
would have filled some of the prescriptions is that when he reviewed 
them, he did not ``know how long [Mr. Fletcher] had been treating those 
patients.'' Id. at 1013.
    Dr. Sullivan also acknowledged that he does not have actual 
knowledge of whether the Volkman patients were abusing or diverting the 
drugs. Id. at 1019. However, he reiterated his opinion that based on 
the quantities and doses that Volkman was prescribing, the drugs were 
either being abused or diverted because the patients would be dead if 
they took the amounts that were prescribed. Id. at 1032. Notably, the 
ALJ found that Dr. Sullivan ``rationally and credibly concluded that 
these patients abused the drugs, diverted the drugs, or [if they had] 
consumed them * * * would be dead.'' ALJ at 35 (citing Tr. 1032); Tr. 
1019.

The State Board Proceeding

    On March 5, 2009, the Ohio State Board of Pharmacy (Board) found 
that on three occasions between August 29, 2006 and November 27, 2007, 
deliveries of controlled substances were made to Respondent when a 
pharmacist was not on duty and that the drugs were not properly 
secured. GX 16, at 2-3 & 4; Tr. 1066. In the first instance, the 
delivery was placed in a hallway closet outside of Respondent; in both 
the second and third instances, the drugs were placed in a pharmacy 
technician's automobile, which was parked in Respondent's parking lot. 
GX 16, at 2. Based on these incidents, the Board found that Respondent 
violated Ohio law. Id. at 2-3 (citing Ohio Rev. Code Sec.  4729.55). 
The Board fined Respondent $1,000.00, id. at 3, and Mr. Fletcher 
$1,500.00. Tr. 1073. In addition, the Board placed Mr. Fletcher's 
pharmacist's license on probation for two years and suspended it for 
twelve weeks, but then waived ten weeks of the suspension.\40\ Tr. 
1074. According to the Board's Order in the case against Respondent, it 
had the right to appeal to the State courts. GX 16, at 3.
---------------------------------------------------------------------------

    \40\ Regarding the Ohio Board proceedings, the ALJ allowed 
Respondent to elicit the testimony of Barton Kaderly, who had 
previously been a citizen member of the Board; Mr. Kaderly testified 
as to his being ``appalled'' over the decision of his fellow board 
members to fine Respondent and Mr. Fletcher. Tr. 1064, 1074-75. 
Beyond the fact that Mr. Kaderly's personal opinion is irrelevant 
and should have been excluded, the ALJ apparently forgot that DEA 
has held that a registrant cannot collaterally attack the results of 
a State board proceeding in proceedings under 21 U.S.C. 823 & 824. 
See Hicham K. Riba, 73 FR 75773, 75774 (2008). I therefore give no 
weight to his testimony.
---------------------------------------------------------------------------

Respondent's Evidence

    Respondent called fifteen witnesses, half of whom testified 
regarding the Government's various excursions into such issues as the 
character of the neighborhood, Mr. Fletcher's practice of carrying a 
gun at work, and his prices. Having concluded that the character of the 
neighborhood and Mr. Fletcher's carrying of a gun are not relevant in 
assessing his compliance with 21 CFR 1306.04(a) and that the Government 
has not proved with substantial evidence that Respondent charged higher 
prices than similar pharmacies, it is not necessary to discuss the 
testimony of those witnesses Respondent called to refute these 
contentions.\41\ Accordingly, only four witnesses offered testimony 
arguably relevant to the issues in this proceeding.
---------------------------------------------------------------------------

    \41\ These witnesses include Ms. Adkins, Ms. Berring, Mr. 
Gordon, Mr. Cates, Dr. Will, Mr. Macke, and Mr. Kimbler. I have, 
however, considered the testimony of these individuals (as well as 
that of Ms. Banks and Ms. Del Guzzo) to the extent they testified as 
to Mr. Fletcher's reputation and character.
     As previously discussed, I have considered the testimony of Mr. 
Newman, Respondent's CPA, in making my findings regarding 
Respondent's structuring activities as well as that of Mr. Kaderly.
---------------------------------------------------------------------------

    Mark Aalyson testified that he had practiced law in Portsmouth, 
Ohio, that his ``practice was devoted exclusively'' to representing 
injured workers before the Industrial Commission of Ohio, and that he 
knew most of the doctors who practiced in Scioto County. Tr. 1156. Mr. 
Aalyson testified that in the ``early fall of 2006,'' Mr. Fletcher 
called him and asked whether he ``had ever heard of a Dr. Paul 
Volkman.'' \42\ Id. According to Mr. Aaylson, Mr. Fletcher told him 
that he was getting patients from the Scioto County area who were 
getting prescriptions for pain medication from Dr. Volkman. Id. at 
1157. Mr. Aalyson testified that he told Mr. Fletcher that he did not 
know who Volkman was and was ``not sure how long he has been around.'' 
Id. at 1158-59. Mr. Aalyson then asked Mr. Fletcher ``what is the 
problem?'' Id. Mr. Fletcher answered: ``I'm getting a lot of people 
coming in, and I'm beginning to wonder if the guy is legitimate.'' Id. 
at 1159.
---------------------------------------------------------------------------

    \42\ Respondent's counsel asked Mr. Aalyson six times when this 
conversation occurred, going so far as to suggest that ``you are not 
sure of the year, you don't have a telephone record, or anything, to 
show what year it would have been, it could have been 2005?'' See 
Tr. 1156, 1166. While Mr. Aalyson answered this last question: ``I 
can't remember, I'm sorry,'' he had previously testified repeatedly 
that the conversation had occurred around the time he entered into 
the agreement by which he sold his law practice and that this 
happened in October 2006. Tr. 1156, 1166.
    .
---------------------------------------------------------------------------

    Julie Fuller worked as a sales representative for AmeriSource 
Bergen, a major drug distributor, from December 2003 until January 
2007. Tr. 1550. She testified that during her visits to Respondent, she 
saw Mr. Fletcher check for early refills and for drug interactions. Id. 
at 1567-68. However, she acknowledged that the purpose of her visits 
was not ``to observe him'' in the practice of pharmacy but to get his 
business. Id. at 1584. Moreover, Ms. Fuller testified that she believed 
that Respondent closed at 6 p.m. and that her visits occurred 
``[s]omewhere between 10 and 5,'' Tr. 1582; she did not testify that 
she observed Mr. Fletcher filling any of Dr. Volkman's controlled-
substance prescriptions. Her testimony is therefore of no probative 
value.
    Respondent also called Mr. Fletcher's cousin, Carisa Cole, who 
worked at Respondent between December 2004 and October 2009. Id. at 
1704-05. In her testimony, Ms. Cole maintained that she never saw 
anyone who appeared under the influence of either drugs or alcohol and 
that Mr. Fletcher would not serve persons who appeared under the 
influence (although it is not clear how she would know that Mr. 
Fletcher would not serve such persons if she never saw any one who 
appeared under the influence). Id. at 1708. However, on cross-
examination, she testified that she could not recall that any of the 
patients Mr. Fletcher refused to dispense to for this reason were 
patients of Dr.

[[Page 66161]]

Volkman. Id. at 1741. She also stated that he turned away a person who 
presented a prescription issued by a Florida-based doctor but could not 
recall when this happened. Id. at 1712. Finally, she testified that he 
also sometimes turned people away because they did not have a photo ID. 
Id. at 1747.
    Ms. Cole maintained that she was present when Dr. Volkman's 
patients came to the pharmacy and that ``a lot of them complained of 
having blood taken too often'' to ``make sure that they were actually 
taking their medication.'' Id. at 1713. She also testified that while 
Respondent's hours were ``until 5:30,'' ``[t]here were a few times'' 
that Mr. Fletcher would stay open later because he knew that Volkman's 
patients were coming. Id. at 1716, 1720. However, Ms. Cole never talked 
with either Dr. Volkman or his security guard. Id. at 1721.
    On cross-examination, Ms. Cole stated that she would typically 
leave Respondent at ``[a]bout 5:30,'' but that sometimes she would stay 
past 5:30 two or three times per week for the Volkman patients, and had 
stayed as late as 9:30 for a Volkman patient. Id. at 1733. However, she 
acknowledged that she would not typically be at the pharmacy after nine 
o'clock because she has ``three children'' and ``child care issues.'' 
Id. at 1743-44. Moreover, she did not work at Respondent on Saturdays. 
Id. at 1740.
    Ms. Cole acknowledged that Volkman's patients were typically not 
from the Columbus area and were coming from Portsmouth and Southern 
Ohio, as well as Kentucky and West Virginia. Id. at 1723. Ms. Cole also 
stated that Mr. Fletcher had asked these patients why they were filling 
their prescriptions at his pharmacy and that the patients had stated 
that other pharmacies did not have the medication or had run out. Id. 
at 1724. When then asked whether she knew if Mr. Fletcher had ever 
asked the patients ``why they never filled their prescriptions at any 
pharmacies in between Portsmouth and Columbus,'' she answered that she 
did not know if there were any pharmacies between these cities even 
though she acknowledged that it was a two hour drive. Id. at 1726-27.
    Ms. Cole also maintained that Mr. Fletcher had tried calling some 
of the pharmacies but then acknowledged that she was ``not real sure'' 
if she was present when any of these calls were made. Id. at 1725. 
Moreover, as found above, during an interview with a DEA Investigator, 
Mr. Fletcher stated that he did not call other pharmacies regarding the 
Volkman prescriptions. Id.
    Ms. Cole also acknowledged that the Volkman prescriptions would 
include at least one schedule II drug, that being oxycodone, which 
would be prescribed in combination with Soma and alprazolam. Id. at 
1732. She further acknowledged that Volkman patients would typically 
present their prescriptions at the same time and that they ``typically 
had the same prescriptions.'' Id. at 1736.
    Subsequently, Ms. Cole testified that ``every time we got a 
prescription from Florida, or anywhere out of the State of Ohio, [or] 
even within the State of Ohio [but from outside of Columbus] * * * that 
we would call and verify the prescriptions,'' which Ms. Cole stated, 
would be done on ``[t]he business line.'' Tr. 1747-48, 1753. Ms. Cole's 
recollection is patently erroneous as shown by the evidence that 
Respondent filled 4,900 controlled-substance prescriptions for 
Volkman's patients and the phone records Respondent submitted, which 
establish that during the five-month period in which it filled 
Volkman's prescriptions, it never made more than ninety-seven long 
distance phone calls in a month.\43\ See RX 19. Ms. Cole also testified 
that she remembered D.S. (who had sponsored A.S.) bringing other people 
to Respondent to have her prescriptions filled. Tr. 1757.
---------------------------------------------------------------------------

    \43\ This also assumes that every single phone call was made to 
Dr. Volkman even though Respondent's phone bills show calls to 
numerous cities in Ohio where there is no evidence that Volkman 
worked or lived, as well as to cities in other States.
---------------------------------------------------------------------------

    Ms. Cole further testified that Mr. Fletcher questioned those 
persons who obtained controlled-substance prescriptions from Florida 
doctors, and that they claimed that they had recently moved to either 
Kentucky or Ohio or were working in Columbus and couldn't go home. Id. 
at 1749. Ms. Cole stated that she was ``skeptical'' of the people 
presenting these prescriptions because of the distances involved. Id. 
With the exception of her testimony as to her skepticism, the remainder 
of this testimony is absurd on its face--if a person had in fact 
recently moved to Kentucky or Southern Ohio, this fact would have been 
verifiable by simply looking at his/her driver's license as Ms. Cole 
claimed Mr. Fletcher always did. Moreover, if a person had recently 
moved to these areas, one must wonder how they would find out so 
quickly that only Respondent would fill their prescriptions. As for 
those persons who claimed they were working in Columbus and could not 
go home, it is odd that they could travel to South Florida to obtain 
the prescriptions in the first place.
    Respondent also called Catherine Smith, who worked as a pharmacy 
technician at Respondent and who considered Mr. Fletcher to be her 
``best friend.'' Id. at 1235.\44\ Ms. Smith testified that her duties 
involved a variety of functions including working at the front window 
and ``talk[ing] to [the] patients,'' ``look[ing] at prescriptions,'' 
and also ``fill[ing] prescriptions.'' Id. Ms. Smith testified that she 
saw the prescriptions ``first,'' and that if one did not ``look legit'' 
(meaning forged), she would ``present it to Mr. Fletcher.'' Id. at 
1425. Ms. Smith also testified that she was the person who ``counted 
the medicine'' and ``put [it] in a bottle'' and that she ``explained it 
to the patients.'' Id. at 1429-30. According to Ms. Smith, Mr. Fletcher 
would enter the prescription information into the pharmacy computer and 
print out the labels. Id. at 1430.
---------------------------------------------------------------------------

    \44\ Ms. Smith testified that she did not work Saturdays and 
that only Mr. Fletcher worked then. Tr. 1240.
---------------------------------------------------------------------------

    Ms. Smith further maintained that if a patient did not seem right 
to her, she would mention it to Mr. Fletcher, who would then question 
the patient and not fill the script if the patient was showing symptoms 
of being under the influence. Id. at 1238. She also claimed that Mr. 
Fletcher would ask Respondent's customers why they were taking the pain 
medicine; he would also tell the patients ``this is a large quantity of 
pills you are taking here'' and ask them ``can you work without the 
medicine?'' Id. at 1253-54. Ms. Smith further maintained that Mr. 
Fletcher would tell the patients ``be careful of the way you take it, 
take it the way you are supposed to take it, the way they prescribe 
it'' and that he would ``tell them some of the cautions to take with 
it.'' Id. at 1254. She maintained that Mr. Fletcher ``talked to 
everybody about their prescriptions.'' Id. at 1281.
    On cross-examination, however, Ms. Smith then qualified her 
testimony, stating: ``I'm not saying he talks to everybody, but the 
majority of them * * * that is on that kind of pain medicine.'' Id. at 
1423. Moreover, when DEA Investigators interviewed numerous patients of 
Dr. Volkman, most of them stated that Mr. Fletcher did not ask about 
their medical conditions. GX 9, at 86; see also GX 23, at 3 (affidavit 
of L.W., ``When having prescriptions filled at [Respondent], most of 
the time I spoke with Eugene's assistants but I did speak with Eugene 
several times also. When we spoke together, Eugene never asked me about 
my medical

[[Page 66162]]

condition but would just make small talk.'').
    Ms. Smith also maintained that Mr. Fletcher would call the doctors 
``and make sure that the script is legit.'' Id. at 1264. However, while 
Mr. Fletcher may have spoken with Dr. Volkman on some occasions, 
according to Volkman's former security guard, the majority of the calls 
Mr. Fletcher made to Volkman's office ``were to determine how late he 
should stay open to fill Dr. Volkman's prescriptions.'' GX 22, at 1-2. 
Moreover, in the calls the security guard answered, ``Eugene never 
asked about the medical condition of any patients and I never recall 
hearing any other staff members discuss with Eugene any patient's 
medical condition or anything else other than to arrange pharmacy 
hours.'' Id. at 3. And as noted above, Respondent's phone records 
suggest that Respondent filled numerous prescriptions without calling 
Dr. Volkman.\45\ Moreover, neither Ms. Smith nor Ms. Cole testified as 
to any specific instances in which Mr. Fletcher had refused to fill 
prescriptions presented by Volkman's patients on the ground that the 
prescriptions lacked a legitimate medical purpose.\46\
---------------------------------------------------------------------------

    \45\ Respondent also asked Ms. Smith, who formerly held a 
license as a registered nurse, a series of questions about the 
proper dosing of pain medications. Tr. 1279-80. Ms. Smith has not, 
however, maintained her license and did not testify as to having any 
expertise in the treatment of chronic pain patients. Id. at 1280.
    \46\ It is acknowledged that the ALJ found that Ms. Cole 
credibly testified that Mr. Fletcher refused to fill a prescription 
for a patient because the ``patient may have been trying to fill a 
schedule II prescription too early.'' ALJ at 20 (quoting Tr. 1737). 
She did not, however, recall the name of the patient, and her 
testimony suggests that this was a one-time occurrence as she did 
not assert that this had happened on more than one occasion. Tr. 
1737. Most significantly, she did not testify that he refused to 
fill the prescription because it lacked a legitimate medical purpose 
and the great weight of the evidence (including the volume of 
prescriptions, the type and quantity of the drugs, and Mr. 
Fletcher's statements to Investigators), supports the conclusion 
that he never refused to fill a prescription issued by Volkman 
because it lacked a legitimate medical purpose.
---------------------------------------------------------------------------

    Finally, notwithstanding the substantial probative evidence offered 
against him, Mr. Fletcher did not testify in this proceeding.

Discussion

    Section 304(a) of the Controlled Substances 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 [its] 
registration under section 823 of this title inconsistent with the 
public interest as determined under such section.'' 21 U.S.C. 
824(a)(4). In determining the public interest in the case of a 
practitioner, the Act directs that the following factors be considered:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing * * * 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. Sec.  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 registrant has committed acts 
which render its registration inconsistent with the public interest. 
Id. Moreover, it is well settled 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).
    The Government has the burden of proving by a preponderance of the 
evidence that the Respondent has committed acts which render its 
registration inconsistent with the public interest. 21 CFR 1301.44(d) & 
(e). However, where the Government has made out a prima facie case, the 
burden shifts to the Respondent to either refute the Government's case 
or to `` `present[] sufficient mitigating evidence' '' to show why, 
notwithstanding that it has committed acts which render its 
registration inconsistent with the public interest, it can be entrusted 
with a new registration. Medicine Shoppe-Jonesborough, 73 FR 364, 387 
(2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting 
Leo R. Miller, 53 FR 21931, 21932 (1988))), pet. for rev. denied, 
Medicine Shoppe-Jonesborough v. DEA, 2008 WL 4899525 (6th Cir.). 
``Moreover, because `past performance is the best predictor of future 
performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), 
[DEA] has repeatedly held that where a registrant has committed acts 
inconsistent with the public interest, the registrant must accept 
responsibility for [his] actions and demonstrate that [he] will not 
engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; see also 
Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); 
Cuong Trong Tran, 63 FR 64280, 62483 (1998); Prince George Daniels, 60 
FR 62884, 62887 (1995).
    Having considered all of the factors, I conclude that the evidence 
pertinent to factors two and four makes out a prima facie showing that 
Respondent ``has committed such acts as would render [its] registration 
* * * inconsistent with the public interest.'' \47\ 21 U.S.C. 
824(a)(4). I further conclude that Respondent has not rebutted the 
Government's prima facie case. Accordingly, I affirm the order of 
immediate suspension.\48\
---------------------------------------------------------------------------

    \47\ As to factor one, the Ohio Board of Pharmacy has not made a 
recommendation in this matter. See 21 U.S.C. 823(f)(1). Moreover, 
while there is no evidence that the State Board has revoked either 
Respondent's or Mr. Fletcher's license, DEA has held repeatedly that 
a registrant's possession of a valid State license is not 
dispositive of the public interest inquiry. See Patrick W. Stodola, 
74 FR 20727, 20730 n.16 (2009); Robert A. Leslie, 68 FR at 15230. As 
DEA has long held, ``the Controlled Substances Act requires that the 
Administrator * * * make an independent determination as to whether 
the granting of controlled substances privileges would be in the 
public interest.'' Mortimer Levin, 57 FR 8680, 8681 (1992).
     It is likewise noted that there is no evidence that either 
Respondent or Mr. Fletcher has been convicted of any offenses under 
Federal or State laws related to the distribution or dispensing of 
controlled substances. 21 U.S.C. 823(f)(3). However, there are 
multiple reasons why even serious misconduct may not be the subject 
of a criminal prosecution. Thus, DEA has recognized that the lack of 
any criminal convictions related to controlled substances is not 
dispositive. See Edmund Chein, 72 FR 6580, 6593 n.22 (2007).
     Accordingly, that Respondent may still hold its Ohio pharmacy 
license and that neither it, nor Mr. Fletcher, has been convicted of 
a criminal offense is not dispositive.
    \48\ While Respondent allowed his registration to expire and has 
not submitted a renewal application, there is no evidence that Mr. 
Fletcher has surrendered Respondent's pharmacy license and his 
pharmacist's license, and neither party argues that this case is 
moot. Moreover, Respondent's registration was immediately suspended 
at which time its controlled substances were seized. Under the CSA, 
``[a]ll right, title, and interest in'' any controlled substances 
seized pursuant to a suspension order ``vest in the United States 
upon a revocation order becoming final'' and ``shall be forfeited to 
the United States.'' 21 U.S.C. 824(f). DEA has previously held that 
``a litigant cannot defeat the effect of this provision by simply 
allowing its registration to expire.'' Meetinghouse Community 
Pharmacy, Inc., 784 FR 10073, 10074 n.5 (2009). Accordingly, there 
are collateral consequences which preclude a finding of mootness. 
See id.; Trinity Health Care Corp., 72 FR 30849, 30853-54 (2007).
---------------------------------------------------------------------------

Factors Two and Four--Respondent's Experience in Dispensing Controlled 
Substances and Compliance With Applicable Laws Relating to Controlled 
Substances

    Under a longstanding DEA 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

[[Page 66163]]

practice.'' 21 CFR 1306.04(a). This 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 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.'' \49\ Id.
---------------------------------------------------------------------------

    \49\ 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)).
---------------------------------------------------------------------------

    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.' '' Medicine Shoppe-
Jonesborough, 73 FR at 381 (quoting 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).
    Respondent contends that ``[t]he [G]overnment can point to no 
specific violation of a known rule, but merely relies upon the general 
and vague allegation that Respondent did not satisfy a `corresponding 
duty' to ensure that [it] dispenses controlled substances for a 
legitimate medical purpose.'' Resp. Exceptions, at 1. It further 
contends that it ``has been held to an unknown and ambiguous standard, 
[which is] higher than any standard previously imposed on any 
pharmacist.'' Id. at 6. Contrary to Respondent's contention, the 
Federal courts have had little problem applying the regulation and long 
ago expressly rejected the argument that the regulation is 
unconstitutionally vague and does not provide fair notice of what 
conduct is prohibited. See, e.g., United States v. Hayes, 595 F.2d 258, 
260 (5th Cir. 1979) (``The regulation gives fair notice that certain 
conduct is proscribed.'') (int. quotations and citations omitted).
    Most significantly, the great weight of the evidence establishes 
that Mr. Fletcher filled numerous controlled-substance prescriptions 
which he had reason to know were not issued for a legitimate medical 
purpose by a practitioner acting in the usual course of professional 
practice. Indeed, Mr. Fletcher knew from the outset that Dr. Volkman's 
prescriptions lacked a legitimate medical purpose. As found above, Mr. 
Fletcher was specifically asked in a phone call by one of Dr. Volkman's 
patients if he would fill prescriptions written by Volkman for multiple 
drugs including oxycodone 30 mg. and hydrocodone 10 mg., which are 
schedule II and III narcotics respectively, Xanax 2 mg., a schedule IV 
benzodiazepine, and Soma (carisoprodol), a muscle relaxant which is 
currently a non-scheduled drug but which is nonetheless popular with 
drug abusers and which metabolizes into meprobamate, a schedule IV 
drug.\50\
---------------------------------------------------------------------------

    \50\ Because of its potential for abuse, DEA has, however, 
initiated a proceeding to place carisoprodol into schedule IV of the 
Controlled Substances Act. See 74 FR 59108, 59109 (2009).
---------------------------------------------------------------------------

    As the Government's Expert explained, the combination of a 
benzodiazepine, a narcotic and carisoprodol is ``well known in the 
pharmacy profession'' as being used ``by patients abusing prescription 
drugs.'' GX 20, at 3. Moreover, as the Government's Expert elaborated, 
Dr. Volkman took this ``to another level'' by prescribing two narcotics 
in addition to a benzodiazepine and carisoprodol, thus distributing a 
schedule II narcotic, a schedule III narcotic, a schedule IV 
depressant, and carisoprodol, for a total of four drugs at the same 
time. Id.
    The Government's Expert further explained that the combination of 
these two narcotics, a benzodiazepine, and a muscle relaxant would have 
a ``synergistic effect'' on a patient's central nervous system and 
cause respiratory depression thus posing a substantial risk to any 
patient actually taking the drugs as prescribed. Thus, from the time 
Mr. Fletcher agreed to fill the prescriptions, he had reason to know 
that Volkman's prescriptions lacked ``a legitimate medical purpose.'' 
21 CFR 1306.04(a).
    Notwithstanding this, there is ample evidence showing that 
Respondent repeatedly dispensed cocktail prescriptions for oxycodone, 
hydrocodone, alprazolam, and carisoprodol. See GX 12 (spreadsheet of 
prescriptions dispensed to A.S. and L.W.); GX 20, at 3 (Gov. Expert's 
report noting that ``75% of the patients received the same four drug 
cocktail which included a benzodiazepine, two narcotic pain killers and 
Soma''). With respect to A.S.\51\ and L.W., many of the oxycodone 
prescriptions were for 30 mg. and were for quantities which would 
provide a daily dose multiple times the amount that the Government's 
Expert--whose testimony was unrefuted--stated was the ``normal dose of 
oxycodone'' and thus indicated that Volkman was running a pill mill. 
Likewise, the prescriptions for hydrocodone and alprazolam were always 
for the strongest formulations of the drug; with respect to the 
alprazolam, the Government's Expert explained that ninety-three percent 
of the prescriptions he reviewed exceeded the FDA-approved maximum 
daily dosage and that the two-milligram strength of the drug is 
generally only prescribed for a patient with post-traumatic stress 
disorder.
---------------------------------------------------------------------------

    \51\ While A.S. testified that she had been in pain caused by an 
auto accident, she also testified that she diverted drugs. Moreover, 
while A.S.'s pain may have justified the prescribing of a controlled 
substance, Respondent offered no evidence refuting the Government 
Expert's testimony that the four-drug cocktail of oxycodone, 
hydrocodone, alprazolam, and carisoprodol, which Volkman repeatedly 
prescribed to her, does not have a legitimate medical purpose.
---------------------------------------------------------------------------

    Respondent also filled prescriptions issued to a single patient for 
multiple schedule II drugs on the same day, as well as three narcotic 
controlled substances on a single day. Moreover, in the prescriptions 
he reviewed, the Government Expert observed that there was ``no 
individualization of dosing based on pain in these patients'' with 
respect to the hydrocodone and alprazolam prescriptions and that 
``[a]ny pharmacist would have known that this was a problem and a 
strong indicator of a doctor operating a controlled substance 
prescribing mill.'' The Government's Expert also noted various 
instances of Respondent dispensing refills that were weeks early.
    In addition, the fact that Mr. Fletcher had been called by D.S., 
who lived in Southern Ohio and was seeing a doctor whose office was 
nearly 100 miles away from his pharmacy, and yet, was obviously having 
problems filling her prescriptions, provided further reason to know 
that the prescriptions were not legitimate. While Mr. Fletcher did not 
ask where D.S. and Dr. Volkman were from and thus may not have had 
actual knowledge at the time of the initial phone call where Volkman 
and the patients were from, see GX 39, at 2; under a DEA regulation, 
each controlled-substance prescription must include the name and 
address of both

[[Page 66164]]

the patient and prescriber. 21 CFR 1306.05(a).
    Thus, the first time one of Volkman's patients presented a 
prescription to him, Mr. Fletcher knew that Volkman was practicing in 
Portsmouth, approximately 90 miles from Columbus, as well as the 
location of the patient's residence; he also knew with each successive 
prescription he received from a Volkman patient that they were 
travelling great distances to fill their prescriptions.
    As the evidence shows, only a few of Volkman's patients lived in 
the Columbus area, and most of them were travelling great distances 
(and sometimes with others) to get their prescriptions filled at 
Respondent, with approximately half of them coming from Kentucky (more 
than two hours away) and many others coming from the Portsmouth area. 
Notwithstanding that many of the patients were travelling for hours to 
fill their prescriptions at Respondent, Volkman's controlled-substance 
prescriptions accounted for seventy-five percent of the total amount of 
controlled-substance prescriptions dispensed by Respondent, and 
controlled substances accounted for approximately ninety-five percent 
of Volkman's prescriptions. As the Government's Expert testified, the 
fact that the patients were driving so far to get their prescriptions 
filled ``would be a major red flag to any pharmacist.''
    Indeed, Mr. Fletcher admitted in an interview that he had been told 
by Volkman's patients that no other pharmacists would fill the 
prescriptions. Yet, even when presented with this fact, he did not call 
any pharmacists to determine why. He also admitted in an interview that 
some of Volkman's patients had asked him to sell them extra pills, a 
clear indication that Volkman's patients were either abusing and/or 
selling the drugs. Yet he continued to fill Volkman's prescriptions.
    Moreover, in substantial contrast to the national average of cash-
paying customers which is approximately ten to eleven percent, nearly 
eighty-seven percent of the Volkman patients paid cash for their 
prescriptions. This, too, was a red flag as ``[a]ny reasonable 
pharmacist knows that a patient that wants to pay cash for a large 
quantity of controlled substances is immediately suspect.''
    The evidence further shows that Respondent and Dr. Volkman's clinic 
would call each other on a daily basis to discuss when Volkman had seen 
his last patient so that Mr. Fletcher would know how late to stay open 
and that he stayed open as late as midnight to await the arrival of 
Volkman's patients and to fill their prescriptions. Relatedly, the 
evidence shows that Volkman directed his patients to go to Respondent 
and even provided driving directions to it. And the evidence also 
showed that Volkman's patients would travel to Respondent in groups.
    Moreover, in early October 2005, Volkman, following a raid by the 
Portsmouth P.D., moved his ``practice'' to Chillicothe. Mr. Fletcher 
knew that Volkman had moved to Chillicothe because he called Volkman at 
this clinic. GX 22. This begs the question of whether Mr. Fletcher 
asked Volkman why he had moved his practice, which, like all of the 
other questions raised by his conduct, Mr. Fletcher has failed to 
address because he did not testify.\52\ See, e.g., Baxter v. 
Palmigiano, 425 U.S. 308, 316 (1976). In light of the substantial 
probative evidence offered against Respondent and Mr. Fletcher, Mr. 
Fletcher's failure to testify supports the drawing of an adverse 
inference against Respondent and Mr. Fletcher. I therefore conclude 
that Mr. Fletcher knew that Volkman's prescriptions lacked ``a 
legitimate medical purpose'' and thus violated Federal law.
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    \52\ The evidence also shows that in October 2005, shortly after 
he had commenced filling Volkman's prescriptions, Mr. Fletcher was 
aware of the $10,000 threshold which triggers a bank's obligation to 
report a cash deposit under the Bank Secrecy Act and that he then 
structured multiple bank deposits in an attempt to avoid his bank's 
filing of Currency Transaction Reports, which would draw attention 
to his activities. This evidence further supports the conclusion 
that Mr. Fletcher clearly knew that by filling the Volkman 
prescriptions, he was engaging in illegal activity.
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    Against this evidence, Respondent elicited the testimony of his two 
employees. Ms. Smith testified that Mr. Fletcher would question his 
customers as to why they were taking the medicine, tell them that they 
were taking a large quantity of pills, and ask them if they could work 
without the drugs. She further maintained on direct examination that 
Mr. Fletcher ``talked to everybody about their prescriptions'' but then 
retreated from this testimony, stating that he did not talk ``to 
everybody'' but only ``the majority of them.'' Moreover, earlier in her 
testimony, she had stated that she explained the medications to the 
patients and most of the patients interviewed by DEA Investigators 
stated that Mr. Fletcher did not ask them about their medical 
condition.
    As for Ms. Cole, much of her testimony is of dubious credibility. 
For example, Ms. Cole testified that Mr. Fletcher had tried calling 
some of the pharmacies which had refused to fill Volkman's 
prescriptions. Yet, when interviewed by a DEA Investigator, Mr. 
Fletcher stated that he did not talk to other pharmacists. Ms. Cole 
also testified that every time Mr. Fletcher received prescriptions from 
outside of the Columbus area, he would call to verify the 
prescriptions. However, Respondent's phone records show otherwise.
    Regardless, even if Mr. Fletcher had called to verify each and 
every prescription that Dr. Volkman issued, the evidence would still 
support the conclusion that he repeatedly violated his corresponding 
responsibility under Federal law because many of the Volkman 
prescriptions patently served no legitimate medical purpose. See United 
States v. Hayes, 595 F.2d at 260 (``[A] pharmacist may not fill a 
written order from a practitioner, appearing on its face to be a 
prescription, if he knows the practitioner issued it in other than the 
usual course of medical treatment.'').
    As the Fifth Circuit has explained, while ``[v]erification by the 
issuing practitioner on request of the pharmacist is evidence that the 
pharmacist lacks knowledge that the prescription was issued outside the 
scope of professional practice[,] * * * it is not an insurance policy 
against a fact finder's concluding that the pharmacist had the 
requisite knowledge despite a purported but false verification.'' Id. 
at 261. A pharmacist has ``the responsibility not to fill an order that 
purports to be a prescription but is not a prescription within the 
meaning of the [CSA] because he knows that the issuing practitioner 
issued it outside the scope of medical practice.'' Id.
    In an interview with a DEA Investigator, Mr. Fletcher admitted that 
``he had questions about'' Dr. Volkman but that he was satisfied 
because Volkman told him that he did an MRI and blood tests.\53\ 
However, as found above, Respondent repeatedly dispensed drug cocktails 
for multiple controlled substances including oxycodone, hydrocodone, 
and alprazolam, as well as carisoprodol, a combination which is widely 
known in the pharmacy profession as being popular with drug abusers, 
and it did so in such quantities that any reasonable pharmacist would 
have asked how the prescriptions could possibly serve a legitimate 
medical purpose. The Government's Expert also explained that these 
cocktails would have a synergistic effect on a person's central nervous 
system and could cause respiratory

[[Page 66165]]

depression. Accordingly, even if Volkman told Mr. Fletcher that he did 
blood tests and MRIs, this would not make the prescriptions any more 
legitimate.\54\
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    \53\ Respondent's employees also testified that some of 
Volkman's patients complained that he was requiring them to undergo 
blood or urine tests. This sliver of evidence provides no reason to 
ignore the overwhelming evidence against Respondent.
    \54\ Respondent also elicited the testimony of Mr. Aalyson, a 
lawyer who practiced workers compensation law in Portsmouth and who 
knew most of the local doctors, that Mr. Fletcher had called and 
asked him if knew whether Dr. Volkman was a legitimate doctor. Tr. 
1159. Mr. Aalyson testified that the phone call occurred in October 
2006, more than a year after Mr. Fletcher started filling Volkman's 
prescriptions and eight months after DEA suspended Volkman's 
registration and thus could no longer prescribe.
    To the extent this testimony was offered to support the 
contention that Mr. Fletcher tried to do due diligence, it provides 
no comfort to him as the conversation occurred more than a year 
after he started filling Volkman's prescriptions. Moreover, even if 
the conversation had occurred shortly after Mr. Fletcher started 
filling Volkman's prescriptions (the apparent point of Respondent's 
repeated questioning of Mr. Aalyson regarding when the conversation 
occurred), his testimony that Mr. Fletcher stated that he was 
``getting a lot of people coming in, and I'm beginning to wonder if 
the guy is legitimate,'' Tr. 1159, would actually support the 
Government's case that Mr. Fletcher knew Volkman's prescriptions 
were not legitimate.
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    This alone supports the conclusion that Mr. Fletcher violated 
Federal law in dispensing the Volkman prescriptions. 21 CFR 1306.04(a). 
The other evidence--such as that related to the quantities of the 
various drugs being prescribed, the dosing, and lack of 
individualization of therapy; the distances the patients were 
travelling and the typical method of payment; the fact that Mr. 
Fletcher knew that other pharmacists had refused to fill Volkman's 
prescriptions; the percentage and number of Volkman's prescriptions 
that were for controlled substances--is simply icing on the cake.
    Moreover, even after a DEA Investigator had interviewed Mr. 
Fletcher and asked him if he found it suspicious that Volkman's 
patients were travelling long distances to fill their prescriptions, 
Mr. Fletcher proceeded to fill numerous oxycodone and alprazolam 
prescriptions for residents of Kentucky who had travelled to South 
Florida to obtain the prescriptions. Indeed, even one of Respondent's 
employees was ``skeptical'' as to whether these were legitimate 
prescriptions. While Respondent contends that Mr. Fletcher stopped 
filling prescriptions issued by Florida pain-clinic physicians after he 
received the Ohio Board of Pharmacy's Notice, Mr. Fletcher did not 
testify in this proceeding and so has failed to offer any explanation 
as to why he filled the prescriptions in the first place. Furthermore, 
a responsible DEA registrant should be able to make these 
determinations without the authorities having to provide the 
information to him on a silver platter.
    Nor was this the end of Respondent's abysmal experience in 
dispensing controlled substances. On November 4, 2009, Respondent 
dispensed to B.A., a recovering drug addict who lived in Morehead, 
Kentucky, four controlled-substance prescriptions issued by a 
Portsmouth physician, including two for Roxicodone 30 mg. (totaling 240 
tablets), one for 120 oxycodone 15 mg., and one for 30 alprazolam; B.A. 
had been directed by the doctor's staff to fill his prescriptions at 
Respondent. Later that day, B.A. got high, and the next morning, he was 
found dead; the detective who found the prescription vials noted that 
there were only nineteen tablets left out of the total of 240 
Roxicodone 30 mg., there were only fifty-two tablets left out of the 
120 oxycodone 15 mg., and only eight tablets out of the 30 alprazolam. 
The quantity of oxycodone provided by these prescriptions totaled 300 
mg. per day, an amount which was five to ten times the normal daily 
dose of oxycodone (5 to 10 mg. every four hours) as testified to by the 
Government's Expert. Moreover, on this single day, Respondent dispensed 
three prescriptions for the same schedule II narcotic. According to the 
Government's Expert, both the multiple prescriptions which B.A. 
presented and the large quantities prescribed were ``red flags'' which 
are suggestive of abuse and ``no reasonable pharmacist would fill'' the 
prescriptions. Here again, however, Mr. Fletcher failed to testify and 
thus offered no explanation as to why he did so.
    DEA Investigators also obtained an OARRS report which showed that 
on eighteen different occasions between November 6, 2007 and October 
30, 2009, Respondent had dispensed oxycodone to S.P. based on 
prescriptions she obtained from seven different doctors; most of the 
doctors practiced in different cities (Waverly, Beavercreek, Dayton and 
Wheelersburg), and while three of the doctors practiced in Portsmouth, 
two of them practiced at different clinics. Notwithstanding that its 
own dispensing records should have shown that S.P. was a doctor shopper 
(indeed, there was no need for Mr. Fletcher to check the OARRS to make 
this determination), Respondent repeatedly dispensed this highly abused 
schedule II controlled substance to her. Here again, Mr. Fletcher did 
not testify and thus has failed to explain why he ignored the 
information in his own records.
    Respondent and Mr. Fletcher also violated the CSA and DEA 
regulations because during the November 6, 2009 inspection, it could 
not produce the biennial inventory of controlled substances which it is 
required to maintain. See 21 U.S.C. 827(a)(1) (``every registrant * * * 
shall * * * as soon * * * as such registrant first engages in the * * * 
dispensing of controlled substances, and every second year thereafter, 
make a complete and accurate record of all stocks thereof on hand''); 
see also 21 CFR 1304.11. Moreover, Mr. Fletcher was unaware that there 
is such a requirement. Finally, as found by the Ohio Board of Pharmacy, 
Mr. Fletcher and Respondent violated Ohio law on three occasions 
because Mr. Fletcher, as ``the responsible pharmacist[,] failed to 
maintain supervision and control over the custody and possession of 
dangerous drugs'' which had been delivered to the pharmacy.
    I therefore conclude that the evidence relevant to Respondent's 
experience in dispensing controlled substances and its record of 
compliance with applicable Federal and State laws related to controlled 
substances shows that it has committed acts which render its continued 
registration inconsistent with the public interest and which justified 
the suspension of its registration. Notably, Mr. Fletcher failed to 
testify in this proceeding; Respondent therefore has not rebutted the 
Government's prima facie case. While there is only the suspension order 
to review (because Respondent allowed its registration to expire), 
which I affirm, had Respondent filed a renewal application, I would 
have denied it.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 824, as well as 
by 28 CFR 0.100(b) and 0.104, I hereby affirm my order which 
immediately suspended the now-expired DEA Certificate of Registration, 
BE5902615, issued to East Main Street Pharmacy. This Order is effective 
immediately.

    Dated: October 15, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-27096 Filed 10-26-10; 8:45 am]
BILLING CODE 4410-09-P