Registrant Actions - 2012
[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Notices]
[Pages 47096-47106]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19221]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11-52]
Physicians Pharmacy, L.L.C.; Decision and Order
On December 15, 2011, Administrative Law Judge Timothy D. Wing
issued the attached recommended decision.\1\ Thereafter, the Government
filed Exceptions to the ALJ's decision.
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\1\ All citations to the ALJ's opinion are to the slip opinion
as originally issued.
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Having carefully considered the ALJ's recommended decision and the
record in light of the Government's Exceptions, I have decided to adopt
the ALJ's rulings, findings of fact, and conclusions of law except as
discussed below.\2\ Accordingly, I will order that Respondent's
application be granted.
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\2\ I do not, however, adopt footnote 20 of the ALJ's opinion.
See Kwan Bo Jin, 77 FR 35021, 35021 n.2 (2012). Moreover, to the
extent the ALJ's decision suggests that a practitioner does not have
an obligation to maintain effective controls against diversion of
controlled substances because this is not a statutory factor under
the public interest standard of section 823(f), see ALJ at 25-26, it
should be noted that factor four authorizes the Agency to consider
an applicant's compliance with applicable federal and state laws
"relating to controlled substances'' and DEA regulations require
that an applicant or registrant "provide effective controls and
procedures to guard against theft and diversion of controlled
substances.'' 21 CFR 1301.71(a).
However, I agree with the ALJ's rejection of the Government's
contention that "in assessing the public interest, the nature and
amount of diversion of controlled substances in a geographical area
is a legitimate area of inquiry and concern when determining whether
an applicant should be granted a DEA registration.'' ALJ at 25
(quoting Gov. Br. 4). Contrary to the Government's understanding,
DEA has held that the public interest inquiry is not a free-wheeling
inquiry but is guided by the specific factors set forth by Congress
for the applicable category of registration. Gregory D. Owens, 74 FR
36751, 36757 (2009). With respect to a practitioner (which includes
a pharmacy), see 21 U.S.C. 823(f), these factors primarily focus on
an applicant's past conduct and the likelihood of future compliance.
Nothing in the texts of any of the five factors set forth in section
823(f) remotely suggests that Congress granted the Agency the
authority to deny an application based on its assessment of "the
nature and amount of diversion of controlled substances in a
geographical area.'' Gov. Br. 4.
Indeed, this is simply the other side of the community impact
coin. However, in multiple cases, DEA has held that such evidence is
not relevant to any of the public interest factors and further noted
that a rule which takes into account the impact on the community
caused by not registering (or de-registering through a revocation
proceeding) a particular practitioner is completely unworkable. See
Linda Sue Cheek, 76 FR 66972, 66973 n.4 (2011) (quoting Owens, 74 FR
at 36757) ("'the ALJ's reasoning begs the question of how many
patients from underserved areas would a practitioner have to treat
to claim the benefit of the rule''').
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The Government's Exceptions
The Government's principal contention is that Mr. Lawrence James,
Respondent's pharmacist-in-charge, "will not adequately fulfill his
corresponding responsibility to prevent drug diversion.'' Exceptions at
1. Ignoring that Mr. James has nearly forty years of experience as a
registered pharmacist and has never been cited for any violation of
state or federal laws, the Government argues that various portions of
Mr. James' testimony support its contention.
First, the Government's argues that "[i]n testifying how he would
prevent diversion and fraud, [its pharmacist-in-charge's] testimony
focused on fraudulent prescriptions, including prescriptions that had
been altered, stolen or forged by the prospective patient.'' Id. at 1-2
(citing Tr. 51). Continuing, the Government argues that "Mr. James did
not address the significant diversion problem that exists with pill-
pushing physicians and [which] is the exact type of pernicious drug
diversion that plagues southern Ohio and surrounding areas.'' Id. at 2.
The Government based this contention on the following colloquy:
Q [by Government Counsel]: Are you aware of any diversion
schemes where the doctor was in cahoots with the patient to issue a
prescription that wasn't for a legitimate medical purpose?
A That question is also very tough because it relies upon
basically the equivalent of hearsay evidence. I have heard of and
been told of some of those things, but at the same difference--and I
am sure somewhere in Ohio, somewhere in the United States, there
probably are doctors, like down in Florida, that will have an
arrangement with a patient where they will supposedly--the doctor
will write them a prescription, they'll get it filled, and the
doctor either gets a cut of the pills or whatever. Have I ever
actually seen any of that or am I totally aware of like any
specifics? No, I am not.
Tr. 52.
While the Government finds this testimony remarkable in light of
Mr. James' extensive experience as a Registered Pharmacist and the
scope of the diversion problem in southern Ohio, it did not ask Mr.
James any further questions regarding his awareness of doctors writing
unlawful prescriptions. Nor did the Government pose to Mr. James any
hypothetical questions regarding how he would handle prescriptions
which raise red flags due to the quantity and strength of the drug or
combination of drugs prescribed, as well as other relevant
circumstances. Thus, to the extent Mr. James did not address to the
Government's satisfaction the problems posed by prescriptions issued by
pill-pushing physicians, the Government ignores that it (and not
Respondent) had the burden of proof in this proceeding, see 21 CFR
1301.44(d), and that Mr. James was only required to
[[Page 47097]]
answer those questions posed by the Government.\3\
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\3\ However, it is also noted that prior to this colloquy, Mr.
James testified that he believed that diversion of controlled
substances is "a major problem'' in both Ohio and nationally. Tr.
44. Mr. James then explained: "[j]ust look at the state of Florida
where they have six doctors who basically from what I understand
work out of the back of their house, back of their car, writing
prescriptions for anybody who has $200 to give them whatever they
want.'' Id. This testimony would seem to address the problem of
pill-pushing physicians.
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The Government also argues that "Mr. James testified that, in his
view, the corresponding responsibility requirement [of 21 CFR
1306.04(a)] exists so the Government can 'nail pharmacists and not go
after doctors.''' Id. While that is true, Mr. James then acknowledged
that this "may be incorrect assumption'' but that it seemed to him
"that they are much harder on pharmacists than they ever are on
doctors until very recently.'' Tr. 53. Contrary to the Government's
view, Mr. James' expression of opinion, whether correct or not, is not
probative of whether he is likely to violate federal law.
The Government further contends that Mr. James "testified that he
would fill any prescription written by a properly licensed physician
unless he had a 'personal reason' not to do so.'' Id. (citing Tr. 52).
No such statement occurs at the cited portion of the transcript and the
Government ignores the following answer Mr. James gave when asked to
describe the responsibilities and duties of a pharmacist:
A pharmacist's duties and responsibilities are to fill all
legitimate and legal prescriptions. We are allowed at any point to
refuse to fill any prescriptions that our own personal conscience
thinks is not correct * * * we don't even really have to have a
reason. I think I've only turned down two in my life for personal
purposes. But to verify that the prescription is legal, legitimate
for lawful use, and then to fill the prescriptions, counsel the
patient, make sure they understand what they're taken for, answer
any questions they may have. That's the rough idea.
Tr. 36.
Indeed, the only evidence that supports the contention that Mr.
James would fill any prescription as long as it was written by a
licensed physician, was the testimony of a DI regarding a round-table
discussion he had with the various principals of Respondent:
Throughout the discussions, we talked heavily about diversion. I
talked to Mr. James or asked Mr. James with regards to his opinion
of the diversion problem in southern Ohio, and he alluded basically
that he didn't think there was a diversion problem. I asked him
about other pharmacists not filling prescriptions for pain
management clinics that were located in southern Ohio. Mr. James was
clear that he thought that was totally wrong of the pharmacist to
even turn down the prescriptions as it's a legitimate prescription
and pharmacists need not to turn those away.
Id. at 138-39.
The DI offered no further testimony to the effect that he discussed
with Mr. James the nature of the prescriptions that were being issued
by the pain management clinics (the drugs, strength, and quantities, as
well as other relevant circumstances which support a finding that the
prescriptions were not legitimate) and which pharmacists were refusing
to fill.\4\ Thus, this testimony does not support a finding that Mr.
James will fill prescriptions even when he has reason to know that they
have not been issued for a legitimate medical purpose.
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\4\ In its Exceptions, the Government argues that the DI
"provided an example of this model of drug diversion by one
particular doctor in Ohio who prescribed large amounts of oxycodone
and other controlled substances to individuals that resulted in
numerous deaths.'' Exceptions at 3 (Tr. 130-31). Continuing, the
Government argues "[t]hese are the types of the prescriptions that
Mr. James indicated that he would fill when he was interviewed by
[the] DI.'' Id. (citing Tr. 138-39).
It is true that the DI testified regarding the prescribing
practices of Dr. Paul Volkman, an ex-registrant and now-convicted
federal drug felon. However, the DI offered no testimony that he
even discussed the type of prescriptions Volkman wrote with Mr.
James, Tr. 130-31, let alone that Mr. James said he would fill such
prescriptions. See id. at 138-39. Accordingly, there is no basis in
the record to support the Government's contention.
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While in determining the public interest, DEA is entitled to
consider the likelihood of an applicant's future compliance with
federal and state laws related to controlled substances, see 21 U.S.C.
823(f)(4), federal law requires that the finding be based "on
consideration of the whole record'' and "supported by * * * the
reliable, probative, and substantial evidence.'' 5 U.S.C. 556(d)
(emphasis added). The Government's Exceptions do not provide a
persuasive reason to reject the ALJ's credibility findings with respect
to Mr. James or his conclusion that Mr. James "demonstrate[d] a
sufficient understanding of a pharmacist's corresponding duties'' under
21 CFR 1306.04.\5\ Accordingly, I adopt the ALJ's ultimate conclusion
that the Government has not proved "by substantial evidence that
Respondent's registration would be inconsistent with the public
interest as that term is used in 21 U.S.C. 823(f),'' ALJ at 29, and
will order that Respondent's application for a DEA Certificate of
Registration as a retail pharmacy be granted.\6\
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\5\ The Government also takes exception to the ALJ's finding
that Mr. Hillman, one of Respondent's owners "was generally
credible.'' Exceptions at 4. It argues that there are
"inconsistencies between Mr. Hillman's answers to DEA's written
questions * * * and his testimony at the hearing.'' Id. More
specifically, the Government argues that while Mr. Hillman answered
"no'' to a written question as to whether he had "any interest,
either personally or professionally'' in one of nine listed pain
clinics, he testified at the hearing "that he had a professional
relationship with several clinics as their attorney.'' Id. (citing
GX 2, at 4; GX 3, at 4; Tr. 123). Even ignoring that the written
question is laced with ambiguity, on the questionnaire, Mr. Hillman
answered "yes'' to the question of whether he had "ever
represented owners and/or physicians in the above list in any civil
or criminal procedures.'' See GX 2, at 5; GX 3, at 4.
Furthermore, the Government offers no explanation as to why Mr.
Hillman's representation of pain clinics in legal proceedings is
relevant under any of the public interest factors.
\6\ The Government takes exception to the ALJ's exclusion of a
video recording on the ground that the Government failed to provide
a written transcript of the recording as required by the ALJ's pre-
hearing ruling. Exceptions at 6. The Government contends that
"[t]here is no statutory or regulatory requirement that a written
transcript be provided.'' Id. However, under the Administrative
Procedure Act, the ALJ is authorized to "regulate the course of the
hearing,'' 5 U.S.C. 556(c), and requiring the production of a
transcript for a recording which a party seeks to admit into the
record, clearly falls within this power. While it appears that this
case was reassigned to the lawyer who tried it, the pre-hearing
ruling was issued more than three months before the hearing, and
thus, the Government had ample time to comply with the Judge's
ruling. Moreover, while the Government noted that Respondent
stipulated to the admission of the exhibit, it is the Judge (and not
the parties) who runs the proceeding.
Nor is it clear why the video, which according to the
Government is of a meeting between Mr. Hillman and members of the
community during which the latter expressed their concerns about
diversion, is relevant to any of the public interest factors. In any
event, the DVD was corrupted and could not be played. I therefore
reject this exception.
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28
CFR 0.100(b), I order that the application of Physicians Pharmacy,
L.L.C., for a DEA Certificate of Registration as a retail pharmacy, be,
and it hereby is, granted. This Order is effective immediately.
Dated: July 25, 2012.
Michele M. Leonhart,
Administrator.
Paul E. Soeffing, Esq.,
D. Linden Barber, Esq., for the Government
Steven E. Hillman, Esq., for the Respondent
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision
of the Administrative Law Judge
I. Introduction
This proceeding is an adjudication pursuant to the Administrative
Procedure Act, 5 U.S.C. 551 et seq., to
[[Page 47098]]
determine whether the Drug Enforcement Administration (DEA, Agency or
Government) should deny an application for a DEA Certificate of
Registration (COR) as a retail pharmacy, pursuant to 21 U.S.C. 823(f)
and 824(a)(4), on the grounds that such registration would be
inconsistent with the public interest as that term is used in 21 U.S.C.
823(f). Without this registration, the applicant, Physicians Pharmacy,
LLC (Respondent) of Piketon, Ohio, will be unable to lawfully
distribute, dispense or otherwise handle controlled substances.
On May 11, 2011, the Deputy Assistant Administrator, DEA, issued an
Order to Show Cause (OSC) to Respondent. The OSC provided notice to
Respondent of an opportunity to show cause as to why the DEA should not
deny Respondent's application for a DEA COR as a pharmacy, pursuant to
21 U.S.C. 824(a)(4), alleging that such registration would be
inconsistent with the public interest as that term is defined in 21
U.S.C. 823(f). (ALJ Ex. 1, at 1.) The OSC alleged \1\ as a basis the
following:
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\1\ Represented to be a "non-exhaustive summary of facts and
law'' in support of the OSC. ALJ Ex.1, at 1.
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1. On January 12, 2011, [Respondent] applied to be registered
with DEA as a pharmacy with a registered location of 727 Second
Street, Piketon, Ohio.
2. The owners and corporate officers of the pharmacy have no
experience owning or operating a pharmacy.
3. On behalf of [Respondent], corporate officer Steven Hillman
told the mayor of Piketon and members of the public that
prescriptions presented to the pharmacy will be filled so long as
they contain a diagnostic code from the physician and match a
facsimile or electronic version of the prescription that will be
sent to the pharmacy by the physician. This statement fails to
acknowledge the full scope of the "corresponding responsibility''
of the pharmacist. See 21 CFR 1306.04(a).
4. On behalf of [Respondent], corporate officer Steven Hillman,
in response to DEA's request to explain the owners' understanding of
diversion in the Piketon region, stated, "I never have been told.''
The remainder of his response was not relevant to the question. The
corporate officers were either deceptively avoiding answering the
question or were willfully ignorant of the rampant pharmaceutical
drug abuse problem in southern Ohio. The response by Mr. Hillman on
behalf of [Respondent] evinces a likelihood that [Respondent] will
ignore signs of diversion and abuse.
5. [Respondent]'s pharmacist, Lawrence James, in response to
DEA's asking if he was aware of the diversion of controlled
substances in southern Ohio, stated that much of the problem stems
from pharmacies not filling prescriptions from pain clinics. Mr.
James stated that prescriptions from pain clinics were valid and
should be filled.
6. On behalf of [Respondent], corporate officer William Caserta
advised DEA that [Respondent] would serve clinics south of Columbus,
Ohio. Columbus is approximately 67 miles from Piketon. When asked if
there were concerns over chronic pain patients travelling from
significant distances to obtain controlled substances, corporate
officer Don Wolery asserted that the problem was local pharmacies
refusing to fill prescriptions because pharmacists believe that the
some [sic] prescriptions are not for legitimate medical problems.
7. The statements made by the corporate officers and pharmacist
demonstrate a lack of understanding about the diversion and illicit
use of pharmaceutical controlled substances. The statements indicate
that [Respondent] will fill prescriptions issued by individual
practitioners under circumstances that are indicative that the
prescriptions are not issued in the usual course of professional
practice or for a legitimate medical purpose.
Following prehearing procedures, a hearing was held in Cincinnati,
Ohio on October 4, 2011, with both parties represented by counsel.\2\
The Government called five witnesses and introduced documentary
evidence. Respondent did not put on any evidence. After the hearing,
both parties filed proposed findings of fact, conclusions of law, and
argument. All of the evidence and post-hearing submissions have been
considered, and to the extent the parties' proposed findings of fact
have been adopted, they are substantively incorporated into those set
forth below.
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\2\ Respondent was represented by Steven Hillman, a member of
Respondent with a fifty percent ownership interest. Mr. Hillman also
testified in this matter.
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II. Issue
Whether the record establishes that Respondent's application for a
DEA COR as a retail pharmacy should be denied on the grounds that such
registration would be inconsistent with the public interest pursuant to
21 U.S.C. 824(a)(4) and 823(f).
III. Evidence and Incorporated Findings of Fact \3\
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\3\ In addition to the evidence discussed in this Section,
additional evidence and findings of fact are discussed in later
Sections of this Recommended Decision.
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I find, by a preponderance of the evidence, the following facts:
A. Background
with a registered address of 727 Second Street, Piketon, Ohio
45661. (Tr. 136; Gov't Ex. 1.) The application contains Mr. Hillman's
e-signature and lists Mr. Caserta as the Respondent is a Limited
Liability Company (LLC) that was initially formed in or about 2010 with
three members, Don Wolery (Mr. Wolery), Steven Hillman (Mr. Hillman),
and William Caserta (Mr. Caserta). (Tr. 14, 25-26, 96-97.) Respondent
currently has two members, Mr. Hillman and Mr. Caserta, who each hold a
one-half ownership interest. (Tr. 26, 97.) Respondent is currently
licensed as a retail pharmacy with the Ohio State Board of Pharmacy.\4\
(Tr. 123; ALJ Ex. 2, at 4.) Lawrence James (Mr. James) is listed on
Respondent's state pharmacy license as the "Responsible Person.'' (Tr.
40-41; ALJ Ex. 2, at 4.) On January 12, 2011, Respondent submitted an
electronic application for a DEA COR as a retail pharmacy in Schedules
II through V, contact person. (Tr. 136; Gov't Ex. 1.)
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\4\ Respondent's state pharmacy license was issued in or about
February 2011. (Tr. 123-24.)
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B. The Government's Evidence
The Government's evidence included testimony from five witnesses:
Mr. Wolery; Mr. Caserta; Mr. James; Mr. Hillman; and DEA Diversion
Investigator (DI) Christopher Kresnak (DI Kresnak). In addition to
testimonial evidence, the Government also introduced various
documentary exhibits, to include: Respondent's master information for
electronic application; \5\ correspondence between DEA and Respondent;
\6\ an agenda and sign-in sheet for a regional meeting on prescription
drug overdoses; \7\ Mr. James's work history; \8\ and three documents
produced by Mr. James for use by Respondent, including a note to its
customers, its mission statement, and information for physicians with
pain patients.\9\
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\5\ Gov't Ex. 1.
\6\ Gov't Exs. 2-4.
\7\ Gov't Ex. 6.
\8\ Gov't Ex. 7.
\9\ Gov't Exs. 8-10.
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Mr. Wolery testified that he is an attorney, and that he and Mr.
Hillman came up with the concept of opening a pharmacy. (Tr. 14.) He
decided to become a member of Respondent because he wanted to make
money and thought "[i]t was a good business idea.'' (Tr. 14, 15.) Mr.
Wolery testified that he contributed $1,330 to the business. (Tr. 18.)
Mr. Wolery testified that he has no experience as a pharmacist, nor has
he ever owned or operated a pharmacy. (Tr. 16.) He testified that he
had no intentions of running the pharmacy: "Mr. James had been chosen
as a pharmacist to run it and had been given the latitude to run it as
he saw fit, and given his experience in this matter, we felt that he
was a good choice to run this operation in a lawful manner.'' (Id.)
[[Page 47099]]
Rather, Mr. Wolery's role in the business was "helping set it up. I
met with the Ohio Pharmacy Board to make sure that plans and
specifications * * * met with their [sic] approval.'' (Tr. 16-17, 18.)
In speaking with representatives at the Ohio Pharmacy Board, Mr. Wolery testified that he asked them
what they would require for a pharmacy, what they would like to see
as far as security for the pharmacy, the type of safe and things
like that, show them the potential schematic of what it would look
like and ask them if there was anything that they would like to see
in order for this pharmacy to be licensed.
* * *
(Tr. 23.)
Mr. Wolery testified that he ended his membership on March 16,
2011, for personal reasons, and expressly stated that he did not leave
the business for financial reasons. (Tr. 15-16.) Mr. Wolery provided a
resignation letter and walked away without getting any of his initial
investment back. (Tr. 17-18.) Mr. Wolery testified that he told Mr.
Hillman that if Respondent gets a DEA COR and eventually makes a
profit, he'd like to get his $1,330 investment back. (Tr. 18.) Although
Mr. Wolery stated that he would not become a member should Respondent
be granted a DEA COR, he testified that he believes the business will
be profitable because "there's a need for it. * * * People can't get
scripts filled, even those that deserve them. So there's a need and I
think the pharmacy will meet that need, as any pharmacy.'' (Tr. 18.)
Mr. Caserta testified that he has no experience as a pharmacist and
has never owned or operated a pharmacy, but he became a member of
Respondent after he was approached by Mr. Wolery and Mr. Hillman. (Tr.
25-26.) He did not make an initial investment, but he currently owns a
fifty-percent share and serves as a managing partner. (Id.) Mr. Caserta
testified that part of his job with Respondent included interviewing
applicants to serve as Respondent's pharmacist. (Tr. 29.) After
interviewing several applicants, Mr. Caserta and the other members
hired Mr. James "because of his work record, it was impeccable. His
background was very good. And he had a lot of experience in managing a
pharmacy, * * *'' (Id.)
Mr. Caserta testified that he spoke to the chief of police, the
planning board, the zoning board, and the "Assistant--to the County
Attorney, the City Attorney'' for Piketon to ensure that they had no
objections to Respondent opening in Piketon. (Tr. 30.) He testified
that the chief of police told Mr. Caserta that if Respondent was not
going to have a doctor and it was simply going to be an apothecary,
then he had no objections. Similarly, none of the other people who Mr.
Caserta spoke to had any objections. (Id.) Mr. Caserta testified that
if Respondent receives a DEA COR, it will fill both non-controlled and
controlled substance prescriptions for customers between an eighteen
and forty-mile radius. (Tr. 27-28.) Mr. Caserta testified that the
Kentucky border is approximately thirty miles away, but he "ha[s] no
idea'' if Respondent will get customers from Kentucky. (Tr. 28.)
Mr. James testified that he completed two years of pre-pharmacy
studies at Ohio Dominican College and then earned a Bachelor of Science
degree in pharmacy from Ohio State University. (Tr. 32.) He graduated
in June 1975, and has been a registered pharmacist in Ohio since August
2, 1975. (Id.) Mr. James has worked continuously as a pharmacist in
Ohio since he was registered, with the exception of "no more than
three weeks' break between any jobs.'' (Tr. 33; see Gov't Ex. 7.\10\)
Mr. James has worked at seven retail pharmacies, one in-house pharmacy
organization that filled prescriptions for patients released from the
James Cancer Center, and one community hospital as the staff
pharmacist. (Tr. 35; Gov't Ex. 7.) Mr. James has also worked for a
company called HealthPro Staffing Agency, where he was given a nine-
month assignment to the Ohio Department of Mental Health, filling
prescriptions for twenty-three prisons in central and south-central
Ohio. (Tr. 43, 44.)
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\10\ Mr. James testified that Government Exhibit 7 shows where
he was working on September 15th of each year when he renewed his
state pharmacy license. (Tr. 33.) Mr. James testified that the
document accurately portrays his work history, with the following
exceptions. First, "for exactly one year to the day, I worked for a
company called Ultimate Care Home Health Care, between Knox
Community Hospital [in 1992] and Meijer [in 1993].'' (Tr. 34-35.)
Second, Mr. James testified that he did not work at CVS Pharmacy in
2010. He actually worked for HealthPro Staffing Agency in 2010. (Tr.
43.)
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Mr. James testified that he was put in touch with Mr. Caserta
through an employment agent. (Tr. 38.) After speaking to Mr. Caserta
and going to see Respondent's location, Mr. James agreed to work as the
main pharmacist. (Id.) Mr. James testified that Respondent is located
in an old brick building in Piketon, Ohio. (Tr. 48.) He believes there
are approximately four other pharmacies within five or ten miles of
Respondent's location. (Tr. 42.) None of the pharmacies in the area,
however, are set up as "strictly an apothecary-type business,'' as
Respondent, but are all "traditional pharmacies, including over-the-
counter drugs, * * * greeting cards, * * * deodorants and other
things.'' (Tr. 91-92.) Although Mr. James is not involved in the
business plan since he is not an owner, (Tr. 85), Mr. James testified
that when he was hired, he understood that decisions as to how the
pharmacy will operate will have to be approved by Mr. Hillman and Mr.
Caserta. (Tr. 84, 92-93.) He testified, however, that "nothing has yet
been turned down by either'' of them. (Tr. 93.)
Mr. James testified that Respondent currently has one other
employee, Theresa Putnam (Ms. Putnam), but that if Respondent obtains a
DEA COR, Mr. James and Mr. Caserta will likely hire a pharmacy
technician as well. (Tr. 41.) Mr. James explained that when he and Mr.
Caserta were previously looking to hire a technician, they both
interviewed the candidates. Mr. James then "ranked them in the order
that I felt the people would be of interest to us.'' (Id.) Mr. Caserta
then ranked the candidates "and then he made the decision ultimately
of which one [they] would hire.'' (Tr. 41-42.)
Although Mr. James accepted the pharmacist position with Respondent
in January 2011, he and Ms. Putnam have been furloughed since March 17,
2011, because Respondent is non-operational. (Tr. 39, 40-41.) Mr. James
testified that although Respondent has a pharmacy license from the
state, it is unable to operate even in non-controlled substances
because the wholesaler does not want to sell just non-controlled
substances to Respondent. (Tr. 67; 80.) The wholesaler "didn't want to
sell anything to us until we got all licenses taken care of, including
the DEA license.'' (Tr. 67.) Mr. James testified that he was ready and
willing to start working for Respondent, selling just non-controlled
substances. (Id.) The last he spoke with the wholesaler, it was ready
to sell to Respondent, but Mr. Caserta later informed Mr. James that
the wholesaler would not sell any drugs until Respondent got its DEA
registration. (Tr. 82.)
Mr. James testified that "[a] pharmacist's duties and
responsibilities are to fill all legitimate and legal prescriptions. We
are allowed at any point to refuse to fill any prescription that our
own personal conscience thinks is not correct according to--we don't
even really have to have a reason.'' (Tr. 36.) Mr. James testified that
he refused to fill two prescriptions during his career "[f]or personal
reasons.'' (Tr. 36.) He clarified later that he turned down two for
"personal purposes,'' but that he turned down "many forged
prescriptions * * * not for personal
[[Page 47100]]
purposes.'' (Tr. 60.) Mr. James explained that he turned down those
prescriptions for "legal purposes'' because he was confident that the
prescriptions were fraudulent. (Tr. 60-61.)
Mr. James testified that diversion is "a major problem'' not only
in southeastern Ohio, but across the entire country. (Tr. 44.) In
addition to testifying that some patients try to alter prescriptions or
bring in forged prescriptions, (Tr. 51), Mr. James testified that in
Florida, for instance, "they have six doctors who basically * * * work
out of the back of their house, back of their car, writing
prescriptions for anybody who has $200 to give them whatever they want,
and then those people wind up coming all over the United States trying
to get them filled.'' (Tr. 44-45.) Mr. James also testified that he is
aware that there are some doctors who "will have an arrangement with
the patient where they will supposedly--the doctor will write them a
prescription, they'll get it filled, and the doctor either gets a cut
of the pills or whatever.'' (Tr. 52.) Mr. James has never "actually
seen any of that,'' nor is he "totally aware of * * * any specifics.''
(Id.)
Mr. James testified that he is aware of a pharmacist's
corresponding responsibility under 21 CFR 1306.05. (Tr. 53.) He
testified, however, that he does not believe that certain pharmacists
are more diligent than others in checking prescriptions. (Tr. 77.) He
agreed that some pharmacists are more fearful of the inspectors from
the State Board of Pharmacy than others. (Tr. 77-78.) Mr. James later
testified that "I believe there are good pharmacists, I believe there
are also bad pharmacists. I believe that people get themselves into
situations that they sometimes think they can't control even though
they really can control them.'' (Tr. 79.) He also testified that he
"absolutely'' believes that some pharmacists fill bad prescriptions.
(Id.) The Government attempted to clarify with the following colloquy:
Q But you wouldn't characterize them as being less diligent than
any other pharmacist?
A In one case, he was more fearful that his supervisor would
find out that he didn't fill it, and the supervisor would raise Cain
for, "Why didn't you fill this prescription?'' It didn't matter
that it was a very questionable prescription for a very questionable
quantity.
The field of pharmacy is not a pretty field anymore. It has
changed so much since the DEA laws of 1976 and what insurances did
around that time that it's a whole different ballgame than it was
back in my early years.
(Tr. 79-80.)
Mr. James testified that he fulfills his corresponding
responsibility by verifying that each prescription contains the
customer's name and address, and by asking each customer for a valid
phone number even though the law does not require that information.
(Tr. 54-55.) Mr. James testified that he also observes each
prescription to see what drug the customer is getting, and
"[s]ometimes I'll ask the person questions like as to what they got
this prescription for on controlled substances, * * * .'' (Tr. 55.) He
explained: " 'It's my license,' I keep telling everybody. I don't care
what these companies say to keep doing, it's my rear end that's on the
line here. If my license gets suspended, it's my job. * * * I want
guidelines for the actual pharmacist to be able to have honest input so
he can decide whether this is really a legitimate prescription, * * *
.'' (Tr. 53-54.)
Mr. James testified that he would like to employ five additional
safeguards as the pharmacist for Respondent. First, he would like to
ask the prescribing physicians to provide an IDC-9 diagnosis code for
each prescription so that Mr. James can "verify that the prescription
was indeed for a legal, legitimate purpose, which has always been a
problem.'' (Tr. 46.) Mr. James testified that the IDC-9 code is
typically used by insurance companies for billing purposes, and he has
never seen it used by a pharmacy. (Tr. 47-48.) He explained, however,
that he thinks it will be useful to pharmacists. (Tr. 47.) Although
none of the pharmacies that Mr. James previously worked for implemented
his idea, he testified that Mr. Hillman responded, "You're the boss of
the pharmacy, and if you think we need it, then we need it basically.''
(Tr. 86-87.)
Second, Mr. James testified that he would like to request that the
prescribing physicians fax a copy of each prescription directly to the
pharmacy so that Mr. James can verify that nothing has been changed on
the prescription carried into the pharmacy by the customer. (Tr. 47,
87.) Mr. James testified that Mr. Hillman and Mr. Caserta agreed to
implement this policy as well. (Tr. 87.)
Third, Mr. James testified that he would like to use OARRS \11\ to
help him determine if a prescription is valid by checking OARRS to see
if the customer has had other controlled substances prescriptions
issued and filled. (Tr. 90.) According to Mr. James, Mr. Hillman and
Mr. Caserta liked this idea as well. (Tr. 91.) Mr. James testified that
OARRS hasn't typically been used in this fashion, explaining that some
of his colleagues think his idea is "blasphemous'' and that he's
"gotten some indication from the State Board of Pharmacy that they
didn't like the idea that I was going to be checking with OARRS.'' (Tr.
90-91.)
---------------------------------------------------------------------------
\11\ OARRS refers to the Ohio Automated Rx Reporting System, a
drug database established and maintained pursuant to Ohio law. Ohio
Admin. Code R. 4731-11-11 (2011).
---------------------------------------------------------------------------
Fourth, Mr. James testified that he would like to require that each
customer provide a valid state-issued license or ID when picking up a
prescription that Mr. James can keep on file. (Tr. 46.) He further
explained that if a customer is unable to pick up a prescription, the
customer will have to notify Respondent that another person will pick
up the prescription on the customer's behalf and that person will have
to provide a valid form of identification. (Tr. 46-47.) Mr. James will
keep a copy of that identification in the customer's file, and
testified that there were copiers for him to do that. (Tr. 87.)
Finally, Mr. James testified that in addition to keeping a log of
all Schedule II drugs, he would also like to keep a log of all other
controlled substances, so that "[a]ll controlled substances would have
an exact inventory at all times.'' (Tr. 47, 88.)
Mr. James also testified that in late February 2009, he prepared
three documents for potential use by Respondent. (Tr. 57-58, 70-71, 71-
72.) Mr. James testified that he gave the documents to Mr. Caserta and
Mr. Hillman to consider, but he did not think the documents had been
approved for use, stating that "until the other day when I saw these
things inside the folder, as far as I was concerned, they were thrown
away.'' (Tr. 58.)
First, Mr. James created a document entitled "Note to Our
Customers with Pain'' that he would like to give to pain medication
customers so that the customers "understand exactly what were [sic]
going to do to verify that their prescriptions were legitimate, legal,
valid and under what circumstances I possibly would tell them, 'Sorry,
I cannot fill your prescription.' '' (Tr. 58; see Gov't Ex. 8.) Mr.
James testified that the document informs customers that they need to
fill all of their prescriptions with Respondent, not just their
controlled substances prescriptions. (Tr. 58; see also Gov't Ex. 8.) He
explained that this will help him identify any potential drug
interactions and also demonstrates that he is not operating a pill
mill. (Tr. 63.) He also testified that the document informs customers
that if the insurance company "rejects the claim as too early, we will
not fill the
[[Page 47101]]
prescription until the proper time. Do not think that you can just pay
cash and get it filled.'' (Tr. 65-66.) He also testified that the
document informs customers that the prescribing physicians "can speed
up the process by faxing all prescriptions in advance to the pharmacy,
along with the proper IDC-9 diagnosis code.'' (Tr. 68; see also Gov't
Ex. 8.) He explained that this will save time for the customers because
otherwise he will have to contact the prescribing physician after the
customer comes into the pharmacy. (Tr. 68.) Mr. James testified that he
assumes some form of this document will be used. (Tr. 59.)
Second, Mr. James testified that he created a document entitled
"Our Mission Statement.'' (Tr. 70-71; see Gov't Ex. 9.) Mr. James
proposed that Respondent provide the mission statement to customers
"to indicate to people what our business was, what we were and what we
hoped to do.'' (Tr. 71.) The document informs customers that Respondent
wants to be their "local pharmacy for all of your prescription
needs.'' (Gov't Ex. 9.) It also informs customers that Respondent does
not offer over-the-counter medications and does not have a doctor on
staff. (Id.)
Third, Mr. James testified that he created a document entitled
"Information for Doctors with Pain Customers.'' (Tr. 71-72; see Gov't
Ex. 10.) Mr. James testified that this document was not approved for
use yet. The draft document sets forth the security measures that Mr.
James "would like to put into place to protect the doctor, the patient
and myself[.]'' (Tr. 73; see Gov't Ex. 10.)
Mr. James also testified to the physical security measures
implemented by Respondent. He testified that the main gate to the
building has a "good major gated lock, so it's harder to get into[.]''
(Tr. 48.) Once inside, the pharmacy department is to the right and the
waiting area is to the left. (Id.) Mr. James testified that the
"pharmacy has a thick door which has an opening, which has * * *
bulletproof glass. * * * The windows into the pharmacy also have bars
which I believe were actually requested by the State Board of
Pharmacy.'' (Tr. 49.) Mr. James also testified that there is a walk-in
safe in the pharmacy, approximately three feet deep, six or seven feet
wide and tall enough for him to stand inside without ducking his head.
He stated that it is the "biggest safe I've ever seen inside a
pharmacy.'' (Id.) Mr. James testified that this is the "best security
I've ever seen'' at a pharmacy. (Tr. 50.) He testified that when the
inspector from the State Board of Pharmacy observed the safe, he made
no negative comments, but simply said " 'Yes, that will do,' or
something to that effect.'' (Tr. 88-89.)
Mr. James did not know if the size of the safe was indicative of
the volume of controlled substances that will be kept on hand. (Tr.
50.) He did indicate, however, that he will keep all of the controlled
substances, rather than just the Schedule II controlled substances, in
the safe. (Id.) Mr. James testified that he does "not really'' know
what the percentage breakdown will be for controlled and non-controlled
substances filled by Respondent once it opens for business. (Tr. 73.)
Although Mr. James testified that he hopes the percentage is
acceptable, he indicated that it has been "rather confusing'' to
determine what an acceptable percentage might be. (Tr. 73, 74.) For
instance, he testified that the State Board of Pharmacy suggested that
no more than twenty-five percent of all prescriptions filled by
Respondent should be for controlled substances, but the wholesaler
indicated that no more than thirty or thirty-five percent should be for
controlled substances. Then, when Mr. James spoke to DI Kresnak, he got
"a different percentage.'' (Tr. 74.)
Mr. Hillman testified that on October 21, 2009, he attended a
regional meeting in Scioto County, Ohio entitled "Epidemic of
Prescription Drug Overdoses: A Call to Action.'' (Tr. 109-10; Gov't Ex.
6.) Mr. Hillman explained that the meeting "was mostly political. * *
* And they talked about * * * having to get better control over the
prescription drugs.'' (Tr. 110.) Mr. Hillman testified that he did not
find the meeting to be educational, explaining that "I don't know a
lot about drugs, but the people who were speaking knew less than I
did.'' (Tr. 111.) Mr. Hillman initially planned to attend the meeting
because "somebody has to be blind not to understand that there's some
serious drug problems,'' so he wanted to get involved. (Id.) Mr.
Hillman explained that he wanted to get involved by talking with
various officials about the fact that there were no laws in place at
the time regarding licensing for businesses that treated pain patients.
(Tr. 111-12.) He also informed the officials that he believed OARRS was
inadequate, suggesting that it should be interactive so that
pharmacists can enter a patient's personal information to determine
what other prescriptions the patient has had filled with other
pharmacies. (Tr. 112-13.) Mr. Hillman eventually started to work with a
state representative who "wound up sponsoring the bill,'' \12\ but the
representative eventually stopped returning Mr. Hillman's calls. (Tr.
113-14.) Mr. Hillman testified that he was not contemplating opening a
pharmacy at the time of the town meeting. (Tr. 114.)
---------------------------------------------------------------------------
\12\ While not entirely clear from the record which "bill'' Mr.
Hillman is referring to, his testimony is consistent with a 2011
Ohio House Bill Number 93, which is now codified at Ohio Rev. Code
Ann. Sec. 4729.51 (2011).
---------------------------------------------------------------------------
Mr. Hillman further testified that he has no experience as a
pharmacist and has never owned or operated a pharmacy. (Tr. 98.) Mr.
Hillman also testified that he is not familiar with DEA's Controlled
Substance Ordering System (CSOS), explaining that he "would never
order controlled substances,'' so he has "[n]o reason to become
familiar.'' (Tr. 98-99.) Mr. Hillman explained that he will have "very
little'' to do with running the pharmacy. (Tr. 97.) Rather, Mr. James
will be the pharmacist in charge and that he "will be 100 percent in
control'' of verifying prescriptions. (Tr. 99.)
Mr. Hillman testified that he was aware of pain management clinics
in southern Ohio, but that all except for one of the clinics have
closed. (Tr. 103-04.) The pain management clinic that Mr. Hillman
believes is still open is located about forty or fifty miles from
Respondent. (Tr. 104.) Mr. Hillman does not know if Respondent will get
customers from that pain management clinic, but he testified that
Respondent will not advertise in that area. (Id.) Mr. Hillman testified
that he does not know where the patients of the other pain clinics now
receive medical care; nor does he know where the patients of those
clinics filled their prescriptions before the pain clinics closed. (Tr.
105.)
Mr. Hillman testified that Respondent is located in "a 160-year
old farmhouse'' that has two rooms on the first floor and two rooms on
the second floor. (Tr. 101.) Upon entering the front door, there is a
room to the right, which will be the actual pharmacy, and a room to the
left, which will be the waiting area. (Tr. 101.) Mr. Hillman testified
that he contacted the City Attorney for Piketon and invited him to look
around the pharmacy and ask any questions. (Tr. 116-17.) The City
Attorney accepted the invitation, and went to the pharmacy with the
chief of police, the mayor, some city council members, as well as some
citizens.\13\ (Tr. 118.)
---------------------------------------------------------------------------
\13\ The Government offered a video recording of the meeting,
obtained from the Internet, arguing that the recording was relevant
to show "the diversion problems in southern Ohio, concerns
expressed by the community and the knowledge * * * of Mr. Hillman
and the steps that he had proposed to take to remain in compliance
with the requirements of DEA in stemming diversion and satisfying
the local community.'' (Tr. 119-20.) I excluded the exhibit as both
irrelevant and noncompliant with the June 28, 2011 Prehearing
Ruling, (Tr. 120), which required that "[a]ny audio or video
recordings must include a written transcript.'' (ALJ Ex. 6, at 2
n.3.)
---------------------------------------------------------------------------
[[Page 47102]]
Mr. Hillman testified that Respondent has been licensed by the Ohio
Board of Pharmacy since early 2011. (Tr. 123-24.) Respondent has not
opened for business yet, however, because the wholesaler will not even
supply Respondent with the non-controlled drugs until it obtains its
DEA COR. (Tr. 124.) If Respondent obtains a DEA COR, Mr. Hillman
testified that, at the outset, Respondent will not sell anything other
than prescription drugs. (Tr. 100.) If, however, Mr. James determines
that there is a need for any over-the-counter medications, then
Respondent may start to sell those medications. (Tr. 100-01.) Mr.
Hillman testified that all of the medication will still be kept behind
the glass with Mr. James, and there will be no displays in the waiting
area. (Tr. 101.)
Mr. Hillman testified that "if 'diversion' is controlled
substances going to someplace they shouldn't be,'' then he believes it
exists in southern Ohio, citing a 2008 case where twenty-two people
died from prescription drug overdoses even though none of them had a
lawful prescription. (Tr. 106, 107-08.) Mr. Hillman was not aware of
any other specific incidents, claiming that "[o]nce Scioto County gave
me that information, they stopped giving me any additional
information.'' (Tr. 108.) He stated, however, that "when people walk
into our pharmacy, those people that the medications are sold to will
be sold to appropriate people, period. If the pharmacist believes for
one second that there's something wrong, he'll deal with it.'' (Id.)
Mr. Hillman also testified that to prevent diversion, he would like
Respondent to maintain contact with the prescribing physicians. (Tr.
100.) He also stated that Respondent has "adopted'' all of Mr. James's
suggestions, including requiring prescribing physicians to fax a copy
of all prescriptions to the pharmacy and requiring customers to present
photo identification before obtaining their medications. (Id.)
DI Kresnak \14\ testified that southern Ohio, northeastern
Kentucky, and West Virginia, were formerly "thriving'' with labor-
intense jobs, leading to a population of coal miners, railroad workers,
and steel workers. (Tr. 130.) According to DI Kresnak, these industries
have left the area over the past couple of decades, and "a population
of drug dealers moved in the area.'' (Id.) Many of the drug dealers are
supplied by questionable doctors in the area. (Id.) DI Kresnak
testified that he obtained information from local coroners and law
enforcement officials indicating that "Kentucky is averaging almost
three bodies a day for prescription drug overdose. The State of Ohio
has indicated they're close to that number for prescription overdose.''
(Tr. 131-32.) DI Kresnak also testified that from approximately 2005 to
2008, southern Ohio had an increase of prescription drug overdoses of
approximately 280 percent. (Tr. 132.)
---------------------------------------------------------------------------
\14\ DI Kresnak has been a DI with DEA for approximately eight-
and-one-half years in Cincinnati. (Tr. 127-28.) Prior to working
with the DEA, DI Kresnak received a four-year degree in management
from Park University, and then completed work in a master's program
at Central Michigan University. (Tr. 128.) DI Kresnak also spent
twenty-two years in the United States Marine Corps, where he retired
as a Master Sergeant. (Id.)
---------------------------------------------------------------------------
In addressing Mr. Hillman's testimony that most of the pain clinics
in the area had closed, DI Kresnak explained that prior to summer 2011,
when House Bill 93 was enacted by the Ohio Legislature, the majority of
the pain clinics in southern Ohio were owned by convicted felons who
would bring in physicians who had previously faced disciplinary action.
(Tr. 132-33.) House Bill 93, however, required that "if you were a
pain clinic, you had to be a licensed practitioner. I believe you had
to be associated with a hospital. There were several other caveats to
the law that I'm not familiar with.'' (Tr. 132.) DI Kresnak explained
now that "there are individuals trying to undermine the current law.''
\15\ (Tr. 132.)
---------------------------------------------------------------------------
\15\ Respondent's counsel questioned DI Kresnak what he meant by
that statement, asking whether DI Kresnak meant these individuals
were actually violating the law "or just that they're obeying it to
the extent that you don't like it?'' (Tr. 151-52.) DI Kresnak
testified that "it's not a matter of I don't like it. There's
probably more to that answer that I'm not at liberty to say at this
time, sir.'' (Tr. 152.)
---------------------------------------------------------------------------
DI Kresnak testified that he became familiar with Respondent's
application for a DEA COR, which was filled out by Mr. Hillman. (Tr.
135; see Gov't Ex. 1.) Although DI Kresnak does not typically conduct
an on-site visit for a new retail pharmacy application, he did conduct
one in this case. (Tr. 136-37.) DI Kresnak contacted Mr. James and went
to the pharmacy in February 2011. (Tr. 137.) DI Kresnak had a round-
table discussion with Mr. James, Mr. Caserta, Mr. Wolery, and Ms.
Putnam. (Id.) He did not interview them individually, but instead
discussed as a group "why the pharmacy was going to be open, the need
for the pharmacy in the area.'' (Tr. 138.) They also talked about
diversion, and according to DI Kresnak, Mr. James "alluded basically
that he didn't think there was a diversion problem.'' DI Kresnak
testified that Mr. James thought it was wrong that other pharmacists
would not fill prescriptions for pain management clinics located in
southern Ohio. (Id.)
DI Kresnak testified that he discussed the procedures that Mr.
James would implement at the pharmacy, including "the need for doctors
to fax the prescriptions over to verify correctness and accuracy.''
(Tr. 139.) DI Kresnak testified that Mr. James also wants to request
IDC-9 codes from prescribing physicians. (Tr. 148.) DI Kresnak refused
to "comment on'' whether he thought it was a good idea "because it's
above what DEA requires.'' (Id.) DI Kresnak also refused to comment on
whether it was a good idea to have the prescribing physician fax the
prescription to Mr. James to compare to the prescription brought in by
the customer, stating "I'm not a pharmacist. I don't run pharmacies.''
(Id.) He agreed, however, that this would "help get the ultimate user
the prescription.'' (Tr. 148-49.)
DI Kresnak also testified that Mr. Caserta informed him that
Respondent would fill prescriptions for "anything south of Columbus.''
(Tr. 139.) When DI Kresnak asked how they would feel about pain
patients traveling so far to have their prescriptions filled, "Mr.
Wolery stated that he felt that it was a shame that they had to travel
that far, that they were legitimate prescriptions and that it's just a
darned shame they have to travel that far.'' (Id.) This concerned DI
Kresnak because "there isn't a pharmacist that is filling for these
pain clinics with exception to one or two, and the ones that were
filling for the one or two, people were traveling great distances. * *
* These customers all of a sudden weren't going to have to be traveling
much longer because there was going to be a pharmacy opening up in the
area.'' (Tr. 140.)
DI Kresnak testified that he is not aware of a guideline setting
forth the percentage of controlled substances that should be sold out
of a pharmacy. (Tr. 149.) He testified that "the DEA is not going to
put limits or percentages within a business.'' (Tr. 150.) DI Kresnak
explained security measures in place at Respondent, based on his
inspection of the building. (Tr. 138, 141.) DI Kresnak testified that
there are numerous cameras on the outside of the building, pointing in
all directions. (Tr. 141.) The windows of the building are secured by
iron bars on the inside. (Tr. 143.) DI Kresnak testified, however, that
having bars on the windows does not "bother[] me.'' (Tr. 156.) The
front door to the
[[Page 47103]]
building is "gated with an iron gate with a padlock.'' (Tr. 141.) Once
inside the building, DI Kresnak testified that the pharmacy is to the
right, and the waiting room is to the left. Beyond the waiting room is
an office where Ms. Putnam "would be accepting the prescriptions and
payment.'' (Id.) DI Kresnak testified that there is a door and
"heavily fortified, very thick, almost bulletproof glass with a
sliding drawer to allow the payment and the prescription to come
through.'' (Tr. 141.) DI Kresnak testified that there is another
"heavily fortified'' door with several glass windows leading to the
pharmacy section. (Id.) The door contains a speaker hole so the
pharmacist can communicate with customers, as well as a four-inch hole
where the pharmacist pushes the medication through to a basket on the
customer's side of the door. (Tr. 142.)
DI Kresnak testified that inside of the pharmacy area, there is a
very large vault, approximately "eight feet wide and four feet deep
[with] a Class V door on it, which is a very heavy steel door with a
combination lock on it.'' (Tr. 142.) DI Kresnak testified that he's
never seen a vault in a pharmacy; he's only seen safes in pharmacies.
(Tr. 143.) He added, "This is a distributor's vault. This is something
that a small mom and pop distributor would have for their Schedule II
narcotics.'' (Id.) "[P]harmacies typically have "3x3 combination
safes with a door on the front.'' (Tr. 144.) DI Kresnak testified,
however, that with regards to diversion, "[t]here's nothing wrong with
being cautious, * * * .'' (Tr. 147.) He also testified that there is
nothing wrong with having that kind of security. (Tr. 156.)
DI Kresnak testified that Mr. Hillman was not present when he
conducted the roundtable and site inspection of Respondent's location.
(Tr. 152-53.) DI Kresnak arranged to meet Mr. Hillman in person, but DI
Kresnak did not show up. (Tr. 155.) As a result, DI Kresnak submitted
written questions to Mr. Hillman. (Tr. 152; see also Gov't Ex. 2.) On
March 7, 2011, Mr. Hillman submitted his responses to DI Kresnak.
(Gov't Ex. 3.) \16\
---------------------------------------------------------------------------
\16\ Although Government Exhibits 2 and 3 were admitted into
evidence by stipulation, (Tr. 7), the Government offered no
testimony pertaining to these exhibits. Nor are they addressed in
the Government's post-hearing brief. I find these exhibits generally
consistent with other evidence of record.
---------------------------------------------------------------------------
Notably, when Government counsel asked DI Kresnak if he believed
granting a DEA COR to Respondent will threaten the public health and
safety, DI Kresnak responded:
I worked in an area which diversion--I claim it as a pandemic
when it comes to prescription drugs. I have seen what it's done to
families. We talked about the history of Portsmouth in regards to
when industry was there. That was a town that you could leave your
bicycle on the sidewalks. It was a town where everybody knew
everybody. It's a ghost town when it comes to neighborly love
anymore because you have to lock everything up. You cannot leave
anything out.
The diversion problem is so bad. It's an underground economy,
sir. The underground economy is that of pills. When people have to
make their mortgage payment or their rent payment or their utility
payments and they're short, they know they can trade their medicines
for cash, for something that will help them continue to survive
until the next payday.
There is just countless numbers of incidents that I've been
involved in. I've sat at the tables and talked to the family members
of overdose victims, and yes, they'll all say that, "Yes, they took
their pills.'' But the physicians and the pharmacists that filled
those, two of them are in prison right now. It is a major problem in
that area.
It was a long answer to your question sir. It is not in the--
I've talked to civic leaders, I've talked to the police chief. They
don't want this, they feel that it is not in the best public
interest to have this apothecary in their community.
(Tr. 144-45.) After Respondent's counsel interposed a relevance
objection, stating that "this has absolutely nothing to do with
Physicians Pharmacy in Piketon, Ohio,'' (Tr. 145), Government counsel
effectively conceded the point and again asked DI Kresnak specifically,
"why will giving a registration to Physicians Pharmacy, this specific
pharmacy, in your opinion, why would that pose a threat to the public
health and safety?'' (Tr. 146.) DI Kresnak stated, "I know from the
addicts I've talked to, they can't wait for it to open.'' (Id.)
C. Respondent's Evidence
As noted above, Respondent did not produce any testimonial or
documentary evidence at the hearing, relying instead on the testimony
and evidence introduced during the Government's presentation of its
case, the majority of which involved testimony by witnesses affiliated
with Respondent.
IV. Discussion
A. The Applicable Statutory and Regulatory Provisions
The Controlled Substances Act (CSA) provides that any person who
dispenses a controlled substance must obtain a registration issued by
the DEA in accordance with applicable rules and regulations.\17\ The
CSA further provides that the "Attorney General shall register
practitioners (including pharmacies, as distinguished from pharmacists)
to dispense, or conduct research with, controlled substances * * * if
the applicant is authorized to dispense, or conduct research with
respect to, controlled substances under the laws of the State in which
he practices.'' \18\ An application for registration may be denied if
the "Attorney General determines that the issuance of such
registration * * * would be inconsistent with the public interest.''
\19\
---------------------------------------------------------------------------
\17\ 21 U.S.C. 802(10), 822(a)(2).
\18\ 21 U.S.C. 823(f).
\19\ Id. The Attorney General has delegated this authority by
regulation to the Administrator of the Drug Enforcement
Administration. 28 C.F.R. Sec. 0.100(b). See e.g. Lawrence Lerner,
M.D., 54 FR 8,014, 8,015 (DEA 1989).
---------------------------------------------------------------------------
B. The Public Interest Standard
The CSA, at 21 U.S.C. 824(a)(4), provides, insofar as pertinent to
this proceeding, that the Administrator may deny an application for a
COR if she finds that an applicant has committed such acts as would
render his registration inconsistent with the public interest as that
term is used in 21 U.S.C. 823(f). Pursuant to 21 U.S.C. 823(f), the
Administrator may deny an application for a DEA COR if she determines
that such registration would be inconsistent with the public interest.
In determining the public interest, the Administrator is required to
consider the following factors:
(1) The recommendation of the appropriate state licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under federal or state
laws relating to the manufacture, distribution or dispensing of
controlled substances.
(4) Compliance with applicable state, federal or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.\20\
---------------------------------------------------------------------------
\20\ I conclude that the reference to "other conduct which may
threaten the public health and safety'' would as a matter of
statutory interpretation logically encompass the factors listed in
Sec. 824(a). See Kuen H. Chen, M.D., 58 FR 65,401, 65,402 (DEA
1993).
---------------------------------------------------------------------------
As a threshold matter, the factors specified in Section 823(f) are
to be considered in the disjunctive: The Administrator may properly
rely on any one or a combination of those factors, and give each factor
the weight she deems appropriate, in determining whether a registration
should be revoked or an application for registration denied. See David
H. Gillis, M.D., 58 FR 37,507, 37,508 (DEA 1993); see also D & S Sales,
71 FR 37,607,
[[Page 47104]]
37,610 (DEA 2006); Joy's Ideas, 70 FR 33,195, 33,197 (DEA 2005); Henry
J. Schwarz, Jr., M.D., 54 FR 16,422, 16,424 (DEA 1989). Application of
the public interest factors requires an individualized determination
and assessment "tethered securely to state law * * * and federal
regulations.'' Volkman v. DEA, 567 F.3d 215, 223 (6th Cir. 2009).
Additionally, in an action to deny a practitioner-registrant's\21\
application for a COR, the DEA has the burden of proving that the
requirements for denial are satisfied.\22\ The burden of proof shifts
to a respondent once the Government has made its prima facie case.\23\
---------------------------------------------------------------------------
\21\ The term "practitioner'' includes pharmacy. 21 U.S.C.
802(21).
\22\ See 21 CFR 1301.44(d). "The Government has the burden of
proof in a hearing for the denial of an application for registration
by a practitioner.'' (Gov't Br. at 3.)
\23\ See Medicine Shoppe--Jonesborough, 73 FR 364, 380 (DEA
2008); see also Thomas E. Johnston, 45 FR 72,311, 72,311 (DEA 1980).
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D. The Factors To Be Considered
Factors 1 and 3: The Recommendation of the Appropriate State Licensing
Board or Professional Disciplinary Authority and Conviction Record
Under Federal or State Laws Relating to the Manufacture, Distribution
or Dispensing of Controlled Substances
In this case, regarding Factor One, it is undisputed that
Respondent currently holds a valid unrestricted pharmacy license in
Ohio. (Tr. 123.) Although not dispositive, Respondent's possession of a
valid retail pharmacy license in Ohio weighs against a finding that
Respondent's registration would be inconsistent with the public
interest. See Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (DEA 2003)
(state license is a necessary, but not a sufficient condition for
registration, and therefore, this factor is not dispositive).
Regarding Factor Three, there is no evidence that any of the
members of Respondent, including Respondent's Ohio-licensed pharmacist,
have ever been convicted under any federal or state law relating to the
manufacture, distribution or dispensing of controlled substances. I
therefore find that this factor, although not dispositive, see Leslie,
68 FR at 15,230, weighs against a finding that Respondent's
registration would be inconsistent with the public interest.
Factors 2, 4 and 5: Respondent's Experience in Handling Controlled
Substances; Compliance With Applicable State, Federal or Local Laws
Relating to Controlled Substances; and Such Other Conduct Which May
Threaten the Public Health and Safety
Regarding Factors Two and Four, the Government argues in substance
that Respondent's application for registration is inconsistent with the
public interest because Respondent's owners do not have "experience as
a pharmacist or as the owner or operator of a pharmacy,'' further
arguing that they have "demonstrated a limited knowledge of diversion
and the issues surrounding diversion.'' \24\ (Gov't Br. at 4.)
Additionally, while facially acknowledging that Respondent's pharmacist
"does have experience,'' the Government argues in substance that his
testimony at hearing "did not address the significant diversion
problem that exists with pill-pushing physicians,'' nor did he have
sufficient experience with refusing to fill prescriptions from
"unscrupulous physicians'' over his thirty-six-year career. (Id.)
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\24\ The Government conceded at hearing that the relevant
consideration under Factor Two would be the experience of the
pharmacist rather than the experience of owners or members who have
no expected operational role in the handling of controlled
substances. (Tr. 161.)
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The credible evidence of record with regard to Respondent's
ownership, operation, and employees, as it pertains to experience in
handling controlled substances, does not support a finding by a
preponderance of the evidence that registration would be inconsistent
with the public interest. As an initial factual matter, it is
undisputed that Respondent is licensed by the State of Ohio as a retail
pharmacy, and Respondent's pharmacist-in-charge, Mr. James, has been a
registered pharmacist in Ohio since 1975. (Tr. 32, 67, 80.)
Agency precedent establishes the relevant parameters of assessing
the conduct of individuals associated with a pharmacy-applicant. "DEA
has consistently held that a pharmacy operates under the control of
owners, stockholders, pharmacists, or other employees, and the conduct
of these individuals is relevant in evaluating a pharmacy's fitness to
be registered with DEA.'' Bradford's Pharmacy Conditional Grant of
Registration, 63 FR 58,418, 58,420 (DEA 1998) (pharmacist-owner
convicted of felony conduct). For example, DEA has consistently held
that a corporate registration may be revoked or denied where "a
natural person who is an owner, officer, or key employee, or who has
some responsibility for the operation of the registrant's controlled
substance business, has been convicted of a felony offense relating to
controlled substances.'' Spoon's Pharmacy, 50 FR 46,520, 46,520-21 (DEA
1985).
The evidence of record pertaining to Respondent's LLC members and
key personnel is undisputed. One former member, Mr. Wolery, credibly
testified that he is an attorney but ended his relationship with
Respondent in March 2011, but had no intention of having an active role
in the operation of Respondent. (Tr. 16.) With regard to the operation
of the pharmacy, Mr. Wolery testified in pertinent part:
Mr. James had been chosen as a pharmacist to run [Respondent]
and had been given the latitude to run it as he saw fit, and given
his experience in this matter, we felt that he was a good choice to
run this operation in a lawful manner. He had no dings, he had no
problems. He had been a manager of a pharmacy. He knew all the ins
and outs. He knew everything that needed to be known in a pharmacy,
and so we felt that he would be the right person to run it. We're
not pharmacists. We had no intentions of running the pharmacy or
telling him how to do his job.
(Tr. 16.)
A second member of the LLC, Mr. Caserta, credibly testified that he
is a retired pilot and businessman, and currently owns a fifty-percent
share in Respondent, serving as a managing partner. (Tr. 24-26.) A
third member, Mr. Hillman, credibly testified that he is a self-
employed attorney, and a current member of Respondent, having half-
ownership along with Mr. Caserta. (Tr. 97.) The testimony by Mr.
Caserta and Mr. Hillman unequivocally and credibly maintained that Mr.
James, Respondent's pharmacist, will be responsible for the handling of
all controlled substances. Testimony by Mr. James was fully consistent.
(Tr. 86-87, 92-93.) There is simply no evidence of record of any
misconduct or other "acts'' by any past or current member-owner of
Respondent, or employee that is inconsistent with the public interest.
See 21 U.S.C. 824(a)(4). Nor is there any evidence that anyone other
than Respondent's pharmacist will have an active role in the handling
of controlled substances, unless under the direct supervision of the
pharmacist.
The Government correctly acknowledges the extensive experience of
Respondent's pharmacist, Mr. James, which spans over three decades. I
find the Government's argument that Mr. James did not adequately
address in testimony the "significant diversion problem that exists
with pill-pushing physicians'' or demonstrate a sufficient
understanding of a pharmacist's
[[Page 47105]]
corresponding duties pursuant to 21 CFR 1301.04, (Gov't Br. at 4), to
be both legally and factually unpersuasive, given the evidence of
record. Of significance, it is the Government that bears the initial
burden of proof in this proceeding, not Respondent. 21 CFR 1301.44(d).
Mr. James credibly and consistently testified at hearing that
diversion is a major problem not only in southeastern Ohio, but across
the entire country. (Tr. 44.) Mr. James further testified that over his
career he has turned down two prescriptions for "personal reasons,''
explaining that to mean a refusal "to fill any prescription that our
own personal conscience thinks is not correct.'' (Tr. 36.) Of
significance, Mr. James further testified that over the course of his
career he has turned down many prescriptions for legal reasons, such as
forged prescriptions. (Tr. 60-61.) With regard to his corresponding
duty as a pharmacist, Mr. James credibly testified that he fully
understands the parameters of applicable regulations. (See e.g. Tr. 53-
60, 69-70, 85-94.) In addition to the required safeguards, Mr. James
also explained in detail his intent to employ five additional
safeguards to "verify that the prescription was indeed for a legal,
legitimate purpose, which has always been a problem.'' (Tr. 46.)
In addition to the foregoing testimony, the record also reflects
that Mr. James has extensive experience as a pharmacist in Ohio, to
include recent employment as a pharmacist at CVS Pharmacy, Columbus,
Ohio, from 2003 to 2009.\25\ (Gov't Ex. 7.) The record is devoid of any
evidence that Mr. James has had any issues pertaining to his
professional qualifications or practice as a pharmacist in Ohio from
1975 to present. Mr. James presented his testimony in a serious and
professional manner. His testimony was internally consistent and
consistent with other credible evidence of record. I find Mr. James's
testimony fully credible and in accord with his over thirty-year,
unblemished record as a licensed pharmacist in Ohio.
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\25\ In 2010, Mr. James worked as a pharmacist at HealthPro
Staffing Agency. See supra note 10.
---------------------------------------------------------------------------
The Government also argues with regard to Factors Two and Five that
"in assessing the public interest, the nature and amount of diversion
of controlled substances in a geographical area is a legitimate area of
inquiry and concern when determining whether an applicant should be
granted a DEA registration,'' \26\ citing by analogy Southwood
Pharmaceuticals, Inc., 72 FR 36,487, 36,491 (DEA 2007) (requirement for
manufacturer of controlled substances to manifest due diligence in
approving new customer). While not addressed in the Government's brief,
the statutory requirements for a manufacturer with regard to "due
diligence for new customers'' differ markedly from those imposed on a
practitioner-applicant. For example, in the case of manufacturers of
controlled substances in Schedules III through V, the public interest
factors include consideration of "maintenance of effective controls
against diversion of particular controlled substances * * * [and] the
existence in the establishment of effective controls against
diversion.'' 21 U.S.C. 823(d)(1) and (5). In addition to the statutory
differences, there are numerous material regulatory differences in the
treatment of different categories of registrants.\27\ Finally, unlike a
practitioner-applicant, "[a]t any hearing on an application to
manufacture any controlled substance listed in Schedule I or II, the
applicant shall have the burden of proving that the requirements of
such registration * * * are satisfied.'' 21 CFR 1301.44(a).
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\26\ Gov't Br. at 4.
\27\ Compare, e.g., 21 CFR 1301.74(a) and (b), with Sec.
1301.75.
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For the foregoing reasons, I decline to apply public interest
factors applicable to other categories of registrants by analogy or
otherwise, since to do so would conflict with the clear and unambiguous
statutory language that sets forth specific public interest factors
that Congress directed be considered for distinct categories of
registrants.\28\ Robinson v. Shell Oil Co., 519 U.S. 337, 340 (1997)
("[I]nquiry must cease if the statutory language is unambiguous and
'the statutory scheme is coherent and consistent.''' (citation
omitted)).
---------------------------------------------------------------------------
\28\ Cf. Cynthia M. Cadet, M.D., 76 FR 19,450, 19,450 n.3 (DEA
2011).
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In light of the foregoing, I have carefully considered the
Government's various arguments along with the evidence of record
pursuant to the applicable factors under 21 U.S.C. 823(f). In so doing,
the paucity of evidence in support of the OSC's allegations that
Respondent's registration is inconsistent with the public interest was
striking. The only Government witness called to testify in support of
the allegations contained within the OSC was DI Kresnak, who testified
in substance that he was the investigator that handled Respondent's
application for a DEA registration as a pharmacy.\29\ (Tr. 134-35.)
While generally credible, DI Kresnak offered little to no substantive
evidence as to why Respondent's registration would be inconsistent with
the public interest. On direct examination, Government counsel asked DI
Kresnak in substance why Respondent posed a threat to the public health
and safety. Initially, DI Kresnak provided a lengthy and non-responsive
answer, essentially concluding that members of the community informed
him "they don't want this.'' \30\ (Tr. 144-45.) Government counsel
again asked DI Kresnak to explain specifically why Respondent posed a
threat to the public health and safety, to which DI Kresnak responded:
"I know from the addicts I've talked to, they can't wait for it to
open.'' \31\ (Tr. 146.)
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\29\ Presumably, DI Kresnak's investigative findings would have
informed the Agency's initial decision not to approve Respondent's
application for registration, but rather to issue an OSC "as to why
DEA should not deny [Respondent's] application for a DEA
registration.'' (ALJ Ex. 1, at 1.)
\30\ Notably, other credible evidence of record establishes that
local community leaders were consulted in advance by Respondent but
apparently voiced no significant objections. (Tr. 29-30.) Of greater
relevance, Respondent is actively licensed by the Ohio Board of
Pharmacy, and also has obtained all requisite local permits. (Tr.
30, 123.) Testimony at hearing also revealed that some of the
security measures employed by Respondent, including the vault, were
put in place at the specific direction of the Ohio Board of
Pharmacy, prior to granting Respondent a license. (Tr. 16-17; 23;
49-50.) ("From what I've been told, State Board of Pharmacy said
that they wanted a certain kind of safe, and that's the one they
bought.'' Tr. 50.) The Government did not call any local or state
officials from Ohio to testify at hearing.
\31\ This served as DI Kresnak's full answer to the serious and
very relevant question asked by Government counsel, which was not
posed a third time. (Tr. 146, 157.)
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DI Kresnak's testimony demonstrates a remarkable lack of evidence
of any articulable reason to support a finding that Respondent's
application for registration may be inconsistent with the public
interest. DI Kresnak's reference to statements by "addicts'' was
devoid of context or any evidence to support the basis, let alone
credibility, for such vague hearsay statements. On cross-examination,
DI Kresnak offered little more in the way of substantive testimony
other than to suggest there might be other evidence that he was not at
liberty to share at hearing. (Tr. 152.) While DI Kresnak credibly
testified to a serious drug abuse and diversion problem in Ohio, not
unlike other regions of the United States, he offered no testimony
linking that issue specifically to Respondent or anyone associated with
Respondent. Nor did the testimony substantively address the fact that
Respondent possesses all requisite state authority to operate as a
pharmacy in Ohio.
The Government's public interest argument relative to illicit drug
abuse and diversion problems within a given
[[Page 47106]]
community, without linkage to specific conduct by a proposed
registrant, is also at odds with analogous Agency precedent. For
example, in East Main Street Pharmacy, 75 FR 66,149 (DEA 2010), the
Agency rejected as irrelevant evidence that the respondent was located
in a high crime area to include the fact that the owner-pharmacist
carried a gun. The "principle issue * * * was whether [the r]espondent
was dispensing controlled-substance prescriptions which it either knew
or had reason to know lacked a legitimate medical purpose and were
issued outside the usual course of professional practice.'' Id. at
66,155. In other contexts, the Agency has also rejected an expansive
reading of the public interest factors, focusing instead on specific
conduct or acts by the registrant. "The public interest standard of 21
U.S.C. [Sec. ] 823(f) is not a freewheeling inquiry but is guided by
the five specific factors which Congress directed the Attorney General
to consider * * * which focus primarily on the acts committed by a
practitioner.'' Gregory D. Owens, D.D.S. 74 FR 36,751, 36,757 (DEA
2009).
In the instant case, the Government's evidence of a serious
diversion problem in Ohio was credibly established through the
testimony of DI Kresnak, but there is simply no credible evidence of
record establishing that Respondent will be a contributing source of
drug diversion through any acts or omissions by any owner-member or
employee of Respondent. As the record evidence reveals, Respondent's
Ohio-licensed pharmacist-in-charge has over thirty years of unblemished
experience and expects to adhere to standards of dispensing above those
required by existing law and regulation.
The Government's further argument that the size of the "walk-in
vault'' alone supports a finding by a preponderance of the evidence
"that the pharmacy intends to do a large business in controlled
substances and this, coupled with the diversion problem that exists in
southern Ohio, would not be in the public interest'' \32\ is equally
unpersuasive. The credible testimony at hearing from Respondent's
pharmacist, Mr. James, established that he did not know the volume of
controlled substances that would be kept at the pharmacy, since there
was no way to know that until the pharmacy was operational. (Tr. 50.)
Similarly, Mr. Hillman testified that he did not know the volume of
expected sales of controlled substances until the business was
operational. (Tr. 100.) He credibly explained that he believed there
was enough business in the area for the pharmacy to be successful,
noting that if "there's not enough business, I'll go broke.'' (Tr.
122.)
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\32\ Gov't Br. at 5.
---------------------------------------------------------------------------
Although Respondent did not establish a specific quantity of
controlled substances expected to be sold once operational, it had no
burden to do so. 21 CFR 1301.44(d). The Government's argument that a
walk-in vault constitutes de facto evidence of the volume of controlled
substances Respondent will handle, and further proof that this will
contribute to the diversion problem in southern Ohio is at best
speculative. "Speculation is, of course, no substitute for evidence,
and a decision based on speculation is not supported by substantial
evidence.'' White ex rel. Smith v. Apfel, 167 F.3d 369, 375 (7th Cir.
1999) (citing Erhardt v. Sec'y, DHS, 969 F.2d 534, 538 (7th Cir.
1992)). More importantly, the Government did not prove by a
preponderance of evidence at hearing that Respondent's handling of
controlled substances, whether in a large volume or small, would be
contrary to applicable state and federal law. In fact, testimony from
DI Kresnak pertaining to various precautions Respondent's pharmacist
intended to take to prevent the diversion of controlled substances were
"above what DEA requires.'' (Tr. 148.) DI Kresnak also testified that
there was nothing wrong with the kind of security measures taken by
Respondent to protect against diversion. (Tr. 147.)
After careful consideration of the entire record, I find that the
Government has failed to establish by a preponderance of the evidence
any acts or demonstrable conduct by any member or employee of
Respondent, that would support a finding by substantial evidence that
Respondent's registration would be inconsistent with the public
interest as that term is used in 21 U.S.C. 823(f). I therefore find
that Respondent's registration under Factors Two, Four, and Five would
not be inconsistent with the public interest.
V. Conclusion and Recommendation
I find that the Government has not established by substantial
evidence a prima facie case in support of denying Respondent's
application for a DEA COR as a retail pharmacy. The Government has
failed to demonstrate by a preponderance of the evidence that such
registration would be inconsistent with the public interest as that
term is used in 21 U.S.C. 824(a)(4) and 823(f). Accordingly, I
recommend approval of Respondent's application for a DEA COR as a
retail pharmacy pursuant to 21 U.S.C. 823(f).
Dated: December 15, 2011.
Timothy D. Wing,
Administrative Law Judge.
[FR Doc. 2012-19221 Filed 8-6-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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