Compounding Matters Quarterly - Spring 2015

IACPRx.org/Publications | Spring 2015
Six Things I Have Learned From
Compounding Pharmacy Crises
The Personality of Personalized Care
IACP Foundation History
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IACP STAFF
David G. Miller, R.Ph.
Cynthia E. Blankenship, Esq.
Dagmar Anderson
Contents
4
A NOTE FROM THE PRESIDENT
Scot Maitland
Jennifer L. Petska, CPhT
Ashlyn Grant
Michelle McMahan
Macy Pruitt
Teresa Roberts
COMMUNICATION COMMITTEE
Richard B. Moon, Pharm.D., R.Ph.,
FIACP, Chair
Lisa Ashworth, BS, Pharm.D., R.Ph.
Kim Hansen, R.Ph.
Robert Harshbarger, III, Pharm.D.
James Matthias, CPhT
Linda McElhiney, Pharm.D., R.Ph.,
FIACP, FASHP
Lauren Onsa, BA
Andy Ruiz, Pharm.D., MSc, FACA
Scott Wepfer, R.Ph., FIACP
PHOTOGRAPHY
Melea Kirk
Scot Maitland
DESIGN
Dianne Stone
6
10
15
18
20
28
SIX THINGS I HAVE LEARNED FROM
COMPOUNDING PHARMACY CRISES
by David A. Ball
THE MEMORANDUM
OF UNDERSTANDING
What It is, What It Says,
And What Happens Next
by David G. Miller, R.Ph.,
Executive Vice President & CEO
THE MOU – A PHARMACIST’S PERSPECTIVE
by Scott Karolchyk, MS, RPh, FIACP
PERSONALITY OF PERSONALIZED CARE:
LOREN MADDEN KIRK
by Scot Maitland
IACP FOUNDATION HISTORY PART 1 2015
by Lisa D. Ashworth, BS Pharm, RPh
SAVE THE DATE FOR THESE
UPCOMING PROGRAMS
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Compounding Matters Quarterly is published
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however, this publication may contain
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errors. The reader assumes all risk concerning
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within this publication. Compounding Matters
Quarterly assumes no responsibility for and
disclaims all liability for any such inaccuracies,
errors or omissions in this publication and
in other documents referred to within or
affiliated with this publication.
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A NOTE FROM THE PRESIDENT
Compounders on Capitol Hill is just around the corner. If you have not yet
made plans to attend, I would like to offer my top ten reasons you should
sign up NOW:
10. Discounted Travel – get discounted travel by visiting IACPRx.org/CCH
and click on meeting discounts.
9. We’re Back in DC – IACP has moved Compounders on Capitol Hill
back to Washington D.C.!
8. Get Away from the store to get re-energized and spend some time
in our nation’s Capitol, and possibly consider bringing the family for
some sight-seeing.
7. The Rx Mixer – a fun-filled night of casino games, music, dancing and
live auctions to raise funds for the IACP Foundation. One highlight
each year is the excitement created by Bob Brensel at the craps table.
6. Networking – an opportunity to network with some of the brightest
minds in the compounding industry. Don’t forget those business cards!
5. Exhibit Hall – Did you know that IACP as more than 70 Corporate
Partners? These are vendors offering every service imaginable for
compounding pharmacy. This is your opportunity to stay abreast of
the new services and innovations in compounding.
4. Continuing Education Credits – The opportunity to catch up on live C.E.
3. Legislative and Regulatory Updates – Learn the latest in Federal and
State proposed and adopted legislation that affects our ability to
provide compounding services to our patients.
2. Litigation Updates – No getting around the fact that there is always
ongoing or pending litigation in our industry.
1. Visit With Your Elected Officials – This is always the number one
reason IACP conducts this annual event. I can’t overestimate
the importance of developing relationships with your elected
representatives and their staff persons. I have found that developing
a relationship with a key staff member is just as important as the
relationship with the Representative or Senator.
The health policy advisor for one of my Senators was in constant
contact with me when legislation was being drafted, and later became
the Drug Quality and Security Act. This person was so interested in
knowing more about the compounding industry that he scheduled a
visit at my pharmacy. Did we eventually get what we wanted? NO. But
we were part of the process, and we developed relationships that will
help in any future legislation. Please, if you do plan on attending CCH
this year, stay for Hill Day on Tuesday, because, in the final analysis,
that is THE reason we go to Washington each year.
4 Spring 2015 | IACPRx.org/Publications

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©2014 Partnership for Personalized Prescriptions. All rights reserved

SIX THINGS I HAVE LEARNED
FROM COMPOUNDING
PHARMACY CRISES
by David A. Ball
Our firm has worked with compounding pharmacies
across the country in dealing with a multitude of crises,
including patient deaths, product contamination, recalls,
FDA warning letters, state board of pharmacy ceaseand-desist
orders, indictments, and civil actions.
We believe strongly in the mission of compounding
pharmacies because their work is vital, and they sustain
and save lives. Since the New England Compounding
Center tragedy in 2012, this profession has been under
attack in a way experienced by few others.
Compounding pharmacies today operate in one of
the most highly regulated environments, and they are
subject to review, inspection, and scrutiny like few
other organizations. At the first hint of an issue with
the quality of a product, a cascade of events begins
that could result in a pharmacy’s temporary or
permanent closure. Sometimes the outcome is worse,
and a pharmacist can be charged with a crime or
personally sued.
All businesses have inherent risks, such as larceny,
fire, and flood, and pharmacies must manage against
those risks. The risks that are specific to compounding
pharmacies add an entirely separate and new layer of
complexity.
In thinking back to all of the pharmacies that we have
been honored to help deal with a crisis, there are six
clear lessons.
1. Putting Potential Crises Out of Mind is Not
A Strategy—Nobody ever wants to think the
unthinkable will happen to them. The odds are,
however, that a compounding pharmacy will be
confronted with a crisis because there are simply so
many things that can go wrong. It is imperative for
compounding pharmacy owners to think through the
scenarios and how they would deal with them, and to
have a crisis plan that is regularly updated on which
staff are briefed and frequently drilled.
2. Budget for a Crisis—The one thing you will need
above all else in a crisis is money. The experts to
guide you, including clinical consultants, lawyers,
recall specialists, and public relations practitioners,
will be costly. If you need to lease satellite space, put
a modular lab in place, or make emergency repairs,
the costs will be even greater. Lastly, in most cases,
once a crisis begins, the revenue stops. Either because
a regulatory agency has shut the pharmacy down
or because of a loss of customer confidence. Either
way, you will need funds to get by and to take care of
loyal staff. Every pharmacy should have a significant
financial reserve and have access to a credit line.
Don’t wait for a crisis to apply for a credit line,
because you likely won’t get one. Have a credit facility
in place.
3. IT is the Backbone of Your Business—Data is king,
and having access to it in a crisis is essential. IT
investment should be a priority for your compounding
6 Spring 2015 | IACPRx.org/Publications

pharmacy because it will enable your business to
grow. Its value in a crisis multiplies. The right database
can have a huge impact if you need to contact all
customers or implement a recall. Making sure that
data is backed up in a safe, accessible, off-site
location is key.
4. Evaluate Your Insurance—How much is enough
insurance for a compounding pharmacy? Whatever
your answer is, it likely needs to be doubled or tripled.
An independent insurance expert should review your
business and its needs and make recommendations
about the right level of coverage. Before filing an
insurance claim, a public insurance adjuster can
provide the expertise you need to ensure fairness in
the claims process.
5. Have Your Experts on Hand—Now is the time to build
professional relationships that can be a lifeline in a
crisis. If you are a compounding pharmacy and your
only attorney is the real estate lawyer who reviews
your lease or the labor attorney who writes your offer
letters, establish a relationship with an attorney that
has the regulatory experience needed to successfully
interact with the federal and state agencies that
would be involved in a crisis. Identify a public relations
practitioner who has crisis management capabilities –
if you engage them to develop a crisis plan there will
be no ramp-up time in a crisis.
6. Keep the Lines of Communication Open with
Patients and Providers—Many organizations in
crisis forget how important it is to keep customers
informed during a crisis. Your website and social
media sites are excellent vehicles for keeping the
public apprised of your challenges and how you are
dealing with them. In our experience, loyalty will be
retained as long as the pharmacy keeps in contact
with its key constituents.
This is a new age for compounding pharmacies.
The public demands the highest level of quality and
compounders are providing it. Still, things can go
wrong. Often, they will be things over which you
have no control.
So give yourself some control.
It is essential to be prepared for whatever may come
your way. If you are ready, you will likely weather
the storm.
David A. Ball is President of Ball Consulting
Group, LLC, a public relations and crisis
management firm that serves the
compounding pharmacy profession.
How PR Can Have an Impact
In much the same way that a slow drip from the hot
water heater can quickly evolve into a ruptured tank
and a basement with six feet of water, the New England
Compounding Center (NECC) crisis began in Fall of 2012
with one or two isolated calls to IACP from reporters
wanting to learn more about compounding pharmacies.
It seemed that there was a meningitis outbreak relating
to a large compounding facility west of Boston and that
there were now patient deaths being reported.
Those early media calls led to a tidal wave of
international media interest, as hundreds of patients
took ill, and deaths began to be reported by the CDC
seemingly every day. As details emerged about unsafe
practices at NECC and a lack of government oversight,
journalists were demanding answers, soon to be
followed by members of Congress.
IACP’s objective was clear: to educate the public
about the compounding pharmacy profession and to
demonstrate that the practices of NECC were in no way
representative of the profession. A backlash that could
have prevented patients from getting their medications
and potentially put compounding pharmacists across
the country out of business had to be stopped.
The volume of media calls for an association with a lean
staff was overwhelming. CNN, Reuters, CBS, NBC, ABC,
Associated Press, The New York Times, The Washington
Post, The Wall Street Journal and hundreds of other
outlets all wanted access and answers. They were
waiting for the profession to say something.
The risk of being unresponsive in a crisis like that is
a loss of credibility among media and the members.
Journalists remember not getting their calls returned
and to do so would limit IACP’s future access to
the media. Moreover, if the message could not be
perfected and provided, the entire profession would
be under an assault that would have deep and farlasting
consequences. A black mark would forever be
associated with the practice of compounding pharmacy.
“For those who lead associations, you often have an
intuitive feel about when an event is so extraordinary
that outside help is urgently needed,” said IACP EVP
& CEO David G. Miller, RPh. “We needed help, our
members needed help, and we activated a plan to bring
in the resources that we needed to gain control over the
situation.”
IACP engaged Ball Consulting Group, LLC, a public
relations and crisis communications firm in the Boston
area that had experience in, and familiarity with,
compounding pharmacy issues. The firm came up
with a strategy for dealing with the crisis. It developed
messages, issued statements, prepared IACP leaders
for media interviews, and ensured that every media call
would get a response.
Continued on page 9
IACPRx.org/Publications | Spring 2015
7

E D U C A T I N G A D V O C A T I N G N E T W O R K I N G
J U N E 6 - 9 , 2 0 1 5 ~ W A S H I N G T O N , D C
J U N E 6 - 9 , 2 0 1 5 ~ W A S H I N G T O N , D C
R E N A I S S A N C E WA S H I N GT O N , D C
To register for CCH, visit
i a c p r x . o r g / c c h
©2014 International Academy of Compounding Pharmacists (IACP). All rights reserved.

REFILL
Continued from Page 7
“NECC came as a complete shock to us,” said David Ball,
President of the firm. “In our many years of working with
the pharmacy profession, we saw the healing, helpful
work of compounding pharmacists. Now here was a
situation that didn’t just contain one element of a crisis,
it had virtually all of them: alleged violations of federal
and state law; cover-ups and obstructed investigations;
patient injuries and deaths; and investigators,
prosecutors, and former employees ready to talk about
the wanton disregard for professional standards and
horrific safety violations that occurred there.”
“We could not let the actions of NECC define this
profession,” Ball said. “We put in place a strategy that
maintained open lines of communications, provided
journalists with essential information, and we made clear
with our messaging that NECC in no way represented
what this industry is about; that NECC, according to the
government, was an illegal manufacturer disguised as a
compounding pharmacy to evade public oversight.”
“We also needed to remember at every turn,” Ball said,
“that this was a national tragedy that took the lives of 64
good people – mothers, fathers, sisters, brothers – and
that sickened almost 700. While the profession at large
and its association were not to blame, we had to be very
sensitive in everything that we said and did. The level of
human suffering, not only by the victims but among the
families that depended on them, was immense.”
The strategy enabled IACP to get a handle on the
situation and ultimately prevented that feared backlash.
While Congress did ultimately enact the Drug Quality
and Security Act, the law identified a continued vital role
for compounding pharmacy – a vast improvement over
earlier dialogue around eliminating the practice of sterile
compounding pharmacy altogether.
With the crisis under control, a second phase of the
strategy involved a media tour that enabled IACP to
educate the media and the public about the continued
need for compounding and that emphasized the high
quality work and rigorous standards currently in place.
One-on-one meetings were conducted with journalists
from Boston, New York, Washington, D.C., and Los
Angeles, and everywhere in between.
IACP and its members have emerged from the cloud
created by one rogue enterprise. The organization
has taken a position at the forefront of Congressional
dialogue over the implementation of the Drug Quality
and Security Act, and the profession continues to enjoy
significant growth.
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IACPRx.org/Publications | Spring 2015
9

THE MEMORANDUM
OF UNDERSTANDING
What It is, What It Says, And What Happens Next
by David G. Miller, R.Ph., Executive Vice President & CEO
In 1997, the Food and Drug Administration
Modernization Act (FDAMA) was enacted by Congress.
In addition to addressing ways to streamline the
drug approval process for branded medications, it
also included the first language providing for federal
oversight over compounding pharmacy practice.
We short-hand reference that language as 503A to
designate its section appearance within the Food,
Drug, and Cosmetics Act (FDCA).
In order to be exempted from specific requirements
for the marketing of “new drugs” – which compounds
are considered to be by the FDA – pharmacists and
physicians must comply with several sections. This
includes the use of bulk ingredients, the preparation
of “copies” of commercially available medications,
and the monitoring of interstate distribution through
a memorandum of understanding (MOU).
The MOU language of FDAMA’s 503A provided for
three things. First, a template would be developed
by the FDA and the National Associations of Boards
of Pharmacy (NABP) for the states to use. Second,
that the MOU would address “inordinate amounts” of
compounded drug products. Third, that a state agency
would be responsible for investigating complaints
about compounds sent in interstate commerce.
Fourth, that in the absence of an executed MOU, a
traditional compounder – defined as both a physician
and a pharmacist – would be automatically limited
to distributing no more than five (5) percent of their
compounds out-of-state.
Shortly after FDAMA was enacted and before many
of the provisions of 503A could be put into place, it
was challenged in court, because of language that
prevented advertising, marketing or even discussions
about compounded medications between physicians
and pharmacists.” In a landmark Supreme Court ruling
that section of 503A was deemed an unconstitutional
restriction of free speech in 2002 (Thompson,
et.al. v. Western States Medical Center et. al.). The
Court decided the case based upon an appeal by
the Department of Health and Human Services that
originated within the Ninth Circuit where 503A was
essentially nullified in its entirety throughout the states
of California, Washington, Oregon, Alaska, Hawaii,
Arizona, Idaho, Montana, and Nevada.
Even though, a draft MOU had been circulated to States
in the late 1990’s, the existence of the Western States
challenge essentially put all further work on hold. The
case was decided, and so many states were no longer
required to engage in a discussion of an MOU with the
FDA. As a result, all work on developing, negotiating,
and instituting the FDAMA MOU stopped.
That remained the case until the enactment of the Drug
Quality and Security Act of 2013. In passing DQSA,
10 Spring 2015 | IACPRx.org/Publications

Congress removed the unconstitutional clause that had
resulted in the original court challenge and reaffirmed
the remaining language of 503A. For the first time since
2002, section 503A was the law throughout the country
and work started again to develop the template for the
MOU. Released formally for initial public comment on
February 18, 2015, the MOU is still “a work in progress.”
WHAT DOES THE LAW SAY
Before examining the draft language of the proposed
“new” MOU, it’s important to look closely at what the
language of 503A says.
• There’s no prohibition on interstate distribution.
The first part of the 503A language requires
that an MOU be put in place that addresses the
interstate distribution of compounded preparations.
It does not say prohibits or prevents or any other
language that would disallow such an act by a
traditional compounder. Just that this issue must be
“addressed” in the MOU. Nothing in the language
mandates that the FDA be involved, or reported
to by a state agency, or anything other than the
MOU has to in some manner deal with interstate
shipments.
• It specifically cites the term “inordinate amounts”.
The MOU is intended to address (not prevent or
prohibit) an undefined and nebulous quantity of
compounded medication deemed “inordinate.”
THE MOU PROVISIONS IN §503A OF
THE FOOD, DRUG, AND COSMETICS ACT
(B) such drug product is compounded in a State–
(i) that has entered into a memorandum of
understanding with the Secretary which addresses
the distribution of inordinate amounts of
compounded drug products interstate and provides
for appropriate investigation by a State agency of
complaints relating to compounded drug products
distributed outside such State; or
(ii) that has not entered into the memorandum
of understanding described in clause (i) and the
licensed pharmacist, licensed pharmacy, or licensed
physician distributes (or causes to be distributed)
compounded drug products out of the State in
which they are compounded in quantities that do
not exceed 5 percent of the total prescription orders
dispensed or distributed by such pharmacy or
physician.
The Secretary shall, in consultation with the National
Association of Boards of Pharmacy, develop a
standard memorandum of understanding for use by
the States in complying with subparagraph (B)(i).
IACPRx.org/Publications | Spring 2015
11

and possibly through this language acknowledged
that office-use sales or distribution is what is
actually to be addressed.
These three points of law will no doubt form the basis
of any legal challenge to the MOU and where the line is
between federal authority over mail-order prescription
services.
THE 2015 DRAFT MEMORANDUM
OF UNDERSTANDING
The FDA distributed a draft MOU on February 13,
2015 and then subsequently filed that document with
the Federal Register on February 18, 2015. The public
– including all health care stakeholders, regulatory
agencies, consumers – are invited to review and submit
comments on the draft no later than June 18, 2015
through the regulations.gov website. As proposed,
the MOU goes far further than the language enacted
by Congress, imposing substantial actions by state
regulatory agencies that agree to sign the MOU.
It’s important to understand that until those comments
are reviewed and considered by the FDA, the MOU still
does not officially exist. A revised draft may be offered
for additional comment. A revised draft may go directly
to the states for signing. The original draft, without
any changes to content regardless of the comments
submitted, may be presented to the states for signing.
What’s contained in the draft?
There is no scientific basis for the determination of
what that means, especially given the varied nature
of pharmacy practice and the geographies of states
which are contiguous to multiple states where it’s
not uncommon for patients to use an out-of-state
pharmacy to meet their medical needs (e.g., New
England, the Mid-Atlantic regions). Without specific
definition by Congress, this is up to substantial
interpretation or guesswork by a regulatory agency,
, the FDA, or by the state agency that is entering
into the MOU. It is entirely possible that “inordinate”
may have two distinctly different meanings to each
of those entities.
• The law uses the terms “dispense” and
“distribute.” These terms are not synonymous
and are specifically used in different ways by
Congress, further indicating that they are not
interchangeable. Dispensing is a formal act by a
pharmacist or other practitioner authorized to
fulfill a valid prescription for a patient or, in some
states, an office-use medication as defined both
at the state level and within other sections of the
FDCA. Distribution, meaning a sales transaction, is
also similarly defined within the FDCA. As written
in 503A, the MOU is intended to address the latter.
No mention is made of the former proper and legal
dispensing of medications. It does not appear that
Congress intended to in any manner limit legal and
appropriate interstate dispensing of valid patientspecific
compounded preparations, at a minimum,
REQUIRING STATE OVERSIGHT
In the draft of the MOU, if a State enters into an MOU
with FDA, the State where the pharmacist, pharmacy,
or physician is located must investigate complaints
received regarding compounded medications
distributed outside the State. Complaints that the
State must investigate include adverse drug experiences
or product quality issues that could lead to public
health risks:
• An adverse drug experience can include an adverse
event occurring in the course of the use of a drug
product in professional practice; an adverse event
occurring from drug overdose, whether accidental
or intentional; an adverse event occurring from
drug abuse; an adverse event occurring from
drug withdrawal; and any failure of expected
pharmacological action.
• A product quality issue can include any incident
that causes the drug product or its labeling to be
mistaken for, or applied to, another article; any
bacteriological contaminations; any significant
chemical, physical, or other change or deterioration
in the distributed drug product; or any failure of one
of more distributed batches of the drug product to
meet the applicable specifications. Contamination
including mold, fungal, bacterial or particulate
contamination is a product quality issue.
The State investigation must include a determination of
whether there is a potential public health risk or safety
concern associated with the compounded medication
and confirmation that any risk or safety concern is
adequately contained. If a complaint is found to be valid,
the State must take action to require the pharmacy
12 Spring 2015 | IACPRx.org/Publications

to determine the root of the problem and correct the
issue, must notify FDA within 72 hours of receiving any
complaint, and keep records of their actions for at least
three years.
Is that what the law, as written by Congress, says? While
it places the responsibility for investigation of complaints
squarely within the jurisdiction of the state agency, most
likely the state Board of Pharmacy, it does not mandate
or provide for a required reporting to the FDA within a
specific time frame, nor does it define what constitutes
a complaint, nor does it mandate recordkeeping. Is that
what Congress truly intended? That question may have
to be answered in the courts.
Of particular concern to many Boards of Pharmacy
is this: there will be a substantial financial burden to
hire new investigators, new staff, and new technical
infrastructure to comply with these requirements. This
new “unfunded mandate” may have the untoward effect
of preventing a state from even considering the MOU
solely upon the basis of an economic impact on budgets
that are already struggling with increased expenses.
DEFINING INORDINATE QUANTITIES
AND THE STATES’ RESPONSIBILITY
In addition to the reporting requirements for adverse
drug reactions or quality issues, the draft MOU
requires that a State review compounding records
during inspections. They need to determine whether
the pharmacy, pharmacist or physician is distributing
inordinate amounts of the compounded medications
interstate. This is where the definition of “inordinate
amounts” appears for the first time:
• “Inordinate Amount”–If the number of units of
compounded human drug products distributed
interstate in a calendar month is equal to or greater
than 30% of the number of units of compounded
and non-compounded drug products distributed or
dispensed both interstate and interstate.
– The only exception to this rule – prescriptions that
have been dispensed to an out-of-state patient at
the facility in which the drug was compounded,
and the patient or the patient’s agent carries
that across state lines, are not counted in the
calculation.
If the State determines that the pharmacy, pharmacist,
or physician has in fact distributed inordinate amounts
of compounded drugs interstate, the State must notify
FDA within seven days. The State must also take action
against the pharmacy, pharmacist, or physician that may
include a warning letter, enforcement action, suspension
or revocation of a license, or other action consistent with
State law. The FDA may also take action against the
pharmacy, pharmacist, or physician.
There’s another important issue here that may require
judicial interpretation. The language of 503A specifies
that the issue or distributing “inordinate amounts” be
“addressed”; as proposed in the draft MOU, it requires
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IACPRx.org/Publications | Spring 2015
13

specific action against the compounder. That isn’t
what the law says. Nothing in the law says that a state
agency has to take any action—including reporting
their findings to the FDA within a seven-day period.
Most importantly, in this draft FDA has defined
“distribution” to include individual patient-specific
prescriptions. That’s dispensing and something that
the law clearly cites as being different.
WHAT’S MISSING?
Section 503A applies to all traditional compounders
and specifically defines those as pharmacists and
physicians. Nothing in the proposed MOU addresses
physician compounding activities nor does it address
the jurisdictional conflict between a state Board of
Pharmacy and a state Board of Medicine. Who will be
responsible for monitoring physicians? Who will be
responsible for collecting adverse event reports? Will
this be shared between multiple state agencies? If so,
what additional cost burden will a state incur in trying
to implement the proposed MOU?
The definition of a traditional compounder is also
important to keep in mind because the MOU provides
for actions against a pharmacist, a physician, and a
pharmacy. Nothing within 503A includes the physical
practice location as subject to the oversight of the FDA.
Of particular concern is the noted absence of possible
actions against a medical practice, an ambulatory
surgery center, a hospital or any other practice location
for physicians. Only pharmacies.
CompoundConf_.25pgAD_3.625x4.75_ad_r3x_Layout 1 11/18/14 5:52 PM Page
SAVE
THE DATE!
August15, 2015
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The Compound Conference is the only conference annually
partnering with a state pharmacy association, bringing together
the leaders in the pharmacy compounding profession.
WHAT HAPPENS NEXT
The timeline for the MOU and its eventual
implementation is still unclear. What we do know at
this point is that all comments on the draft must be
submitted to the FDA no later than June 18, 2015. After
that, the FDA will publish the final MOU and begin
circulation to the states for review and adoption.
The unknown: when will that happen and how long
will that take?
Once the states have received the MOU, each state will
need to follow its internal process for review, negotiation
of terms, and whether or not to agree to the MOU. That
process varies significantly from state to state and will
no doubt involve Boards of Pharmacy and Medicine,
Attorneys General offices, and potentially legislatures.
That may involve state-level hearings that are subject to
public notification and publication requirements. Those
hearings may need to occur at multiple occasions and
could result in requests for changes to the MOU as the
impact on both in-state businesses and consumers are
addressed.
The unknown: when will that happen and how long
will that take?
Given that the ability to execute the MOU is dependent
upon a state’s agreement to take on the additional
reporting burdens, and the costs associated with those,
state budget changes may be required. That involves
submission by the Governors’ offices to the legislature,
hearing and review and eventual voting by the
legislators, and then the allocation of those resources.
The budget process in most states lasts for a good year.
The unknown: when will that happen and how long
will that take?
There are already sufficient discrepancies between
the intent of Congress, the law as written within 503A,
and how the draft MOU has been presented for public
comment. Although the MOU does not yet formally
exist, there is no real cause for petitioning a court for
redress. However, once it is final and, states begin to
take it up for consideration the clock begins to count
down for when a pharmacist or physician may be
harmed professionally or economically by the language
and can take the judicial remedy. FDAMA was enacted
in 1997. It took five years for court challenges to be
resolved. Might the new MOU trigger another five-year
court challenge by pharmacists, physicians, and even
states themselves?
That’s also an unknown–and one that will be uppermost
on the minds of all those impacted by these four lines
of law in the DQSA.
iacprx.org/TheCompoundConference
©2015 The Compound Conference. All rights reserved
106.14.158 IACP Compound Conference –.25 Page 4/c (3.625 x 4.75”) –IJPC • bertsDesign 713.825.5002
David G. Miller, R.Ph., IACP’s Executive Vice
President and CEO, works with our volunteer
Board and leadership to set and execute the
IACP agenda. Whether working on legislation on
Capitol Hill, acting as compounding pharmacy’s
liaison to other pharmacy and medical
organizations, or defending against overzealous government
regulation, his primary responsibility is always keeping the
professional and proprietary business interests of IACP
members first and foremost.
14 Spring 2015 | IACPRx.org/Publications

THE MOU:
A PHARMACIST’S
PERSPECTIVE
by Scott Karolchyk, MS, RPh, FIACP
On Friday, February 13, 2015, the Food and Drug
Administration released four guidance documents that
further explain the regulatory framework the agency
intends to use in enforcing the Drug Quality and Security
Act (DQSA). One of them is the Memorandum of
Understanding (MOU).
After reviewing FDA’s most recent MOU regarding a
30% interstate shipping cap restriction for pharmacies,
it begs the question: what are we trying to accomplish
with this new rule? DQSA is supposed to increase patient
safety and quality of sterile compounding, yet the MOU
does nothing to address these issues. It reduces patient
access, restricts interstate commerce and punishes
successful law abiding pharmacies. Compounding
pharmacies were already regulated heavily before
DQSA by our state boards of pharmacy, the FDA, out of
state boards of pharmacy, NABP, and our accreditation
associations.
The intent of the original MOU was to limit compounders
from becoming manufacturers, by limiting office use. The
newly issued MOU includes patient specific, dispensed
scripts. The rules have changed with no scientific or
evidence basis. There should be no limit to shipping
scripts across state lines as long as the pharmacy follows
the laws of both their state and that of the state where
the patient resides. The cap is a more restrictive 5%
if a state fails to sign an agreement – a memorandum
of understanding – with the FDA. This MOU has
emboldened certain compounders’ arguments that
other compounders should only work within their state. I
disagree for reasons outlined in this article and because
of principle and what’s a right of pharmacy. That attitude
has been prevalent in all areas of the business when one
person is more successful than another, and it’s shortsighted,
ignorant and wrong. If you are good at what you
do, follow the regulations and laws of your state and the
state you are shipping into, there is no difference where
your patient lives.
Patient access to medically necessary treatments will
be compromised and limited. Compounding pharmacies
are not interchangeable. Many medication formulas
are proprietary and require highly trained formulators,
pharmacists and technicians to prepare these doses in a
safe and effective manner. Expensive capital equipment
and adhering to accreditation standards are additional
factors that set apart these pharmacies. The advent
of modern technology and logistics has created the
opportunity to service any patient’s custom medication
needs from a centralized pharmacy location. With next
day FedEx (and in emergencies same day delivery) and
E-prescribing, the patient experience has been elevated
to having the convenience of home health care services
within 24-72 hours. The triad relationship is the same
whether the patient lives in your state or across the
country.
The implementation of this MOU is an unfunded
mandate, implemented by an agency of the Federal
Government with no authority to tax or set fees. The
State Boards of Pharmacy would incur additional costs
to monitor and enforce these provisions, depending on
whether a pharmacy is using the 5% or 30% standard
and whether the home state signs the MOU. Limited
resources are already near bandwidth and in some
states already maxed so one can only imagine the extra
taxpayer dollars this added requirement would cost.
The main argument is that the proposed MOU does not
increase patient safety or quality. In fact, these new
proposals seem to benefit Big Pharma, especially where
Avastin compounding is concerned and how Big Pharma
is influencing the proposed changes. When recently
asked by a New
York Times reporter if I had proof of this statement,
I answered that there was no proof I was wrong.
The implementation of any MOU would force pharmacies
to turn away the patients they serve. How do they
explain this to their loyal and trusted prescribers that
IACPRx.org/Publications | Spring 2015
15

eside outside their state? Where will patients find
pharmacies willing and able to serve them, case by
case? Will they be accredited? Will they have the
expertise and capability to prepare the treatments? But
more importantly, uniformed ‘experts’ and lobbyists for
Big Pharma have recently weighed in on this issue: ‘The
landscape is shifting,” says Gabrielle Cosel, the manager
of drug safety at Pew Trusts. “Access is very important,
but you don’t want to preserve access at the expense
of quality and safety.” This is a telling statement in
America, proactively limit and restrict compounding
in case something happens in the future. Exactly
how does an MOU increase quality and safety? The
FDA prides itself on being evidence based, but there
is no scientific evidence on where these restrictive
percentages originated.
One final thought about drug safety and quality: while
the FDA has set its’ eyes on compounding pharmacies,
Hospira has had 52 recalls since January 2014, including
IV bags of saline. It seems their primary mandate from
Congress needs to be addressed. Your voices are
needed by the patients you serve, by the physicians you
assist, by the health professionals you work with and
by your colleagues and IACP. IACP is collaborating with
other pharmacy groups and the medical associations,
which recognize there are numerous problems and
unanswered questions which will jeopardize and affect
patients and their access to needed medications.
Speak up, write and send comments to IACP and your
representatives and attend Compounders on Capital Hill
this June. If not now, when?
David Miller, EVP of IACP, recently wrote in article that
appeared in the winter 2015 Compounding Matters
Quarterly that the MOU’s potential for disrupting patient
access isn’t limited to pharmacies. Section 503A applies
to all practitioners engaged in compounding in all
settings – doctors, nurses, physician assistants, dentists,
hospitals, surgery centers – the MOU will apply to then
as well. Since the MOU is being created by the FDA in
conjunction with the National Association of Boards of
Pharmacy, IACP is asking “how will each state board of
pharmacy will oversee compliance with that agreement
when they have no authority over doctors, nurses,
dentists, etc?”
Scott Karolchyk, MS, RPh, FIACP is VP of
Formulations at QmedRx Compounding
Pharmacy in Maitland, Florida. He is a past
President of IACP and has worked in and
taught compounding for the past 30 years.
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16 Spring 2015 | IACPRx.org/Publications

PERSONALITY OF PERSONALIZED CARE:
LOREN MADDEN KIRK
by Scot Maitland
Photo by Melea Kirk
Welcome back to another edition of The Personality
of Personalized Care. This issue we reached out to one
of our student members of IACP, Loren Madden Kirk.
Loren is a pharmacy student at East Tennessee State
University, and I met him several years ago at IACP’s
Compounders on Capitol Hill when he was interning
for PCAB. I caught up with Loren right before the
APhA trade show in San Diego.
Scot Maitland: Loren, I have the benefit of not just
being a colleague of yours, but your friend too. So I
know that you’re more than just a pharmacy student.
You posted a photo on Facebook, which started
this conversation, can you tell our readers about
the photograph?
Loren Madden Kirk: So, I’ve ridden horses competitively
in multiple different disciplines since I was seven. When
I would try and escape pharmacy school or try and get
pharmacy school off my mind, I would go out to the
barn, and I wouldn’t be able to necessary escape that.
I wouldn’t be able to forget about my to-do list. Or all
of the things that I needed to study before an exam.
Even on horseback, when I used to be able to be able
to experience was the escape. Where I didn’t have to
think about anything except me and the horse and what
was going on underneath me. And what was going on
with the horse, how fast they were going, how slow they
were going, what they were looking at. But like I said,
it has now become autopilot. I’m no longer focused on
the horse. I was focused on what I was supposed to be
18 Spring 2015 | IACPRx.org/Publications

doing instead of what I was doing right then and there on
the back of a horse.
So my solution to that was to try something new. So I
had a break here, for spring break, and I the coach of
the North Carolina Polo Team. And asked him if I could
have a few lessons. And he offered a spot, and I went out
and I took my first two polo lessons. Polo is, in my mind,
attractive for two reasons. It’s something new; I hadn’t
tried it before. And two it adds the element, a completely
different element, that you’re hitting a ball from atop
a horse, which is unique to any other horse discipline.
There’re not many other ways of riding that involves
hitting a ball into a goal from the top of a horse.
SM: I think it’s brilliant that you took something that you
love, but was becoming stale for you and mixed it up.
You found a new way revitalize it. I know our readers
can take a lot from that because pharmacy can get that
way. It can become monotonous, compounding in the lab
or behind the counter. Even doing patient consults can
become tedious, and you can lose your passion for it. I
think one of the great things about pharmacy today is the
variety it offers. As I mentioned at the beginning of the
interview, I met you when you were interning for PCAB
and Compounders on Capitol Hill. What other things have
you been up to as part of your student career?
LMK: Since my time at the Pharmacy Compounding
Accreditation Board, I’ve begun to focus on the broader
aspects of pharmacy. I’ve worked primarily with the
American Pharmacist Association’s Academy of Student
Pharmacists. At this point, I am three weeks away from
finishing my year-long term as the APhA-ASP Speaker
of the House*. In that role, I am one of the five student
pharmacists that represent over 34,000 student
pharmacists across the country. It’s an honor and a
privilege and quite a heavy responsibility to be able to
represent those individuals and be a facilitator of all the
policy and advocacy actives that APhA offers to student
pharmacists. I kind of got started within the policy and
advocacy realm when my chapter at East Tennessee
University in Johnson City Tennessee began to approach
collaborative practice within Tennessee. And how the
state’s pharmacy practice act did not include provisions
for pharmacists to be able to collaborate with other
health care providers. So my school began to take that
on as a larger issue. And I got involved with that, and it
rolled on from there to where I became very interested
and enjoyed the policy and advocacy side of pharmacy.
And from then on I pursued a regional position with
APhA-ASP and then finally was elected last year to the
APhA-ASP Speaker of the House position.
SM: So what’s the next step?
LMK: Well that is a very good question Scot. At this
point, my next step is to graduate. It has always been the
constant pursuit, but I have a lot of unique experiences,
that I’m very excited about planned for my fourth and
final year as a student pharmacist, in that rotation year,
so I’m quite, excited to hone in on those experiences and
make sure I get the most out of those over the next year.
But that doesn’t mean I won’t be involved extracurricular
with both riding as well as APhA-ASP. I’ll likely seek a few
more positions and see where I can be helpful to student
pharmacists in facilitating their policy and advocacy
actives as well as empowering them to get involved
within the profession.
SM: So, one final question for you, what would you say
to fellow student pharmacists out there who might be
struggling with their course load and trying to be active
and having a personal life?
LMK: I would have to say that the one piece of advice
is to learn to prioritize. There are times when an
example is the priority. There are times when finishing
a compounding lecture or finishing reviewing a lecture
for a quiz, and that’s the priority. There are times when
working with a group member, in order to complete an
assignment for class, is the priority. There are also times
when you are the priority. When you’ve been studying
all night, and ultimately you are the priority at the end
of the night whenever you need to get rest and go into
the exam fresh. So learning those priorities is going to
be able to allow you to strike a balance within life and
by no means have I found the balance. And by no means
have I not struggled with finding that balance. But the
designation of priorities is what has allowed me to find
some degree of success as I’ve worked through finding
that balance within life.
*Publisher’s note: at the time of the interview, Loren was
still serving as the Speaker of the House for APhA-ASP.
Scot Maitland is the publisher of IACP’s two
publications Compounding Matters Quarterly and
Pharmacy Marketing Quarterly and host of our
new IACPodcast. He coordinates with other IACP
Communications staff to promote the visibility of
IACP and the IACP Foundation.
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IACPRx.org/Publications | Spring 2015
19

IACP FOUNDATION HISTORY
by Lisa D. Ashworth, BS Pharm, RPh
Will Rogers said, “If you want to be successful, it’s just
this simple. Know what you are doing. Love what you
are doing. And believe in what you are doing. “
This is why, in 1991, a group of passionate compounding
pharmacists formed Professionals and Patients for
Customized Care (P2C2). Originally consisting of less
than 300 members, its mission was to protect the
birthright of pharmacy, the practice of compounding.
In 1996, P2C2 changed its name to the International
Academy of Compounding Pharmacists (IACP),
expanded its mission and scope, and had grown to
almost 4,000 pharmacist, technician and student
pharmacist members.
In hitting the stride of those teenage years, IACP was
seeing constant change in the highly complex and everevolving
world of the art and science of compounding
medications for humans and animals, not unlike today,
this shifting landscape presented challenges.
In the Spring of 2003, the IACP Board established the
non-profit IACP Foundation to acquire its own physical
space for IACP and the IACP Foundation offices (that
was housed at Professional Compounding Centers
of America (PCCA) since its inception) and pursue
growth along with endeavors to provide scientific data
supporting compounding. The “Bricks, Mortar and
Pestle: Building a Foundation for the Future” Capital
Campaign was launched to raise $1.5 million for the
new facility as well as establish an endowment to
support research and education for the profession of
pharmacy, specifically compounding. One million dollars
would go to secure or acquire a building for IACP to
establish a permanent home and prepare for growth as
well as honor achievement within our profession and
$500,000 to establish an endowment. Protection and
advancement of the compounding profession were of
the utmost importance.
As the first-ever permanent endowment in the field of
compounding pharmacy, the Foundation pledged to
fund research studies and develop programs to:
• Raise awareness with consumers and healthcare
professionals of the critical role compounding
pharmacists play in promoting patient health
• Develop and validate best practices for pharmacy
compounding
• Promote studies to ensure employee safety and
quality of medications (e.g. effectiveness, stability)
• Advocate for basic scholastic education and training
necessary for compounding in pharmacy school /
college curriculums
• Promote programs that facilitate interested students
to pursue a career in this profession (e.g. scholarships)
• Enhance the credibility and reputation of pharmacy
compounding
The support from the compounding community was
phenomenal, the goal of $1.5 million was met…and
exceeded.
In a suite at the Washington Court Hotel, Washington,
DC in the summer of 2003, a group of around 40
pharmacists who were passionate advocates for
compounded medications convened to establish the
Research arm for the Foundation. Our goals were to
develop a grant application process, determine what
kinds of studies we wanted to fund and when we were
going to start distributing funding.
20 Spring 2015 | IACPRx.org/Publications

Over the last 12 years, the endowment has been used in
ways to educate the public and healthcare professionals
in an effort to maintain the profession’s viability. Did
you know that just about every pharmacy compounds?
Most retail pharmacists compound something at some
point, hospitals and homecare pharmacists may do both
sterile and nonsterile, even prisons and jails may have
a pharmacy owned by the government that employs
pharmacists that compound necessary medications.
Hospital ships, military installation hospitals or floating
hospitals, the veterans affairs, even the mail order PBMs,
nuclear and Positron Emission Tomography (PET)
pharmacies, research facilities (including BIG Pharma
research facilities), the National Institutes of Health,
AND let’s not forget our animal companions who need
sterile and nonsterile medications compounded that are
supplied by veterinary schools, veterinarian, veterinarian
offices, and retail pharmacies all compound. Education
about how to compound, quality of all compounds,
testing, stability, etc. is of the utmost importance to the
IACP Foundation.
In June 2004 the Foundation started an annual fundraiser
aptly titled the “RxMixer” and dubbed, “A Party with A
Purpose.” Since that time more than $1.6 million dollars
have been raised to sustain the endowment and fund
research and educational grants.
Through lawsuits such as the Western States vs Tommy
Thompson with the Supreme Court Ruling, Midland
States vs FDA, split on estriol and the current demands
from payers to provide evidence for use of compounded
preparations the Foundation continues to educate
patients, patient caregivers, prescribers, and pharmacists
to the benefit of compounded medications.
Personalized medications are becoming more
personalized in both the human and animal world, and
most have to be compounded. Compounding is not
going away.
Many people have played many roles in the formation
and growth of the IACP Foundation. The original
committee in 2003 consisted of:
John Preckshot and Kathy Jackson as Co-Chairs
John was the Lead for Campaign Development with
two committees:
• Facilities Committee—Lead by Eric Vidrine with
members of Dean King, Chuck Leiter, and Phil Pylant.
• Public Relations, Marketing & Advertising Committee—
Lead by Peter Ford with members of Patricia Paget,
Shelley Capps, and Patti Storey
Kathy was the Lead for Solicitation with three
committees:
• Membership—Lead by Matt Kopacki with members
of Mike Stein, Jim Paoletti, Ray Moreno and Eldon
Armstrong
• Stakeholders—Lead by Mike Leake with members
of Mike Jones, Ron Petrin and Tom Marks
• Foundations – Lead by Bill Letendre with member
Leo Blais
Keeping track of this ever evolving landscape is a
challenge. The IACP Foundation and its committees are
focused on providing education and research support to
patients, prescribers, pharmacists, and students who are
studying to become prescribers and pharmacists through
scholarships to attend meetings and grants for research.
“Rewind: Back to the 80’s” and join us at this year’s
RxMixer – “A Party With A Purpose” to raise funds for a
good cause and have fun at the same time on Sunday,
June 7, 2015 in Washington D.C. during Compounders on
Capitol Hill (CCH).
In the next issues read more about the IACP Foundation:
Part II – History of the RxMixer and the celebration of 15
years in 2019
Part III – History of Research and Education funded
References:
Lisa D. Ashworth, BS Pharm, RPh is the
Compounding Specialist and Clinical Pharmacist
at Children’s Health System of Texas. She is
President of the IACP Foundation and has worked
in the pharmacy industry for over 35 years.
IACP Foundation. Bricks Mortar & Pestle: Building A Foundation
For The Future Campaign Brochure. 2003.
2003 Annual Meeting & Compounders on Capitol Hill, An Official
Publication of the International Academy of Compounding
Pharmacists. 2003
2015_RxMixer_.25pgAD_3.5x4.625_ad_rx_Layout 1 9/30/14 12:55 PM Page 1
B E N E F I T I N G
T H E I A C P F O U N D A T I O N
11TH ANNUAL RX MIXER PRESENTS:
SUNDAY, JUNE 7, 2015
6:30PM – MIDNIGHT
RENAISSANCE WASHINGTON, D.C.
©2014 International Academy of Compounding Pharmacists Foundation. All rights reserved.
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IACPRx.org/Publications | Spring 2015
21

SAVE THE DATE FOR THESE UPCOMING PROGRAMS
Learn More at http://tiny.cc/IACPRxCalendarSpring
Now, IACP is your one-stop shop for all things compounding! Compounder Calendar
provides a comprehensive listing of compounding events and continuing education
programs offered by IACP, state pharmacy associations, national pharmacy associations,
IACP corporate partners and IACP affiliates.
MAY
MAY 1–3
Contemporary Compounding–
Intensive CE - A Certificate Course
Location: Ponoma, California
MAY 8–9
Freedom Pharmaceuticals Inc.
CPCSI Training Course
Location: New Orleans, Louisiana
MAY 13–15
Letco Medical: Fundamental
Compounding & Calculations
Location: Bartlett, Tennessee
MAY 13
Webinar: 2015 OSHA Training–
Bloodborne Pathogens
JUNE
JUNE 1
Pharmacy Compounding: Past,
Present, and Future Webinar
JUNE 6–9
Compounders on Capitol Hill–
Register today at IACPRx.org/CCH
Location: Washington D.C.
JUNE 20
Sterile Compounding–New Laws
and Regulations 2015 Update
Location: Pomona, California
JUNE 22–24
Letco Medical: Comprehensive
Sterile Compounding
Location: Bartlett, Tennessee
JUNE 23
Webinar: 2015 OSHA Training–
Bloodborne Pathogens
JUNE 26–27
Letco Medical: Compounding for
Natural Hormone Replacement
Location: Bartlett, Tennessee
JUNE 29–30
Letco Medical: Compounding
Options for Pain, Wound, & Scar
Location: Bartlett, Tennessee
JULY
JULY 17–18
Letco Medical: Veterinary
Compounding Essentials
Location: Bartlett, Tennessee
JULY 17–18
Freedom Pharmaceuticals Inc.:
CPCSI Training Course
Location: Tulsa, Oklahoma
JULY 23
Chicago, IL Regional
Education Meeting
Location: Chicago, Illinois
JULY 25
MEDISCA NETWORK:
Preparing for a State Board
of Pharmacy Compounding
Practice Inspection Pro
Location: Los Angeles, California
We are currently developing the
2015-2016 calendar. If you would
like your compounding related
events included, send an email to
Macy Pruitt at macy@iacprx.org.