Compounding Matters Quarterly - Spring 2015

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.
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THE DATE!
August15, 2015
Hilton Columbus at Easton – Columbus, Ohio
The Compound Conference is the only conference annually
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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.
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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