Innovations-Magazine-June-2023 - 6

INTERVIEW WITH A BOARD EXECUTIVE OFFICER
Susan B. McCoy, RPh
Executive Director, Mississippi Board of Pharmacy
How long have you served as
executive director of the Board?
What was your role prior to
working with the Board?
I began working for the Mississippi Board of
Pharmacy as a compliance officer in 2009.
Before coming to the Board, I worked in
various roles - as a nursing home consultant,
prison pharmacist, and independent
community pharmacist. In 2019, I was selected
to become executive director of the Board.
Mississippi Board
of Pharmacy
Number of Board
Members
7 pharmacist members
Number of
Compliance
Officers/Inspectors
5
Rules & Regulations
Established by
Board of Pharmacy
and approved by
the Mississippi
Occupational
Licensing Review
Commission
Number of
Pharmacist Licensees
6,789
Number of
Pharmacies
1,674
Number of
Wholesale
Distributors
620
What is one of the most
significant challenges or issues
that your Board addressed in the
past year or so?
Researching and preparing comments
on the intent of the Drug Supply Chain
Security Act (DSCSA) and seeing how
it will affect the Board's licensing and
enforcement activities was crucial for our
state to be able to regulate trading partners.
When Food and Drug Administration
(FDA) proposed rules on wholesalers and
third-party logistics providers (3PLs), we
realized that there is a lot of conflict with our
current regulations. We researched federal
preemption extensively. We do not believe
that the intent of " floor " and " ceiling " is
meant to be the requirements. If so, this will
truly inhibit our ability to regulate quickly
and efficiently. We feel that the current
thinking of FDA should be reconsidered
concerning this expanded federalism. There
are many administrative requirements,
background considerations, inspection and
renewal frequencies, and more that also
conflict with our current regulations.
What actions were taken by the
Board to address the issue?
The Board submitted comments to FDA
to address Board and staff concerns. These
comments were discussed among staff and
Board members as they were being drafted.
Staff has been working on these issues since
2016 with the first FDA guidance, has
become well versed in the DSCSA, and
has written our current regulations. Many
of these will have to be rewritten once the
FDA-proposed rules become final. The staff
is waiting on FDA to review the public
comments and publish the final documents.
What other key issues has the
Board been focusing on?
As of 2011, the Board is required by statute
with the task of regulating pharmacy benefits
managers (PBMs). Prior to this, PBMs
were regulated by the Mississippi Insurance
Department. The legislature believed that
this regulation should be under the Board.
We have been working to develop the needed
language that is crucial to enforcement.
What insights do you have for
other states that may be facing
similar challenges?
Get started now with deciding how your
board of pharmacy will regulate wholesalers
and 3PLs. Make sure that you are aware
of how it will affect your rules if the board
of pharmacy is the enforcement body.
Many states have a separate board that
regulates wholesalers and 3PLs, but it is
crucial to work with them because of the
DSCSA's trading partner requirements.
Pharmacies will be tasked with gathering
the information, so even if the regulatory
authority does not fall under the board of
pharmacy, it will affect the pharmacy board's
licensees. Some statute or regulation changes
may be necessary.
4 | JUNE 2023
Innovations-Magazine-June-2023

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