Innovations-Magazine-September-2023 - 10

After press time, FDA announced that it would delay enforcement of
certain provisions of DSCSA until November 27, 2024. The August 28,
2023 Federal Register announcement and final guidance offer more
details. The agency views this as being a " stabilization period " that
will enable trading partners to continue with implementation. NABP
encourages trading partners to take advantage of the additional year
to ensure their organizations are prepared for full enforcement.
In October 2021, NABP convened a DSCSA workshop in
which representatives of several boards of pharmacy and other
state regulators discussed the implementation of DSCSA. The
workshop focused its efforts on how state regulators will be able
to assess authorized trading partner compliance with DSCSA and,
further, how they will be able to communicate with trading partners
within an electronic and interoperable system when conducting
investigations into suspect or illegitimate products.
The recommendations that came out of that discussion prompted
NABP to begin developing a system to facilitate requests for
information from state regulators while allowing those groups to
fulfill their regulatory obligations as defined by DSCSA and related
federal guidance.
In the first quarter of 2022, NABP conducted an initial pilot
project to simulate scenarios in which regulators would communicate
with trading partners as they conducted investigations into suspect
products. The results helped to provide a clearer picture of the
solution that NABP would develop in support of its member
boards of pharmacy. Later in 2022, NABP published a detailed
report that includes a summary of those findings and makes key
recommendations for both state regulators and FDA.
An additional tracing pilot was conducted in the first quarter of
2023. This involved 93 participants representing state regulators,
distributors, manufacturers, and others from across the supply chain.
As development continued and NABP worked with regulators and
trading partners from across the supply chain, it soon became clear
that the platform being built would be a tool that connected the
supply chain in ways beyond DSCSA compliance. At the Healthcare
Distribution Alliance conference in March 2023, NABP announced
that the platform would be known as Pulse by NABP™.
NABP Support for Trading Partners and Regulators
DSCSA represents a significant change in the way regulators ensure
the safety and reliability of the prescription drug supply chain
within the US. It provides additional tools to combat the serious
challenges posed by counterfeit and adulterated drugs and establishes
a framework for enhanced tracking and tracing of prescription drug
products throughout the supply chain. While the requirements set
forth by DSCSA place a burden of responsibility on trading partners
within the supply chain, they also present new opportunities for the
industry and its regulatory bodies to work together to help ensure the
protection of public health.
Recognizing the importance of a seamless transition to meeting
the final requirements, NABP remains committed to further
collaboration with its member boards of pharmacy and other
stakeholders, as evidenced by the development of Pulse (see page 9
for more information). NABP has also provided webinars for both
regulators and trading partners in 2023 (details are available in the
Educational Programs section of the NABP website).
By leveraging collective expertise and resources, the Association
will ensure that the supply chain is well equipped to comply
with the legislation. Through ongoing collaboration, NABP
further endeavors to support its member boards in fulfilling their
regulatory responsibilities, and with this collective effort, the
integrity of the supply chain will be strengthened along with the
safety and well-being of the public.
MILESTONE
NABP's 2023 tracing pilot involved 93 participants representing large and small manufacturers,
distributors, dispensers, state regulators, and other stakeholders from the prescription drug supply chain.
It was the largest and most inclusive tracing pilot that has ever been conducted for DSCSA.
8 | SEPTEMBER 2023

https://nabp.pharmacy/pulse/

Innovations-Magazine-September-2023

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