Innovations-Magazine-May-2022 - 8

Since it became law in 2013, the Drug Quality and Security Act (DQSA) has had an outsized impact
on pharmacy regulation of all members of the drug product supply chain. The law, which was passed
in the aftermath of the New England Compounding Center tragedy, included DSCSA in Title II that
established several requirements to be developed and enacted over the course of 10 years.
As the 10-year anniversary of the law approaches, many of
these requirements are being finalized, and state regulators and
stakeholders are now processing, adjusting, and taking other steps
to ensure that they are prepared when the requirements take effect.
The DSCSA State Regulator Pilot began with a special kick-off
session in January. The initial pilot of communication between
boards of pharmacy and authorized trading partners started in early
February 2022 and continued through March 2022. The results
of this pilot will inform the development of the Partnership for
DSCSA Governance (PDG) and GS1 standards and will help to
provide a clearer picture of the solution that NABP will develop in
support of its member boards of pharmacy.
One of the most complex requirements of the DSCSA calls
for authorized trading partners in the supply chain to track each
product transaction as it occurs and retain the information so that
it can be produced upon request by authorized trading partners and
state and federal officials.
Currently, the tracking requirements are limited to the lot level;
however, in November 2023, the requirements will be expanded
to require tracking at the individual package level, as detailed in
the recently released Food and Drug Administration (FDA) draft
guidance titled Enhanced Drug Distribution Security at the Package
Level Under the Drug Supply Chain Security Act. The guidance notes
that state regulators should be " able to initiate a single, targeted
request to trading partners via the enhanced system. "
Early NABP Outreach and Engagement Efforts
NABP has been monitoring developments since the DQSA was
passed and has been taking steps to support its member boards
of pharmacy at every stage of implementation. The Association
has undertaken significant outreach and engagement efforts with
member boards of pharmacy, authorized trading partners, DSCSA
solution providers, and other stakeholders to ensure that the state
regulatory perspective is heard and understood during this process.
In October 2021, NABP convened a DSCSA workshop where
representatives of several boards of pharmacy and other state
regulators discussed the implementation of the DSCSA. The
workshop focused its efforts on how state regulators will be able
to assess authorized trading partner compliance with the DSCSA
and, further, how they will be able to communicate with trading
partners within an electronic, interoperable system when conducting
investigations into suspect or illegitimate products.
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This discussion resulted in three recommendations for how
NABP can support state regulators and authorized trading
partners with DSCSA implementation:
1. provide education and training for both regulators and
authorized trading partners;
2. create uniform guidelines and inspection tools for
DSCSA compliance; and
3. develop a system to facilitate regulator requests for information
from authorized trading partners.
These recommendations prompted NABP to begin planning
development of a system that will facilitate requests for information
from state regulators and allow those groups to fulfill their regulatory
obligations as outlined by the DSCSA and related guidances.
This process began in November 2021, when NABP provided
comments during FDA's Public Meeting on Enhanced Drug
Distribution Security. NABP communicated the need for
additional education for dispensers on DSCSA compliance
and the Association's intent to develop a system for helping
state regulators communicate with authorized trading partners
during investigations.
Since that meeting, trade associations, authorized trading
partners, DSCSA solution providers, and standards organizations
have expressed interest, and NABP has participated in dozens of
meetings with these entities. In December 2021, NABP convened
a second DSCSA state regulator workshop.
The Association has also been presenting on the DSCSA to several
national organizations, including the PDG, Healthcare Distribution
Alliance, and the Association for Accessible Medicines, and will
continue to do so as the 2023 implementation date draws near.
Communication With FDA
FDA and NABP will continue to look for opportunities to increase
communication and collaboration between the agency and the boards of
pharmacy and other state regulatory authorities charged with overseeing
drug distribution. Additionally, FDA has reiterated its stance that state
regulators (via NABP) are authorized under the DSCSA to pursue tools
that facilitate regulator-authorized trading partner communication.
It is still unclear what type of system FDA intends to develop for its
own communication with authorized trading partners, but this creates
an opportunity to build significant uniformity regarding how state
regulators and authorized trading partners will communicate.
http://www.fda.gov/media/149704/download http://www.fda.gov/media/149704/download
Innovations-Magazine-May-2022

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