Innovations-Magazine-September-2023 - 9

M
10th
ore than a decade ago, the United States pharmacy profession experienced one of the
most significant adverse public health tragedies in recent history when improperly
compounded and contaminated injectable drugs were produced at the New England
Compounding Center and shipped to multiple states. The reckless actions of the pharmacy
resulted in a large-scale fungal meningitis outbreak, resulting in at least 750 infections and 64
deaths. Many of the patients who survived the infection continue to experience adverse effects.
In response to these events and to overall concerns about the
integrity of the pharmaceutical supply chain, lawmakers in Congress
passed the Drug Quality and Security Act with broad bipartisan
support. The complex law was divided into two parts. Title I, known as
the Compounding Quality Act, gave Food and Drug Administration
(FDA) more authority to regulate and monitor compounded drugs
that are shipped across state lines. Title II, the Drug Supply Chain
Security Act (DSCSA), established requirements for the tracing of
prescription drug products throughout the supply chain.
The last requirements of DSCSA are set to go into effect on the
anniversary of the bill's signing on November 27, 2023. As
stakeholders across the country prepare for this final milestone of the
law's implementation, NABP is among those providing educational
opportunities and business solutions that can help trading partners
meet these requirements.
The DSCSA Implementation Journey
DSCSA represents a monumental change to the way medications
are tracked and traced as they move through the supply chain. The
first major shift occurred in 2015 with the requirement that trading
partners be authorized. Since then, the guidance from relevant
agencies has gradually gone into effect, with additional requirements
for all parts of the supply chain being rolled out as part of the law's
implementation. For example, FDA established a publicly available
database of wholesale distributors, manufacturers, and repackagers;
began serializing products using standardized numerical identifiers;
and trading partners are now required to conduct investigations into
products that they believe may be suspect or illegitimate.
Along the way, several provisions were delayed. For instance, in
2020, FDA delayed enforcement of salable return requirements for
wholesale distributors and dispensers for three years.
On November 27, 2023, trading partners are expected to meet
all DSCSA requirements. Some of the most important include:
* Interoperable exchange: Trading partners will be required
to exchange transaction information and statements in an
interoperable, secure, and electronic format that utilizes unique
product identifiers at the package level.
* Verification: Trading partners will be required to verify the product
identifiers and to validate shipments in certain circumstances.
* Tracing: Trading partners must be able to provide information
for each transaction going back to the manufacturer or repackager
within one business day, should FDA or another authorized
trading partner request it.
* Detection and response: Trading partners must make sure their
teams understand how to properly handle, investigate, and report
suspicious or illegitimate products.
* Notification: Trading partners must notify FDA and other
trading partners within 24 hours of determining that a product is
illegitimate or after receiving an illegitimate product notification
from FDA or another trading partner.
In summary, the entire supply chain is required to become
interoperable, using secure and electronic means to track each
medication at the package level. This presents a monumental challenge
to trading partners at every level of the supply chain. In response,
NABP has been working closely with its member boards and other
stakeholders to explore how some of these requirements might be met.
Facilitating Regulator-Trading Partner
Information Exchange
The security of the prescription drug supply chain is a top priority
of concern for many boards of pharmacy and other stakeholders,
both to meet DSCSA requirements and to ensure patient safety. To
help facilitate this, NABP has engaged in multiple pilot projects to
test systems for sharing information between regulators and trading
partners, including distributors, manufacturers, and more.
SEPTEMBER 2023 | 7

Innovations-Magazine-September-2023

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