Life Sciences Horizons Brochure 2025 - Flipbook - Page 115
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2025 Horizons Life Sciences and Health Care
Increasing state board enforcement against device firms, and the
role of the DSCSA
In recent years, U.S. state Boards of Pharmacy have
significantly ramped up enforcement actions against
prescription medical device manufacturers and
distributors, and the Drug Supply Chain Security Act
(DSCSA) — although not applicable to medical device
firms — has indirectly fueled this existing trend.
Historically, the Boards of Pharmacy have been tasked with
protecting public health by concentrating regulatory efforts on
the manufacture of drugs and the pharmaceutical supply chain,
with their authority extending to manufacturers, pharmacists,
pharmacies, and pharmaceutical distributors. However, the
growing recognition of the risks posed by prescription medical
devices — such as long-term implantables, software as a medical
device, radiation emitting products, sophisticated insulin pumps,
and metered-dose inhalers — has prompted state boards to assert
more oversight in this space.
In particular, regulatory requirements that have exclusively
pertained to drugs are increasingly enforced against medical
device firms. Although some of these changes can be found in
updated state laws and regulations, a surprising number of
requirements have been imposed through state boards’
interpretations of their enabling statutes and related regulations.
Specifically, many states not only require licenses or permits for
prescription medical device manufacturers and distributors, but
application requirements and associated compliance measures
are increasingly analogous to what has historically been limited to
pharmaceutical entities. This shift can be partly attributed to
concerns about patient safety, counterfeit products, and supply
chain transparency; but it can occasionally be inadvertent (e.g.,
licensing requirements applicable to those who “dispense”
prescription-only software products).
In most cases, regulatory expectations can be discerned and are
relatively predictable; however, in other cases, state boards have
pursued legal action or imposed fines or other discipline on device
manufacturers for failing to comply with distribution and
licensing requirements that were previously unenforced.
Band 1
The DSCSA, enacted in 2013, was designed to enhance the security
of the pharmaceutical supply chain by establishing national
track-and-trace requirements for prescription drugs. The law
mandates, in part, that pharmaceutical manufacturers,
distributors, and dispensers implement electronic systems to
verify and trace prescription drugs throughout the supply chain.
However, the DSCSA explicitly excludes medical devices from its
requirements, leaving a regulatory gap that has spurred individual
states to take action. Without a unified federal standard governing
medical device distribution in the same manner as pharmaceuticals,
state Boards of Pharmacy have increasingly imposed some of the
complex obligations inspired by or arising out of the DSCSA on
medical device firms.
for Life Sciences:
Regulatory/Compliance,
Chambers USANationwide, 2025
Accordingly, this patchwork of regulations frequently creates
compliance challenges for medical device manufacturers and
distributors, as they must navigate varying, and often confusing,
state-by-state requirements. While there may be an intuition on
the part of industry about how certain states should regulate
different types of medical device firms and activities, it is
common for this not to completely align with a states’
interpretation or requirements in practice.
