LSHC Horizons Brochure 2024 - Flipbook - Page 97
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | United States
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Responding to the discovery of controlled substances in your facility
Imagine that an unknown substance is
discovered at your manufacturing facility
or laboratory. Upon testing, you learn that
the substance is a Schedule II controlled
substance, but your U.S. Drug Enforcement
Administration (DEA) registration permits you
to handle Schedule III-V controlled substances
only. Or, perhaps this is the first time that a
controlled substance has ever appeared at your
facility and you are not a DEA registrant. This
is not an infrequent occurrence for entities that
engage in research and development. What do
you do?
Navigating the discovery of controlled
substances at your facility can be challenging.
Whether the substances were inadvertently
brought in, created in the lab, or are remnants
of previous activities, it is crucial to take
immediate action. Importantly, the disposal
of controlled substances is a highly regulated
activity and can be challenging for a facility
without the appropriate DEA and state license.
The moment controlled substances are
discovered, prioritize identifying the type and
quantity of substances found and store them
in a secure location. Consider conducting a
thorough sweep of the facility to assess whether
other unknown substances are present.
Lynn Mehler
Partner
Washington, D.C.
It is critical to understanding the regulations
governing controlled substances at the
federal level and in your state. This step is
vital to ensuring that all subsequent actions
meet regulatory requirements. Prompt
and organized cooperation with local law
enforcement and regulatory authorities,
such as the DEA and similar agencies in your
jurisdiction, is key and can help demonstrate
your commitment to compliance and abate
agency concerns of wrongdoing.
Identifying how the controlled substances
entered the facility is paramount as well.
To that end, evaluate current policies and
procedures to determine what safeguards
need to be put into place to prevent the
reoccurrence of this issue. This may also be a
good opportunity to update internal policies
related to ordering chemicals and controlled
substances, inventory management, and
employee training. If you are a DEA registrant,
every employee handling controlled substances
should be familiar with the scope of the
facility’s registration.
Throughout this review, maintain thorough
records of everything discovered and actions
taken, any corrective measures implemented,
and correspondence with authorities. Following
the outlined steps will help your company
navigate the situation responsibly, mitigate
potential legal consequences, and work towards
preventing such incidents in the future.
Lowell M. Zeta
Partner
Washington, D.C.
Stephanie Agu
Senior Associate
Miami
