LSHC Horizons Brochure 2024 - Flipbook - Page 93
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | United States
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Navigating listed chemicals compliance requirements
The U.S. Federal Controlled Substances Act
(CSA) establishes a closed distribution system
to regulate and monitor substances that pose
a risk of abuse and dependence. Drugs
designated as controlled substances (i.e.,
substances subject to regulation) often garner
the most attention from the Drug Enforcement
Administration (DEA) and the general public.
However, less well known, but also within the
DEA’s purview, are chemicals that can be used
to manufacture controlled substances, known
as “listed chemicals”.
Like controlled substances, listed chemicals
are subject to compliance requirements. The
primary compliance requirement for listed
chemicals is registration with the DEA. Unless
a statutory exemption exists, companies
engaged in the manufacture, import, export,
or distribution of listed chemicals must
register with federal and many state regulatory
authorities. Registrants may engage only
in specific activities within the scope of
their registrations.
Registrants must also comply with regular
reporting and recordkeeping obligations.
Registrants may be required to report its
inventory, changes in production volumes and
usage patterns, and transactions involving a
listed chemical. Authorities may also require
registrants to submit customer data to confirm
the customer’s identity and the purpose for
which the chemical is being used.
Lynn Mehler
Partner
Washington, D.C.
Nonetheless, inherent to the CSA is the notion
that listed chemicals have an overall lower
risk of contributing to abuse and diversion
than controlled substances, and the degree
of risk varies by the extent to which the
chemical can be used for lawful purposes
unrelated to controlled substances. Many listed
chemicals are integral to legitimate industrial
processes, including use in pharmaceutical
manufacturing, industrial solvents, and food
flavoring agents. Accordingly, the CSA assigns
listed chemicals to two tiers, List I and List II,
based on the significance of the listed chemical
to controlled substances manufacturing. List I
chemicals are subject to stricter requirements
than List II chemicals. Additional exemptions
exist for chemical mixtures containing listed
chemicals at or below established thresholds.
Compliance with listed chemical requirements
is not merely a legal obligation; it is a critical
aspect of responsible business practices.
Companies must conduct regular reviews
of their inventories to ensure any activities
involving listed chemicals are within the
scope of their registration, and have robust
monitoring processes in place to ensure that
their operations are compliant with federal
and state requirements.
Lowell M. Zeta
Partner
Washington, D.C.
Stephanie Agu
Senior Associate
Miami
