Most people know what controlled substances are, but may not be as familiar with the settings in
which they are used. So, what does it mean
to use controlled substances in a non-clinical
setting? In research, this distinction refers to
the fact that human subjects are not involved;
instead, the controlled substance is
used in bench (wet lab) experiments
or for animal research.
The Drug Enforcement Agency
(DEA) requires individual research-
ers to complete an application
for a research registration to use
controlled substances for research
purposes in the non-clinical set-
ting. In this article, these individuals
are referred to as registrants. Upon DEA
approval, the registrant will receive approval
documents called registrations (akin to
Authorized users are individuals the
registrant has granted permission (by way
of their registration and DEA Authorized
Users Log) to have access to the controlled
substances. Many states mimic this pro-
cess, meaning researchers have to maintain
both federal and state registrations. And,
last but not least, in the world of controlled
substances, a diversion is when controlled
substances go purposefully missing by
Who is responsible?
Last year, I spoke at a conference about the
ins and outs of controlled substances, going
over the regulations and implementation
within my institution. One of the questions I received was, “Who is responsible?”
The answer is one that most compliance
professionals don’t like, but have become
accustomed to giving…it depends. It depends
on your institutional commitment, infrastructure, internal resources, risk tolerance, etc. I
also had one person ask why the institution
would be involved at all, given that the registrant is solely responsible for the registration,
documentation, and storage of the controlled
I thought this was a very interesting
question; however, from my perspective
by Kelé Piper, MS, CIP, CHRC
Controlled substances in
» Determine your institutional involvement in the use and management of controlled substances.
» Know your baseline compliance to determine resources needed to create an effective program to prevent diversion of controlled substances and meet regulatory requirements.
» Write a clear policy and/or standard operating procedure, and educate staff to enhance compliance.
» Make the process simple; standardize where possible.
» Go to the source; don’t be afraid to contact your regulatory officials.
Kelé Piper ( email@example.com) is Director, Research Compliance at
Beth Israel Deaconess Medical Center, Boston. /in/kele-piper