[Pharmwaste] RE: More on the DEA Issue
Richard at StrongServices.com
Thu Feb 16 18:45:41 EST 2006
Regarding the email exchange early last week regarding the current
Some clarification and amplification of the statement: "If they [the
pharmacy] are accepting controlled substances..." needs to be made.
Pharmacies cannot accept controlled substances from citizens
legally. DEA will not allow it, as the CSA only allows for transfer
of controlled substances with in a closed-loop framework: from one
DEA Registrant to another. Once dispensed to a citizen, it is
outside of the DEA's closed-system of distribution. A citizen is not
a Registrant of the DEA, and therefore it is not legal to transfer
the controlled substances to the pharmacy.
However, the DEA, in 21 CFR 1301.24 waives the registration
requirement for local law enforcement acting in official duty. This
little distinction is important for all to know. It is also VERY
important to know that the local DEA diversion office will have
something to say about this. We know of at least one that will not
Additionally, there has been some correspondence from the DEA that
indicates "..controlled substances cannot be commingled with the non-
controlled substances..." during these unwanted medication disposal
projects. This probably stems from inventory responsibilities, and
should be clarified as well.
We call this issue "the DEA obstacle", and we brought this matter up
in September 2005 with the DEA. While on an invited panel discussion
at a DEA hosted conference, with the headquarter DEA, Strong
characterized the current laws as a regulatory roadblock, not
allowing for an efficient means of recapturing unwanted controlled
substances - thus hindering the entire pharmaceutical collection effort.
DEA's response was well received, and we believe that DEA recognizes
more each year that this as an issue that must be addressed. DEA is
hand-tied because the law simply doesn't allow for distribution/
transaction between the consumer (non-registrant) and any other
entity (except law enforcement as we have seen).
DEA, understandably, has reason to be wary of this sort of 'reverse-
distribution; however, they also clearly see the net benefit.
So, a change must be made to the law that restricts the transactions
from consumers. Specifically, we suggested 21 CFR part 1307.21, and
related affected sections, be modified to achieve the goal. Strong
will work with DEA to suggest and implement a regulatory mechanism
that achieves the mutual goals of properly governed disposal. We have
sent a letter to DEA and continued to have conversations regarding
temporary and permanent changes to this DEA obstacle.
Richard Verch, CHMM
Alysia at StrongServices.com
Strong Pharmaceutical Services, a division of Strong Environmental,
is the leading provider of destruction services to the pharmaceutical
industry. Our experienced professionals manage and ensure the
appropriate witnessed destruction of DEA controlled substances, as
well as proper disposition of RCRA hazardous and non-hazardous
finished goods and manufacturing wastes.
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