[Pharmwaste] RE: More on the DEA Issue

[Richard Verch]

Regarding the email exchange early last week regarding the current  
DEA impasse:

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  
allow this.

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.


Regards,

Richard Verch, CHMM
     President
     770.409.1500 x111
     770.409.1449 fax
     www.StrongServices.com

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Supported by:
     Alysia Billingslea
     Executive Assistant
     770.409.1500 x142
     Alysia at StrongServices.com

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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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