DEA Changes Rules on Disposal of Controlled Substances

In its latest decision, the DEA changed the landscape of disposal of controlled substances in a positive way by allowing registrants, including retail pharmacies, hospitals, etc., to collect unused medication from the public at large for destruction. Until now, the disposal choices were slim and many doses of prescription opioids that were no longer needed by the patients for whom they were prescribed were diverted for illegitimate purposes. Now, the public will have few more options for disposal outside of the semi-annual Drug Take Back days. DEA CS Disposal Final Rule.

While this rule making is a step in the right direction, one question remains. That is, who will bear the cost of such disposal? Proper disposal of medication is not cheap and thus it can be reasonably expected that in the absence of government funding many registrants may hesitate to participate in such endeavor.

2 thoughts on “DEA Changes Rules on Disposal of Controlled Substances

  1. Ivan, thanks for the link to the Final Rule. I spent about 30 minutes reviewing it (I think it will take 3 or 4 hours) and I have some significant unanswered questions. Mainly, I still don’t understand how we (in an clinic pharmacy located in a hospital) will get around the issue of “chain of custody” of any narcotics coming into our facility. Even though they are placed in a receptacle and even though someone will then seal the enclosure and store it in a secure place until it is mailed back, there is still a significant opportunity for diversion because there is zero documentation of what has been dropped off in the bin. This potential diversion could be possibly quite large, given that this is a controlled substance drop box and is presumably filled up to capacity prior to emptying. Who then takes legal responsibility for this potential diversion; the pharmacy, the hospital, the State Board of pharmacy, the DEA?

    Upon my 30 minute review I did not find a provision for current “drug take back” drivers to pick up the controlled substance take back box and dispose of it. If I understand correctly, we will either need to certify that we are capable of destroying the sealed container ourselves, or mail it back to the DEA for destruction. In addition, I assume that the local State Board of pharmacy also needs to weigh in on the subject and then we would follow which ever is the more controlling of the two regulations.

    Thanks
    Steve

    • Steve,
      Thanks for your comment. Indeed, the regulation seems to present more questions than answers. I would expect the states to provide some guidance in the near future. Since no system is absolutely secure, the collection programs established pursuant to this rule will also present an opportunity for diversion, but I believe that this risk can be reasonably mitigated within the healthcare industry.
      However, your questions bring up some very good reasons for registrants not to participate in this program. There are firms that specialize in destruction of pharmaceutical waste, but their fees are quite high and without some sort of government funding, I expect that for-profit businesses may opt out to avoid increase in operating costs.

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