Regulatory Brief

 Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users (December 2010)


Formal title: Docket Number [DEA-316N] Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users

On December 22, 2010, the Drug Enforcement Administration (DEA) announced that it would hold a public meeting in Washington, D.C. on January 19 – 20, 2011, to discuss procedures for the surrender of unwanted controlled substances by ultimate users and long term care facilities and that written comments were welcome.

Brief Description:

The Drug Enforcement Administration (DEA) is conducting a public meeting to discuss procedures for the surrender of unwanted controlled substances by ultimate users and long term care facilities in the development of regulations to implement the Secure and Responsible Drug Disposal Act of 2010. Specifically, DEA invites all interested persons, including ultimate users, pharmacies, law enforcement, reverse distributors, and other third parties to express their views at the meeting or by written comment concerning the most safe and effective method of disposal of controlled substances consistent with the Controlled Substances Act and the Secure and Responsible Drug Disposal Act of 2010.

AVMA Response:

If take-back programs are allowed and offered for non-registrants / ultimate users in their respective areas:

  • The AVMA believes law enforcement agencies are the appropriate entities to undertake the safe disposal of such substances.
  • Take-back programs involving law enforcement or the DEA enacted for ultimate users (clients) would provide the greatest security.

If take-back programs are not allowed or offered for non-registrants / ultimate users in their respective areas:

  • The AVMA strongly suggests that DEA and the U.S. Environmental Protection Agency (EPA) collaborate to establish the basic protocols and procedures for practical disposal of controlled substances by means that prevent diversion and that are environmentally sound either through the development and standardization of take-back programs or the development of alternative means of disposal by non-registrants. EPA's recently released draft "Guidance Document: Best Management Practices for Unused Pharmaceuticals at Heath Care Facilities" (http://water.epa.gov/scitech/wastetech/guide/upload/unuseddraft.pdf), provides valuable information for both registrants and non-registrants regarding disposal of controlled substances in accordance with DEA regulations as well as providing an environmental perspective.
  • The AVMA's "Best Management Practices for Pharmaceutical Disposal" policy encourages pharmaceutical disposal by alternative means other than those involving direct introduction into the sewer system.

Confusion exists among non-registrants regarding how to properly dispose of unwanted controlled medications in a manner which is legal and environmentally safe. The process, as described in 21CFR1307.21, Procedure for Disposing of Controlled Substances, for non-registrants to obtain permission from their respective DEA Special Agent in Charge for disposal of controlled substances on a case by case basis is complicated.

The variation among State and local laws [regarding pharmaceutical disposal] is a contributing factor to the confusion regarding proper disposal of unwanted controlled substances. Providing a clear, practical, and uniformly interpreted and enforced position would be greatly beneficial.

Background Documents:

January 12, 2011 – Full AVMA Response (PDF)

December 22, 2010 – Federal Register Notice (PDF)

Relevant AVMA Policies