DEA proposes rule changes to expand options for collecting unused medicines

The Drug Enforcement Administration (DEA) published its Notice of Proposed Rulemaking for the Disposal of Controlled Substances in the Federal Register Dec. 21.  The proposed regulations seek to implement the Secure and Responsible Drug Disposal Act of 2010.

According to the 2011 Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health, more than six million Americans abuse prescription drugs.  That same study revealed more than 70 percent of people abusing prescription pain relievers got them through friends or relatives, a statistic that includes raiding the family medicine cabinet. Medicines that languish in home medicine cabinets are highly susceptible to diversion, misuse, and abuse. Rates of prescription drug abuse in the U.S. are alarmingly high—more Americans currently abuse prescription drugs than the number of those using cocaine, hallucinogens, and heroin combined. 

This rule proposes requirements to govern the secure disposal of controlled substance medications by both DEA registrants and what the Controlled Substances Act refers to as “ultimate users” of these medications (patients and animals).  The proposed regulations seek to expand the options available to collect these medications from ultimate users for the purpose of disposal, to include take-back events, mail-back programs, and collection box locations.  The proposed regulations contain specific provisions that:

• Continue to allow law enforcement agencies to voluntarily conduct take-back events, administer mail-back programs, and maintain collection boxes;
• Allow authorized manufacturers, distributors, reverse distributors, and retail pharmacies to voluntarily administer mail-back programs and maintain collection boxes;
• Allow authorized retail pharmacies to voluntarily maintain collection boxes at long term care facilities.

The public can review an electronic copy of this document at http://www.gpo.gov/fdsys/pkg/FR-2012-12-21/pdf/2012-30699.pdf and has 60 days to submit comments, until February 19, 2013.  DEA encourages interested parties to comment on this important proposed rule.