DEA Publishes Proposed Regulations for Disposing of Controlled Substance Prescription Drugs

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DEC26 (WASHINGTON, D.C.) – The Drug Enforcement Administration (DEA) published itsNotice of Proposed Rulemaking for the Disposal of Controlled Substances in theFederal Register Dec. 21.  The proposedregulations seek to implement the Secure and Responsible Drug Disposal Act of2010.
Accordingto the 2011 Substance Abuse and Mental Health Services Administration’sNational Survey on Drug Use and Health, more than six million Americans abuseprescription drugs.  That same studyrevealed more than 70 percent of people abusing prescription pain relievers gotthem through friends or relatives, a statistic that includes raiding the familymedicine cabinet. Medicines that languish in home medicine cabinets are highlysusceptible to diversion, misuse, and abuse. Rates of prescription drug abusein the U.S. are alarmingly high—more Americans currently abuse prescriptiondrugs than the number of those using cocaine, hallucinogens, and heroincombined. 
Thisrule proposes requirements to govern the secure disposal of controlledsubstance medications by both DEA registrants and what the ControlledSubstances Act refers to as “ultimate users” of these medications (patients andanimals).  The proposed regulations seekto expand the options available to collect these medications from ultimateusers for the purpose of disposal, to include take-back events, mail-backprograms, and collection box locations. The proposed regulations contain specific provisions that:
•           Continue to allow law enforcementagencies to voluntarily conduct take-back events, administer mail-backprograms, and maintain collection boxes;•           Allow authorized manufacturers,distributors, reverse distributors, and retail pharmacies to voluntarilyadminister mail-back programs and maintain collection boxes;•           Allow authorized retail pharmacies tovoluntarily maintain collection boxes at long term care facilities.
Thepublic can review an electronic copy of this document at http://www.gpo.gov/fdsys/pkg/FR-2012-12-21/pdf/2012-30699.pdfand has 60 days to submit comments, until February 19, 2013.  DEA encourages interested parties to commenton this important proposed rule. 
DEA’ssixth National Prescription Drug Take-Back Day is scheduled for Saturday, April27.  DEA’s first five Take-Back eventsresulted in the removal from circulation of more than 2 million pounds (over athousand tons) of prescription drugs.