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DEA Issues Notice of Proposed Rulemaking Regarding Disposal of Controlled Substances

Beveridge & Diamond, P.C., December 27, 2012

On December 21, 2012, the U.S. Drug Enforcement Administration (“DEA”) issued a notice of proposed rulemaking to address the disposal of unused, unwanted, or expired controlled substances by ultimate users.  See Disposal of Controlled Substances, 77 Fed. Reg. 75784 (Dec. 21, 2012) (available here). The rulemaking is authorized under the 2010 Secure and Responsible Drug Disposal Act (“Disposal Act” or “Act”) (enacted October 2010), which amended the Controlled Substances Act.  Prior to the Act, ultimate users had limited options for disposal of controlled substances (e.g., flushing or discarding in the trash, surrender of controlled substances to law enforcement, or seeking assistance of DEA).  Prompted by public health and safety concerns arising from misuse of accumulated controlled substances within households, the Disposal Act sought to facilitate more convenient, secure, and responsible collection and disposal methods that would allow ultimate users to transfer unwanted controlled substances to authorized entities for destruction.  DEA has also recognized that establishment of lawful alternative methods for disposal of unwanted pharmaceuticals may help to reduce the introduction of pharmaceuticals into the environment, particularly in water.

DEA’s proposed rule would authorize ultimate users to dispose of unwanted controlled substances through take-back events, mail-back programs, or collection receptacles located at DEA-registered locations.  Collection and disposal programs could be operated by law enforcement or certain authorized collectors (registered manufacturers, distributors, reverse distributors, and retail pharmacies), as follows:

  1. Take-back events could be conducted only by law enforcement agencies, with or without the participation of other private entities or community partners;
  2. Mail-back programs could be conducted by law enforcement agencies and authorized collectors that have and utilize an on-site method of destruction at their registered location;
  3. Collection receptacles could be hosted by law enforcement agencies and authorized collectors at DEA-registered locations, but not at unregistered community collection locations such libraries.  Registered authorized retail pharmacies could provide collection receptacles within long-term care facilities (“LTCFs”) for use by ultimate users who reside at the LTCF or by a LTCF on behalf of an ultimate user who resides or has resided at the LTCF.

The methods for collection and disposal are voluntary, and the regulations would not impose take-back or collection requirements on any entity.  The proposed regulations also set forth specific standards to prevent diversion and ensure the security of mail-back programs and collection programs by, e.g., establishing requirements for mailer type, design and placement of the collection receptacle, tracking, and limitations on the handling or inventory of collected substances.  For all collection methods, the rule would require destruction that makes the controlled substances “non-retrievable.” 

In addition to the regulations on disposal of controlled substances by ultimate users, the regulations would also consolidate and, in some cases, augment existing rules on the return of controlled substances by registrants and drug returns/recall.

There is a 60-day comment period for the proposed rule; written or electronic comments must be received by DEA by February 19, 2013.  For more information, please contact Mark Duvall (mduvall@bdlaw.com; 202-789-6090), Aaron Goldberg (agoldberg@bdlaw.com; 202-789-6052), or Jennifer Abdella (jabdella@bdlaw.com; 301-481-0811).

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