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Overview of DEA Disposal of Controlled Substances Final Rule

Published Mar 20, 2015 in Other
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Presentation Slides & Transcript

Presentation Slides & Transcript

Thomas P. LenoxSupervisory Special Agent Drug Enforcement Administration Overview of DEA Disposal of Controlled Substances Final RuleFebruary 17, 2015San Diego County Hazard Waste Education

Secure and Responsible Drug Disposal Act of 2010Legislation that provides ultimate users and long-term care facilities (LTCFs) with additional methods to dispose of unused, unwanted, or expired controlled pharmaceuticals in a secure, safe, and responsible manner.Authorized DEA to promulgate regulations that allow ultimate users to transfer pharmaceutical controlled substances to authorized entities for disposal.Specific language in the regulation continues to allow State, tribal, and local law enforcement to maintain collection receptacles at the law enforcement’s physical location; and either independently or in partnership with private entities or community groups, to voluntarily hold take-back events and administer mail-back programs.Created an exception for LTCFs to transfer pharmaceutical controlled substances for disposal on behalf of patients who reside or have resided at that facility.

Secure and Responsible Drug Disposal Act of 2010Regulations do not limit the ways ultimate users may dispose of pharmaceutical controlled substances – they expand them. Any method of pharmaceutical disposal that was valid prior to these regulations continues to be valid. Participation is voluntary. DEA may not require any person to establish or operate a disposal program.

Methods of CollectionCollection receptacles Mail-back programsTake Back Events

Collection ReceptaclesOnly ultimate users shall put the controlled substances directly into the collection receptacle.Controlled and non-controlled substances may be comingled. Collected substances shall not be counted, sorted, inventoried, or otherwise individually handled.Registrants shall not dispose of stock/inventory in collection receptacles.21 CFR § 1317.75(b) and (c)

Design of Collection ReceptacleSecurely fastened to a permanent structure.Securely locked, substantially constructed container with permanent outer container and removable inner liner.Outer container must have small opening that allows for contents to be added but does not allow for removal of contents. 21 CFR § 1317.75(e)

Collection Receptacle LocationMust be securely placed and maintained:Inside collector’s registered locationInside law enforcement’s physical location, orInside an authorized LTCF

Access & Handling Sealed Inner LinersOnly employees of the collector may access the inner liners.The inner liner shall be sealed by two employees immediately upon removal from the permanent outer container.Sealed inner liner shall not be opened, x-rayed, analyzed, or otherwise penetrated. 21 CFR §§ 1317.60(b) and (c), 1317.05(c)

Mail-Back Program SpecificationsPackages may be made available for sale or free of charge;Any person may partner with a collector or law enforcement to make packages available to the public;Nondescript and no markings that indicate it contains controlled substances;Water- and spill-proof, tamper-evident, tear-resistant, and sealable;Pre-addressed with the collector’s registered address;Pre-paid postage; Unique ID number so package can be tracked; andInstructions for mailing. 21 CFR § 1317.70 (c)

Destruction of Controlled SubstancesAll controlled substances destroyed by a registrant or caused to be destroyed by a registrant shall be destroyed in compliance with applicable Federal, State, tribal, and local laws and regulations and shall be rendered non-retrievable-incineration.21 CFR § 1317.90  

Registrant DisposalDestruction of Mail-Back PackagesMail-Back Packages (upon receipt of a sealed mail-back package):Promptly destroy the package using an on-site method of destruction; orSecurely store the package at the collector’s registered location until prompt on-site destruction.  21 CFR § 1317.05(c)(1) 

Community EffortsEducate the Community: DEA encourages voluntary, educational outreach to the public on the abuse potential and proper disposal of pharmaceutical controlled substances, whether it be through law enforcement, community groups, or professional organizations.Conduct Take-Back Events: Entities may choose to establish disposal programs for various reasons, including for profit, to build goodwill in the community, to attract customers, to advertise businesses, and to preserve the environment.

Law EnforcementLaw enforcement continues to have autonomy with respect to how they collect controlled substances from ultimate users, including:maintaining collection receptaclesconducting mail-back programsconducting take-back events 21 CFR § 1317.35

Take Back EventsTake-back events are intended to be limited-duration events that may take place at an unregistered location that is easily accessible to the public, such as a community center or town center.Law Enforcement may continue to conduct take-back events.Any person may partner with Law Enforcement.Law Enforcement shall maintain control and custody of collected substances until secure transfer, storage, or destruction has occurred.Authorized collection receptacles and inner liners “should” be used.21 CFR §§ 1317.35 and 1317.65

26 Collection Boxes7 Collection Boxes1 Collection Box at each of below PDs

Contact Information Supervisory Special Agent Thomas 616-4365QUESTIONS?