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DEA Controlled Substance Disposal Requirements Take Effect October 9, 2014

On September 9, 2014, the U.S. Drug Enforcement Administration (DEA) published a rule pertaining to the secure disposal of controlled substances (the Rule), in large part to implement the Secure and Responsible Drug Disposal Act of 2010 ("Disposal Act"). The Rule broadens the range of permissible collection and disposal methods for unused, unwanted, or expired pharmaceutical controlled substances.


Under the Controlled Substances Act (CSA), patients could only dispose of unused controlled substances themselves, or deliver them to a law enforcement official. The Disposal Act was enacted on October 12, 2010 in order to facilitate more convenient, secure, and environmentally responsible disposal options. The Disposal Act amended the CSA to authorize “ultimate users” to deliver their pharmaceutical controlled substances to a broader range of entities for the purpose of disposal in accordance with requirements to be promulgated by DEA. An ultimate user is a “person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household.” 21 U.S.C. §802(27). The Rule establishes the requirements envisioned by the Disposal Act and consolidates and revises existing rules on disposal in other contexts, such as transfers from DEA registrants to "reverse distributors."

Collection and Disposal Provisions

Collection of Controlled Substances

The Rule authorizes “collectors” to conduct mail-back collection programs and maintain collection receptacles at authorized collection locations. The Rule allows, on a voluntary basis, manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy and retail pharmacies to register with the DEA as “collectors.”  21 CFR §§1301.51 and 1317.40. In addition, hospitals/clinics with an on-site pharmacy and retail pharmacies are permitted to maintain collection receptacles at long-term care facilities. 21 CFR §1317.40(b)(2). These entities must submit a written request to the DEA Registration Unit in order to obtain authorization to act as a “collector.”  21 CFR §1301.51. They must also notify the DEA in writing when they intend to stop providing collection services. 21 CFR §1301.52.

In addition, in a continuation of current practice, Federal, State, tribal, or local law enforcement may voluntarily promote collection and disposal of controlled pharmaceutical substances from ultimate users through (1) take-back events, (2) mail-back programs, and (3) collection receptacles. 21 CFR §§1317.65, 1317.70, and 1317.75.

Security Controls and Collection Protocols

Under the Rule, only “ultimate users” or those entitled to dispose of their decedent property can transfer ownership of controlled substances to registered collectors or law enforcement. Hospitals, pharmacies, and other entities cannot dispose of their unwanted pharmaceuticals or controlled substances by adding them to materials collected from ultimate users. The Rule allows all pharmaceutical controlled substances collected through take-back events, mail-back programs, and collection receptacles to be comingled with non-controlled substances. 21 CFR §§1317.65, 1317.70, and 1317.75.

Once deposited in a receptacle, pharmaceutical controlled substances cannot be individually counted, handled or sorted.  At least two employees of the collector must perform or supervise installation and removal of the liners of all collection receptacles. 21 CFR §1317.75(g).  Sealed mail-back packages and inner liners, prior to destruction, must be stored in a securely locked, substantially constructed cabinet or a securely locked room with controlled access. 21 CFR §§1317.05(c) and 1317.75(c).

All collection receptacles must meet certain requirements.  They must be securely placed and maintained, securely locked, and substantially constructed. They must have a permanent outer container and removable inner liner, and they must be inside a collector’s registered location, authorized long-term care facility, or a law enforcement physical location. 21 CFR §1317.75. The inner liner must bear a permanent, unique identification number that allows it to be tracked, and must be sealed immediately upon removal from the outer container. 21 CFR §1317.60.  The Rule requires detailed record-keeping by entities responsible for collection. 21 CFR §1304.22.

Reverse Distributors

The Rule also seeks to create a clear and consistent set of regulations for entities that are “reverse distributors.” To “reverse distribute” is to acquire controlled substances from another DEA registrant or law enforcement (rather than from an ultimate user) for the purpose of destruction or return to the registered manufacturer or an entity authorized to accept returns on a registered manufacturer’s behalf. Entities that engage in this activity must immediately store controlled substances upon receipt in a secure manner, as described above, at the reverse distributor’s location until the time of destruction or return to the registered manufacturer. 21 CFR §1317.15.

Disposal Requirements

All controlled substances collected under the Rule shall be destroyed in a manner compliant with all applicable Federal, State, tribal, and local laws and regulations. 21 CFR §1317.90. Destruction must render the substances “non-retrievable.” 21 CFR §1317.90. A controlled substance is “non-retrievable” when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue. 21 CFR §1300.05. The rule does not specify a required disposal method. Any registered entity that destroys or causes destruction of a controlled substance must maintain a complete and accurate record of the destruction on a DEA Form 41. The record must include the signature of two employees who witnessed the destruction. 21 CFR §1304.21.


The Rule becomes effective on Thursday, October 9th, 2014, thirty days after publication in the Federal Register. 

© 2020 Beveridge & Diamond PC National Law Review, Volume IV, Number 262


About this Author

Donald J. Patterson, Jr. Environmental Litigation Attorney Beveridge & Diamond Washington, DC

Don’s extensive environmental counseling practice enables him to represent his clients effectively in rulemakings, enforcement, and appellate litigation.

His environmental litigation, negotiation and enforcement experience allows him to evaluate complex and nuanced environmental issues that arise in environmental due diligence and the drafting of stock and asset purchase agreements. Moreover, his experience with many federal and state environmental programs – Resource Conservation and Recovery Act (RCRA) hazardous and solid waste, state medical and infectious waste, the Clean Water...

Paul E. Hagen Environmental Attorney Beveridge & Diamond Washington, DC

Paul helps clients navigate increasingly complex environmental requirements governing global supply chains and products across their life-cycle.

He works with leading companies to anticipate and comply with product-related environmental requirements in the U.S. and in key markets worldwide. He has represented U.S. business interests in the negotiation and implementation of regional and global environmental agreements that drive national legislation and the circular economy.

Extended Producer Responsibility (EPR) 

Paul advises companies on compliance with expanding EPR laws governing the management of used and end-of-life electronic equipment, batteries, medical devices, unwanted pharmaceuticals, and plastics packaging in the U.S. and in other countries. He has advised clients on the successful launch of regional and global take-back programs.

Basel Convention and Circular Economy

Paul serves as a strategic advisor to companies on new circular economy initiatives with a focus on reuse of products and materials recovery. He regularly advises on requirements governing transboundary shipments of electronic products for reuse, repair, and recycling. For more than two decades, he has represented clients in the electronics sector on the negotiation and implementation of international waste shipment controls and trade bans arising under the Basel Convention, OECD Council Decision, and U.S. bilateral agreements.

Market Access Legislation

Paul provides compliance advice on market access requirements for products subject to RoHS measures and material ban legislation, energy efficiency mandates, product design requirements, and labeling.

Responsible Sourcing

Paul also advises a diverse group of companies on due diligence, supply chain communication, and disclosure requirements related to the responsible sourcing of timber, conflict minerals, and other raw materials.

Conservation Leadership

Paul is active with many of the country’s leading conservation organizations. He serves on the board of the Conservation Fund which since its founding has protected over 8 million acres of natural lands and working landscapes. He is a former board chair of the Environmental Law Institute (ELI) and Chesapeake Conservancy. He has also served on the boards of the American Bird Conservancy and World Environment Center. He has advised non-profit clients on protecting whales, establishing nature reserves, advancing global protections for albatrosses, and sustainable fisheries management. He also serves on the NatureServe strategic advisory council. 

Aaron H. Goldberg Hazardous Waste Regulatory Law Attorney Beveridge & Diamond Washington, DC

Aaron applies his decades of experience with hazardous waste regulatory law to help clients comply with the rules, help mold the rules, and defend against allegations of noncompliance.

He holds an advanced degree in chemistry, has extensive training in economics, and is a former consultant to the U.S. Environmental Protection Agency. His unique, multidisciplinary background—law, science, economics, and government—informs nearly every aspect of his work and makes him a valuable bridge between attorneys, engineers, business managers, consultants, and regulators.

Aaron has...