David Cali is senior director of Security and DEA Compliance at Reworld

, a leader in sustainable waste solutions. He leads the company’s physical security, investigations, and DEA compliance. Prior to joining Reworld

, David spent 30+ years in law enforcement including serving as a Special Agent with the US Drug Enforcement Administration (DEA), the Baltimore Police Department, and as an advisor to the Department of Defense.

David Cali

David Cali is senior director of Security & DEA Compliance at Reworld

Pharmaceutical manufacturers are under growing pressure to ensure that expired, damaged, or off-spec products are disposed of securely and compliantly (1). These products, which include R&D waste and unused inventory, often fall under strict regulatory oversight (2). When not handled correctly, they can pose risks to public safety, the environment, and a company’s reputation. To address these risks, the US Drug Enforcement Administration (DEA) requires all controlled substances to be destroyed in a way that renders them “non-retrievable” (3).

To meet this standard, manufacturers must understand the technologies, facility requirements, and procedural considerations involved in pharmaceutical destruction. They also need to avoid common pitfalls and identify qualified partners who can support secure, sustainable outcomes.

Regulatory requirements and common pitfalls

Treating destruction as a critical compliance function will help manufacturers comply with DEA requirements. The non-retrievable standard means that the substance cannot be reconstructed or recovered in any form (4). This applies most directly to controlled substances, but non-controlled substances may also be regulated by state environmental agencies or internal quality protocols.

DEA also requires that destruction be witnessed and properly documented (4). Depending on the substance and pathway chosen, this documentation may include a signed certification, custody records, or video evidence. Companies that fail to follow compliant destruction practices risk fines, recalls, and regulatory scrutiny (5).

Common missteps include improper use of general waste streams, landfill disposal, or chemical neutralization methods. These approaches often fail to meet DEA expectations and may lead to environmental or security risks.

Destruction technologies and facility standards

High-temperature thermomechanical treatment is the most secure and sustainable destruction method available. Controlled substance pharmaceuticals should never be mixed with municipal waste or held for extended periods. Instead, delivering controlled substance pharmaceuticals directly into high-temperature chambers that operate at up to 2000 °F renders them completely unrecoverable (6).

This method also supports environmental performance. Energy is recovered from the process, emissions are controlled, and materials are diverted from landfills. In contrast, chemical neutralization or landfill disposal not only falls short of DEA standards but also increases exposure to environmental and reputational risks (7).

The thermomechanical process is conducted within secure, access-controlled facilities. Chain of custody remains unbroken, and destruction is witnessed on-site by the manufacturer or facility personnel who maintain destruction records at the facility (8).

Two DEA-compliant destruction models are available to manufacturers and distributors (4).

In the first model, the manufacturer retains custody of the material and delivers it directly to a thermomechanical treatment facility. The destruction is witnessed on-site by the manufacturer or distributor, and the manufacturer receives the documentation needed to confirm compliance.

In the second model, the manufacturer formally transfers custody to a sustainable waste solutions partner that is licensed to manage the full process. The controlled substance pharmaceuticals are then stored, secured, and destroyed and the manufacturer is provided all regulatory paperwork.

Manufacturers should consider which model fits best based on volume, classification, risk level, and internal protocols for chain of custody.

Best practices for managing expired, excess, and off-spec materials

Pharmaceutical waste streams should be separated by classification and clearly marked to avoid errors or violations (9).Coordination across compliance, operations, quality assurance, and logistics teams is crucial. Miscommunication or breakdowns in handoff points often lead to delayed destruction or misrouted materials.

A sustainable waste solutions partner should be engaged when pharmaceuticals are no longer eligible for credit through reverse distributors, or when risk and regulatory complexity require a direct, witnessed destruction pathway. Relying solely on reverse distributors in these situations can create compliance gaps (10).

Manufacturers should also include destruction as a step in their product recall and R&D off-ramp procedures. Pre-approved vendor relationships and logistics plans will reduce delays and improve accountability.

Learnings from DEA prescription drug take back

DEA’s National Prescription Drug Take Back program, which work by processing materials collected at public collection days, involve sealed containers, tracked custody, and witnessed destruction, offering an example of how large-scale collection and destruction can be handled securely (11).

For pharmaceutical companies managing large quantities of expired or obsolete products, this model highlights the importance of formalized custody, clear documentation, and secure delivery. While public takeback programs serve consumers, the operational approach can inform how manufacturers handle sensitive waste.

Pharmaceutical destruction is more than a matter of logistics. It is a compliance obligation and an essential safeguard for public safety. Manufacturers should regularly review their handling protocols, verify that their destruction methods meet DEA expectations, and ensure that documentation is maintained.

They should look for a sustainable waste solutions partner that provides the technical infrastructure, regulatory expertise, and secure processing capabilities needed to help pharmaceutical manufacturers destroy sensitive and controlled substance pharmaceuticals compliantly, efficiently, and sustainably.

9 Key Capabilities for DEA Controlled Substance Reverse Distribution Partners. Triumvirate Environmental

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Medication & Pharmaceutical Waste Disposal Explained

. July 11, 2025. (accessed Aug. 25, 2025).

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Articles

Pharmaceutical manufacturers face increasing pressure to securely and compliantly dispose of expired, damaged, or off-spec products, including R&D waste and unused inventory. The DEA mandates that controlled substances be destroyed to a "non-retrievable" standard, necessitating an understanding of destruction technologies and facility requirements. High-temperature thermomechanical treatment is the most secure method, ensuring complete destruction and environmental performance. Manufacturers can choose between retaining custody or transferring it to a licensed partner. Best practices include clear classification, coordination across teams, and engaging sustainable waste solutions partners for complex regulatory scenarios.

Pharma manufacturers must securely destroy expired or off-spec drugs to meet DEA standards, avoid compliance risks, and protect public safety.