John McQuillan is the founder, chairman and CEO at Triumvirate Environmental.
Twice a year—in April and October—the U.S. Drug Enforcement Administration (DEA) hosts National Prescription Drug Take Back Day, an initiative designed to mitigate the dangers of unused or expired medications. In October 2024 alone, the DEA collected 629,953 pounds, or 314 tons, of unused pharmaceuticals from the public. This staggering figure underscores the growing challenge of managing and disposing of medications safely and responsibly.
But what about all the controlled substances that need to be disposed of by pharmaceutical manufacturers, life science organizations, biotech companies, hospitals, medical offices and higher education research labs on an even larger scale and on an ongoing basis?
Over the past 20 years, the pharmaceutical industry has expanded rapidly, bringing cutting-edge treatments and life-changing therapies to market. Use of prescription drugs has increased, especially in the past few years, with the rising popularity of weight-loss medications. People with chronic conditions also often depend on prescription medicines.
At the end of 2023, the U.S. prescription drug market reached a valuation just shy of $50 billion and is projected to grow to $74.3 billion by 2031. That’s a massive volume of controlled substances that organizations must track, manage and dispose of properly—a task that is increasingly complex and high-risk.
Compliance Challenges
Throughout my career, I have worked with hospitals, pharmaceutical companies and healthcare facilities to navigate compliance challenges, as well as life sciences labs to manage hazardous and controlled substance waste in strict accordance with DEA and Environmental Protection Agency (EPA) regulations.
I’ve seen that for many organizations, the management and disposal of controlled substances can be overwhelming. The regulatory landscape is complex and ever-evolving, and it affects a wide range of industries, including corrections facilities and police stations, which handle seized or confiscated drugs; pharmacies, elder care facilities and hospitals, which manage large volumes of expired or unused medications; veterinary clinics, which must safely dispose of controlled substances used for animal treatment; and drug manufacturers and research labs, which face strict regulations around waste disposal.
While controlled substances and their disposal are federally regulated, state-specific laws can create additional hurdles. Some substances are subject to different regulations across jurisdictions. States’ different stances and requirements on certain substances can create challenges for businesses and organizations that operate across multiple states, making compliance an ongoing struggle.
Risks Of Improper Disposal
Failing to properly manage and dispose of controlled substances can have severe legal and financial repercussions. Violations can result in hefty fines, legal liability and reputational damage.
More importantly, improper disposal practices put public safety at risk and can lead to dangerous outcomes. Inadequate destruction protocols can leave trace amounts of controlled substances accessible, creating diversion and misuse risks. Incorrect waste segregation during disposal can also result in hazardous chemicals entering the environment.
Secure disposal is essential. Handlers must ensure that every drug they transport is destroyed with precision, down to the last pill, to prevent diversion or theft.
Taking A Proactive Approach
Given the complexity of controlled substance regulations, organizations must take a proactive approach to compliance and disposal. For organizations thinking of working with outside vendors, it’s important to ensure they meet stringent requirements for drug management and disposal. Look for:
1. DEA-compliant disposal programs that include on-site and off-site pharmaceutical waste destruction, backed with strict chain-of-custody protocols.
2. Customized compliance solutions that can help your organization meet evolving DEA, EPA and state regulations.
3. Expert guidance on pharmaceutical waste stream classification and disposal best practices.
By working with a trusted partner, organizations can mitigate risk, streamline compliance and protect public health.
Internally, organizations should also establish regular employee training on proper handling and disposal protocols, as well as conduct periodic audits to identify and correct gaps before they escalate into compliance violations. Organizations cannot assume that once a system is in place, it will maintain itself. In reality, without ongoing education, oversight and adaptation to evolving regulations, even well-intentioned programs can quickly fall out of compliance.
Beyond internal compliance efforts, companies should actively participate in community initiatives such as the DEA’s National Prescription Drug Take Back Day. Encouraging employees and stakeholders to take part in these programs not only strengthens community well-being but also helps prevent medication misuse and environmental contamination.
Ultimately, by prioritizing compliance, working with the right experts, enhancing employee training and engaging in community efforts, organizations can ensure they are protecting their businesses, their employees and the broader public. Safe and responsible drug disposal isn’t just about following the law—it’s about doing the right thing for the environment, public health and the communities we serve.
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