David Cali is Covanta's Director of DEA Compliance, overseeing all areas that pertain to the safe and sustainable management of pharmaceutical waste in accordance with federal policy. Prior to joining Covanta, David spent 30+ year in law enforcement, including 27 years with the Drug Enforcement Administration.
While pharmaceuticals can be vital for maintaining health and saving lives, pharmaceutical waste, like expired, unused or unsellable prescriptions, can have the exact opposite effect. Should they contaminate the environment, fall into the wrong hands or simply violate compliance standards due to improper management and disposal, they can have significant legal and financial ramifications for your business and put your customers and communities at risk.
But properly disposing of pharmaceutical waste is easier said than done. Even some of the world’s largest pharmaceutical organizations struggle to keep up with the complex web of rules and regulations that dictate how waste should be handled. For example, a pharmaceutical retailer giant recently paid a $3.5 million fine for improper waste disposal of over-the-counter and prescription medicines, among other hazardous materials.
While safe waste disposal practices are a top priority of every organization that works with pharmaceuticals, there can be tremendous challenges in maintaining compliance. The first step is to understand what these challenges are. By doing so, you can learn to take the necessary steps to make sure you’re not jeopardizing your business or those it serves.
Pharmaceutical waste is a highly regulated field that receives attention from numerous state licensing agencies, the U.S. Environmental Protection Agency, the U.S. Drug Enforcement Administration (DEA) and international bodies. While it's your responsibility to maintain compliance, managing all of these requirements, plus keeping track of new or updated rules, can be difficult. Without constant education across your entire team, it’s easy for staff to inadvertently send the wrong type of pharmaceutical waste to a landfill instead of to a regulated disposal facility.
Every regulation requires its own specific forms and procedures, not to mention particular methods for submitting paperwork and accurately keeping and storing records. For a busy organization, this work can add up to more than a full-time job, which can take highly qualified employees away from their primary tasks—the work you hired them for—and what generates revenue.
In addition to the paperwork required, not all pharmaceutical waste is created equal. Controlled and noncontrolled pharmaceutical waste can require multiple, different—types of collection boxes that need to be sent to two different types of facilities, which can mean coordinating and managing multiple waste disposal vendors.
That said, as pharmaceuticals undergo various processes and change hands throughout their lifecycle, there is ample opportunity for something to go wrong without the right solutions in place. Whether it’s due to mishandling, poor tracking or any variety of management errors that span their cradle to grave journey, pharmaceuticals can slip between the cracks at any step of the way, knocking them out of the supply chain and creating a domino effect of compliance liabilities.
Should your compliance slip, your organization is potentially liable for millions of dollars in fines. That’s because each violation can cost as much as $15,000 per instance. Depending on how many of these individual violations are flagged, and how long your organization is out of compliance before it remedies the situation, the total fine assessed could be large enough to bankrupt your business.
In addition to fines, facilities can be the target of lawsuits by private citizens, cities and states that have been affected by pharmaceutical waste. Not only can this expose your business to expensive litigation and potentially massive judgments, but it will put your organization’s name in the news in a way that can be ruinous for your brand.
Beyond fines and lawsuits, a large-enough violation can impact your company’s ability to conduct business moving forward. That’s because the DEA has shown that it will revoke an organization’s DEA registration, which is required for managing controlled substances, for egregious violations. Without it, your business can’t produce or work with controlled substances, which, for some organizations, could significantly disrupt or even halt operations.
To protect your business, it pays to work with a sustainable materials management partner who is an expert in pharmaceutical waste regulations and offers end-to-end capabilities in safely handling and disposing of such high-risk materials.
Also keep in mind that post-consumer pharmaceutical waste remains a significant area of concern due to its impact on communities and the environment. Apart from the financial and reputational losses that stem from these materials falling into the wrong hands, mismanaged drugs destroy communities, as evidenced by the ongoing opioid crisis. What’s more, is these materials extend beyond communities into soils and water sources, where they spread to and contaminate crops, animals and unsuspecting people.
The right partner will not only have expertise in disposal, but will have experience working with municipalities, law enforcement agencies and the DEA to safely, securely and compliantly destroy post-consumer pharmaceuticals and protect communities, the environment, and ultimately, your ESG goals.
Because that type of partner does this all day, every day, they can help your company stay up to date with the latest rules and deliver tailor-made solutions that meet your business needs while helping you achieve higher standards of efficiency and sustainability.
To learn more about the risks of pharmaceutical waste and what to look for in a disposal partner, read our article Pharmaceutical Waste: The High Cost of Non-Compliance.