Safe and compliant disposal of pharmaceutical waste
Pharmaceutical waste disposal and management affects more than just the bottom line—it also has real implications for the environment, consumers and employees. With increasing oversight from regulatory agencies, every facility that disposes of pharmaceuticals, from controlled substances to OTC medication, must meet strict handling and disposal mandates. Beyond harsh financial penalties, failure to meet these requirements can result in violations that have a lasting impact on brand perception. Clean Earth's expertise assists customers – from a single retail pharmacy to a large medical complex— with the safe and compliant disposal of pharmaceutical waste.
Controlled substances are closely regulated by the federal Drug Enforcement Administration (DEA), which monitors manufacturers, distributors and providers to prevent the diversion of potentially dangerous or illegal substances. The DEA also has the authority to deliver harsh penalties to any noncompliant facility. Compliance with evolving pharmaceutical waste disposal regulations requires constant diligence throughout the entire process and meticulous documentation for accurate reporting. Clean Earth's comprehensive controlled substance management program provides robust DEA waste management solutions to help avoid and minimize these costly violations. To avoid fines and violations, waste from any location must be properly documented, segregated and destroyed, with every step from identification through disposal accurately recorded and reported to all relevant regulatory bodies. Full compliance demands that this process is regularly monitored and audited to avoid any costly oversights.
As a DEA registrant, our pharmaceutical waste disposal services are authorized to manage the destruction and disposal of controlled substances (C-II through C-V). To accomplish this, we utilize a network of Clean Earth-owned, DEA-permitted Treatment, Storage and Disposal Facilities (TSDFs). A proprietary web-based reporting tool and technicians’ electronic scales, mobile printers and laptops ensure that every step of the process is thoroughly documented and recorded in accordance with regulatory requirements. This DEA waste management approach includes regular consultations, employee compliance monitoring, delivery of appropriate waste management supplies and separation and segregation of waste for transportation. This expertly managed process helps customers avoid or minimize any regulatory penalties while protecting their brands and consumers at the same time.
Businesses that need to dispose of over-the-counter medications face extensive penalties for violating any one of numerous regulations, regardless of waste quantity. Clean Earth helps customers manage the complex and changing regulatory requirements of pharmaceutical waste disposal, which includes disposal of over-the-counter medications. Whether customized for a single facility or for thousands of nationwide locations, these pharmaceutical waste services offer fine-tuned solutions for accountable, standardized and compliant disposal. Clean Earth's regulatory and reverse-logistics experts collaborate with pharmacies and manufacturers to ensure compliance with all state and federal regulations, including those enforced by the following agencies:
A truly successful service call is a focused appointment that impacts business operations as little as possible while protecting the customer from potential violations and penalties. Technicians bring the highest level of professionalism and efficiency to every on-site visit. They identify, segregate, document and transport waste for compliant destruction, offering a complete solution for disposal of over-the-counter drugs.
Clean Earth has expertise in both pharmaceutical waste management and hazardous waste management. Given that their waste profiles include a wide array of chemicals, solvents and other hazardous and nonhazardous waste in addition to pharmaceuticals, it is critical that pharmaceutical manufacturers engage vendors with the expertise to properly manage all waste streams. Proper characterization is vital to the successful management of any waste, but it is a particularly important aspect of managing the hazardous waste materials generated by pharmaceutical manufacturing facilities. Clean Earth's waste characterization expertise helps manufacturers minimize their risk of violations and penalties by properly identifying and separating DEA hazardous and nonhazardous material, including byproducts, chemicals, solvents, R&D wastes, waste water and excess inventory. The process begins with an initial waste characterization to determine the appropriate designation for all wastes, leveraging the tools and experience gained from processing countless pharmaceutical returns and recalls. Clean Earth's proprietary database profiles more than 450,000 National Drug Code (NDC) numbers, and waste characterization includes a review of substances identified by:
EPA (40 CFR §262.11 and 261.3)
To protect customers’ employees, reputations and local communities, periodic re-characterization of wastes and frequent audits of all Treatment Storage and Disposal Facilities (TSDFs) are required. Characterization results in a waste profile, which is a description of all the chemical constituents and generating process for a hazardous or nonhazardous waste. Finally, technicians print signature-ready waste manifests (tracking and shipping records) and coordinate all waste transportation logistics, allowing customers to focus on their business instead of regulatory requirements.
To help reduce the impact of pharmaceutical waste on the environment, the Environmental Protection Agency (EPA) will soon be releasing a Final Rule on the management of hazardous waste pharmaceuticals. While the new regulations have not been officially released, here are the highlights of the proposed rule and potential impact.
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