Clean Earth experts are fluent 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 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)
DOT (49 CFR § 173)
National Institute of Occupational Safety and Health (NIOSH)
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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