On August 31, 2015, the U.S. Environmental Protection Agency (EPA) proposed an important rule under the Resource Conservation and Recovery Act (RCRA) that would ease the standards for healthcare facilities that dispose of hazardous waste pharmaceuticals. The proposal is of interest to all participants in the pharmaceutical value chain, from manufacturers to health care providers to end users. This column explains why.
THE PROPOSED RULE
Some pharmaceuticals when discarded are regulated as hazardous waste under RCRA. This is neither new nor surprising given the inherent toxicity of certain pharmaceuticals. The EPA has long recognized that only approximately 5% of drugs are regulated under RCRA, while the remaining 95% may be “hazardous” using the traditional criteria for measuring toxicity and “new” measures including antibiotic resistance, endocrine disruption and related metrics.
Healthcare and associated facilities that generate hazardous waste pharmaceuticals have long reported difficulties complying with the RCRA Subtitle C hazardous waste regulations. Healthcare workers may not be knowledgeable about RCRA regulations, but often are involved in their implementation. Healthcare facilities can have thousands of items at its disposal, making it difficult to ascertain which are hazardous wastes and which are not.
To facilitate compliance and respond to these concerns, the EPA proposes revising the regulations to improve the management and disposal of hazardous waste pharmaceuticals and tailor them to address the specific issues that hospitals, pharmacies and other healthcare-related facilities face. The revisions also are intended to clarify regulation of the reverse distribution mechanism used by healthcare facilities for managing unused or expired pharmaceuticals. The EPA proposes adding a new Subpart P under 40 C.F.R. Part 266, and requiring healthcare facilities that are currently small quantity generators (SQG) or large quantity generators (LQG) and all pharmaceutical reverse distributors, regardless of their RCRA generator category, to manage their hazardous waste pharmaceuticals under Subpart P of 40 C.F.R. Part 266, instead of 40 C.F.R. Part 262. That is, the proposed standards are not an optional alternative to managing hazardous waste pharmaceuticals under 40 C.F.R. Part 262; they are mandatory standards.
This article was originally published on our sister site, Chemical Processing. Continue reading the article here