Since the early 1980’s hazardous waste management in this country has largely consisted of a “one size fits all” set of stringent regulations promulgated under the Resource Conservation and Recovery Act (RCRA). The regulations presume that manufacturers and commercial operations generate relatively predictable amounts of hazardous waste from specific locations and processes. Hazardous waste is managed, from generation to final disposition, by trained technical experts.
However, hazardous waste can also be generated by other business sectors under very different circumstances, with unpredictable points of generation and times of generation. Healthcare facilities that generate hazardous waste pharmaceuticals have reported difficulties complying with the existing RCRA regulatory framework (EPA, 2015):
- Healthcare workers, by and large, have no working knowledge of hazardous waste management regulations
- A healthcare facility can have thousands of items in its formulary, making it difficult to ascertain which ones are hazardous wastes when disposed
- Some active pharmaceutical ingredients are acute hazardous wastes, which are subject to stringent regulation and control in small amounts
To facilitate compliance and to respond to these concerns, the U.S. Environmental Protection Agency is proposing to establish regulations specifically directed at the management and disposal of hazardous waste pharmaceuticals at healthcare-related facilities. The proposed standards (40 CFR 261, 262, 266, 268, and 273) were published on September 25, 2015 (80 Federal Register 186, 58014).
Virtually any pharmacy, supplier, manufacturer and distributor of pharmaceutical products in the United States may be subject to a portion of these regulations.