Starting on August 21, 2019, the discharge of pharmaceutical products by Healthcare facilities and Reverse Distributors, considered hazardous wastes by the Resource Conservation and Recovery Act (RCRA) is strictly prohibited. Specifically, the 40 CFR section 266.505, prohibits this practice, no matter the healthcare facility or reverse distributor has a pretreatment permit issued either by the POTW or the state.
This prohibition is part of a more comprehensive regulation EPA has promulgated for the management of hazardous wastes generated at healthcare facilities and managed by reverse distributors.
In terms of applicability, healthcare facilities are places authorized to provide any kind of care to humans and animals ( i.e., preventive, palliative, rehabilitative, diagnostic, and therapeutic). This definition is extensive to long-term care, nursing, hospice facilities and veterinary clinics as well.
A reverse distributor is a person or business dedicated to receiving and accumulate pharmaceutical products that are potentially hazardous wastes for the purpose of facilitating or verifying manufacturer credit. Healthcare facilities use reverse distributors to handle expired pharmaceutical products to obtain some monetary benefit and save in disposal costs.
Although this regulation is applicable to the management of hazardous wastes pharmaceuticals, EPA strongly discourage the discharge to the sewer of any pharmaceutical waste (hazardous on non-hazardous), with few exceptions.
The criteria to determine that a pharmaceutical waste is hazardous is essentially the same as any other hazardous waste: it is either listed (P or U wastes, except over-the-counter nicotine replacement therapies) or by characteristics (i.e., ignitability, reactivity, corrosivity and TCLP toxicity).
The new hazardous wastes management regulations for pharmaceutical products were adapted to facilitate healthcare facilities compliance, and, at the same time ,enhance the protection of human health and the environment.
For more information to assist your healthcare or reverse distribution facility in addressing compliance issues with this new rule before are discovered by EPA or NJDEP, or the POTW providing sewerage disposal services in your business area, please contact Baron Environmental Associates at (908) 508-9000.