The United States Environmental Protection Agency (“EPA”) regulates pharmaceutical hazardous waste. Under the EPA, unused and disposed of pharmaceuticals are evaluated, managed and disposed of as potential “hazardous waste” under the Resource Conservation and Recovery Act (RCRA) Regulations. The RCRA establishes procedures and standards for hazardous and solid waste material management and disposal. Under the RCRA, solid waste includes “solids, liquids and gases and must be discarded to be considered waste.”[i]
When a health care facility has unused pharmaceuticals, it will commonly send the drugs to what is called a “reverse distributor” or dispose of the drugs at the facility. A reverse distributor is defined as “any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit."[ii]Once a reverse distributor receives unused pharmaceuticals, it will then determine whether the drugs can be shipped back to the manufacturer for a credit. If the product cannot be resold, the distributor will dispose of the pharmaceutical under proper environmental regulations. Under prior federal standards, a pharmaceutical was not considered a “waste” under the RCRA until it was officially discarded, after the reverse distributor determined it was unusable. This operation line allowed health care facilities to ship all unused prescription and non-prescription pharmaceuticals to a reverse distributor without having to consider whether any of those products were considered hazardous wastes under federal law.
However, on December 11, 2018 the EPA signed a new rule, effective six months from its signing, that now holds all unused pharmaceuticals are considered “waste” before a reverse distributor makes any determination. The Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine now requires health care facilities, including hospitals, clinics, pharmacies and long-term care facilities, to identify all unused pharmaceuticals as discarded waste before they leave the facility, compelling facilities to abide and report under RCRA waste standards. Under the new rule, the health care facility must now follow RCRA protocol and management standards of all hazardous and non-hazardous waste in regard to its unused prescription pharmaceuticals.
Among other requirements, all health care facilities that dispose of hazardous prescription pharmaceuticals are required to register with the EPA, and must separate hazardous pharmaceuticals from non-hazardous pharmaceuticals. Additionally, health care facilities are prohibited from flushing any hazardous waste down the sink or toilet (also known as “sewering”). The rule establishes new standards for healthcare facilities and reverse distributors that require specific training to all relevant personnel, including storage, labeling, recordkeeping, reporting and off-site shipment of discarded pharmaceuticals under the RCRA.
The EPA proposes that the new rule will simplify the management of hazardous waste pharmaceuticals generated at health care facilities, improve compliance of the RCRA, and will reduce the risk caused by hazardous waste pharmaceuticals that are flushed down the sink or toilet. The EPA contends that healthcare workers and pharmacy employees lack the understanding of RCRA hazardous waste management requirements, which results in thousands of tons of hazardous waste material to be flushed into the local surface water every year. The final rule’s goal is to “establish cost-saving, streamlined standards” for health care facilities to properly handle and dispose of hazardous waste pharmaceuticals in an environmentally friendly manner.[iii]
This new rule requires all health care facilities to implement educate its employees on RCRA requirements. In addition, healthcare facilities must ensure that they have the proper capacities to manage and dispose of hazardous and non-hazardous pharmaceuticals under the RCRA, which must be done within one year of being determined a waste. There are several exemptions from the rule that should be noted: all FDA-approved nicotine replacement therapies, such as patches or gum are exempt from hazardous waste disposal requirements. Additionally, any controlled substance regulated by the DEA and any regulation medications collected during drug take-back programs are exempt as well. Non-prescription pharmaceuticals will continue to be evaluated by the reverse distributor as to their waste status. Healthcare facilities that fall under the EPA’s new rule should take extra measures and care to ensure complete compliance by the rule’s effective date in June 2019.
[i] Resource Conservation and Recovery Act (RCRA) Overview, United States Environmental Protection Agency (July 9, 2018), https://www.epa.gov/rcra/resource-conservation-and-recovery-act-rcra-overview.
[ii] Frequent Questions about the Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine Final Rule, United States Environmental Protection Agency (Nov. 13, 2018), https://www.epa.gov/hwgenerators/frequent-questions-about-management-standards-hazardous-waste-pharmaceuticals-and.
[iii]Rule Summary, Final Rule: Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine, United States Environmental Protection Agency (Jan. 30, 2019), https://www.epa.gov/hwgenerators/final-rule-management-standards-hazardous-waste-pharmaceuticals-and-amendment-p075#rule-history.
See Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine Pain, No. EPA-HQ-RCRA-2007-0932, E.P.A. (2018).
Hayley Scheer, J.D., LL.M. is an attorney who practices health law with Cabaniss, Johnston, Gardner, Dumas & O’Neal.
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