USP <800> establishes comprehensive protocols to ensure the safe handling of hazardous substances throughout their lifecycle, encompassing everything from initial reception and unpackaging by pharmacy staff to the administration by clinicians and final disposal in environmental services. The guidelines provide detailed instructions for disposal methods, ranging from basic waste disposal in designated containers to effectively managing incidents involving potentially hazardous spills, such as vomit.
Although disposal may not always receive the same level of attention, it remains an indispensable and vital component of the overall safe-handling process for hazardous drugs. Disposal also requires that healthcare facilities partner with a waste hauler or waste management company that safely disposes of hazardous pharmaceutical waste in compliance with strict regulations.
USP <800> Guidelines for Waste Transport
While waste management companies are bound to regulations for hazardous waste disposal, USP <800> is not directly applicable to the processes except when transporting and disposing of hazardous drugs.
In the Transport 11.3 guidelines, USP <800> says, “hazardous drugs that need to be transported must be labeled, stored, and handled per applicable federal, state, and local regulations. Hazardous drugs must be transported in containers that minimize the risk of breakage or leakage.”
USP <800> clearly states in Disposal, 11.4, that when it comes to waste disposal, including “unused hazardous drugs and trace-contaminated PPE and other materials,” healthcare facilities “must comply with all applicable federal, state, and local regulations.”
Regulations for Waste Management Companies
Even though waste handling companies are not tied to USP <800> or other USP guidelines, they are regulated by the Environmental Protection Agency (EPA) and state agencies that regulate substance waste management activities, including pharmaceutical waste.
However, pharmaceutical waste was not explicitly regulated until 2019, when the EPA signed the final Management Standards for Hazardous Waste Pharmaceuticals rule. Prior to this regulation, hazardous waste pharmaceuticals were managed under the same regulations as other hazardous wastes through the Resource Conservation and Recovery Act (RCRA).
The Management Standards for Hazardous Waste Pharmaceuticals established guidelines for handling and disposing of pharmaceutical hazardous waste produced by healthcare facilities. These standards offer regulatory transparency and compliance flexibility for healthcare facilities that manage hazardous pharmaceutical waste.
The Role of EPA in Pharmaceutical Waste Management
Waste haulers transporting hazardous waste pharmaceuticals from healthcare facilities must specifically comply with the applicable requirements in the EPA’s 40 CFR Part 266 Subpart P and 40 CFR Part 263. These two regulations cover standards for the management of specific hazardous wastes and hazardous waste management facilities, as well as general standards expected of transporters of hazardous waste.
According to the EPA, common violations that waste management companies face when disposing of hazardous drugs include:
- Failure to make accurate hazardous waste determinations.
- Improperly sealed waste containers, which could leak volatile organic compounds.
- Storage of hazardous waste beyond the 90 days allowed.
- Improperly labeled hazardous waste containers.
- Failure to develop and implement an adequate hazardous waste management training program.
- Failure to conduct hazardous waste inspections.
Waste haulers and management companies are exempt from direct compliance with USP <800> regulations, which are primarily applicable to healthcare facilities that handle hazardous drugs. However, waste haulers are responsible for safely disposing of hazardous drugs and are accountable to the EPA for their practices. Healthcare facilities and systems must select a waste hauler partner that complies with applicable regulations and ensures proper disposal of hazardous drugs.
USP <800> Resources
You're not alone if you’re not fully prepared for USP <800> inspections. In a survey of Rpharmy USP <800> Preparedness webinar attendees, 86% of respondents were not yet fully compliant. If you’d like to learn more about what to expect from USP <800> inspections and how to prepare for the November 1, 2023, deadline, check out the free Rpharmy USP <800> preparedness video series. Also, the Rpharmy Hazardous Drug Resource page may be helpful as you work to protect healthcare workers from exposure to hazardous drugs through compliance with USP <800>.