New Pharmaceutical Management Rule for Healthcare Facilities
EPA issued the final rule titled, “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine” on December 11, 2018. Waste pharmaceuticals that were previously required to be managed as Resource Conservation and Recovery Act (RCRA) hazardous waste under hazardous waste generator rules will now have tailored, streamlined standards for management of these wastes under Subpart P of 40 CFR Part 266.
Highlights of the rule applicability and timeline for implementation include:
- Only applies to healthcare facilities and reverse distributors that generate and manage hazardous waste pharmaceuticals;
- Healthcare facilities include those for both humans and animals;
- Does not apply to manufacturers, production facilities or other generators of hazardous waste pharmaceuticals;
- Updated applicability for managing FDA-approved over-the-counter nicotine replacement therapies, such as patches and gum, stating these will no longer meet the definition of a P075 hazardous waste for nicotine;
- Goes into effect 6 months after publication in federal register, in June 2019, for states under EPA RCRA authority;
- States that are authorized to implement the RCRA program must adopt the more stringent portions of the rule, which become effective in that state upon adoption; and
- The rule ban on flushing of hazardous waste pharmaceuticals down the drain becomes effective in all states regardless of RCRA authority 6 moths after publication in the federal register.
EPA lists the following benefits of the rule for healthcare facilities that manage hazardous waste pharmaceuticals:
- A healthcare facility will not become a large quantity generator (LQG), with all the associated requirements, when it generates more than 1 kg of acute hazardous waste pharmaceuticals in a month;
- A healthcare facility will not have to comply with the satellite accumulation area regulations, which are a poor fit for healthcare facilities;
- A healthcare facility will not need to specify hazardous waste codes on manifests;
- A healthcare facility will be able to accumulate hazardous waste pharmaceuticals on site without a RCRA permit for 365 days, an increase of 275 days over the current generator regulations; and
- A healthcare facility will have basic training requirements.
The rule only applies to pharmaceutical wastes; non-pharmaceutical wastes at healthcare facilities and reverse distributors will still be subject to all applicable requirements under the RCRA hazardous waste rules.
VBA professionals have years of experience assisting the healthcare industry with environmental compliance. If you would like a review of operations to see how this rule impacts you or if you need environmental compliance assistance or an environmental applicability review, please contact VBA.