The US Environmental Protection Agency Focus on Compliant Pharmaceutical Waste Management Now Includes Long-term...

Area of Science:

• Environmental Science
• Regulatory Affairs
• Pharmacy Practice

Background:

• The US Environmental Protection Agency (EPA) previously regulated hazardous waste pharmaceuticals, impacting healthcare facilities.
• Long-term care facilities were not explicitly defined as regulated entities under prior EPA hazardous waste rules.

Purpose of the Study:

• To summarize the EPA's Final Rule on hazardous waste pharmaceutical management.
• To clarify the rule's impact on long-term care pharmacies and facilities.
• To highlight changes in hazardous waste generator status calculations.

Main Methods:

• Review of the EPA's Final Rule: Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine.
• Analysis of the rule's applicability to healthcare settings, including long-term care.
• Examination of waste-generation parameters and generator status implications.

Main Results:

• The Final Rule, effective August 22, 2019, applies nationwide and explicitly includes long-term care facilities.
• Over-the-counter nicotine products are no longer regulated as P-listed hazardous waste.
• Hazardous waste pharmaceuticals are removed from future generator status calculations, potentially lowering generator status for facilities.

Conclusions:

• The new EPA rule simplifies hazardous waste management for pharmacies and long-term care facilities.
• Facilities can now more easily meet requirements for Very Small Quantity Generators or Small Quantity Generators.
• Notification via Form 8700-12 is required for Small Quantity and Large Quantity Generators once states adopt the Final Rule.