The New Hazardous Waste Pharmaceuticals Rule: A Few Practical Steps to Prepare

On February 22, 2019, the federal Environmental Protection Agency (EPA) issued a final version of the hazardous waste pharmaceuticals rule. The new rule was promulgated under the federal Resource Conservation and Recovery Act (“RCRA”), that provides for significant civil and criminal penalties for violation. According to the EPA, the new rule is a “better fit” for healthcare organizations managing hazardous waste pharmaceuticals (HWPs) because it reduces overlapping regulation by the FDA and the DEA, and it provides regulatory clarity and national consistency on the application of federal environmental law to the reverse distribution and reverse logistics processes used in the healthcare industry. The updated rule also protects the environment by prohibiting the sewering (i.e., pouring down the drain or flushing down the toilet) of all HWPs effective August 21, 2019. 

The new HWP rule applies to “healthcare facilities,” which is defined to include any person/entity that is lawfully authorized to provide preventive, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, or counseling or assessment services for humans or animals, or that distributes, sells or dispenses pharmaceuticals, including prescription drugs, over-the-counter drugs, dietary supplements or homeopathic drugs. Home care agencies are not covered to the extent they provide care only in patient’s homes. Long-term care facilities (LTCs) that were once exempt under an interpretation that considered an LTC facility a resident’s “home,” are now covered, as are assisted living facilities that operate on-site nursing facilities.

Some Practical Steps to Prepare for the HWP Rule

The new HWP rule is detailed and merits in-depth review by those in your organization who are responsible for pharmacy operations, patient care that involves drug administration, or management and disposal of unused, expired or unwanted drugs. Here are a few practical steps to prepare for implementation of the new HWP rule:

• Provide appropriate training on the new HWP rule for staff who “touch” HWPs.
• Review your HWP collection, storage and disposal policies and procedures and update as needed.
• Update HWP collection practices and containers to meet HWP rule standards.
• Post HWP sewering ban “Notice” signs in key locations in your facility.
• Review and update controlled substance wasting policies and procedures to conform to the HWP rule.
• Review your HWP disposal vendor arrangement to confirm the arrangement complies with the new HWP rule.
• Update your waste vendor contract as needed.
• Access resources regarding the HWP rule when needed (see below). 

HWP Resources

• Michigan Department of Environment, Great Lakes and Energy (EGLE) website on Michigan’s pharmaceutical waste regulations and the new federal HWP rule
• EGLE’s email address for questions about HWPs
• EPA’s online FAQs about the HWP rule
• EPA webinar on the HWP rule