Pharmaceutical Waste Compliance Program Frequently Asked Questions Q: A: If EPA/RCRA laws were enacted years ago, why are they being enforced now? A 1999-2000 US Geological Survey study found the presence of pharmaceutical contaminates in rivers, streams and ground-water across the country. Since then the Environmental Protection Agency (EPA) has taken a closer look at regulating and enforcing hazardous and Pharmaceutical waste regulations in hospitals. Since 2003, several hospitals have been fined up to $250,000 for hazardous waste violations. Q: A: Why can’t we put all Pharmaceutical waste in one container? First, the vast majority of the Pharmaceutical waste will go into one container – the blue Pharmaceutical waste container. But there are US EPA regulations that prohibit the combining of “incompatible” waste in containers with “compatible” waste. These “incompatible” drugs are hazardous and if placed in the same containers, they could ignite or explode. Fortunately, there are only about 20-25 NDCs in a typical hospital’s formulary that are “incompatible” and these are usually found in the pharmacy or a few select units. The second reason is the Department of Transportation (DOT) shipment regulations. Hazardous waste shipments must be defined by specific US DOT waste streams, and can’t be combined into one container. Q: Why can’t we continue putting pharmaceutical waste in the red bag and sharps containers like we’ve been doing for years? Pharmaceutical waste, including environmentally hazardous and non-hazardous waste, must be managed and disposed of per US EPA and DOT regulations. Disposing of Pharmaceutical waste as “regulated medical waste” is in violation of both EPA and DOT regulations. In the majority of states, only pharmaceutical waste identified as “blood products” or “live vaccines” can be disposed of as regulated medical waste. A: Q: A: What about empty bottles and IV containers – how are they to be disposed of? To keep the process easy, all pharmaceuticals and the containers that they came in should be managed in either the Blue or Black containers; full, partials, and empty. Q: A: Where do the Pharmaceutical satellite containers get placed? Satellite containers must be located “at or near” the point of waste generation and must be under the control of the waste generator. Soiled utility rooms and Medication rooms are frequently used. Q: A: Who moves the Pharmaceutical containers? The BioSystems technicians that service the Sharps containers will be the primary service staff for these containers. Environmental Services/Housekeeping will provide assistance when containers are filled during non-service days. Q: A: How should controlled substance Pharmaceutical waste be disposed of? Until the DEA and EPA devise a mutually compliant disposal method, hospitals should continue to follow their current policy and procedures for witnessed/wasting of controlled substances. Q: A: How are nurses going to know what Pharmaceutical waste goes where? The Pharmacy will identify which pharmaceutical wastes that must be either placed into the Black containers or Returned to the Pharmacy. This messaging will appear on the Accudose and EPIC eMARs (“Dispose in Black Container” and “Return to Pharmacy for Disposal”). If a pharmaceutical does not have a disposal message, then it must be placed in the Blue containers. Pharmaceutical Waste Compliance Program Frequently Asked Questions Q: A: How should chemo drug waste be handled? With the exception of Trisenox (a P-Listed waste), “trace” chemo drug waste containers (RCRA empty syringes, IV bags, vials, etc.) should continue to be placed in a yellow sharps container and disposed of as regulated medical waste. “Bulk” chemo drug waste should be placed in a black “bulk” chemo waste container and, disposed of as pharmaceutical waste. Q: A: How should tubing and/or an IV bag be disposed of? IF the IV contains a regular maintenance solution or electrolyte (saline, lactated ringers, potassium, sodium bicarbonate, etc.), then the IV can be drained to the sewer and placed into the garbage. If the IV contains a pharmaceutical, then it must be placed in either the Blue or Black container (as identified by the Pharmacy).