Guidance on managing warfarin pharmaceuticals as dangerous waste. The requirements for managing warfarin depend on the concentration of the product.
Designating warfarin waste
When a product with warfarin as the sole active ingredient is discarded or not used for its intended purpose, it is a Resource Conservation and Recovery Act (RCRA) hazardous waste. Brand names of warfarin pharmaceuticals include: Coumadin, Jantoven, Marevan, and Waran. Warfarin is on the P and U lists of hazardous waste (depending on the concentration in the product).
It is a violation of the dangerous waste rules to dispose of these pharmaceuticals in the sewer, or in a sharps container or regulated medical waste container destined for a landfill.
If warfarin tablets cannot be returned to a reverse distributor for credit, they are discarded product and RCRA listed waste.
- If tablets have warfarin as the sole active ingredient and have a concentration of more than 0.3% warfarin (or 0.000003 mg/mg), the waste warfarin tables are P001 acutely hazardous waste.
- If tablets have warfarin as the sole active ingredient and have a concentration of less than or equal to 0.3% warfarin (or 0.000003 mg/mg), the waste warfarin tablets are U248 dangerous waste.
- Containers or packaging that held warfarin tablets that are to be administered would not carry the RCRA listed waste codes since the tablets are removed as product. The containers (foil/blister packs, bulk bottles, and paper/plastic cups to administer individual doses) can be managed as solid waste.
- If the tablets are determined to be waste while still in the container, the P- and U- waste codes may apply to both tablets and packaging.
Warfarin for injection
Unused or partially administered doses of injectable warfarin are considered discarded chemical product since they were not used for their intended purpose.
- If liquid formulations have warfarin as the sole active ingredient and have a concentration of more than 0.3% warfarin (or 0.000003 mg/mL), the residual warfarin is P001 acutely hazardous waste.
- If liquid formulations are P001 listed waste, the containers are also P001 listed waste since it is not practical to triple-rinse pharmaceutical containers, such as syringes, IVs, and vials.
- If liquid formulations have warfarin as the sole active ingredient and have a concentration of less than or equal to 0.3% warfarin (or 0.000003 mg/mL), the residual warfarin is U248 dangerous waste.
- Formulations where warfarin is not the sole active ingredient are not RCRA listed waste, but you must determine if they are RCRA characteristic waste.
Managing warfarin waste
Warfarin that is eligible for credit from a manufacturer, wholesaler, or reverse distributor is a viable pharmaceutical and not considered waste. Viable pharmaceuticals include unused or unopened pharmaceuticals that receive a credit. Items not receiving a credit must be managed as waste.
RCRA hazardous warfarin waste
Non-viable formulations of warfarin and warfarin salts that designate as listed waste (WAC 173-303-080 ) or under the RCRA characteristics of ignitability, corrosivity, reactivity or toxicity (WAC 173-303-090). This includes discarded containers with warfarin residue that have not been triple-rinsed.
- Manage as dangerous waste at a RCRA-permitted facility.
- Under the dangerous waste rules, accumulating more than 2.2 pounds (or 1 liter) of any P-listed waste will make you a large quantity generator with additional requirements.
- Under the Interim Pharmaceutical Waste Policy, the listed waste will not count towards your generator status if it is sent to a RCRA-permitted incinerator as RCRA hazardous waste on a Uniform Hazardous Waste Manifest.
State-only dangerous waste
You can assume warfarin formulations that are not RCRA hazardous waste are state-only dangerous waste. You must know the concentration of the warfarin and all other ingredients as well as the acute toxicity information of those ingredients to determine that it is not a state-only dangerous waste.
Manage as either dangerous waste at a RCRA-permitted facility or as excluded waste at an incinerator meeting the criteria of the Conditional Exclusion.