Pharmaceutical Waste

Sole active ingredient means the ingredient (that potentially may be a P or U listed hazardous waste) is the only chemically active component in the pharmaceutical that performs the function of the pharmaceutical.

Between 5% to 10% of pharmaceutical products are correctly classified as hazardous waste. There are four questions that must be answered to determine if a pharmaceutical product is regulated by the EPA as a hazardous waste:
1) Is it a solid waste?
2) Does it qualify for an exemption?
3) Is it a characteristic waste?
4) Is it a listed waste?

A solid waste is considered hazardous waste if it meets a listing or exhibits a characteristic described in title 40 of the Code of Federal Regulations (40 CFR) Part 261.

Medication remaining in an IV bag (or other container) is unused for the purposes of hazardous waste categorization. This is true even if a portion of the medication was administered (i.e., used) and the remaining medication is prohibited from being administered to another patient. The P and U hazardous waste listings only apply to unused commercial chemical products. So, if medication remaining in a container is discarded, that portion is unused and must be evaluated to determine if it is a listed or characteristic hazardous waste.

Due to its reactivity, i.e. explosive properties, Nitroglycerin was listed as a hazardous waste. However, medicinal nitroglycerin does not exhibit the characteristic of reactivity and therefore, is not classified as listed hazardous waste P075, however it may exhibit another hazardous waste characteristic.

Drugs and medications, broadly classified as Pharmaceuticals, are defined by the Resource Conservation and Recovery Act (RCRA) as hazardous waste when deemed nonviable (returned, expired or damaged). The volume and type of listing can dictate pharmaceutical volumes permitted to be stored, the generator status, and the packaging requirements for disposal.