P-listed waste, or “acutely toxic” waste, is formally defined by the EPA as “pure and commercial grade formulations of certain unused chemicals that are being disposed.” To meet this definition, the unused chemical must be listed under 40 CFR 261.33 and be part of a commercial chemical product, such as a medication.
In the healthcare and pharmaceutical sector, P-listed wastes are found in medicines (examples: warfarin, nicotine, eserine) or unused chemicals in a lab (examples: nitric oxide, sodium azide). A key component of the “P-listed” definition is that the chemical component is unused – still in its original manufactured state. For instance, if you use a sodium azide buffer for lab analysis, the waste solvents would not be P-listed as it was used in a procedure.
As a waste generator, it is imperative that inventory items that contain chemicals listed under 40 CFR 261.33 (the P-list) be tracked once declared “waste” – after expiration, patient discharge, etc. The amount of P-listed waste a Very Small Quantity Generator (VSQG) and a Small Quantity Generator (SQG) can have on-site at a time is <2.2 pounds. If this amount is exceeded, the site is required to follow state and federal hazardous waste policies for a Large Quantity Generator (LQG). This limit is for material that has been determined to be waste only. If the product is still valid for use, it does count towards this limit.
After the medicine(s) or chemical(s) have been determined to be waste, store the P-listed waste separately from the other hazardous wastes. Adding P-listed waste to a drum with other hazardous waste renders the entire drum P-listed, and the full weight of the container counts towards the accumulation limit. As an example, to add three loose warfarin tablets directly into a pharmaceutical collection receptacle with four pounds of expired insulin would result in now having four pounds of P-listed waste and exceed the VSQG/SQG limits. Keeping the P-listed waste separate, for instance in a small sealable bag, keeps it distinct for auditing purposes and generator level verification.
Under current regulations:
- Manage all P-listed waste chemicals separate from the site’s other hazardous waste
- Packaging that last contained P-listed chemicals should be managed as hazardous waste
The EPA has published a new rule under 40 CFR 266 Subpart P that will affect the accumulation of P-listed waste. Under this rule, the waste code P075 will not apply to FDA approved nicotine replacement therapies (i.e., lozenges, patches). Additionally, stock, dispensing, and unit-dose containers are defined as empty once all medications have been dispensed, so the empty containers that once held P-listed drugs may be disposed of in the trash. The final rules may vary by state adoption.
If your company has P-listed waste, Sharps Compliance can help. We provide compliant management disposal services of P-listed hazardous wastes. Let our experts handle the regulatory compliance so you can focus on your core job. Call Sharps today at 800.772.5657 for help in managing your hazardous waste disposal.