Reverse distributors and training, accumulation, and labeling

• Reverse distributors are not required to count their hazardous waste pharmaceuticals when determining their part 262 generator category for their non-pharmaceutical hazardous waste.
• Healthcare facilities have up to one year to accumulate non-creditable hazardous waste pharmaceuticals.

Reverse distributor means any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit. Any person, including forward distributors, third-party logistics providers, and pharmaceutical manufacturers, that processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor.

All reverse distributors are subject to Subpart P for the management of their hazardous waste pharmaceuticals, including reverse distributors that are very small quantity generators (VSQGs).

Reverse distributors are not required to count their hazardous waste pharmaceuticals when determining their part 262 generator category for their non-pharmaceutical hazardous waste.

Training

The Environmental Protection Agency (EPA) believes requiring large quantity generator (LQG) training for healthcare personnel who only sporadically generate hazardous waste pharmaceuticals is excessive, but it’s important to have at least some familiarity with the dangers hazardous waste pharmaceuticals can pose. So, the Agency came up with training requirements similar to a small quantity generator (SQG) and small quantity universal waste handlers for healthcare facilities operating under Subpart P. This means healthcare facilities must inform all employees that handle or have responsibility for generating and/or managing hazardous waste pharmaceuticals of the proper handling and emergency procedures appropriate to their responsibilities during normal facility operations and emergencies. This training can be done verbally or through written documentation.

Healthcare facilities that are also LQGs due to non-pharmaceutical waste may choose to continue training to the LQG regulations for all personnel.

Accumulation and labeling

Healthcare facilities have up to one year to accumulate non-creditable hazardous waste pharmaceuticals. Containers of hazardous waste pharmaceuticals being managed under Subpart P must be labeled with the words “Hazardous Waste Pharmaceuticals.” As with the universal waste rules, the accumulation start date doesn’t have to be marked on the container, but that’s a good way to keep track of when the waste must be shipped offsite. Alternatively, the facility can use an inventory system that identifies dates when the hazardous waste pharmaceuticals were first accumulated or identify in the accumulation area the earliest date that a hazardous waste pharmaceutical first became a hazardous waste.