Healthcare facilities - TO DO CHECKLIST
A - Perform initial analysis - Determine your generator status
- Perform or outsource (About PTI) an accurate and up-to-date drug waste characterization to determine which drugs in your inventory are considered hazardous by the EPA. Only the hazardous pharmaceuticals are subject to Subpart P. HW Drugs
- Determine your generator status
- Generator Status Determination
- If you are a LQG or SQG, you must follow Subpart P.
- If you are a VSQG, Determine whether or not it makes sense for you to follow Subpart P - VSQG's & Subpart P
B - Procedures
- [Subpart P Only] - Notify regional EPA that you are operating under Subpart P (further explained below).
- Mark all HW drugs in your inventory. Physically (sticker) or electronically.
- Do you generate Potentially Creditable Hazardous Waste Pharmaceuticals? If so, select Reverse Distributor (see below comments). About PTI
- Do you generate Non-Creditable Hazardous Waste Pharmaceuticals or Non-Prescription Hazardous Waste Pharmaceuticals? If so, select a Hazardous Waste Vendor (see below comments). About PTI
- [Subpart P Only] Determine Policies & Procedures: Refer to Potentially Creditable Hazardous Waste Pharmaceuticals and Non-Creditable Hazardous Waste Pharmaceuticals for general guidance on requirements.
- Use the below Disposal Flow Chart to determine the disposition and destination facility for your pharmaceutical waste.
- Determine supplies needed: Waste container(s), inner liners, HW stickers, PPE, etc.
- Restrict sewering of any hazardous waste drugs.
- [Subpart P Only] - Perform Training if generating non-creditable hazardous waste pharmaceuticals. A healthcare facility must train employees to the extent that that they are thoroughly familiar with the proper handling and emergency procedures relevant to their responsibilities during normal operations and emergencies. The training can be verbal or written. Although no documentation of training is required, it may be a good best management practice to do so.
Notification - EPA Regional Administrator - [Subpart P Only]
- EPA has 10 Regions each with a Regional Administrator.
- Fill out EPA form 8700-12 indicating your facility is operating under subpart P within 60 days of the effective date of Subpart P.
- If a VSQG becomes a SQG or LQG, then notify EPA within 60 days of the generator status change date.
- If you are a LQG, OK to notify EPA when filing biennial report, but can do sooner.
- If you are a SQG and your state requires a biennial report, OK to notify EPA when filing your biennial report, but can do it sooner.
- If you are a VSQG’s choosing to operate under Subpart P, there are no notification time requirements. However, you must be in compliance with Subpart P requirements on the date notification is submitted.
- Your facility must keep a copy of the notification on file.
- Consider electronically filing the EPA form 8700-12 at myRCRAid
Selecting a Reverse Distributor
- Verify RD is VAWD accredited (highly recommended). VAWD Facility Search
- Verify RD has valid return procedures that address Subpart P
- Handling, management, training and shipping DOT hazardous materials
- Restrictions should be consistent with what is indicated on the above Flow Chart
- Contact PTI for vetted reverse distributor partner referrals.
Selecting a Disposal Vendor
- Verify vendor is legitimate :
- licensed appropriately;
- can handle, package transport and dispose of RCRA hazardous waste
- Contact PTI for vetted disposal vendor partner referrals.
Multiple facilities under the same control.
Healthcare facilities can receive hazardous waste pharmaceuticals from VSQG’s under the same control. However, there are additional requirements to follow such as recordkeeping and mandatory operating under Subpart P.
- There is more than one way to approach this check list. Tweaks can be made along the way to better meet your specific situation. Under Subpart P, there is no one size fits all approach. If desired, PTI can review your specific situation to customize a process that best meets your needs. Contact PTI