Determination of Applicability of Hazardous Waste Pharmaceuticals Rule

Step 1 – Evaluate all the solid waste streams generated by your facility, including waste and expired pharmaceuticals.

Step 2 – Determine which solid wastes meet the definition of hazardous waste through analysis and/or generator knowledge.

Step 3 – Determine which hazardous wastes are hazardous waste pharmaceuticals.

Step 4 – Count all hazardous waste generated in a calendar month, including hazardous waste pharmaceuticals.

Step 5 – Determine your hazardous waste generator status

Step 6 – If you are a Reverse Distributor, Large Quantity Generator or Small Quantity Generator, and you are a healthcare facility that generates hazardous waste pharmaceuticals, you MUST notify that you are subject to Subpart P. If you are a Very Small Quantity Generator, you have the option to opt in to Subpart P for your hazardous waste pharmaceuticals, or to continue to manage them as hazardous waste.

Step 7 – If you are required to comply with Subpart P, re-count your hazardous waste and this time do not include hazardous waste pharmaceuticals. This is your new hazardous waste generator status.

Notification Requirements

Subpart P Notification: Each Healthcare Facility (HF)and Reverse Distributors (RD)must notify DEQ using the EPA Site Identification Form 8700-12 that it is a HF operating under Subpart P. HFs that already have an EPA identification number must update the existing notification to include Subpart P. HFs (not including RDs) that are required to submit a biennial report(BR)can submit this notification as part of its next BR. Otherwise, all facilities subject to Subpart P must notify within 60 days of the effective date of this Subpart, or within60 days of becoming subject to this Subpart. HFs and RDs that do not already have an EPA ID number will be assigned one when the notification of Subpart P activity is submitted. A facility must keep a copy of its notification on file for as long as the healthcare facility is subject to this Subpart.

Withdrawal Notification: Healthcare Facility (HF) (HFs) that operated under this Subpart, but are no longer subject to this Subpart (Very Small Quantity Generator(VSQG)that opted in but elects to withdraw from this Subpart) must notify DEQ using EPA Site Identification Form 8700-12 that it is no longer operating under this Subpart prior to operating under the conditional exemption for VSQGs in lieu of Subpart P. A copy of its withdrawal must be kept on file for three (3) years from the date of signature on the notification of its withdrawal. All notifications should be made using MyRCRAID

Please note, facilities that were LQG or SQG and were required to opt in that re-calculate their generator status after no longer counting hazardous waste pharmaceuticals are NOT eligible to withdraw from Subpart P.

Frequently Asked Questions to EPA – Pharmaceuticals Rule

EPA’s Frequent Questions About Implementing the Hazardous Waste Pharmaceuticals Final Rule, this link is managed by EPA’s website.