40 CFR Part 266 Subpart P
Management Standards for Hazardous Waste Pharmaceuticals and Amendment To The P075 Listing For Nicotine
2/22/2019 - EPA published Final Rule in Federal Register
Basic introduction to the new Subpart P regulations - Introduction
Effective date of final rule
The final rule for Management Standards for Hazardous Waste Pharmaceuticals and Amendment To The P075 Listing For Nicotine goes into effect on 8/21/2019 for the states of Iowa and Alaska. It will go into effect for the remainder of the states when adopted by the state. The sewer ban of hazardous waste pharmaceuticals by healthcare facilities is effective nationally on 8/21/2019. Non-adoption of Subpart P is not an option and states can choose to enact more stringent regulations. However, since the nicotine exemption is less stringent, each state can decide whether or not to adopt it. States like Florida and Michigan that allow pharmaceuticals to be handled as universal wastes will no longer be able to do so. Refer to State Adoptions
These new EPA/RCRA regulations change the way hazardous waste drugs are handled in the healthcare industry.
Only those pharmaceuticals that are considered hazardous waste by the EPA are covered under this new regulation. Generally, we have found this be around 5% of the pharmacy's total inventory.
One significant change is that prescription pharmaceuticals moving through a Reverse Distributor (RD) are solid wastes at the healthcare facility (HCF). Therefore, the HCF is actually the generator of these wastes. Previously, waste determination, other than obvious waste, was typically made by the RD. Subpart P addresses the management of the solid waste pharmaceuticals that are hazardous.
Subpart P is mandatory for healthcare facilities that are: SQG (Small Quantity Generators), LQG (Large Quantity Generators) and RD (Reverse Distributors). It is optional for VSQGs (Very Small Quantity Generators), except where noted (e.g., hazardous pharmaceutical waste sewer ban). Due to EPA's Hazardous Waste Generator Improvements Rules, some states may still refer to VSQG's as CESQG's (Very Small Quantity Generator's) or state equivalent.
Various healthcare facilities generate pharmaceutical waste. See Impacted Facilities. The purpose of this website it to address some of the main issues of EPA's subpart P from a healthcare facility's perspective.
Hazardous Waste Pharmaceuticals Flow Chart
- 266.500 - Definitions
- 266.501 - Applicability
- 266.502 - Standards - Non-creditable
- 266.503 - Standards - Potentially creditable
- 266.504 - VSQG's
- 266.505 - Sewer ban
- 266.506 - DEA/HWP exemption
- 266.507 - Empty container exemption
- 266.508 - Shipping - Non-creditable
- 266.509 - Shipping - Potentially creditable
- 266.510 - Standards - Reverse distributors
Disclaimer: Use this website as an education tool to help you learn more about Subpart P. It provides an overview of the regulations from the healthcare facility's point of view. Select links on the right side of this page to learn more. Information is provided “AS IS” and is not intended to be an all-encompassing or legal advice.