CFR Part 266 Subpart P
Management Standards for Hazardous Waste Pharmaceuticals
On 9/25/2015 The Environmental Protection Agency (EPA) proposed Management Standards for Hazardous Waste Pharmaceuticals. These new EPA/RCRA regulations change the way hazardous waste drugs are handled in the healthcare industry. EPA projects a pre-publication version to be available shortly.
Under this proposal, EPA is adding a new subpart P under 40 CFR part 266 entitled “Standards for the Management of Specific Hazardous Wastes and Specific Types of Hazardous Waste Management Facilities. Only those drugs already considered hazardous waste are covered under this new rule.
Subpart P is mandatory for: SQG (Small Quantity Generators), LQG (Large Quantity Generators) and RD (Reverse Distributors). It is optional for CESQGs (Conditionally Exempt Small Quantity Generators). CESQGs are now referred to as VSQGs (Very Small Quantity Generators) in some states due to EPA’s passage of Hazardous Waste Generator Improvements Rules. Eventually, all states will need to adopt the VSQG designation. For purposes of this website, we will refer to CESQG's as VSQG's.
Various facilities generate pharmaceutical waste. See Impacted Facilities. EPA's Subpart P and this website addresses the issue of: Potentially Creditable and Non-Creditable Pharmaceutical Waste generated in the healthcare industry.
Use this website as an education tool to help you learn more about Subpart P as it is currently proposed. It provides an overview of the regulations from the generators point of view. SELECT LINKS ON THE RIGHT SIDE OF THIS PAGE TO LEARN MORE. As of today, the information found on this site is based off of the proposed regulations. When the new regulations are published, this site will be updated accordingly.
Disclaimer: Information is provided “AS IS” and is not intended to be an all-encompassing or legal advice. Please refer to Refer to 40 CFR 266 Subpart P for the actual publication.