40 CFR Part 266 Subpart P
STANDARDS FOR THE MANAGEMENT OF SPECIFIC HAZARDOUS WASTES AND SPECIFIC TYPES OF HAZARDOUS WASTE MANAGEMENT FACILITIES
Access Official Pre-Publication Document
12/11/2018 - EPA Releases pre-publication version MANAGEMENT STANDARDS FOR HAZARDOUS WASTE PHARMACEUTICALS AND AMENDMENT TO THE P075 LISTING FOR NICOTINE [RIN 2050-AG39; FRL-9924-08-OLEM. Docket number EPA-HQ-RCRA-2007-0932. Pre-Publication Version.
Basic introduction to the new Subpart P regulations - PTI Brochure
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 6 (six) months after publication in the Federal Register for the states of Iowa and Alaska. It will go into effect for the remainder of the states when approved by the state. Note, non-approval is not an option and states can be more stringent in some regulations when it adopts Subpart P.
On 12/11/2018 The Environmental Protection Agency (EPA) Administer signed the MANAGEMENT STANDARDS FOR HAZARDOUS WASTE PHARMACEUTICALS AND AMENDMENT TO THE P075 LISTING FOR NICOTINE [RIN 2050-AG39; FRL-9924-08-OLEM.
These new EPA/RCRA regulations change the way hazardous waste drugs are handled in the healthcare industry. Although not the official publication, it is meant to replicate the wording when the final rule is published in the federal register.
Under this rule, EPA is adding a new subpart P under 40 CFR part 266. IMPORTANT - ONLY THOSE DRUGS 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 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. EPA's Subpart P and this website addresses the issue of: Potentially Creditable and Non-Creditable Pharmaceutical Waste generated in the healthcare industry.
- 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.