Subpart P: Important information your company should know about the EPA’s Hazardous Waste Management Rule
Subpart P is a new group of healthcare specific regulations covering hazardous waste pharmaceuticals generated at healthcare facilities. The EPA now recognizes that healthcare is fundamentally different from other industries that generate hazardous waste. Their regulations have been updated to reflect that change.
Who does this new rule affect?
These new regulations apply, but are not limited to
- veterinary hospitals or clinics
- wholesale distributors or retailers
- Pyrophoric, gases, aerosol, unknown, reactive, explosive and shock-sensitive materials
- Ethers, THF, dioxane and sodium azide
What does the EPA consider ‘pharmaceutical’?
- prescription medication
- OTC (over the counter) drugs
- dietary supplements
- compounded drugs
- investigational drugs
- personal protective equipment (PPE) contaminated with pharmaceutical waste
- clean-up material from pharmaceutical spills
- any item for which the FDA requires a “drug Fact” sheet
When do these rules become effective?
For the moment, current Resource Conservation and Recovery Act (RCRA) rules are enforced. Although Subpart P Rule is final, it will not become effective until six months after publication in the Federal Register. Individual States are required to adopt the rule, but they will have the ability to make changes. Actual rules and effective dates will differ by state.