Determining your generator status
- Perform or outsource a pharmaceutical drug waste characterization (a.k.a., formulary review) of the pharmaceuticals at your facility to determine which drugs have the potential for being hazardous waste.
- Add up the total amount of hazardous waste (pharmaceutical and non-pharmaceutical) generated on a monthly basis by your facility to determine your generator status. PTI Porthole. You do not need to include packaging when determining total weight of pharmaceutical hazardous waste generated.
- Just because a hazardous pharmaceutical is in your inventory does not mean it is waste. Only include the hazardous pharmaceuticals that are considered waste (non-creditable & potentially creditable sent back to reverse distributor).
- Refer to below chart to determine your generator status.
- LQGs (Large Quantity Generators) and SQGs (Small Quantity Generators) must follow Subpart P.
- Subpart P is optional for VSQGs (Very Small Quantity Generators). VSQGs need to consider whether or not voluntarily following Subpart P makes sense for them. Refer to VSQGs and Subpart P.
- Some states have different generator categories (California, District Of Columbia, Kansas, Maine, Maryland, Massachusetts, Minnesota (Minnesota Lethal), New Hampshire, Rhode Island, Washington). Make sure to take that into account when determining your generator status.
- Most facilities will qualify as a VSQG.
- An example of an acute (P-Listed) drug that may be found in a healthcare setting is Warfarin Sodium. However, there are more.
- Examples of a non-acute hazardous drugs are those whose EPA waste code starts with a "U" or "D".
- VSQGs cannot generate more than 1 kg of acute HW per month unless your state allows for episodic events. Check with your state to see if they have adopted EPA’s Hazardous Waste Generator Improvements Rule. .
- There is a difference between HW generation and HW accumulation. Generation is the HW generated during a particular time period (monthly), while accumulation is the amount of HW onsite any given time. Example, if a facility generates 1 pound of HW per month for 5 months. Their monthly generation is 1 pound per month and their total accumulation is 5 pounds. It is also important to note, A healthcare facility that accumulates above the VSQG quantity thresholds would not be subject to part 266 subpart P; it would remain subject to part 262. However, VSQG that accumulates above the quantity thresholds must manage its hazardous waste in accordance with the conditions of either the SQG or LQG regulations, but the generator would remain a VSQG (Generator Improvements Rule - if applicable in your state).
||Acute (P-Listed) HW Generated Monthly
||Non-Acute HW Generated Monthly
|VSQG (Very Small Quantity Generator)
≤ 1 kg (and)
≤ 100 kg
|SQG (Small Quantity Generator)
||< 1 kg (and)
||> 100 kg and < 1000 kg
|LQG (Large Quantity Generator)
||> 1 kg (or)
||≥ 1000 kg
1 kg = approximately 2.2 lb
100 kg – approximately 220 lb
1,0000 kg = approximately 2,200 lb
State Specific Considerations
Some states have their own generator categories - State specific
Generator status change - for non-pharmaceutical waste
- It is possible for your facility's generator status to change if you choose to operate under Subpart P since under Subpart P, your pharmaceutical hazardous waste generated no longer applies to your overall hazardous waste generation. However, you must be operating under Subpart P for your pharmaceutical hazardous waste generated not to count towards your generator status.
- A change to a lesser generator status may result in less regulations to follow for the non-pharmaceutical hazardous waste your facility generates.