We recognize the unique challenges and conflicts in regulations when it comes to pharmaceuticals and managing pharmaceutical waste. Facilities often work with multiple regulatory agencies to dispense, store, and dispose of pharmaceutical wastes. Here are the most common questions we receive.
Pharmaceutical Frequently Asked Questions (FAQs)
How do I determine my generator status if I follow the Interim Pharmaceutical Waste Policy?
If you follow the management and disposal requirements in the Interim Pharmaceutical Waste Policy, the amount of pharmaceutical waste will not count toward the total dangerous waste generated throughout your facility.
Your facility is an SQG if:
You may then manage:
- The amount of non-pharmaceutical dangerous waste is less than 2.2 pounds of either P-listed acutely hazardous waste or WT01 extremely hazardous waste per month;
- All other dangerous waste is less than 220 pounds per month; and
- You never accumulate more than 2200 pounds on site at any time.
- Non-pharmaceutical waste as an SQG.
- Pharmaceutical waste according to the policy.
How do I prove my facility is a small quantity generator?
You must show an inspector that:
Remember these rules as you count your dangerous waste:
- Your facility creates less than 2.2 pounds of either P-listed acutely hazardous waste or WT01 extremely hazardous waste per month, and
- Less than 220 pounds of all other dangerous waste per month.
Here are some examples:
- Keep records showing the generation locations and rates.
- Monthly generation rates apply throughout your facility.
- If the amount of dangerous waste generated nears the limit or fluctuates, consider managing your waste at a higher medium or large quantity generator status to ensure compliance in any given month.
- Your lab generates 30 pounds of dangerous pharmaceutical waste per month. Elsewhere on site you generate 200 pounds of dangerous waste per month. You must count these wastes together as 230 pounds per month. In this case you are an MQG, not an SQG, and must follow MQG requirements.
- The total dangerous waste from your facility is 150 pounds per month but that includes 3 pounds of epinephrine P-listed waste. You have exceeded the 2.2 pound Quantity Exclusion Limit (QEL) for P-listed waste and are an LQG and must follow LQG requirements.
- Your facility generates no more than 200 pounds of dangerous waste per month and you have no P-listed or WT01 wastes. But, you have accumulated more than 2200 pounds of dangerous waste on site to minimize disposal costs. In this case you are an LQG and must follow LQG requirements.
To learn more:
If our hospital or pharmacy hosts a community take-back for pharmaceutical waste, how do we manage this waste?
You have two options for managing this waste:
- Mix household pharmaceutical waste with your business waste and manage appropriately. Under the dangerous waste regulations, these collected pharmaceuticals would have to be designated and counted towards your generator status. If you are a small quantity generator, you may become a medium or large quantity generator and additional compliance requirements may apply. If you are managing the pharmaceutical wastes under the Interim Pharmaceutical Waste Policy, you just need to continue managing according to the policy requirements.
- Keep the collected household pharmaceuticals separate from your business waste. Returned household-exempt pharmaceutical waste collected in a separate container can be managed as moderate risk waste under WAC 173-350-360. You cannot include business waste with this waste. You must demonstrate procedures for keeping the wastes separate and clearly labeled. Hospital pharmacies that offer a separate medicine return collection program can be classified as a Product Take-Back Center under the definition of WAC 173-350-100, and are exempt from solid waste permitting if the waste is managed under specific criteria.
Can I manage state-only pharmaceutical waste under the Conditional Exclusion in WAC 173-303-071(3)(nn)?
Yes. By doing so, you may benefit from lower disposal costs. However, educating your staff on accurate segregation of waste and ensuring compliance may increase internal costs. Conditionally excluded pharmaceutical waste must be disposed of at:
- A permitted municipal solid waste incinerator, or
- An incinerator that has a heat input greater than 250 million btu (British thermal units) per hour or a combustion zone greater than 1,500°F.
If you choose to mix state-only waste with RCRA hazardous waste, you must manage the combined wastes according to:
Find additional info under the Rules, policy, & guidance page.
Can I take pharmaceutical wastes to a moderate risk waste (MRW) facility?
Yes, under certain conditions. Individual MRW facilities decide the type of waste they accept and if they will accept waste from businesses. Many MRW facilities are incapable of handling this type of waste, nor are they licensed to handle pharmaceutical waste by either the Washington State Board of Pharmacy or the U.S. DEA.
- MRW facilities can only accept dangerous waste from:
- You cannot take your waste to a MRW facility if you generate more than 2.2 pounds (or 1 quart) of epinephrine or other P-listed waste in one month.
- If your business chooses to manage pharmaceutical waste according to the dangerous waste regulations, you must prove that:
- Your facility is an SQG.
- The MRW facility can accept the waste.
- If your business chooses to manage pharmaceutical waste according to the Interim Pharmaceutical Waste Policy:
Can I send my expired or unused pharmaceuticals to a reverse distributor?
Only if they are a licensed hazardous waste transporter or a RCRA-permitted treatment, storage, and disposal (TSD) facility. Most reverse distributors are not licensed to transport or accept dangerous wastes.
Pharmaceuticals returned to a manufacturer, wholesaler, or reverse distributor for credit are considered viable pharmaceuticals. Viable pharmaceutical are not regulated by the dangerous waste regulations.
Non-viable pharmaceuticals cannot receive a credit and are considered waste. Non-viable pharmaceuticals commonly designate as dangerous waste. Each generator must manage their dangerous pharmaceutical waste properly.
Can I dispose of waste pharmaceuticals to a sanitary sewer?
This is illegal, unless you have authorization from your wastewater treatment plant or delegated publicly-owned treatment works (POTW) or Ecology’s Water Quality Program to discharge specific pharmaceuticals.
Most pharmaceutical waste is dangerous waste. Wastewater treatment plants, which sewers lead to, are not equipped to treat dangerous waste. These treatment plants cannot remove the pharmaceutical compounds from either the wastewater or biosolids. The pharmaceutical compounds therefore end up in waterways such as streams, rivers, lakes, and oceans.
The Conditional Exclusion does not allow for sewer disposal.
What do I do with abandoned, confiscated, or pharmaceutical waste dropped off at the hospital?
Keep collected household pharmaceuticals separate from your business waste:
- Returned household-exempt pharmaceutical waste collected in a separate container can be managed as moderate risk waste under WAC 173-350-360.
- Business waste cannot be included with household-exempt pharmaceutical waste.
- Provide clear procedures to staff.
- Provide clear labeling.
Hospital pharmacies who offer a separate medicine return collection program can be classified as a Product Take-Back Center under the definition of WAC 173-350-100, and are exempt from solid waste permitting if the waste is managed under specific criteria.