Frequently Asked Questions
Purpose of the Interim Pharmaceutical Waste Policy
Why are regulations focused on the health care industry?
The requirements contained in the Dangerous Waste Regulations, Chapter 173-303 Washington Administrative Code (WAC) have been in effect since 1982 and apply to all businesses in Washington that generate dangerous waste. This includes small, family-owned businesses, large, international manufacturers, and government and military facilities. In the realm of health care, this includes:
Ecology created the policy in 2007 to clarify the requirements about pharmaceutical waste. Ecology will not enforce portions of the dangerous waste regulations at facilities meeting the conditions of this policy.
Why does Ecology require additional waste management measures?
Ecology’s technical assistance visits have shown that many health care facilities don't follow the dangerous waste regulations. The policy recognizes some unique challenges and conflicts in regulations surrounding pharmaceuticals and pharmaceutical waste management. Patient care facilities work with multiple regulatory agencies for dispensing, storing, and disposing of pharmaceutical waste. The policy clarifies how the dangerous waste regulations interact with the requirements of the Washington State Board of Pharmacy and the U.S. Drug Enforcement Administration (USDEA).
Are state regulations different than federal regulations for hazardous waste?
Yes. The Department of Ecology is delegated by the U.S. Environmental Protection Agency (EPA) to enforce RCRA. Delegated authorities can choose to be more strict than EPA, but cannot be less strict. Washington’s dangerous waste regulations are more strict than RCRA and the regulations dangerous waste generators must follow. For more information, please refer to WAC 173-303 and Ecology publication State and Federal Rule Differences.
Can I still manage state-only pharmaceutical waste under the Conditional Exclusion in WAC173-303-071(3)(nn)?
Yes. You may choose to segregate and manage state-only pharmaceutical waste under the Conditional Exclusion. If you do this, you may benefit from lower disposal costs. However, educating your staff on accurate segregation 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 1500°F.
If you mix state-only pharmaceutical waste with RCRA hazardous pharmaceutical waste, you must manage the combined waste according to the dangerous waste regulations or according to the IPWP. If the wastes are managed according to the IPWP, Ecology will refrain from enforcing portions of the dangerous waste regulations within its enforcement discretion.
Can I take these wastes to a moderate risk waste (MRW) facility?
You may be able to take your wastes to an MRW facility under certain conditions. Individual MRW facilities can decide whether they will accept waste from businesses but MRW facilities can only accept dangerous wastes from households and small quantity generators (SQG). Many MRW facilities are not licensed by the Washington State Board of Pharmacy or the USDEA and they may not be able to handle this type of waste.
You cannot take your waste to an MRW facility if you generate more than 2.2 pounds (one quart) of epinephrine or other P-listed waste in one month.
If your business manages pharmaceutical waste according to the dangerous waste regulations, you must prove that you are an SQG and that the appropriate MRW facility can accept the waste. If your business manages pharmaceutical waste according to the policy, wastes containing federally regulated pharmaceuticals must be shipped to a RCRA-approved incinerator, regardless of generator status.
How can I prove my facility is a small quantity generator (SQG)?
You need to be able to show that you generate 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. The easiest way is to keep records showing the generation locations and rates. The monthly generation rates apply throughout your facility. If your waste generation is close to the limit or fluctuates, you may want to consider managing your waste at the higher medium quantity generator (MQG) or large quantity generator(LQG) status to ensure compliance.
Example 1: You have a lab that 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.
Example 2: 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, are an LQG, and must follow LQG requirements.
Example 3: Your facility generates less than 220 pounds of dangerous waste per month and you have no P-listed or WT01 wastes. But you have accumulated more than 2,200 pounds of dangerous waste on your site to help minimize disposal costs. In this case you are an LQG and must follow LQG requirements.
To learn more about generator status and related requirements, please refer to the dangerous waste regulations, the Guide for Dangerous Waste Generators in Washington State, or call the Hazardous Waste and Toxics Reduction Program at your regional Ecology office.
To compare compliance conditions between the dangerous waste regulations and the IPWP please refer to the Guide for Dangerous Pharmaceutical Waste Generators in Washington State.
How do I determine my generator status if I follow the IPWP for my pharmaceutical waste?
If you are managing your pharmaceutical waste under the IPWP, you must follow the management and disposal requirements as prescribed. By following the IPWP, the amount of pharmaceutical waste does not count toward the total of dangerous waste generated throughout your facility.
If 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, less than 220 pounds of all other dangerous waste per month, and you never accumulate greater than 2,200 pounds on site at any one time, your facility is a small quantity generator (SQG). You may then manage the non-pharmaceutical waste as an SQG and the pharmaceutical waste according to the IPWP.
Proper pharmaceutical waste management
Can I put pharmaceutical waste in my red bags?
No. Disposal of pharmaceutical wastes into red bags is illegal disposal of a dangerous waste. This management is in violation of the dangerous waste regulations and does not meet the requirements of the Interim Pharmaceutical Waste Policy.
Red bags are designated for biomedical, biohazardous, and infectious materials, which are not considered dangerous waste. The Washington Department of Health regulates biomedical waste, which is defined in RCW 70.95K. Standards for managing and disposing of biomedical waste do not meet the more stringent requirements for managing and disposing of dangerous waste. Companies that collect and dispose of biomedical waste are not licensed to transport, treat, or store dangerous waste.
In Washington, most red bags are sterilized and sent to a landfill for disposal, some are sent for incineration at a permitted municipal incinerator or a medical waste incinerator. Neither are permitted to accept dangerous waste, so putting pharmaceutical wastes into red bags is considered illegal disposal of a dangerous waste.
Can I put pharmaceutical waste in my sharps containers?
No. This is not an approved disposal method for dangerous waste pharmaceuticals. Most sharps containers in Washington are microwaved or autoclaved to sterilize the contents and then sent to solid waste landfills. Putting pharmaceutical waste into sharps containers is in violation of the dangerous waste regulations and does not meet the requirements of the Interim Pharmaceutical Waste Policy.It is considered illegal disposal of a dangerous waste.
Can I send all my expired or unused pharmaceuticals to a reverse distributor?
No. Pharmaceuticals that are returned to a manufacturer, wholesaler, or reverse distributor for credit are considered a product or a viable pharmaceutical and are not regulated by Washington's dangerous waste regulations. Non-viable pharmaceuticals that can't receive a credit are considered waste. Since pharmaceuticals commonly designate as dangerous waste, generators must manage the pharmaceutical waste as dangerous waste.
Most reverse distributors are not licensed to transport or accept dangerous waste. It is a violation of the dangerous waste regulations and the Interim Pharmaceutical Waste Policy to send non-viable pharmaceuticals to a reverse distributor unless they are a licensed hazardous waste transporter or a RCRA permitted treatment, storage, and disposal (TSD) facility.
Can I dispose of waste pharmaceuticals to a sanitary sewer?
No. Most pharmaceutical waste designates as dangerous waste. The publicly owned treatment works (POTWs) are not allowed to accept dangerous wastes because these wastes are not readily treatable by the wastewater treatment process. The treatment methods that most POTWs use fail to remove pharmaceutical compounds from the wastewater or the biosolids. Pharmaceutical compounds pass through the treatment plant into receiving waters or remain in biosolids that are land applied across the state creating potentially negative impacts on human health and the environment.
As a result, this is an illegal disposal option unless you have authorization from either your delegated POTW or Ecology’s Water Quality program to discharge specific pharmaceuticals. The Conditional Exclusion to the dangerous waste regulations [WAC 173-303-071(3)(nn)] excludes state-only pharmaceutical wastes if they are incinerated at a permitted municipal solid waste incinerator or an incinerator that meets the following criteria: heat input greater than 250 million British Thermal Units (BTU)/hour or a combustion zone greater than 1500°F. Sewer disposal is not allowed under this exclusion, so any disposal of pharmaceuticals in this manner is a violation of Chapter 173-303 WAC.
Household hazardous pharmaceutical waste
What do we do with pharmaceutical waste that is abandoned, confiscated, or dropped off at the hospital?
Keep the collected household pharmaceuticals separate from your business waste. Returned household-exempt pharmaceutical waste that is collected in a separate container can be managed as moderate risk waste under 173-350-360 WAC. Your business waste cannot be included with this waste, and clear procedures and labeling will need to be demonstrated. Hospital pharmacies who offer a separate medicine return collection program can be classified as a Product Take-Back Center under the definition of 173-350-100 WAC, and are exempt from solid waste permitting if the waste is managed under specific criteria.
If our hospital hosts a community take-back for pharmaceutical waste, how would we have to manage this waste?
A hospital or pharmacy that chooses to host a community take-back event for pharmaceutical wastes has two options for managing this waste.
Option 1: Your hospital or pharmacy can choose to mix this household pharmaceutical waste with your 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 (SQG), you may become a medium quantity generator (MQG) or large quantity generator (LQG) 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.
Option 2: Your hospital or pharmacy can choose to keep the collected household pharmaceuticals separate from your business waste. Returned household-exempt pharmaceutical waste that is collected in a separate container can be managed as moderate risk waste under 173-350-360 WAC. You cannot include business waste with this waste. You must demonstrate procedures for keeping these 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 173-350-100 WAC, and are exempt from solid waste permitting if the waste is managed under specific criteria.
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