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My Watershed

  Frequently Asked Questions

Purpose of the Interim Enforcement Policy for Pharmaceutical Waste in health care (Policy)

Generator status

Proper pharmaceutical waste management

Household hazardous pharmaceutical waste



Purpose of the Interim Enforcement Policy for Pharmaceutical Waste in health care (Policy)
Q: Why are there regulations focused on the health care industry? Is this a new policy?

A: The requirements, contained in the Dangerous Waste Regulations [Chapter 173-303 WAC], have been in effect since 1982 and apply to all businesses in Washington state that generate dangerous waste. This includes small, family-owned businesses, large, international manufacturers and government/military facilities. In the realm of health care, this includes hospitals, retail pharmacies, health care clinics, doctor’s offices, dental offices, and veterinary clinics and hospitals. The Resource Conservation and Recovery Act (RCRA) is the federal regulation, which became effective in 1976, that encompasses all solid waste and hazardous waste. 

Ecology created the Policy in 2007 to clarify the requirements as they pertain specifically to pharmaceutical waste. Within its enforcement discretion, Ecology will refrain from enforcing portions of the Dangerous Waste Regulations at facilities meeting the conditions of this policy.
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Q: Why does Ecology require additional waste management measures?

A: Ecology’s technical assistance visits have shown that many patient care facilities don't comply with the Dangerous Waste Regulations [Chapter 173-303 WAC]. 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 the dispensing, storage, and disposal of pharmaceutical wastes. The intent of the Policy is to clarify how the Dangerous Waste Regulations interact with the requirements of the Washington State Board of Pharmacy and the U.S. Drug Enforcement Administration.
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Q: Are state regulations different than federal regulations for hazardous waste?

A: Yes, the Washington Department of Ecology is delegated by the U.S. Environmental Protection Agency (EPA) to enforce RCRA. Delegated authorities can choose to be more stringent than EPA, but cannot be less stringent.  Washington State’s Dangerous Waste Regulations [Chapter 173-303 WAC] are more stringent than RCRA and are the regulations dangerous waste generators must follow. For more information, please refer to the Dangerous Waste Regulations and Ecology publication # 96-401: State and Federal Rule Differences – Highlights
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Q: Can I still manage State-only pharmaceutical waste under the Conditional Exclusion in WAC 173-303-071(3)(nn)?

A: Yes, you can choose to segregate the State-only pharmaceutical wastes and manage these under the Conditional Exclusion.  If you do this, you may benefit from lower disposal costs.  However, educating your staff on proper segregation, and ensuring compliance could increase internal costs. Conditionally excluded pharmaceutical waste must be disposed of at either a permitted municipal solid waste incinerator or an incinerator that meets the following criteria: heat input greater than 250 million btu (British thermal units) per hour or a combustion zone greater than 1500°F. 

If you choose to mix the State-only pharmaceutical waste with the RCRA hazardous pharmaceutical waste, then you must manage the combined wastes according to the Dangerous Waste Regulations [Chapter 173-303 WAC] or according to the Policy. If the wastes are managed according to the Policy, Ecology will refrain from enforcing portions of the Dangerous Waste Regulations within its enforcement discretion.
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Q: Can I take these wastes to a Moderate Risk Waste (MRW) facility?

A: Individual MRW facilities can decide the type of waste they accept and whether they will accept waste from businesses but MRW facilities can only accept dangerous wastes from households and Small Quantity Generators (SQG) of dangerous waste. Many MRW facilities are not licensed to handle pharmaceutical waste by either the Washington State Board of Pharmacy or the U.S. DEA, and they may not be capable of handling this type of waste. 

If you generate more than 2.2 pounds (or 1 quart) of epinephrine or other P-listed waste in 1 month, you are a Large Quantity Generator (LQG). 

If a business chooses to manage pharmaceutical waste according to the Dangerous Waste Regulations [Chapter 173-303 WAC], they would have to prove that they are an SQG and that the appropriate MRW facility can accept the waste. If a business chooses to manage pharmaceutical waste according to the Policy, any wastes containing federally regulated pharmaceuticals must be shipped to a RCRA-approved incinerator, regardless of generator status. 
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Generator status
Q: How can I show my facility is a Small Quantity Generator (SQG)?

A: You need to show an inspector 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 logs to show the generation locations and rates. The monthly generation rates apply throughout your facility. If your 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 in any given month. 

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 and are an LQG and must follow LQG requirements

Example 3: 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 at your facility to minimize disposal costs. In this case you are an LQG and must follow LQG requirements.

To learn more about generator status and the different 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 for assistance.

To compare compliance conditions between the Dangerous Waste Regulations and the Policy please refer to the Guide for Dangerous Pharmaceutical Waste Generators in Washington State.
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Q: How do I determine my generator status if I follow the Interim Enforcement Policy for my pharmaceutical wastes?

A: If you are managing your pharmaceutical waste under the Policy, you must follow the management and disposal requirements as prescribed. By following the Policy, the amount of pharmaceutical waste does not count toward the grand 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, and less than 220 pounds of all other dangerous waste per month, and you never accumulate greater than 2200 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 Policy

To compare compliance conditions between the Dangerous Waste Regulations and the Policy please refer to the Guide for Dangerous Pharmaceutical Waste Generators in Washington State.
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Proper pharmaceutical waste management
Q: Can I put pharmaceutical waste in my red bags?

A:  No. This is not an approved disposal method for dangerous waste pharmaceuticals. Most red bags in Washington state are sterilized and sent to a landfill for disposal. This management is in violation of the Dangerous Waste Regulations and does not meet the requirements of the Interim Enforcement Policy.

Red bags are designated for biomedical, biohazardous, and infectious materials. These biomedical solid wastes are regulated by the Washington State Department of Health and defined in RCW 70.95K. The criterion for the management and disposal of biomedical solid waste do not meet the more stringent requirements for management and disposal of dangerous waste. Companies that collect and dispose of regulated medical waste are not licensed to transport, treat, or store dangerous waste. 

Even if the biomedical waste is sent for incineration, the red bags will be sent to either a permitted municipal incinerator or a medical waste incinerator. Neither is permitted to accept dangerous wastes. So disposal of pharmaceutical wastes into red bags is illegal disposal of a dangerous waste.
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Q: Can I put pharmaceutical waste in my sharps containers?

A: No. This is not an approved disposal method for dangerous waste pharmaceuticals. Most sharps containers in Washington State are either microwaved or autoclaved to sterilize the contents and then sent to solid waste landfills. This management is in violation of the Dangerous Waste Regulations and does not meet the requirements of the Interim Enforcement Policy.
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Q: Can I send all my expired or unused pharmaceuticals to a reverse distributor?

A:  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 Ecology’s Dangerous Waste Regulations. The non-viable pharmaceuticals that cannot receive a credit are considered a waste. Since pharmaceuticals commonly designate as a dangerous waste, each generator must manage the dangerous pharmaceutical waste properly. 

Most reverse distributors are not licensed to transport or accept dangerous wastes. It is a violation of the Dangerous Waste Regulations and the Interim Enforcement 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. 
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Q: Can I dispose of waste pharmaceuticals to a sanitary sewer?

A: 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 these pharmaceutical compounds from either the wastewater or the biosolids. Therefore pharmaceutical compounds pass through the treatment plant into the receiving waters or remain in the biosolids that are land applied across the state, which creates a potential impact 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 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.
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Household hazardous pharmaceutical waste
Q: What do we do with pharmaceutical waste that is abandoned, confiscated, or dropped off at the hospital?

A: You can elect 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. 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.
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Q: If our hospital hosts a community take-back for pharmaceutical waste, how would we have to manage this waste?

A: 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 trigger the additional compliance requirements. If you are managing the pharmaceutical wastes under the Interim 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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