The Environmental Protection Agency (EPA) recognizes that healthcare is different from other industries that generate hazardous waste. That’s why new standards were developed to improve the overall management of hazardous waste pharmaceuticals in the healthcare sector by streamlining the process. 40 CFR part 266 subpart P (subpart P) is a section of the Resource Conservation and Recovery Act (RCRA) that became effective on August 21, 2019. Tailoring the rules with healthcare-specific regulations addressed some of the challenges in healthcare facilities, such as the requirement for healthcare professionals to make hazardous waste determinations.
Healthcare facilities under the rule include, but are not limited to, the following: hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics (including those co-located within facilities that are not healthcare facilities), physicians’ offices, long-term care facilities, veterinary clinics and hospitals, optical and dental providers, chiropractors, ambulance services, pharmacies, mail-order pharmacies, long-term care pharmacies, and retailers of pharmaceuticals. Whether or not an organization is required to operate under Subpart P is determined by their generator status.
Hazardous Waste Generator Categories
The specific regulations a hazardous waste generator must follow are determined by the volume of hazardous waste that the generator produces in a calendar month. EPA established three categories of generators – Large Quantity Generators (LQGs), Small Quantity Generators (SQGs) and Very Small Quantity Generators (VSQGs). It’s necessary to know which classification applies to your facility to determine the specific regulatory requirements you must comply with. Also, it’s important to note that if an organization is operating under Subpart P, pharmaceutical waste no longer counts toward their waste generator status.
LQGs generate significant amounts of hazardous waste, including pharmaceutical waste. Generating more than 2,200 lbs of hazardous waste per month or more than 2.2 lbs of acute hazardous waste per month subjects these facilities to stringent regulations. SQGs generate between 220 lbs and 2,200 lbs of hazardous waste per month, and less than 2.2 lbs of acute hazardous waste per month. Finally, VSQGs produce less than 220 lbs of hazardous waste per month and less than 2.2 lbs of acute hazardous waste per month.
Most states have hazardous waste generator categories that are the same as the federal categories. However, some states are authorized to establish different generator categories and have regulations that differ from the federal regulations. It’s always a good idea to check with your state for a complete list of requirements.
Healthcare facilities that generate more than VSQG amounts of hazardous waste must manage their non-creditable hazardous waste pharmaceuticals under Subpart P. VSQGs are not federally required to operate under Subpart P. However, they may elect to follow these regulations. Even if they do not, there are parts of the rule that VSQGs must follow.
VSQGs Must Follow These Three Sections of Subpart P
Even though VSQGs are not subject to the full hazardous waste regulations that apply to generators of larger waste quantities, they must still adhere to these three sections of the rule. (These sections apply to reverse distributors as well.)
Ban on Sewering Hazardous Waste Pharmaceuticals
All healthcare facilities, including VSQGs, are prohibited from disposing of hazardous waste pharmaceuticals in a sewer system that passes through to a publicly owned treatment works. This means that no pharmaceuticals may be disposed of down the drain, including pouring down a sink or flushing. When medications are flushed down a toilet or drain, they enter the wastewater treatment system and can contaminate the water. Treatment works are not equipped to remove pharmaceuticals from wastewater and those medications could endanger public health as well as affect the environment. The sewer prohibition is enforced through RCRA inspections by state or federal officials. (EPA projected that the final rule would prevent the flushing of 1,644 to 2,300 tons of hazardous waste pharmaceuticals annually.)
Empty Container Standards
The container standards for VSQGs provides guidance on which residues are regulated as hazardous waste and how to manage residues of hazardous waste pharmaceuticals in unused, partially administered, or fully administered containers.
This includes the following:
- Stock, dispensing and unit-dose containers
- Intravenous (IV) bags
- Other containers, including delivery devices (inhalers, aerosol cans, tubes of creams, etc.)
Details about standards for managing residues of hazardous waste pharmaceuticals in empty containers can help maintain compliance in this area.
Optional Provisions for VSQGs
There are additional optional provisions for VSQGs of both hazardous and non-hazardous pharmaceutical waste. Healthcare facilities that generate both types of waste may:
- Send their potentially creditable hazardous waste pharmaceuticals to a reverse distributor.
- Send their hazardous waste pharmaceuticals off-site to another healthcare facility if both facilities meet certain conditions.
Also, long-term care facilities that are VSQGs for both hazardous waste pharmaceuticals and non-hazardous pharmaceutical waste may dispose of their hazardous waste pharmaceuticals in an on-site collection receptacle of an authorized collector as defined by the Drug Enforcement Administration (DEA). Contaminated personal protective equipment or clean-up materials may NOT be included. The contents must be collected, stored, transported, destroyed, and disposed of in compliance with all DEA regulations.
There are also provisions for long-term care facilities with 20 beds or fewer – these facilities are presumed to be VSQGs; however, they must demonstrate that their hazardous waste quantities are within the VSQG limits. Read more about all provisions for generators of both types of pharmaceutical waste.
Subpart P is a sector-specific rule that was created to be a better fit for managing hazardous waste pharmaceuticals at healthcare facilities and reverse distributors. While VSQGs are not required to operate under Subpart P, they may opt in. If they do so, they are required to notify their state environmental agency.
Have questions? We have answers. If you’d like to learn more about requirements for VSQGs or operating under Subpart P, contact TriHaz for a free consultation. We provide education and smart solutions for managing hazardous pharmaceutical waste.