Hazardous Waste Pharmaceuticals
EPA's Hazardous Waste Pharmaceuticals Rule, 40 CFR 266 Subpart P became effective in
North Dakota on July 1, 2021. These new regulations can be found in Sections 33.1-24-05-310
through 320 NDAC.
Hazardous waste pharmaceuticals are pharmaceuticals that when expired or discarded can potentially cause harm to human health and the environment if not managed properly.
Pharmaceuticals become a solid waste when expired, damaged, or partially administered and some pharmaceuticals
are Controlled Substances regulated under the Drug Enforcement Adminstration.
Hazardous Waste Pharmaceuticals meet the definition of hazardous waste because they are either listed, or because
they exhibit a characteristic of hazardous waste.
Healthcare facilities and Reverse Distributors are required to determine what solid wastes are generated or
otherwise managed at their facility. Both Reverse Distributors and Healthcare Facilities that are Small Quantity
Generators (SQGs) or Large Quantity Generators (LQGs) for their monthly combined totals (pre-rule) of hazardous waste (HW)
and hazardous waste pharmaceuticals (HWPs) (combined total) must comply with the following; NDAC Sections 33.1-24-05-310 through 33.1-24-05-320.
Generator status is determined by counting all hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste generated
per month at a facility. Once generator status has been determined and proper notification has been submitted pursuant to that
determination, you no longer need to count hazardous waste pharmaceuticals in your category determination. This is effectively
a two-step generator category determination process, the first to assess whether you have to comply with the new pharmaceutical
rule and the second to assess under what category you must manage your non-pharmaceutical hazardous waste. It is possible that your
generator status for non-pharmaceutical hazardous waste drops and you are subject to less stringent requirements for those wastes.
Additionally, once you are managing hazardous waste pharmaceuticals under the new Subpart P rule, the amount of hazardous waste pharmaceuticals
that you generate does not matter. Once you are managing your hazardous waste pharmaceuticals pursuant to the P-rule, there are no generator categories
for these wastes and all requirements are the same. Therefore, you may mix your non-hazardous waste pharmaceuticals with your hazardous waste
pharmaceuticals and manage all of these wastes together pursuant to the Subpart P requirements without affecting your generator status.
Compliance with Subpart P is optional for Healthcare Facilities that are Very Small Quantity Generators.
means any person that is lawfully authorized to:
(1) Provide preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care,
and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a
human or animal or that affects the structure or function of the human or animal body; or
(2) Distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals,
dietary supplements, homeopathic drugs, or prescription pharmaceuticals.
Healthcare facilities include, but are not limited to:
• Psychiatric hospitals
• Health clinics
• Long-term care facilities
• Outpatient surgery centers
• Physician, Dental, and Optical offices
• Ambulance Services
• Veterinary clinics and hospitals
• Pharmacies – including mail-order
• Vape Shops
• Retailers of pharmaceuticals
Healthcare facilities does not include pharmaceutical manufacturers, reverses distributors, or reverse logistic centers.
"Long-term care facility"
means a licensed entity that provides assistance with activities of daily living,
including managing and administering pharmaceuticals to one or more individuals at the facility.
Long-term care facilities include:
• hospice facilities
• nursing facilities
• skilled nursing facilities
• the nursing and skilled nursing care portions of continuing care retirement communities.
Long-term care facility does not include group homes, independent living communities, assisted living facilities, and the
independent and assisted living portions of continuing care retirement communities.
“Hazardous Waste Pharmaceutical”
means a pharmaceutical that is a solid waste, and exhibits one or more hazardous waste characteristics.
Pharmaceuticals include, but are not limited to:
• Dietary Supplements
• Prescription drugs
• OTC drugs
• Homeopathic drugs
• Compounded drugs
• Investigational drugs
• Pharmaceuticals remaining in non-empty containers
• Personal protection equipment (PPE) contaminated with pharmaceuticals
• Clean-up waste from spills of pharmaceuticals
• Electronic nicotine delivery systems (ENDS), such as, e-cigarettes and vape pens
• Nicotine e-liquid/e-juice packaged for retail sale used for ENDS, such as, pre-filled cartridges and vials.
Pharmaceutical does not include dental amalgam, sharps, or infectious waste. Sharps and other infectious waste are
considered solid wastes and must be managed in accordance with North Dakota’s regulations governing Regulated Infectious Waste as applicable.
means any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste
pharmaceuticals for the purpose of facilitating or verifying manufacturer credit. Any person, including forward distributors, third-party logistics providers,
and pharmaceutical manufacturers, that process prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor.
The Pharmaceuticals Rules includes a Sewer Prohibition for the management of Hazardous Waste Pharmaceuticals.
This Sewer Prohibition became effective nationally on August 21, 2019.
The Sewer Prohibition is found in Section 33.1-24-05-315 NDAC. Under this provision, all healthcare facilities including Very Small Quantity Generators (VSQGs)
operating under the generator requirements in lieu of Subpart P and reverse distributors, are prohibited from discharging Hazardous Waste Pharmaceuticals to a
sewer system that passes through to a publicly-owned treatment works.
Hazardous Waste Pharmaceuticals that are also controlled substances under the Drug Enforcement Act (DEA) are also subject to the ban, as sewer
disposal does not meet the DEA non-retrievable standard for destruction.
Healthcare facilities and reverse distributors remain subject to the prohibitions in 4o CFR 403.5(b)(1) related to the sewering of hazardous wastes.
Additionally, hazardous waste pharmaceuticals may not be disposed of through drains (sinks, toilets, etc.) connected to an on-site septic tank drain field.
Subpart P Notification
Healthcare Facilities and Reverse Distributors must
notify NDDEQ using the EPA Site Identification Form 8700-12 that it is operating under Subpart P.
Healthcare facilities that already have an EPA identification number must
update their exitsting notification to include Subpart P. Healthcare facilites
(not including reverse distributors) that are required to submit a biennial report can submit this notification as part of its next biennial report (due March 1, 2022), however,
they may re-notify anytime before then.
Otherwise, all facilities must notify within 60 days of becoming subject to this Subpart. Healthcare facilites and reverse distributors that do not already have an EPA ID number
will be assigned one when the notification of Subpart P activity is submitted. A facility must keep a copy of its notification on file for as long as the healthcare facility is subject
to this Subpart.
Instructions for completing the 8700-12 Site Identification Form and submitting notifications are found on our State/EPA Site Identification
Management of Residues in Pharmaceutical Containers
The Hazardous Waste Pharmaceuticals Rule made some changes to the regulatory status of residues in certain types of containers that once held
hazardous waste pharmaceuticals and under what conditions
such containers are "RCRA empty." These new empty containers provisions are not just limited to healthcare facilities and reverse distributors operating
under Subpart P, but appy to any generator
of hazardous waste pharmaceuticals.
Containers of hazardous waste pharmaceuticals are subject to the requirements found in Section 33.1-24-05-317 NDAC. Under this regulation, empty is re-deifined for hazardous waste
pharamaceuticals remaining in the following types of containers:
• Stock, Dispensing and unit-dose containers;
• Intravenous (IV) bags;
• Other containers, including but not limited to inhalers, aerosol cans, nebulizers, and tubes of ointments, gels, or creams,
• Note that triple rinsing of these types of containers with acute P-listed hazardous waste pharmaceuticals is no longer
required or allowed based on the type of container.
The US EPA has numerous guidance documents, guidance memos and letter and Q and A's relating to the Subpart P rule and hazardous waste pharmaceuticals. These documents can be