FAQ: EPA Final Rule on Hazardous Waste Pharmaceuticals

Issues in the News

Effective August 21, 2019, healthcare facilities and other businesses that generate pharmaceutical hazardous waste are required to manage those products according to the provisions of the Environmental Protection Agency’s (EPA) Management Standards for Hazardous Waste Pharmaceuticals (HWP) and Amendment to the P075 Listing for Nicotine Final Rule.

Why did the EPA update the Hazardous Waste Pharmaceutical Rule?

The EPA issued the Final Rule to make it easier for the healthcare industry to manage the proper disposal of HWPs and to protect human health and the environment. It’s anticipated that banning the drain disposal (flushing, sewering) of HWPs will keep between 1,644 and 2,300 tons of HWPs out of the environment every year. The Final Rule is expected to lessen the negative effect of hazardous waste pharmaceutical on aquatic ecosystems and on fish and animal populations.

Does the Final Rule apply to dental practices?

The Final Rule applies to all healthcare facilities and reverse distributors that generate and manage Hazardous Waste Pharmaceuticals (HWPs). Dental providers are specifically mentioned in the Final Rule’s definition of healthcare facilities which are “defined as 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.
“This definition includes, but is not limited to, wholesale distributors, third-party logistics providers that serve as forward distributors, military medical logistics facilities, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of pharmaceuticals, veterinary clinics, and veterinary hospitals.”
Which pharmaceuticals are considered hazardous waste under the Final Rule?

While it’s impossible to provide a single comprehensive list that details every item covered under the Final Rule, the EPA has determined that a large portion of the pharmaceutical wastes generated at healthcare facilities will not meet the definition of a hazardous waste. It’s also important to note that the Final Rule does not add any new pharmaceuticals to the universe of regulated hazardous waste.

How does the Final Rule define “pharmaceuticals?” Are dental amalgam or sharps included?

Dental amalgam and sharps are not classified as pharmaceuticals under the Final Rule. Items that are considered pharmaceuticals that are relevant to dentistry include any drug or dietary supplement for use by humans or other animals, such as:

  • any drug or dietary supplement as defined by 21 CFR 203.3 of the Federal Food, Drug and Cosmetic Act
  • prescription drugs
  • over-the-counter drugs
  • homeopathic drugs
  • compounded drugs
  • investigational new drugs
  • pharmaceuticals remaining in non-empty containers
  • personal protective equipment contaminated with pharmaceuticals
  • clean-up material from spills of pharmaceuticals

From a broader oral health perspective, the Final Rule also classifies electronic nicotine delivery systems (e.g., electronic cigarettes or vaping pens) and any liquid nicotine (e-liquid) packaged for retail sale for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials) as pharmaceuticals.

What does my practice need to do to comply with the Final Rule?

The Final Rule prohibits healthcare facilities from disposing of HWPs by pouring them down drains or into sewers.

The Final Rule also relates to the management of hazardous waste pharmaceutical residues that may be found in empty containers. Exemptions may apply to:

  • Stock bottles, dispensing bottles, vials, or ampules that do not exceed 1 liter or 10,000 pills
    Unit-dose containers (unit-dose packets, cups, wrappers, blister packs, or delivery devices) may be considered empty providing that the pharmaceuticals have been removed from container using common practices for removing materials from that type of container.
  • Syringes
    Syringes may be considered empty and the residues are not regulated as hazardous waste as long as the contents have been removed by fully depressing the plunger of the syringe. Any syringe that is not empty must be placed with its remaining hazardous waste.
  • Intravenous (IV) bags
    IV bags can be considered empty and the residues are not regulated as hazardous waste provided the pharmaceuticals in the IV bag have been fully administered to a patient. IV bags that are not empty must be placed with any remaining HWPs into a container that is managed and disposed of as a non-creditable hazardous waste pharmaceutical unless the IV bag held non-acute HWPs and is empty as defined in § 261.7(b)(1).

The sewering ban of HWPs applies to all health care facilities and reverse distributors without exception. However, the disposal of other non-hazardous waste materials rests on EPA suggestions and is not prohibited by the Final Rule itself. For example, the EPA recommends the secure disposal of OTC nicotine replacement therapies and the EPA strongly recommends against sewering non-hazardous waste materials.

Despite only being EPA recommendations, sewering is already banned or severely limited in some states and it’s possible that other states will enact their own prohibitions. Be aware that states may have more restrictive rules for the disposal of non-hazardous materials with requirements beyond what is found in the EPA’s Final Rule. It’s a good rule of thumb to analyze your state’s specific requirements since they may be more stringent rules than the federal ones. Consult a qualified attorney or authority for more information to confirm you’re in compliance.

Are there penalties for non-compliance?

Failure to comply with the Final Rule may result in civil penalties of up to $25,000 per day, per violation, per site, criminal penalties up to $50,000 per day, per violation or imprisonment, or both.

Does the Final Rule impact hazardous waste pharmaceuticals that the practice disposes of via reverse distributors?

Practices may continue to dispose of waste pharmaceuticals through reverse distributors.

The Final Rule applies to reverse distributors that generate and manage HWPs.