Hazardous Drugs vs Hazardous Waste Pharmaceuticals

Hazardous Drugs

NIOSH vs RCRA

Are you confused by the terms “hazardous drug” and “hazardous waste pharmaceutical” (HWP)?  Well, you are not alone.  At first glance, it would appear they are the same, but they are not. Knowing the difference can save your facility money and potential regulatory citations. So, let’s clear the confusion.

NIOSH/OSHA Hazardous Drugs

The CDC’s National Institute for Occupational Safety and Health (NIOSH) is the federal agency responsible for conducting research and making recommendations for the prevention of work-related injury and illness.

NIOSH has developed a list of Hazardous Drugs based on the potential hazard and occupational exposure. NIOSH uses the following six criteria to determine if a drug is hazardous:

  • Carcinogenicity,
  • Teratogenicity or other developmental toxicity,
  • Reproductive toxicity,
  • Organ toxicity at low doses,
  • Genotoxicity, and
  • Structure and toxicity profiles of new drugs that mimic existing drugs that have previously been determined to be hazardous.

The drug categories that most often fit the hazardous drug criteria are chemotherapy or antineoplastic agents, antiviral drugs, hormones, some bioengineered drugs, and other miscellaneous drugs.

In order for healthcare personnel to reduce occupational exposure when handling hazardous drugs, they must employ safe handling measures congruent with the potential exposure.

For example, antineoplastic drugs that are solid, intact coated tablets or capsules and are administered to the patient without any modifications of formulation may not pose a significant risk of direct occupational exposure. Therefore, they do not require any special handling measures.

However, if there is a modification to the formulation, such as crushing a tablet or making a solution outside of a ventilated hood, then possible contact, inhalation, or splash exposure could occur, thus requiring proper engineering and work practice controls, as well as PPE. This should sound very familiar if you have received OSHA Hazard Communication (HazCom) training, which includes training on Safety Data Sheets (MSDS) maintained on hazardous drugs to which you may be exposed.

NIOSH’s list of Hazardous Drugs is located here.

Remember NIOSH hazardous drugs must be safely handled and disposed of; but, they are not necessarily disposed of as RCRA hazardous waste.

RCRA Hazardous Waste Pharmaceuticals

In contrast to the NIOSH list of hazardous drugs, the Resource Conservation and Recovery Act (RCRA) regulates and lists hazardous waste pharmaceuticals – those drugs that must be managed as hazardous waste.

RCRA was passed with three goals in mind:  to protect human health and the environment; to reduce waste and conserve energy and natural resources; and to reduce or eliminate the generation of hazardous waste as expeditiously as possible.

With the passage of RCRA comes the requirement that any generator of waste is required to determine if that waste is hazardous. RCRA has created lists of drugs that are hazardous waste pharmaceuticals. These lists include the P-List, U-List, or Characteristic waste and can be found on the EPA’s website.

As well as the drug itself, empty P-listed hazardous waste pharmaceutical containers, such as syringes, IV bags, tubing, and vials are also considered hazardous waste. Empty containers that held either a U-list and/or a characteristic hazardous waste do not need to be managed as hazardous waste.

Finally, remember, drugs classified as DEA Controlled Substance (or narcotics) pharmaceuticals are managed separately from non-controlled waste pharmaceuticals.

For further information on these and other relevant topics, see our articles on Hazardous Waste, RCRA Hazardous Waste, Medication Disposal, Hazard Communications, and Chemo Waste. In addition, be sure to reference OSHA and your state’s hazardous waste pharmaceutical regulations, as well as your facility’s Hazard Communication Program and policies on proper containment and disposal of RCRA hazardous waste pharmaceuticals.

RCRA Hazardous waste pharmaceuticals must be disposed of as hazardous waste but are not necessarily considered NIOSH hazardous drugs.

Drug Disposal Options

Even though most drugs are not classified as hazardous waste pharmaceuticals, to keep our communities and environment safe, it’s important not to place drugs down the sewer or into the trash.

Some states, such as California, do not allow facilities to sewer or trash ANY drugs. Many facilities have turned to the Sharps Compliance TakeAway Environmental Return Systems, which include prepaid UPS return shipping boxes, as a safe and compliant way to dispose of unused non-controlled drugs that are not classified as hazardous waste pharmaceuticals. For those drugs that ARE classified as hazardous waste pharmaceuticals, Sharps Compliance also provides services for compliant packaging, labeling, transport, tracking, and disposal.

Wanda Lingner

Wanda Lingner

Clinical Specialist – Strategic Regulatory Customer Compliance at Sharps Compliance
Wanda Lingner holds a BA in Nursing from Texas Woman’s University and a BBA in Management from Texas A&M University. She has over 20 years of clinical practice in both hospitals and private practice in a variety of medical specialties. As Clinical Specialist, she assists Sharps’ customers in evaluating current federal and state-specific medical and pharmaceutical waste regulations, developing medical waste management plans, and implementing compliant regulated medical and pharmaceutical waste management processes.
Wanda Lingner

Author: Wanda Lingner

Wanda Lingner holds a BA in Nursing from Texas Woman’s University and a BBA in Management from Texas A&M University. She has over 20 years of clinical practice in both hospitals and private practice in a variety of medical specialties. As Clinical Specialist, she assists Sharps’ customers in evaluating current federal and state-specific medical and pharmaceutical waste regulations, developing medical waste management plans, and implementing compliant regulated medical and pharmaceutical waste management processes.