US federal laws, including those enforced by the Environmental Protection Agency (EPA), Drug Enforcement Administration (DEA), Department of Transportation (DOT), and Occupational Safety and Health Administration (OSHA), mandate the proper disposal of various types of pharmaceutical waste.
To comply with the law, avoid costly penalties, and prevent negative media attention, your healthcare practice can apply these 5 best practices for disposing your pharmaceutical waste.
1. Identify what type of pharmaceutical waste you have.
In 1976 the Resource Conservation and Recovery Act (RCRA) (pronounced WRECK-rah or RICK-rah) empowered the EPA with the authority to define and regulate hazardous waste, including pharmaceutical hazardous waste.
The first best practice is to identify your pharmaceutical waste.
The EPA refers to this as “waste determination” or more specifically, “hazardous waste determination.” Waste determination is a regulatory requirement and a best practice that involves distinguishing what type of wastes you produce — in terms of potential threat to humans, animals, and the environment — and the quantity you produce or “generate.” Identifying how much you generate is essential to understanding what regulations may apply to you.
If you work in a large healthcare facility, you may already have a pharmaceutical formulary, or list of pharmaceuticals being disposed of, to share with your specialty waste company. If you do not, your specialty waste service representative can provide information to help you manage your responsibility as the “generator” of the waste to properly identify it.
2. Characterize your waste.
Characterization may sound a bit like something out of your freshman English class. But after making a waste determination, each healthcare facility must “characterize” or “profile” its hazardous waste.
What characteristics make the pharmaceutical hazardous? Is the pharmaceutical waste toxic? Flammable? A strong acid or base? Is it corrosive or reactive?
Some people confuse waste “characterization” and “waste determination.” Characterization is a very specific term that only applies to wastes that are hazardous.
RCRA identifies several different categories of hazardous wastes, but the ones that most often apply to healthcare pharmaceutical waste are:
- U-listed wastes, which are typically chemotherapy drugs but include other medicines, too
- P-listed wastes, which are acutely hazardous to drinking water and the environment (eg, nicotine and warfarin)
- Characteristically hazardous or D-listed wastes, which have characteristics that make them toxic, reactive, flammable, or corrosive (eg, chloroform, silver, aerosol inhalers, strong acids and bases)
3. Segregate hazardous substances based on their characterization.
The word “segregate” has negative connotations from a social perspective. However, in the world of pharmaceutical waste disposal, segregation — or separating out certain types of hazardous pharmaceuticals — is legally required.
Your facility must know which pharmaceutical hazardous wastes can’t be disposed together (or commingled). A qualified specialty disposal company can help you set up the logistics that will aid in your staff’s compliance with the laws.
4. Consider the laws of all regulatory bodies.
The EPA isn’t the only regulatory bodies with jurisdiction over pharmaceutical waste. The DOT, DEA, and OSHA also regulate the handling and disposal of pharmaceutical waste.
Your state, county, and municipality also may have more stringent requirements for specific types of pharmaceutical waste.
The DOT, for example, requires you to segregate pharmaceutical waste according to chemical compatibility to prevent reactions from taking place inside waste containers during transportation.
The DEA requires you to separately dispose of controlled substances, also called “scheduled” drugs. These include street drugs such as heroin; pain medications such as morphine, codeine, and hydrocodone; and some anti-anxiety medications and sleep aids. To help prevent these drugs from being diverted for nonmedical uses, only handlers who are specifically registered with the DEA are allowed to manufacture, transport, dispense, or dispose of controlled substances. If you are a DEA registrant managing controlled substances, be sure to follow all DEA regulations.
OSHA is concerned about providing a safe and healthful work environment for those who work with pharmaceutical waste. For example, pregnant women should not be exposed to some pharmaceuticals.
5. Choose a knowledgeable, qualified disposal company for all your waste streams.
First, be sure that your vendor is legally capable of disposing your waste. For example, if you are disposing controlled substances, be sure your vendor is a DEA-registrant.
Furthermore, skilled specialty waste providers can help reduce your risk by developing the correct procedures and documentation to ensure that your organization’s pharmaceutical waste is handled correctly and within the appropriate timeframes.
In addition to in-person consultations and informational materials, you may want to choose a waste solution partner that offers educational programs to meet your staff members’ training needs —helping both new and experienced staff members stay up-to-date and compliant.
This blog summarizes an extremely complex topic and is not intended as legal or regulatory advice. For a more thorough synopsis, the EPA provides a 430-page, “user-friendly” summary of hazardous waste regulations that was updated in August 2012.