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5 Pharmaceutical Waste Disposal Best Practices Cheat Sheet (DRAFT) by [deleted]

This is a draft cheat sheet. It is a work in progress and is not finished yet.


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

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

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

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 disposal company

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 time frames.

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.