Pharmaceutical waste is a source of concern for many medical facilities, so how do you manage it effectively? While most types of regulated medical waste fall into broad and generally applicable categories, pharmaceutical waste is more complex.
With a wide variety of highly specific stipulations, waste-type categories, and exclusions, how can busy administrators ensure their facilities stay in compliance while maintaining efficient operations?
Fortunately, you can ensure your medical facility meets its obligations by familiarizing yourself with the various types of regulated pharmaceutical products and partnering with a fully certified and permitted medical waste service provider.
Here’s what you need to know about the basics of pharmaceutical waste.
What Is Pharmaceutical Waste?
Pharmaceutical waste is any pharmaceutical product that is designated for disposal, no longer used as intended, or unable to be returned to the manufacturer.
Disposal regulations ensure that active ingredients are deactivated or destroyed and that all accompanying materials are properly disposed of since pharmaceutical substances present a clear risk to humans, animals, and the environment.
Typical examples of pharmaceutical waste include:
- Discontinued or unused medication
- Partially filled vials and syringes
- Pre-filled syringes and IVs
- Sample medications
Categories of Pharmaceutical Waste
The federal government provides extensive regulatory guidelines for classifying pharmaceutical waste to determine its disposal requirements, but individual states may have different or more stringent requirements.
Pharmaceutical waste is either hazardous or non-hazardous. Hazardous waste can be divided into three primary categories: listed pharmaceutical waste (RCRA), chemotherapy waste (bulk), and controlled substances.
Listed Pharmaceutical Waste
Listed black-container waste is on one of the four hazardous waste lists by the Resource Conservation and Recovery Act (RCRA). The P-list and the U-list pertain to hazardous waste pharmaceuticals, which also include commercial chemical products.
The P-list covers a range of pharmaceuticals, with two important exceptions. Both epinephrine salts and nitroglycerin are technically P-listed substances, but the federal government has excluded epinephrine salts from the list’s requirements since 2007, and weak medicinal nitroglycerin has been excluded since 2001. Some states still maintain protected categorization for those products.
The hazardous medical waste disposal requirements include any drug that contains a P-listed component when two primary conditions are met:
First, the drug waste to be discarded must have the pertinent P-listed component as its sole active ingredient. A product is not P-listed waste if it contains a listed component as a secondary or inactive component.
Secondly, the drug waste must not have been used for its intended purpose. In this case, that means it has not been used for a patient. That designation includes products that were never opened and products that were partially used but have remaining substances and containers to be discarded.
P-listed waste containers are only considered to be legally empty under the RCRA when they have been appropriately triple-rinsed, with the rinsing liquid disposed of as hazardous waste. Since most medical facilities are not able to maintain compliant triple-rinsing facilities, the rule of thumb is that all P-listed drugs, dispensing devices such as syringes and IVs, and holding containers or bottles must be managed and destroyed as hazardous waste.
In most cases, a properly certified waste management services provider is the best option to meet those requirements.
The U-list contains 21 drugs that are chiefly listed because of their toxicity. Like P-listed waste, substances on the U-list are covered by waste regulations when they are the sole active ingredient in a product and have not been used for their intended purpose.
Containers holding U-listed substances are only considered empty by the RCRA when all contents have been removed as much as possible in normal use, such as emptying a syringe by hand, and when no more than 3 percent of the product remains by weight of the total capacity of the container. The residual substance that is removed must be treated as hazardous waste for disposal, and any containers that have not met the two emptying criteria are also hazardous waste.
The D-list covers waste products that are not strictly pharmaceutical, but exhibit hazardous properties that make them flammable, corrosive, toxic or highly reactive.
Medical facilities are individually responsible for determining whether a substance meets D-list criteria. However, in most cases, manufacturers clearly denote such qualities in product information. You should also consult with a knowledgeable medical waste management services provider to determine which products in your facility’s inventory may qualify.
Products covered by the D-list are only considered non-hazardous once you have found a way to remove their hazardous properties. In most cases, it’s best to simply treat them as hazardous waste to be managed by your disposal provider.
Chemotherapy waste is technically a pharmaceutical waste that is covered as a single category in legal terms. However, the medical disposal industry breaks it into two sub-categories:
- Bulk chemotherapy waste: This category includes any product that is characteristic waste, listed, and still contains more than 3 percent by weight of the regulated ingredient. Examples include IV bags leftover after treatment, and materials used to clean up chemotherapy spills.
- Trace chemotherapy waste: This category includes intact and unused EPA "listed" or "characteristic" chemotherapy waste that is less than 3% by weight of the ingredient (RCRA Empty). It also consists of any items that came into contact with hazardous substances, such as rubber gloves and gowns.
Controlled substances are divided into five schedules as determined by the Drug Enforcement Administration. To be properly discarded, they must be “destroyed beyond reclamation” with two healthcare professionals documenting the process. Incineration is the preferred method.
Disposal of controlled substances is tightly regulated regardless of their hazardous qualities under the RCRA.
If your medical facility is a DEA registrant, it may destroy substances on-site in accordance with regulations. If your facility is not a registrant, or otherwise not able to properly destroy substances, you must send the waste to a DEA-registered reverse distributor. If you have dispensed any controlled substance, you cannot return that substance to a registrant.
Special Permits for Transporting Pharmaceutical Waste
To transport pharmaceutical waste, you or your designated provider must maintain a specific transportation permit. You are also required to maintain a hazardous waste permit to handle hazardous pharmaceutical materials, as described above.
Although the regulatory requirements for managing pharmaceutical waste are complex, they are easily manageable once you familiarize yourself with the broader categories and partner with a fully certified and permitted waste management provider. Need help managing your pharmaceutical waste? Let’s talk. Schedule a free consultation today.