What Determines Hazardous and Non-Hazardous Pharmaceuticals

November 02, 2022 | Pharmaceutical Waste Disposal

Pharmaceuticals are a necessary part of our society, but when they are no longer needed or have expired, it’s important to dispose of them properly.

According to the EPA, the determination of what is considered hazardous pharmaceutical waste is based on:

• the composition of the drug
• how it is used and disposed of
• whether it poses a threat to public health or the environment.

However, not all pharmaceuticals are considered hazardous. Determining hazardousness is based on the federal Resource Conservation and Recovery Act (RCRA) as well as state and local regulations.

Why is it important to know the difference between hazardous pharmaceuticals and non-hazardous ones?

For medical and pharmaceutical facilities, it’s critical to know the difference between hazardous and non-hazardous pharmaceuticals because there are different storage and disposal requirements for each. But those aren’t the only places where medications can be found. Many non-healthcare professionals may also encounter prescription drugs that need to be disposed of including firefighters, police officers, first responders, and municipal workers. Whatever the situations, being prepared and proactive can save time, stress, and cover liabilities before they occur.

What is the Resource Conservation and Recovery Act?

The Resource Conservation and Recovery Act (RCRA, 42 U.S.C. §6901 et seq. (1976)) is the main federal law governing hazardous waste disposal. The Environmental Protection Agency (EPA) enforces RCRA and has established regulations for classifying, managing, and disposing of hazardous waste. This includes regulation “from cradle to grave” – meaning from the time hazardous waste is generated until it is disposed of properly. RCRA also gives states the option to develop their own hazardous waste programs as long as they are at least as stringent as the federal program. This can help to ensure that hazardous waste is managed properly within state-specific contexts, and does not pose a threat to human health or the environment.

What are the criteria for a pharmaceutical to be considered hazardous?

The EPA has established three main criteria for a pharmaceutical to be considered hazardous. The waste needs to meet one of the following to be considered hazardous:

1) The pharmaceutical must be listed as a hazardous waste in the Code of Federal Regulations (CFR).

2) The pharmaceutical must exhibit one or more of the four characteristics of hazardous waste: ignitability, corrosivity, reactivity, or toxicity.

3) The pharmaceutical must be a Hazardous Drug (HD) as defined by the FDA.

The first criterion is relatively straightforward – if a pharmaceutical is listed as a hazardous waste in the CFR, then it is considered hazardous. The second criterion is a bit more complex. A pharmaceutical “must exhibit one or more of the four characteristics of hazardous waste” to require unique disposal methods.

These characteristics are: ignitability, corrosivity, reactivity, and toxicity.

• Ignitability means that the pharmaceutical can catch fire and burn easily.
• Corrosivity means that the pharmaceutical can eat away at metal or other materials.
• Reactivity means that the pharmaceutical can explode or release toxic gasses when mixed with other chemicals.
• Toxicity means that the pharmaceutical is poisonous and can cause harm to humans or animals if ingested, inhaled, or absorbed through the skin.

The third criterion is that the pharmaceutical must be a Hazardous Drug (HD) as defined by the FDA or CDC.

The FDA defines a Hazardous Drug (HD) as any drug that meets one or more of the following criteria:

• The drug is known to be carcinogenic, mutagenic, or teratogenic in humans.
• The drug is known to be toxic to humans in acute exposure situations.
• The drug is a reproductive toxin in humans.
• The drug is an animal carcinogen, mutagen, or teratogen that is also likely to be a human carcinogen, mutagen, or teratogen.
• The drug is an animal toxin that is also likely to be a human toxin in acute exposure situations.

Many pharmaceuticals meet one or more of these criteria and are therefore considered hazardous. These drugs must be managed as hazardous waste to ensure that they are not released into the environment where they can pose a threat to human health or the environment.

What should you know about the disposal of non-hazardous pharmaceutical waste?

When waste is determined to be non-hazardous, it can be disposed of in a variety of ways. However, this does not mean that you can dispose of the waste without any thought or care. With regard to pharmaceutical waste disposal and other regulated activities associated with pharmaceuticals, always follow applicable federal, state, local, and tribal laws/regulations.

Precautions to take when disposing of non-hazardous pharmaceutical waste include:

1. Do not flush pharmaceuticals down the toilet or pour them down the drain. Effective on August 21, 2019, EPA prohibited all healthcare facilities and reverse distributors from disposing of their hazardous waste pharmaceuticals down the drain (e.g., no flushing or pouring down a sink).
2. With regard to pharmaceutical waste disposal and other regulated activities associated with pharmaceuticals, always follow applicable federal, state, local, and tribal laws/regulations.
3. Never put expired or unused pharmaceuticals in the trash.
4. Be sure to follow all instructions on the label when disposing of pharmaceuticals.
5. Never give expired or unused pharmaceuticals to someone else.
6. Never sell or trade expired or unused pharmaceuticals.

When in doubt, always contact your local DEA Agent for guidance on how to properly dispose of your non-hazardous pharmaceutical waste.

What are the steps to take to try to identify pharmaceutical waste?

1. Check the product label. To abide by the law, pharmaceutical manufacturers are required to list active ingredients on product labels. This will give you a good indication as to whether or not something is a hazardous pharmaceutical.

2. Identify the manufacturer. If the product label does not list any active ingredients, try to identify the manufacturer. You can usually find contact information for the manufacturer on the product label. Once you have the manufacturer’s contact information, you can call or email them to try to obtain more information about the product.

3. Research the product online. If you are still unsure whether or not something is a pharmaceutical, try researching the product online. A simple online search can often provide you with more information about a product, as well as its ingredients.

4. Review any available Material Safety Data Sheets (MSDSs). If you are still unsure whether something is a pharmaceutical, review any available Material Safety Data Sheets (MSDSs). MSDSs are required by law to be provided by manufacturers for all products that contain hazardous materials. The MSDS will list all of the product’s ingredients, as well as any associated hazards.

5. Contact a professional. If you are still unsure whether something is a pharmaceutical, contact a professional. A qualified hazardous waste disposal company will be able to help you identify any potential waste that you may have.

How can Rx Destroyer help?

The Rx Destroyer drug disposal starter kit system includes everything you need to safely dispose of your unwanted pharmaceuticals. By using Rx Destroyer, you can ensure that your pharmaceutical waste will be rendered harmless before it is disposed of. Additionally, Rx Destroyer can help to prevent public safety risks associated with improper disposal of pharmaceuticals.

With regard to pharmaceutical waste disposal and other regulated activities associated with pharmaceuticals, always follow applicable federal, state, local, and tribal laws/regulations.