Pharmaceutical WasteMedical Waste Disposal Services
Pharmaceutical waste includes expired and partially used
drugs and vaccines, that are no longer required and need
to be disposed.
This category of waste also includes contaminated pharmaceutical products, discarded items used in the handling of pharmaceuticals, such as bottles or boxes with residues, Personal Protective Equipment (PPE) such as gloves and masks, connecting tubing, and drug vials.
Pharmaceutical waste is categorized as either non-hazardous or hazardous waste. If the pharmaceutical waste is deemed hazardous waste it must be properly disposed through a Hazardous Waste company. All 50 states have pharmaceutical waste regulations. It is important to check with your state to know the facts.
Who regulates and/or enforces the proper disposal of pharmaceutical waste?
- US Environmental Protection Agency (EPA)
- Drug Reinforcement Agency (DEA)
- Department of Transportation (DOT)
- Fish and Wildlife Services (FWS)
- The Joint Commission (JC)
What should you do with pharmaceutical waste?
Pharmaceutical waste should be separated and collected at the source of generation.
Non-hazardous pharmaceutical waste should be segregated properly from regulated medical waste. Pharmaceutical waste will be incinerated through a licensed medical incineration site. Hazardous waste is segregated and placed in approved black continuers for proper disposal.
Trace amounts (< 3% of original dose) of chemotherapy materials can be processed by MWA as non-hazardous waste. This waste should be segregated into proper yellow containers but should not include any sharps waste unless the container is also an approved sharps container. Other examples of this type of waste can include: Gloves, gowns, empty syringes, etc. exposed to chemotherapy drugs.
Please note that any trace chemo product that includes a P or U listed waste should be segregated and placed in a black container as hazardous waste.
What NOT to do with pharmaceutical waste?
Pharmaceutical waste should never be poured down the sink or flushed down the toilet. The EPA has ruled that the practice of “sewering” is prohibited by federal regulations. Most states also have laws prohibiting health care workers disposing medications in this fashion.
Medical Waste of America is licensed and qualified for non-hazardous waste
MWA is licensed and qualified to transport and dispose of non-hazardous waste streams whether pharmaceutical or trace. Proper segregation is key to staying compliant with regulations at the point of generation. This includes packaging and labeling requirements. Many of the characteristics of pharmaceutical products are detailed in current Safety Data Sheet (SDS) from the manufacturer. The SDS is always a good starting point if you are determining how to segregate a product and MWA is here to help with this process.
What is Hazardous Pharmaceutical Waste?
Hazardous pharmaceutical waste is defined as liquid or solid wastes that contain properties that are dangerous or potentially harmful to human health or the environment.
In 1976 Congress gave the EPA the authority to develop The Resource Conservation and Recovery Act, which is often referred to as “RCRA”. RCRA is pronounced “rick-rah” and created several categories of “listed” hazardous wastes, three of which apply to pharmaceutical waste: P, U, and D.
How do you determine what is a Hazardous Pharmaceutical Waste?
The most straight-forward way to determine whether a pharmaceutical waste material should be treated as a hazardous waste is by following the regulations under RCRA. In addition to being compliant under RCRA, there may be requirements that apply in your state.
Pharmaceuticals that are being returned to the manufacturer for credit are not considered to be wastes (i.e. reverse distribution).
RCRA regulations provide several categories or “lists” of materials that are automatically considered hazardous wastes. If the waste you are are disposing appears on one of the lists, the waste must be handled as a hazardous waste. As mentioned earlier, there are three hazardous lists that apply to pharmaceuticals: P, U, and D.
Examples of P-Listed Pharmaceutical Waste
- Arsenic trioxide (P012)
- Physostigmine (P204)
- Epinephrine (P042)
- Physostigimine Salicylate (P188)
- Nicotine (P075)
- Warfarin >0.3% (P001)
- Phentermine (CIV) (P046)
Also, containers or bottles that previously contained a P-listed medication should be treated as hazardous waste.
(The complete list of P-listed chemicals can be found at 40 CFR section 261.33.)
Examples of U-Listed Pharmaceuticals:
- Uracil mustard
(The complete list of U-listed wastes can be found at 40 CFR section 261.33)
What are D-Listed Pharmaceuticals?
RCRA also categorizes pharmaceutical waste as being hazardous if they meet specific characteristics. There are four characteristics for D-Listed wastes: toxicity, ignitability, corrosivity, reactivity.
- Examples of ignitable wastes include:
- flammable liquids (flash point <140° F or 60° C)
- solids that can ignite by friction or absorption of moisture
- certain compressed gases
For pharmaceuticals, the presence of a flammable solvent is the most common reason that it must be considered ignitable. Pharmaceutical formulations often contain mixtures of alcohol and water. Fortunately, there is a special stipulation in the RCRA definition of ignitability, called the “alcohol exclusion” which makes it fairly straight-forward to classify a pharmaceutical as ignitable. The “alcohol exclusion” sets a threshold of 24% alcohol. If it contains more than 24% alcohol, it should be considered an ignitable hazardous waste. For flammable materials other than alcohol present in pharmaceutical formulations, such as aerosol propellants, it is will be required to perform the test procedure for measuring the flash point which is a standard laboratory test.
The complete regulations covering the ignitability characteristic is defined in Title 40 of the Code of Federal Regulations, (40 CFR 261.21).
This RCRA characteristic refers to strong acids (pH < 2) and bases (pH >12.5).
Only a handful of pharmaceutical formulations will meet this characteristic. Glacial acetic acid, silver nitrate, potassium permanganate, and concentrated sodium hydroxide may sometimes be used in compounding customized off-the-shelf pharmaceuticals. Any of these materials could be considered as corrosive hazardous wastes.
The complete regulations covering the corrosivity characteristic can be found in Title 40 of the Code of Federal Regulations (40 CFR 261.22).
The only pharmaceutical that would fall under this characteristic is nitroglycerin but because of the amount of nitroglycerin used in pharmaceutical dosage it is exempt from the D-List. However nitroglycerin still falls under the RCRA P-list.
Pharmaceutical waste that falls under the toxicity characteristic are considered harmful when ingested or absorbed through the skin. Pharmaceutical waste that meet the RCRA definition of toxicity present a concern because they may be able to leach from waste and pollute groundwater. Here are a few examples of D-listed chemicals commonly associated with pharmaceuticals: