A Growing Problem

According to the Environmental Protection Agency (EPA), contaminants of emerging concern (CECs), which include pharmaceuticals and personal care products (PPCPs), are increasingly being found in US surface water and leachate – contaminated liquid generated from water percolating through a solid waste disposal site. These biologically active drugs and personal care product chemicals are coming from a growing number of sources and now exist in the environment in concerning concentrations – concentrations that could potentially harm drinking water and plant life, as well as surrounding human communities. Couple this with Baby Boomers’ escalating patient pool of chronic diseases and the growing number of medications being used to treat them, and it’s no wonder that increasing attention is being paid to how, when and where pharmacies are disposing of pharmaceutical waste.

 

Classifications of Pharmaceutical Waste

Depending on its chemical properties and risk to people and/or the environment, pharmaceutical waste can be classified as either hazardous or non-hazardous, as determined by the EPA’s Resource Conservation and Recovery Act (RCRA). Disposal of these products is regulated by the EPA and must follow established criteria and procedures. EPA regulations do not require non-RCRA pharmaceutical waste to be treated as hazardous; however, it is considered best practice for pharmacies to properly dispose of all pharmaceutical waste, regardless of classification.

 

RCRA Categories of Hazardous Pharmaceutical Waste

There are three categories of RCRA hazardous pharmaceutical waste: P-listed products; U-listed products; and/or products found to be toxic based on their characteristics. Chemicals in these wastes must be either 100 percent pure or the sole active ingredient in a given product. Examples of each hazardous category include the following:

 

P-List Waste:

  • Warfarin
  • Prescription nicotine patches and e-cigarettes, including packaging and drug remnants
  • Arsenic trioxide
  • Epinephrine
  • Phentermine
  • Physostigmine
  • Physostigmine salicylate

 

U-List Waste:

  • Diethylstilbestrol (DES)
  • Cyclophosphamide
  • Daunomycin
  • Melphalan
  • Streptozotocin

 

Characteristic Waste, also known as D-List Waste:

  • Drugs that are ignitable – such as alcohol-based cough syrups and aerosol cans with flammable propellants
  • Corrosive drugs — like glutaraldehyde, drugs preserved in nitric acid and bases used as compounding chemicals
  • Reactive drugs — including waste that interacts negatively with other chemicals as indicated on a drug’s Safety Data Sheet
  • Toxic drugs — containing toxic chemicals such as selenium, silver, mercury, chloroform, arsenic, cadmium, chromium, barium, lindane, or m-cresol in specific concentrations.

 

DEA Controlled Pharmaceutical Waste

Drugs that are highly addictive, regularly abused or toxic when accidentally taken in high doses are regulated by the Drug Enforcement Agency (DEA) and considered controlled substance drug waste. Typically, they are prescription/pharmaceutical drugs.

 

Non-hazardous Waste

As defined by the RCRA, what is considered non-hazardous pharmaceutical waste is not necessarily harmless if it enters the environment. Consequently, it requires careful handling and safe, specific disposal practices(3). Some examples of non-hazardous pharmaceutical waste include:

  • Over-the-counter medications
  • Over-the-counter nicotine replacement therapies, in certain states
  • Antibiotics
  • Hormones
  • Contraceptives
  • Endocrine-disrupting compounds
  • P- and U-listed wastes in which the listed chemicals are not the sole active ingredient
  • Drugs OSHA lists as toxic even though the RCRA does not

 

Disposal Practices, Past and Present

Prior to 2019, pharmacies were able to dispose of hazardous waste pharmaceuticals by “sewering” or flushing them down the drain. Now with the 2019 EPA Final Rule, drain disposal is prohibited. In addition, pharmacies must register with U.S. EPA, provide training to staff, appropriately label containers and segregate listed or characteristically hazardous (toxic, flammable, reactive, or corrosive) pharmaceuticals from unlisted, non-hazardous materials. Because complying with hazardous waste regulations can be both challenging and expensive, many pharmacies opt to use medical waste disposal services to save time and resources while staying within the law.

Similarly, for non-hazardous, non-controlled pharmaceuticals, EPA recommends that pharmacies send the pharmaceuticals to a reverse distributor for potential credit and proper disposal. Non-hazardous pharmaceutical waste should not be sewered, but rather should be disposed of in a solid waste landfill or incinerated in a solid waste incinerator, in accordance with all state and/or local environmental regulations.

DEA controlled substance waste can only be transferred to DEA-registered reverse distributors for eventual incineration.

 

Innovative Disposal Approaches

One option for disposing of your pharmaceutical waste is the Pharma Logistics PharmaWaste program. Send your pharmacy’s non-hazardous pharmaceutical waste disposal in conjunction with its reverse distribution services for a singular solution to both creditable and non-creditable pharmaceutical products.

Non-hazardous products accepted include repackaged medications, compound pharmaceuticals, IV solutions bags and loose pills.