An Overview of Pharmaceutical Waste Disposal

regulatorydisposal
September 6, 2016

Why is it important to be in compliance when it comes to pharmaceutical waste disposal?

Federal law requires healthcare facilities such as veterinary clinics, to follow regulations set forth by the Environmental Protection Agency (EPA) with its enactment of the Resource Conservation and Recovery Act (RCRA). The RCRA enforces the protection of human and environmental health through regulating and tracking the storage, transportation and disposal of general and hazardous pharmaceutical waste. Some states such as California, Washington, Colorado, Minnesota and Florida have additional requirements; you can check with your individual state environmental protection agency.

What is pharmaceutical waste?


It is defined by the EPA as a prescription or nonprescription drug or proprietary medicine that is no longer suitable for its intended purpose. It cannot be sold or returned to the manufacturer, wholesaler or reverse distributor for credit because it is expired, compromised or partially unused or is otherwise being discarded.

For the purpose of disposal regulations, pharmaceutical waste can fall into one of three categories:

  • Hazardous- has one of four of the following characteristics regulated by EPA or state laws: ignitability, corrosively, reactivity, and toxicity, or is defined by RCRA as being on one of three EPA created lists:
    • P-list drugs are considered acutely toxic. The container of the drug on this list is also considered hazardous and must be disposed in the same manner as the drug itself: Examples include nicotine, arsenic trioxide, epinephrine, nitroglycerin, physostigmine, warfarin >0.3%
    • U-list: chemotherapy drugs, selenium sulfite, reserpine.
    • D-list: insulin, certain vitamin formulations, rubbing alcohol
  • Controlled Substances (CS) - regulated by the Drug Enforcement Agency (DEA)
  • Non-Hazardous and Non-Controlled

What are the basic requirements for CESQG?

According to the EPA, these are some requirements for CESQG:

  • Identify all hazardous waste at your facility. Consult the Safety Data Sheet (SDS) of the product, EPA website or an authorized hazardous waste management company.
  • Comply with storage quantity limits. No more than 2,200 lbs (1,000 kg) of hazardous waste and no more than 2.2 lbs of P-listed pharmaceutical waste should be on site at any time.
  • Ensure proper treatment and disposal of your waste, including compliance with the Department of Transportation (DOT) regulations. Use DOT rated and RCRA approved containers when segregating, storing and transporting hazardous wastes to a permitted, licensed disposal facility.
  • Keep detailed records of receipts, shipping manifests and indicating waste type, amount, destination and date stored.

For questions regarding pharmaceutical waste disposal, simply contact your Covetrus sales representative, or email Covetrus Regulatory department at [email protected].

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