South Florida Hospital News
Monday August 10, 2020

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April 2010 - Volume 6 - Issue 10

Florida Hazardous Pharmaceutical Waste Compliance

The Florida Department of Environmental Protection (FDEP) issued a guidance document to assist in the categorization of hospital waste and determination of whether hospital wastes are regulated as hazardous wastes under the federal Resource Conversation and Recovery Act (RCRA) and related state law.(1)

Pharmaceutical waste that meets the definition of hazardous waste under 40 CFR 261.33 & 261.24 as adopted in 62-730, FAC, may be managed as "universal waste" in Florida. These waste are also referred to as P-listed waste or "acutely hazardous" waste.(2) To be in compliance, a facility must dispose of unused preparations and spills of these acutely hazardous wastes as a universal waste. This includes emptied bottles, vials and partially used IV bags.

Following simple guidelines will help your facility comply with RCRA and related state laws.

1. Store all P-listed waste in a separate labeled container. Not in a biohazardous red bag. Only the emptied syringe and needle can go in a red sharps box.

2. The container must be picked up and disposed of by an FDEP registered hazardous waste transporter or other transporter who has notified FDEP of its activities. Check these credentials.

3. The transporter must provide the hospital a copy of the manifest. The manifest must be kept on file for three years by the hospital.

4. A facility that generates less than 2.2 pounds (1 kilogram) of acutely hazardous waste or 220 pounds (100 kilograms) of non-acutely hazardous waste(3), in one calendar month is categorized as an Exempt Small Quantity Generator. Thus subject to less strict regulations. Once this volume is exceeded stricter guidelines prevail.

It is important to note that an expired product is considered waste and must also follow these guidelines unless they can be returned to the manufacturer.

Sharon Roberts is a former State of Florida, Department of Health Inspector, and is now a practicing healthcare law attorney and pharmacist in Palm Beach County, FL, who specializes in healthcare and regulatory law practice with the law firm of Strawn & Monaghan, P.A. She can be reached at (561) 278-9400 or visit

2. P-listed waste are found in 40 CFR 261.33. These include Epinephrine, Nicotine, Nitroglycerin, phenteramine and Coumadin/Warfarin >0.3%.
3. Non acutely hazardous wastes are U-Listed hazardous wastes. These include cyclophosphamide, daunomycin, lindane, phenol, resorcinol, warfarin <0.3%, etc.

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