Managing Pharmaceutical Wastes

FDEP recommends that pharmaceutical wastes should be disposed of as a hazardous waste unless there is definitive knowledge that the waste is not hazardous. An alternative approach would be to collect non-hazardous pharmaceutical wastes and dispose of the materials at a regulated medical waste incinerator or a municipal waste incinerator permitted to burn non-hazardous pharmaceutical waste. Based on the FDEP’s new guidance, a summary of the five step plan for managing pharmaceutical wastes is provided as follows:

1) Establish a pharmaceutical waste management plan.  A pharmaceutical waste management plan can reduce the amount of waste generated, lower the cost of disposal, and decrease the risk of potential liability. A good plan can also be used to educate and train personnel in the proper procedures for identifying, separating, and properly managing pharmaceutical wastes.

2) Identify your hazardous and non-hazardous wastes.  Pharmaceutical wastes include all pharmaceuticals including out dated materials; returned items; used, spilled, or broken products that are no longer useable for their intended purpose; and any items that are used for spill cleanup (i.e. paper towels, clothes, etc.). Once a decision is made to discard a pharmaceutical, a determination must be made as to whether or not the discarded item is a hazardous waste.

A pharmaceutical waste is a hazardous waste if it is a characteristic waste (ignitable, corrosive, reactive or toxic waste) or if it is a P-listed or U-listed hazardous waste in accordance with 40 CFR 261.

The Universal Pharmaceutical Waste (UPW) Rule allows certain pharmaceutical wastes to be managed as universal wastes. The UPW rule applies to pharmaceutical wastes that are no longer saleable. If pharmaceuticals are handled as a universal waste then the generator must determine their handling status and must manage the pharmaceutical wastes in accordance with the UPW rule, which can be found at 62-730.186, F.A.C.

3) Implement best management practices for container maintenance, storage, labeling, recordkeeping, and spills. Pharmaceutical wastes should be managed by separating and storing individual hazardous and nonhazardous waste streams. Wastes must be placed into compatible containers and labeled with the name and address of the facility generating the pharmaceutical wastes. Each container must be labeled with a start date at the beginning of waste accumulation and the words “hazardous waste” or “non-hazardous waste” as necessary. Containers must be inspected weekly and a written log must be maintained documenting the results of any actions required during the inspections. 

4) Determine your generator status by tracking how much waste is generated monthly. The rules that must be followed depend on the quantity of hazardous or acutely hazardous wastes generated in accordance with 40 CFR 262.

5) Comply with the guidelines for transportation and disposal.  A thorough inventory should be maintained of all pharmaceutical wastes being shipped off site. If it is a hazardous waste, you need to follow all of the requirements for shipping hazardous wastes under RCRA. If your wastes contain controlled substances then you also need to contact FDEP and follow all of the DEA regulations. Records for waste determinations, management, and disposal must be maintained for at least three years.

Additional information on pharmaceutical wastes can be found at the following links:

FDEP Pharmaceutical Waste Management – http://www.dep.state.fl.us/waste/pharm/

Current Pharmaceutical Waste Transporters – http://appprod.dep.state.fl.us/www_rcra/Reports/Pharmaceutical_Trans.asp

Commercial Biomedical Waste Treatment Facilities – http://www.doh.state.fl.us/environment/community/biomedical/treatment.htm

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