Medical Waste

Non-Hazardous Medical Waste

Medical wastes that are not hazardous waste are subject to regulation under Tennessee’s solid waste regulations, Rule Chapter 0400-11-01.

Within these regulations, information pertaining to medical waste can be found on pages 7, 8, 11 (under “special waste”) and 14, Rule Chapter 0400-11-01.

The Division has developed guidance for the disposal of non-hazardous medical waste in a class I landfill starting on page 133 of the Division’s Policy and Guidance Manual. 

Hazardous Medical Wastes

Hazardous Medical Wastes are those medical wastes which contain chemicals (such as Nicotine, Epinephrine, Nitroglycerine, Warfarin, chemotherapy drugs, etc) that the EPA has determined must be managed under the strict criteria established by federal regulations. More information about hazardous medical waste is available below including some examples of possible listed hazardous waste that healthcare facilities may generate. 

Reverse Distribution for Unused and Unopened Pharmaceuticals

Tennessee follows EPA’s guidance on the reverse distribution process for unused pharmaceuticals that are in the original packaging, have not been sold or distributed, and are returned by the healthcare facility or retailer to the manufacturer under a legitimate reverse distribution system for evaluation, potential credits, and final disposition or resale or reuse.

New Management Standards for Hazardous Waste Pharmaceuticals

EPA finalized regulations for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors in a rule published in the Federal Register on February 22, 2019. 

The Final Rule applies to healthcare facilities that generate, accumulate, or otherwise handle hazardous waste pharmaceuticals and reverse distributors engaged in the management of prescription hazardous waste pharmaceuticals. However, the Final Rule does not apply to non-pharmaceutical hazardous waste or to hazardous waste pharmaceuticals by facilities other than healthcare facilities and reverse distributors.

The Final Rule will affect industries such as pharmacies and drug stores, veterinary clinics, physicians’ and dentists’ offices; health care practitioners such as chiropractors, outpatient care centers, ambulatory surgical centers, hospitals, nursing care facilities, continuing care retirement communities, some medical examiners and coroners’ offices, wholesale distributors, supermarkets, warehouse clubs and supercenters, retailers of pharmaceuticals, and reverse distributors that help healthcare facilities calculate and receive credit from pharmaceutical manufacturers when healthcare facilities have unused pharmaceuticals they no longer need.

Pharmaceuticals are defined as any drug or dietary supplement for use by humans or other animals; any electronic nicotine delivery system; or any liquid nicotine packaged for retail sale for use in electronic nicotine delivery systems. The definition includes dietary supplements, prescription drugs, over-the-counter drugs, homeopathic drugs, compounded drugs, investigational new drugs, pharmaceuticals remaining in non-empty containers, personal protective equipment contaminated with pharmaceuticals, and clean-up material from spills of pharmaceuticals. However, the Final Rule exempts FDA-approved over-the-counter nicotine replacement therapies such as patches, gums, and lozenges from regulation as a RCRA hazardous waste.

As with any other waste, a pharmaceutical waste is considered hazardous waste if it is a solid waste meeting a listing or exhibiting a characteristic described at Tennessee Rule 0400-12-01-.02 (40 C.F.R. Part 261).

Final Rule Implications

First, the Final Rule explicitly prohibits discharges of hazardous waste pharmaceuticals into public sewer systems. In addition, the Final Rule lays out a list of requirements that affected facilities must follow in order to qualify for relief, including:

• Training for employees who handle and accumulate these wastes
• Hazardous waste determinations
• New, unique accumulation rules and time limits
• Specific labeling requirements for certain hazardous waste pharmaceutical containers
• Reporting, recordkeeping, and release response standards
• Land disposal restrictions (LDR) for certain hazardous waste pharmaceuticals
• Manifests for certain off-site shipments

Non-prescription hazardous waste pharmaceuticals and other unsold retail items such as over-the-counter pharmaceuticals, dietary supplements, and homeopathic drugs sent through reverse logistics to a reverse logistics center will not be considered wastes at the healthcare or retail facility if they have a reasonable expectation of being lawfully used or reused for their intended purpose or reclaimed. If the reverse logistics center decides that these products cannot be reused or reclaimed, then they must be disposed of as solid waste. The rules applicable to reverse logistics are effective immediately at the federal level.

Prescription hazardous waste pharmaceuticals moving through the reverse distribution process, whereby reverse distributors receive shipments of unused or expired prescription pharmaceuticals from healthcare facilities and facilitate the process of crediting those healthcare facilities for the unused products, are considered solid wastes at the healthcare facility. These products, if potentially creditable, must be managed under the new Subpart P standards. The rules applicable to reverse distribution are effective in non-authorized states on August 21, 2019, and effective in authorized states when the state adopts Subpart P.

The Final Rule will not become effective in states authorized for the RCRA program until states have adopted the Final Rule, with one notable exception. The sewer prohibition is effective in all states on August 21, 2019, regardless of whether the state is authorized or has adopted Subpart P.  Tennessee has adopted the Final Rule, and Subpart P became effective on April 11, 2022.