EPA Final Rule on Pharmaceutical Waste Regulations Has Been Released. Last updated becomes effective August 21, 2019.

Why be concerned about pharmaceuticals?
Pharmaceuticals are drugs that are used to treat human and animal ailments. Some pharmaceuticals are toxic (chemotherapy agents) while others function to cause more limited physiological changes. Unused pharmaceuticals are problematic because they do not readily break down once released into the environment. As such, they generally remain intact and can be absorbed by other plants, animals, and/or humans.

What is the environmentally preferred disposal option for unused pharmaceuticals?
The preferred disposal method for unused pharmaceuticals is incineration. Incineration is preferred because of its high burn temperatures and effective emission-control systems, which prevent unused drugs from cycling back into our water.

Incineration of pharmaceuticals prevents unused drugs from entering our water.

Why was the Florida Health and Hospital Association (FHA) Health Care Pharmaceutical Waste Guide developed? There are many different regulations that apply to the hundreds of thousands of pharmaceuticals manufactured today. Under the U.S. Environmental Protection Agency (U.S. EPA) and the Florida Department of Environmental Quality (FDEQ) environmental regulations, unused medications that can no longer be used for their original intended purpose are a waste. Waste pharmaceuticals from Florida businesses can be classified as a hazardous waste, liquid industrial waste, non-hazardous solid waste, or a mixed medical waste (also referred to as “dual” waste). The waste classification depends on the character, nature, and composition of the waste. It also depends on what types of waste are mixed together. Because pharmaceutical waste is a common waste, the FDEQ has established pharmaceutical waste as a universal waste type that can be managed under streamlined hazardous waste standards. Complicating the waste classification determination further is the fact that the less hazardous waste a site generates, the less regulation they must meet and the more disposal options available to the site. To determine the level of management that must be met and how pharmaceuticals must be disposed, each site must characterize each of their waste streams, evaluate how the waste is mixed with other waste types, and determine how much hazardous waste is generated on a monthly basis. Based on this information, they can determine the waste classification. Ultimately, pharmaceutical waste should not be mixed with regulated medical waste unless a specific decision to do so is made as it results in the highest disposal cost due to the additional management requirements that must be met. When evaluating a site’s hazardous waste generator status, hazardous waste from medical and diagnostic tests and services (e.g., xylene, methanol, etc.); from histology, cytology, pathology, and chemistry; from building maintenance (fluorescent bulbs, batteries, computers, and degreasing solvents); and from pharmaceutical preparation (infusion/dispensing, and vaccinations) all need to be evaluated for inclusion in the monthly hazardous waste generator status determination, which must be documented to prove the management standards a site must meet when managing hazardous waste.

Office of Florida Department of Environmental Protection 

Navigating environmental requirements, controlled substance regulations, medical professional licensing, and the occupational safety drug handling requirements is complicated enough as it is.

Add to that all of the newly developed pharmaceuticals, each with many different names and dosages, and you have an especially daunting task of determining how to manage pharmaceutical waste. This guide is meant to simplify the process of determining the management standards that apply to pharmaceutical and regulated medical waste in a manner that advocates a practical approach to incinerating pharmaceuticals as a best management practice (BMP. This guide provides target compliance options for meeting the waste regulations in a manner that will facilitate proper handling for meeting the many other requirements that apply to pharmaceuticals in a health care setting. This guide provides a tool to quickly evaluate how to meet the laws and regulations set forth by the many governing bodies. Most significantly, this guide simplifies the actions health care facilities can take to protect patients and employees, as well as current and future generations from exposure to harmful substances used in health care.

How do I use this waste guide? This guide does not create any new regulatory requirements that a health care facility must meet. This guide is a tool that provides target compliance options a health care facility can use for managing pharmaceutical and regulated medical waste. This guide advocates the use of best practices. This guide focuses strictly on the environmental waste storage, transportation, and disposal requirements for handling bulk hazardous pharmaceutical waste, trace chemotherapy waste, universal waste pharmaceuticals, non-hazardous pharmaceutical waste, and mixed medical/dual waste. Moreover, this guide assumes that any health care facility using this guide is in compliance with the environmental requirements for waste characterization, personnel training, contingency planning, biennial reporting, regulated medical waste management planning, as well as any other requirements that may apply. To gain a general understanding of the environmental regulations related to hazardous and non-hazardous liquid waste that apply to all Florida businesses, please go to Pharmaceutical Waste Management for Businesses and Homeowners, select “ Any of the options that better describe what information you need in  Learning Curriculum” and view the FDEP online, on-demand recorded “Introduction to Hazardous Waste Regulation Webinars.”

To ensure a successful pharmaceutical waste management program, health care facilities should consider using the ten step process for managing pharmaceutical waste. To develop a pharmaceutical waste management program, each health care facility must first characterize their entire pharmaceutical inventory, along with other hazardous and non-hazardous liquid wastes, and maintain a record of each waste determination. For pharmaceuticals, this requires a waste characterization determination for each pharmaceutical at each dosage. Newly purchased pharmaceuticals must be added to the pharmaceutical inventory and characterized when they become a waste. After characterizing, the facility must evaluate on a continuous, monthly basis whether the pharmaceuticals they generate that are defined as hazardous waste must be managed in accordance with the hazardous waste regulations. This is determined by calculating the amount of hazardous waste generated at the facility (all contiguous property under the same ownership) each month, or ”determining the facility’s hazardous waste generator status.” Only waste specifically approved for discharge to the sanitary sewer by the local sanitary sewer authority may be disposed down the drain. Moreover, heavy loading of pharmaceuticals to on-site septic systems, especially chemotherapy agents, can quickly cause even newly installed septic systems to fail. The pharmaceuticals take a huge toll on bacterial action in a septic tank. As such, the use of on-site septic systems at health care facilities with high levels of pharmaceutical use should be avoided.

In choosing the management standards that best suits a facility’s circumstances, a facility may segregate hazardous waste pharmaceuticals from non-hazardous pharmaceuticals or commingle all pharmaceuticals. If segregating pharmaceutical waste under this guide, the bulk hazardous pharmaceutical, trace chemotherapy, non-hazardous pharmaceutical, and mixed medical/dual waste guide sheets would be used. If commingling pharmaceutical waste under this guide, the universal pharmaceutical, trace chemotherapy, and mixed medical/dual waste guide sheets would be used. If segregating pharmaceuticals under this guide, waste collected in accordance with the bulk hazardous pharmaceutical guide sheet that does not include spill cleanup waste and does not include personal protective equipment may be managed in accordance with the universal waste guide sheet. This would minimize the volume of pharmaceutical waste destined for ultimate disposal as a hazardous waste while providing the facility with the benefits afforded under the universal waste standards (e.g. allow for the collected waste to be accumulated/stored for up to a year and the weight of the waste would not need to be included when determining generator status).

Presently, only about 15 percent of a pharmacy’s inventory is defined as a hazardous waste. However, the U.S. EPA is in the early stages of rulemaking to expand the list of pharmaceuticals defined as a hazardous waste to comport with the list of hazardous drugs issued by the National Institute for Occupational Safety and Health (NIOSH). This action is of increasing importance in light of the Office of Inspector General’s findings in May 2012 that the U.S. EPA’s inaction to expand this list may be resulting in unsafe disposal. In light of these factors and the knowledge that pharmaceuticals are persistent in the environment, this guide advocates managing all NIOSH hazardous drugs, pharmaceuticals defined as a hazardous waste, and investigative chemotherapy agents in accordance with the hazardous waste regulations as a BMP. Moreover, commingling hazardous and non-hazardous pharmaceuticals and managing them as a universal waste destined for hazardous waste incineration is the best environmental disposal option with the least long term impact on the environment. Segregated hazardous waste, as mentioned above, may also be managed as a universal waste to lessen the impact on generator status.

When considering the overhead cost associated with segregation (e.g., increased generator status, increased labeling, and increased container maintenance, training, etc.), commingling may ultimately be the most cost effective option, even when considering the increased disposal cost. This is particularly true for facilities generating smaller volumes of pharmaceutical waste. Regulated medical waste, which may include trace chemotherapy commingled with regulated medical waste, should not be mixed with pharmaceutical waste so as to minimize disposal costs since mixed medical waste drives a premium cost as a result of the additional handling requirements.

How do I verify that this guide comprehensively serves to meet other pharmaceutical regulations? Consistent with the ten step process for managing pharmaceuticals, health care facilities should consider establishing a team of pharmacy; environmental, health, and safety; housekeeping; and nursing staff to determine what measures work best to handle pharmaceuticals in a manner that satisfies all the requirements that apply to their management in a health care setting. The regulations to be considered would include the U.S. EPA’s waste and water regulations, the FDEP waste and water regulations, the Florida Board of Pharmacy’s patient safety regulations, the NIOSH and Occupational Health and Safety (OSHA) worker safety regulations, the American Nurses Association’s worker safety regulations, any hospital accreditation agency’s regulations, and the U.S. Drug Enforcement Administration’s (U.S. DEA’s) controlled substance regulations. Be sure to coordinate with your disposal vendor(s) and ensure they understand how you are collecting and managing your pharmaceutical and regulated medical waste in order to ensure your facility meets the various regulations for managing your waste, including the U.S. Department of Transportation (U.S. DOT) regulations.

 What regulations and guidelines were considered in creating this guide?

The Federal Resource Conservation and Recovery Act (RCRA) and Title 40, Parts 260-279, of the Code of Federal Regulations (40 CFR 260-279); Part 111, Hazardous Waste, of the Natural Resource and Environmental Protection Act (NREPA) and the Part 111 Rules; Part 115, Solid Waste Management, of the NREPA and the Part 115 Rules; Part 121, Liquid Industrial Waste, of the NREPA; Part 138, Medical Waste Regulatory Act, of the Public Health Code, Act 368 (Act 368) and the Part 138 Rules;Act 138, Hazardous Materials Transportation Act (Act 138); Part 161, General Provisions, of Act 368;Part 177, Pharmacy Practice and Drug Control, of Act 368 (Board of Pharmacy) and the Part 177 Rules; NIOSH Guidelines for Controlling Occupational Exposure to Hazardous Drugs, OSHA Technical Manual, OSHA 2012 Hazard Communication Standard, 29 CFR 1910.1200(g); and 49 CFR Parts 100-199 (Hazardous Materials and Oil Transportation).

Who do I contact for questions on this guide? Contact the FDEP Environmental Assistance Center at 1-850-245-2118 or deq-public.services@dep.state.fl.us for questions on this guide related to Florida Environmental Regulations.

The Medical Waste, Inc HealthCare Pharmaceutical Waste Guide is published jointly by the U.S. Environmental Protection Agency and the FDEP. This guide is intended for guidance only and may be impacted by changes in legislation, rules, and regulations adopted after the date of publication. The guide makes every effort to help users evaluate how to meet applicable regulations. This guide advocates the use of BMP. The information in this guide does not constitute the rendering of legal advice. Diligent attention was given to assure that the information presented herein is accurate as of the date of publication; however, there is no guarantee, expressed or implied, that use of this guide will satisfy all regulatory requirements mandated by laws and their respective enforcement agencies. Reliance on information from this document is not usable as a defense in any enforcement action or litigation. The state of Florida shall be held harmless for any cause of action brought on as a result of using of this publication.