SEPA ERA'S BAN ON SEWERING PHARMACEUTICALS Introductory Fact Sheet Effective on August 21, 2019, EPA prohibited all healthcare facilities and reverse distributors from disposing of their hazardous waste pharmaceuticals down the drain (e.g., no flushing or pouring down a sink). This "sewer ban" is in effect at healthcare facilities and reverse distributors of all sizes in all states, territories, and Indian country. In addition to the sewer ban, EPA strongly discourages the sewering of any pharmaceutical, with very few exceptions, by residents or by any type of facility. What facilities are considered healthcare facilities that must comply with the sewer ban? The definition of healthcare facility is very broad (see Title 40 of the Code of Federal Regulations (CFR) section 266.500). it includes: 1. Locations that are as hes , including hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians' offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, etc. 2. Locations that provide animal care, such as veterinary clinics and veterinary hospitals. 3. Locations not typically referred to as healthcare facilities, such as pharmacies (retail pharmacies, mail-order pharmacies, long-term care pharmacies), retailers of pharmaceuticals (including retail vape shops), wholesale distributors, third-party logistics providers that serve as forward distributors, and military medical logistics facilities. Examples of healthcare facilities Those typically considered healthcare facilities Animal care facilities Pharmacies, distributors, military medical logistics facilities, etc. 1 The contents of this document do not have the force and effect of law and are not meant to bind the public in any way. This document is intended only to provide clarity to the public regarding existing requirements under the law or agency policies. EPA 530-F-22-003 April 2022 1 ------- Which pharmaceuticals are considered hazardous waste and subject to the sewer ban? The sewer ban applies to pharmaceuticals that meet the definition of hazardous waste under the Resource Conservation and Recovery Act (RCRA). Legally, it is up to the healthcare facility or reverse distributor to determine which of their pharmaceuticals meet the definitior of RCRA hazardous waste when discarded. Alternatively, a healthcare facility or reverse distributor can follow EPA's recommendation not to sewer any pharmaceutical. As thousands of over-the-counter and prescription drugs are currently approved for sale in the United States, it is difficult to provide a precise number of pharmaceuticals that are considered hazardous waste. However, as with any other waste, a solid waste is considered hazardous waste if it meets a listing or exhibits a characteristic described in 40 CFR Part 261. There are approximately 30 commercial chemical products listed on the P- and U- hazardous waste lists that have pharmaceutical uses. As the P- and U-lists are based on chemical designations, this number does not completely represent the total number of brand name pharmaceuticals that may actually be listed hazardous wastes. For example, the following chemotherapy drugs, CTX, Cytotoxan, Neosar and Procytox, are all designated as a U058 hazardous waste for cyclophosamide. Therefore, there are many more branded pharmaceuticals that are considered listed hazardous waste when discarded than the number of listed active ingredients. In addition, many waste pharmaceuticals are hazardous because they exhibit one or more of the four characteristics of hazardous waste: ignitability, corrosivity, reactivity and toxicity. For example, solutions containing more than 24 percent alcohol exhibit the ignitability characteristic. Pharmaceuticals exhibiting the corrosivity characteristic are generally limited to compounding chemicals, including strong acids, such as glacial acetic acid, and strong bases, such as sodium hydroxide. Depending on the concentration in different pharmaceutical preparations, pharmaceuticals may also exhibit the toxicity characteristic because of the use of arsenic (hazardous waste code D004), barium (D005), cadmium (D006), chloroform (D022), chromium (D007), lindane (D013), m-cresol (D024), mercury (D009), selenium (D010), and silver (D011). Listed hazardous waste pharmaceuticals may also exhibit one or more of the hazardous waste characteristics. Does the sewer ban apply to U.S. Drug Enforcement Administration (DEA) controlled substances? The sewer ban applies to DEA controlled substances that are also RCRA hazardous wastes. Pharmaceuticals Banned from Sewering Pharmaceuticals that are hazardous and may not be flushed down a toilet or drain: S Exhibit a characteristic of hazardous waste described in 3 (i.e., ignitable, corrosive, reactive, or toxic). S Contain any of about 30 chemical products with pharmaceutical uses listed that are on thelMmiilB hazardous waste lists 2 ------- What is the U.S. Food and Drug Administration's (FDA) "Flush List" and how does it relate to EPA's sewer ban? EPA's and FDA's primary recommendation is for households to use a drug take-back location or drug mail- back envelope, even for drugs that are on the FDA's Flush List. FDA maintains a list of potentially dangerous drugs that it recommends should be flushed in limited situations to help ensure that they are not misused or accidentally ingested or touched. FDA's "Flush List" is for households only, and not for healthcare facilities or any other type of facility. It is important to note the limited role of FDA's Flush List: 1. It consists of 13 active pharmaceutical ingredients (10 of which are opioids) that are placed on the list because they can be lethal in low doses. 2. It is not guidance for healthcare facilities. 3. It is guidance for households where children or pets may access the medicines if they are placed in the household trash, and only in the relatively rare situation when a drug take-back option (e.g., kiosk or mail-back envelope) is not readily available. In contrast, healthcare facilities are required to comply with EPA's sewer ban, even for items that are on the Flush List. Where can I find additional information on EPA's sewer ban? For additional information on EPA's ban on sewering pharmaceuticals, see EPA's Frequent Questions. United States Environmental Protection kl »» Agency 3 ------- |