Frequent Questions about the Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine Final Rule
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- Why is EPA finalizing management standards for hazardous waste pharmaceuticals?
- What environmental benefits does EPA expect from new management standards for hazardous waste pharmaceuticals?
- Who is affected by this final rule?
- What is the definition of healthcare facility under the final rule?
- What is the definition of reverse distributor under the final rule?
- What is the definition of pharmaceutical under the final rule?
- Which pharmaceuticals are considered hazardous waste?
- Why is management of hazardous waste pharmaceuticals difficult under the RCRA subtitle C hazardous waste generator regulations?
- Why do hazardous waste pharmaceuticals need new management standards?
- How do these final regulations differ from the current hazardous waste generator regulations?
- How will discarded over-the-counter nicotine replacement therapies be regulated?
- When will this final rule go into effect?
Question: Why is EPA finalizing management standards for hazardous waste pharmaceuticals?
Answer: EPA has two primary reasons for this final rule. First, to address concerns raised by stakeholders regarding the difficulty in implementing the industry-oriented Resource Conservation and Recovery Act (RCRA) hazardous waste regulations for the management of hazardous waste pharmaceuticals generated at healthcare facilities and managed at reverse distributors. This rule revises and tailors the hazardous waste regulations to improve the management of hazardous waste pharmaceuticals by the healthcare sector and thereby enhance protection of human health and the environment.
Second, a number of studies have documented the presence of various pharmaceutical active ingredients and metabolic by-products in surface waters and groundwater in the United States. The pharmaceuticals entering the environment, through flushing or other means, are having a negative effect on aquatic ecosystems and on fish and animal populations. These findings highlight the increasing importance of pharmaceutical use and management, and have led EPA to finalize a prohibition on disposing hazardous waste pharmaceuticals down the drain by those entities subject to this rule.
Question: What environmental benefits does EPA expect from new management standards for hazardous waste pharmaceuticals?
Answer: EPA’s final rule will reduce the risk caused by hazardous waste pharmaceuticals that enter the environment through flushing down the sink or toilet. Specifically, this final rule is projected to prevent the flushing of 1,644 to 2,300 tons of hazardous waste pharmaceuticals annually by banning the drain disposal (flushing, sewering) of hazardous waste pharmaceuticals.
With this final rule, EPA strives to improve compliance at healthcare facilities (including hospitals, clinics, and retail stores with pharmacies) and reverse distributors that generate and manage hazardous waste pharmaceuticals in order to improve environmental protection. Specifically, EPA enhances public health protection by decreasing the risk of diversion of unused hazardous waste prescription pharmaceuticals onto the black market by requiring basic tracking of these pharmaceuticals from healthcare facilities to reverse distributors. Additionally, this final rule creates an environmentally preferable, convenient and practical management system that EPA encourages the healthcare sector to use for all waste pharmaceuticals.
Question: Who is affected by this final rule?
Answer: Healthcare facilities and reverse distributors that generate and manage hazardous waste pharmaceuticals will follow these new, tailored standards for managing their hazardous waste pharmaceuticals instead of the industry-oriented hazardous waste generator regulations.
This rule does not apply to pharmaceutical manufacturers (unless they act as reverse distributors), production facilities or other generators of hazardous waste pharmaceuticals.
In addition, anyone who generates or manages discarded FDA-approved over-the-counter nicotine replacement therapies (i.e., patches, gums and lozenges) is also affected by the amendment to the P075 listing for nicotine that is also part of this final rule. See the Question & Answer below for more information on the amendment to the P075 listing for nicotine that is part of this final rule.
Question: What is the definition of healthcare facility under the final rule?
Answer: In the final rule, a healthcare facility is defined as any person that is lawfully authorized to:
- provide preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or
- distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals.
This definition includes, but is not limited to, wholesale distributors, third-party logistics providers that serve as forward distributors, military medical logistics facilities, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of pharmaceuticals, veterinary clinics, and veterinary hospitals.
This definition does not include pharmaceutical manufacturers, reverse distributors, or reverse logistics centers.
Answer: Reverse distributors are entities that help healthcare facilities calculate and receive credit from pharmaceutical manufacturers when healthcare facilities have unused pharmaceuticals that they no longer need. Reverse distributors generally have contracts with healthcare facilities to help the healthcare facility manage its unused and sometimes expired waste pharmaceuticals.
Healthcare facilities send their unused pharmaceuticals to a reverse distributor they have a contract with and the reverse distributor reviews the unused pharmaceuticals received and works with the pharmaceutical manufacturer to facilitate providing manufacturer credit back to the healthcare facility. Then reverse distributor sends the waste pharmaceuticals for disposal.
In the final rule, a reverse distributor is defined as:
any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit. Any person, including forward distributors, third-party logistics providers, and pharmaceutical manufacturers, that processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor.
Question: What is the definition of pharmaceutical under the final rule?
Answer: In the final rule, pharmaceutical is defined as:
any drug or dietary supplement for use by humans or other animals; any electronic nicotine delivery system (e.g., electronic cigarette or vaping pen); or any liquid nicotine (e-liquid) packaged for retail sale for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials).
This definition includes, but is not limited to, dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act; prescription drugs, as defined by 21 CFR 203.3(y); 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.
This definition does not include dental amalgam or sharps
EPA believes a broad definition of pharmaceutical will benefit the healthcare sector, which has struggled with complying with the industry-oriented framework of the RCRA regulations.
Question: Which pharmaceuticals are considered hazardous waste?
Answer: 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 title 40 of the Code of Federal Regulations 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.
In addition, waste pharmaceuticals may also be 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 (D004), barium (D005), cadmium (D006), chloroform (D022), chromium (D007), lindane (D013), m-cresol (D024), mercury (D009), selenium (D010), and silver (D011).
Question: Why is management of hazardous waste pharmaceuticals difficult under the RCRA subtitle C hazardous waste generator regulations?
Answer: Hazardous waste generation and management practices at healthcare facilities differ from practices of industrial hazardous waste generators in several ways that make the application of RCRA subtitle C hazardous waste regulations difficult. Pharmaceutical waste is typically generated at a large number of points in relatively small quantities across a facility, such as at nursing stations, pharmacies and patient, emergency and operating rooms. Furthermore, generators of hazardous waste pharmaceuticals tend to generate hundreds of different types of pharmaceutical waste while, in contrast, many industrial generators tend to generate only a few predictable waste streams in large quantities at relatively few generation points. Some of the difficulties that generators of hazardous pharmaceutical wastes have expressed concerning the current hazardous waste generator regulations relate to making the waste determination, generator status upgrade due to generation of acutely hazardous waste, hazardous waste listings, and accumulation time limits.
Question: Why do hazardous waste pharmaceuticals need new management standards?
Answer: Healthcare workers and retail pharmacy employees are often unfamiliar with or confused by RCRA hazardous waste management requirements, prompting them to dispose of hazardous pharmaceuticals as municipal waste or medical waste. This final rule streamlines the current regulations governing these wastes, ensuring that larger quantities of hazardous pharmaceutical wastes are managed properly. Additionally, the rule finalizes a tailored set of management standards specifically designed to reduce the complexity of the RCRA hazardous waste regulations for hazardous waste pharmaceuticals. It streamlines the collection and handling requirements for widely-dispersed hazardous wastes and facilitates their inclusion in the hazardous waste management system.
Under this final rule, EPA expects that the management of hazardous waste pharmaceuticals to improve and the regulatory burden for many hazardous waste pharmaceutical generators will decrease. This final rule provides a solution to many of the issues facing healthcare facilities. By finalizing a convenient and practical system for the management of hazardous waste pharmaceuticals that is easy to comply with, EPA encourages healthcare facilities to manage all of their pharmaceutical waste - non-hazardous and hazardous - under the final rule.
Question: How do these final regulations differ from the current hazardous waste generator regulations?
Answer: Under previous requirements, any facility that generates hazardous waste pharmaceuticals was subject to the RCRA hazardous waste generator regulations. These regulations vary depending on the total amount and type of hazardous waste generated at the site in a calendar month. Many healthcare facilities are considered large quantity generators (LQGs) because they generate more than 1 kilogram (kg) of acute hazardous waste per month. Under the final management standards, generators of hazardous pharmaceutical wastes will manage their hazardous waste pharmaceuticals under subpart P of part 266 in title 40 of the Code of Federal Regulations (CFR), instead of the standard RCRA generator regulations found in part 262. Compared to the hazardous waste generator regulations, healthcare facilities operating under the new standards will have the following benefits:
- A healthcare facility will not become a LQG, with all the associated requirements, when it generates more than 1 kg of acute hazardous waste pharmaceuticals in a month;
- A healthcare facility will not have to comply with the satellite accumulation area regulations, which are a poor fit for healthcare facilities;
- A healthcare facility will not need to specify hazardous waste codes on manifests;
- A healthcare facility will be able to accumulate hazardous waste pharmaceuticals on site without a RCRA permit for 365 days, an increase of 275 days over the current generator regulations; and
- A healthcare facility will have basic training requirements.
Additionally, the final standards are tailored to how reverse distributors operate and will replace the standard generator regulations for the accumulation and management of hazardous waste pharmaceuticals at reverse distributors.
Answer: This final rule exempts FDA-approved over-the-counter nicotine replacement therapies (i.e., patches, gums and lozenges) from regulation as a RCRA hazardous waste (specifically, these wastes are exempt from the RCRA Hazardous Waste Code P075 for nicotine). Therefore, under the federal hazardous waste regulations, generators of these wastes (e.g., retail stores) may discard them as non-hazardous waste. This provision of the final rule must be in effect in your state in order for facilities to use this exemption. Please check with your state.
Answer: This final rule will be effective at the federal level six months after the rule is published in the Federal Register.
Authorized states are required to adopt this final rule and to modify their RCRA programs in order to retain their authorized status because this rule is more stringent than current RCRA generator regulations. This rule will not become effective in states authorized for the RCRA program until states have adopted the rule, with one exception.
The exception is the ban on flushing hazardous waste pharmaceuticals. This particular requirement is being finalized under the Hazardous and Solid Waste Amendments (HSWA). Requirements promulgated under HSWA authority become effective in all states on the effective date of the federal regulation, which is six months after publication of the final rule in the Federal Register.
The exemption from the P075 listing for FDA-approved over-the-counter nicotine replacement therapies is less stringent than current regulation. Authorized states are not required to adopt less stringent regulations. The exemption for over-the-counter nicotine replacement therapies will not become effective in states authorized for the RCRA program until states have adopted the exemption.