Q. Why is EPA finalizing management standards for hazardous waste pharmaceuticals?
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 U.S. 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.
Q. What environmental benefits does EPA expect from new management standards or hazardous waste pharmaceuticals?
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.
Q. Which pharmaceuticals are considered hazardous waste?
As thousands of over-the-counter and prescription drugs are currently approved for sale in the U.S., it is difficult to provide a precise number of pharmaceuticals that are considered hazardous waste. However, as with any other waste, solid waste is considered hazardous if it meets a listing or exhibits a characteristic described in Title 40 of the Code of Federal Regulations (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.
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% 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 toxicity characteristics 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).
Q. Who is affected by this final rule?
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 Food and Drug Administration (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.
Q. Why do hazardous waste pharmaceuticals need new management standards?
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.
Q. What is the definition of reverse distributor under the final rule?
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 the reverse distributor with which they have a contract. The reverse distributor reviews the unused pharmaceuticals it receives and works with the pharmaceutical manufacturer to provide manufacturer credit back to the healthcare facility. Then the reverse distributor sends the waste pharmaceuticals for treatment and/or 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.
Q. Can a non-prescription pharmaceutical be sent to a reverse distributor?
Yes, under some circumstances. EPA has concluded that a healthcare facility may send a non-prescription hazardous waste pharmaceutical to a reverse distributor provided the non-prescription pharmaceutical: 1) has a reasonable expectation of receiving manufacturer credit; 2) is in original manufacture packaging; 3) is undispensed; 4) is unexpired or less than one year past expiration; and 5) is managed as a potentially creditable hazardous waste pharmaceutical under Part 266 Subpart P.
Under Subpart P, a non-prescription pharmaceutical sent to a reverse logistics facility (which is different from a reverse distributor) is not a solid waste if it has a reasonable expectation of being used/reused or reclaimed. On the other hand, a prescription pharmaceutical sent to a reverse distributor is a solid waste and/or hazardous waste.
When generators choose to send a non-prescription hazardous waste pharmaceutical to a reverse distributor as a potentially creditable hazardous waste pharmaceutical — rather than sending it to a reverse logistics facility as a non-waste — we would consider this practice to be “over-management” of the non-prescription hazardous waste pharmaceutical (i.e., for practical reasons generators may sometimes choose to manage certain materials along with other wastes subject to more stringent regulatory requirements).
Although reverse distributors primarily manage prescription pharmaceuticals, EPA has learned that in some cases, healthcare facilities send their non-prescription pharmaceuticals to a reverse distributor to receive manufacturer credit. For example, pharmacies keep some non-prescription pharmaceuticals behind the counter with their prescription pharmaceuticals (e.g., DEA regulations require pharmaceuticals containing pseudoephedrine (e.g., Sudafed) to be kept behind the counter of the pharmacy). EPA believes that clarifying that healthcare facilities may continue to send non-prescription hazardous waste pharmaceuticals to reverse distributors, consistent with the criteria described above, makes practical sense and the resultant, voluntary “over-management” of these materials does not present any concerns.
We caution, however, that if the non-prescription hazardous waste pharmaceutical has no reasonable expectation of receiving manufacturer credit, or otherwise does not meet the above criteria, then it would be a solid and hazardous waste at the healthcare facility and prohibited from being sent to a reverse distributor. Instead, it must be managed under Part 266 Subpart P as a non-creditable hazardous waste pharmaceutical and must be sent to a RCRA designated facility (e.g., a permitted or interim status treatment, storage, or disposal facility) via a hazardous waste transporter.
