The U.S. Environmental Protection Agency (EPA) recently finalized its standards for managing hazardous waste (HW) pharmaceuticals. The goals of these standards are to create cost-saving, streamlined regulations that better fit the operations of the healthcare sector and maintain protection of human health and the environment. The final rule was published in the Federal Register on Feb. 22, 2019, and will become fully effective in Iowa on Aug. 21, 2019. Healthcare facilities and reverse distributors are subject to this final rule. However, parts of the final rule may also potentially impact entities including grocery stores, pharmacies, supercenters, veterinary services, physicians’ offices, dentists’ offices, health practitioners, outpatient care centers, nursing care facilities, and other drug or health care services.
The final rule regarding the management of HW pharmaceuticals can be summarized into three parts. The first part of the rule will go over Subpart P; this part defines and outlines requirements for healthcare facilities, potentially creditable and non-creditable HW pharmaceuticals, reverse distributors, and reverse logistics. The second part of the rule will explain the sewer prohibition and empty container provision, and lastly, the third part will go over the Nicotine listing revision.
Designed to improve and clarify the regulation of hazardous waste pharmaceuticals, Subpart P defines and outlines waste specific requirements for two different entities: healthcare facilities and reverse distributors.
To start, let's begin by defining healthcare facilities. Healthcare facilities are defined, in Subpart P, 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
distribute, sell, or dispense pharmaceuticals (this includes over-the-counter-pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals)
For healthcare facilities, HW pharmaceuticals are defined as either: “non-creditable” or “potentially creditable.” Non-creditable hazardous waste pharmaceuticals (i.e., broken or leaking, repackaged, dispensed, of more than one year past its expiration date, contaminated PPE, or clean up material) are to be managed on-site at the healthcare facility in accordance with § 266.502 and § 266.508 requirements. These requirements include that storage be contained in a closed, structurally sound container labeled “Hazardous Waste Pharmaceuticals” and off-site disposal be sent to an RCRA-designated facility, typically a permitted Treatment Storage Disposal Facility (TSDF).
Potentially creditable HW pharmaceuticals are defined as those having a reasonable expectation of receiving manufacturer credit and includes pharmaceuticals that are in original manufacturer packaging, undispensed, and unexpired (or less than one year past its expiration date). There are no on-site management requirements for potentially creditable HW pharmaceuticals, however, healthcare facilities are required to ship them to a reverse distributor.
Now let’s go on to define the other two types of entities: reverse distributors and reverse logistics.
Reverse Distributors are a new type of hazardous waste management facility. They receive and evaluate “potentially creditable” HW pharmaceuticals from healthcare facilities to determine if they are eligible for manufacturer credit. The prescription pharmaceuticals at RD are not reused nor resold and are to be discarded. Reverse distributors are allowed to accept these prescription pharmaceuticals as solid waste from offsite healthcare facilities without an RCRA permit as long as they comply with the requirements in § 266.510.
Reverse Distributors must:
Inventory and evaluate each potentially creditable hazardous waste pharmaceutical within 30 days of arrival
Appropriately manage and dispose of evaluated hazardous waste pharmaceuticals as a hazardous waste. Including storage in a compatible container to prevent leaks, labeled “hazardous waste pharmaceuticals” and with the appropriate hazardous waste codes, and disposed of off-site through an RCRA permitted TSDF.
Reverse Logistics are entities that receive nonprescription pharmaceuticals. The EPA has a policy on the regulatory status of nonprescription pharmaceuticals (e.g., over-the-counter and dietary supplements) that are sent through reverse logistics; this is where redistribution can sometimes occur via donation and liquidation. If there is a reasonable expectation of legitimate use/reuse or reclamation, the nonprescription pharmaceuticals are not considered a solid waste at the healthcare or retail facility.
Reverse Logistics are designed to:
Evaluate unsold retail items including nonprescription pharmaceuticals
Analyze secondary markets
Assess the suitability of the unsold retail items for reuse in those secondary markets
Note: Additional requirements for healthcare facilities and reverse distributors such as notification submittal and personnel training are also required under this regulation.
SEWER BAN 266.505
Now let’s go onto the sewer prohibition part of the rule. Healthcare facilities (including very small quantity generators) and reverse distributors are prohibited from flushing or sewering hazardous waste pharmaceuticals down a sink, toilet or drain. Although this part of the rule doesn’t apply to non-hazardous waste pharmaceuticals or households, the EPA strongly recommends against sewering of any pharmaceuticals by any entity. By reducing the number of HW pharmaceuticals entering these waterways, drinking and surface water will be a lot safer and healthier.
EMPTY CONTAINER PROVISION
EPA is also setting management standards for determining when containers with hazardous waste pharmaceutical residues are considered Resource Conservation and Recovery Act (RCRA) empty. Container standards include the following:
Stock, dispensing and unit-dose containers (not exceeding 1 liter or 10,000 pills) will be considered RCRA empty if the pharmaceuticals from the container have been removed properly by using the standard practices employed to remove materials from that type of container.
Syringes will be regarded as empty if the contents have been removed by fully depressing the plunger of the syringe.
Intravenous (IV) bags will be considered empty provided that the pharmaceuticals in the IV bag have been fully administered to the patient. In cases where the IV bag has not been fully administered to the patient and the IV bag has held non-acute hazardous waste pharmaceuticals, then IV bag can be shown to be empty and the remaining residues are not regulated as hazardous waste per § 261.7(b)(1).
As for other containers or delivery devices (which includes but is not limited to inhalers, aerosols, nebulizers, tubes of ointments, gels or creams), details vary depending on the container type. Containers that held non-acute hazardous waste pharmaceuticals should be able to use the RCRA empty container standards under § 261.7(b)(1) or (2). If other containers once held an acute hazardous waste pharmaceutical or if they held a non-acute hazardous waste pharmaceutical but cannot meet the RCRA empty container standard of § 261.7, then the residues of these HW pharmaceuticals (and their containers) must be managed as non-creditable hazardous waste pharmaceuticals under this subpart. More can be read in detail at § 266.507
Note: triple rinsing of containers with acute hazardous waste pharmaceuticals is no longer allowed
NICOTINE LISTING REVISION
Now onto the last part of the final rule, the nicotine listing revision. This final rule of the acute hazardous waste listing for nicotine is being amended such that FDA approved over-the-counter nicotine replacement therapies will no longer be included under the P075 listing for hazardous waste. Meaning that nicotine patches, gums, and lozenges can be discarded as non-hazardous waste. Other unused formulations of nicotine will still be considered acute hazardous waste with the hazardous waste code of P075 and will be managed as HW pharmaceuticals under 40 CFR part 266 subpart P when they are discarded, including:
E-liquids/e-juices in e-cigarettes cartridges or vials
Legacy pesticides containing Nicotine
Nicotine used in research and manufacturing
SUMMARY OF SUBPART P
As we stated before, HW pharmaceuticals in healthcare facilities are either “potentially creditable” or “non-creditable”. For the “potentially creditable” HW pharmaceuticals, there are no standards or time limit when it comes to the on-site accumulation. As for the shipping standards, “potentially creditable” HW pharmaceuticals should be sent to a reverse distributor with a common carrier and confirmation of delivery.
For “non-creditable” HW pharmaceuticals, their on-site accumulation should consist of Universal Waste-like standards and have a one-year maximum time limit. As for the shipping standards, the “non-creditable” HW pharmaceuticals should be sent to a TSDF with an HW transporter and manifest (PHARMS).
Standards for reverse distributors, however, differ slightly from healthcare facilities. The HW pharmaceuticals at the reverse distributors are classified as either “potentially creditable” or “evaluated”. The on-site accumulation for the “potentially creditable” HW pharmaceuticals is set at a time limit of being evaluated within 30 days. As for the shipping standards, “potentially creditable” HW pharmaceuticals should be sent to a reverse distributor with a common carrier and confirmation of delivery.
For the “evaluated” HW pharmaceuticals, their on-site accumulation should consist of Large Quantity Generator-like standards and have a time limit of 180 days after the evaluation. As for the shipping standards, “evaluated” HW pharmaceuticals should be sent to a TSDF with an HW transporter and manifest (including applicable waste codes).
For more information on this final rule, click here
To download the fact sheet, click here