Earlier this year, the U.S. Environmental Protection Agency promulgated new management standards for generators of hazardous waste pharmaceuticals pursuant to the Resource Conservation and Recovery Act (RCRA). These new streamlined requirements for the accumulation, storage, and ultimate disposal of pharmaceuticals that are subject to RCRA, are meant to provide clarity and consistency regarding how generators should manage this specific category of hazardous waste, which was previously ill-defined and did not fit easily within the framework of RCRA’s general hazardous waste disposal provisions. The new management standards, which comprise a new 40 C.F.R. part 266 subpart P, apply to a newly defined category of “hazardous waste pharmaceuticals” that are generated by facilities qualifying as “healthcare facilities” or “reverse distributors.”

Pharmaceutical compounds are considered emerging contaminants, as they are being detected in surface water and ground water at levels that could pose a risk to aquatic life or human health. The nature of that risk is not yet fully understood. Pharmaceutical compounds typically make their way through sewers to these water bodies either by consumption and excretion or by disposal via flushing. Reverse distribution, which was not accounted for under RCRA’s general hazardous waste disposal provisions, is a more environmentally beneficial method for handling potential waste pharmaceuticals. The trend of reverse distribution of pharmaceuticals helps reduce contamination by pharmaceutical compounds by encouraging the return of expired or unused pharmaceuticals to manufacturers in exchange for credit instead of consigning them to immediate disposal. Manufacturers can then repackage unused pharmaceuticals or recycle compounds from the materials returned, thus reducing the volume that is ultimately disposed. “Reverse distributors,” or companies that collect and store the pharmaceuticals to be returned and ensure they reach their destination, facilitate this process.

Not all of these pharmaceuticals are certain to be accepted for credit; once evaluated by the reverse distributor, some of them are slated for disposal, which is where hazardous waste regulations come into play. Since RCRA was framed around the generation of hazardous waste by industrial manufacturers, compliance with its hazardous waste management requirements has long been a challenge for both healthcare and reverse distribution facilities.  These entities are considered to generate hazardous waste when they harbor hazardous unused pharmaceuticals that will be disposed of.  A challenge particular to them has been efficiently harmonizing waste regulations with other potentially applicable requirements (e.g., those pertaining to controlled substances, or state laws regarding biomedical waste).

During the regulatory process, EPA examined the typical business practices associated with the reverse supply chain. This process led to a broad regulatory definition of “pharmaceutical” to help streamline waste management for healthcare facilities. “Pharmaceutical” is defined to include prescription drugs, over-the-counter drugs, dietary supplements, homeopathic drugs, electronic nicotine delivery systems (such as e-cigarettes or vaping pens), liquid nicotine (e.g., in cartridges for the aforementioned systems), non-empty drug containers, clean-up material from spills, or personal protective equipment contaminated with any of the above.

Furthermore, “hazardous waste pharmaceuticals” are defined as pharmaceuticals to be disposed that contain compounds that are listed as hazardous wastes under RCRA. These compounds may be found on the P list (acute hazardous wastes) and U list (non-acute hazardous wastes) set forth at 40 C.F.R. § 261.33. Also included in the definition of “hazardous waste pharmaceuticals” is any pharmaceutical waste that exhibits one or more of the hazardous waste characteristics outlined in RCRA: ignitability, corrosivity, toxicity, or reactivity.

Based on the typical fate of prescription pharmaceuticals that have undergone reverse distribution (more often disposal) as opposed to that of non-prescription pharmaceuticals in the reverse supply chain (more often reuse or reclamation), EPA has determined that reverse distributed prescription pharmaceuticals are considered “solid waste” – subject to regulation under RCRA, and thus under the new management standards – when they are collected for reverse distribution by the healthcare facility, regardless of whether or not they are potentially eligible for manufacturer credit. Meanwhile, non-prescription pharmaceuticals are only considered waste at the time when the healthcare facility or reverse distributor makes the discrete decision to dispose of them rather than return them for credit. To more easily differentiate between the two, and in keeping with industry practice, EPA refers only to the return of prescription pharmaceuticals as “reverse distribution,” while the return of non-prescription pharmaceuticals is denominated “reverse logistics.”

Having clarified what exactly constitutes a hazardous waste pharmaceutical as opposed to a non-hazardous waste pharmaceutical, the new management standards apply specifically to hazardous waste pharmaceuticals generated (i.e., collected for disposal) by “healthcare facilities” such as hospitals or pharmacies, as well as those generated by reverse distributors. These management standards assign generator categories to healthcare facilities and reverse distributors based on the volume of hazardous waste pharmaceuticals handled; for each category, there is a set of requirements related to accumulation time, storage, recordkeeping/reporting, and employee training. In conjunction with these requirements, all generators are prohibited from disposing hazardous waste pharmaceuticals via sewer.

EPA has also provided for situations when pharmaceuticals are subject to a recall, and therefore must automatically be considered non-creditable hazardous waste pharmaceuticals. Because of the timing concerns associated with executing a recall, the new standards allow healthcare facilities and reverse distributors to request extensions of the time period for which they are permitted to accumulate these wastes prior to disposal.

The new standards take effect on August 21, 2019. At this point, the new standards will apply in any state that has not taken over the administration of its RCRA program with EPA’s permission. States managing their own programs have until this time to ensure that their pharmaceutical disposal regulations are at least as stringent as these new federal regulations. Healthcare facilities and reverse distributors also have until August 21, 2019 to bring their waste management regimes into compliance with the new standards.