Health Care: New Rules for Hazardous-Waste Pharmaceuticals

The U.S. Environmental Protection Agency (EPA) will soon publish new rules that provide tailored standards for handling hazardous-waste pharmaceuticals in the health care sector. The rules streamline the requirements for the accumulating, labeling, shipping, and disposing of pharmaceutical waste classified as hazardous due to its ignitability, corrosivity, reactivity, and/or toxicity, or because it is specifically identified as hazardous under the Resource Conservation and Recovery Act (RCRA).

Prior Law: Previously, facilities generating hazardous-waste pharmaceuticals followed RCRA regulations, which vary depending on the amount and type of waste generated at the site. The new rules remove generators of hazardous-waste pharmaceuticals from the standard RCRA regulations and add tailored standards for these facilities.

The Goal of the New Rules: The rules aim to simplify the management of hazardous-waste pharmaceuticals generated at health care facilities. Unlike industrial hazardous-waste generators, health care facilities typically generate hundreds of different types of pharmaceutical waste in small quantities at multiple locations within the facility (e.g., nursing stations, pharmacies, and emergency rooms). EPA has now attempted to address concerns that (1) the standard RCRA regulations did not fit with the operations of health care facilities and (2) those regulations created confusion among health care workers and pharmacy employees.

Applicability of the New Rules: The new rules apply to health care facilities and reverse distributors that generate hazardous-waste pharmaceuticals. Health care facilities include hospitals, clinics, retail stores with pharmacies, military medical logistics facilities, ambulance services, veterinary clinics, optical and dental providers, and wholesale distributors. There are also provisions that apply to reverse distributors, defined as “entities that help healthcare facilities calculate and receive credit from pharmaceutical manufacturers when healthcare facilities have unused pharmaceuticals that they no longer need.”

What the New Rules Do: The new rules establish tailored regulations that require hazardous waste management training, create new labeling and recordkeeping requirements, create new on-site accumulation and storage requirements, and do not distinguish facilities based on the quantities of hazardous waste they generate. The EPA estimates that the new rules will improve compliance at regulated facilities and prevent the flushing of 1,644 to 2,300 tons of hazardous waste pharmaceuticals annually.

Addressing the Challenge of Nicotine Products: Nicotine is specifically identified as hazardous under RCRA regulations. Under prior law, waste nicotine products were considered acutely hazardous, triggering onerous requirements. The new rules exempt FDA-approved over-the-counter nicotine replacement therapies from that acutely hazardous classification. The rules no longer consider nicotine patches, gums, and lozenges to be hazardous waste when these products are disposed of. Therefore, under federal hazardous-waste regulations, generators of these nicotine replacement therapies may discard them as nonhazardous waste. It should be noted, however, that states are not bound by this reclassification and may continue to regulate the management and disposal of nicotine replacement therapies.

When Do the New Rules Go Into Effect? Are States Required to Adopt the New Rules? The new rules will go into effect at the federal level six months after they are published in the Federal Register. After the rules go into effect at the federal level, states will be required to revise their RCRA hazardous-waste management programs to adopt the new rules. However, when a state adopts the new rules, it may retain any elements of the state program that are more stringent than the new rules. The state may also add elements to its rules to make the state program more stringent or broader than the new rules.

There are two exceptions to the above requirements. First, the new rules’ ban on flushing hazardous-waste pharmaceuticals will become effective in all states six months after publication of the new rules in the Federal Register. No state action is required for this provision to become effective at the state level.  Second, as noted above, states may or may not choose to adopt the new rules’ exemption of FDA-approved nicotine replacement therapies from the hazardous-waste classification.

Associate Elissa Walter contributed to the writing of this client alert.