The U.S. Environmental Protection Agency (EPA) recently promulgated new rules regarding management of unused, unwanted or expired pharmaceuticals that are regulated as hazardous waste.  The rules, promulgated under the Resource Conservation and Recovery Act (RCRA), impact a broad range of healthcare facilities, including hospitals, physicians’ and dentists’ offices, and retail pharmacies, as well as manufacturers that are “reverse distributors” of pharmaceuticals.

Compliance with RCRA requirements has been a challenge for healthcare facility personnel, who, unlike industrial manufacturing facility staff, are primarily focused on providing care for patients and generally do not have the expertise to make hazardous waste determinations for the wide variety of pharmaceuticals generated in small quantities across any given facility.

EPA’s goals in issuing the new rule are to protect waterways and wastewater treatment systems by preventing pharmaceuticals from being “drain disposed” and to improve management of unused and expired pharmaceuticals that are reverse distributed (i.e., returned) to manufacturers.

Key aspects of the new rule are as follows:

• Healthcare facilities that generate more than 100 kg (220 lbs) of hazardous waste or 1 kg (2.2 lbs) of acute hazardous waste per month are subject to the new regulations.  Those facilities generating below these threshold amounts are categorized as “very small quantity generators” (VSQGs) and are largely exempt from the new rule but must comply with certain limited requirements.
• Healthcare facilities subject to the rule will no longer be required to maintain central hazardous waste storage facilities and will be able to store expired pharmaceuticals up to one year (rather than just 90 days).
• All healthcare facilities (including VSQGs) are prohibited from “sewering” or “flushing” waste pharmaceuticals and are also subject to new “empty container” standards.
• VSQGs may take advantage of less onerous off-site disposal standards, provided they meet certain conditions.
• While prescription pharmaceuticals are still defined as regulated waste when sent to a reverse distribution center, over-the-counter (OTC) pharmaceuticals are exempt from the new rule so long as there is a “reasonable expectation” they will be “legitimately used/reused or reclaimed when sent to such a center.”  While facilities must still make a judgment call as to what may be sent to a reverse logistics center, EPA clarifies in guidance that unsold non-prescription pharmaceuticals where the outer packaging is damaged, but the inner container remains intact with no leaks, would not be considered a waste.
• In response to a long-standing request from retailers, OTC nicotine replacement therapies (patches, gums, and lozenges, but not e-cigarettes) are specifically excluded from regulation as hazardous waste. 

The federal rules become effective on August 21, 2019.  However, states that are authorized to administer their own RCRA programs (e.g., all of the New England states), may have more stringent state rules governing pharmaceutical wastes on the books.  Until such state rules are brought in line with the new federal approach, healthcare facilities should proceed cautiously in amending their waste pharmaceutical management practices.