On August 31, 2015, the Environmental Protection Agency (“EPA”) issued its long-awaited Management Standards for Hazardous Waste Pharmaceuticals Proposed Rule, which is designed to prevent facilities from disposing of hazardous waste pharmaceuticals by flushing them down the toilet or drain. The proposal creates a new subpart under the Resource Conservation and Recovery Act’s (“RCRA”) hazardous waste regulations for the regulation of hazardous waste pharmaceuticals generated by “healthcare facilities” and “pharmaceutical reverse distributors.”

Although the rule only applies to healthcare facilities that are small- or large-quantity generators and pharmaceutical reverse distributors, regardless of the quantity of hazardous waste pharmaceuticals generated, the rule broadly defines those terms. A healthcare facility is defined as any person that provides medical care to a human or animal or that sells over-the-counter or prescription pharmaceuticals. The definition includes hospitals, psychiatric hospitals, health clinics, doctors’ offices, long-term care facilities, optical and dental providers, veterinary clinics and hospitals, and pharmacies, among others. A pharmaceutical reverse distributor is defined as “any person that receives and accumulates potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer’s credit.” Drug manufacturers or wholesalers may fall under this definition.

One of the more interesting aspects of the proposed rule is the broad definition of “pharmaceutical.” Pharmaceutical is defined as “any chemical or biological product that is intended for use in the diagnosis, cure, mitigation, care, treatment, or prevention of disease or injury of a human or other animal; or any chemical or biological product that is intended to affect the structure or function of the body of a human or other animal.” This definition includes not only “drugs” as defined under the Federal Food, Drug, and Cosmetics Act (see 21 U.S.C. § 321(g)), but also dietary supplements, residues of pharmaceuticals in containers, personal protective equipment contaminated with pharmaceutical residues, and cleanup material from the spills of pharmaceuticals. The definition also includes delivery devices that have the primary purpose of delivering or dispensing a pharmaceutical, but not sharps (i.e., needles from IV bags or syringes), which are regulated as medical waste at the state level. This broad definition is intended to benefit healthcare facilities by allowing them to manage drugs and dietary supplements under one simplified regulatory scheme.

Under the rule, healthcare facilities are required to follow management standards for non-creditable and creditable hazardous waste pharmaceuticals. A potentially creditable waste would be considered solid waste at the healthcare facility—the “point of generation.” There are no accumulation time limits, container requirements, or labeling for potentially creditable hazardous waste pharmaceuticals at healthcare facilities under the rule. Additionally, healthcare facilities can ship creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor via a common carrier in compliance with the Department of Transportation’s requirements as long as advance notice is provided in writing and a mechanism is used to confirm delivery.

For non-creditable hazardous waste pharmaceuticals, however, healthcare facilities are subject to slightly more stringent requirements. Non-creditable hazardous waste pharmaceuticals can be accumulated in containers and simply labeled as “hazardous pharmaceutical waste.” The waste can be accumulated onsite for up to a year, without quantity restrictions, but must be transported as hazardous waste and sent to a hazardous waste RCRA permitted or interim status facility.

As for pharmaceutical reverse distributors, the rule allows hazardous waste pharmaceuticals to be managed under reduced accumulation, storage, and labeling requirements, but it includes new provisions that require maintaining an updated inventory and processing potentially creditable hazardous waste pharmaceutical shipments within 21 days, which may require significant procedural and technological updates for some reverse distributors.

What this means to you

EPA intends to publish the new rule in the Federal Register in the coming weeks, and will accept public comments on the rule for 60 days following its publication. Potentially impacted persons and organizations should review the proposed requirements in order to assess potential compliance options and, if necessary, provide written comment on the proposal. The pre-publication copy of the rule is available for review.