On Tuesday, the Environmental Protection Agency (EPA) announced that its Administrator signed the proposed rule: Management Standards for Hazardous Waste Pharmaceuticals Rule. The announcement and EPA blog post are here. The summary of the pre-publication proposed rule is available here and the 267-page proposal is available for download here. EPA is expected to publish the proposed rule in the Federal Register in “the coming weeks” according to the EPA blog post, and will have a 60-day comment period.
As the title of this post suggests, don’t be lulled into complacency thinking the rule wouldn’t apply to you because you don’t have hazardous waste pharmaceuticals in your business. We’ve only just begun our review and analysis of the proposal but one thing is clear: it merits very close attention if you have FDA-regulated products. Among other things, the proposed rule goes far beyond the traditional FDA definition of what is a pharmaceutical. It also introduces new concepts regarding products that are “creditable,” which are relevant when a waste pharmaceutical becomes hazardous and, therefore, must be handled as a hazardous waste pharmaceutical.
The proposal rescinds EPA’s previous 2008 attempt to grapple with the disposal of pharmaceuticals when it proposed to add hazardous waste pharmaceuticals to the existing federal universal hazardous waste program. Instead, EPA proposes a brand new program for the management of hazardous waste pharmaceuticals.
At its most basic, the rule proposes new standards for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. To fall within the proposed rule’s requirements, among other things, an entity must be a “healthcare facility” that has a “pharmaceutical” which becomes “waste” that is “hazardous.” From this basic summary, we’ve already identified the following potential issues:
Definition of “Pharmaceutical”
In order for a product to potentially come within the ambit of the proposed rule, it would have to be a pharmaceutical. But the definition of “pharmaceutical” isn’t what you would expect:
Pharmaceutical means 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, but is not limited to: dietary supplements as defined by the Federal Food, Drug and Cosmetic Act, prescription drugs, over-the-counter drugs, residues of pharmaceuticals remaining in containers, personal protective equipment contaminated with pharmaceuticals, and clean-up material from spills of pharmaceuticals.
Notably, EPA proposes to include dietary supplements in the definition of “pharmaceutical.” It also covers containers with pharmaceutical residues and clean-up materials. Further, the traditional definition of “drug” in the FDC Act, § 201(g)(1)(C), includes “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” The “other than food” qualifier is not present in the proposed EPA definition.
What’s a “Hazardous Pharmaceutical”?
In the preamble to the proposal, EPA explains that a pharmaceutical can become a hazardous waste if it is a commercial chemical product that is listed under RCRA’s P- or U-list and has not been used for its intended purpose. See 40 C.F.R. § 261.33 (e) and (f). Discarded nicotine patches and Coumadin (warfarin) are examples of such products included on these lists. A discarded pharmaceutical may also be hazardous waste if it exhibits one or more of the hazardous waste characteristics, including ignitability, toxicity, corrosiveness, or reactivity. See 40 C.F.R. §§ 261.21‒24. The proposed rule provides information on where more information can be obtained about these definitions and lists. Anyone dealing in a “pharmaceutical”’ as newly defined by EPA should carefully check these resources to determine if its products appear on these lists.
Definition of “Healthcare Facility”
Healthcare facilities that generate hazardous waste pharmaceuticals would be subject to the rule if finalized as proposed. The definition of “healthcare facility” also is broader than traditional establishments that provide medical care to humans and animals.
Healthcare facility means any person that (1) provides 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; or (2) sells or dispenses over-the-counter or prescription pharmaceuticals. This definition includes, but is not limited to, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, coroners and medical examiners, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of over-the-counter medications; and veterinary clinics and hospitals.
This definition encompasses pharmacies and other retailers that sell products labeled as OTC drugs, such as convenience stores, grocery stories, warehouse and club stores, gas stations, pet stores, and kiosks. EPA also proposes including 503A compounding facilities and 503B outsourcing facilities.
Creditable and non-creditable hazardous waste pharmaceuticals
EPA introduces the concepts of “creditable” and “non-creditable” hazardous waste pharmaceuticals and makes important distinctions in how these products must be handled by a healthcare facility. Non-creditable hazardous waste pharmaceuticals – products not expected to be eligible to receive manufacturer’s credit – must be managed on-site as hazardous waste and must be transported as such. EPA proposes less stringent requirements for healthcare facilities handling and transporting potentially creditable hazardous waste pharmaceuticals to a reverse distributor for further handling and determination of eligibility for manufacturer’s credit. This would include, for example, unopened, unused nicotine patches that are within one year after their expiration date. EPA proposes that products that are opened or used, or that are unopened but a year beyond their expiration date, are not expected to be creditable and would have to be handled as hazardous waste pharmaceuticals.
Other Important Provisions
- EPA proposes prohibiting healthcare facilities and reverse distributors from disposing of hazardous waste pharmaceuticals in the toilet or drain.
- EPA proposes aligning disposal of hazardous waste pharmaceuticals that are also controlled substances with DEA’s own waste disposal rules. EPA notes that it has identified relatively few controlled substances that will also have to be regulated as hazardous waste. For those controlled substances, they would be “conditionally exempt” from the proposal if incinerated at a permitted hazardous waste or municipal solid waste incinerator and managed in accordance with DEA disposal regulations.
As we said, the proposed rule merits very close review. We will be updating with more information as we continue our review. Please contact us if you have any questions.