Paul Sarahan and John Riley are attorneys in Holland & Knight's Austin office, Robert P. Frank is an attorney in Holland & Knight's Philadelphia office and Bonni F. Kaufman is a partner in Holland & Knight's Washington, D.C. office
- The U.S. Environmental Protection Agency (EPA) has published a new rule to address the handling, storage, transportation and disposal of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors.
- The new rule provides streamlined standards that better fit operations within the healthcare sector, eliminate the disposal of hazardous waste pharmaceuticals in sewer systems, and clarify applicable regulations and provide national consistency in their enforcement.
- Affected entities will need to look carefully at their operations and design or revise operational systems to ensure compliance with the new rule.
The U.S. Environmental Protection Agency (EPA) has published a new rule to address the handling, storage, transportation and disposal of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. See 40 C.F.R. Part 266, Subpart P. The rule, published on Feb. 22, 2019, is the result of policy discussions between EPA and the pharmaceutical industry that date back to 1981. Through the rule, EPA seeks to create regulations that better fit operations within the healthcare sector; eliminate the disposal of hazardous waste pharmaceuticals in sewer systems; clarify the applicable regulations and provide national consistency as to how the Resource Conservation and Recovery Act (RCRA) and regulations promulgated thereunder apply to the reverse distribution and reverse logistics operations of healthcare facilities; and, in the process, provide regulatory relief to these facilities. The rule also amends the listing status of over-the-counter nicotine replacement therapies approved by the U.S. Food and Drug Administration (FDA).
Prescription Pharmaceuticals vs. Non-Prescription Pharmaceuticals and Retail Goods
The rule distinguishes between: 1) prescription pharmaceuticals1 and 2) non-prescription pharmaceuticals, such as over-the-counter drugs and dietary supplements, and all other unsold retail items.2 Under the rule, prescription pharmaceuticals sent to reverse distributors are solid waste and must be handled as such at the healthcare facility. Non-prescription pharmaceuticals and all other unsold retail items that are sent to a reverse logistics operation are not solid waste if there is a reasonable expectation that the material will be legitimately used, reused or reclaimed. If there is not such a reasonable expectation, the material is solid waste and must be handled as such by the facility.
What Is a Healthcare Facility?
Under the rule, a healthcare facility is broadly defined. It includes any person that is lawfully authorized to provide care, counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status of a human or animal, or to distribute, sell or dispense pharmaceuticals. Such facilities include: wholesale distributors, third-party logistics providers that serve as forward distributors, military medical logistics facilities, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians' offices, optical and dental providers, chiropractors, long-term care facilities (LTCFs),3 ambulance services, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of pharmaceuticals, and veterinary clinics and hospitals. The definition includes locations that sell pharmaceuticals over the internet, through the mail or through other distribution mechanisms. Pharmaceutical manufacturers, reverse distributors and reverse logistics centers are not included within the definition.
What Rules Are Applicable?
Hazardous waste pharmaceuticals must be managed under the new rule, Part 266, Subpart P by: 1) healthcare facilities that generate above the Very Small Quantity Generator threshold for hazardous waste and 2) all reverse distributors. The rule does not apply to the management of non-pharmaceutical hazardous waste or hazardous waste pharmaceuticals by facilities other than healthcare facilities and reverse distributors. Healthcare facilities and reverse distributors remain subject to Part 262 for the management of non-pharmaceutical hazardous wastes, to Part 273 for the management of universal wastes and to other regulations, as applicable.
A facility that is subject to and operating under the new rule is no longer required to track the amount of hazardous waste pharmaceuticals it generates per month or to segregate acute and non-acute hazardous waste pharmaceuticals.
In addition to its treatment of non-prescription pharmaceuticals and other retail goods, EPA has established certain exemptions from the rule's applicability. These include provisions for recalled pharmaceuticals; pharmaceuticals under preservation orders, investigations or judicial proceedings; investigational new drugs; and household waste pharmaceuticals. The exemption for the first three categories of materials listed above is removed once a decision is made to discard the material.
Investigational New Drugs
The definition of "pharmaceutical" includes "investigational new drugs." Although EPA's new rule does not apply to pharmaceutical manufacturers, it may have ramifications for the timing of any decision they make to discard investigational new drugs during clinical trials. EPA acknowledges that investigational drugs might have proprietary ingredients that the manufacturer might not be willing to divulge during trials. Seeking to provide clarity on how to manage these items when discarded, EPA noted that, because the FDA requires investigational drugs to be returned to the sponsor of a new drug application, EPA does not consider these returned drugs to be solid waste. Such drugs would therefore not be subject to RCRA, including 40 C.F.R. Part 266 Subpart P – unless a decision has been made to discard the investigational new drug or the FDA has approved its destruction. At that point, such drugs must be regarded as solid waste and, if hazardous waste, become subject to 40 C.F.R. Part 266 Subpart P if discarded by a healthcare facility or reverse distributor. Because physicians' offices are healthcare facilities, if the investigational new drug is a hazardous waste pharmaceutical when the decision to discard it is made, the physician's office has an obligation to comply with RCRA, which it may not have if an investigational new drug application is in effect in accordance with FDA's regulations. If, as is typical, investigational new drugs that are part of a clinical trial are returned to the manufacturer when the clinical trial ends, the manufacturer would be responsible to comply with RCRA by complying with 40 C.F.R. Part 262.
The rule strictly prohibits the disposal of hazardous waste pharmaceuticals into sewer drains. The sewer prohibition goes into effect on Aug. 22, 2019, six months from the rule's publication. With limited exceptions,4 the rule is otherwise effective only after the authorized state adopts the federal rule. States are not required to adopt the amendments to the nicotine listing, but they must adopt Part 266, Subpart P by July 1, 2021, or, if the state requires a statutory amendment, by July 1, 2022. We anticipate that the rule will go into effect in most states within the next year.
Although the new rule does provide additional flexibility to healthcare facilities, EPA has noted that there are some issues to keep in mind, including the following.
- Once a reverse logistics center makes a decision to discard an item, it becomes a solid waste and, if it is listed or exhibits a characteristic, a hazardous waste. The reverse logistics center is subject to the applicable RCRA regulations, such as Part 262, for the generation and accumulation of hazardous waste, including hazardous waste pharmaceuticals.
- Although nonprescription pharmaceuticals and other retail items that are sent through reverse logistics are not solid wastes at the retail store if they have a reasonable expectation of being legitimately used/reused or reclaimed, the items must be shipped in accordance with all applicable U.S. Department of Transportation (DOT) regulations.
- If a manufacturer has established business rules that prohibit unsold retail items from being legitimately used/reused (e.g., lawfully redistributed for their intended purpose) because the items are subject to a "destroy disposition," and that prohibit the unsold retail items from being reclaimed, the items are considered solid waste at the retail store or healthcare facility.
- There are instances when a hazardous waste pharmaceutical will also pose a biological hazard. The healthcare industry often refers to pharmaceutical wastes that are both RCRA hazardous and a biological hazard as "dual wastes," and such wastes must be managed in accordance with RCRA, state and/or local medical waste regulations.
- LTCFs may no longer use the household hazardous waste exclusion. LTCFs need to manage their hazardous waste pharmaceuticals in accordance with the standards in this rule and their non-pharmaceutical hazardous wastes in accordance with the applicable RCRA hazardous waste generator regulations.
EPA's new pharmaceutical rule provides streamlined standards that better fit operations within the healthcare sector, eliminate the disposal of hazardous waste pharmaceuticals in sewer systems, and clarify applicable regulations and provide national consistency in their enforcement. However, the new rule comes with its own complexities, and entities subject to this rule will need to look carefully at their operations and design or revise operational systems to ensure compliance with the new rule. In addition, entities subject to the rule should monitor their state environmental agencies to determine when the federal rule is adopted as a state rule and becomes effective and enforceable.
1 "Pharmaceuticals" include any drug or dietary supplement for use by humans or other animals; any electronic nicotine delivery systems, such as an e-cigarette or vaping pen; and any liquid nicotine or e-liquid used in such a system. Under the rule, it also includes personal protective equipment (PPE) contaminated with pharmaceuticals, and clean-up material from a spill of pharmaceuticals. "Pharmaceuticals" does not include dental amalgam or sharps. EPA considers sharps to be medical wastes presently regulated at both the state and local levels.
2 Examples of unsold retail items include aerosol cans, pool chemicals, mercury-containing lightbulbs, some pesticides, certain cleaning products, paint thinner, ammunition and fireworks.
3 LTCFs include hospice, nursing and skilled nursing facilities, but not group homes or independent or assisted living facilities. Continuing care retirement communities are apportioned depending on the types of areas within the community – e.g., the nursing and skilled nursing portion of the community is an LTCF, the independent and assisted living portion of the community is not.
4 The exceptions are the non-authorized states of Iowa and Alaska, Native American tribal governments and U.S. territories, with the exception of Guam. In these areas, the rule is effective on Aug. 22, 2019.
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