Earlier this year, the Environmental Protection Agency (EPA) published its final rules revising management standards for hazardous waste pharmaceuticals, which will take effect in August, 2019. Healthcare facilities that provide a host of healthcare-related services or distribute, sell or dispense pharmaceuticals, and reverse distributors of pharmaceuticals will need to learn a whole new set of regulations under the Resource Conservation and Recovery Act (RCRA), or risk being assessed steep penalties.
Arnall Golden Gregory attorneys Brooke Dickerson and Jennifer Hilliard presented a webinar guiding participants through the new regulatory framework included in these rules and the possible implications for a range of healthcare facilities including: hospitals, health clinics, skilled nursing facilities, long-term care facilities, in-patient hospice facilities, pharmacies, and others.
Below are answers to the questions asked by our webinar attendees about the new rules. For more information on the rule, view our Legal Insight.
1. How Long Can We Hold on to Hazardous Waste Before Disposing of It?
The amount of time that a facility may accumulate pharmaceutical waste under the new federal rules vary according to the type or nature of the waste. (1) Hazardous waste prescription pharmaceuticals that are not eligible for manufacturer’s credit if returned and hazardous waste non-prescription pharmaceuticals that are not intended for reuse, reclamation or recycling can be accumulated on-site for one year before being sent off-site for treatment, storage or disposal. (2) There is no time limit on how long hazardous waste prescription pharmaceuticals that are potentially creditable can be accumulated on-site. (3) There is no time limit on how long non-prescription hazardous waste pharmaceuticals that are intended for reuse, reclamation or recycling can be accumulated on-site. (4) Reverse distributors can accumulate hazardous waste prescription pharmaceuticals for 180 days after the materials have been finally evaluated (for a total maximum of 210 days).
2. Does Hazardous Waste Need to be Stored in a Locked Room?
The new federal rules do not specifically require that waste materials be kept in a locked room. However, healthcare facilities must keep non-creditable and non-recyclable hazardous waste pharmaceuticals in containers secured against unauthorized access. EPA commentary provides that healthcare facilities may use containers designed to prevent unauthorized access located in areas with uncontrolled access or containers in areas with controlled access such as locked storage lockers, locked rooms or behind a pharmacy counter with restricted access. There are no particular storage requirements for potentially creditable hazardous waste pharmaceuticals by a healthcare facility. Reverse distributors, however, must prevent the “unknowing entry” and minimize unauthorized
3. Would Gloves Used to Pass a Hazardous Waste Medication be Considered a Noncreditable Hazardous Waste?
Under the new rules, personal protective equipment such as a glove is not considered hazardous waste if it only has trace amounts of a hazardous waste pharmaceutical. For example, if a glove has touched a pill that would itself be a hazardous waste pharmaceutical, it is not subject to regulation under RCRA; but if a liquid hazardous waste pharmaceutical spills so that it cannot be removed from a glove, the glove also becomes a hazardous waste pharmaceutical. In that case, it would be a non-creditable hazardous waste pharmaceutical.
4. To Estimate the Amount of Hazardous Waste to be Collected, Should We Collect All Waste for One Month Then Weigh the Contents and Multiply by 12 to Estimate How Much Waste a Facility Would Generate in One Year?
The ability to extrapolate data on generated hazardous waste would depend on the consistency and timing of a facility’s operations. The requirements under the new rules are the same regardless of the amount of waste pharmaceuticals generated.
5. How are Pharmaceutical Distributors Classified?
Pharmaceutical Distributors are health care facilities under the new rules. A health care facility for purposes of Subpart P is defined in 40 C.F.R. § 266.500 as any person that is lawfully authorized to— (1) Provide 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) Distribute, sell, or dispense pharmaceuticals, including over-the counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals. This definition includes, but is not limited to, wholesale distributors, third-party logistics providers that serve as forward distributors, military medical logistics facilities, hospitals, psychiatric hospitals, ambulatory surgical centers, ambulance services, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of pharmaceuticals, veterinary clinics, and veterinary hospitals. This definition does not include pharmaceutical manufacturers, reverse distributors, or reverse logistics centers.
6. Our Long-Term Care Communities Use a Charcoal-based Product that Neutralizes Medications, as Opposed to Flushing, and Sends the Neutralized Chemicals to the Contracted Biohazardous Waste Company for Final Disposal. Does this Meet the Intent of the Law?
The new federal rules prohibit disposing of hazardous waste pharmaceuticals by flushing down a drain or in a toilet. Sending the materials off-site would comply with the regulations as long as the contractor isn’t intending to flush the materials itself. However, more information is necessary to determine specifically if use of the charcoal-based product is allowed to be used on hazardous waste pharmaceuticals on-site without a permit under RCRA. “Treatment” includes neutralization and generally speaking, RCRA requires facilities that treat hazardous wastes to have a permit.
7. Is the Flushing of Narcotics for Destruction Still Allowed if You Cannot Return Them to the Dispensing Facility or Does this Fall Under the New “Sewering” Rule?
Narcotics that qualify has a “hazardous waste” under RCRA, because they are listed or because they exhibit hazardous characteristics, are prohibited from being disposed of into a sewer under the new rules.
8. Can My Long-Term Care Facility Flush Fentanyl Patches?
Generally, pure fentanyl is not a hazardous waste under RCRA, but may become one if mixed with other materials such as alcohol. If it is a hazardous waste, then the new regulations would prohibit a fentanyl patch from being flushed by any type of facility.
9. The Nuances of these Rules Seem Confusing and Difficult to Follow. I am Not Familiar with the Wording Used by the EPA. What Should I Do Next?
We understand your concerns about the confusing language of the rules. Although what we can say during a webinar may be limited because we can’t provide legal advice absent an attorney-client relationship, we have published a Legal Insight to help make content of the rules more understandable. Please contact Jennifer Hilliard for specific legal advice on these rules.