By Sandy Woodthorpe
Signed by the EPA Acting Administrator Andrew Wheeler on December 11, 2018, the EPA’s final rule addresses and clarifies compliance with the agency’s Resource Conservation and Recovery Act (RCRA) hazardous waste regulations for certain pharmaceuticals generated at healthcare facilities and managed at reverse distributors.
According to EPA, this final rule establishes cost-saving, streamlined standards for handling hazardous waste pharmaceuticals to better fit the operations of the healthcare sector while maintaining protection of human health and the environment.
EPA asserts that this final rule will make our drinking and surface water safer and healthier by reducing the amount of hazardous waste pharmaceuticals entering our waterways by 1,644 to 2,300 tons, on an annual basis, by prohibiting all facilities subject to the rule from sewering such waste. EPA further states that this action will help address the issue highlighted by a growing body of publicly available studies documenting the presence of pharmaceuticals in drinking and surface waters as well as their negative impacts to aquatic and riparian ecosystems.
The EPA rule also adds another layer of control to prevent prescription drugs from reaching the black market, a contributing factor to the U.S. opioid crisis.
In addition, under this final rule, FDA-approved, over-the-counter nicotine replacement therapies (i.e., nicotine patches, gums and lozenges) will no longer be considered hazardous waste when discarded, which it claims will result in significant cost savings and burden reduction in the management of these types of nicotine wastes.
The new requirements apply to prescription pharmaceuticals only. The rule does not apply to potentially reusable and reclaimable over-the-counter drugs and dietary supplements, dental amalgam or sharps.
The final rule reaffirms EPA’s existing policy that non-prescription pharmaceuticals and other unsold retail items that have a reasonable expectation of being legitimately used/reused or reclaimed are not solid waste. It also provides regulatory certainty that the Resource Conservation and Recovery Act (RCRA) applies when healthcare facilities send unused, unsaleable prescription hazardous waste pharmaceuticals to reverse distributors to receive manufacturer credit. Simultaneously, the rule incorporates flexibilities to accommodate current reverse distribution business practices to facilitate its implementation.
The waste classification and requirements spelled out in the EPA’s final rule also impose new evaluation, documentation, record-keeping and training requirements on the following: hospitals and outpatient facilities; nursing care and long-term care facilities; medical, dental and veterinary, ambulatory and chiropractic clinics and offices; pharmacies and drug stores; supermarkets and other grocery stores and warehouse club retailers, as well as drug wholesalers and reverse distributors.
- Healthcare providers must develop training, documentation and compliance systems for pharmaceutical waste.
- Each healthcare provider that handles pharmaceuticals must register with the U.S. EPA, and separate listed or characteristically hazardous (toxic, flammable, reactive or corrosive) pharmaceuticals from unlisted, non-hazardous pharmaceuticals.
- Once a determination for disposal is made, the pharmaceuticals are considered solid waste and must be disposed within a year of the determination.
- Flushing hazardous waste medication down the toilet is banned.
How do these final regulations differ from the current hazardous waste generator regulations?
Under previous requirements, any facility that generates hazardous waste pharmaceuticals was subject to the RCRA hazardous waste generator regulations. These regulations vary depending on the total amount and type of hazardous waste generated at the site in a calendar month. Many healthcare facilities are considered large quantity generators (LQGs) because they generate more than 1 kilogram (kg) of acute hazardous waste per month. Under the final management standards, generators of hazardous pharmaceutical wastes will manage their hazardous waste pharmaceuticals under subpart P of part 266 in title 40 of the Code of Federal Regulations (CFR), instead of the standard RCRA generator regulations found in part 262.
Which pharmaceuticals are considered hazardous waste?
As thousands of over-the-counter and prescription drugs are currently approved for sale in the United States, it is difficult to provide a precise number of pharmaceuticals that are considered hazardous waste. However, as with any other waste, a solid waste is considered hazardous waste if it meets a listing or exhibits a characteristic described in title 40 of the Code of Federal Regulations Part 261.
There are approximately 30 commercial chemical products listed on the P and U hazardous waste lists that have pharmaceutical uses. As the P and U lists are based on chemical designations, this number does not completely represent the total number of brand name pharmaceuticals that may actually be listed hazardous wastes. For example, the following chemotherapy drugs, CTX, Cytotoxins, Neosar and Procytox, are all designated as a U058 hazardous waste for cyclophosamide.
In addition, waste pharmaceuticals may also be hazardous because they exhibit one or more of the four characteristics of hazardous waste: ignitability, corrosivity, reactivity and toxicity. For example, solutions containing more than 24 percent alcohol exhibit the ignitability characteristic. Pharmaceuticals exhibiting the corrosivity characteristic are generally limited to compounding chemicals, including strong acids, such as glacial acetic acid, and strong bases, such as sodium hydroxide.
Depending on the concentration in different pharmaceutical preparations, pharmaceuticals may also exhibit the toxicity characteristic because of the use of arsenic (D004), barium (D005), cadmium (D006), chloroform (D022), chromium (D007), lindane (D013), m-cresol (D024), mercury (D009), selenium (D010), and silver (D011).
FDA-approved over-the-counter nicotine replacement therapies (i.e., patches, gums and lozenges). The requirements do not apply to potentially reusable and reclaimable over-the-counter drugs and dietary supplements, dental amalgam or sharps.
What is the definition of healthcare facility under the final rule?
A healthcare facility is defined as any person that is lawfully authorized to:
- 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
- distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals.
Compared to the hazardous waste generator regulations, healthcare facilities operating under the new standards will have the following benefits:
- A healthcare facility will not become a LQG, with all the associated requirements, when it generates more than 1 kg of acute hazardous waste pharmaceuticals in a month;
- A healthcare facility will not have to comply with the satellite accumulation area regulations, which are a poor fit for healthcare facilities;
- A healthcare facility will not need to specify hazardous waste codes on manifests;
- A healthcare facility will be able to accumulate hazardous waste pharmaceuticals on site without a RCRA permit for 365 days, an increase of 275 days over the current generator regulations; and
- A healthcare facility will have basic training requirements.
- Additionally, the final standards are tailored to how reverse distributors operate and will replace the standard generator regulations for the accumulation and management of hazardous waste pharmaceuticals at reverse distributors.
Exemptions from the rule
- The rule does not apply to pharmaceutical manufacturers.
- Food and Drug Administration-approved nicotine replacement therapies, such as patches and gum.
- Medications collected during drug take-back programs and events.
- Dual regulation of hazardous waste pharmaceuticals under EPA rules if they are also regulated by the DEA as controlled substances.
Reverse distribution impact
Reverse distributors that move unsold saleable inventory and unsaleable inventory in the pharmaceutical supply chain already comply with certain federal and state regulations. The rule does impose some new requirements, including:
- Authorization for storing hazardous waste pharmaceuticals (limited to 180 days except when managing materials subject to recall or a litigation hold).
- Authorization to complete the initial pharmaceutical sorting process (which must be completed within 30 days).
Reverse distribution accounts for 3.5 percent to 4 percent of all pharmaceutical sales—more than 120 million product units—exceeding $13 billion in product value, according to a report published by the HDA Research Foundation in 2018.
Is there confusion ahead?
According to a National Law Review article authored by attorneys for the Foley Lardner LLC law firm, “The changes will create significant regulatory uncertainty, and potential liability, for entities in the pharmaceutical distribution chain that suddenly find themselves evaluating compliance with the new rule.”
When will this final rule go into effect?
The rule takes effect six months after it is published in the Federal Register. The rule may be subject to petitions for reconsideration, or to challenge in the Court of Appeals for the D.C. Circuit.
Authorized states are required to adopt this final rule and to modify their RCRA programs in order to retain their authorized status because this rule is more stringent than current RCRA generator regulations. This rule will not become effective in states authorized for the RCRA program until states have adopted the rule, with one exception.
The exception is the ban on flushing hazardous waste pharmaceuticals. This particular requirement is being finalized under the Hazardous and Solid Waste Amendments (HSWA). Requirements promulgated under HSWA authority become effective in all states on the effective date of the federal regulation, which is six months after publication of the final rule in the Federal Register.
The exemption from the P075 listing for FDA-approved over-the-counter nicotine replacement therapies is less stringent than current regulation. Authorized states are not required to adopt less stringent regulations. The exemption for over-the-counter nicotine replacement therapies will not become effective in states authorized for the RCRA program until states have adopted the exemption.
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