The U.S. Environmental Protection Agency (EPA) finalized its standards for managing hazardous waste pharmaceuticals.
The updated standards, “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the Hazardous Waste Listing for Nicotine,” aim to reduce the cost and compliance burden for the healthcare sector and ensure the safe management of hazardous waste pharmaceuticals, according to the agency.
Additionally, the changes look to provide regulatory certainty and national consistency on how the Resource Conservation and Recovery Act (RCRA) applies to the reverse distribution of prescription pharmaceuticals. With this rule, EPA is also taking a regulatory approach to the disposal of Food and Drug Administration (FDA)-approved, over-the-counter nicotine replacement therapies (patches, gums and lozenges), which will no longer be considered hazardous waste when discarded.
The first part of the rule, Subpart P, which is bulk of the rule, creates more flexible regulations for the healthcare sector, prohibits sewer disposal of hazardous waste and eliminates some regulations that also fall under FDA.
The second part of the rule is to provide regulatory and national consistency on how RCRA applies to reverse distribution and reverse logistics.
And the third part of the rule is an amendment to Part 261, the amendment of nicotine for P075 hazardous waste listings.
“Even though the rule is out and published, you can’t implement the rule yet,” said Kristin Fitzgerald, an environmental protection specialist with EPA’s Office of Resource Conservation and Recovery in a webcast. “It won’t be effective in authorized states until each state adopts it.”
Currently, nicotine is listed as an acute hazardous waste under P075. This final rule amends the P075 listing for nicotine for FDA-approved, over-the-counter nicotine replacement therapies. That means nicotine gums and lozenges can be discarded as nonhazardous waste after the rule takes effect.
Subpart P of the final rule is effective six months after publication in the Federal Register—also August 2019—but only in nonauthorized states and in U.S. territories.
Subpart P rules are more stringent, and states are required to adopt them. Authorized states will have until July 1, 2021, to adopt Subpart P, unless they have a statutory amendment, then they would have until July 1, 2022.
The following are not subject to the RCRA Subpart P regulation:
• Pharmaceuticals that are not solid waste because they are legitimately used/reused or reclaimed.
• Over-the-counter pharmaceuticals, dietary supplements or homeopathic drugs not solid waste because they have a reasonable expectation of being legitimately used/reused or reclaimed.
• Recalled pharmaceuticals, which do become subject to Subpart P when the decision is made to discard.
• Pharmaceuticals under preservation order or during an investigation or judicial proceeding. (They do become subject to Subpart P when the decision is made to discard.)
• Investigational new drugs, which do become subject to Subpart P when the decision is made to discard.
• Household waste pharmaceuticals.
When it comes to the sewer prohibition of the rule, there are no exceptions and the regulations are even more stringent. The sewer prohibition will be effective in all states six months after published in the Federal Register, regardless of whether the state is authorized or the final rule is adopted in the state. The effective date of the sewer prohibition aspect of the rule is August 2019 for all the states.
According to EPA, hazardous waste pharmaceuticals may not be sewered, meaning no drain disposal or flushing. The sewer prohibition applies to all healthcare facilities and all reverse distributors. Hazardous wastes that are Drug Enforcement Agency-controlled substances are also subject to the sewer prohibition.