FDA seeks public feedback for in-home opioid disposal units
The US Food and Drug Administration (FDA) is asking for public feedback on potential new standards for in-home opioid disposal products as part of its efforts to fight the ongoing opioid crisis. The agency noted that it is required to provide public guidance on safe in-home disposal of opioids under a law passed last year.Currently, opioid analgesics manufacturers provide prepaid mail-back envelopes to outpatient pharmacies and other dispensers that patients can use to send their unused pills back and prevent them from getting into the hands of people who may abuse the drugs. However, FDA said it is considering a change to require makers of opioids used in outpatient or in-home settings to provide safe disposal systems under a risk evaluation and mitigation strategy (REMS).
In a 5 March request for information (RFI), FDA said it wants feedback from manufacturers, health care providers, and other interested parties on the developing standards for in-home disposal kits. The agency also noted that the initiative is part of its mandate under the 2025 SUPPORT for Patients and Communities Reauthorization Act, which requires it to issue guidance on in-home safe opioid disposal.
Last year, FDA revised the existing Opioid Analgesic REMS to enable outpatient pharmacies and dispensers to order free prepaid envelopes from opioid makers to make it easier for patients to return unused opioids.
Now, the agency said it is conducting an analysis on whether it should require opioid makers to provide in-home disposal systems to outpatient pharmacies and dispensers as another option for safe opioid disposal. The effort builds on several years of information gathering, beginning in 2021, when the agency asked the makers of nine commercially available in-home disposal systems, and which continued in 2023, when the agency issued request for comment on in-home disposal systems and convened a panel of experts to discuss such systems. FDA also said it reviewed real-world use experiences with opioid disposal systems but noted that neither it nor any other federal agencies regulate such systems.
"At present, FDA recommends dropping off unused opioids at a drug take-back location or mailing them back using a pre-paid envelope provided by a pharmacy," said FDA. "Alternatively, the FDA recommends flushing unused opioids down the toilet (something the agency only recommends for certain high-risk medications).”
Anticipating concerns about flushing the pills down the toilet, FDA noted that a 2017 study found that the practice presented a “negligible eco-toxicological risk.” However, the agency is considering whether it should instead require the dispensers to provide in-home opioid disposal systems that patients can use to safely get rid of the pills.
“Having unused opioids laying around at home can be a significant risk to those struggling with opioids and can be a gateway for opioid-naïve family members,” said FDA Commissioner Marty Makary, in an agency statement. “We need to develop creative ways to address opioid misuse and abuse.”
Stakeholders can comment on the request for information on www.regulations.gov until 6 April under docket no.FDA-2026-N-1001.
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