FDA requires manufacturers facilitate return of unused opioids

FDA has amended its Risk Evaluation and Mitigation Strategy to require that opioid manufacturers provide pharmacies and dispensaries with materials to facilitate the return of unused opioid analgesics, according to a press release.

Approved changes to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) now require that opioid manufacturers provide prepaid mail-back envelopes to outpatient pharmacies and other dispensers of opioid analgesics. The FDA said the goal of the change is to provide patients and caregivers with free method to return unused or leftover opioids provided by the outlet that dispensed the medication.

Additional OA REMS modifications will also require manufacturers update the drug’s Patient Guide to include guidance about the risk of unused opioids and safe disposal of unused doses. It will also require a new education sheet for patients be provided with prepaid mail-back envelopes that explains the risks associated with unused opioids and the value of safe disposal.

“We want to ensure patients have access to opioid analgesics in their pain management regimens and that they are educated about methods available to safely dispose of any leftover medicines, which could pose a real danger to their loved ones and pets,” Marta Sokolowska, PhD, deputy center director for substance use and behavioral health at the FDA’s Center for Drug Evaluation and Research, said in the release. “That is why we approved this modification and are continuing to explore other innovative in-home drug disposal methods to increase safe disposal of unused [opioid analgesic]s.”

The FDA has set a compliance date of March 31, 2025, for opioid manufacturers to start providing mail-back envelopes to requesting providers, according to the release.