The Food and Drug Administration April 3 announced that it will require manufacturers of opioid analgesics used in outpatient settings to modify their Risk Evaluation and Mitigation Strategy within 180 days to make prepaid mail-back envelopes and educational materials on safe opioid disposal available to outpatient pharmacies and other dispensers. The agency anticipates approving the modified REMS in 2024. Once implemented, outpatient pharmacies and other dispensers would have the option to order the prepaid mail-back envelopes and educational materials from manufacturers to provide to patients, FDA said.
The FDA also seeks comments through Aug. 28 on whether requiring opioid analgesic manufacturers to make in-home disposal products available to patients under a REMS would reduce the risk of nonmedical use or overdose.
The Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 authorized the FDA to require certain packaging and disposal measures to mitigate the risk of abuse or misuse of a drug.