The FDA has amended its Risk Evaluation and Mitigation Strategy for opioid analgesics to require manufacturers to provide prepaid mail-back envelopes to outpatient pharmacies and other dispensers. This change aims to facilitate the return of unused opioids and educate patients on safe disposal methods. In addition to the envelopes, manufacturers must update the drug’s Patient Guide to include information on the risks of unused opioids and provide an education sheet for patients. The compliance date for providing mail-back envelopes is March 31, 2025. The FDA is also exploring other innovative methods for in-home drug disposal to increase the safe disposal of unused opioids.
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FDA requires manufacturers facilitate return of unused opioids
