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# FDA Addressing TIRF REMS Recertification Concerns
- URL: https://www.fdaweb.com/fda-addressing-tirf-rems-recertification-concerns/
- Published: 2021-04-29T12:00:00.000Z
- Updated: 2026-09-14T16:56:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149223

FDA says it is aware that some prescribers and pharmacies have had difficulties recertifying in the modified Transmucosal Immediate-release Fentanyl (TIRF) risk evaluation and mitigation strategies (REMS) that was fully implemented 3/29\. “FDA is working with manufacturers of TIRF medicines to address these concerns,” an agency [notice](https://content.govdelivery.com/accounts/USFDA/bulletins/2d1af27?ref=fdaweb.com) says. “For example, manufacturers of TIRF medicines have added additional staff and hours to the TIRF REMS Call Center to better address and resolve issues.”

The notice says that due to changes in the requirements, providers who were previously certified in the REMS to prescribe TIRF medicines for outpatient use, and pharmacies that were previously certified to dispense TIRF medicine, are required to complete new training, complete the knowledge assessment, and re-certify into the modified REMS.

Because some providers and pharmacies have experienced difficulty recertifying, FDA says, some patients have had difficulties filling their prescriptions.