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Pharmaceuticals / Regulatory Affairs

FDA Seeks Comments on Blister Packs for Immediate-Release Opioids

June 7, 2019

The FDA called for comments on a potential change to the agency’s Risk Evaluation and Mitigation Strategy (REMS) for opioid pain meds to require blister packaging for certain immediate-release products.

FDA Acting Commissioner Ned Sharpless said the agency “must focus on encouraging ‘right size’ prescribing” while ensuring access for patients.

The proposed initiative would implement provisions in the SUPPORT for Patients and Communities Act of 2018 to require five, ten or 15-count blister packs of certain commonly-prescribed IR opioids. The agency is specifically seeking input on the potential public health impact of blister packages, suggested drug candidates and quantities, and any potential challenges.

Having the blister packs available might make prescribers think twice before doling out opioids—but they would still retain the ability to write prescriptions in patient-specific quantities, Sharpless said.

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