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# Drug Shortage Risk Management Guidance
- URL: https://www.fdaweb.com/drug-shortage-risk-management-guidance/
- Published: 2022-05-19T12:00:00.000Z
- Updated: 2026-09-14T17:45:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151850

FDA has published a draft guidance, *Risk Management Plans to Mitigate the Potential for Drug Shortages*, to help stakeholders develop, maintain, and implement risk management plans (RMPs) to proactively assist in preventing human drug product and biological product shortages. The [document](https://www.fda.gov/media/158487/download?ref=fdaweb.com) says RMPs can provide stakeholders with a framework to proactively identify, prioritize, and implement strategies to mitigate hazards that can cause a supply disruption.

“Such a supply disruption may lead to a drug shortage,” the guidance says. “Effective quality risk management can facilitate better, more informed decisions; can provide FDA with greater assurance that stakeholders understand and can manage the associated risks, and can potentially affect the extent and level of direct regulatory oversight.”