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# High Absenteeism Planning Guidance
- URL: https://www.fdaweb.com/high-absenteeism-planning-guidance/
- Published: 2019-01-30T12:00:00.000Z
- Updated: 2026-09-15T00:58:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143257

FDA has issued a guidance, *Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products*, to encourage manufacturers of medically necessary drug products and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production facilities. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM196497.pdf?ref=fdaweb.com) “provides considerations for the development and implementation of a plan for production of medically necessary products during a crisis, including specific elements that should be included in the plan.” It also discusses CDER’s intended approach to helping to avoid drug product shortages that could have a negative impact on the national public health during such emergencies.

The guidance is intended for manufacturers of drug and therapeutic biological products regulated by CDER and manufacturers of raw materials and components used in those products. FDA says it strongly recommends that drug product manufacturers show the guidance to all suppliers and contractors associated with the manufacture of medically necessary products and discuss the guidance with them to stimulate planning to avoid or mitigate disruptions in supply.