FDA Issues DSCSA Exemptions for Covered COVID-19 Products

U.S. Food and Drug Administration sent this bulletin at 05/11/2023 08:00 AM EDT

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FDA | Center for Drug Evaluation and Research | Office of Compliance

FDA Issues DSCSA Exemptions for Covered COVID-19 Products

In an effort to transition after the COVID-19 public health emergency (PHE) expires on May 11, 2023, FDA is announcing exemptions for covered COVID-19 products from certain requirements in the Food, Drug and Cosmetic Act (FD&C Act), as added by the Drug Supply Chain Security Act (DSCSA). The exemptions will assist with avoiding potential supply chain disruptions that could harm the COVID-19 response and recovery.

FDA has determined that these exemptions are appropriate to maintain public health and has determined that these exemptions address covered COVID-19 products outlined in the exemptions (i.e., prescription drug products approved or authorized by FDA to diagnose, cure, mitigate, treat, or prevent COVID-19).

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The Drug Supply Chain Security Act (DSCSA) will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. These requirements will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.