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1 Background: How Compounders Gained—and Lost—Access Federal law under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permits 503A compounding pharmacies and 503B outsourcing facilities to compound copies of FDA-approved drugs when those drugs appear on the agency's shortage list
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Among the proposed measures are: Better management of the European medicines regulatory network’s expert resources Streamlining assessment procedures
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