The FDA issued a guidance highlighting flexibility under the Drug Supply Chain Security Act (DSCSA). It is intended to facilitate the distribution of prescription drug products needed to respond to COVID-19, including drugs to treat symptoms of the condition. During the COVID-19 emergency, the DSCSA requirements that relate to certain product tracing and product identification activities, and wholesale distribution, do not apply to qualifying distribution activities. This flexibility, the agency notes, “balances the need for effective distribution of products under emergency conditions with protecting consumers from exposure to products that may be counterfeit, stolen or otherwise harmful.”

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