FDA Issues Guidance Highlighting Flexibility Under the Drug Supply Chain Security Act (DSCSA)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/exemption-and-exclusion-certain-requirements-drug-supply-chain-security-act-during-covid-19-public?utm_campaign=FDA%20issues%20guidance%20highlighting%20flexibility%20under%20the%20DSCSA&utm_medium=email&utm_source=Eloqua

FDA Issues Guidance Highlighting Flexibility Under the Drug Supply Chain Security Act (DSCSA)

Today, the FDA issued a guidance highlighting flexibility under the Drug Supply Chain Security Act (DSCSA) for trading partners responding to the COVID-19 public health emergency. During the COVID-19 public health emergency, DSCSA requirements related to certain product tracing and product identification activities, and wholesale distribution, do not apply to the emergency distribution of prescription drugs issued an emergency use authorization to combat COVID-19 or approved by FDA to diagnose, cure, mitigate, treat or prevent COVID-19.  Currently, there are no products approved by FDA to diagnose, cure, mitigate, treat or prevent COVID-19.  Similarly, the DSCSA requirements described in the guidance do not apply in certain circumstances to products used for emergency medical reasons such as supportive care for COVID-19 patients, where distribution of such products is directly affected by the COVID-19 public health emergency.  This legal flexibility, triggered by emergency medical needs such as addressing the COVID-19 public health emergency, strikes a balance between the need to effectively distribute prescription drugs under emergency conditions and helping protect consumers from exposure to prescription drugs that may be counterfeit, stolen or otherwise harmful.

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