FDA Relaxes Track and Trace Requirements for COVID-19 Related Products

On April 30, 2020, the Food and Drug Administration (FDA) issued new guidance relaxing certain requirements under the Drug Supply Chain Security Act (DSCSA) for COVID-19 related drug products.  In the guidance, FDA explained that under the DSCSA “specific activities are automatically excluded from certain DSCSA requirements upon the declaration of a public health emergency.”

This is in an effort to facilitate the efficient distribution of prescription drug products needed to respond to COVID-19, including drugs to treat symptoms of COVID-19.  More specifically, FDA indicated that the distribution of a drug for emergency medical reasons is exempted from the definition of a “transaction” and excluded from the definition of “wholesale distribution.”  In other words, certain DSCSA requirements do not apply to covered products during the public health emergency.  The FDA also notes that the new guidance is meant to strike a balance between facilitating “the effective distribution of products under emergency conditions while helping protect consumers from exposure to products that may be counterfeit.”

How Frier Levitt Can Help

Frier Levitt regularly counsels wholesalers, drug distributors and pharmacies on various regulations set forth by federal and state agencies including, but not limited to, DSCSA.  If you want to learn more about the FDA’s new guidance or have general questions concerning regulations in the drug supply chain, contact Frier Levitt today to speak with an attorney.