FDA Eases Supply Chain Requirements During Pandemic

To keep prescription drugs moving smoothly through the supply chain during the pandemic, the FDA released emergency final guidance yesterday exempting certain COVID-19 products from tracing and identification requirements.

Companies distributing drugs with Emergency Use Authorizations (EUAs) or approvals to diagnose, treat, cure, mitigate or prevent COVID-19, or firms engaging in distribution activities directly affected by the pandemic do not have to comply with the FDA’s product tracing and identification requirements, the agency said.

For example, companies distributing a drug product to an area that is seeing limited availability and high demand for a medicine due to the pandemic are exempt from the regulations, as are companies that need to establish a new, temporary facility for distribution because of the pandemic.

Read the guidance here: www.fdanews.com/04-30-20-ExemptionExclusion.pdf. — James Miessler