How many days before operating must a drug establishment be registered with the FDA?

How many days before operating must a drug establishment be registered with the FDA?

• A. 7 Days
• B. 30 Days
• C. 60 Days
• D. 5 Days

Answer: (D)

Facilities must be registered with the FDA before they begin manufacturing, processing, packing, or holding drug products. The typical lead time given is five days prior to starting operations, which allows FDA to process the registration and assign an establishment number. This short window is the standard expectation, ensuring the facility is on FDA’s radar before any drug activities occur. Starting operations without registering can put products at risk of being considered unregistered and subject to regulatory action.

Facilities must be registered with the FDA before they begin manufacturing, processing, packing, or holding drug products. The typical lead time given is five days prior to starting operations, which allows FDA to process the registration and assign an establishment number. This short window is the standard expectation, ensuring the facility is on FDA’s radar before any drug activities occur. Starting operations without registering can put products at risk of being considered unregistered and subject to regulatory action.