In this short video, FDA compliance attorney Lisa Capote covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa Capote, an FDA compliance attorney. If you’re an OTC drug manufacturer or distributor, adverse event reporting is a compliance obligation you cannot ignore.
Under the Federal Food, Drug, and Cosmetic Act and FDA regulations, manufacturers, packers, and distributors of OTC drugs must report serious adverse drug experiences to the FDA. This requirement applies to marketed drugs whether or not they’re approved through an NDA — including drugs marketed under OTC monographs.
A serious adverse event for a drug includes any experience that results in death, a life-threatening situation, inpatient hospitalization, significant disability or incapacity, congenital anomaly, or requires intervention to prevent permanent impairment.
For prescription drugs, there are well-established 15-day expedited reporting requirements and periodic safety reporting. For OTC drugs, the Dietary Supplement and Nonprescription Drug Consumer Protection Act established mandatory reporting of serious adverse events within 15 business days of receiving a report.
You must also maintain records of all adverse events — not just serious ones — for at least six years. These records are subject to FDA inspection.
Building a proper adverse event intake, documentation, and reporting system is a fundamental compliance requirement. If you don’t have one, now is the time to establish it. We can help you build or audit your adverse event reporting program. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.