In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm covers how OTC drug brands can navigate FDA regulatory changes and maintain compliance. Watch below, then read the full transcript.
Full Transcript
The regulatory landscape for over-the-counter drugs is not static. FDA regularly updates OTC monographs, issues new guidance documents, and revises labeling requirements — and brands that don’t actively monitor these changes can find themselves out of compliance without realizing it. Under the CARES Act, FDA’s OTC Monograph system was modernized in 2020, giving FDA more authority to update monographs through an administrative order process that moves faster than the old rule-making system.
For OTC brands, this means your formula or labeling that was compliant last year may require updates today. Active ingredient concentrations, permitted indications, labeling format, and Drug Facts panel requirements can all change. If your product falls under a monograph category that has been updated, you need to review your current labels and formulations against the new requirements and understand any applicable compliance deadlines.
Proactive compliance is far less expensive than reactive enforcement defense. Brands that monitor FDA guidance, engage qualified regulatory counsel, and build change-control processes into their operations are far better positioned to adapt quickly when the rules shift. Don’t wait for an FDA observation or warning letter to discover that your product is no longer compliant.
👉 Contact Capote Law Firm today for expert OTC drug regulatory compliance guidance.