In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm 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 planning to import OTC drugs into the United States, this video is for you.
Importing OTC drugs into the U.S. is more complex than importing most consumer goods. The FDA has authority under the Federal Food, Drug, and Cosmetic Act to refuse admission of any drug product that appears to be in violation of the law — and that includes products that aren’t properly registered, labeled, or manufactured.
First, the foreign facility that manufactures the OTC drug must be registered with the FDA under 21 CFR Part 207. Registration isn’t optional — it’s a requirement before the product can legally be marketed in the U.S.
Second, the drug must comply with FDA drug labeling requirements. For OTC drugs, that means a Drug Facts panel formatted in accordance with 21 CFR 201.66, with all required elements including active ingredients, uses, warnings, directions, and inactive ingredients.
Third, if the product uses an OTC drug monograph, it must conform to the monograph’s specifications for ingredients, concentrations, and labeling. If it doesn’t qualify under a monograph, it needs an approved New Drug Application.
Import alert listings are a real risk — if the FDA places your product or facility on an import alert, your shipments can be detained without physical examination. Avoid this by getting your compliance in order before you import. We can help you navigate the requirements. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.