In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm breaks down navigating fda compliance for otc drugs: a beginner’s guide. Watch the video below, then read the full transcript.
Video Transcript
Hey there. If you’re a manufacturer or brand owner in the OTC drug space, welcome. I’m Lisa, an FDA compliance lawyer, and I’m here to make FDA rules a little less intimidating. Let’s start with the basics. The FDA regulates over-the-counter drugs to make sure they’re safe, effective, and properly labeled. That means your product has to follow specific rules, even if it’s not prescription. Most OTC drugs follow something called a monograph — think of it like a recipe book. It tells you what ingredients you can use, how much, and what you need to say on the label. If you stick to the monograph, you don’t need FDA pre-approval. But you do need to register your facility and list your products. Compliance isn’t just about avoiding fines. It builds trust with your customers and keeps your business running smoothly. And if you ever feel stuck, that’s what we’re here for. Stick around for more quick tips on FDA compliance, and if you’ve got questions, reach out. See you in the next video.
Have questions about FDA compliance? Contact Capote Law Firm or call (786) 207-1174 to speak with an FDA compliance attorney.