OTC drug approvals and compliance should be simple, right? After all, we are talking about over-the-counter drugs, nothing more complex than that. But in fact, there are a few key factors of which manufacturers and distributors should be aware when it comes to OTC drug approval and compliance by the US Food and Drug Administration (FDA):
1. OTC Drugs Are Not Always What You Might Think.
OTC drugs including products that we usually don’t even think of as drugs. Of course anti-acne products containing benzoil peroxide are OTC drugs, as are aspirin and acetaminophen, ibuprofen, etc. But there are some products that are also OTC drugs that no one would think are regulated by the FDA as drugs at all: These include antiperspirants that are often sold as deodorants as well, sunscreens, and toothpaste, as well as mouthwash. Companies could be refused access for products to the US market unless they comply with FDA regulations regarding OTC drugs for these products as well.
2. You Need Proper Labeling.
The FDA is very strict about what OTC drug labeling should contain. Any deviation could bring an enforcement action and even a recall of the products from the shelves. Common mistakes made involve format of labels (simple issues but issues that are easily missed), product claims that are not approved for OTC drugs by the FDA, and lack of correct ingredient content descriptions (in terms of correct units to be used under the Food and Drug Administration rules for weight and volume, for example). Proper regulatory and legal compliance counseling is essential for labels.