7 Legal Keys to Getting Your OTC Drug to Market

So you have an OTC drug and you want to get to market but don’t know how. If you’re in the OTC drug market, you’re probably fairly sophisticated.  You probably already know that your product is not: A cosmetic A dietary supplement A medical food An Rx drug or homeopathic drug You have an OTC drug because your product claims to prevent, treat, mitigate, or cure a disease, plain and simple, and the active ingredient and the labeling conforms to an OTC monograph. This is a good start.  Here are 3 other key things you need to know to get your OTC product to market. Key # 1: Understand the FDA Regulatory Basics of the OTC Drug Pathway An OTC drug is generally recognized as safe and effective and is not misbranded if it meets each of the conditions contained 21 CFR Part 330 (Over-The-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded) and each of the conditions contained in any applicable monograph. 21 CFR…

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