An Introduction to FDA’s Regulation of Over-the-Counter (OTC) Drug Products

Why Should You Attend:

All OTC drugs are regulated by the U.S. Food and Drug Administration’s (“FDA”) and can enter the market in one of the following ways: (a) by complying with an applicable monograph; (b) as the subject of an FDA approved New Drug Application; or (c) via an FDA approved Rx-to-OTC Switch.

Most of the OTC drugs available today are marketed and sold as OTC monograph drug products. Although still a very, very small percentage of the total number of OTC drug products on the market, the Rx-to-OTC Switch regulatory pathway is becoming increasingly popular for placing OTC drugs on the shelves as companies look for ways to extend the life cycle of their branded prescription products.

Learning Objectives:

• Gain a basic understanding of FDA's regulation of OTC Drug Products.
• Learn to distinguish between the various regulatory pathways for bringing an OTC drug to market.
• Understand how to use an OTC monograph and the various categories of drugs covered by them.
• Have a working knowledge of the Rx-to-OTC Switch option for bringing an OTC drug to market.
• Be able to identify the primary required elements of an OTC drug label.
• Recognize potential marketing and promotional risks.

Areas Covered in the Seminar:

• FDA's regulation of over-the-counter drug products or OTC drugs.
• Bringing an OTC drug to market under an OTC monograph.
• Where to find FDA's list of existing monographs and identification of the various product categories covered by monographs.
• An introduction to FDA's Rx-to-OTC Switch procedures and the benefits / challenges of pursuing such an option.
• Labeling an OTC drug product.
• Potential FDA enforcement risks.