OTC Drug Regulations

This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.

Why Should You Attend:

This webinar will discuss U.S. FDA and Consumer Product Safety Commission regulation of OTC drug products and strategic recommendations for mitigating the risk of enforcement action in the future. Attendees will gain an understanding of various available options for producing and selling an OTC drug product.

FDA and CPSC requirements for OTC drugs will be covered. There will also be some discussion of the market differences between Rx and OTC products.

Learning Objectives:

• Gain a comprehensive understanding of how OTC drug products are regulated in the U.S.
• Learn to distinguish between a potential Rx pharmaceutical product and an OTC drug.
• Recognize the difference between the various pathways for commercializing an OTC drug product.
• Understand how to identify and successfully navigate an OTC Drug Monograph.
• Recognize when reliance on a Proposed Rule, Final Rule and/or Drug Monograph is appropriate.
• Understand how to determine whether an Ingredient is considered Safe or GRAS/E for use in an OTC drug and understand the difference between Category I, II and II Ingredient designations.
• Identify the required elements of a compliant OTC Drug Label.
• Take away strategies for marketing and promoting OTC drug products, and for mitigating potential enforcement risks.
• Possess a working knowledge of the Rx-to-OTC Switch Process.
• Review and evaluate several of FDA’s current OTC Monographs

Areas Covered in the Webinar:

• Claims for drugs, devices, medical foods and cosmetics
• NDA, ANDA and OTC Monographs for OTC Drugs
• Rx to OTC Switches
• cGMPs for OTC drugs
• Tamper Evidence and Poison Control
• Branded Innovator, Branded Generic and Generics

Who Will Benefit:

• Regulatory affairs managers, directors and associates
• Compliance specialists
• Marketing managers
• Quality professionals
• Document control specialists
• Record retention specialists

Instructor Profile:

Loren Gelber
Regulatory Compliance Consultant (Ex-FDA Official)

Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has been involved in numerous launches of OTC drugs and in Rx to OTC switches. Her specialty is compliance with US regulatory compliance. She has a BA in Biology, an MS in Chemistry and a Ph.D. in Medicinal Chemistry.

Topic Background:

The Food and Drug Administration and the Consumer Product Safety Commission have regulations pertaining to OTC drugs. The U.S. Food and Drug Administration’s (“FDA”) is responsible for the regulation and oversight of the U.S. OTC drug market. Congress has granted FDA regulatory authority over the formulation, manufacturing, labeling, marketing and promotion; and import / export of OTC drug products into the U.S. Under this current regulatory regime, there are 4 pathways that a company may follow to enter the OTC drug market including (a) following an appropriate Drug Monograph; (b) with an Agency approved New Drug Application (“NDA”); (c) via the currently popular Rx-to-OTC Switch Process or (d) via an ANDA citing a previously-approved product.