Best Practices in choosing a Regulatory Pathway for your Over-the-Counter (OTC) Drug Product

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Over-the-counter (OTC) drug products are sold directly to consumers without the need of a prescription from a healthcare provider. In the US, these products are regulated by the Food and Drug Administration (FDA). Because of the large number of marketed OTC drug products, FDA reviews the active ingredients and labeling of over 80 therapeutic classes of drugs (e.g., analgesics) instead of individual drug products. This webinar will provide clarification on determining a regulatory pathway to bring your OTC drug product to market.

OTC drug products are vital to the health care of America. Regulatory pathways for OTC products include utilizing the monograph system or gaining approval through the FDA New Drug Application (NDA) process. The Division of Nonprescription Regulation Development (DNRD) in the Office of Drug Evaluation is responsible for the development of OTC drug monographs. Data presented to support the safety and efficacy of different active ingredients in a particular drug monograph is reviewed by the appropriate scientific personnel. Although DNRD is considered to be the lead division in the development of an OTC drug monograph, reviewers (e.g., medical officers, statisticians, pharmacologists) from multiple divisions within the Office of New Drugs (OND) are involved. It is important to note that if a drug cannot comply with the drug monograph, an approved NDA is necessary before the drug product may be marketed.

Sponsors seeking to market its product OTC, either as a new NDA or a switch from a prescription product, must apply to the Division of Nonprescription Clinical Evaluation (DNCE) in the Office of Drug Evaluation. After the sponsor submits an NDA, DNCE reviews the consumer studies, the post marketing safety data, the OTC labeling, and any regulatory issues. Additional input is obtained from other disciplines outside of DNCE, including, clinical pharmacology, statistics, and chemistry.

Navigating these OTC regulatory routes can be formidable. It is imperative to have a clear understanding of the regulations involved to determine the best pathway for your OTC product. Upon completion of this session, you will have a better understanding of how OTC drug products are regulated by FDA and will know the regulatory pathways (monograph and NDA), labeling and marketing requirements, and potential enforcement risks

Areas to be Covered:

Overview of FDA OTC drug product regulation
Utilizing the OTC monograph system as a regulatory pathway
Following the NDA route as a regulatory pathway
Direct to OTC
Rx-to-OTC Switch
Monograph Deviation
OTC labeling and marketing considerations
Potential FDA enforcement risks

Who will Benefit:

Regulatory Affairs professionals
Project Managers
QA & QC Managers
OTC drug manufacturers
Any individuals interested in the OTC drug industry

Camille Davis Thornton

Camille Davis Thornton, M.S., RAC is the founder of MACE Concepts, LLC, an independent consultancy specializing in providing innovative regulatory, compliance, and training solutions. Ms. Thornton has an M.S. in Biotechnology from The Johns Hopkins University and certifications from the Regulatory Affairs Professionals Society (RAC-US) and the National Restaurant Association (ServSafe® Food Protection Manager, Instructor, and registered Examination Proctor). Additionally, she has over 15 years of experience in multiple regulated industries and actively teaches at the college level.

Ms. Thornton’s areas of expertise include regulatory filings, the FDA Electronic Submissions Gateway (ESG), and liaising with government agencies. Also known as the “Perpetual Inquisitive Geek”, she regularly reviews applicable guidance documents, notifications, newsletters, blog postings, and email alerts from various government agencies to stay up-to-date with current requirements and industry trends. Ms. Thornton is a regulatory affairs professional and trainer with a true passion for sharing knowledge effectively.

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