Life Sciences Blog

Over-the-Counter Drug Product Monographs: FDA Requirements for Oral Pharma Products

by | Jul 26, 2021


We recently hosted the fourth in a series of OTC-focused webinars featuring Reed Tech subject-matter experts and some of our industry friends and colleagues. For more fundamental information on OTC drug monographs, read the blog or view the webinar from the first event in the Reed Tech OTC series. 


This presentation featured speakers Julia Frasch of Reed Tech and Shelly Garg and Javier Gonzalez Rivera of Amin Talati Wasserman LLP. The speakers provided help for companies producing or distributing over-the-counter oral pharmaceutical products. Examples included internal analgesics (i.e. ibuprofen), oral healthcare products, cold, cough and allergy products and others. View the presentation to understand what is required for these products to become and stay compliant with the FDA.

What are Over-the-Counter Drugs? OTC drugs are intended for the diagnosis, cure, mitigation, treatment or prevention of disease. Additionally, they must be safe and effective for use by the general public without seeking treatment from a medical professional. They are required to be formulated and labeled according to an applicable monograph. These monographs are regulated by the CARES Act. These OTC drugs are also regulated by the Code of Federal Regulations (Title 21). The claims are also under advertising claims regulations.

Key Learning

The main focus of the webinar was over-the-counter oral drugs. Some examples of these products include teeth whiteners, oral anesthetics and cough suppressants. Common advertising claims for these products include “clinically proven”, “natural” and “extra strength”.

As a result, FDA holds the companies that manufacture and distribute these drug products to very high labeling claim standards. Claims must be truthful and not misleading, scientifically valid and reproduce-able. They must be supported by substantial evidence.

For more information, view the full OTC oral focused webinar.

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