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U.S. Department of Health and Human Services

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U.S. - Canada Regulatory Cooperation Council (RCC) Over-the-Counter (OTC) Products Monograph Alignment Working Group

FDA and Health Canada’s RCC OTC monograph working group was established as a result of the U.S.- Canada Joint Action Plan on Regulatory Cooperation released by President Obama and Prime Minister Harper on December 7, 2011. (http://trade.gov/RCC/

The objectives of the RCC OTC monograph alignment working group are to conduct a pilot program to develop aligned monograph elements for a selected over-the-counter (OTC) drug category (e.g. aligned directions, warnings, indications and conditions of use) and subsequently, develop recommendations to determine the feasibility of an ongoing mechanism for alignment in review and adoption of these OTC drug monograph elements. 

As part of this collaboration under the U.S.-Canada RCC, FDA will be proposing a rule to add the common cold indication to certain over-the-counter (OTC) antihistamine active ingredients. 

For more detailed information on the RCC initiative please reference the following links:


Return to Over-the-Counter (OTC) Related Federal Register Notices, Ingredient References, and other Regulatory Information