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MoCRA Regulations and Topical Botanical Product Development

Overview

This course introduces U.S. cosmetic regulation under the Modernization of Cosmetics Regulation Act (MoCRA), focusing on botanical based topical products. Students learn how MoCRA shapes facility registration, product listing, safety substantiation, adverse event reporting, labeling, and good manufacturing practices, while applied labs build hands-on experience with emulsification, preservative strategies, and learn about shelf stability, and microbial testing relevant to topical botanical therapeutic and cosmetic products. Graduates will be prepared to work in MoCRA-compliant manufacturing facilities or to design a small, legally compliant line of topical botanically based products, using sound documentation, safety, and quality practices. Students analyze how regulations inform research design, product development, and market access for botanical therapeutic and cosmetic products.

Learning Outcomes

  • Analyze the regulatory framework established by MoCRA in order to determine the federal requirements governing botanical-based topical and cosmetic products.

  • Apply MoCRA requirements for facility registration, product listing, and good manufacturing practices in order to operate within a compliant manufacturing environment.

  • Evaluate safety substantiation, adverse event reporting, and labeling requirements in order to ensure botanical-based topical products meet MoCRA standards.

  • Plan formulation and quality-control techniques in order to develop stable, safe topical botanical therapeutic and cosmetic products.

  • Develop documentation, safety, and quality practices in order to support compliant product development and market access.

  • Analyze how regulatory requirements inform research design, product development, and market access in order to plan legally compliant lines of botanical-based topical products.

Prerequisites

More details

Required Course Pack:

  • Online Materials and Library Resources (OMLR)

Required Textbooks:

View the required textbooks for this class, including ISBN, edition, and retail price, by visiting our Required Textbooks page.

Total Course Price:

View the total course price including tuition, fees, course materials, and shipping online here.

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