Tag: 2
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Cosmetic Adverse Events: US FDA Requirements, MoCRA Rules, and Compliance Obligations
Cosmetic safety does not end once a product reaches the market. Under United States law, cosmetic companies are legally responsible for monitoring, documenting, and reporting cosmetic adverse events. With the enactment of the Modernization of Cosmetics Regulation Act (MoCRA), adverse event reporting has become a mandatory and enforceable requirement under the authority of the US…
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Cosmetic Labeling Requirements Under US FDA: Compliance Framework for Cosmetic Brands
Cosmetic labeling is not just a marketing activity—it is a legal obligation under United States law. Every cosmetic product sold in the US must carry labeling that is truthful, not misleading, and compliant with regulations enforced by the US FDA. With the implementation of the Modernization of Cosmetics Regulation Act (MoCRA), labeling compliance has become…
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Serious Adverse Event Reporting for Cosmetics: US FDA MoCRA Compliance Explained
The Modernization of Cosmetics Regulation Act (MoCRA) has significantly strengthened post-market safety oversight for cosmetic products in the United States. One of the most critical obligations introduced under MoCRA is mandatory serious adverse event reporting to the US FDA. Cosmetic companies are now legally required to report serious adverse events associated with their products within…
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Modernization of Cosmetics Regulation Act of 2022 (MoCRA): Comprehensive Compliance Guide for Cosmetic Brands
In December 2022, the United States enacted a landmark law that fundamentally reshaped cosmetic regulation—the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This legislation represents the most significant update to cosmetic law in over 80 years and dramatically expanded US FDA authority over cosmetic products marketed in the United States. Before MoCRA, cosmetic regulation…
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US FDA/USP Substance Registration System (SRS): Complete Guide
The FDA/USP Substance Registration System (SRS) is a critical regulatory framework used in the United States to uniquely identify and standardize information about substances found in FDA-regulated products. Whether you manufacture pharmaceuticals, biologics, excipients, or combination products, understanding SRS is essential for compliant submissions and smooth regulatory interactions. What Is the FDA/USP Substance Registration System…
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US FDA NDC Code: Complete Guide for Drug Identification and Compliance
The US FDA NDC code plays a critical role in how drugs are identified, listed, distributed, and monitored in the United States. Whether you are a pharmaceutical manufacturer, distributor, importer, or regulatory professional, understanding the National Drug Code (NDC) system is essential for staying compliant with US FDA requirements and avoiding costly regulatory issues. This…