Tag: What are tier 1
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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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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 OTC Drug Registration: Complete Guide for Over-the-Counter Drug Compliance
Over-the-counter (OTC) drugs are widely sold in the United States without a prescription, but they are still subject to strict regulatory control. Any company manufacturing, processing, packing, or labeling OTC drug products for the US market must comply with FDA OTC drug registration and listing requirements enforced by the U.S. Food and Drug Administration (FDA).…
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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…