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Which FDCA ammendment established GMP?

User Plexcell
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Final answer:

The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938, not the FDAAA of 2007, established the Good Manufacturing Practice (GMP) regulations to ensure product quality and safety.

Step-by-step explanation:

The amendment that established Good Manufacturing Practice (GMP) regulations was not the Food and Drug Administration Amendments Act (FDAAA) of 2007, but rather it was part of the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938.

The FD&C Act was enacted to address the shortcomings of the Pure Food and Drug Act of 1906 and established comprehensive regulations over food, drugs, and cosmetics, including GMP requirements. The GMP regulations are designed to ensure that products are consistently produced and controlled according to quality standards.

GMP stands for Good Manufacturing Practices. The FDCA amendment that established GMP is the Food and Drug Administration Amendments Act (FDAAA) of 2007. This amendment is a set of regulations that outline the requirements for the manufacturing, testing, and quality control of pharmaceutical products. GMP ensures that drugs are consistently produced and controlled to meet quality standards.

User Lukas Bystricky
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