What are the regulations regarding the manufacture of pharmaceuticals?
In Florida, pharmaceuticals must be manufactured in accordance with the regulations set out in the Florida Statutes. These regulations are designed to ensure the safety and quality of pharmaceuticals meant for public sale and consumption. Manufacturers of pharmaceuticals must obtain an annual license from the Florida Department of Health. This license must be renewed each year, and manufacturers must provide evidence of good manufacturing practices and meet other requirements. Manufacturers of pharmaceuticals must also establish and maintain a quality control system. This system must include standard operating procedures and records that demonstrate that the products meet the desired specifications. In addition to these requirements, pharmaceutical manufacturers must ensure that their products are free from contamination or adulteration. They must properly package their products and label them in accordance with federal, state, and local law. The labels must include ingredients, warnings, and directions. Finally, pharmaceutical manufacturers must keep records of all production operations. These records must include raw materials, production methods, finished products, and all test results. These records must be kept for a period of three years and must be made available to the Department of Health.
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