What is the legal framework governing the manufacture of drugs?
The legal framework governing the manufacture of drugs in Nebraska is set by the Nebraska Statutes Chapter 71. The regulations outline the requirements and licensing process for drug manufacturers. Manufacturers are required to be registered with the Nebraska Department of Health and Human Services, submit a certificate of inspection, and obtain a license to manufacture and distribute drugs in the state. Additionally, manufacturers must comply with Good Manufacturing Practice (GMP) rules determined by the US Food and Drug Administration (FDA). GMP regulations ensure that all manufactured products meet certain standards of safety and quality. Manufacturers must maintain adequate records, document processes, and have qualified personnel to ensure that the products they produce meet these standards. The Nebraska Department of Health and Human Services also acts as an enforcement body when GMP and other regulations are not followed. They are responsible for inspecting facilities and ensuring that manufacturers, suppliers and distributors are in compliance with laws and regulations that protect public health. Overall, the legal framework governing the manufacture and distribution of drugs in Nebraska is designed to protect public health and safety from unsafe or low-quality products. It is important for manufacturers to understand and follow the regulations to ensure that they are in compliance with the law.
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