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UNOFFICIAL COPY22 RS BR 3431AN ACT relating to public health and declaring an emergency.2WHEREAS, in September 2000, the Food and Drug Administration (FDA×3approved the distribution and use of (brand
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Biological products are regulated under the Public Health Service Act.
Manufacturers and distributors of biological products are required to file.
The filing process involves submitting information on the product, manufacturing process, and safety data.
The purpose is to ensure the safety, efficacy, purity, and potency of biological products.
Information such as product description, manufacturing process, and safety data must be reported.
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