Congress then introduced two bills, both enacted on July 1, 1902. One bill established the Public Health and Marine Hospital Service, the other authorized this new service to regulate the sale and transportation of any virus, therapeutic serum, toxin, or analogous product in interstate commerce or from a foreign country. All establishments engaged in the sale, barter, or exchange, or offering for sale, barter, or exchange of biological products in interstate commerce must be licensed, and each product must be licensed individually. Each licensee must be inspected annually by agents and officers of the Federal government. The second act is known as the Biologics Control Act or the Virus-Toxin Act. This act has been amended by Congress several times to incorporate additional product classes, including blood, blood components, and blood derivatives. Today the regulated biologics include vaccines, blood and blood products, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.
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An image of the 1902 Biologics Control Act or the Virus Toxin Act.
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The Division of Biologics Standards [Public Health Service Publication No. 1744] by Dr. Roderick Murray published in 1968.