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When the Division of Biologics Standards (DBS) was established in 1955, this centralized the biologics regulatory function at the National Institutes of Health (NIH) was centralized into one division rather than spread across multiple laboratories and institutes. However; however, for the first five years, the staff was still spread amongst multiple buildings on the NIH campus. In 1960, Building 29 was completed, and the staff was consolidated into one space. During the early 1960s, the laboratories and the sections within them were still being finalized and organized based on the growing needs and demands of vaccine production and other biologics regulations. By 1968, the DBS had the below seven laboratories.

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Mycoplasma

By the early 1980s, the FDA Bureau of Biologics had a laboratory on mycoplasma, but scientists had been investigating mycoplasmas since before the DBS moved into Building 29 in 1960. Mycoplasmas are single-celled bacteria lacking a cell wall and are able to penetrate other cells; they constituted a challenging source of contamination of cell cultures. A DBS regulation in 1960 required manufacturers to test for mycoplasmas in human viral products that relied on cell cultures.  As As mycoplasma tests advanced over the years, the testing rules changed accordingly. With the emergence of hybridoma technology to generate biological products (in which a target antigen is injected into a mouse, a resulting antibody-producing cell is harvested from the spleen, and the splenic cell fused with a tumor cell to produce the desired antibody), mycoplasmas found their way into the new products from this technology, such as monoclonal antibodies. The Bureau of Biologics’ rulemaking and research interests by the 1980s thus had shifted to controlling mycoplasma contamination of the products developed from this newer approach to biologics production.

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In addition to these moves in the regulation of blood, the Bureau quickly proposed revisions to the licensing standards for blood plasma, the source for various products including gamma globulins, antihemophilic factor, and serum albumin. Also, as mentioned earlier, previously only about 500 interstate blood banks were regulated by the federal government; the 6000-7000 intrastate blood banks operated with little to no oversight. The Bureau invoked authorities under the 1938 Food, Drug, and Cosmetic Act to apply to all blood collection and processing centers. Blood banks and other blood collection facilities now had to be registered and inspected. Plasmapheresis centers (sites where blood is collected, the plasma is separated from the red blood cells, the latter are returned to the patient, and the plasma either treated and returned or repurposed) had to be licensed and inspected. Nearly 6000 establishments were registered in the first 15 months, and Bureau and Bureau-trained field office personnel inspected about 1000. The Bureau trained FDA field investigators such that the latter were able to take over the inspection responsibilities of the nearly 250 plasmapheresis facilities by 1977. Two years earlier, FDA for the first time revoked a biologics establishment license for cause, a recidivist plasmapheresis firm. In 1977, FDA pursued its first criminal prosecution of a plasmapheresis firm. In this case, the corporation was charged with providing false documents to FDA, intentional and non-intentional violations of the Food, Drug, and Cosmetic Act by adulterating and misbranding plasma, and violation of the Public Health Service Act by misbranding a biological product. A jury found the three charged officers of the firm guilty. Each was sentenced to 18-24 months in prison and their company fined $27,000. The plasmapheresis center and its ancillary facilities were enjoined and closed.

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a woman holding samples of blood collected at a blood bank

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FDA Inspector Mildred Woodward collects a blood sample from a blood bank for testing at the Bureau of Biologics (from the FDA Consumer June 1973). 

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FDA History Office

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