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of the
Treasury. This board was given the power to issue, suspend, and revoke licenses to produce and sell biological products. The Biologics Control Act also mandated that all products be labeled accurately with the name of the product and the address and license number of the manufacturer. Laboratories could be subjected to unannounced inspections by the Treasury Department. The punishment for the violation of this law was a fine of up to $ 500 or up to a year in prison.
214:, established on Staten Island, NY, in 1887, was in charge of testing biologics before the Biologics Control Act. It was moved to Washington, D.C., in 1891, and renamed the Hygienic Laboratory of the Public Health and Marine Hospital Service in 1902. The Hygienic Laboratory was responsible for renewing licenses annually, testing products, and performing inspections. In 1930, the
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The
Biologics Control Act established a board to oversee the implementation of regulations of biological products. The board consisted of the Surgeon-General of the Army, the Surgeon-General of the Navy, and the Surgeon-General of the Marine Hospital Service, and was to be overseen by the Secretary
193:, died from contaminated smallpox vaccines. These incidents led the Hygienic Laboratory and the Medical Society of the District of Columbia to propose a law regulating the production of biological products. On July 1, 1902, Congress passed the Biologics Control Act.
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When the large scale production of vaccines and anti-toxin serum began in the late 19th century, the United States had no government regulations on biological products. In 1901, a 5-year-old girl died of tetanus in St. Louis, Missouri, after being given a
189:, was killed, the Board of Health continued to use the serum to treat diphtheria. It was later discovered that 12 other children had died from the same contaminated anti-toxin serum in St. Louis. That same year, nine children in
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An Act to regulate the sale of viruses, serums, toxins, and analogous products in the
District of Columbia; to regulate interstate traffic in said articles, and for other purposes.
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The Marine
Hospital, Staten Island, N.Y. In 1887, National Institute of Health began as a single room Laboratory of Hygiene for bacteriological investigation established by the
185:. Investigations found that the St. Louis Board of Health produced the contaminated anti-toxin using the blood of a horse infected with tetanus. While the infected horse,
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The
Biologics Control Act set a precedent for the federal regulation of biologics such as vaccines and blood components. With the development of biotechnology, the FDA's
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transformed the
Hygienic Laboratory into the National Institute of Health and gave it a larger role in public health research. In 1948, the name was changed again to the
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421:"Center for Biologics Evaluation and Research History - The Road to the Biotech Revolution - Highlights of 100 Years of Biologics Regulation"
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at
Stapleton, Staten Island, New York. From 1887 to 1891, the Laboratory was located in the attic of the Marine Hospital on Staten Island.
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222:, as it encompassed many institutes and centers dedicated to biomedical research. In 1972, biologics regulation was moved to the
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in the United States. It was enacted in response to two incidents involving the deaths of 22 children who had contracted
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has taken a larger role in reviewing and approving new biological products intended for medical purposes, including
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351:"Selections From FDLI Update Series on FDA History - Biologics Centennial: 100 Years of Biologics Regulation"
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of 1902, also known as the Virus-Toxin Law, was the first law that implemented federal regulations of
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148:. This law paved the way for further regulation of drug products under the
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502:"About the Center for Biologics Evaluation and Research (CBER)"
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of 1938. Biologics control is now under the supervision of the
489:. New Series, Vol. 72, No. 1861: 214–215. August 29, 1930.
381:"The Public Health Service and the Control of Biologics"
300:"Regulation of Vaccines: Strengthening the Science Base"
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Center for
Biologics Evaluation and Research (CBER)
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Center for
Biologics Evaluation and Research (CBER)
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500:Research, Center for Biologics Evaluation and.
379:Parascandola, John (November–December 1995).
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444:Kennedy, Donald (November–December 1978).
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556:United States biotechnology law
304:Journal of Public Health Policy
270:Affairs, Office of Regulatory.
226:and later became known as the
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317:10.1057/palgrave.jphp.3190016
220:National Institutes of Health
20:Biologics Control Act of 1902
224:Food and Drug Administration
174:U.S. Marine Hospital Service
531:57th United States Congress
298:Milstien, Julie B. (2004).
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150:Pure Food and Drug Act
450:Public Health Reports
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183:diphtheria anti-toxin
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130:Biologics Control Act
546:1902 in American law
248:xenotransplantation
197:Contents of the Act
134:biological products
104:Legislative history
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191:Camden, New Jersey
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117:Theodore Roosevelt
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64:July 1, 1902
551:Drug safety
506:www.fda.gov
425:www.fda.gov
355:www.fda.gov
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16:1902 US law
525:Categories
511:2017-05-05
430:2017-05-05
360:2017-05-05
281:2017-05-05
258:References
244:probiotics
74:Public law
34:Long title
69:Citations
61:Effective
42:Nicknames
326:15255384
146:vaccines
138:vaccines
136:such as
91:32
487:Science
463:1431953
407:8570833
398:1381822
334:6219580
164:History
160:(FDA).
142:tetanus
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234:Impact
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93:Stat.
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250:and
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