In 1924, USP developed standards for vitamin A and D content in cod liver oil, leading to the inclusion of a bioassay reference standard for vitamin A in USP X. In order to facilitate the adoption of this biological assay, the Bureau of Chemistry worked with USP to supply reference standards meeting USP requirements. In 1930, the Bureau discontinued this service and transferred full responsibility for the reference standards program to USP. Consequently, in 1932, the Board of Trustees announced the establishment of the Vitamin Advisory Board to provide expert advice on the development of vitamin standards. During the 1930s this board distributed 5,000 standardized packages of USP Reference Cod Liver Oil. After the success of the Vitamin Advisory Board, USP formed Advisory Boards for sterile products, hormone products, and anti-anemia preparations pursuant to FDA's request. These advisory boards included Nobel Prize-winning scientists, as well as staff members from several government organizations.
The USP Reference Standards program has become essential to FDA's laboratory-based regulatory programs and the pharmaceutical industry, serving as an invaluable tool, with legal standing to aid FDA in enforcing the quality requirements for marketed drugs. Maintenance of the USP Reference Standards Program has grown into a joint effort among USP, FDA, industry, and other participating labs, who collaboratively analyze proposed reference standard material.
Published Oct 7, 2010
