In 1941, the Insulin Amendment was passed by the U.S. Congress requiring the U.S. Food and Drug Administration (FDA) to certify batches of insulin for safety, potency and identity to ensure patients had access to high quality products. The testing was conducted by a unit in the Pharmacology Division.

The program was so successful in safeguarding the quality of insulin that by the 1990s it was no longer necessary to elevate industry practices, and it ended under the Food and Drug Administration Modernization Act of 1997.