Insulin Amendment

The Insulin Amendment requires FDA to test and certify the purity and potency of insulin. 

Insulin Amendment passed to require FDA testing/certification of purity and potency. 

Filler G, Amend P, Kohnert KD, Devaux S, Ehrich JH. Glucose tolerance and insulin secretion in children before and during recombinant growth hormone treatment. Horm Res 1998 50(l) 32-7. 

There was still no requirement to prove product efficacy. But in 1941, with most of the world at war, an often overlooked piece of US legislation was passed. The FD C Act was amended, to reflect an FDA proposal. Henceforth, FDA was empowered to certify the potency of insulin. This required a bioassay, and for the first time FDA was able to regulate pharmacodynamics. It was a short step to therapeutic efficacy. 

Between 1941 and 1945, Congress amended the 1938 FD C Act to reflect the development of insulin, penicillin, and other new antibiotics. 

Hvidt, A., Linderstr0m-Lang, K. (1955) The kinetics of the deuterium exchange of insulin with DjO An amendment. Biochimica et Biophysica Acta, 16 (1), 168-169. 

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