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December 27, 1941


JAMA. 1941;117(26):2257. doi:10.1001/jama.1941.02820520053015

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Congressional action on legislation to protect the users of insulin was completed on December 19. Prompt action was necessary because the patent on insulin, held by the University of Toronto, under which patent adequate standards of purity and strength have been maintained, expired on December 23.

The legislation that has been enacted amends the Federal Food, Drug and Cosmetic Act by declaring a drug to be misbranded if it is, or purports to be, or is represented as a drug composed wholly or partly of insulin unless (1) it is from a batch with respect to which a certificate or release has been issued under regulations to be promulgated by the Federal Security Administrator and (2) such certificates or release is in effect with respect to such drug. The Federal Security Administrator is directed to provide for the certification of batches of drugs composed wholly or partly of insulin. A

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