Helmsley Charitable Trust and Partners Announce Funding of Quantitative Analysis of Insulin Purchased from Pharmacies in the U.S.

Thursday, October 11, 2018

Helmsley Charitable Trust and Partners Announce Funding of Quantitative Analysis of Insulin Purchased from Pharmacies in the U.S.

JDRF International, the American Diabetes Association (ADA) and The Leona M. and Harry B. Helmsley Charitable Trust (Helmsley) together announce the awarding of funding to the University of Florida for a one-year investigation by Dr. Timothy Garrett of the consistency and potency of insulin that is purchased at retail pharmacies across the United States.

This effort was prompted by a small study published in the December 2017 edition of the Journal of Diabetes Science and Technology, by Carter and Heinemann1. The study, which was not initiated or supported by JDRF, the ADA or Helmsley, found a wide variation in the level of activity in insulin available at U.S. pharmacies.

Carter and Heinemann examined 18 10-mL vials of NPH and regular insulin produced by two major manufacturers and randomly purchased in U.S. pharmacies. It found an average dosage of 40.2 U/mL with levels ranging from 13.9 to 94.2 U/mL. None of the vials met the 95-U/mL standard at the time of testing. The U.S. Pharmacopeia and the U.S. Food and Drug Administration require insulin vials and cartridges to contain a minimum of 95 percent intact insulin (95 U/mL)....
 

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