Ely Lilly and Insulin Vials

Ely Lilly and Insulin Vials

ELI LILLY AND INSULIN
VIALS

by Ed Bryant

Last June 3, the U.S. Food and Drug

Administration called a meeting of insulin manufacturers, government regulators, and

concerned organizations, to discuss the inclusion of tactile codes on insulin vials sold

in the United States. This is an issue of public safety. Thousands of blind diabetics, and

those losing vision, need reliable means to identify their insulin types, without sighted

assistance. Prototypes were displayed, and concerns were aired, about tactile clarity,

manufacturing reliability, and Federal regulations. It sounded at that time like we'd soon

see the tactile-marked vials on pharmacy shelves.

Much like the Federal Budget, there is a lot of

distance between proposal and completion. Where are the tactile insulin vials today?

Sources at Eli Lilly and Company report they are testing vial labels, to make certain the

prototypes will be repeatable, in high volume, with absolute reliability. Lilly makes a

lot of insulin, and they want to be sure.

Adding to the complexity, the FDA is
working to revise color-coding of insulin types, on the vial label. It is also
said to be in the process of revising the CFR (Code of Federal Regulations)
as it relates to the labeling of injectable medications. These developments
have given industry executives something else to think about, and have slowed
down the process. "Slowed" is not stopped. We have not been forgotten,
and work continues. Our Diabetes Action Network will keep up the pressure, and
I will keep you informed.