Why Isn’t Braille Required on US Pharma Packaging?

Braille is mandatory on pharmaceutical packaging in all EU countries, so why doesn’t the United States follow suit?

Pulneo box featuring braille. / Image: PharmPro
Pulneo box featuring braille. / Image: PharmPro

A recent PharmPro article discussed the role of braille in pharmaceutical packaging and the differences between the U.S. and Europe. While the U.S. has proven progressive with regard to rules and regulations designed to aid the handicapped, they’ve fallen short in the arena of pharmaceutical packaging by not requiring braille labeling. When the EU ordered mandatory braille packaging a decade ago, U.S. manufacturers packagers, distributors and dispensaries expected to be next in line.

The FDA dropped the ball on making braille mandatory, and a committee of the United States Access Board issued guidelines encouraging but not requiring the addition of braille. The industry took matters into its own hand at the pharmacy level with big chains like CVS, Walgreens, and Rite-Aid making braille instructions available to the visually impaired, but very few OTC medications participated. Kim Charlson, President of the American Council of the Blind, says they can make requests to individual companies, but without the support of an FDA mandate, it’s a lost cause.

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