Why pharmaceutical products in the US don't include braille labeling


While braille is mandatory on all pharmaceutical packaging in Europe, U.S. regulatory agencies remain quiet on the issue, according to Pharmaceutical Processing.

The U.S. Food and Drug Administration does not mandate the inclusion of braille lettering on pharmaceutical drug packaging — an action that presents difficulties for visually impaired individuals who seek to obtain medication.

Despite the lack of federally mandated rules specifying the inclusion of braille on pharmaceutical packaging, a committee of the United States Access Board issued guidelines in 2013 highlighting best practices to make prescription drug container labels more accessible to visually impaired individuals. The guidelines encourage the addition of braille, but do not require it.

Prior to the USAB's guidelines, the International Association of Diecutting and Diemaking, in conjunction with the Braille Authority of North America, created "Can-Am Braille" in 2009, which comprises a set of guidelines and recommendations facilitating the use of braille on pharmaceutical drug packaging in North America, according to PharmaBraille.

Though some progress on the issue has been made, several advocacy groups suggest the rules in place aren't enough and do not extend to over-the-counter medication, Pharmaceutical Processing reports.

In a statement to Pharmaceutical Processing, an FDA spokesperson said the agency "would be open to reviewing braille labeling on a drug product if a sponsor were to submit for review."


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