Does an accessible prescription label have to say the same thing as the print label?
In the US, the Access Board's best practices say accessible prescription drug container labels, whether braille, large print or audio, should preserve the integrity of the print label and go through the same quality control processes used for print labels. An accessible label is another copy of the same words, so a correctly spelled wrong word can be carried over or introduced in the copy, and fewer reviewers can check it.
This page is general information, not legal or regulatory advice.
What the best practices say
The US Access Board's best practices for accessible prescription drug container labels apply to all formats, including audible, braille and large print labels. They say pharmacists should make those options available, provide the label in the format the patient selects, ensure that duplicate accessible labels preserve the integrity of the print prescription drug container label, and subject accessible labels to the same quality control processes used for print labels to ensure accuracy and patient safety.
In the EU: braille on the pack
In the EU, Directive 2001/83/EC, Article 56a, says the name of the medicinal product must also be expressed in braille format on the packaging. It also says the marketing authorisation holder must make sure the package leaflet is available on request from patients' organisations in formats appropriate for blind and partially sighted people.
Where wording errors enter
Our view: each format is a transcription step. Text is re-keyed, converted or read aloud, sometimes shortened to fit, and each of those is a chance for a real word to replace the intended one.
Made-up example: a large-print label should say "dysphagia" (difficulty swallowing) in a warning, but the re-keyed version says "dysphasia" (difficulty with language). The print label is correct, and the patient relying on the large-print copy gets the wrong warning.
Why spellcheck misses it
Both words are real and spelled correctly, so spellcheck passes them. A check that the accessible label exists, or matches in length, won't catch a word swap.
Who checks the accessible version
Practice advice:
- Have someone who can read the format check it against the print label, line by line, for meaning.
- For audio labels, listen to the full recording, not only the start.
- Give the accessible copy the same sign-off as the print label, as the best practices recommend.
- For related copy steps, see bilingual and translated drug labels and readability user testing.
This is our reading of public guidance, not legal or regulatory advice.
Sources
- US Access Board: Best Practices for Making Prescription Drug Container Label Information Accessible
- EUR-Lex: Directive 2001/83/EC (consolidated text), Article 56a
Last reviewed: October 18, 2026
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FAQ
Does an accessible label have to say the same thing as the print label?
US Access Board best practices say duplicate accessible labels should preserve the integrity of the print label and get the same quality control processes used for print labels.
Do medicine packs need braille?
In the EU, yes for the product name. Directive 2001/83/EC, Article 56a, says the name of the medicinal product must also be expressed in braille format on the packaging.
What formats do the US best practices cover?
Audible, braille and large print prescription drug container labels.
Who checks wording on braille or audio drug labels?
Practice advice: someone who can read that format, checking it against the print label for meaning.
Can an accessible label have a wrong word the print label doesn't?
Yes. Re-keying, converting or recording the text can introduce a correctly spelled wrong word.