According to an article in Pharmacy Times, “In California, pharmacists and patients face a catch-22: patients who cannot understand English say they cannot read the labels on their medications, and that translating the labels would help them. The act of translation, however, would create a situation in which pharmacists are dispensing medications that they cannot verify because they do not know the language in which the labels are written.”
The California Board of Pharmacy will consider whether drug labels should be translated into a language the patient understands at its meeting today.
California pharmacists would be legally liable for any mistake on the translated label, since they are not FDA approved.
There is only one FDA-approved label for any given product, and that is the label that is approved for use by the FDA in English. This appears to be a clear-cut case of Federal Preemption.
The full Pharmacy Times story can be found here.
