Drug Labels

pill bottleThe Board is leading an effort to develop advisory guidance on making prescription drug container labels accessible to people who are blind or visually impaired or who are elderly. This initiative is authorized by the “Food and Drug Administration Safety and Innovation Act" which President Obama signed into law in July 2012.  A provision of the act (section 904) authorizes the Board to convene a working group to develop best practices for making information on prescription drug container labels accessible to people who are blind or visually impaired.

Shortly after the law was enacted, the Board formed the Working Group on Accessible Prescription Drug Container Labels, an 18-member stakeholder panel comprised of representatives from advocacy organizations and industry. The working group explored various access alternatives, including braille, large print labels, and auditory technologies such as “talking bottles” and radio frequency identification tags. It prepared and submitted to the Board best practices for pharmacies on providing independent access to prescription drug container labels.  These recommendations are advisory only, not mandatory, and will not have the force of guidelines or standards.

The law also calls upon the National Council on Disability to conduct an informational and educational campaign in cooperation with the stakeholder working group to inform the public, including people with disabilities and pharmacists, of the best practices. The Comptroller General will undertake a review at a later date to assess the extent to which pharmacies are following the best practices and to what extent barriers to information on prescription drug container labels remain.

Three national pharmacy chains now offer talking prescription information for blind customers:  CVS, Walmart, and Walgreens.

The Access Board Working Group’s Final Report Regarding Best Practices for Making Prescription Drug Container Label Information Accessible to Persons who are Blind or Visually-Impaired is referenced in section 3.2 and 3.5 of the agreement that led to today's announcement. The agreement and announcement is the result of Structured Negotiations between CVS and the American Council of the Blind, the California Council of the Blind and the American Foundation for the Blind. The organizations were represented by the Law Office of Lainey Feingold and by Linda Dardarian of the Oakland civil rights firm Goldstein, Borgen, Dardarian and Ho.