Must include:

• Name & address of pharmacy owner
• Date compounded (filled)
• Prescription number
• Prescriber’s name
• Patient’s name & address
• Directions for use

• Labels may include non-English instructions for patient clarity.
• Required: All label and pharmacy record information must also appear in English.

Braille Prescription Labels in the U.S.: Current Status
Braille prescription labels are not federally required in the United States, but there are advisory guidelines and state-level efforts aimed at improving accessibility:
Federal Guidelines

• The FDA Safety and Innovation Act (2012) authorized the U.S. Access Board to develop best practices for accessible prescription labeling, including Braille, large print, and auditory formats like “talking bottles”.
• These recommendations are advisory only, not mandatory. Pharmacies are encouraged—but not required—to offer Braille labels.
• The FDA has approved Braille labeling on specific drugs, such as Hetlioz, but only when submitted by the manufacturer.

• California, Colorado, Virginia, Michigan, and Minnesota have passed laws related to accessible labeling.
• New York (S1740) has introduced legislation for accessible prescription labeling, but it’s not yet law.
• Other states like Texas, Iowa, Missouri, and Illinois have bills in progress.

• Major chains offer accessible options such as ScripTalk (audible labels) and Braille overlays upon request.
• Pharmacies may partner with others that have Braille embossing capabilities to fulfill occasional requests.

• Label: Info on the immediate container and outer packaging.
• Labeling: Includes all printed/pictorial matter on or accompanying the drug/device/cosmetic.

• Patient name
• Directions for use (in full sentences)
• Drug name & strength

• Pharmacy name, address, phone
• Patient address
• Prescriber name
• Fill/refill date
• Prescription number

A list of the active and inactive ingredients
~ The lot or batch number
~ The statement that the drug is not for resale, and the statement (“Office Use Only)”