Regulatory Environment for Pharmacies Serving Customers with Limited English Proficiency

Since early 2000, there has been a growing movement at federal and local levels to enact and enforce laws and regulations that mandate providing translation and interpreting services to pharmacy customers who have limited English-speaking ability.

RxTran has a simple affordable solution for the translation of patient instructions (SIGs), Patient Education sheets, auxiliary warning labels (AWL) and telephone interpreting services to help pharmacies comply with all existing federal, state and local regulations related to language access. Please contact RxTran for more information.

Federal Regulations on Provision of Translation Services in US Pharmacies

The federal regulatory framework was set more than 45 years ago with the enactment of Title VI of The Civil Rights Act of 1964, but only in the last decade have the US Department of Health and Human Services (HHS) and the Department of Justice (DOJ) started applying Title VI aggressively to protect national origin minorities with limited English proficiency (LEP) in the healthcare settings.

The attitude of federal agencies was particularly affected by President Bill Clinton’s Executive Order 13166, signed on August 11, 2000. This order served to remind federal agencies to examine the services they provide, identify any need for services to those with limited English proficiency and to develop and implement a system to provide those services so LEP persons can have meaningful access. By and large, the courts have agreed that language barriers are a form of discrimination.

Continue reading about federal regulations on translation services for limited English proficiency (LEP) population and the specific impact of these regulations on community pharmacies.


The State of Oregon passed ORS 689.564 mandating that all Oregon Pharmacies provide language assistance services to their LEP (limited English proficiency) patients. The legislation stipulates that prescription labels be translated into 14 languages and signage be posted of LEP patients’ right to receive this service.

Continue reading about the Oregon legislation governing pharmacy translation requirements.

New York State Regulations on Pharmacy Obligations to Provide Translation Services Under Attorney General’s Agreement

So far, the most wide-reaching impact on community pharmacies was made in New York state by the Attorney General’s office under Andrew Cuomo.

In April 2009, Mr. Cuomo signed an agreement with seven large pharmacy chains – Target, Walmart, Duane Reade, CVS, Rite-Aid, A&P, and Costco. These companies have agreed to provide New York customers with prescription medication instructions in their primary language. Under the terms of these agreements, the companies will counsel all pharmacy customers about prescription information in their own language and provide written translations in 6 specific languages—Spanish, Chinese, Italian, Russian, Polish and French.

Continue reading about New York State regulations on pharmacy translation services.

New York City Regulations

In August 2009, the New York City Council passed the Language Access Pharmacies Act (LAPA). This law, technically called “Introductory Number 859-A,” was signed by Mayor Bloomberg on September 3, 2009. The law requires every chain pharmacy to provide free translation and interpretation of prescription medication Directions for Patients (SIGs), warning labels and patient information sheets (CMI) to each LEP individual. The bill stipulates that the chain pharmacy must translate medical instructions into the seven languages most commonly spoken by LEP individuals in New York City—Spanish, Chinese, Korean, Russian, Haitian Creole, Italian and Polish.

Continue reading about New York City new law governing pharmacy translation requirements.

California Regulations

The State of California passed SB 853 (Statutes of 2003). The bill mandates that all California health plans provide language assistance services to their enrollees. The legislation stipulates that all vital documents, including medication labels and instructions must be translated into threshold languages and interpretation services made available to enrollees.

Continue reading about the California legislation governing pharmacy translation requirements.


One of the best resources about language access laws and regulations on federal, state and local levels is The National Health Law Program, a national public interest law firm.

How to Learn More about RxTran Pharmacy Language Solutions

To get more information about our pharmacy language services, call 617-621-0945 or email at info@RxTran.com to find out how RxTran can help you provide a more comprehensive set of services to your pharmacy clients.

Legal Disclaimer

On this site we informally and briefly describe the gist of some laws and regulations enacted or being considered in various jurisdictions. These descriptions are not intended to be a complete or exhaustive presentation of the laws and regulations. They are not intended, nor should be relied upon, as a source of legal advice. Please consult qualified counsel for any questions regarding interpretation of any laws and regulations mentioned on this site.