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California Regulations of the Provision of Translation and Interpreting Services by Pharmacies
A few States, as well as New York City, have passed comprehensive pharmacy language access laws to ensure that community pharmacies provide free translation and interpreting services to their customers with limited English proficiency (LEP).
Below we describe informally and briefly the gist of some specific requirements enacted in the state of California. This is not intended to be a complete or exhaustive description of the laws and regulations. It is 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.
California Law SB 472
California Senate Bill SB 472 was signed by Governor October 11, 2007. The Bill requires that by January 1, 2011, California adopt a standardized prescription drug label. Specifically, the Bill tasks the California State Board of Pharmacy to design such a standardized, patient-centered, prescription drug label and mandate it's use by state pharmacies on all prescription medication dispensed in California.
The Bill requires the Board of Pharmacy to specifically consider the needs of patients with limited English proficiency in designing the new standardized drug label.
Implementation of the Law
The Medication Label Subcommittee of the California Board of Pharmacy is currently in the process of implementing SB 472. During 2008, the board held a series of public meeting throughout California, to gather information and input from consumers and the health professions. In 2009, the board is working on adopting regulations to standardize prescription labels. In 2010, all pharmacies dispensing drugs to California patients must convert their labels to this new format by the 2011 deadline.
The Board is still grappling with questions such as:
- Should the board develop translations of standardized SIGs in the top five languages for directions for use? Should the pharmacies themselves be required to translate the custom SIGs?
- How should the board address the requirement to include the physical description of the contents of a medication on the label? Should the board require these be translated into diverse languages, or should a picture of the pill be considered as complying with the directions?
- If the board translates the directions for use, how should the board deal with translating other patient-centered items on the label, such as the auxiliary warning labels?
Currently, California Endowment is sponsoring a project for evaluating and translating the standardized directions for use in the top 5 languages in California.
Implementation Schedule:
The new standardized labels are to be implemented by January 1, 2011. However, whether and how the labels are to be translated, and into how many languages, has not yet been decided by the California Board of Pharmacy.
Text of the California Law SB 472
The full text of the California SB 472 can be downloaded here.
For More Information
To get more information about our pharmacy language services, call Evan (617-621-0940 x. 141 or 800-240-0246) 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 describe, informally and briefly, 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.
