California Translation Regulations for Pharmacies

California has approved two bills related to pharmacies providing translation. They are California SB 472, and California AB 1073.

California Bill SB 472

Bill 472 required that the state adopt a standardized prescription drug label. It also required the Board of Pharmacy to specifically consider the needs of patients with limited English Proficiency (LEP) in designing the new standardized label.

In late 2009, the Pharmacy Board adopted regulations called the Patient-Centered Labels for Prescription Drug Containers and among other items, specified that pharmacies must have policies and procedures in place to assist LEP patients.

Here is the text of CA Pharmacy Regulations that specifically address Language Requirements:

The pharmacy shall have policies and procedures in place to help patients with limited or no English proficiency understand the information on the label as specified in subdivision (a) in the patient’s language. The pharmacy’s policies and procedures shall be specified in writing and shall include, at minimum, the selected means to identify the patient’s language and to provide interpretive services in the patient’s language. The pharmacy shall, at minimum, provide interpretive services in the patient’s language, if interpretive services in such language are available, during all hours that the pharmacy is open, either in person by pharmacy staff or by use of a third-party interpretive service available by telephone at or adjacent to the pharmacy counter.

California Pharmacy Regulation Language Requirements:

Under the California regulations, pharmacies must at a minimum provide interpreting services to all LEP patients. This may be done by pharmacy staff members or through telephone interpreting. This must be available for all hours that the pharmacy is open.

California pharmacies must post a notice to make LEP patients aware of their rights to an interpreter free of charge. This notice must be translated into all major languages spoken in California, and has been created by the California Board of Pharmacy. If a pharmacy opts to use its own sign, it must be approved by the California Board of Pharmacy.

Implementation Schedule:

The new standardized labels were to be implemented by January 1, 2011. The California Board of Pharmacy provided standardized SIGs (Directions for Use) into 5 languages on its website:

Spanish

Chinese

Korean

Russian

Vietnamese

There are 15 standardized SIGs translated into each of these languages. However, while pharmacies are encouraged to use these translations, they are not required to. Therefore, most pharmacies are simply ignoring them. In 2013, SB 204 was introduced that would mandate that pharmacies use these translated SIGs. This bill was not passed.

California AB 1073

AB 1073 primarily amended the California Business and Professional Code Relating to Pharmacy to include Section 4076.6 that requires the dispenser to print translations of SIGs directly on prescription container or the label. This bill was signed into law by Governor Jerry Brown on October 11, 2015.

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