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.
The three California bills that relate to pharmacy language requirements are:
California Law SB 472
California Senate Bill SB 472 was signed by Governor Arnold Schwarzenegger on October 11, 2007. The Bill required that by January 1, 2011, California adopt a standardized prescription drug label. Specifically, the Bill tasked the California State Board of Pharmacy to design such a standardized, patient-centered, prescription drug label and mandate its use by state pharmacies on all prescription medication dispensed in California.
The Bill required the Board of Pharmacy to specifically consider the needs of patients with limited English proficiency in designing the new standardized drug label.
During 2008, the Medication Label Subcommittee of the California Board of Pharmacy held a series of public meeting throughout California, to gather information and input from consumers and the health professions.
On November 20, 2009, the board adopted regulations called the Patient-Centered Labels for Prescription Drug Containers; Requirements to standardize prescription labels, to standardize SIGs (prescription Directions for Use), and to specify that pharmacies must have policies and procedures in place to assist LEP patients. These Regulations were finally approved on November 17, 2010, and went into effect January 1, 2012.
According to Title 16 of the California Code of Regulations Division 17 Article 2 Section 1707.5, all pharmacies dispensing drugs to California patients must:
- convert their labels to a new standardized format by the 2011 deadline
- use specified standardized Directions for Use
- have policies and procedures in place to help patients with limited or no English proficiency
These regulations were to be re-evaluated by December 2013 to ensure optimal conformance with Business and Professions Code section 4076.5.
The Board at the time was 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 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?
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.
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 their website:
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 use them. The result is that most pharmacies are simply ignoring them. In 2013, SB 204 was introduced that would mandate that pharmacies use these translated SIGs.
CALIFORNIA SB 204
On February 8, 2013 at SEN Business, Professions & Economic Development, California State Bill 204 was first introduced. However, at that time, the committee recommended opposing this bill as introduced.
With SB 204, California has reintroduced legislation that requires pharmacies to use the standard medication instructions that have been translated into the 5 languages provided on the Board of Pharmacy’s website. This will provide LEP patients with prescription instructions that they will understand, with the goal of increasing patient compliance and reducing medical errors.
Here is the quote from SB 204 (Corbett) Prescription Drugs: Labeling (Translations):
Existing Pharmacy Law requires that a prescription container dispensed to a patient include the directions for use of the drug (Section 4076). Board regulation at 16 CCR 1707.5 specifies standardized “directions for use” that shall be used, if they are applicable to the prescription. In addition, the board maintains on its website translations in five languages of the “directions for use” that are found at 16 CCR 1707.5(a)(D)(4). SB 204 would add Section 4076.5 to require a pharmacist to use the translations for the “directions for use” available on the board’s website, as applicable, when labeling a prescription. The section would also authorize a pharmacist to translate the directions for use into additional non-English languages if certified translation services are utilized to complete the translations.
On April 12, 2013 the Legislation Committee met and voted on SB 204. They reported that they considered SB 204 during their committee meeting, which was drafted to require that labels be printed in 12-point font. The committee felt it was poorly drafted and voted against it.
The CA Board of Pharmacy shall re-evaluate existing pharmacy language requirements by December 2013 to ensure optimal conformance. Evaluation of these existing language requirements began in April 2013.
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.
For More Information
To get more information about our pharmacy language services, call 617-621-0945 or email info@RxTran.com to find out how RxTran can help you provide a more comprehensive set of services to your pharmacy clients.
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.
Available 24/7 365 days a year in over 150 languages:
- No Setup Fees
- No Monthly Fees
- No Minimum Usage
- No Special Equipment needed
Massive online, growing database of foreign language drug instructions to print directly onto prescription labels:
- Directions for Use (SIGs)
- Auxiliary Warning Labels
- Patient Education Sheets
Available 24/7 365 days a year in over 150 languages:
- Help your Limited English Proficiency Patients understand how to take their medication
- Download CMI Leaflets instantly when you need them
- Fast, Convenient and Integrated with you Pharmacy Management System