Translations of Pill Directions as Specified in 16 California Code of Regulations Section 1707.5
Being able to read a prescription label is an essential element of being able to understand how to take medication appropriately.
In January 2016 new California requirements for prescription labels took effect that establish a mechanism by which patients with limited English skills may often obtain translated directions on their prescription container labels or as a supplement to the label.
This law was authored by Assembly Member Ting as AB 1073, and amends Business and Professions Code sections 4076 and 4199 and creates new section 4076.6.
4076.6. Patient-Centered Prescription Labels; Translated Directions for Use; Requirements
(a) Upon the request of a patient or patient’s representative, a dispenser shall provide translated directions for use, which shall be printed on the prescription container, label, or on a supplemental document. If translated directions for use appear on a prescription container or label, the English-language version of the directions for use shall also appear on the container or label, whenever possible, and may appear on other areas of the label outside the patient-centered area. When it is not possible for the English-language directions for use to appear on the container or label, it shall be provided on a supplemental document.
(b) A dispenser may use translations made available by the board pursuant to subdivision (b) of Section 1707.5 of Title 16 of the California Code of Regulations to comply with this section.
(c) A dispenser shall not be required to provide translated directions for use beyond the languages that the board has made available or beyond the directions that the board has made available in translated form.
(d) A dispenser may provide his or her own translated directions for use to comply with the requirements of this section, and nothing in this section shall be construed to prohibit a dispenser from providing translated directions for use in languages beyond those that the board has made available or beyond the directions that the board has made available in translated form.
(e) A dispenser shall be responsible for the accuracy of the English-language directions for use provided to the patient. This section shall not affect a dispenser’s existing responsibility to correctly label a prescription pursuant to Section 4076.
(f) For purposes of this section, a dispenser does not include a veterinarian.
(Added by Stats. 2015, Ch. 784, Sec. 2. Effective January 1, 2016.)
The law recognizes that many dispensers already provide translations on prescription containers. The enacted legislation allows this practice to continue.
The requirements of the new law implement three concepts:
1. A pharmacist shall use professional judgment when selecting the wording of directions that appear on a prescription container label in any language.
The specific requirement is:
4076(e) A pharmacist shall use professional judgment to provide a patient with directions for use that enhance the patient’s understanding of those directions, consistent with the prescriber’s instructions.
2. A dispenser shall provide translated directions for use on a prescription container when requested by the patient or a patient’s representative, provided:
a)The appropriate direction is among the 15 standardized directions for use that have been translated and made available on the board’s website in Spanish, Vietnamese, Korean, Russian and Chinese [see the translations below.], and the pharmacist believes the direction for use is appropriate.
Translations into additional languages or translations of additional directions are not required.
b)The dispenser may provide its own translations in place of the translations available from the board, And
c)The dispenser is responsible for the accuracy of the English directions provided to the patient.
3. The translated direction should, whenever possible, appear in the patient-centered area of the prescription container label. When this occurs, the English version should appear whenever possible on the prescription container label outside the patient-centered area. When the English translation cannot be printed on the prescription container, the English translation may be provided on a supplemental sheet.
A translated direction may be provided on a supplemental sheet when it cannot be added to the prescription container label. In this case, the patient-centered area of the label shall contain the English version of the direction.
The California Endowment, in an effort to support quality labels for those who do not read English, funded a project with national patient literacy researchers to develop and vet translations of the standardized directions for use that are contained in the board’s patient-centered label requirements. While every effort was made to ensure accuracy and reliability of these translations, the Board cannot ensure that a particular translation is appropriate for a particular patient. The Board recommends that each pharmacy and pharmacist confirm the validity and the medical appropriateness of any given translation for a particular patient before using it for the patient’s drug label.