Washington Regulations
Prescription Label Translation Requirements Under ESHB 1852
Overview
In 2022, Washington State advanced patient safety and health equity by passing Engrossed Substitute House Bill 1852 (ESHB 1852). This legislation requires prescription drug labels and related information to be translated into multiple languages, ensuring that patients with limited English proficiency (LEP) receive clear, accurate, and understandable instructions for their medications. Lawmakers recognized that language barriers pose serious risks—including medication errors, reduced adherence, and worse health outcomes—and acted to protect LEP patients from preventable harm. By mandating translation, Washington joins a growing number of states taking proactive steps to reduce health disparities and promote equitable access to care.
The law directs the Pharmacy Quality Assurance Commission to adopt rules that define how pharmacies must comply. These rules will establish which languages are required, which elements of prescription information must be translated, and the standards for making translations available. The legislation applies not only to in-state pharmacies, but also to nonresident pharmacies licensed in Washington, ensuring consistency for all patients. In addition to bilingual labeling requirements, ESHB 1852 includes provisions to make prescription information accessible for individuals who are blind, low-vision, or otherwise print-disabled. Together, these measures reinforce Washington’s commitment to patient safety, language access, and healthcare equity.
Key Provisions Required by Rulemaking
By the July 2024 deadline, the Commission must require:
- Translation of critical elements
- Directions for use (e.g., dosage instructions)
- Auxiliary warnings (e.g., “Take with food”)
- Dual-language display
- Both the translated text and English version of the directions for use must appear on the prescription label or container.
- Provision upon request
- Pharmacies (including nonresident pharmacies licensed in Washington) must provide these translations whenever requested by a patient, authorized representative, or prescriber and if the requested language is one selected by the Commission.
- Pharmacies (including nonresident pharmacies licensed in Washington) must provide these translations whenever requested by a patient, authorized representative, or prescriber and if the requested language is one selected by the Commission.
Rulemaking Specifications
Per ESHB 1852, rules must also establish:
- Languages required for translation
- At least 15 languages, aiming to include any language spoken by at least 5% of the state’s population or by 1,000 individuals with limited English proficiency (LEP).
- The Commission must consult the Washington State Office of Equity and the Governor’s Interagency Council on Health Disparities, and reassess/update the list at least every five years.
- Scope of materials translated
- Decide which elements (e.g., label directions, warning stickers, information sheets or side-effects information) must be translated.
- Pharmacy settings subject to the rules
- Apply to outpatient prescriptions dispensed for home use, including both in‑state and nonresident pharmacies. Hospital or institutional inpatient pharmacy settings may be excluded.
- Translation procurement & provision process
- Establish how pharmacies will access or obtain translations (e.g., via third-party services or internal resources).
- Signage requirements
- Pharmacies must display signage alerting customers to the availability of translated prescription information.
Timeline & Enforcement
- Report to Legislature: The Commission reported rulemaking progress, including language selections and procurement plans—to relevant legislative committees.
- Implementation deadline: Once rules are adopted, pharmacies get a minimum of 120 days to comply.
- Compliance penalties: The Commission may fine, suspend, or revoke a nonresident pharmacy license, up to $1,000 per violation.
Accessibility for Print-Disabled Individuals
In addition to language translation, ESHB 1852 requires rules to ensure accessibility for individuals who are blind, low-vision, or otherwise print-disabled.
Health & Equity Impact
- Language access reduces health inequities
Evidence indicates that translated prescription labels improve patient safety, medication adherence, and health outcomes, especially for patients with limited English proficiency. - Statewide significance
With more than 20% of Washington households speaking a language other than English, and approximately 7.6% of residents aged 5+ having limited English proficiency, the policy aims to improve access across diverse communities.
Summary Table: ESHB 1852 Requirements
Requirement | Details |
Languages | Minimum 15; include languages covering ≥5% of population or ≥1,000 LEP individuals; reassessed every 5 years |
Materials to Translate | Directions for use, auxiliary warnings, possibly information sheets/side effects |
Label Format | Bilingual: translated + English directions appear on label/container |
Applicability | Outpatient/home-use; applies to in-state and nonresident pharmacies |
Signage | Notification of translation availability required |
Rulemaking Date | Rules adopted by July 1, 2024; report due by July 1, 2023 |
Implementation Period | Minimum 120-day compliance window after rules adopted |
Enforcement | Up to $1,000 fine and potential license actions for nonresident pharmacies |
Accessibility for Print-Disabled Individuals | Rules required by July 1, 2024 |
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