The Pharmacy Quality Assurance Commission (PQAC) has issued an updated proposed rule on accessible prescription labeling. This regulation would require dispensing facilities and dispensing practitioners to provide prescription labels in a specific format for individuals with limited English proficiency and those who are visually impaired.
WSHA recently submitted comments in support of the updated proposal, while continuing to advocate for an exemption for health care entity-dispensed prepackaged medications.
While the requirements do not apply to hospital inpatient pharmacies or medications administered directly by a licensed health care practitioner, they may still affect hospitals and other health care organizations in specific circumstances.
PQAC initially adopted rule language in early 2025. However, in October 2025, the commission determined that the regulation was overly restrictive, costly, and did not accommodate emerging technologies. These issues were consistently raised by WSHA and other impacted parties throughout the rulemaking process. WSHA is encouraged that many of its highest-priority concerns were addressed in the latest version.
These changes include removing 4 specific technologies that dispensing facilities and dispensing practitioners must make available (large-print, Braille, QR code or equivalent, and prescription reader). Instead, dispensing facilities and practitioners are now required to “provide a means of access.”
Additionally, the rule specifies that a dispensing facility or dispensing practitioner must provide visual translation and oral interpretation for the 10 most common non-English languages utilized in Washington. Prior rule versions did not limit the number, meaning dispensing facilities and providers would have needed to provide an unlimited number of languages for translation and interpretation. Lastly, prepackaged medications delivered by a mobile health care team as part of a public health outreach program are exempted.
Although WSHA supports the updated proposal, one significant concern remains unresolved. The revised rule exempts prepackaged medications distributed through hospital emergency departments, but it does not extend the same exemption to health care entity-dispensed prepackaged medications.
As the Legislature recognized in 2025, both hospital emergency departments and health care entities play a critical role in ensuring access to medications, particularly in communities when retail pharmacy access is limited. In our comments, WSHA urged PQAC to provide the same exemption for health care entity-dispensed prepackaged medications.
The regulation primarily applies to retail pharmacies and certain other licensed dispensing entities. Organizations should carefully review the proposed rule’s definitions of “dispensing facility” and “dispensing practitioner” (page 9), as well as the exemption provisions (page 10), to determine whether and how the requirements may apply to their operations. WSHA will provide updates via Weekly and a bulletin when the rule is finalized. (Remy Kerr)