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(Effective June 10, 2024)

PDFWAC 182-52-0070

Prescription drug affordability boardAmount of fine(s) based on culpability.

(1) In determining the amount of any fine, the authority considers the level of culpability associated with the violation. The levels of culpability, in the order of least severe to most severe, are as follows:
(a) Did not know. The manufacturer did not know (and, by exercising reasonable diligence, could not have known) the violation had occurred.
(b) Reasonable cause. The manufacturer knew, or by exercising reasonable diligence should have known, that the violation had taken place, but the manufacturer did not act with willful neglect.
(c) Willful neglect – Corrected. The violation was due to the manufacturer's intentional failure or reckless indifference, and the violation was corrected within 30 calendar days from the date the manufacturer knew or with reasonable diligence should have known of the violation.
(d) Willful neglect – Uncorrected. The violation was due to the manufacturer's intentional failure or reckless indifference, and the violation was not corrected within 30 calendar days from the date the manufacturer knew or with reasonable diligence should have known of the violation.
(2) Culpability and fines.
Culpability Category
Fines Per Violation
Did not know
$25,000
Reasonable cause
$50,000
Willful neglect – Corrected
$75,000
Willful neglect – Uncorrected
$100,000
[Statutory Authority: RCW 41.05.021, 41.05.160, chapter 70.405 RCW, and 2022 c 153. WSR 24-02-078, § 182-52-0070, filed 1/2/24, effective 6/10/24.]
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