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WAC 246-945-005 requires responsible pharmacy managers (or equivalent managers) of pharmaceutical firms to conduct an annual self-inspection in March and within 30 days of naming a new responsible pharmacy manager. The self-inspections are completed on commission provided worksheets and may be accessed from the links below and soon on the inspections page on our website.
The primary objective of these worksheets and the self-inspection process, is to provide facilities the opportunity to identify and correct areas of non-compliance with state and federal laws and rules. Following the self-inspection process, completed worksheet(s) must be filed on-site and made readily available to commission inspectors during inspections. This year, the commission developed a DSCSA Guidance Document and Optional DSCSA Self-Inspection Worksheet.
As you complete the 2025 self-inspections worksheets, please send any feedback you have to WSPQAC@doh.wa.gov. This will allow stakeholders to submit timely feedback and assist in preparing the 2026 self-inspection worksheets.
Self-Inspection Worksheets
General Self-Inspection Worksheet (Word)
Hospital HPAC Self-Inspection Worksheet (Word)
Manufacturer Self-Inspection Worksheet (Word)
Wholesaler Self-Inspection Worksheet (Word)
Health Care Entity (HCE) Self-Inspection Worksheet (Word)
Addendums
Non-Sterile Compounding Addendum – USP 795 (Word)
Sterile Compounding Addendum – USP 797 (Word)
USP 800 – Hazardous Drugs Addendum (Word)
USP 825 – Radiopharmaceuticals Addendum (Word)
Long-Term Care Addendum Self-Inspection Worksheets (Word)
2025 Optional DSCSA Self-Inspection Addendum (Word)
2025 DSCSA Assessing Compliance G005
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