Pharmacy Commission

Pharmacy inspections will follow a statement of deficiency-plan of correction model. Once an inspection occurs, pharmaceutical firms will receive an inspection report that may include deficiencies found during the inspection. Pharmaceutical firms must then submit to PQAC a plan of correction addressing how it will correct deficiencies cited on the inspection report.

WAC 246-945-005 requires responsible pharmacy managers (or equivalent managers) of pharmaceutical firms to conduct an annual self-inspection of the pharmaceutical firm on the self-inspection worksheet(s) provided by the commission. Self-inspections must occur within the month of March each year and within 30 days of naming a new responsible pharmacy manager. 

Inspection process

Below you'll find information and resources about pharmacy inspections.

• Plan of Correction – Instruction Pamphlet (PDF)
• Plan of Correction – Template (Word)
• Plan of Correction – Template (PDF)

Self-inspection worksheets

• General Self-Inspection Worksheets
  • General Self-Inspection Worksheet (Word)
  • General Self-Inspection Worksheet (PDF)
• Hospital HPAC Self-Inspection Worksheets
  • Hospital HPAC Self-Inspection Worksheet (Word)
  • Hospital HPAC Self-Inspection Worksheet (PDF)
• Manufacturer Self-Inspection Worksheets
  • Manufacturer Self-Inspection Worksheet (Word)
  • Manufacturer Self-Inspection Worksheet (PDF)
• Wholesaler Self-Inspection Worksheets
  • Wholesaler Self-Inspection Worksheet (Word)
  • Wholesaler Self-Inspection Worksheet (PDF)
• Health Care Entity (HCE) Self-Inspection Worksheets
  • Health Care Entity (HCE) Self-Inspection Worksheet (Word)
  • Health Care Entity (HCE) Self-Inspection Worksheet (PDF)

Addendums

• Non-sterile Compounding Addendum – Revised USP 795 (effective November 1, 2023)
  • Non-Sterile Compounding Addendum – USP 795 (Word)
  • Non-Sterile Compounding Addendum – USP 795 (PDF)
• Sterile Compounding Addendum – Revised USP 797 (effective November 1, 2023)
  • Sterile Compounding Addendum – USP 797 (Word)
  • Sterile Compounding Addendum – USP 797 (PDF)
• USP 800 – Hazardous Drugs Addendum
  • USP 800 – Hazardous Drugs Addendum (Word)
  • USP 800 – Hazardous Drugs Addendum (PDF)
• USP 825 – Radiopharmaceuticals Addendum
  • USP 825 – Radiopharmaceuticals Addendum (Word)
  • USP 825 – Radiopharmaceuticals Addendum (PDF)
• Long-Term Care Addendum Self-Inspection Worksheets
  • Long-Term Care Addendum Self-Inspection Worksheets (Word)
  • Long-Term Care Addendum Self-Inspection Worksheets (PDF)

* Worksheets and addendums are in both .docx and PDF (pending) fillable format. Microsoft Word and Adobe (Reader or Pro) are not needed/required to complete these fourms. You may print and complete forms by hand (PDF is the best print choice).

Inspectors listed by county

Please note, the most efficient method of contacting your specific inspector is via email. Our inspectors are often in the field and often unable to answer phone calls.

You may find your inspector using this list of zip codes.

Pharmacist inspector supervisor
Si Bui, si.bui@doh.wa.gov, 360-791-4301

Inspection Area 1
Island, King, San Juan, Skagit, Snohomish, and Whatcom counties
Tina Lacey, tina.lacey@doh.wa.gov, 360-628-4703

Inspection Area 2
Clark, Cowlitz, Lewis, Pacific, Pierce, Skamania, Thurston, and Wahkiakum counties
Position vacant. If you have questions please contact the commission's Inspector Supervisor Si Bui via email or call 360-791-4301.

Inspection Area 3
Adams, Asotin, Benton, Columbia, Franklin, Garfield, Grant, Kittitas, Klickitat, Walla Walla, Whitman, and Yakima counties
Shelley Feldner-Schuerman, shelley.feldner-schuerman@doh.wa.gov, 509-590-5743

Inspection Area 4
Chelan, Douglas, Ferry, Grant, Lincoln, Okanogan, Pend Oreille, Spokane, and Stevens counties
Danielle A. Lee, danielle.lee@doh.wa.gov, 509-688-5476

Inspection Area 5
King County
Position vacant. If you have questions contact the commission's Inspector Supervisor Si Bui via email or call 360-791-4301.

Inspection Area 6
King and Snohomish counties
Mariam Boulos, mariam.boulos@doh.wa.gov, 360-485-5088

Inspection Area 7
King, Lewis, Pierce, and Thurston counties
Scott Craig, scott.craig@doh.wa.gov, 360-742-7823

Inspection Area 8
Clallam, Grays Harbor, Jefferson, Kitsap, Mason, Pacific, Pierce, and Thurston counties
Crystal Phipps, crystal.phipps@doh.wa.gov, 360-742-9817

Inspection Area 9
King County
Justin Sisney, justin.sisney@doh.wa.gov, 360-502-5539

Nonresident Pharmacy Inspection Reports FAQs

In 2019 the legislature passed House Bill 1412. This bill amends RCW 18.64.360 to require a nonresident pharmacy to submit an inspection report that has substantially equivalent standards to Washington state at initial licensure and at renewal. The report must have been issued within two years of an initial application or renewal of the nonresident pharmacy license.

What does this mean for you (nonresident licensee)?

For an applicant for a nonresident pharmacy license, or upon renewal of a current nonresident pharmacy license, this means an inspection report from an approved state or third-party approved program must be submitted with the application to the commission.

• If the resident state is on the Approved States and Third Party Inspection Programs DOH 690-330, the nonresident pharmacy can submit an inspection report from the last two years upon renewal of its license or with its initial application.
• If the resident state is not on the Approved States and Third Party Inspection Programs, the nonresident pharmacy can get an inspection through an approved third-party inspector. Currently the only approved inspection program is the National Association of Boards of Pharmacy Verified Pharmacy Program (NABP VPP).
• Some states have substantially equivalent standards but do not conduct inspections within the necessary time frame. In this case a nonresident pharmacy can work with its regulatory body to get an inspection conducted or use the approved third-party inspection program.

How did the commission determine which states would be on the approved list?

Current RCW 18.64.270 requires that any medicinal products that are compounded shall at a minimum meet the standards of the official United States Pharmacopeia. Staff members reviewed the laws in each state and determined which states require compliance with USP. Compliance with USP compounding standards was one of the primary focuses in determining the equivalency of states and third-party inspection programs. The Commission also looked at and approved states that are a part of the NABP's BluePrint Program or who use NABP's Verified Pharmacy Program as their inspection model. Both programs inspect to standards substantially equivalent to Washington State.

How do I know if my state has been approved as having equivalent standards to Washington?

The commission has published a list of Approved States and Third Party Inspection Programs (PDF).

What if my pharmacy doesn't do compounding?

The commission will accept inspection reports from some non-approved states (see the attached chart, page 3-4 (PDF) to determine if your state's inspection report will be accepted), provided the pharmacy does not perform any compounding. There will be a box to check on your renewal attesting to not compounding. You will need to submit an approved inspection report. If you have specific questions regarding applying for a non-resident pharmacy license or your renewal, contact commission staff members at WSPQAC@doh.wa.gov.

What happens if my pharmacy does not get its inspection in time for renewal?

The commission will determine case-by-case whether disciplinary action or a citation needs to occur.

When does this law go into effect?

July 28, 2019.

My nonresident pharmacy is currently licensed. When do I need to submit my inspection report?

For currently licensed nonresident pharmacies, the inspection report will need to be submitted upon renewal and at every renewal thereafter.

I am a new nonresident pharmacy applicant. When do I need to submit my inspection report?

Any new nonresident pharmacy applying after July 28, 2019, will need to submit an inspection report with its initial application, and at every renewal thereafter.

What if I have a nonresident inspection report from a state that I am not located in?

The commission will accept a nonresident inspection report done by a state that is on the approved list.