Nonresident Pharmacy Inspection Reports Frequently Asked Questions
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.