NABP Drug Distributor Accreditation
Supply Chain Inspection Overview
Written-by: Deneen Fumich, RPh
Effective January 1, 2022, NABP made major changes to the Drug Distributor Accreditation (DDA fka VAWD) process. Some of the major changes to note are to the policy and procedure assessment and the inspection. The changes were made in an effort to streamline the process and help applicants reach accreditation faster than the previous process.
Online Application and Policy & Procedure Assessment
The first change to the process that you’ll notice is that NABP has updated the online application to include uploading the facility’s policies and procedures as well as the updated Supply Chain Inspection (SCI) P&P Assessment. The new SCI P&P Assessment is an abbreviated version of the previous DDA P&P Assessment. Also included in the online application updates are also newly formatted customer and source list spreadsheets.
Supply Chain Inspection
Once your application has been reviewed and approved to move forward, you’ll see the next big change. The new Supply Chain Inspection (SCI) will happen within 8 weeks, unannounced. At this time, the 8-week timeframe may be extended due to the number of COVID cases in your area. NABP has a list of states in which they ARE completing inspections, and outside of that list of states the inspections will be conducted on a case-by-case basis depending on the COVID numbers in each facility’s county/area.
Once the SCI has been completed, the SCI report will be provided in about 30 days to the facility and the appropriate state licensing agency. The facility will have 30 days to submit a response to the findings. The response can be categorized as Additional Information, Clarification, Correction, Explanation, Improvement, or Policy/Procedure Info. The SCI report will not identify areas that did not meet standards, but we can help you review the 233 line-item report.
NABP will also use the SCI report to determine if you are eligible to move forward with the DDA process. If this is a reaccreditation, and your facility has been diligent in remaining current in NABP’s standards, you may be deemed expedited eligible and may receive your accreditation within 14 days.
The more likely response will be ‘eligible’. If you are eligible to move forward with DDA, you will receive a Post Survey Letter (PSL) from NABP, highlighting the areas in which more information or corrections are needed. You will have 30 days to respond to the PSL.
The least common response in the eligibility letter should be ‘ineligible’. If your facility has reviewed the ineligibility matrix to ensure there are no areas that will automatically flag you as ineligible and are following all your written policies and procedures that were submitted, it should be unlikely that your facility would be deemed ineligible.
While this seems like a lot of information, we are here to help. Pharma Solutions has a plan in place to guide you through every step of the process. If you’d like to know more, send an email to firstname.lastname@example.org.
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