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As if this year hasn’t been wild enough of a ride thus far, fasten your seat belts folks because COVID-19 is increasing the complexity of achieving the “Drug Distributor Accreditation”. Yes, you heard that right! If Murder Hornets, Saharan Desert Dust, and a squirrel testing positive for botulism are keeping you awake at night, you now have one more thing to add to the list. All joking aside, applicants pursuing the National Association of Boards of Pharmacy (NABP) Drug Distributor Accreditation (formerly the Verified Accredited Wholesale Distributor program or VAWD) are not being cleared for survey unless the applicants sufficiently prove they have a process in place to detect and prevent the spread of COVID-19. I think we can all agree from a public health perspective this makes sense. However, the challenge here, as everyone who has ever been through this accreditation process is well aware of, NABP is not the best at providing clear guidance as to what they specifically want from the applicant to satisfy their standards. This new requirement is no exception as many applicants find themselves going back and forth with NABP hoping to mitigate costly and time consuming survey delays. This new COVID-19 response requirement appears to be the latest and greatest hurdle for many applicants in the accreditation pipeline.

So, what does this hurdle look like? Once an applicant has completed all the steps necessary to be survey eligible, the NABP will send the applicant an email requesting the following:

  1. An attestation that your facility has requested NABP to conduct an onsite survey.
  2. A written description of the methods in place to detect and prevent the spread of COVID-19.
  3. (if applicable) A document describing prior cases of COVID-19 impacting the facility, facility personnel, and family members of facility personnel [do not provide information that identifies impacted individuals].
  4. An attestation that the facility agrees it will notify NABP prior to survey if information in items one thru three at all change [if a change takes place absent notification to NABP and a survey is scheduled or attempted but is not completed, the facility is responsible for all incurred survey costs]. 

The applicant is given 10 calendar days to provide the written response at which time NABP will evaluate the response to determine if all guidelines are met. Seems simple enough right? Wrong! As is customary in this accreditation process, the applicant is left to figure it out on their own. If they get a survey date, they got it right, if they don’t, well better luck next time ;). My advice here is to be specific, don’t over promise and under deliver, and craft it like you would a standard operating procedure because it soon may be. If all else fails perhaps Dr. Fauci, the nations leading expert on infectious diseases, would be willing to write a recommendation letter to the NABP on your behalf. That last one was a joke of course. Nonetheless, there is a bigger picture laid out here and if you blink, you just might miss it. Accreditation programs that do not continually raise the bar, end up sitting at the bar. In other words, those that don’t continually raise their standards eventually cease to be relevant.

In the battle to maintain relevance the COVID-19 pandemic provides a suitable pathway to a new set of accreditation standards for the NABP Drug Distributor Accreditation program. It should not come as a surprise in the near future to see pandemic response protocols and/or public health related procedures becoming routine accreditation requirements. Given the influence of the State Boards of Pharmacy (SBOP), the Drug Enforcement Administration (DEA), and the Food & Drug Administration (FDA) on the requirements of the Drug Distributor Accreditation program, it is not a stretch to surmise the Center for Disease Control (CDC) may soon be a backdrop for future accreditation standards.

 

GTC CONSULTING, based out of Cincinnati, Ohio is a leading consultancy that provides superior quality and regulatory support services to the pharmaceutical industry. These support service include; NABP Drug Distributor Accreditation (formerly VAWD) assistance, DEA Compliance consultation, Licensing/Registration support, Opioid Litigation support, Proper & Safe Drug Disposal support, and Drug Diversion Investigation & Prevention guidance. For more information contact us by email at info@gtcconsults.com.