Drug and device facilities seeking Drug Distributor Accreditation, or DDA (formerly known as VAWD), may notice that the National Association of Boards of Pharmacy (NABP) has recently revamped the accreditation process. These changes became effective in January 2022.
Previous applicants may recall the former process as first completing an e-profile, then submitting the application and written policies and procedures. This was followed by NABP’s Compliance Assessment (review of license, source, and customer lists) and policy and procedure review. Once that all took place, a surveyor would conduct a scheduled on-site visit.
The newly implemented pathway to accreditation requires facilities to undergo a Supply Chain Inspection (SCI) prior to submitting a DDA application. The SCI is estimated to occur within 8 weeks. In this new process, not only does the facility inspection come before the Compliance Assessment, but the inspection is also unannounced. Once the SCI is complete, the facility will receive an inspection report and an eligibility status. This is where the facility will find out if they are eligible to submit a DDA application, or if NABP will require some corrections to the facility and operations prior to becoming eligible to apply. Once deemed eligible, a DDA application may be submitted, after which the Compliance Assessment and policy and procedure review will take place.
NABP has referred to the new process as streamlined and has indicated that facilities will have advantages that were not available under the old process. For example, facilities will have a defined time window within which to expect a SCI once they’ve applied for a SCI. Also, the detailed inspection report will illustrate where improvements need to be made, which will allow the facility to come into program compliance prior to applying for DDA. The SCI results also allow for facilities who did not have any, or had very minor deficiencies noted, to become eligible to submit the DDA application sooner than a facility who must first correct some more significant facility or operational deficiencies.
While the pathway has changed, REAL Solutions Group has the expertise to guide you through the accreditation process. Contact us today to learn more.