DSCSA Inspections & Verification Inquiries: What Wholesalers Should Know
With DSCSA lot level requirements now in full effect, wholesale distributors should be prepared for both inspections and verification inquiries. Learn the basic parameters for both types of investigations so you know what to expect – and what the consequences could be if you are unprepared. Then, click on the blue button to access an additional inspection readiness checklist.
What are inspections and inquiries under DSCSA?
Inspections: Inspections may be performed to verify compliance with DSCSA rules and regulations.
Inquiries: Inquiries may be performed to verify product and transaction information under request for information and verification requirements in DSCSA.
Who will conduct DSCSA inspections or inquiries?
Inspections: Wholesale distributors could be inspected for DSCSA by a variety of officials. The FDA, who has jurisdiction over monitoring compliance, could perform a random compliance check. State officials may also inspect your business if DSCSA compliance is a precondition for their licensure. And if you are VAWD accredited, the National Association of Boards of Pharmacy (NABP) may inspect you; their expectation is that VAWD members comply with DSCSA.
Inquiries: An official verification inquiry may be conducted by an FDA or state official.
What will they inspect?
Inspections: Random compliance checks will not necessarily follow a predictable protocol, but we have some information from both initial DSCSA inspections and Florida Pedigree days to help set expectations.
Inspectors will likely pick a product off your shelves and step through the elements of the law,
Inquiries: Verification inquiries will be focused
- Identified by a given NDC
- Purchased from a specified upstream partner
- Received during a given date range
- Sold to a specified downstream partner
- Belonging to a given lot number
Where might the inspection occur?
Inspections and inquiries: Because regimes are not formally documented, you should expect that an inspection or inquiry could occur at any place that you do business, including both corporate offices or one of your distribution centers where
Why would my company be inspected?
Inspections: Inspections can occur to confirm that wholesale distributors are complying with DSCSA regulations. They may be either a completely random check, or they may be initiated because DSCSA compliance is part of some other requirement with an upcoming deadline, like licensure or accreditation.
Inquiries: Official verification inquiries will be held if there is suspicion of counterfeit, diversion, or other illicit activity with a drug product.
What are the potential consequences?
Inspections: If you are unable to produce the required T3 documentation or it is deemed inaccurate, there are a variety of potential consequences. Under DSCSA, you could potentially be fined and the product without matching T3 could be quarantined, impacting your ability to sell products and meet customer demands. In addition, if outbound T3 that you provided when you sold product contained inaccurate data, that may place your company at risk for further sanctions.
If you are VAWD-accredited, the NABP may suspend your accreditation which could jeopardize your relationship with trade partners and in some states, your license to operate.
Inquiries: Similar to inspections, if you are unable to produce the required compliance documentation,
One concern in the industry is that individual companies’ poor procedures may lead to “false positive” findings: one trade partner’s inability to produce documentation may cause a ripple effect, as their partners must then undergo “unnecessary” investigations with cost, effort, and potential product quarantine consequences.
When might my company be inspected?
Inspections: Random inspections could happen at any time, on very short notice. If your state or federal wholesale distribution license or your VAWD license is up for renewal, you should anticipate an inspection.
Inquiries: Official verification inquiries will happen quickly after counterfeit, diverted, or otherwise questionable product is suspected. Authorities will want to move quickly to increase their chances of apprehending the responsible parties.
The bottom line is, you never know when an investigation may