DSCSA Inspections and Verification Inquiries: What Dispensers Need to Know
August 6, 2015
DSCSA lot-level requirements have been in full effect for dispensers since July 1, 2015. Pharmacies, hospitals, clinics, and other dispensers should be prepared for both inspections and verification inquiries. Read on to 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: Dispensers could be inspected for DSCSA by a variety of officials. The FDA, who has the responsibility for implementation of DSCSA and jurisdiction over monitoring compliance, could perform a random compliance check. State officials may also inspect your business.
Inquiries: An official request for information or verification inquiry may be conducted by the FDA or an appropriate federal or state official when investigating potentially suspect or illegitimate products or in certain recall situations.
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 may pick a product off your shelves and ask to see the DSCSA Transaction History, Information and Statement (T3) for that product. They may look at the T3 to ensure it contains the required data elements and meets a certain format. The inspector may also ask you to explain how you know that the specific T3 you produced goes with the specific product they selected. Finally, you may be asked to describe the processes you have in place to meet certain requirements such as archival and retrieval of T3 documentation. This may include a spot check request to demonstrate these processes by asking to see all the archived T3 for product that meets given criteria, like a specific NDC.
Inquiries: Verification inquiries will be focused around the attributes of the product under investigation. The law doesn’t describe details around an inquiry and the FDA hasn’t provided specific guidance on how an inquiry may be performed, but we can make certain assumptions based on the definition of a suspect product. An investigation may be initiated into any product where there is reason to believe it may be potentially counterfeit, diverted, stolen or adulterated, may be part of a fraudulent transaction or appears otherwise unfit for distribution. So, you may be asked to produce documentation for product based on a variety of different criteria related to the date in the Transaction History, including but not limited to:
- Identified by a given NDC
- Purchased from a specified upstream partner
- Received during a given date range
- Sold, loaned, or bartered to another dispenser
- 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 corporate offices, centralized distribution facilities or one of your dispensing locations where product is physically located.
Why would my company be inspected?
Inspections: Inspections can occur to confirm that dispensers 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. Request for information inquiries may also be initiated in the event of a product recall.
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 serve patients. In addition, if you loan, barter, or resell product and the outbound T3 that you provided contained inaccurate data, that may place your company at risk for further sanctions.
Inquiries: If you are unable to produce the required compliance documentation in a request for information or verification inquiry, you may be found not in compliance and subject to the consequences as noted above.
More importantly, by being unable to produce or verify the required DSCSA documentation, you are in effect adding evidence to the inquiry about the potentially suspect nature of that product. At minimum, this may result in the product being quarantined while an internal investigation is conducted. But it may also lead to “false positive” findings whereby you as a dispenser are required to initiate an investigation in conjunction with the suppliers of that product even if the product was truly legitimate. This may force your suppliers to 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.
Inquiries: Official verification inquiries will happen quickly after counterfeit, diverted, or otherwise questionable product is suspected. Authorities will want to move rapidly to increase their chances of apprehending the responsible parties.
The bottom line is, you never know when an investigation may occur, and need to be prepared for it to happen at any time.