DSCSA Inspections Have Begun

This week, TraceLink was contacted by a specialty pharmacy and wholesale distribution client following a DSCSA inspection of their company by the Arizona State Board of Pharmacy. The inspectors wanted to review the Transaction History of drug products at an Arizona facility. As reported by our client, the inspectors were particularly focused on reviewing how specific Transaction Information fields across the Transaction History, such as "Transfer From" and "Transfer To", were populated and represented in the TraceLink system. The inspectors commented that they had a different opinion than the FDA on the documentary requirements.

This news highlights that inspections have begun, and that DSCSA compliance is not just the purview of the FDA but will also be examined by state and other government officials. It raises the question of how actively state entities will monitor compliance, and if different states will have different criteria for their reviews.

It also demonstrates that these examinations will likely go beyond simply confirming that businesses possess compliance documents. It proves that these kinds of checkups will actually evaluate – and question -- the detailed information that is required under DSCSA. This is a situation that we saw as a common occurrence during the Florida pedigree days when inspectors showed up to interrogate compliance documentation and even question the visual layout of the fielded data.

The advent of inspections marks a new chapter in DSCSA Implementation. It serves as a reminder to the industry that your business may be held accountable at any time now and underscores the importance of having a DSCSA compliance solution in place before the FDA’s May 1 enforcement date.