Pharma distributor warned for DSCSA failings by FDA

A wholesale distributor based in Florida has been sent a warning letter from the FDA for non-compliance with the requirements of the Drug Supply Chain Security Act (DSCSA), including failure to identify and investigate a product later determined to be falsified.

The letter – addressed to Sterling Distributors president Dean Berry – also says that the company has been operating without being properly licensed in Florida, Arkansas or Mississippi, conducted transactions with unauthorised trading partners, and failed to respond to enquiries from federal officials.

"Sterling did not notify FDA of the illegitimate product and was not able to demonstrate that it notified immediate trading partners that Sterling had reason to believe may have also received the illegitimate product," according to the letter.

The identity of the medicine in question has been redacted from the letter, but the text suggests it is a brand that has been the subject of multiple alerts over counterfeits in the last few years.

Other failings include poor record-keeping with regard to transactions, a lack of systems to allow compliance with the DSCSA's verification requirements, and filing an inadequate response to FDA requests for information of how Sterling intends to set its house in order.

The DSCSA requires trading partners in the pharma supply chain to implement traceability systems that allow prescription medicines to be tracked at the pack level, using serialised codes. The objective is to deploy product tracing, identification, and verification measures to improve the security of the supply chain and prevent counterfeit and otherwise illicit medicines from reaching patients.

This is the first warning letter sent by the FDA for non-compliance with the legislation since 2023, when another distributor – Safe Chain Solutions – was also rapped for failing to identify and follow up suspect medicines properly.