Drug Supply Chain Security: Wholesalers Exchange Most Tracing Information

WHY OIG DID THIS REVIEW

Drug diversion, counterfeiting, and the importation of unapproved drugs may result in potentially dangerous drugs entering the drug supply chain, posing a threat to public health and safety. To enhance drug supply chain security, the Drug Supply Chain Security Act (DSCSA) requires trading partners in the drug supply chain to create a record of each drug product transaction. FDA can then use such tracing records to investigate suspect and illegitimate drug products and potential diversion.

HOW OIG DID THIS REVIEW

We interviewed 31 of 353 wholesalers sampled from FDA's wholesaler database. We asked about how they comply with the DSCSA and challenges they encountered. We also reviewed examples of drug product tracing information provided by each of the 31 wholesalers. These wholesalers were of varying sizes from across the country and included the three largest wholesalers.

WHAT OIG FOUND

We found that all 31 selected wholesalers exchange drug product tracing information. Of these, 17 wholesalers -- including the 3 largest wholesalers that account for more than 80 percent of drug distribution revenue -- exchange all required drug product tracing information. The remaining 14 exchange most elements of drug product tracing information but are missing a few of the required elements. The DSCSA requires the exchange of drug product tracing information for every transaction to create a tracing record for drug products as they move through the drug supply chain. Complete drug product tracing information can improve drug supply chain security by supporting FDA and other appropriate State and Federal agencies' investigations of suspect and illegitimate drug products and potential diversion.

The 31 wholesalers in this study exchange drug product tracing information using a wide variety of transmission modes and formats, taking advantage of the latitude provided by the DSCSA and FDA guidance. Wholesalers may eventually coalesce around one means of exchange as the DSCSA requirements are implemented. However, at this time, a standardized way to exchange this information has not emerged.

Wholesalers also reported that two issues, drug product exemptions and 340B contract pharmacies, create challenges for exchanging drug product tracing information.

WHAT OIG RECOMMENDS AND HOW THE AGENCY RESPONDED

To ensure that all wholesalers comply with the DSCSA, we recommend that FDA offer technical assistance where appropriate. Specifically, we recommend that FDA provide technical assistance to wholesalers regarding direct purchase statements, exempt drugs, and exchanging drug product tracing information for transactions involving 340B-covered entities and 340B contract pharmacies. FDA concurred with all three of our recommendations.