Drug Supply Chain Security: Dispensers Received 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 the security of this supply chain, the Drug Supply Chain Security Act (DSCSA) requires trading partners in the drug supply chain to create a record of each drug product transaction. The FDA can then use such records to investigate suspect and illegitimate drug products and potential diversion.

HOW OIG DID THIS REVIEW

Between December 2016 and February 2017, we interviewed 40 dispensers. These dispensers varied in size and type and included independent retail pharmacies, chain retail pharmacies, and small and large hospital pharmacies. We requested that dispensers submit examples of drug product tracing information provided by their trading partners.

WHAT OIG FOUND

We found that all 40 selected dispensers received at least some drug product tracing information from their trading partners, and 26 of these received all required elements of this information. The remaining 14 dispensers were missing a few of the required elements. Two of these dispensers were unaware of the DSCSA and requirements for drug product tracing. DSCSA requires that dispensers receive complete tracing information before accepting ownership of a drug product. Although dispensers are generally implementing these requirements, missing information and a lack of awareness of DSCSA requirements raise concerns that a complete tracing record for a drug product may not always be available to support investigations of suspect and illegitimate drug products in the supply chain.

The 40 dispensers in this study received drug product tracing information in a variety of transmission modes and formats. This variety is a result of dispensers and their trading partners using different systems rather than adopting a standardized way to exchange this information. Neither the DSCSA nor FDA guidance require the exchange of drug product tracing information in the same way.

WHAT OIG RECOMMENDS AND HOW THE AGENCY RESPONDED

To facilitate dispensers' compliance with the DSCSA, we recommend that FDA offer educational outreach to dispensers where appropriate. Specifically, we recommend that FDA provide education to ensure dispensers understand their responsibilities to receive complete drug product tracing information from trading partners before taking ownership. FDA concurred with our recommendation.