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 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. This study is the second in a series of Office of Inspector General (OIG) examinations of drug supply chain security, each following the implementation of various DSCSA provisions. The previous study found that selected wholesale distributors exchanged drug product tracing information with other trading partners and about one-half of wholesalers exchanged all required information. Future OIG work will test whether drug product tracing information can be used to trace drug products through the entire drug supply chain. 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 drug dispensers received at least some drug product tracing information from their trading partners, and 26 of these dispensers 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 Drug Supply Chain Security Act (DSCSA) and requirements for drug product tracing. The DSCSA requires that dispensers receive complete tracing information before accepting ownership of a drug product. Although dispensers are generally implementing the requirements for drug product tracing, 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. Complete tracing information for drug products should help the Food and Drug Administration (FDA), State agencies, and other Federal agencies investigate and identify harmful drugs in the supply chain to prevent further distribution and facilitate efficient recalls of drugs. The 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 requires a uniform transmission mode or format for the exchange of drug product tracing information. What OIG Recommends. 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 that dispensers understand their responsibilities to receive complete drug product tracing information from trading partners before taking ownership of drug products. FDA concurred with our recommendation.
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