In response to growing concern about the security of the nation’s drug supply chain, and to support full enforcement of the Food and Drug Administration’s (FDA) Drug Supply Chain Security Act (DSCSA), VHHA has partnered with InfiniTrak, the premiere cloud-based software-as-a-service DSCSA compliance solution. Reliance on a wholesaler’s portal and services does not guarantee DSCSA compliance. 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. A recently released report from the Office of Inspector General (OIG) details findings from a study conducted as part of a series of examinations of drug supply chain security. A previous study found that selected wholesale distributors exchanged drug product tracing information with other trading partners, and that about half of wholesalers exchanged all required information. The OIG study, involving interviews with 40 dispensers conducted from December 2016-Feburary 2017 about DSCSA readiness found that selected dispensers are only slowly moving toward full implementation of DSCSA’s requirements for the tracing of drug products. Concerns also exist about missing information and a lack of awareness of DSCSA requirements. Other key takeaways include:
- Just 26 of the dispensers received all required elements of the DSCSA.
- The remaining 14 dispensers were missing some of the required elements.
- Two of those dispensers were unaware of the DSCSA and requirements for drug product tracing.
- All 40 dispensers in this study received drug product tracing information in a variety of transmission modes and formats even though electronic formats are now mandatory.
The OIG report, released in March 2018, can be viewed here. InfiniTrak offers an affordable complete compliance solution with discounts available to VHHA members. To learn more or schedule a compliance assessment with the InfiniTrak team, contact Brain Files at 703-298-5121 or e-mail firstname.lastname@example.org.