From now through November 2020, the deadlines for meeting the Drug Supply Chain Security Act (DSCSA) happen every year. The pace of change has accelerated and companies need to remain vigilant to stay compliant. Fortunately, there are three important new DSCSA resources that became available in the last two weeks.
- FDA Guidance: “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act”
This four-page draft guidance document includes FDA’s new definitions for certain words that were used, but not defined, in the original text of the DSCSA. The original DSCSA included the definition of the terms “Suspect Product” and “Illegitimate Product”, but those definitions themselves made use of a number of terms that the FDA has now defined in this guidance, to avoid ambiguity. The terms that are defined here are:
- “Fraudulent Transaction”
- “Unfit for Distribution”
This guidance is particularly helpful for those who need to properly define standard operating procedures for detecting and handling suspect and illegitimate product within manufacturers, repackagers, wholesale distributors and dispensers. Download a copy from the FDA website here. Submit
- FDA Guidance: “Standardization of Data and Documentation Practices for Product Tracing”
This 19-page draft guidance document is intended to help companies standardize the data contained within the transaction documents they are required to exchange under the DSCSA. The required transaction documents under the DSCSA include transaction information (TI), transaction history (TH) and transaction statements (TS). The guidance includes a wide range of direction about different data elements within those documents, as well as under different transaction scenarios, including some that are very specific and detailed.
This guidance is particularly helpful for those who need to understand how certain data elements should be included and formatted under certain circumstances. Every company will need this kind of information to ensure that they can properly understand the DSCSA transaction documents they receive, and are able to construct transaction documents for their shipments that their customers will understand. This includes manufacturers, repackagers, wholesale distributors and dispensers. Download a copy from the FDA website here. Submit .
- Systech’s 2018 DSCSA Infographic: “How to comply with the DSCSA”
It is a concise, graphical explanation of what the DSCSA is, what and when the coming deadlines are and how and why the DSCSA works. The Systech DSCSA infographic is aimed at all members of the supply chain, including drug manufacturers, repackagers, wholesale distributors and dispensers. Download a copy here.
FDA draft guidances contain nonbinding recommendations and they are not for implementation, but they represent the FDA’s current thinking about the topics they cover. In fact, the FDA is asking companies to review these two documents and submit comments to dockets that have been opened for that purpose. Use the links above to submit comments about these documents to the FDA.
In any case, these new resources should be a part of every company’s DSCSA toolkit.