This article, provided by Regina Fullin, Sr. Compliance/Validation Consultant from Compliance Team, Inc., provides an executive summary of the FDA Drug Supply Chain Security Act (DSCSA), passed into law to address a growing problem with counterfeit products which are defined as “adulterated goods” within regulatory guidelines.

With the implementation of the DSCSA, responsibility for assuring the integrity of the pharmaceutical product from the firm’s shipping dock to receipt by the final distribution group (generally a pharmacy) now lies with the company producing and marketing the drug product.

The final outcome of the law, targeted for the year 2023, is a large database (Interoperable System) which will allow tracking of each individual drug product unit from manufacture to delivery to the patient. The objective is to quickly identify suspect product units which can then be quarantined and removed from the market supply chain. As the drug product is transferred through the supply chain, a manifest must be provided naming all previous owners through the release of the product. The drug product unit can then be authenticated by scanning a bar code and verifying against the information provided by the database. Use of individual bar codes for each product unit is to begin in 2017.

The law also provides the need to report any suspicious product to the FDA, along with completing an investigation along the entire supply chain to determine the legitimacy of the drug product. The FDA provides specific guidance on what is needed in these investigations, and requires that investigation data be retained for 6 years following the investigation conclusion.

The law now also pulls operations of pharmacies and pharmaceutical logistics providers under Federal jurisdiction. These business entities have commonly been regulated by state licensure, etc. These operations will now have to incorporate significantly different requirements under the added jurisdiction.  

These are just a few points I gathered from the article. If any of this has peaked your interest, the full article can be read here

Given the needs for labeling addressed in the DSCSA, audits of labeling suppliers, and serialization tools for individual drug product units can be a valuable and beneficial activity. If you have any needs in this auditing area, please reach out to Richard D Schlabach, VP of Global Quality Auditing, at or at 540-208-7151. 

As always, any feedback and/or questions regarding this blog are most welcome.