OR WAIT null SECS
© 2025 MJH Life Sciences™ and Pharmaceutical Commerce - Biopharma Business News, Market Insights. All rights reserved.
Addressing the most common concerns surrounding the legislation intended to establish interoperability within the pharma supply chain.
DSCSA stands for the Drug Supply Chain Security Act, and is enforced by the FDA. It was originally signed into law aspart of the Drug Quality and Security Act (DQSA) in November of 2013 as a way to help bolster security and traceability of products passing through the pharma supply chain.
Essentially, it was designed as a unified federal standard for pharmaceutical drug tracing, giving manufacturers, distributors, and dispensers steps to establish an interoperable electronic system to identify and trace prescription drugs at the package level to prevent harmful drugs from entering the US drug supply and protect healthcare providers and patients from counterfeit, unapproved, or potentially dangerous products.
The serialization process is where each drug package is assigned a unique identifier-combined that enables end-to-end visibility from the manufacturer to the end consumer.
GS1’s global standards such as EPCIS (electronic product code information services) are considered the go-to. Global location numbers—GLNs—are used to track product location.
Official documentation from the FDA notes that:
“To be considered an authorized trading partner, a manufacturer or repackager must have a valid registration in accordance with section 510 of the FD&C Act and accept or transfer direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser. To be considered an authorized trading partner, a wholesale distributor must have a valid license under State law or section 583 of the FD&C Act, in accordance with section 121 582(a)(6) of the FD&C Act , comply with the licensure reporting requirements in section 122 503(e) of the FD&C Act, as amended by DSCSA, and accept or transfer direct ownership 123 of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser.
“Similarly, to be considered an authorized trading partner, a 3PL must have a valid license under State law or section 584(a)(1) of the FD&C Act, in accordance with section 582(a)(7) of the FD&C Act, comply with the licensure reporting requirements under section 584(b) of the FD&C Act (21 U.S.C. 360eee-3), and accept or transfer direct possession of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser. A dispenser must have a valid license under State law and accept or transfer direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser.”
Yes it has, several times before.
Most recently, On Oct. 9, 2024—49 days before the end of the one-year stabilization period under the DSCSA—the FDA issued an exemption for eligible trading partners that will continue to delay enforcement regarding compliance with the law’s final enhanced drug distribution security requirements.
The exemption duration varies by partner type:
The general mood and sentiment from around the sector is that data is being exchange at a much higher rate. Most of the distributors and manufacturers are saying that they’re we’re fully connected with most, if not all their customers and that data is actually moving.
Related Content:
