FDA announces stabilization period of DSCSA until November 2024
The FDA has announced it does not intend to act on the enforcement of DSCSA until November 27, 2024. While the DSCSA law still goes into effect this November, this creates a 1-year stabilization period that allows manufacturers, distributors, dispensers, and all trading partners within the pharmaceutical supply chain additional time to refine systems and processes necessary to maintain compliance under DSCSA. The FDA has stated that it is critical that everyone must continue to show progress during this discretionary enforcement. This additional timeframe also offers an extended opportunity for education, understanding, and preparation for dispensers.
The Drug Supply Chain Security Act (DSCSA) is a federal law that outlines requirements that must be followed by all entities involved in the pharmaceutical supply chain to enhance unit level tracing of prescription drugs throughout the supply chain – making it easier to protect patients from suspect or illegitimate drugs.
This resource center brings together valuable education to help you better understand what to expect and how to prepare for the upcoming federal regulations.
Preparing for the future of the supply chain
What dispensers should know about DSCSA
Global Location Number (GLN)
A Global Location Number (GLN) is the key to unique location identification. It is a unique number licensed by GS1 US that identifies a single location or business entity in the supply chain. A GLN is required for all locations. GLNs are used to meet the FDA tracing requirements from DSCSA. They also provide critical data in the EPCIS messaging standard that are used in DSCSA transactions. We are loading GLNs from GS1 now, if you don’t already have one, we will provide one.
Electronic Product Code Information Services (EPCIS)
Electronic Product Code Information Services (EPCIS) file is the automated electronic, interoperable data exchange method for serialized data. By default, we will provide this in ABC Order for all AmerisourceBergen customers to receive. If you want the EPCIS proactively sent through a DSCSA solution, please contact us to ensure proper set up.
Returns
There will be an added step to the returns process as distributors will only be able to accept returns purchased through that distributor originally. You will no longer be able to return bulk product that may have been purchased from multiple wholesalers. Returns will require Standardized Numerical Identifier (SNI).
DSCSA standard operating procedures
Consider establishing processes and procedures to investigate and properly handle suspect and illegitimate drugs.
DSCSA support for manufacturers
By streamlining packaging and logistics guidelines for our manufacturer partners, we ensure sites of care receive their products quickly and safely. We have created additional resources to help our
manufacturer partners prepare for the enhanced unit level tracking requirements effective November 2023.
DSCSA in the news
