Announcements from the FDA
Waivers and exemptions beyond the stabilization period
On June 12, 2024, the FDA announced exemptions for small dispensers from certain requirements of section 582 of the FD&C Act until November 27, 2026, while those who do not meet this exemption can request a waiver, exception, or exemption if they have concerns about readiness or patient access.
Stabilization period of DSCSA until November 2024
The FDA has announced it will not enforce DSCSA until November 27, 2024, allowing an additional year for manufacturers, distributors, dispensers, and trading partners to refine their systems and processes while continuing to show progress and prepare for compliance.
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. Cencora is actively participating in an industry-wide GLN cleanup led by GS1 to reconcile and remove duplicate GLNs created over the past year, and any changes to GLNs will be reflected in ABC Order.
DSCSA Reporting
Electronic Product Code Information Services (EPCIS), also known as the DSCSA report, file is the automated electronic, interoperable data exchange method for serialized data. By default, we will provide access to the DSCSA report in ABC Order for all Cencora customers. Alternatively, you can work with a third-party vendor solution to have the EPCIS file proactively sent.
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). The new returns process still goes into effect November 27, 2024 despite any exemptions.
DSCSA standard operating procedures
Consider establishing processes and procedures to investigate and properly handle suspect and illegitimate drugs. If you qualify for the small dispenser exemption or have submitted a Waiver, Exception, or Exemption (WEE) application, you have additional time for SOPs to be in place.
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.
