Pharmacy Owners, Groups & Organizations,

You may be hearing that in a letter dated June 2, 2023, the Healthcare Distribution Alliance (HDA), the trade organization that represents primary pharmaceutical distributors, recommended to the FDA a plan to phase in the last three components of DSCSA after the November 27, 2023 deadline to achieve the prescription drug traceability and security goals of DSCSA. HDA‘s series of recommendations are to address and acknowledge the fact that some wholesalers and manufacturers are not ready to send package-level data to their customers or to track drugs in the supply chain at the individual package level, which takes effect November 27, 2023.

So, what does this mean to pharmacies? There are three main points we want to bring to your attention. First, this is a recommendation, and the FDA may not acknowledge or respond. Second, this DOES NOT have any effect on the requirements of the Act that are currently being enforced. Third, this DOES NOT mean that there will be a delay to the 11/27/23 DSCSA Compliance deadline for the remaining three requirements that comprise the EDDS component of the Act.

HDA’s recommendations would only affect only those portions of DSCSA scheduled to be required in November, NOT the current requirements that will still be in effect and enforceable. Thus, every Pharmacy dispenser still needs a solution to these DSCSA requirements:

  • License and registration verification and validation of authorized trading partners (ATPs)
  • Verifying the receipt of products with the product identifier (NDC, Serial Number, Lot Number, and Expiration Date) in a human-readable and 2D machine-readable barcode format
  • Receive and verify the 3Ts from ATPs
  • Maintain 3Ts for six years
  • Conduct investigations of suspect products following DSCSA policy
  • Report illegitimate products to the FDA using proper procedures
  • Respond to information requests from the FDA, State Board of Pharmacy, and other regulators
  • Additionally, you should have DSCSA Compliance Policies and Procedures as well as employee training

To summarize, there is currently no delay to DSCSA implementation, and you still need to be compliant with the existing DSCSA requirements today and the upcoming DSCSA EDDS requirements on 11/27/2023.

And remember, PRS and Advasur have the solution to all dispenser DSCSA requirements, and our program is endorsed by Pharmacy buying groups and organizations representing over 80% of Independent Pharmacies.

As always, we will continue to closely monitor DSCSA developments and update you with the most current and correct information.

Please contact us with any questions you may have about DSCSA.