The FDA guidance letter is a delay in enforcement with the expectation pharmacies continue to progress toward DSCSA implementation. The FDA would like all trading partners to make full use of the stabilization period to complete implementations and make sure they work well.
This stabilization period does not push back the deadline, nor does it prevent State Boards of Pharmacy from undertaking audits to ensure that pharmacies have systems in place by November 27, 2023.
It is also very important to note that stopping efforts in place now leave pharmacies exposed to both the first Phase of the law, as well as doing the opposite of the FDA’s recent guidance.
To read the full FDA guidance letter click here