Category Archives: Saleable Returns Verification

DSCSA, FDA, Saleable Returns Verification

Why the FDA Extended The Saleable Returns Verification from 2020 to 2023

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In 2020, most things did not go as planned. Considering the overwhelming impact of the worldwide pandemic, the pharmaceutical industry was far from immune to last year’s instability.

One of the major changes came with the Saleable Returns Verification’s extension. Despite being originally scheduled for a 2020 enactment, the FDA recently announced their plan to extend, yet again, the Saleable Returns Verification enforcement until 2023.

What does this really mean? Well the FDA won’t enforce it. So should you not care? It’s not that simple.

Legal liability

Remember, the law is the law. So the Saleable Returns Verifcation did become a requirement of the law this past November 27th 2020.

Continue reading Why the FDA Extended The Saleable Returns Verification from 2020 to 2023 →
Product Identifier Authentication, Saleable Returns Verification

DSCSA: Saleable Returns Verification

The Healthcare Distribution Alliance (HDA) Traceability Seminar that was held back in early November was so packed with valuable information that I still have a number of topics queued up from that event for RxTrace essays in the future.  Today I want to take a closer look at the results of the Saleable Returns Pilots conducted by the HDA last year to figure out the most efficient way to verify saleable returns.  I discussed the overall project in my report of the Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”) but today I want to focus in on just two of the approaches piloted.  These are:

  • Manufacturer sends to wholesale distributor product identifiers for only the units purchased by that wholesale distributor, and,
  • Verification Router Service (VRS).

Continue reading DSCSA: Saleable Returns Verification →