GET THE SCOOP ON THE NEWEST CHANGES TO DSCSA EXEMPTIONS

Inmar Intelligence | April 6, 2023

DCSCA exemptions video

We all know the Drug Supply Chain Security Act (DSCSA) is changing how the industry operates, but even after full enactment, it won’t be a one-time change. Especially when it comes to what is or isn’t exempt. 

WITH THE PANDEMIC WANING, CERTAIN EXEMPTIONS ARE ENDING.

Health and Human Services has announced their official Public Health Emergency (PHE) will end May 11th, 2023. Because of this, DSCSA exemptions for certain COVID-19 practices and products are drawing to a close. Once the PHE has ended, it’ll be up to you to ensure these previously exempt products meet current DSCSA standards.

THE DSCSA IS SHIFTING INTO HIGH GEAR, WHICH MEANS YOU’VE GOT TO STAY ON YOUR TOES. 

Compliance requirements are about to be even more stringent with full implementation set for November 27th. It's vital you keep an eye on any guidance released by manufacturers and the FDA for true product exemption. 

Get some advice from a trusted source! Inmar’s own DSCSA industry expert, Dwight de Vera, VP of Product Strategy, Healthcare Intelligence, is reviewing key requirements you need to know to cover your staff, patients, and pharmacy. 

WATCH OUR VIDEO TO LEARN MORE ABOUT THESE AND OTHER DSCSA EXEMPTIONS!

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Join us for additional guidance and a demo of RxTransparent, our DSCSA solution. Register Now!

 

Disclaimer: The FDA continues to release industry guidance periodically, but this document will not be updated regularly or in response to any specific updates. Accordingly, this document has been prepared for educational and information purposes only. The information in this document does not constitute legal advice or legal opinions on any specific matters. No person should act or fail to act on any compliance matter based on the contents of this document. For FDA updates regarding exemptions, click here.

 

Disclaimer: This content was developed prior to FDA’s establishing a one-year stabilization period to give trading partners additional time to meet the DSCSA 2023 requirements. Per the FDA “This period is not intended to provide, and should not be viewed as providing, a justification for delaying efforts to comply with the DSCSA”