Waivers and Exemptions Beyond The Stabalization Period

The FDA recently determined that Small Dispensers could be exempt from the Nov 2024 DSCSA requirements.

Below is a link for the FDA information on the waivers and exemptions.


PRS/Advasur–One of our partners through FPN– has put together a helpful flyer and FAQ Doc that better explains the exemptions (see links below). It is important to note that even if a pharmacy feels they qualify, they need to apply for exemption, they are not automatically exempt just because they meet the qualifications.

DSCSA Extension Clarification

Important FDA Update Flyer