FDA Grants Exemption to Connected Trading Partners - FDA.gov

• If your company needs a California Designated Representative - Wholesaler, or a California Designated Representative - 3PL, they'll need Board-approved training to apply for their Designated Representative license application. 
• Board-approved California Designated Representative courses: - Wholesaler Training Course - 3PL Training Course - Reverse Distributor Training Course 

The FDA has issued another DSCSA exemption, and posted a summary of it, on their Waivers and Exemptions Beyond the Stabilization Period webpage. 

In a nutshell, in the October 9, 2024 exemption, the exemptions apply to any partners who have completed or made documented compliance efforts but still face data exchange challenges. The FDA said it is granting additional time to avoid supply chain disruptions that may impact patients’ access to needed medications.

Go to the Waivers and Exemptions Beyond the Stabilization Period webpage:  https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period

Return Home:  The Designated Representative and Exemptee Blog

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute