FDA Publishes DSCSA-Related Guidance on Verification Systems

• California Designated Representative Training (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy
• Sign-up for a course now, for:
     Wholesalers | 3PL | Reverse Distributors

Updated October 6, 2025

You might also be interested in a collection of the FDA's DSCSA-related guidances, all in one location:

Drug Supply Chain Security Act Law and Policies - FDA.gov

- - - original post follows below - - -

According to this newly published FDA guidance:

Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry (PDF)

"Certain trading partners (manufacturers, wholesale distributors, dispensers, and repackagers) are required to have verification systems in place" . . .

Background  

Section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54), established requirements to facilitate the tracing and verification of certain prescription drug products through the U.S. pharmaceutical distribution supply chain.

FDA is issuing this guidance to describe FDA’s interpretation of the requirements of section 582 of the FD&C Act regarding verification systems. This guidance provides recommendations for a robust verification system for the determination, quarantine, and investigation of suspect products, as well as the quarantine, notification, and disposition of illegitimate products.

Return Home:  The Designated Representative and Exemptee Blog

-------------

California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy

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