Florida’s final submission: November 2023 documents for its Canadian drug importation program

In January 2024, PSM filed a FOIA request asking the state of Florida for a copy of the final SIP application it submitted to the FDA in November 2023. These are the documents that PSM received:

• Updated SIP Application
• SOP 2002 Handling, Storage, Packing, & Distribution
• SOP 7003 Prescription Drug Returned Merchandise
• SOP 7005 Prescription Drug DSCSA Track and Trace Regulatory Requirements
• WI 600.03 Prescription Drug DSCSA Track/Trace
• WI 600.04 Prescription Drug Customer Setup
• WI 600.09 Prescription Drug Relabeling Requirements
• WI 600.27 Prescription Drug Vendor Returns and Quarantine Shipping
• AHCA response tracker

PSM confirmed that these redlined documents were the documents submitted by AHCA and approved by the FDA. If you look at the change history section, there are changes from November 16, 2024, the date of final approval.