Resources

Making Compounding Convenient and Consistent

FI℞ST® Kits help facilitate your obligations under 503A and USP <795> to make compounding convenient, and consistent.

• FI℞ST® Kits contain pre-weighed, pre-measured components
• FI℞ST® Kits have API Certificate of Analysis verified by independent laboratory testing
• FI℞ST® Kits have stability and beyond-use (BUD) established by documented testing
• FI℞ST® Kit API’s sourced from, and FIRST Kits manufactured at, FDA-registered facilities

• FDA approval exemption

  

• USP <795> How FI℞ST® Kits help pharmacists

  

• FDCA 503A Policies; How FI℞ST® Kits help pharmacists

  

• Response – First Data Bank

  

USP Resources Toolkit:

• USP <795> GAP Analysis Worksheet

  

• USP <797> GAP Analysis Worksheet << RECENTLY RELEASED

  

• USP <800> GAP Analysis Worksheet

  

To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch