Resources

Making Compounding Convenient and Consistent

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

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

• FDA approval exemption

  

• USP <795> How FIRST® Kits help pharmacists

  

• FDCA 503A Policies; How FIRST® Kits help pharmacists

  

USP Resources Toolkit:

• USP <795> GAP Analysis Worksheet

  

• USP <797> GAP Analysis Worksheet

  

• 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