FAQs
-
Are FIRST® Kits FDA Approved?
FIRST® Kits are not required to be FDA approved. They are considered bulk ingredients for pharmacists to compound medications for patients under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA), and as such, are exempt from FDA approval.
-
Do you have Certificates of Analysis and/or stability data on file for your products?
Yes, relevant stability data and documentation to support compliance with USP<795> and Section 503A of the FDCA are available for FIRST® Kits. Please contact us and we will provide you with this information. 800-461-7449
-
How do I order a FIRST® Kit?
FIRST® Kits are available to order for your pharmacy through most wholesalers. For more information please see the ordering information on each product page on our website or contact your local wholesaler.