FAQs

1. I did not refrigerate my medication, can I still use it?

   Depending on the medication, the product is stable for use even if stored at room temperature for a short period of time. FIRST® – Omeprazole will remain stable at room temperature for at least 24-48 hours.

   If you find that your medication was stored at room temperature beyond 24-48 hours, place the medication back in the refrigerator and call us at, 1-800-461-7449 for further information.

2. Why aren’t your products covered by insurance anymore?

   Unfortunately, there have been several substantial changes in insurance coverage of compounded prescriptions over the last few years. In 2014, several large insurers decided to stop coverage of compounded prescriptions or introduce significant restrictions on coverage. Subsequently, in 2016 many insurers decided to stop coverage specifically on compounding kits such as FIRST® Kits.

   Reasons commonly cited by insurance companies for why they no longer cover our product include that the products are: a) exempt from FDA-approval, and/or b) not considered medically necessary.

   Azurity fundamentally disagrees with the actions that insurers have taken to restrict access of valuable compounded medications to the patients that need them. We feel that these actions are unfounded; and FIRST® Kits provide an important need to patients for whom there are no currently available FDA approved products. Fortunately, FIRST® Kits are priced responsibly, in line with typical generics.

3. 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. Please click on this link for a full explanation of regulations governing compounding and how FIRST® Kits help facilitate pharmacists obligations under applicable regulations and compounding guidelines.

4. Can some of your FIRST® Kits (e.g. FIRST® - Omeprazole and FIRST® - Lansoprazole kits be administered via gastrostomy tube (“g-tubes”)?

   Although Azurity Pharmaceuticals, Inc. has not conducted specific studies with our FIRST® Kits using this route of administration, we understand that it is common practice to administer compounded oral liquid products via g-tube whether compounded traditionally or using our FIRST® Kits.

5. Can I mix the medication with food or juice?

   We recommend you contact your physician or pharmacist with regards to mixing the medication with food or juice. Our data is based on compounding FIRST® Kits per our package insert using the components provided in the Kit. We advise pharmacists to use their discretion based on patient need or physician request and ensure that their practice adheres to USP <795> and Section 503A of the FDCA.

6. How should I use this product that I have been prescribed?

   Please contact your physician or pharmacist for recommended dosage or administration instructions.

7. What other ingredients does your product contain, are there any allergens?

   All of the excipients contained in our FIRST® Kits are listed in the package insert; refer to the specific product package insert on our website for details. If you have additional questions, please contact us; 800-461-7449.

8. What is the carbohydrate content of your products?

   Please see the information on our product page. If you need additional information, please contact us; 800-461-7449.

9. 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

10. 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.