Depending on the medication, the product is stable for use even if stored at room temperature for a short period of time. FI℞ST® – 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, 800-449-7449 ext. 119 for further information.
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 FI℞ST® Kits.
Reasons commonly cited by insurance companies for why they no longer cover our product include that the products are: a) not FDA approved, b) not listed anymore by First Databank (FDB), a drug listing service, and/or c) not considered medically necessary.
CutisPharma 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 FI℞ST® Kits provide an important need to patients for whom there are no currently available FDA approved products. Fortunately, FI℞ST® Kits are priced responsibly, in line with typical generics.
FI℞ST® 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 FI℞ST® Kits comply with applicable regulations and compounding guidelines.
Although CutisPharma has not conducted specific studies with our FI℞ST® 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 FI℞ST® Kits.
We recommend you contact your physician or pharmacist with regards to mixing the medication with food or juice. Our data is based on compounding FI℞ST® 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.
Please contact your physician or pharmacist for recommended dosage or administration instructions.
All of the excipients contained in our FI℞ST® 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 Ext. 119.
Please see the information on our product page. If you need additional information, please contact us; 800-461-7449 Ext. 119.
Yes, relevant stability data and documentation to support compliance with USP<795> and Section 503A of the FDCA are available for FI℞ST® Kits. Please contact us and we will provide you with this information. 800-461-7449 Ext. 119