Per FDA requirements, in order to order, stock, and dispense TIKOSYN new pharmacies are required to secure a one-time certification. Even if your institution has been certified prior to 2011, you are required to secure a one-time recertification. To become (re)certified you must review the following materials:
And sign the Institution Certification Form:
NOTE: A designated representative must complete and sign this form as part of the TIKOSYN REMS requirement.
When you have reviewed all the materials, please print, sign, and mail or fax back the Certification Form. The fax number is 1-800-788-2637. After the Certification Form is received, you will receive written confirmation of receipt. In addition, before dispensing TIKOSYN, you are required to confirm that the prescriber has been certified.
Before dispensing TIKOSYN, the pharmacist is required to confirm that the prescriber has been certified. In addition, the institution must agree to stock and provide patients prior to discharge a free 7-day (14 count) supply of TIKOSYN and the Medication Guide. As a contingency, if the initiating/re-initiating institution does not have outpatient licensing privileges to dispense the free 7-day supply of TIKOSYN, the institution will ensure the patient's take home prescription is ordered and filled at a retail pharmacy prior to patient discharge.
Should you have any questions regarding the TIKOSYN certification program, please call 1-877-TIKOSYN.