Tracleer - Food and Drug Administration

The Bosentan Applicants must ensure that healthcare providers, patients, pharmacies, and wholesalers-distributors comply with the following requirements:

Bosentan Applicants must provide training to healthcare providers who prescribe bosentan.
The training includes the following educational material: Prescriber Guide. The training must be available online and hard copy format via fax or mail.

Bosentan Applicants must provide training to pharmacies that dispense bosentan.
The training includes the following educational material: Pharmacy Guide. The training must be available online and hard copy format via fax or mail.

To support REMS operations, Bosentan Applicants must:

1. Authorize the initial (first dose) dispensing for each patient based on receipt of a Patient Enrollment Form and verifying that the prescriber is certified and the pharmacy is certified. If the Patient Enrollment Form is not complete, the patient is not authorized to receive drug until the completed form is received.
For subsequent dispensings: authorize dispensing based on verifying the patient is enrolled, the prescriber is certified, the pharmacy is certified, if counseling is complete, and liver testing is complete or the prescriber authorizes the refill. The patient is not authorized to receive drug until all verification components are complete.
2. Establish and maintain a REMS Website, www.BosentanREMSProgram.com. The REMS Website must include the capability to complete prescriber and pharmacy certification online, the capability to enroll and manage patients online, the capability to verify prescriber certification and patient enrollment online, and the option to print the Prescribing Information, Medication Guide, and REMS materials. All product websites for consumers and healthcare providers must include prominent REMS-specific links to the REMS Website. The REMS Website must not link back to the promotional product website(s).
3. Make the REMS Website fully operational and all REMS materials available through the REMS Website and Contact Center within 60 calendar days of REMS modification (03/03/2026).
4. Establish and maintain a Contact Center for REMS participants at 1-866-359-2612.
5. Establish and maintain a validated, secure database of all REMS participants who are enrolled and certified in the REMS.
6. Ensure prescribers and pharmacies are able to complete the certification process online and by fax.
7. Notify prescribers and pharmacies within one business day after they become certified in the REMS.
8. Ensure prescribers are able to complete the patient enrollment process online and by fax.
9. Ensure prescribers are able to confirm liver testing, and counseling online and by fax by using the Testing and Patient Counseling Reporting Form.
10. Ensure pharmacies are able to document confirmation of liver testing by phone and online.
11. Ensure pharmacies are able to document confirmation of counseling by phone and online.
12. Ensure pharmacies are able to obtain authorization to dispense by phone and online.
13. Ensure the Contact Center or the outpatient pharmacy confirms completion of liver testing and counseling on a monthly basis if the Testing and Patient Counseling Reporting Form has not been received.
14. Ensure the Contact Center reminds prescribers who cannot confirm that testing was completed of the requirement to order and review monthly liver tests.
15. Ensure pharmacies are able to certify as inpatient (including, but not limited to, pharmacies in hospitals, long-term care facilities, prisons, and state psychiatric units) or outpatient pharmacies.
16. Provide certified prescribers access to the database of certified pharmacies and enrolled patients.
17. Provide certified pharmacies access to the database of certified prescribers and enrolled patients.
18. Provide the Prescriber Enrollment Form, Prescriber Guide, Fact Sheet, Patient Enrollment Form, Patient Guide, and the Testing and Patient Counseling Reporting Form to prescribers who:

1. attempt to prescribe bosentan and are not yet certified or
2. inquire about how to become certified

To ensure REMS participants’ compliance with the REMS, Bosentan Applicants must:

19. Verify the name and contact information of the pharmacy’s authorized representative every two years. If different than the current authorized representative on file, the pharmacy is required to certify with a new authorized representative.
20. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: Bosentan Wholesaler-Distributor distribution and Pre-Dispense Authorization; certification of prescribers and pharmacies; authorized wholesalers-distributors; enrolled patients; and audits of certified pharmacies and authorized wholesalers-distributors. These records must be readily available for FDA inspections.
21. Establish and maintain a plan for addressing noncompliance with REMS requirements.
22. Establish and maintain an ongoing annual audit plan for pharmacies and wholesalers-distributors.
23. Monitor prescribers, pharmacies, and wholesalers-distributors on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if noncompliance is identified, including de-certification.
24. Audit 10 pharmacies or one percent (1%), whichever is greater, of newly certified outpatient pharmacies no later than 180 calendar days after the pharmacy is certified in the REMS to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements. Additionally, audit 10 pharmacies or one percent (1%), whichever is greater, of the certified outpatient pharmacies annually to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements. Bosentan Applicants must institute corrective action if noncompliance is identified.
25. Audit 10 pharmacies or one percent (1%), whichever is greater, of newly certified inpatient pharmacies no later than 180 calendar days after the pharmacy is certified in the REMS to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements. Additionally, audit 10 pharmacies or one percent (1%), whichever is greater, of the certified inpatient pharmacies annually to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements. Bosentan Applicants must institute corrective action if noncompliance is identified.
26. Audit all wholesalers-distributors no later than 180 calendar days after the wholesaler-distributor is authorized and annually to ensure that all processes and procedures are in place and functioning to support the requirements of the Bosentan REMS. Bosentan Applicants must institute corrective action if noncompliance is identified.
27. Take reasonable steps to improve operations of and compliance with the requirements in the Bosentan REMS based on monitoring and evaluation of the Bosentan REMS.