Probuphine® (buprenorphine) is only available through the Probuphine Risk Evaluation and Mitigation Strategy (REMS) Program, a restricted distribution program. Only prescribers and pharmacies enrolled in the program can prescribe, insert/remove, dispense and receive Probuphine. Before Probuphine is provided, pharmacies must:
- Designate an authorized representative to carry out the certification
process and oversee implementation and compliance with the REMS
Program on behalf of the pharmacy.
- Have the authorized representative enroll in the REMS Program by
completing the Pharmacy Enrollment Form and submitting it to the REMS
- Train all relevant staff involved in dispensing that Probuphine is
dispensed only to healthcare settings in which a certified prescriber is
practicing and that the drug is not dispensed directly to the patient.
- Establish processes and procedures to verify that Probuphine is provided
to a healthcare setting in which a certified prescriber is practicing and
the drug is not dispensed directly to the patient.
- Verify that the prescriber who will receive the drug is certified to prescribe Probuphine.