Qsymia is Only Available Through Certified Pharmacies
To become a certified pharmacy, the Authorized Representative must:
- Carry out the certification process and oversee implementation and compliance with the Qsymia REMS on behalf of the pharmacy
- Complete the Pharmacy Training
- Complete the Pharmacy Enrollment Form and submit it to the Qsymia REMS
- Train all relevant staff involved in dispensing on the risks associated with Qsymia and the requirement to provide the Medication Guide and Risk of Birth Defects with Qsymia patient brochure using the Pharmacy Training
- Establish processes and procedures to provide the Medication Guide and Risk of Birth Defects with Qsymia patient brochure to each patient each time the drug is dispensed
Before dispensing, all pharmacy staff must:
- Provide the patient with the Medication Guide and the Risk of Birth Defects with Qsymia patient brochure through the processes and procedures established as a requirement of the Qsymia REMS
At all times, all pharmacy staff must:
- Not distribute, transfer, loan, or sell Qsymia
- Maintain records of standard operating procedures, training, and providing the Medication Guide and the Risk of Birth Defects with Qsymia patient brochure
- Maintain and submit compliance reports to the Qsymia REMS
- Comply with audits carried out by VIVUS to ensure that all processes and procedures are in place and are being followed
- Have a new Authorized Representative enroll in the Qsymia REMS by completing the Qsymia REMS Pharmacy Training and the Pharmacy Enrollment Form
The list of certified pharmacies will be updated within 5 business days after a new pharmacy is certified and eligible to dispense. Prescribers and patients will be able to use a "Certified Pharmacy Locator" tool to identify certified pharmacies in their area.