Steps for Pharmacy Certification

All inpatient and outpatient pharmacies must be certified in the Clozapine REMS Program in order to purchase and dispense clozapine. Certification requires the identification of an authorized representative for the pharmacy to complete the certification process. The authorized representative must ensure all pharmacists with privileges to dispense understand that clozapine is only available to certified pharmacies through the Clozapine REMS Program.

Pharmacy Staff must enroll in the Clozapine REMS Program to obtain a Predispense Authorization (PDA) from the Clozapine REMS Program Website, to enter absolute neutrophil count (ANC), verify the prescriber is certified, or verify the patient is enrolled. If the pharmacy is a non-switch pharmacy, to comply with the REMS the pharmacy staff will either need to obtain a PDA by calling the program or by signing in to the website. For more information on the Pharmacy Staff enrollment process, please go to Pharmacy Staff Enrollment.

Certification in the Clozapine REMS Program includes the following four steps:

1. Enroll: Complete the Enrollment Form (name, address, NPI, DEA)
2. Educate: Review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
3. Assess: Successfully complete the Clozapine REMS Knowledge Assessment for Healthcare Providers
4. Implement: Implement the necessary staff training and processes to comply with the Clozapine REMS Program requirements
If your browser closes during certification, you can come back to the same point in the process.

Please use the Begin Now button to start your certification today.

For additional information about the Clozapine REMS Program, please call 844-267-8678.