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PHARMACIES

Outpatient Pharmacy Requirements

How do I become certified to dispense FINTEPLA?

  1. Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the pharmacy.
  2. Have the authorized representative review the Pharmacy Guide and REMS Program Overview.
  3. Have the authorized representative enroll in the REMS by completing the Outpatient Pharmacy Enrollment Form and submitting it to the REMS.
  4. Train all relevant staff involved in dispensing FINTEPLA on the REMS requirements using the Pharmacy Guide.

To Ensure Compliance with the FINTEPLA REMS Requirements, Pharmacies must:

Before dispensing FINTEPLA

  1. Obtain authorization to dispense by contacting the REMS to verify that the prescriber is certified, and the patient is enrolled, and authorized to receive the drug.

To maintain certification to dispense

  1. Have the new authorized representative enroll in the REMS by completing the Outpatient Pharmacy Enrollment Form if the authorized representative changes.

At all times

  1. Not distribute, transfer, loan, or sell FINTEPLA, except to certified pharmacies.
  2. Maintain records of dispensing information.
  3. Maintain records that all processes and procedures are in place and being followed.
  4. Maintain records documenting staff’s completion of REMS training.
  5. Comply with audits carried out by Zogenix, Inc. or a third party acting on behalf of Zogenix, Inc. to ensure that all processes and procedures are in place and are being followed.

 

Inpatient Pharmacy Requirements:

How do I become certified to dispense FINTEPLA?

  1. Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS requirements on behalf of the pharmacy.
  2. Have the authorized representative review the Pharmacy Guide and REMS Program Overview.
  3. Have the authorized representative enroll in the REMS by completing the Inpatient Pharmacy Enrollment Form and submitting it to the REMS.
  4. Train all relevant staff involved in dispensing FINTEPLA on the REMS requirements using the Pharmacy Guide.

To Ensure Compliance with the REMS Requirements Pharmacies must:

Before dispensing FINTEPLA

  1. For patients initiating treatment: Obtain authorization to dispense each prescription by contacting the REMS to verify that the prescriber is certified, and the patient is enrolled and authorized to receive the drug.
  2. For patient continuing treatment: Obtain authorization to dispense each prescription by contacting the REMS to verify that the patient is enrolled and authorized to receive the drug.

At discharge

  1. Dispense no more than 15 days’ supply.

To maintain certification to dispense

  1. Have the new authorized representative enroll in the REMS by completing the Inpatient Pharmacy Enrollment Form if the authorized representative changes.

At all times

  1. Not distribute, transfer, loan, or sell FINTEPLA.
  2. Maintain records of dispensing information
  3. Maintain records that all processes and procedures are in place and being followed.
  4. Maintain records documenting staff's completion of REMS training.
  5. Comply with audits carried out by Zogenix, Inc. or a third party acting on behalf of Zogenix, Inc. to ensure that all processes and procedures are in place and are being followed.