International Wholesale Distributor Permit - Status Update
Posted on: Oct 05, 2020

Prescription Drug Importation Programs

Legislation enacted under CS/HB 19 authorizes the establishment of two new programs to import safe and effective, FDA approved prescription drugs into the state of Florida: the Canadian Prescription Drug Importation Program under the Agency for Healthcare Administration and the International Prescription Drug Importation Program under the Department of Business and Professional Regulation. Additionally, the bill contains various provisions and requirements to ensure compliance with federal law and to set safety standards consistent with the current federal requirements. While the effective date of this bill is July 1, 2019, federal approval of both programs must be obtained before either becomes active.

Upon federal approval, the Canadian Prescription Drug Importation Program will focus on the importation of drugs for programs such as Medicaid, the Department of Corrections and county health departments. For additional information related to the Canadian Prescription Drug Importation Program, please visit the AHCA website.

Upon federal approval, the International Prescription Drug Importation Program will allow prescription drug importation from other countries in addition to Canada through the creation of two new permit types and a registration process. The Department of Business and Professional Regulation will be responsible for implementing a new international prescription drug wholesaler permit and The Florida Department of Health will be responsible for creating a new international export pharmacy permit. In addition, a registration process for participating importers and exporters will be created by the Department of Business and Professional Regulation. For additional information related to the international export pharmacy permit, please visit the Florida Department of Health website.

The DDC has sent the new rules over to the budget deparment and it should be reviewed over the next 3 months.  The State is moving forward as swiftly as possible to get this process up and running. 

Call us for further consultation on this new permit type.