The Petitioner is seeking a variance/waiver from the statutory requirement that applicants for the prescription drug wholesale distributor permit or the out-of-state prescription drug wholesale distributor permit name a certified designated ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

The Department of Business & Professional Regulation, Division of Drugs, Devices, and Cosmetics hereby gives notice:

The Petitioner is seeking a variance/waiver from the statutory requirement that applicants for the prescription drug wholesale distributor permit or the out-of-state prescription drug wholesale distributor permit name a certified designated representative. Petitioner asserts that “the sum of Accelis Pharma’s actions do encompass and fulfill the requirements set forth in the statutes for a variance/waiver to be granted in this specific situation.” Accelis is in fact seeking a variance/waiver from Section 499.012 (16), Florida Statutes, which is the statutory provision that requires the certified designated representative for prescription drug wholesale distributors and out-of-state prescription drug wholesale distributors. Thus, Accelis has not fulfilled the requirements for a variance/waiver.

Because Petitioner seeks a variance/waiver from a statutory requirement, the Department is prohibited by law from granting the request. The petition for variance/waiver is therefore denied.

A copy of the Order or additional information may be obtained by contacting: The Department of Business & Professional Regulation, Division of Drugs, Devices, and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399, [phone].