A Prescription Drug Wholesale Distributors are required to apply for a permit and a $100,000 surety bond (or other means of acceptable security).
The bond ensures compliance with the requirements of the Florida Drug and Cosmetic Act, and secures payment of any administrative penalties imposed by the Department of Business and Professional Regulation.
Prescription Drug Wholesale Distributors are required to apply for a permit through the Florida Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics.
Applicants must complete the application and pay the permit fee.
Applicants must designate a person to be the "Certified Designated Representative" (CDR) who is at least 18 years of age. The certified designated agent will need to have at least two years of full-time work experience in a licensed pharmacy, must take the state exam on prescription drugs and have a 75% passing score, and must have held a managerial position with a wholesale distributor. The certified designated representative must also be physically present during normal work hours and can only serve as designated representative for one wholesale distributor at a time.
The applicant is required to obtain a $100,000 surety bond. In lieu of a bond, another form of security of equal value must be deposited with the State.
The applicant will need to submit a Personal Information Statement and pass a criminal background check for each of the following individuals: the CDR, the manager of the business, the next four top-ranking employees which can be: a director, trustee, officer, committee member, partner, the applicant or permittee, any person who directly or indirectly controls, manages, or oversees operations, etc.
If applicable, primary wholesalers must complete the Primary Wholesaler Determination Form.
An onsite inspection of the business will be required prior to the permit being issued.
The permit and bond will renew annually.
The premium that you pay for a Florida Prescription Drug Wholesale Distributor Bond is dependent on credit, and personal and business financial statements.
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