Rosine Imperato, RIA International LLC, 11 Melanie Lane, Unit #17, East Hanover, New Jersey 07936; Based on the foregoing, Petitioner’s questions are answered as follows: A. Can we sell raw materials powders or API’s (sic) to Florida with just a ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

NOTICE IS HEREBY GIVEN that The Department of Business & Professional Regulation, Division of Drugs, Devices, and Cosmetics has issued an order disposing of the petition for declaratory statement filed by Rosine Imperato, RIA International LLC, 11 Melanie Lane, Unit #17, East Hanover, New Jersey 07936 on June 3, 2015. The following is a summary of the agency’s disposition of the petition:

Based on the foregoing, Petitioner’s questions are answered as follows: A. Can we sell raw materials powders or API’s (sic) to Florida with just a certified designated representative license? No. The CDR registration is only done in conjunction with a prescription drug wholesale distributor or out-of-state prescription drug wholesale distributor permit. See, Sections 499.003(43); 499.01(2)(e), and 499.012(16)(a), Florida Statutes. B. What kind of permit do we need to apply for in Florida? Based on the facts as set forth in the Petition, the Petitioner would need a permit to operate as an out-of-state prescription drug wholesale distributor in order to sell prescription API into the State of Florida. See, Section 499.01(2)(e), Florida Statutes. However, if Petitioner meets one of the exemptions described herein, a permit may not be needed, but Petitioner would have to comply with the procedures for obtaining the exemption. C. Is there another application we need to fill out to sell raw materials powders or APIs to Florida? In addition to the out-of-state prescription drug wholesale distributor permit application, which requires a natural person to serve as the designated representative, the applicant would have to be permitted in the state in which it is a resident to engage in the wholesale distribution of prescription drugs. See, Sections 499.01(2)(e) and 499.012(16)(a), Florida Statutes. If Petitioner meets one of the exemptions described herein, Petitioner would have to apply to the Department for the exemption. D. Since you offer a prescription drug wholesale license to brokers who do not sell RX drugs in Florida, do you offer the same to out-of-state brokers? No. The Department does not offer an out-of-state prescription drug wholesale distributor- broker only permit.

A copy of the Order Disposing of the Petition for Declaratory Statement may be obtained by contacting: The Department of Business and Professional Regulation, Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399.

Please refer all comments to: Reginald Dixon, Division Director, The Department of Business and Professional Regulation, Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399.