Notice of Development of Rulemaking
DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION
Drugs, Devices and Cosmetics
RULE NO.: RULE TITLE:
61N-2.036 Application for International Prescription Drug Wholesale Distributor Permit
PURPOSE AND EFFECT: This rule development will consider rules necessary to adopt the form used to apply for participation as an International Prescription Drug Wholesale Distributor in the International Prescription Drug Importation Program as authorized by 499.0285, F.S., 21 U.S.C. § 384 and 21 C.F.R. Part 251.
SUBJECT AREA TO BE ADDRESSED: International Prescription Drug Importation Program
RULEMAKING AUTHORITY: 499.0285
LAW IMPLEMENTED: 499.01, 499.0285
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE REGISTER.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Taya Orozco, Senior Legal Assistant, Office of the General Counsel, Division of Drugs, Devices, and Cosmetics, Department of Business and Professional Regulation; taya.orozco@myfloridalicense.com or (850)717-1177.
THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:
61N-2.036 Application for International Prescription Drug Wholesale Distributor Permit
An international prescription drug wholesale distributor permit is required for any person located outside the United States that engages in the international wholesale distribution of prescription drugs into this state. A person, prior to engaging in any activity for which a permit as an international prescription drug wholesale distributor is required, must file with the Department a complete application on form number DBPR-DDC-_____ , Application for permit as an international prescription drug wholesale distributor, effective _________, adopted and incorporated herein by reference. And comply with all the requirements for permitting in Chapter 499, F.S. and Chapter 61N, F.A.C.
Rulemaking authority: 499.0285, 499.05, 559.79, FS. Law implemented 499.01, 499.0285, FS. History - New __-__-____.