Florida Regulations
Department of Business and Professional Regulation/Division of Drugs, Devices, and Cosmetics
Vol. 47, Issue 11, Florida Administrative Register 2021-01-19 pp.371-372
PUBLICATION DATE: 01/19/2021
ACTION DATE: 01/19/2021
PUBLICATION TYPE: Register

Notice of Development of Rulemaking

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.: RULE TITLE:

61N-2.034 Application for Registration to participate in the International Prescription Drug Importation Program - Exporter

PURPOSE AND EFFECT: This rule development will consider rules necessary to adopt the form used to apply for participation as an Exporter 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.

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 PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

61N-2.034 Application for Registration to participate in the International Prescription Drug Importation Program - Exporter

A registration is required for any person licensed to wholesale prescription drugs by Health Canada and registered with the Food and Drug Administration as a Foreign Seller, to participate in the prescription Drug Importation Program. A person, prior to engaging in any activity for which registration as an exporter in the international prescription drug importation program is required, must file with the Department a completed application on form number DBPR-DDC-_____ , Application for Registration to participate in the International Prescription Drug Program - Exporter, effective _________, adopted and incorporated herein by reference, and comply with all the requirements for permitting in Chapter 499, F.S., 21 U.S.C. § 384(b)-(h), and Chapter 61N, F.A.C.

Rulemaking authority: 499.0285, 499.05, 559.79, FS. Law implemented 499.01, 499.0285, FS. History - New __-__-____.