To adopt and incorporate the federal requirements pertaining to the tracking and tracing of certain prescription drug products.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NOS.:RULE TITLES:

61N-1.028Product Tracking and Tracing – Definitions

61N-1.029Product Tracking and Tracing – Manufacturer Requirements

61N-1.030Product Tracking and Tracing – Wholesale Distributor Requirements

61N-1.031Product Tracking and Tracing – Dispenser Requirements

61N-1.032Product Tracking and Tracing – Repackager Requirements

PURPOSE AND EFFECT: To adopt and incorporate the federal requirements pertaining to the tracking and tracing of certain prescription drug products.

SUBJECT AREA TO BE ADDRESSED: The proposed rule development addresses the product tracking and tracing requirements for entities that engage in the manufacture, repackaging, wholesale distribution, and dispensing of specific prescription drug products falling under Title II, Drug Supply Chain Security Act, of the federal Drug Quality and Security Act.

RULEMAKING AUTHORITY: 499.05, 499.0121 FS.

LAW IMPLEMENTED: 499.002, 499.0121, 499.05, 499.052 FS.

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: Dinah Greene, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 1940 N. Monroe St., Suite 26A, Tallahassee, FL 32399-1047, [e-mail], [phone]

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS NOT AVAILABLE.