16162060, 61N-1.028 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 16162060

Notice of Development of Rulemaking

Department:

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Division:

Drugs, Devices and Cosmetics

Chapter:

REGULATIONS FOR DRUGS, DEVICES AND COSMETICS

Overview

RULE:

61N-1.028	Product Tracking and Tracing – Definitions
61N-1.029	Product Tracking and Tracing – Manufacturer Requirements
61N-1.030	Product Tracking and Tracing – Wholesale Distributor Requirements
61N-1.031	Product Tracking and Tracing – Dispenser Requirements
61N-1.032	Product Tracking and Tracing – Repackager Requirements

PURPOSE:

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

SUBJECT:

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:

499.002, 499.0121, 499.05, 499.052, FS.

PRINT PUBLISH DATE:

6/30/2015 Vol. 41/126

RELATED STATUTES
AND LAWS:

499.05, 499.0121, FS., 499.002, 499.0121, 499.05, 499.052, FS.

OVERSIGHT COMMITTEE:

Joint Administrative Procedures Committee
Florida Administrative Law Central Online Network (F.A.L.C.O.N.)

RELATED COURT CASES:

Division of Administrative Hearings

FEDERAL eRULEMAKING
WEB PORTAL:

Regulations.gov

HOW TO LINK TO
THIS NOTICE:

http://flrules.org/gateway/ruleno.asp?id=61N-1.028&PDate=6/30/2015&Section=1

REFERENCE MATERIALS:

No reference(s).

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