4433693, 64F-12.001 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 4433693

Notice of Proposed Rule

Department:

DEPARTMENT OF HEALTH

Division:

Division of Family Health Services

Chapter:

REGULATIONS FOR DRUGS, DEVICES AND COSMETICS

Overview

RULE:

64F-12.001

General Regulations; Definitions (Transferred)

PURPOSE:

The 2006 Florida legislature enacted session law 2006-310, amending Chapter 499, Part I, F.S., which changed requirements for prescription drug pedigrees in some instances; added a statutory provision authorizing drop shipment of prescription drugs in certain situations to allow an end user to obtain prescription drugs directly from the manufacturer without first obtaining a pedigree paper; authorized a cancer drug donation program. It is the purpose of this rule to clarify what is meant by specific terms used to address the changes, address other definitions, including but not limited to defining terminology related to common carriers.

SUMMARY:

The proposed amendments will provide a definition for statutory and rule terms and define the terms “directly from the manufacturer”, “intracompany transfer”, “pedigree”, “point of origin” “specific unit of a prescription drug”, “usual course of business as carriers” and “affiliated group”. The changes will make the definitions set forth in this rule section applicable to both Chapter 64F-12, Florida Administrative Code and to Chapter 499, Florida Statutes.

RULEMAKING AUTHORITY:

499.05, 499.024, 499.025(5), 499.003(31), 499.01(6), 499.03(4), 499.0121(6), 499.0122(2), 499.014(5), 499.013(3), 499.012(12) FS.

LAW:

499.003, 499.004, 499.005, 499.0054, 499.0057, 499.006, 499.007, 499.008, 499.009, 499.01, 499.012, 499.0121, 499.0122, 499.013, 499.014, 499.015, 499.023, 499.024, 499.025, 499.028, 499.03, 499.033, 499.035, 499.039, 499.041, 499.05, 499.051, 499.052, 499.06, 499.066, 499.067, 499.069, 499.61, 499.62, 499.63, 499.64, 499.65, 499.66, 499.67, 499.71, 499.75, 499.081 FS.

PRINT PUBLISH DATE:

8/3/2007 Vol. 33/31

COMMENTS:

From 8/3/2007 To 8/24/2007 (21 Days)
The public comment period for this notice has already expired.

REFERENCE MATERIALS:

No reference(s).

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