8494792, 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: 8494792

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 Department proposes to amend the rule section to update revise and modify the definitions for terms used in Chapter 499, Florida Statutes and Chapter 64F-12, Florida Administrative Code. The proposed changes will also include updating statute and rule citations in this section. Some of the revisions will be in response to possible objections from the Joint Administrative Procedure Committee.

SUMMARY:

The rule promulgation will delete the definition for the terms: “Affiliated group”; “Propagation of a drug”; “Specified drug”; Wholesale distribution”; and “Written agreement”. The rule promulgation will add definitions for the terms: “Broker”; “Limited quantities” and “Principal address.” The rule promulgation, in response to possible objections from The Joint Administrative Procedure Committee (JAPC), clarifies the definition of the state “good manufacturing practices” term for drugs and devices. The rule promulgation also materially revises the following terms in this section: “Directly from the manufacturer”; “Established safe and effective indications”; “Intracompany transfer”; “Legend Device or Restricted Device”; “Readily available” and “readily retrievable”; “Sale”; “Separate and distinct cosmetic product”; “Separate and distinct device product”; “Separate and distinct drug product”; “Specific unit of a prescription drug”; and “Verifiable account”.

RULEMAKING AUTHORITY:

499.003(31), 499.024, 499.025(5), 499.01(6), 499.0121(6), 499.0122(2), 499.012(5), (12), 499.013(3), 499.01(2)(g), 499.014(5), 499.03(4), 499.05, 499.701 FS.

LAW:

499.002, 499.003, 499.004, 499.005, 499.0051, 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, 499.04, 499.033, 499.035, 499.039, 499.041, 499.05, 499.051, 499.052, 499.055, 499.06, 499.066, 499.067, 499.069, 499.61, 499.62, 499.63, 499.64, 499.65, 499.66, 499.67, 499.701, 499.71, 499.75 FS.

PRINT PUBLISH DATE:

4/9/2010 Vol. 36/14

COMMENTS:

From 4/9/2010 To 4/30/2010 (21 Days)
The public comment period for this notice has already expired.

REFERENCE MATERIALS:

No reference(s).

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