292763, 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: 292763

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)
64F-12.015	Licensing, Application, Permitting (Transferred)

PURPOSE:

The proposed amendment to Rule 64F-12.001, F.A.C., adds the definition of “propagation” as this term appears in the definition of “manufacture” at Section 499.003(27), F.S. The definition clarifies that the manufacturing process includes the various establishments that may be part of that process, including a private relabeler and an affiliated or contract distribution center. The proposed amendment to Rule 64F-12.015, F.A.C., expands the scope of the on-site inspection requirement to additional permit applicants within the scope of Chapter 499, F.S. The amendment to this rule also provides the department with an option to on-site inspection of a permit applicant’s establishment. This option is designed to protect public health when the department’s workload requires an alternative to an inspection. Finally, the proposed amendment to this rule also adopts a new attachment to the Application for Permit under Chapter 499, F.S., which attachment is directed to manufacturer and prescription drug repackager permit applicants located in Florida.

SUMMARY:

The proposed amendment to Rule 64F-12.001, F.A.C., adds the definition of “propagation” clarifying that term as it appears in the definition of “manufacture” at Section 499.003(27), F.S. The proposed amendment to Rule 64F-12.015, F.A.C., expands the scope of the on-site inspection requirement to additional permit applicants within the scope of Chapter 499, F.S., provides the department with an option to on-site inspection of a permit applicant’s establishment, and adopts a new attachment to the Application for Permit under Chapter 499, F.S., which attachment is directed to manufacturer and prescription drug repackager permit applicants located in Florida.

RULEMAKING AUTHORITY:

499.05, 499.0121, 499.0122, 499.013, 499.014, 499.052 FS.

LAW:

499.012, 499.0121, 499.0122, 499.013, 499.014, 499.051, 499.052 FS.

PRINT PUBLISH DATE:

4/21/2006 Vol. 32/16

COMMENTS:

From 4/21/2006 To 5/12/2006 (21 Days)
The public comment period for this notice has already expired.

REFERENCE MATERIALS:

No reference(s).

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