7822970, 64F-12.011 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 7822970

Notice of Proposed Rule

Department:

DEPARTMENT OF HEALTH

Division:

Division of Family Health Services

Chapter:

REGULATIONS FOR DRUGS, DEVICES AND COSMETICS

Overview

RULE:

64F-12.011

Wholesale Distribution of Prescription Drugs - Exceptions and Specific Distributions Authorized (Transferred)

PURPOSE:

This rule section is being revised to facilitate the movement of prescription drugs by or on behalf of the Department of Health to community pharmacies to assist in protecting the public health from conditions that pose an imminent threat to public health. The rule will exempt such distributions from Florida prescription drug pedigree requirements.

SUMMARY:

This rule provides an emergency medical reason that is exempt from the definition of wholesale distribution under Chapter 499 Part I, F.S. The exemption applies to transfers of prescription drugs by or on behalf of the Department of Health to a community pharmacy for dispensing to patients in need of emergency medical services, including protection from communicable diseases or providing protection from conditions that pose an imminent threat to public health.

RULEMAKING AUTHORITY:

499.003(53)(b), 499.012, 499.03, 499.05 FS.

LAW:

499.003(53)(b), 499.012, 499.03, 499.05 FS.

PRINT PUBLISH DATE:

10/23/2009 Vol. 35/42

COMMENTS:

From 10/23/2009 To 11/13/2009 (21 Days)
The public comment period for this notice has already expired.

REFERENCE MATERIALS:

No reference(s).

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