9104437, 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: 9104437

Notice of Development of Rulemaking

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:

The Department intends to review changes in this rule chapter for the purpose of better enabling the Department to provide for the movement of prescription drugs to areas, facilities and health care providers within the state to allow a more efficient response to natural disaster, communicable disease or other health care emergencies for which the Department has responsibility to protect the public health. This also includes enacting “rules established by the department” within the meaning of Section 499.003(54)(b). Florida Statutes. Finally, the Department will review this section for the possibility of rule changes for implementing Section 499.03, F.S. related to authorizing qualified persons engaged in research teaching and testing to lawfully possess prescription drugs.

SUBJECT:

Exemption to the definition of “wholesale distribution” for emergency medical reasons; exemption letters to facilitate the lawful possession of prescription drugs for research teaching and testing.

RULEMAKING AUTHORITY:

499.003(54), 499.012, 499.03, 499.05 FS.

LAW:

499.003(54), 499.012, 499.03, 499.05 FS.

PRINT PUBLISH DATE:

9/10/2010 Vol. 36/36

RELATED STATUTES
AND LAWS:

499.003(54), 499.012, 499.03, 499.05 FS., 499.003(54), 499.012, 499.03, 499.05 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://www.flrules.org/gateway/ruleno.asp?id=64F-12.011&PDate=9/10/2010&Section=1

REFERENCE MATERIALS:

No reference(s).

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