532838, 64F-12 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 532838

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	REGULATIONS FOR DRUGS, DEVICES AND COSMETICS
64F-12.001	General Regulations; Definitions (Transferred)
64F-12.012	Records of Drugs, Cosmetics and Devices (Transferred)
64F-12.013	Prescription Drugs; Receipt, Storage and Security (Transferred)
64F-12.025	Certification Authority and Digital Signatures For Self-Authenticating Pedigree (Transferred)
64F-12.026	Cancer Drug Donation Program (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 development process to enact rules to implement the changes to Chapter 499, Part I, F.S., made by session law 2006-310 (House Bill 371).  Other changes or new text within the rule chapters listed above may also be addressed.

SUBJECT:

The proposed amendments will affect the type of pedigree paper that is to be used in wholesale distributions of prescription drugs.  The proposed amendments will affect the type of authentication of pedigree papers required under Chapter 499, Part I, F.S.  The rule amendments will implement the drop-ship provisions of House Bill 371.  The rule amendments will implement the new cancer drug and supply donation program established in House Bill 371.  The rule amendments may also address other issues within the rule chapters listed above.

RULEMAKING AUTHORITY:

499.05, 499.61, 499.701 499.0121, 499.0122, 499.013, 499.014, 499.052, F.S.

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, 49.039, 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, 49.66, 499.67, 499.71, 499.75, F.S.

PRINT PUBLISH DATE:

8/4/2006 Vol. 32/31

RELATED STATUTES
AND LAWS:

499.05, 499.61, 499.701 499.0121, 499.0122, 499.013, 499.014, 499.052, F.S., 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, 49.039, 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, 49.66, 499.67, 499.71, 499.75, F.S.

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&PDate=8/4/2006&Section=1

REFERENCE MATERIALS:

No reference(s).

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