109433, 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: 109433

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-12.001	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-12.015	Licensing, Application, Permitting (Transferred)
64F-12.018	Fees (Transferred)
64F-12.023	Restricted Prescription Drug Distributor Permits; Special Provisions (Transferred)

PURPOSE:

The 2003 Legislature passed Senate Bill 2312, The Prescription Drug Protection Act amending Chapter 499, Florida Statutes.  The Bill provided for a phase-in of enhanced regulation of the wholesaling of prescription drugs intended to further safeguard and protect the prescription drug supply in Florida.   Effective July 1, 2006, a pedigree that traces all previous distributions of all prescription drugs back to the manufacturer must be provided by each wholesale distributor to its customers.  This workshop is the second conducted by the department and is intended to continue gathering information and input from affected persons and the public to craft additional rules that will facilitate industry's compliance with the pedigree requirements that go into effect on July 1, 2006.

SUBJECT:

The subject areas include, but are not limited to Certificate Authorities for digital signatures that may be used for authentication of an electronic pedigree; pedigree provisions for emergency distributions; inventory on-hand at on July 1, 2006 and handling prescription drugs distributed prior to July 1, 2006 but returned to a wholesaler on or after July 1, 2006; pedigree requirements for drop shipments; general matters related to implementation of the July 1, 2006 requirements for pedigree papers as may be raised by workshop participants; paper submissions to document establishment conditions when an on-site inspection cannot be performed within the statutory application processing timeframes; permitting of in-state private label distributors; and the possibility of establishing new restricted prescription drug distributor permit types and the application and fee requirements for such permits.

RULEMAKING AUTHORITY:

499.003(31) FS., 499.0121(6) FS., 499.014 FS., 499.05 FS.

LAW:

499.003(31) FS., 499.0121(4) FS., 499.0121(6)(f) FS., 499.013 FS., 499.014 FS.

PRINT PUBLISH DATE:

3/3/2006 Vol. 32/09

RELATED STATUTES
AND LAWS:

499.003(31) FS., 499.0121(6) FS., 499.014 FS., 499.05 FS., 499.003(31) FS., 499.0121(4) FS., 499.0121(6)(f) FS., 499.013 FS., 499.014 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-12.001&PDate=3/3/2006&Section=1

REFERENCE MATERIALS:

No reference(s).

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