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 ...  

  • Division of Health Awareness and Tobacco

    RULE NOS.: RULE TITLES:

    64F-12.001 General Regulations; Definitions

    64F-12.012 Records of Drugs, Cosmetics and Devices

    64F-12.013 Prescription Drugs; Receipt, Storage and Security

    64F-12.015 Licensing, Application, Permitting

    64F-12.018 Fees

    64F-12.023 Restricted Prescription Drug Distributor Permits; Special Provisions

    PURPOSE AND EFFECT:  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 AREA TO BE ADDRESSED:  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.

    SPECIFIC AUTHORITY:  499.003(31) FS., 499.0121(6) FS., 499.014 FS., 499.05 FS.

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

    A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

    DATE AND TIME: Monday, April 3, 2006, 1:00 p.m. 4:00 p.m. (EST)

    PLACE:  4052 Bald Cypress Way (Capital Circle Office Complex Building 4052) Room 301, Tallahassee, Florida

    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT IS:  Rebecca Poston, R. Ph., Acting Bureau Chief, Bureau of Statewide Pharmaceutical Services, 2818-A Mahan Drive, Tallahassee, Florida 32308, (850)922-5190, rebecca_poston@doh.state.fl.us

    THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS NOT AVAILABLE AT THIS TIME.  DRAFT LANGUAGE WILL BE PUBLISHED ON THE BUREAU'S WEBSITE AT www.doh.state.fl.us/pharmacy/drugs AT LEAST 10 DAYS PRIOR TO THE SCHEDULED WORKSHOP.

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Document Information

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 ...
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. ...
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.
Contact:
Rebecca Poston, R. Ph., Acting Bureau Chief, Bureau of Statewide Pharmaceutical Services, 2818-A Mahan Drive, Tallahassee, Florida 32308, (850)922-5190, rebecca_poston@doh.state.fl.us
Related Rules: (6)
64F-12.001. General Regulations; Definitions
64F-12.012. Records of Drugs, Cosmetics and Devices (Transferred)
64F-12.013. Prescription Drugs; Receipt, Storage and Security
64F-12.015. Licensing, Application, Permitting (Transferred)
64F-12.018. Fees
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