4428455, 64F-12.013 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 4428455

Notice of Proposed Rule

Department:

DEPARTMENT OF HEALTH

Division:

Division of Family Health Services

Chapter:

REGULATIONS FOR DRUGS, DEVICES AND COSMETICS

Overview

RULE:

64F-12.013

Prescription Drugs; Receipt, Storage and Security (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. It is the purpose of this rule to clarify authentication of pedigree requirements, clarify who is required to verify that a prescription drug, as of the time of receipt, matches the description on the corresponding pedigree provided with the drug, as well clarifying the information that should be found on the pedigree. The Department proposes to make changes in the authentication requirements for pedigrees, as well as delete out dated language no longer relevant because of statutory changes that became effective July 1, 2007 concerning prescription drug pedigrees.

SUMMARY:

The proposed rule changes will clarify that establishment and adherence to policies and procedures for random authentication of copies of pedigrees according to statistically valid standards is required in some situations. The proposed rule changes will also require establishment and adherence to policies and procedures that provide for the random verification of the authenticity of pedigrees for the purposes of establishing a wholesaler purchased prescription drugs directly from the manufacturer according to statistically valid standards, in some situations. The proposed rule adds the requirement that a repackager notify the Department of discovery of a significant loss of prescription drugs. The proposed rule requires that a chain pharmacy warehouse or person authorized to administer or dispense a prescription drug that receives a prescription drug, is required to verify that the information on the corresponding pedigree matches up with the drug received.

RULEMAKING AUTHORITY:

499.0121(1), 499.05 FS.

LAW:

499.004, 499.006, 499.007, 499.0121, 499.028(6), 499.052 FS.

PRINT PUBLISH DATE:

8/3/2007 Vol. 33/31

COMMENTS:

From 8/3/2007 To 8/24/2007 (21 Days)
The public comment period for this notice has already expired.

REFERENCE MATERIALS:

No reference(s).

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