4432820, 64F-12.012 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 4432820

Notice of Proposed Rule

Department:

DEPARTMENT OF HEALTH

Division:

Division of Family Health Services

Chapter:

REGULATIONS FOR DRUGS, DEVICES AND COSMETICS

Overview

RULE:

64F-12.012

Records of Drugs, Cosmetics and Devices (Transferred)

PURPOSE:

The Department intends to enact rules that implement the pedigree provisions of Florida Session Law 2006-310 concerning implementing the direct purchase statement pedigree related provisions of that session law. The Department intends to provide clarification as to when wholesale distributions of prescription drugs are eligible for the direct purchase pedigree, as well as conditions on content of the direct purchase pedigree. The Department intends to revise the rule chapter to delete outdated pedigree language for pedigree requirements that were deleted from Chapter 499, Florida Statutes, effective July 1, 2006. The Department intends to make changes regarding when the operating systems of businesses licensed under Chapter 499, Florida Statutes, are required to be maintained separately for each type of business. The Department also intends to make changes to the emergency distributions paragraph within this rule, changing the documentation requirements for use of this provision. The Department intends to make changes to the requirements for permitting for contract distributors of prescription drugs on behalf of manufacturers, who do not have to pass pedigrees. The Department proposes to provide additional language regarding the requirements for returns of prescription drugs to wholesalers.

SUMMARY:

The rule implements the direct purchase pedigree provisions of Florida Session Law 2006-310; the rule provides for clarification on use of the pedigree and the content thereof, including but not limited to, the number of intracompany transfers allowed by use of the direct purchase pedigree. The rule deletes language related to deleted statutory pedigree requirements, found in subsection 16 of the rule. The rule allows Restricted Drug Distributor-Health Care Entity permitted prescription drug distributors to commingle drugs used for in house administration and for wholesale distribution. The rule adds restrictions to the documentation required for use of the “Emergency Distributions” distribution of prescription drugs without the passing of a pedigree. The rule clarifies the permitting requirements for third party logistics providers and the manufacturers they are contract distributors for, in order for the third party contract distributors to be exempt from licensure as wholesale distributors who would be required to pass pedigrees. The rule will require the contract distributor to be permitted at the distribution point as well as the manufacturer. In addition, the manufacturer will be required to be permitted at the location from which it is passing title to the prescription drugs. The rule provides the conditions under which a specified prescription drug can be can be returned and re-distributed.

RULEMAKING AUTHORITY:

499.003, 499.05, 499.0121, 499.0122, 499.013, 499.014, 499.052 FS.

LAW:

499.01, 499.003, 499.012, 499.0121, 499.0122, 499.013, 499.014, 499.028, 499.04, 499.041, 499.05, 499.051, 499.052, 499.06, 499.063, 499.064, 499.066, 499.067 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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