7824522, 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: 7824522

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 proposes to revise the rule language regarding pedigree requirements to be compliant with Chapter 499 F.S. and to delete language that is no longer relevant to pedigrees because of statutory changes. The department proposes to amend the audit trail and pedigree requirements for wholesale distributions of prescription drugs, to the extent necessary to protect the public health safety and welfare.

SUMMARY:

The rule revisions will provide an alternative to the present requirements for how financial information is included in required audit trail records for prescription drug distributions. It will require the recipient of a prescription drug to be included in the audit trail information. It clarifies that all audit trail information required by subsection 64F-12.012(2), and paragraph 64F-12.023(3)(a), F.A.C., be received by a reverse distributor or destruction establishment no later than the time when the prescription drugs described in the documents are received at the establishment. The rule expands the possible use of the direct purchase pedigree, while requiring more descriptive information on direct purchase pedigree documents that also reference prescription drugs that are not within the normal distribution chain. The rule clarifies that use of a wholesaler as the repository of a recipient’s pedigree does not relieve the provider and recipient of a prescription drug in a wholesale distribution of a prescription drug to pass and receive a pedigree. The rule clarifies the emergency distributions exemption from the pedigree requirements that is currently in this rule section. The rule clarifies the time period for persons not required to be permitted, but regulated under Chapter 499, F.S., to provide records to the department or to the Florida Department of Law Enforcement. The rule provides that a Retail Pharmacy Drug Wholesale Distributor and a Restricted Drug Distributor-Health Care Entity are not required to keep distribution inventory stock separate from stock that is to be dispensed. The rule prohibits wholesale distribution records of a pharmacy from being commingled with patient related records in a manner that production of the wholesale distribution records to the Department would require the release of patient records or records that reveal the identity of a patient. The rule deletes language related to pedigree requirements that are no longer part of Chapter 499, F.S.

RULEMAKING AUTHORITY:

499.003, 499.05, 499.0121 FS.

LAW:

499.002, 499.01, 499.003, 499.005, 499.012, 499.0121, 499.028, 499.05, 499.051, 499.052, 499.06, 499.063, 499.064, 499.066, 499.067 FS.

PRINT PUBLISH DATE:

10/23/2009 Vol. 35/42

COMMENTS:

From 10/23/2009 To 11/13/2009 (21 Days)
The public comment period for this notice has already expired.

REFERENCE MATERIALS:

No reference(s).

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