292860, 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: 292860

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)
64F-12.025	Certification Authority and Digital Signatures For Self-Authenticating Pedigree (Transferred)

PURPOSE:

A proposed amendment to Rule 64F-12.012, F.A.C., requires an inventory of drugs at each wholesaler establishment, of drugs it has on hand as of June 30, 2006, so as to give the Department information useful to determining compliance as the drug pedigree law transitions effective July 1, 2006 from the requirements of Section 499.0121(6)(d) and (e), F.S., to Section 499.0121(6)(f), F.S. An additional proposed amendment to this rule would allow adjustments to the pedigree requirements for an emergency distribution, where a pharmacy or health care practitioner certifies to the wholesaler a need to treat a life threatening medical condition, or medical condition that will result in serious bodily harm, even if a drug pedigree compliant with Section 499.0121(6)(f), F.S. is not available.
Rule 64F-12.025, F.A.C., is proposed to establish standards for a certification authority to issue a digital certificate to an employee of a wholesale establishment, where the establishment employs this person to certify the accuracy and completeness of a pedigree paper. Through this rule the Department seeks to facilitate a self authenticating drug pedigree.

SUMMARY:

A proposed amendment to Rule 64F-12.012, F.A.C., would require an inventory of drugs on hand as of June 30, 2006. An additional amendment to this rule also allows adjustments to the pedigree requirement in certain emergency situations.
Proposed Rule 64F-12.025, F.A.C., would facilitate the use of a self-authenticating electronic drug pedigree. Self authentication is facilitated when the digital signature of the person authenticating the information that person provides on the pedigree is certified by an independent Certification Authority.

RULEMAKING AUTHORITY:

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

LAW:

499.012, 499.0121, 499.0122, 499.013, 499.014, 499.051, 499.052 FS.

PRINT PUBLISH DATE:

4/21/2006 Vol. 32/16

COMMENTS:

From 4/21/2006 To 5/12/2006 (21 Days)
The public comment period for this notice has already expired.

REFERENCE MATERIALS:

No reference(s).

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