8293032, 64F-12.011 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 8293032

Notice of Proposed Rule

Department:

DEPARTMENT OF HEALTH

Division:

Division of Family Health Services

Chapter:

REGULATIONS FOR DRUGS, DEVICES AND COSMETICS

Overview

RULE:

64F-12.011

Wholesale Distribution of Prescription Drugs - Exceptions and Specific Distributions Authorized (Transferred)

PURPOSE:

This rule section is being revised in response to a comment and possible objection received from the Joint Administrative Procedures Committee concerning a “written agreement” requirement in paragraph (1)(j) of the rule section. The written agreement determines the manner and under what conditions undispensed medications would be returned to the Department by community pharmacies who received the medications under the authority of the “emergency medical reasons” exemption from the definition of wholesale distribution in Section 499.003(53), F.S.

SUMMARY:

This rule deletes the “written agreement” provision for determining the manner and under what conditions returns of un-dispensed prescription drugs will be returned to the Department by a community pharmacy.

RULEMAKING AUTHORITY:

499.003(53)(b), 499.012, 499.03, 499.05 FS.

LAW:

499.003(53)(b), 499.012, 499.03, 499.05 FS.

PRINT PUBLISH DATE:

2/19/2010 Vol. 36/07

COMMENTS:

From 2/19/2010 To 3/12/2010 (21 Days)
The public comment period for this notice has already expired.

REFERENCE MATERIALS:

No reference(s).

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