19309516, 64B16-27.700 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 19309516

Notice of Proposed Rule

Department:

DEPARTMENT OF HEALTH

Division:

Board of Pharmacy

Chapter:

PHARMACY PRACTICE

Overview

RULE:

64B16-27.700

Definition of Compounding

PURPOSE:

The Board proposes the rule amendment so that the rule does not conflict with state or federal law and to make clear that office use compounding of products intended for human use (sterile and nonsterile) shall require being registered as an Outsourcing Facility as defined by §465.003(19), Fla. Stat. (2016). 
SUMMARY: Office use compounding of sterile and nonsterile products for human use shall comply with federal law to include being a registered Outsourcing Facility.

SUMMARY:

Office use compounding of sterile and nonsterile products for human use shall comply with federal law to include being a registered Outsourcing Facility.

RULEMAKING AUTHORITY:

465.005 FS.

LAW:

465.003, 465.0155, 465.0265 FS.

PRINT PUBLISH DATE:

8/18/2017 Vol. 43/161

COMMENTS:

From 8/18/2017 To 9/8/2017 (21 Days)
The public comment period for this notice has already expired.

REFERENCE MATERIALS:

No reference(s).

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