19215329, 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: 19215329

Notice of Development of Rulemaking

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 development and amendment to update the rule for any identified needed changes and to amend the rule to require and make clear that the compounding of human products (sterile and nonsterile) for office use must be in full compliance with 21 U.S.C. §353b, including being registered as an Outsourcing Facility.  In addition, the purpose and effect is to ensure that the rule does not conflict with state and federal law.

SUBJECT:

Compounding; the compounding for human use; office use compounding for human use of sterile and nonsterile products.

RULEMAKING AUTHORITY:

465.005 FS.

LAW:

465.003, 465.0155, 465.0265 FS.

PRINT PUBLISH DATE:

7/21/2017 Vol. 43/141

RELATED STATUTES
AND LAWS:

465.005 FS., 465.003, 465.0155, 465.0265 FS.

OVERSIGHT COMMITTEE:

Joint Administrative Procedures Committee
Florida Administrative Law Central Online Network (F.A.L.C.O.N.)

RELATED COURT CASES:

Division of Administrative Hearings

FEDERAL eRULEMAKING
WEB PORTAL:

Regulations.gov

HOW TO LINK TO
THIS NOTICE:

http://flrules.org/gateway/ruleno.asp?id=64B16-27.700&PDate=7/21/2017&Section=1

REFERENCE MATERIALS:

No reference(s).

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