27608157, 64B16-27.797 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 27608157

Notice of Proposed Rule

Department:

DEPARTMENT OF HEALTH

Division:

Board of Pharmacy

Chapter:

PHARMACY PRACTICE

Overview

RULE:

64B16-27.797

The Standards of Practice for Compounding Sterile Products

PURPOSE:

The Board proposes the rule amendment to update the rule to comply with the revised  Standards of Practice for Compounding Sterile Products, Chapters of the United States Pharmacopeia, standards related to Outsourcing Facilities (aka 503b facilities), and the incorporated and adopted current good manufacturing practices found in 21 C.F.R. Parts 210 and 211.

SUMMARY:

The rule amendment will comply with the revised Standards of Practice for Compounding Sterile Products, Chapters of the United States Pharmacopeia, standards related to Outsourcing Facilities (aka 503b facilities), and the incorporated and adopted current good manufacturing practices found in 21 C.F.R. Parts 210 and 211.

RULEMAKING AUTHORITY:

465.005, 465.0155, 465.022 FS.

LAW:

465.0155, 465.022 FS.

PRINT PUBLISH DATE:

9/28/2023 Vol. 49/189

COMMENTS:

From 9/28/2023 To 10/19/2023 (21 Days)
The public comment period for this notice has already expired.

REFERENCE MATERIALS:

No reference(s).

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