Rule: 64B16-27.797 Prev   Up   Next

Rule Title: The Standards of Practice for Compounding Sterile Products
Department: DEPARTMENT OF HEALTH    Add to MyFLRules Favorites
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Division: Board of Pharmacy
Chapter: PHARMACY PRACTICE

Latest version of the final adopted rule presented in Florida Administrative Code (FAC):

VIEW_RULE Effective Date: 12/20/2016
History Notes: Rulemaking Authority 465.005, 465.0155, 465.022 FS. Law Implemented 465.0155, 465.022 FS. History–New 6-18-08, Amended 1-7-10, 10-1-14, 12-18-16.
References in this version: Ref-04436 21 U.S.C. s. 351 (2012)
Ref-04437 21 C.F.R. Parts 210 and 211 (2013)
History of this Rule since Jan. 6, 2006
Notice /
Adopted
Section Description ID Publish
Date
View Text Withdrawal
64B16-27.797
The Standards of Practice for Compounding Sterile Products 21703961 4/5/2019
Vol. 45/67
View Text Hearing
64B16-27.797
The Standards of Practice for Compounding Sterile Products 21393464 1/16/2019
Vol. 45/11
View Text Hearing
64B16-27.797
The Standards of Practice for Compounding Sterile Products 21159403 11/15/2018
Vol. 44/223
View Text Proposed
64B16-27.797
The Board proposes the rule amendment to provide the standards of practice for compounded products prepared utilizing a process that includes lyophilization. 20881207 9/11/2018
Vol. 44/177
View Text Development
64B16-27.797
The Board proposes the rule amendment to provide the standards of practice for compounded products prepared utilizing a process that includes lyophilization. 20826208 8/24/2018
Vol. 44/166
View Text Variances
64B16-27.797
of the issuance of an Order regarding the Petition for Waiver or Variance, which was filed on January 12, 2018, by Moffitt Cancer Center. The Notice of Petition for Waiver or Variance was published in Volume 44, Number 14, .... 20197163 3/20/2018
Vol. 44/55
View Text Variances
64B16-27.797
variance or waiver filed by Thomas E. Henry III, MBA, RPh, CPh, Chief Pharmacy Officer, on behalf of Moffitt Cancer Center seeking a variance or waiver of the requirement of Rule 64B16-27.797, Florida Administrative Code, .... 19975130 1/22/2018
Vol. 44/14
View Text Final
64B16-27.797
The Standards of Practice for Compounding Sterile Products 18339225 Effective:
12/20/2016
View Text Proposed
64B16-27.797
The Board proposes the rule amendment to update the standards of practice for compounding sterile products. 18087510 10/3/2016
Vol. 42/192
View Text Development
64B16-27.797
The Board proposes the rule amendment to update the standards of practice for compounding sterile products. 18008746 9/14/2016
Vol. 42/179
View Text Variances
64B16-27.797
variance or waiver filed by Martin R. Dix, Esquire, on behalf of Adventist Health System for Florida Hospital Altamonte and Winter Park Memorial Hospital, seeking a variance or waiver of the requirement of Rule 64B16-27.797, .... 17719395 7/1/2016
Vol. 42/128
View Text Variances
64B16-27.797
variance or waiver filed by Dorinda Segovia, PharmD, on behalf of Memorial Healthcare System, seeking a variance or waiver of the requirement of Rule 64B16-27.797, Florida Administrative Code, and the rule’s incorporated .... 17541885 5/17/2016
Vol. 42/96
View Text Petition
64B16-27.797
Columbia Plantation General Hospital Pharmacy filed on March 17, 2016.
  Except for good cause shown, motions for leave to intervene must be filed within 21 days after the publication of this notice.
17459144 4/26/2016
Vol. 42/81
View Text Petition
64B16-27.797
Madeline Camejo, Pharm. D., on behalf of Memorial Regional Hospital South filed ....
  The Petitioner seeks a Declaratory Statement from the Board with regard to whether the ceiling tiles in the IV rooms at the hospital ....
17293565 3/16/2016
Vol. 42/52
View Text Variances
64B16-27.797
that it has issued an Order on the Petition for Variance or Waiver filed on May 1, 2015, by Michael J. Glazer, on behalf of Tenet Good Samaritan, Inc. d/b/a Good Samaritan Medical Center. Petitioner was seeking a variance .... 16248002 7/21/2015
Vol. 41/140
View Text Variances
64B16-27.797
variance or waiver filed by Michael Glazer, Esquire, on behalf of Good Samaritan Medical Center, Inc., seeking a temporary waiver of the requirement of Rule 64B16-27.797, Florida Administrative Code, that requires non-low .... 15969321 5/6/2015
Vol. 41/88
View Text Variances
64B16-27.797
variance or waiver filed by Mark Schneider on behalf of TeamCare Infusion, Inc., seeking a permanent waiver of the requirement of Rule 64B16-27.797(4)(c), which requires that HEPA-filtered supply air shall be introduced .... 15524770 1/12/2015
Vol. 41/07
View Text Final
64B16-27.797
The Standards of Practice for Compounding Sterile Products 15068967 Effective:
10/01/2014
View Text Change
64B16-27.797
Standards of Practice for Compounding Sterile Preparations (CSPs) 14950627 8/19/2014
Vol. 40/161
View Text Variances
64B16-27.797
variance or waiver filed by Michael J. Glazer on behalf of Tenet Good Samaritan, Inc. d/b/a Good Samaritan Medical Center, seeking a temporary waiver of proposed Rule 64B16-27.797, that requires non-low volume oncology, .... 14871766 7/28/2014
Vol. 40/145
View Text Variances
64B16-27.797
a variance or waiver filed by Michael J. Glazer on behalf of St. Mary’s Medical Center, seeking a temporary waiver of proposed Rule 64B16-27.797, that requires non-low volume oncology, chemotherapeutic and hazardous sterile .... 14862357 7/24/2014
Vol. 40/143
View Text Change
64B16-27.797
Standards of Practice for Compounding Sterile Preparations (CSPs) 14728012 6/24/2014
Vol. 40/122
View Text Proposed
64B16-27.797
The Board proposes the rule amendment for the specific purpose of determining the necessity of incorporating and setting as the minimum standards to follow when compounding sterile products, the following chapters of the .... 14300824 3/11/2014
Vol. 40/48
View Text Development
64B16-27.797
The Board proposes to open the rule for development to comprehensively review the rule for any necessary or needed technical or substantive changes, and for the specific purpose of determining the necessity of incorporating .... 13965689 12/20/2013
Vol. 39/246
View Text Workshop
64B16-27.797
To discuss USP 797 and necessary amendments to rule 64B16-27.787.
  Friday, May 10, 2013, at 10:00 a.m.
  The Peabody Orlando, 9801 International Drive, Orlando, Florida ....
12866970 4/11/2013
Vol. 39/71
View Text Petition
64B16-27.797
Robert H. Wilson, BPharm., on behalf of The Towers Pharmacy, Inc.
  The petitioner is seeking a variance or waiver of Rule 64B16-27.797, Florida Administrative Code, which requires antineoplastic drugs ....
10601923 11/4/2011
Vol. 37/44
View Text Variances
64B16-27.797
Robert H. Wilson B. Pharm., on behalf of The Towers Pharmacy, Inc., seeking a variance or waiver of Rule 64B16-27.797, Florida Administrative Code, which requires antineoplastic drugs to be compounded in a vertical flow, .... 10382606 9/9/2011
Vol. 37/36
View Text Variances
64B16-27.797
Robert Campbell, PharmD., on behalf of Bay Medical Center, seeking a variance or waiver of Rule 64B16-27.797, Florida Administrative Code, which lists the requirements for standards of practice for compounding sterile preparations .... 8443576 3/26/2010
Vol. 36/12
View Text Final
64B16-27.797
Standards of Practice for Compounding Sterile Preparations (CSPs) 8103882 Effective:
01/07/2010
View Text Correction
64B16-27.797
Standards of Practice for Compounding Sterile Preparations (CSPs) 7968470 11/25/2009
Vol. 35/47
View Text Proposed
64B16-27.797
The Board proposes the rule amendment to include the standard of practice for radio-pharmaceuticals as compounded sterile products. 7674948 9/25/2009
Vol. 35/38
View Text Development
64B16-27.797
The Board proposes to review the existing language in this rule to determine whether changes are necessary. 6926399 3/27/2009
Vol. 35/12
View Text Variances
64B16-27.797
GE Healthcare, seeking a variance or waiver of Rule 64B16-27.797, Florida Administrative Code, which requires that the buffer area is to be maintained within ISO Class 7 level of particulate contamination. 6954141 3/27/2009
Vol. 35/12
View Text Variances
64B16-27.797
Cardinal Health, seeking a variance or waiver of Rule 64B16-27.797, Florida Administrative Code, which requires that the buffer area is to be maintained within ISO Class 7 level of particulate contamination. 6720759 1/30/2009
Vol. 35/04
View Text Final
64B16-27.797
Standards of Practice for Compounding Sterile Preparations (CSPs) 5736015 Effective:
06/18/2008
View Text Change
64B16-27.797
Standards of Practice for Compounding Sterile Preparations - (CSPs) 5571697 5/2/2008
Vol. 34/18
View Text Proposed
64B16-27.797
The Board proposes the rule promulgation in order to create standards of practice for compounding sterile preparations. 3993895 4/13/2007
Vol. 33/15
View Text Development
64B16-27.797
The Board proposes to review the existing language in this rule to determine whether changes are necessary. 3459425 1/19/2007
Vol. 33/03