64B16-27.797 : The Standards of Practice for Compounding Sterile Products - Florida Administrative Rules, Law, Code, Register

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

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

	Effective Date:	11/16/2023
	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, 8-19-19, 11-16-23.
	References in this version:	No reference(s).

History of this Rule since Jan. 6, 2006

Notice / Adopted	Section	Description	ID	Publish Date

	Proposed 64B16-27.797	The Board proposes the rule amendment to update language regarding when a pharmacy engaged in sterile compounding is determined to be in noncompliance with any state or federal standards during an inspection.	29022417	11/27/2024 Vol. 50/232
	Development 64B16-27.797	The Board proposes the rule development to discuss formally incorporating a corrective action plan submission procedure for permit holders found in violation of certain standards during a sterile compounding permit inspection ....	28538096	7/11/2024 Vol. 50/135
	Final 64B16-27.797	The Standards of Practice for Compounding Sterile Products	27714372	Effective: 11/16/2023
	Proposed 64B16-27.797	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 ....	27608157	9/28/2023 Vol. 49/189
	Development 64B16-27.797	The Board proposes the rule development to comprehensively review any needed updates to the Standards of Practice for Compounding Sterile Products. The review will include, but not be limited to, specifically reviewing the ....	27134797	5/17/2023 Vol. 49/96
No File	Validity 64B16-27.797	HYBRID PHARMA LLC, Petitioner vs. DEPARTMENT OF HEALTH and BOARD OF PHARMACY, Respondents; Case No.: 23-1604RX; Rule No.: 64B16-27.797; Petition	27082029	5/1/2023 Vol. 49/84
	Variances 64B16-27.797	of the issuance of an Order regarding the Petition for Waiver or Variance, which was filed on October 5, 2022, by Shanel L. Fisher, PharmD, MS, BCOP, on behalf of Moffitt Cancer Center. The Notice of Petition for Waiver ....	27071941	4/27/2023 Vol. 49/82
	Variances 64B16-27.797	variance or waiver filed by Shanel L. Fisher, PharmD, MS, BCOP, on behalf of Moffitt Cancer Center, seeking a variance or waiver of the requirement of Rule 64B16-27.797, Florida Administrative Code, and the rule’s incorporated ....	26407685	10/12/2022 Vol. 48/199
	Final 64B16-27.797	The Standards of Practice for Compounding Sterile Products	22230865	Effective: 08/19/2019
	Change 64B16-27.797	The Standards of Practice for Compounding Sterile Products	22094580	7/3/2019 Vol. 45/129
	Public Hearing 64B16-27.797	A rule hearing on above rule, as notice in Vol. 45, No. 82, April 26, 2019, issue of the Florida Administrative Register, will be held to discuss .... Monday, June 17, 2019, at 2:00 p.m., or as soon thereafter as .... Rosen Plaza Hotel, 9700 International Drive, Orlando, Florida ....	21828412	5/8/2019 Vol. 45/90
	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.	21788254	4/26/2019 Vol. 45/82
	Withdrawal 64B16-27.797	The Standards of Practice for Compounding Sterile Products	21703961	4/5/2019 Vol. 45/67
	Hearing 64B16-27.797	The Standards of Practice for Compounding Sterile Products	21393464	1/16/2019 Vol. 45/11
	Hearing 64B16-27.797	The Standards of Practice for Compounding Sterile Products	21159403	11/15/2018 Vol. 44/223
	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
	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
	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
	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
	Final 64B16-27.797	The Standards of Practice for Compounding Sterile Products	18339225	Effective: 12/20/2016
	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
	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
	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
	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
	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
	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
	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
	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
	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
	Final 64B16-27.797	The Standards of Practice for Compounding Sterile Products	15068967	Effective: 10/01/2014
	Change 64B16-27.797	Standards of Practice for Compounding Sterile Preparations (CSPs)	14950627	8/19/2014 Vol. 40/161
	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
	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
	Change 64B16-27.797	Standards of Practice for Compounding Sterile Preparations (CSPs)	14728012	6/24/2014 Vol. 40/122
	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
	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
	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
	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
	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
	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
	Final 64B16-27.797	Standards of Practice for Compounding Sterile Preparations (CSPs)	8103882	Effective: 01/07/2010
	Correction 64B16-27.797	Standards of Practice for Compounding Sterile Preparations (CSPs)	7968470	11/25/2009 Vol. 35/47
	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
	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
	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
	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
	Final 64B16-27.797	Standards of Practice for Compounding Sterile Preparations (CSPs)	5736015	Effective: 06/18/2008
	Change 64B16-27.797	Standards of Practice for Compounding Sterile Preparations - (CSPs)	5571697	5/2/2008 Vol. 34/18
	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
	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

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