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 |
|
| 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). |
| Notice / Adopted |
Description | ID | Publish Date |
|
|---|---|---|---|---|
|
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 |
|
|
|
The Standards of Practice for Compounding Sterile Products | 27714372 |
Effective: 11/16/2023 |
|
|
|
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 |
|
|
|
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 | 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 |
|
|
|
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 |
|
|
|
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 |
|
|
|
The Standards of Practice for Compounding Sterile Products | 22230865 |
Effective: 08/19/2019 |
|
|
|
The Standards of Practice for Compounding Sterile Products | 22094580 |
7/3/2019 Vol. 45/129 |
|
|
|
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 |
|
|
|
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 |
|
|
|
The Standards of Practice for Compounding Sterile Products | 21703961 |
4/5/2019 Vol. 45/67 |
|
|
|
The Standards of Practice for Compounding Sterile Products | 21393464 |
1/16/2019 Vol. 45/11 |
|
|
|
The Standards of Practice for Compounding Sterile Products | 21159403 |
11/15/2018 Vol. 44/223 |
|
|
|
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 |
|
|
|
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 |
|
|
|
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 |
|
|
|
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 |
|
|
|
The Standards of Practice for Compounding Sterile Products | 18339225 |
Effective: 12/20/2016 |
|
|
|
The Board proposes the rule amendment to update the standards of practice for compounding sterile products. | 18087510 |
10/3/2016 Vol. 42/192 |
|
|
|
The Board proposes the rule amendment to update the standards of practice for compounding sterile products. | 18008746 |
9/14/2016 Vol. 42/179 |
|
|
|
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 |
|
|
|
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 |
|
|
|
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 |
|
|
|
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 |
|
|
|
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 |
|
|
|
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 |
|
|
|
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 |
|
|
|
The Standards of Practice for Compounding Sterile Products | 15068967 |
Effective: 10/01/2014 |
|
|
|
Standards of Practice for Compounding Sterile Preparations (CSPs) | 14950627 |
8/19/2014 Vol. 40/161 |
|
|
|
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 |
|
|
|
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 |
|
|
|
Standards of Practice for Compounding Sterile Preparations (CSPs) | 14728012 |
6/24/2014 Vol. 40/122 |
|
|
|
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 |
|
|
|
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 |
|
|
|
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 |
|
|
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 |
|
|
|
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 |
|
|
|
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 |
|
|
|
Standards of Practice for Compounding Sterile Preparations (CSPs) | 8103882 |
Effective: 01/07/2010 |
|
|
|
Standards of Practice for Compounding Sterile Preparations (CSPs) | 7968470 |
11/25/2009 Vol. 35/47 |
|
|
|
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 |
|
|
|
The Board proposes to review the existing language in this rule to determine whether changes are necessary. | 6926399 |
3/27/2009 Vol. 35/12 |
|
|
|
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 |
|
|
|
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 |
|
|
|
Standards of Practice for Compounding Sterile Preparations (CSPs) | 5736015 |
Effective: 06/18/2008 |
|
|
|
Standards of Practice for Compounding Sterile Preparations - (CSPs) | 5571697 |
5/2/2008 Vol. 34/18 |
|
|
|
The Board proposes the rule promulgation in order to create standards of practice for compounding sterile preparations. | 3993895 |
4/13/2007 Vol. 33/15 |
|
|
|
The Board proposes to review the existing language in this rule to determine whether changes are necessary. | 3459425 |
1/19/2007 Vol. 33/03 |
|