64B16-28.802 : Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities - Florida Administrative Rules, Law, Code, Register

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Rule Title: Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities
Department:	DEPARTMENT OF HEALTH	Add to MyFLRules Favorites
Division:	Board of Pharmacy
Chapter:	GENERAL REQUIREMENTS - PERMITS

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

	Effective Date:	10/29/2024
	History Notes:	Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.0196 FS. History–New 6-18-13, Amended 10-20-13, 5-8-16, 12-18-16, 11-5-17, 10-29-24.
	References in this version:	No reference(s).

History of this Rule since Jan. 6, 2006

Notice / Adopted	Section	Description	ID	Publish Date

	Final 64B16-28.802	Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities	28861494	Effective: 10/29/2024
	Correction 64B16-28.802	Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities	28701056	8/30/2024 Vol. 50/171
	Proposed 64B16-28.802	The Board proposes the rule amendment to clarify language regarding special sterile compounding permits for pharmacies and outsourcing facilities.	28662838	8/20/2024 Vol. 50/163
	Development 64B16-28.802	The Board proposes the rule amendment to clarify language regarding special sterile compounding permits for pharmacies and outsourcing facilities.	28594453	7/31/2024 Vol. 50/149
	Variances 64B16-28.802	of the issuance of an Order regarding the Petition for Waiver or Variance, which was filed on January 25, 2024, by Belcher Pharmaceuticals, LLC and BPI Labs, LLC. The Notice of Petition for Waiver or Variance was published ....	28207908	3/28/2024 Vol. 50/62
	Variances 64B16-28.802	variance or waiver filed by Belcher Pharmaceuticals, LLC and BPI Labs, LLC, seeking a waiver of the requirement of Rule 64B16-28.802(1), Florida Administrative Code, which states that a Special Sterile Compounding Permit ....	28007603	1/31/2024 Vol. 50/21
No File	Validity 64B16-28.802	HYBRID PHARMA LLC, Petitioner vs. DEPARTMENT OF HEALTH and BOARD OF PHARMACY, Respondents; Case No.: 23-1604RX; Rule No.: 64B16-28.802; Petition	27081932	5/1/2023 Vol. 49/84
	Variances 64B16-28.802	that the Petition for Variance or Waiver received on September 30, 2021, from Martin R. Dix, Esquire, on behalf of Integrated Medical Supplies, LLC, seeking a variance or waiver of Rule 64B16-28.802(6)(b), Florida Administrative ....	25286947	11/22/2021 Vol. 47/226
	Variances 64B16-28.802	variance or waiver filed by Martin R. Dix, Esquire, on behalf of Integrated Medical Supplies, LLC, seeking a variance or waiver of the requirement of Rule 64B16-28.802(6)(b), Florida Administrative Code, which states that ....	25105557	10/6/2021 Vol. 47/194
	Final 64B16-28.802	Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities	19558612	Effective: 11/05/2017
	Change 64B16-28.802	Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities	19422133	9/19/2017 Vol. 43/181
	Proposed 64B16-28.802	The Board proposes the rule amendment to add a subsection regarding SSCP for a Modified II B Pharmacy.	18960704	5/12/2017 Vol. 43/93
	Development 64B16-28.802	The Board proposes the rule amendment to add a subsection regarding SSCP for a Modified II B Pharmacy.	18899206	4/26/2017 Vol. 43/81
	Final 64B16-28.802	Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities	18339322	Effective: 12/18/2016
	Proposed 64B16-28.802	The Board proposes the rule amendment to update the rule regarding special sterile compounding permits for pharmacies and outsourcing facilities.	18087704	10/3/2016 Vol. 42/192
	Development 64B16-28.802	The Board proposes the promulgation of the rule to update the rule regarding special sterile compounding permits for pharmacies and outsourcing facilities.	18008843	9/14/2016 Vol. 42/179
	Final 64B16-28.802	Special Sterile Compounding Permits	17464479	Effective: 05/08/2016
	Proposed 64B16-28.802	The Board proposes the rule amendment to provide a more comprehensive rule for special sterile compounding permits.	17256317	3/8/2016 Vol. 42/46
	Development 64B16-28.802	The Board proposes the rule amendment to provide a more comprehensive rule for special sterile compounding permits and for clarification purposes.	17180851	2/18/2016 Vol. 42/33
	Final 64B16-28.802	Special Sterile Compounding Permits	13649663	Effective: 10/20/2013
	Proposed 64B16-28.802	The board proposes the rule amendment to add language and clarification to the existing rule.	13271654	7/22/2013 Vol. 39/141
	Development 64B16-28.802	The board proposes the rule development to clarify the requirements for a Special Sterile Compounding Permit.	13190077	7/3/2013 Vol. 39/129
	Final 64B16-28.802	Special Sterile Compounding Permits	13083765	Effective: 06/18/2013
	Proposed 64B16-28.802	To review the necessity of creating a new rule for classification or sub classification and permitting of special pharmacies. This includes the topic of compounding.	12884333	4/16/2013 Vol. 39/74
	Workshop 64B16-28.800 ......	To discuss the proposed text of rules. 64B16-28.800 Rule Development was published on January 9, 2013, in Vol. 39, No. 06; and 64B16-28.802 .... Friday, March 22, 2013 , at 10:00 a.m. The Peabody Orlando, 9801 International Drive, Orlando, Florida ....	12728066	3/7/2013 Vol. 39/46
	Development 64B16-28.802	To review the necessity of creating a new rule for classification or sub classification and permitting of special pharmacies. This includes the topic of compounding.	12499534	1/11/2013 Vol. 39/08

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