Rule: 64B16-28.802 Prev   Up   Next

Rule Title: Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities
Department: DEPARTMENT OF HEALTH    Add to MyFLRules Favorites
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):

VIEW_RULE Effective Date: 11/5/2017
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.
References in this version: No reference(s).
History of this Rule since Jan. 6, 2006
Notice /
Adopted
Section Description ID Publish
Date
View Text 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
View Text 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
View Text 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
View Text 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
View Text Final
64B16-28.802
Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities 19558612 Effective:
11/05/2017
View Text Change
64B16-28.802
Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities 19422133 9/19/2017
Vol. 43/181
View Text 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
View Text 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
View Text Final
64B16-28.802
Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities 18339322 Effective:
12/18/2016
View Text 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
View Text 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
View Text Final
64B16-28.802
Special Sterile Compounding Permits 17464479 Effective:
05/08/2016
View Text 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
View Text 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
View Text Final
64B16-28.802
Special Sterile Compounding Permits 13649663 Effective:
10/20/2013
View Text 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
View Text 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
View Text Final
64B16-28.802
Special Sterile Compounding Permits 13083765 Effective:
06/18/2013
View Text 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
View Text 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
View Text 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