Rule: 64B16-27.700 Prev   Up   Next

Rule Title: Definition of Compounding
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: 1/28/2018
History Notes: Rulemaking Authority 465.005 FS. Law Implemented 465.003, 465.0155, 465.0265 FS. History–New 10-1-92, Formerly 21S-27.700, 61F10-27.700, 59X-27.700, Amended 11-2-03, 10-7-08, 3-21-13, 6-22-14, 1-28-18.
References in this version: Ref-04180 21 U.S.C. 353b (eff 11/27/2013)
History of this Rule since Jan. 6, 2006
Notice /
Adopted
Section Description ID Publish
Date
View Text Proposed
64B16-27.700
The Board proposes the rule amendment to update language regarding compounding. 28620740 8/7/2024
Vol. 50/154
View Text Development
64B16-27.700
The Board proposes the rule amendment to update language regarding compounding. 28566226 7/22/2024
Vol. 50/142
View Text Disposition
64B16-27.700
Corie Hawks
  The Notice of Petition for Declaratory Statement was published in Volume 47, No. 176, of the September 10, 2021, Florida Administrative ....
25549429 2/9/2022
Vol. 48/27
View Text Petition
64B16-27.700
Cori Hawks, filed on September 1, 2021.
  Petitioner seeks a Declaratory Statement from the Board requesting that language be added to the rule giving veterinarians clarity ....
24990806 9/10/2021
Vol. 47/176
View Text Final
64B16-27.700
Definition of Compounding 19960483 Effective:
01/28/2018
View Text Hearing
64B16-27.700
Definition of Compounding 19677340 11/3/2017
Vol. 43/214
View Text Proposed
64B16-27.700
The Board proposes the rule amendment so that the rule does not conflict with state or federal law and to make clear that office use compounding of products intended for human use (sterile and nonsterile) shall require being .... 19309516 8/18/2017
Vol. 43/161
View Text Development
64B16-27.700
The Board proposes the rule development and amendment to update the rule for any identified needed changes and to amend the rule to require and make clear that the compounding of human products (sterile and nonsterile) for .... 19215329 7/21/2017
Vol. 43/141
View Text Development
64B16-27.700
The Board proposes the rule amendment to determine whether changes are necessary and to review for conflict with federal law. 16295241 8/3/2015
Vol. 41/149
View Text Petition
64B16-27.700
William M. Blackshear, Jr., M.D., on behalf of Prescription Health Network, LLC, ....
  The Petitioner seeks a Declaratory Statement from the Board with regard to Rule 64B16-27.700, Florida Administrative Code, as to whether ....
16016657 5/21/2015
Vol. 41/99
View Text Disposition
64B16-27.700
Brian A. Kahan, Esquire, on behalf of Lato Drug Company and Robert Fishman, RPH
  The Notice of Petition for Declaratory Statement was published in Volume 41, No. 44, of the March 5, 2015, Florida Administrative ....
15969903 5/6/2015
Vol. 41/88
View Text Petition
64B16-27.700
Brian A. Kahan, Esquire, on behalf of Lato Drug Company Inc. d/b/a Post Haste Pharmacy ....
  The Petitioners seek a Declaratory Statement from the Board with regard to section 465.185(1), F.S. and Rule 64B16-27.700, Florida ....
15747094 3/5/2015
Vol. 41/44
View Text Final
64B16-27.700
Definition of Compounding 14677572 Effective:
06/22/2014
View Text Proposed
64B16-27.700
The Board proposes the rule amendment so that the rule does not conflict with 21 U.S.C. § 353b relating to office use compounding of sterile products intended for human use. 14516649 5/2/2014
Vol. 40/86
View Text Development
64B16-27.700
The Board proposes to open the rule for development to comprehensively review the rule for any necessary or needed changes of a technical or substantive nature or changes necessary to make the rule clearer, and for the specific .... 13965592 12/20/2013
Vol. 39/246
View Text Final
64B16-27.700
Definition of Compounding 12867940 Effective:
03/21/2013
View Text Final
64B16-27.700
Definition of Compounding 12720694 Effective:
03/21/2013
View Text Proposed
64B16-27.700
The Board proposes the rule amendment to clarify the requirements for compounding for office use. 12356168 12/5/2012
Vol. 38/84
View Text Development
64B16-27.700
The Board proposes the rule amendment to clarify the requirements for compounding for office use. 11405180 4/27/2012
Vol. 38/17
View Text Petition
64B16-27.700
Jeffrey Gibbs.
  The petition requests the Board to issue a declaratory statement regarding the applicability of Rule 64B16-27.700, F.A.C., and whether ....
8938761 7/30/2010
Vol. 36/30
View Text Disposition
64B16-27.700
Unique Pharmaceuticals
  The Notice of Petition for Declaratory Statement published on January 23, 2009, Vol. 35, No. 3, of the Florida Administrative Weekly. ....
7826462 10/23/2009
Vol. 35/42
View Text Variances
64B16-27.700
David Weinstein, M.D., on behalf of University Urologists. Although there is no reference to a specific rule number in the petition, it appears that the petitioner is seeking a variance or waiver of Rule 64B16-27.700, Florida .... 6687585 1/23/2009
Vol. 35/03
View Text Petition
64B16-27.700
Timothy Weathers on behalf of Unique Pharmaceuticals on January 8, 2009.
  The petition seeks the Board’s interpretation of Rule 64B16-27.700, Florida Administrative Code, concerning the practice of compou....
6687294 1/23/2009
Vol. 35/03
View Text Final
64B16-27.700
Definition of Compounding 6215583 Effective:
10/07/2008
View Text Petition
64B16-27.400
......
Samuel Jones III, Pharm.D.
  The petition seeks the Board’s interpretation of Rules 64B16-27.700, 64B16-27.400, and 64B16-27.420, Florida Administrative Code, ....
5970852 8/8/2008
Vol. 34/32
View Text Hearing
64B16-27.700
Definition of Compounding 5088249 1/11/2008
Vol. 34/02
View Text Correction
64B16-27.700
Definition of Compounding 5007836 12/21/2007
Vol. 33/51
View Text Change
64B16-27.700
Definition of Compounding 4842645 11/9/2007
Vol. 33/45
View Text Conference
64B16-27.700
The Committee will approve minutes from previous meeting, review rule status of 64B16-27.700-Office Use Compounding; 64B16-27.431-Responsibilties ....
  March 9, 2007, 1:00 p.m.
  Conference Call Number: 1-888-808-6959, Conference Code 564....
3811632 2/23/2007
Vol. 33/08
View Text Hearing
64B16-27.100
......
Display of Wall Certificate and Renewal Certificates, Oral Prescriptions and Copies, Conduct Governing Registered Pharmacists and Pharmacy Permittees, General Terms and Conditions to Be Followed by a .... 348053 5/19/2006
Vol. 32/20
View Text Final
64B16-27.700
Definition of Compounding 2471383 Effective:
11/02/2003