Published on: 19309516. 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 registered as an Outsourcing Facility as defined by §465.003(19), Fla. Stat. (2016).
SUMMARY: Office use compounding of sterile and nonsterile products for human use shall comply with federal law to include being a registered Outsourcing Facility.
Published on: 19215329. 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 office use must be in full compliance with 21 U.S.C. §353b, including being registered as an Outsourcing Facility. In addition, the purpose and effect is to ensure that the rule does not conflict with state and federal law.
Published on: 16016657. William M. Blackshear, Jr., M.D., on behalf of Prescription Health Network, LLC, filed on May 14, 2015; The Petitioner seeks a Declaratory Statement from the Board with regard to Rule 64B16-27.700, Florida Administrative Code, as to whether the ingredients used in the company’s weight loss injections, as described and outlined in the petition, fall under the restrictions placed on office use of compounding drugs.
Except for good cause shown, motions for leave to intervene must be filed within 21 days after the publication of this notice.
Published on: 15969903. 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 Register. The Petitioners sought a Declaratory Statement from the Board with regard to section 465.185(1), F.S. and Rule 64B16-27.700, Florida Administrative Code, that the petitioners’ contemplated business arrangement for compounding medications for veterinary use, as outlined in the petition, would not subject Petitioners to discipline under the cited statute and rule.
The Board of Pharmacy considered the Petition at a duly-noticed public meeting held on April 7, 2015, in Tampa, Florida. After discussion regarding the merits of the Petition, Petitioner moved to withdraw the Petition for Declaratory Statement. The Board’s Order, filed on April 28, 2015, granted the request to withdraw the Petition for Declaratory Statement and dismiss the cause.
Published on: 15747094. Brian A. Kahan, Esquire, on behalf of Lato Drug Company Inc. d/b/a Post Haste Pharmacy and Robert Fishman, RPh.; The Petitioners seek a Declaratory Statement from the Board with regard to section 465.185(1), F.S. and Rule 64B16-27.700, Florida Administrative Code, that the petitioners’ contemplated business arrangement for compounding medications for veterinary use, as outlined in the petition, would not subject Petitioners to discipline under the cited statute and rule. Except for good cause shown, motions for leave to intervene must be filed within 21 days after the publication of this notice.