Nonresident Sterile Compounding Permit for an Outsourcing Facility  

  •  

    DEPARTMENT OF HEALTH

    Board of Pharmacy

    RULE NO.:RULE TITLE:

    64B16-32.009Nonresident Sterile Compounding Permit for an Outsourcing Facility

    NOTICE OF CHANGE

    Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 42 No. 104, May 27, 2016 issue of the Florida Administrative Register.

    The change is in response to written comments submitted by the staff of the Joint Administrative Procedures Committee and discussion and subsequent vote by the board at the public meeting held July 29, 2016. The rule shall now read as follows:

    64B5-32.009 Nonresident Sterile Compounding Permit for an Outsourcing Facility.

    This permit is required before an outsourcing facility that is located outside of Florida, ships, mails, delivers, or dispenses, in any manner a compounded sterile product into Florida.

    (1) through (2) No change. 

    (3) An outsourcing facility applicant seeking a nonresident sterile compounding permit shall submit an application using Form DH5004-MQA (eff. 07/16 04/16), “Nonresident Sterile Compounding Permit Application for Outsourcing Facilities” which is hereby incorporated by reference.  This Form is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-    or http://floridaspharmacy.gov.

    Rulemaking Authority 456.0158, FS.  Law Implemented 465.0158, 456.065(3) FS  History New __________.

     

    The following changes have been made to incorporated form DH5004-MQA, 04/16:

    The effective date of the form has been changed to July 2016.

    Minor punctuation and formatting changes have been made.

    Page 1 of 7, section 8: the word “hour” has been added to this section.

    Page 2 of 7, section 12b., the word “principle” has been changed to “principal.”

    Page 2 of the instructions have been changed as follows: Submit a current and satisfactory inspection report from an entity approved by the board. Approved entities can be found on the Board’s website at www.floridaspharmacy.gov

    Beginning on Page 2 of the application, the questions asked pursuant to Section 465.0635, F.S., were updated to reflect the current version of that statute.  The older form made reference to the federal Medicare program which was taken from a 2012 version of Section 465.0635, F.S. That language was removed from the questions, so they are consistent with the 2016 version of Section 465.0635, F.S.

    What was previously question 11 on page 2 of the application was removed in its entirety and the remainder of the form was renumbered. This question asked for toll-free number available 6 days a week for forty hours.

    On Page 7 of the application, the attestation was updated to remove the language “under penalties of perjury” and the word “affirm” was removed so it will no longer say “attest and affirm.”

     

    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Allison Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254