RULE NO.:RULE TITLE:
64B16-32.007Nonresident Sterile Compounding Permit for Nonresident Pharmacies
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:
64B16-32.007 Nonresident Sterile Compounding Permit for Nonresident Pharmacies
This permit is required before a nonresident pharmacy ships, mails, delivers, or dispenses, in any manner, a patient-specific compounded sterile product into Florida.
(1) through (2) No change.
(3) A nonresident pharmacy applicant seeking a nonresident sterile compounding permit shall submit an application using Form DH5003-MQA (eff. 07/16 04/16), “Nonresident Sterile Compounding Permit Application for Nonresident Pharmacies,” which is hereby incorporated by reference. The Form is available at http://www.flrules.org/Gateway/reference.asp?No=Ref- or http://floridaspharmacy.gov. An applicant for this permit must comply with all provisions of section 465.0158, F.S.
Rulemaking Authority 456.0158, FS. Law Implemented 465.0158, 456.0635, 456.065(3), 465.0156 FS History New __________.
The following changes have been made to incorporated form DH5003-MQA, 04/16:
The effective date of the form has been changed to July 2016.
Page 1 of 7, section 8: the word “hour” has been added to this section.
Page 2 of 7, the numbering of the questions has been corrected.
Minor punctuation and formatting changes have been made.
Beginning on Page 2 of the application, the questions asked pursuant to Section 465.0635 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 s. 465.0635, F.S.
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.” Added to signature is “PDM/PIC of sterile compounding”
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
