RULE NO.:RULE TITLE:
64B16-27.797Standards of Practice for Compounding Sterile Preparations (CSPs)
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. 40, No. 48, March 11, 2014 issue of the Florida Administrative Register.
A previous Notice of Change for this rule published in Vol. 40, No. 122, of the June 24, 2014, 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 input at the rule hearing. The changes are as follows:
1. Paragraph (1)(b) will be removed in its entirety. Therefore, paragraphs (1)(c) through (1)(e) will be renumbered (1)(b) through (1)(d).
2. Paragraph (1)(f) will be removed in its entirety.
3. The second sentence located under paragraphs (1)(a) through (1)(e) which states, “A copy of the USP chapters referenced in this rule may be examined and inspected, but not copied, at the office of the Board of Pharmacy in Tallahassee, Florida.” will be removed in its entirety due to redundancy.
4. Subsection (3) shall now read as follows:
(3) Current Good Manufacturing Practices: The Board deems that this rule is complied with for any sterile products that are compounded in strict accordance with Current Good Manufacturing Practices per 21 U.S.C. § 351 (2012), adopted and incorporated herein by reference, available at http://www.flrules.org/Gateway/referernce.asp?No=Ref-______ and 21 C.F.R. Parts 210 and 211 (2013), adopted and incorporated herein by reference, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-________.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Patrick Kennedy, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254
