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.
The change is in response to written comments submitted by the staff of the Joint Administrative Procedures Committee and input at the hearing. The changes are as follows:
1. The following language will be added to the end of the paragraph located above subsection (2):
The Board has determined that posting the incorporated material on the Internet would constitute a violation of federal copyright law. At the time of adoption, the copyrighted incorporated material will be available for public inspection and examination, but may not be copied, at the Department of Health, 4052 Bald Cypress Way, Tallahassee, Florida 32399-3254 and at the Department of State, Administrative Code and Register Section, Room 701, The Capitol, Tallahassee, Florida 32399-0250.
2. 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 (2011), adopted and incorporated herein by reference, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-_____.
3. For subsection (4), subparagraph (c) will be added and shall read as follows:
(c) USP Chapter 797 provides as follows in the “Facility Design and Environmental Controls” section: “An ISO Class 7 (see Table 1) buffer area and ante-area supplied with HEPA-filtered air shall receive an ACPH of not less than 30. The PEC is a good augmentation to generating air changes in the air supply of an area but cannot be the sole source of HEPA-filtered air. If the area has an ISO Class 5 (see Table 1) recirculating devise, a minimum of 15 ACPHs through the area supply HEPA filters is adequate, providing the combined ACPH is not less than 30. More air changes may be required, depending on the number of personnel and processes. HEPA-filtered supply air shall be introduced at the ceiling, and returns should be mounted low on the wall, creating a general top-down dilution of area air with HEPA-filtered make-up air. Ceiling-mounted returns are not recommended.” Notwithstanding the quoted provision, pharmacies that meet the standards set forth in the section quotes as of the effective date of this rule are not required to change the location of supply air or return filters or ducts so long as the ISO standards are maintained.
4. Subsections (5) and (6) shall be removed in their entirety.
5. The language that reads “THIS RULE SHALL TAKE EFFECT OCTOBER 1, 2014” shall now read as follows: “PROPOSED EFFECTIVE DATE: OCTOBER 1, 2014.”
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
