RULE NO.:RULE TITLE:
64B16-28.140Record Maintenance Systems for All Pharmacy Permits
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. 48 No. 202, October 17, 2022 issue of the Florida Administrative Register.
The change is in response to written comments submitted by the staff of the Joint Administrative Procedures Committee. The Board voted at the duly-noticed public board meeting held February 9, 2023, in Kissimmee, Florida, to amend the rule. The rule shall now read as follows:
64B16-28.140 Record Maintenance Systems for All Pharmacy Permits.
(1) Requirements for records maintained in a data processing system.
(a) The pharmacy must comply with the provisions of 21 C.F.R. Section 1304.04 (a regulation of the Federal Drug Enforcement Administration), which is hereby incorporated by reference as of June 28, 2021 March 1, 1998, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref- when such is applicable to operate such a data processing system if any controlled substances (as that term is used in Chapter 893, F.S.) are dispensed from the pharmacy.
(b) Any pharmacy using a data processing system must meet the requirements of 21 C.F.R. Section 1306.22, which is hereby incorporated by reference as of March 31, 2010 1, 1998 and available at http://www.flrules.org/Gateway/reference.asp?No=Ref- .
(c) through (g) No change.
(h) Loss of Data. The prescription department manager shall report to the Board in writing any significant loss of information from the data processing system within 10 days of discovery of the loss.
(2) All transfers of prescriptions must be strictly in accordance with the provisions of Section 465.026, F.S., and Rule 64B16-27.105, F.A.C.
(3) through (6) No change.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.003(14), 465.022, 465.026, 465.035, 893.07 FS. History–New 3-16-94, Formerly 61F10-28.140, Amended 3-12-97, 6-4-97, Formerly 59X-28.140, Amended 10-29-97, 6-15-98, 11-11-98, 10-15-01, 3-24-14, .
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Traci Zeh, Acting Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254; Traci.Zeh@flhealth.gov.
