Notice of Development of Rulemaking

DEPARTMENT OF HEALTH
Board of Pharmacy
RULE NO: RULE TITLE
64B16-28.108: All Permits - Labels and Labeling of Medicinal Drugs
64B16-28.1081: Regulation of Daily Operating Hours
64B16-28.120: All Permits - Storage of Legend Drugs; Prepackaging
64B16-28.502: Labels and Labeling of Medicinal Drugs Institutional Permit I. (Nursing Homes)
64B16-28.602: Class II Institutional Dispensing
64B16-28.6021: Class II Institutional Pharmacy - Emergency Department Dispensing
64B16-28.603: Class II Institutional Pharmacy Operating Hours
64B16-28.604: Class II Institutional Pharmacy Department Security
64B16-28.702: Modified Class II Institutional Pharmacies
64B16-28.800: Special Pharmacies
64B16-28.820: Sterile Products and Special Parenteral/Enteral Compounding
64B16-28.870: Special-ALF
64B16-28.902: Nuclear Pharmacy - Minimum Requirements
PURPOSE AND EFFECT: The Board proposes the rule amendment in order to make corrections; for consideration of hour and day requirement; for clarification of language; for consideration of requirements; to add application; to add specific application information; to add application; to clarify language; and to review the existing language in the rules to determine whether other changes are necessary.
SUBJECT AREA TO BE ADDRESSED: All Permits – Labels and Labeling of Medicinal Drugs; Regulation of Daily Operating Hours; All Permits – Storage of Legend Drugs; Prepackaging; Labels and Labeling of Medicinal Drugs Institutional Permit I (Nursing Homes); Class II Institutional Pharmacies; Class II Institutional Pharmacy – Emergency Department Dispensing; Class II Institutional Pharmacy Operating Hours; Class II Institutional Pharmacy Department Security; Modified Class II Institutional Pharmacies Special Pharmacies; Sterile Products and Special Parenteral/Enteral Compounding; Special-ALF; Nuclear Pharmacy – Minimum Requirements.
SPECIFIC AUTHORITY: 465.005, 465.007, 465.019(4), 465.022 FS.
LAW IMPLEMENTED: 465.007, 465.018, 465.019(2)(b), (c), (4), 465.0193, 465.0196, 465.022(1), 465.022 FS.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE WEEKLY.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Rebecca Poston, Executive Director, Board of Pharmacy/MQA, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS NOT AVAILABLE.