64B16-28.120: All Permits - Storage of Legend Drugs; Prepackaging
PURPOSE AND EFFECT: The Board proposes the rule amendment to add language concerning accessibility of stored medicinal drugs and propriety preparations.
SUBJECT AREA TO BE ADDRESSED: Storage of medicinal drugs and propriety preparations.
SPECIFIC AUTHORITY: 465.005, 465.022 FS.
LAW IMPLEMENTED: 465.022, 465.003(7), 465.019(2) 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:
64B16-28.120 All Permits – Storage of Legend Drugs; Prepackaging.
(1) All medicinal drugs or drug preparations as defined by Section 465.003(8), F.S., shall be stored:
(a) Within the confines of the prescription department of a community pharmacy permittee as defined in Section 465.018, F.S.
(b) In a Class II Institutional pharmacy as defined by Section 465.019(2)(b), (c), F.S., within the confines of the pharmacy provided, however, that those medicinal drugs established by the consultant pharmacist as supportive to treatment procedures such as medical drugs, surgical, obstetrical, diagnostic, etc., may be permitted to be stored in those areas where such treatment is conducted consistent with proper control procedures as provided by the policy and procedure manual of the pharmacy.
(2) All medicinal drugs or drug preparations as defined in Section 465.003(8), F.S., within Class I Institutional permittees as defined in Section 465.019(2)(a), F.S., and Special ALF Permit Rule 64B16-28.870, F.A.C., shall:
(a) Be administered from individual prescription containers to the individual patient; and
(b) Be prohibited within the confines of Class I Institutional pharmacies unless obtained upon a proper prescription and properly labeled in accordance with Chapter 499, F.S., and the rules and regulations contained in Chapter 59A-4, F.A.C., incorporated by reference and effective August 1, 2006, pertaining to the licensure of nursing homes and related facilities.
(3) Prepackaging of medication, whether a part of a unit dose system or a part of a multiple dose drug distribution system in an extended care facility or hospital holding a valid Class II Institutional pharmacy permit, must be done in accordance with procedures set up by the consultant pharmacist in the policy and procedure manual; and in the case of a pharmacy holding a valid community pharmacy permit must be done in accordance with procedures set up by the prescription department manager.
(4) Medicinal drugs and proprietary preparations as identified above that are stored in treatment areas must be accessible only to licensed staff (pharmacists, nurses, physicians, Advanced Registered Nurse Practitioner’s, physician assistants, respiratory and physical therapists, radiology technicians and pharmacy technicians, etc.) in accordance with their license and or practice act.
Specific Authority 465.005, 465.022 FS. Law Implemented 465.022, 465.003(7), 465.019(2) FS. History–New 9-18-84, Formerly 21S-1.44, 21S-1.044, Amended 7-31-91, Formerly 21S-28.120, 61F10-28.120, 59X-28.120, Amended 2-8-07,__________.