Florida Regulations 64B16-28.120: All Permits – Storage of Legend Drugs; Prepackaging
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(1) All medicinal drugs or drug preparations as defined by Florida Statutes § 465.003(8), shall be stored:
(a) Within the confines of the prescription department of a community pharmacy permittee as defined in Florida Statutes § 465.018
(b) In a Class II Institutional pharmacy as defined by Section 465.019(2)(b), 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 Florida Statutes § 465.003(8), within Class I Institutional permittees as defined in Section 465.019(2)(a), F.S., and Special ALF Permit Fl. Admin. Code R. 64B16-28.870, 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 Florida Statutes Chapter 499, and the rules and regulations contained in Fl. Admin. Code Chapter 59A-4, incorporated herein by reference and effective August 25, 2023, which may be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-16160 or https://www.flrules.org/gateway/ChapterHome.asp?Chapter=59A-4, 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 of record 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 practitioners, physician assistants, respiratory and physical therapist, radiology technicians and registered pharmacy technicians, etc.) in accordance with their license, practice act, or to other personnel specifically authorized by the institution.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 435.019(2), 465.003(7), 465.022 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, 8-16-10, 12-18-23.
(a) Within the confines of the prescription department of a community pharmacy permittee as defined in Florida Statutes § 465.018
(b) In a Class II Institutional pharmacy as defined by Section 465.019(2)(b), 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 Florida Statutes § 465.003(8), within Class I Institutional permittees as defined in Section 465.019(2)(a), F.S., and Special ALF Permit Fl. Admin. Code R. 64B16-28.870, 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 Florida Statutes Chapter 499, and the rules and regulations contained in Fl. Admin. Code Chapter 59A-4, incorporated herein by reference and effective August 25, 2023, which may be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-16160 or https://www.flrules.org/gateway/ChapterHome.asp?Chapter=59A-4, 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 of record 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 practitioners, physician assistants, respiratory and physical therapist, radiology technicians and registered pharmacy technicians, etc.) in accordance with their license, practice act, or to other personnel specifically authorized by the institution.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 435.019(2), 465.003(7), 465.022 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, 8-16-10, 12-18-23.