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Florida Administrative Code (Last Updated: April 18, 2024) |
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64. Department of Health |
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64B16. Board of Pharmacy |
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64B16-28. General Requirements - Permits |
1(1) The Special-ALF permit is an optional facility license for those Assisted Living Facilities providing a drug delivery system utilizing medicinal drugs provided in unit dose packaging.
28(2) Medicinal Drugs.
31(a) Medicinal drugs may not be dispensed on the premises.
41(b) 42All medicinal drugs must be maintained in individual prescription containers for the individual patient.
56(c) Medicinal drugs dispensed to the residents of a Special-ALF permit shall meet the labeling requirements of Rules 7464B16-28.502 75and 7664B16-28.108, 77F.A.C.
78(d) 79Medicinal drugs may not be dispensed on the premises. Medicinal drugs dispensed to patients of Special-ALF permits may be returned to the dispensing pharmacy’s stock under the provisions of Rule 10964B16-28.118, 110F.A.C. Dispensed controlled substances that have been discontinued shall be disposed of under the provisions of Rule 12764B16-28.301, 128F.A.C.
129(3) Consultant Pharmacist of Record.
134(a) 135Each facility holding a Special-ALF permit shall designate a consultant pharmacist of record to ensure compliance with the laws and rules governing the permit. The Board office shall be notified in writing within ten (10) days of any change in the consultant pharmacist of record.
180(b) The consultant pharmacist of record shall be responsible for the preparation of the Policy and Procedure Manual required by subsection 20164B16-28.800(2), 202F.A.C. Policy and Procedure Manuals must provide for the appropriate storage conditions and security of the medicinal drugs stored at the facility.
224(c) The consultant pharmacist of record shall inspect the facility and prepare a written report to be filed at the permitted facility at least monthly.
249(d) The consultant pharmacist of record shall conduct Drug Regimen Reviews as required by Federal or State law, inspect the facility, and prepare a written report to be filed at the permitted facility at least monthly. In addition, the consultant pharmacist of record must monitor the facility’s system for maintaining medication administration records and physician order sheets to ensure that the most current record of medications is available for the monthly drug regimen review. The consultant pharmacist of record may utilize additional consultant pharmacists to assist in this review and 339or 340in the monthly facility inspection.
345(e) A consultant pharmacist licensed in Florida may remotely access a facility or pharmacy’s electronic database from outside the facility or pharmacy to conduct supplemental drug regimen review services, subject to the pharmacy or facility establishing policies and procedures to ensure the security and privacy of confidential patient records, including compliance with applicable Federal HIPAA regulations.
401Rulemaking Authority 403465.005, 404465.022 FS. 406Law Implemented 408465.003(11)(a), 409465.016(1)(l), 410465.0196 FS. 412History–New 2-23-98, Amended 7-19-17.
