64B16-28.100. Pharmacy Permits - Applications and Permitting

CHAPTER 64B16-28 GENERAL REQUIREMENTS – PERMITS 64B16-28.100 Pharmacy Permits – Applications and Permitting 64B16-28.101 Prescription Area Accessible to Inspection 64B16-28.102 Sink and Running Water, Sufficient Space, Refrigeration, Sanitation, Equipment 64B16-28.103 Sufficient Space in Prescription Department (Repealed) 64B16-28.1035 Patient Consultation Area 64B16-28.104 Refrigeration (Repealed) 64B16-28.105 Sanitation (Repealed) 64B16-28.106 Right to Inspect Invoices (Repealed) 64B16-28.107 Pharmacy Equipment (Repealed) 64B16-28.108 All Permits – Labels and Labeling of Medicinal Drugs 64B16-28.1081 Regulation of Daily Operating Hours; Commencement of Operations 64B16-28.10801 All Permits – Delivery of Medicinal Drugs 64B16-28.109 Prescription Department; Padlock; Sign: “Prescription Department Closed” 64B16-28.110 Outdated Pharmaceuticals 64B16-28.111 Storage of Equipment (Repealed) 64B16-28.112 Violations (Repealed) 64B16-28.113 Permits; Single Entity; Single Location 64B16-28.1135 Change of Ownership (Transferred) 64B16-28.114 Prescription Refills (Repealed) 64B16-28.118 Unit Dose and Customized Patient Medication Package Returns 64B16-28.119 Data Processing Systems in Pharmacy (Repealed) 64B16-28.1191 Unclaimed Prescriptions 64B16-28.120 All Permits – Storage of Legend Drugs; Prepackaging 64B16-28.121 Permit Fees (Repealed) 64B16-28.130 Transmission of Prescription Orders (Repealed) 64B16-28.140 Record Maintenance Systems for All Pharmacy Permits 64B16-28.141 Requirements for use of an Automated Pharmacy System by a Community Pharmacy (Repealed) 64B16-28.150 Record Maintenance Systems for Institutional and Animal Shelter Permits (Repealed) 64B16-28.201 Definitions (Repealed) 64B16-28.202 Closing of a Pharmacy; Transfer of Prescription Files 64B16-28.2021 Change of Ownership 64B16-28.203 Transfer of Medicinal Drugs; Change of Ownership; Closing of a Pharmacy 64B16-28.301 Destruction of Controlled Substances – Institutional Class I Pharmacies (Nursing Homes) 64B16-28.303 Destruction of Controlled Substances All Permittees (Excluding Institutional Class I Nursing Homes) 64B16-28.402 Labels and Labeling of Medicinal Drugs – Community Pharmacy Permit (Repealed) 64B16-28.404 Regulation of Daily Operating Hours (Repealed) 64B16-28.450 Centralized Prescription Filling, Delivering and Returning 64B16-28.451 Pharmacy Common Database; Exceptions for Prescription Drug Processing Only Pharmacies 64B16-28.501 Consultant Pharmacist of Record; Initial Designation; Change 64B16-28.502 Class I, Class II and Class III Institutional Permit – Labels and Labeling of Medicinal Drugs for Inpatients of a Nursing Home 64B16-28.503 Transmission of Starter Dose Prescriptions for Patients in Class I or Modified II B Institutional Facilities 64B16-28.602 Institutional Class II and Class III Dispensing 64B16-28.6021 Institutional Class II and Class III Pharmacy – Emergency Department Dispensing 64B16-28.603 Class II and Class III Institutional Pharmacy Operating Hours 64B16-28.604 Class II and Class III Institutional Pharmacy Department Security 64B16-28.605 Class II and Class III Institutional Pharmacies – Automated Distribution and Packaging 64B16-28.606 Remote Medication Order Processing for Class II or Class III Institutional Pharmacies or Special Pharmacy Permits Servicing Class I, Class II, Modified Class II, Class III, and Special ALF Permitted Facilities 64B16-28.607 Automated Pharmacy System – Long-Term Care, Hospice, and Prison 64B16-28.608 Automated Filling Systems within a Pharmacy 64B16-28.702 Modified Class II Institutional Pharmacies 64B16-28.750 Class III Institutional Pharmacies 64B16-28.800 Special Pharmacies 64B16-28.802 Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities 64B16-28.810 Special Pharmacy – Limited Community Permit 64B16-28.820 Sterile Products and Special Parenteral/Enteral Compounding 64B16-28.830 Special – Closed System Pharmacy 64B16-28.840 Special – Non Resident (Mail Service) (Repealed) 64B16-28.850 Special Pharmacy – ESRD 64B16-28.860 Special Pharmacy – Parenteral/Enteral Extended Scope Permit 64B16-28.870 Special-ALF 64B16-28.900 Definitions – Nuclear Pharmacy 64B16-28.901 Nuclear Pharmacy – General Requirements 64B16-28.902 Nuclear Pharmacy – Minimum Requirements 64B16-28.903 Training Qualifications (Repealed) 64B16-28.904 Nuclear Pharmacist – Continuing Education (Repealed) 64B16-28.905 Nonresident Sterile Compounding Permit Inspections; Approved Inspection Entities (Transferred) 64B16-28.100 Pharmacy Permits – Applications and Permitting. This rule section establishes the application and permitting requirements for pharmacies regulated under Chapter 465, F.S. Any pharmacy establishment shall apply to the board for the appropriate permit on forms indicated in this rule. Applications and forms referenced in this section may be accessed or downloaded from the web at http://floridaspharmacy.gov/resources/ or may be obtained by contacting the Board the Board of Pharmacy, at 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, or (850)488-0595. Inquiries regarding the status of the application or license verification may be obtained at http://www.FLHealthsource.gov. The application must be accompanied by the appropriate fee as specified by Rule 64B16-26.1022, F.A.C. (1) All Permits: (a) A permit is valid only for the name and, pursuant to Rule 64B16-28.113, F.A.C., physical location (address) to which it is issued. The name in which the permit is issued must be the name in which the company is doing business, i.e., the name that appears on purchase and sales invoices. 1. The name in which a permit is issued may be changed upon notification to the board. To change the name in which a permit is issued the person or establishment must file with the board an original Form DH-MQA 1227 “Pharmacy Permit Name Change Form” effective December 2010, which is incorporated by reference herein, and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-02297 or on the web at http://floridaspharmacy.gov/resources/. 2. A pharmacy permit holder may request a change of practice location by completing the appropriate section(s) of the application form for the permit type. 3. Pharmacy permits are non-transferrable. However, pursuant to Rule 64B16-28.2021, F.A.C., transfers of ownership interests of business entities holding a permit may be allowed. A pharmacy permit holder shall notify the Board of changes of ownership interests of business entities by completing the appropriate section(s) of the application form for the permit type. (b) Each applicant must comply with the fingerprinting requirements in Section 465.022, F.S. Electronic fingerprint information (“EFI”) that has been submitted to the Florida Agency for Health Care Administration may be accessible by the Florida Department of Health for a period of sixty (60) months. If the Department is able to access EFI from AHCA, applicants will not be required to resubmit EFI for additional or new applications submitted during this time period. After sixty (60) months, new electronic fingerprint information must be submitted as part of all applications. (c) An onsite inspection demonstrating full compliance with all applicable rules and statutes is a prerequisite to issuance of a new permit, whether based on an initial application, change of ownership, or change of address. (d) Pursuant to Section 465.022(4), F.S., each applicant must attach to the application the applicant’s written policies and procedures for preventing controlled substance dispensing based on fraudulent representations or invalid practitioner-patient relationships. The policy and procedure manual shall contain, at a minimum, the following: 1. Provisions to identify and guard against invalid practitioner-patient relationships. 2. Provisions to guard against filling fraudulent prescriptions for controlled substances. 3. Provisions to identify prescriptions that are communicated or transmitted legally. 4. Provisions to identify the characteristics of a forged or altered prescription. (2) A Community Pharmacy Permit, as authorized by Section 465.018, F.S., is required for every location where medicinal drugs are compounded, dispensed, stored, or sold or where prescriptions are filled or dispensed on an outpatient basis. Applicants for a community pharmacy permit must complete an application for a permit using an original Form DH-MQA 1214, “Community Pharmacy Permit Application and Information,” Rev 01/18, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09431. Applicants for a Community Pharmacy Permit must comply with all permitting requirement found in subsection (1) of this rule and designate a prescription department manager as required by Section 465.018, F.S. (3) An Institutional Pharmacy Permit, as authorized by Section 465.019, F.S., is required for any location in any health care institution where medicinal drugs are compounded, dispensed, stored or sold. Applicants for an Institutional Pharmacy permit must complete an application for a permit using an original Form DH-MQA 1215, “Institutional Pharmacy Permit Application and Information,” Rev 01/18, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09432. Applicants for an Institutional Pharmacy Permit must comply with all permitting requirements found in subsection (1) of this rule and designate a consultant pharmacist of record as required by section 465.019, F.S. (4) A Nuclear Pharmacy Permit, as authorized by Section 465.0193, F.S., is required for every location where radioactive drugs and chemicals within the classification of medicinal drugs are compounded, dispensed, stored, or sold. Applicants for a Nuclear Pharmacy permit must complete an application for a permit using an original Form DH-MQA 1218, “Nuclear Pharmacy Permit Application and Information,” Rev 01/18, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09433. Applicants for a Nuclear Pharmacy Permit must comply with all permitting requirements found in subsection (1), of this rule and designate a nuclear pharmacist as the prescription department manager as required by subsection 64B16-28.901(1), F.A.C. (5) A Special Pharmacy Permits as authorized by Section 465.0196, F.S., is required for any location where medicinal drugs are compounded, dispensed, stored, or sold and which is not a community pharmacy, institutional pharmacy, nuclear pharmacy or internet pharmacy. Applicants for a Special-Limited Community, Special – Parenteral and Enteral, Special – Closed System Pharmacy, Special – End Stage Renal Disease (ESRD), Special – Parenteral/Enteral Extended Scope, and Special – Assisted Living Facility (ALF) permits must complete an application for a permit using an original Form DH-MQA 1220, “Special Pharmacy Permit Application and Information,” Rev 01/18, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09434. (a) Applicants for a Special Pharmacy Permit must comply with all permitting requirement found in subsection (1) of this rule; and designate a prescription department manager or consultant pharmacist of record as required by Section 465.0196, F.S. (b) The Board recognized the following types of Special Pharmacy permits: 1. A Special Limited Community Permit is required for any Institutional Class II Pharmacy that dispenses medicinal drugs to employees, medical staff, emergency room patients, and other patients on continuation of a course of therapy. 2. A Special Parenteral and Enteral Permit is required for any pharmacy which provides parenteral (IV), enteral, and cytotoxic pharmacy services to outpatients. The applicant must be compliant with the Standard for Compounding Sterile Preparations found in Rule 64B16-27.797, F.A.C. Special – Parenteral and Enteral Pharmacy Permits may stand-alone or be used in conjunction with a Community Pharmacy or Special – Closed System Pharmacy Permit. The permittee must provide 24-hour telephone accessibility. 3. A Special Closed System Pharmacy Permit is required for any pharmacy not open to the public and where prescriptions are individually prepared for dispensing utilizing closed delivery systems, for ultimate consumers in health care institutions including nursing homes, jails, Assisted Living Facilities (ALFs), Intermediate Care Facilities for the Developmentally Delayed (ICF-IID) or other custodial care facilities when defined by AHCA rules which the Board may approve. This permit may not provide medications to in-patients in a hospital. 4. A Special Pharmacy – End Stage Renal Disease (ESRD) Permit is required for any pharmacy which is limited in scope of pharmacy practice to the provision of dialysis products and supplies to persons with chronic kidney failure for self-administration at the person’s home or specified address. 5. A Special Pharmacy – Parenteral/Enteral Extended Scope Permit is required for any pharmacy which compounds patient specific parenteral/enteral preparations in conjunction with institutional pharmacy permits, as provided in Rule 64B16-28.560, F.A.C. 6. Special – Assisted Living Facility (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. (6) An Internet Pharmacy Permit, as authorized by Section 465.0197, F.S., is required for any location not otherwise licensed or issued a permit under this chapter, within or outside this state that uses the Internet to communicate with or obtain information from consumers and uses the information to fill or refill prescriptions or to dispense, distribute, or otherwise engage in the practice of pharmacy in this state. Applicants for an Internet Pharmacy permit must complete an application for a permit using an original Form DH-MQA 1216, “Internet Pharmacy Permit Application and Information” which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09435 Rev 01/18. Applicants for an Internet Pharmacy Permit must comply with all permitting requirements found in subsection (1) of this rule and designate a prescription department manager or consultant pharmacist of record as required by Section 465.0197, F.S. (7) Special Sterile Compounding Permit: Except those pharmacies which already hold an active stand-alone Special Parenteral/Enteral or Special Parenteral/Enteral Extended Scope Compounding permit, or a pharmacy permittee compounding sterile products for immediate-use in full compliance with Rule 64B16-28.802, F.A.C., any pharmacy, including an outsourcing facility, engaged in sterile compounding must obtain a special sterile compounding permit by filing an application on form DH-MQA 1270, “Special Sterile Compounding Permit Application and Information,” Rev 10/2024, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-17808. Applicants for a Special Sterile Compounding Permit must comply with all permitting requirements in subsection (1) of this rule and designate a prescription department manager or consultant pharmacist of record.