Florida Regulations 64B16-28.100: Pharmacy Permits – Applications and Permitting
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This rule section establishes the application and permitting requirements for pharmacies regulated under Florida Statutes Chapter 465 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 Fl. Admin. Code R. 64B16-26.1022
(1) All Permits:
(a) A permit is valid only for the name and, pursuant to Fl. Admin. Code R. 64B16-28.113, 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 Fl. Admin. Code R. 64B16-28.2021, 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 Florida Statutes § 465.022 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 Florida Statutes § 465.022(4), 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 Florida Statutes § 465.018, 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 Florida Statutes § 465.018
(3) An Institutional Pharmacy Permit, as authorized by Florida Statutes § 465.019, 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 Florida Statutes § 465.019
(4) A Nuclear Pharmacy Permit, as authorized by Florida Statutes § 465.0193, 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 Florida Statutes § 465.0196, 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 Florida Statutes § 465.0196
(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 Fl. Admin. Code R. 64B16-27.797 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 Fl. Admin. Code R. 64B16-28.560
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 Florida Statutes § 465.0197, 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 Florida Statutes § 465.0197
(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 Modified Class II-B pharmacy that meets the requirements of subsection 64B16-28.802(6), 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 01/18, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09436.
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.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 456.013, 456.025(3), 456.0635, 465.003, 465.018, 465.019, 465.0193, 465.0196, 465.0197, 465.022 FS. History-New 2-21-13, Amended 9-23-13, 5-31-17, 6-5-18, 12-19-21.
(a) A permit is valid only for the name and, pursuant to Fl. Admin. Code R. 64B16-28.113, 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 Fl. Admin. Code R. 64B16-28.2021, 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 Florida Statutes § 465.022 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 Florida Statutes § 465.022(4), 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 Florida Statutes § 465.018, 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 Florida Statutes § 465.018
(3) An Institutional Pharmacy Permit, as authorized by Florida Statutes § 465.019, 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 Florida Statutes § 465.019
(4) A Nuclear Pharmacy Permit, as authorized by Florida Statutes § 465.0193, 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 Florida Statutes § 465.0196, 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 Florida Statutes § 465.0196
(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 Fl. Admin. Code R. 64B16-27.797 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 Fl. Admin. Code R. 64B16-28.560
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 Florida Statutes § 465.0197, 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 Florida Statutes § 465.0197
(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 Modified Class II-B pharmacy that meets the requirements of subsection 64B16-28.802(6), 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 01/18, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-09436.
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.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 456.013, 456.025(3), 456.0635, 465.003, 465.018, 465.019, 465.0193, 465.0196, 465.0197, 465.022 FS. History-New 2-21-13, Amended 9-23-13, 5-31-17, 6-5-18, 12-19-21.