The Board proposes the rule amendment to update and revise the rule and to update the application forms incorporated through the rule.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.100Pharmacy Permits - Applications and Permitting

PURPOSE AND EFFECT: The Board proposes the rule amendment to update and revise the rule and to update the application forms incorporated through the rule.

SUMMARY: Incorporated forms will be updated; the rule will be revised and updated.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 465.005, 465.022 FS.

LAW IMPLEMENTED: 456.013, 456.025(3), 456.0635, 465.018, 465.019, 465.0193, 465.0196, 465.0197, 465.022 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-28.100 Pharmacy Permits – Applications and Permitting.

This rule section establishes addresses the application and permitting requirements for pharmacies of business establishments regulated under Chapter 465, F.S. Any pharmacy establishment that is required to have a permit 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/ http://www.doh.state.fl.us/mqa/pharmacy or may be obtained by contacting the Board of Pharmacy, at 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, or [phone]. 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. with a $250 initial permit fee, payable to the Board.

(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.

(a) A permit shall be issued only to a single entity at a single location. The service provided by the permit shall be consistent with the issued permit. A single location shall be defined as:

1. A contiguous area under the control of the permit holder. For purposes of this rule, a public thoroughfare will be considered to have not broken the area of contiguity; and,

2. An area not more than one half (1/2) mile from the central location of the permit.

1.  (b) 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/ http://www.doh.state.fl.us/mqa/pharmacy.

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, 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) (c) Each applicant must comply with the fingerprinting file with the board a legible set of fingerprint cards and a $48 fee for each person who submits an application meeting the requirements of section 465.022(3), 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. An applicant may register demographic information and purchase fingerprint cards (FD-258) at http://http://www.fldoh.sofn.net/. If an applicant chooses not to purchase a fingerprint card, the applicant must make sure the police or agency that rolls the fingerprints uses a FD-258 fingerprint card. A Non-Resident Pharmacy Registration applicant is not required to submit a legible set of fingerprints upon application.

(c)(d) No change.

(d)(e) Pursuant to section 465.022(4), F.S., eEach 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, effective August 2012 which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-     02298. (a) Applicants for a Community Pharmacy Permit must: 1. cComply with all permitting requirement found in subsection (1), of this rule; and, 2. dDesignate a prescription department manager as required by Section 465.018, F.S.

(b) The permittee and the newly designated prescription department manager shall notify the board within 10 days of any change in the prescription department manager using an original Form DH-MQA PH10, “Prescription Department Manager Change,” effective December 2010, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-02299.

(c) The policy and procedure manual for Community Pharmacies shall contain the procedures implemented to minimize the dispensing of controlled substances based on fraudulent representations. The policy and procedural manual shall provide 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.

(3)  An Institutional Pharmacy Permits, 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 effective August 2012, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-       02300.  (a) Applicants for an Institutional Pharmacy Permit must: 1. cComply with all permitting requirements found in subsection (1) of this rule; and, dDesignate a consultant pharmacist of record as required by Section 465.019, F.S.

(b) The Board shall be notified in writing within 10 days of any change in the consultant pharmacist of record using an original Form DH-MQA 1184, “Change of Consultant Pharmacist of Record,” effective December 2010, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-02301.

(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 effective August 2012, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-      02302. (a) Applicants for a Nuclear Pharmacy Permit must: 1. cComply with all permitting requirements found in subsection (1), of this rule; and, 2. dDesignate a nuclear pharmacist as the prescription department manager as required by Rule 64B16-28.901(1), F.A.C. nuclear pharmacist of record as required by Section 465.0193, F.S.

(b) The permittee and the newly designated prescription department manager shall notify the board within 10 days of any change in the prescription department manager using an original Form DH-MQA PH10, “Prescription Department Manager Change,” effective December 2010.

(5) A Special Pharmacy Permits as authorized by in Section 465.0196, F.S., is required for any location where medicinal drugs are compounded, dispensed, stored, or sold and which is are 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 effective August 2012, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-      02303.

(a) Applicants for a Special Pharmacy Permit must: 1. cComply with all permitting requirement found in subsection (1), of this rule; and, 2. dDesignate a prescription department manager or consultant pharmacist of record as required by Section 465.0196, F.S.

(b) The permittee and the newly designated prescription department manager shall notify the board within 10 days of any change in the prescription department manager using an original Form DH-MQA PH10, “Prescription Department Manager Change,” effective December 2010.

(c) The Board shall be notified in writing within 10 days of any change in the consultant pharmacist of record using an original Form DH-MQA 1184, “Change of Consultant Pharmacist of Record,” effective December 2010.

(b)(d)The Board recognized the following types of Special Pharmacy permits:

1. A Special Limited Community Permit is required for any may be obtained by an 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 to provide 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) Facility/Mentally Retarded (ICF-MR’s) 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 a type of special 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 pharmacies to compounds patient specific parenteral/enteral preparations in conjunction with institutional pharmacy permits, as provided in Rule 64B16-28.560, F.A.C., provided requirements set forth herein are satisfied.

6. No change.

(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 1220, “Special Pharmacy Permit Application and Information,” Rev 01/18 effective August 2012.  (a) Applicants for an Internet Pharmacy Permit must: 1. cComply with all permitting requirements found in subsection (1), of this rule; and, 2. dDesignate a prescription department manager or consultant pharmacist of record as required by Section 465.0197, F.S.

(b) As set forth in Section 465.0197, F.S., the permittee shall notify the board within 30 days of any change of location, corporate officers, and the pharmacist serving as the prescription department manager using an original Form DH-MQA PH10, “Prescription Department Manager Change,” effective December 2010.

(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 Rule 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  effective May 2013, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-       03142.

(a) All applicants that hold an active pharmacy permit that are currently engaged in sterile compounding have 180 days from the effective date of this amendment (eff. 9/23/13) to obtain a Special Sterile Compounding Permit. All pharmacies, which obtain the permit within the 180 days, on or before March 21, 2014, are exempt from paying an additional application or license fee.

(b) Applicants for a Special Sterile Compounding Permit must: 1. cComply with all permitting requirements in subsection (1), of this rule, and 2. dDesignate a prescription department manager or consultant pharmacist of record.

(c) The permittee and the newly designated prescription department manager of record or consultant pharmacist of record shall notify the board within 10 days of any change in the prescription department manager or consultant pharmacists of record on FORM DH-MQA PH10, “Prescription Department Manager Change,” effective December 2010 or FORM DH-MQA 1184, “Change of Consultant Pharmacist of Record.”

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 456.013, 456.025(3), 456.0635, 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,                      .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Pharmacy

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 6, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 12, 2017