The Board proposes the rule promulgation to provide a single rule for permitting of pharmacies by combining the permitting rules into one rule and to incorporate new applications.

 

DEPARTMENT OF HEALTH
Board of Pharmacy

RULE NO.: RULE TITLE:
64B16-28.100: Pharmacy Permits - Applications and Permitting

PURPOSE AND EFFECT: The Board proposes the rule promulgation to provide a single rule for permitting of pharmacies by combining the permitting rules into one rule and to incorporate new applications.

SUMMARY: A new rule will be created to provide a single rule for permitting of pharmacies.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COST AND LEGISLATIVE RATIFICATION:

During discussion of the economic impact of the rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Cost (SERC) was not necessary and that the rule amendment will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time. The Board has determined that this rule will not have an adverse impact on small business, or likely increase regulatory costs in excess of $200,000 in the aggregate within 1 year after implementation of the rule.

Any person who wishes to provide information regarding the statement of estimated costs, or to provide a proposal for a lower regulatory cost 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), 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 FAW.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Mark Whitten, Executive Director, Board of Pharmacy/MQA, 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 section addresses the application and permitting requirements of business establishments regulated under Chapter 465, F.S. Any 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 board’s website at 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.com. The application must be accompanied with a $250 initial permit fee, payable to the Board.

(1) All Permits: A permit is valid only for the name and 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.

(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 on the board’s website at http://www.doh.state.fl.us/mqa/pharmacy.

(c) Each applicant must file with the board a legible set of fingerprint cards and a $48 fee for each person who submits an application meeting the requirements in Section 465.022(3), F.S. An applicant may register demographic information and purchase fingerprint cards (FD-258) at 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.

(d) Passing an on-site inspection is a prerequisite to issuance of a new permit, whether based on an initial application, change of ownership, or change of address. At the time of the on-site inspection, the board inspector will document the applicant’s compliance with all applicable rules and statutes.

(e) 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.

(2) 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,” effective October 2011 which is incorporated by reference herein.

(a) Applicants for a Community Pharmacy Permit must:

1. Comply with all permitting requirement found in paragraph (1) of this rule; and

2. Designate a prescription department manager as required by Section 465.018, Florida Statutes;

(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.

(3) 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 a Institutional Pharmacy permit must complete an application for a permit using an original Form DH-MQA 1215, “Institutional Permit Application and Information,” effective December 2010, which is incorporated by reference herein.

(a) Applicants for an Institutional Pharmacy Permit must:

1. Comply with all permitting requirement found in paragraph (1) of this rule; and

2. Designate a consultant pharmacist of record as required by Section 465.019, Florida Statutes;

(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, “Consultant Pharmacist of Record Change Form,” effective December 2010, which is incorporated by reference herein.

(4) 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,” effective December 2010, which is incorporated by reference herein.

(a) Applicants for an Nuclear Pharmacy Permit must:

1. Comply with all permitting requirement found in subsection (1) of this rule; and

2. Designate a nuclear pharmacist of record as required by Section 465.0193, Florida Statutes;

(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.

(5) Special Pharmacy Permits as authorized in Section 465.0196, F.S., is required for any location where medicinal drugs are compounded, dispensed, stored, or sold and which 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,” effective December 2010, which is incorporated by reference herein.

(a) Applicants for a Special Pharmacy Permit must:

1. Comply with all permitting requirement found in paragraph (1) of this rule; and

2. Designate a prescription department manager or consultant pharmacist of record as required by Section 465.0196, Florida Statutes;

(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.

(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, “Consultant Pharmacist of Record Change Form,” effective December 2010, which is incorporated by reference herein.

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

1. Special Limited Community Permit 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. Special Parenteral and Enteral Permit is required 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. Special Closed System Pharmacy Permit is not open to the public and prescriptions are individually prepared for dispensing utilizing closed delivery systems, for ultimate consumers in health care institutions including nursing homes, jails, ALF’s, Intermediate Care 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. Special Pharmacy – End Stage Renal Disease (ESRD) Permit is 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. Special Pharmacy – Parenteral/Enteral Extended Scope Permit is required for pharmacies to compound patient specific parenteral/enteral preparations in conjunction with institutional pharmacy permits, provided requirements set forth herein are satisfied.

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) 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,” effective December 2010, which is incorporated by reference herein.

(a) Applicants for an Internet Pharmacy Permit must:

1. Comply with all permitting requirement found in paragraph (1) of this rule; and

2. Designate a prescription department manager or consultant pharmacist of record as required by Section 465.0197, Florida Statutes;

(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, which is incorporated by reference herein.

(7) Non-Resident Pharmacy Registration as authorized by Section 465.0156, F.S., is required for those pharmacies located outside the state and which ships, mails, or delivers a dispensed medicinal drug into this state. Applicants for a Non-Resident Registration must complete an application for a registration using an original Form DH-MQA 1217, “Non-Resident Pharmacy Permit Application and Information,” effective December 2010, which is incorporated by reference herein. Applicants for registration as a non-resident pharmacy must comply with all requirements found in Section 465.0156, F.S.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 456.013, 456.025(3), 465.018, 465.019, 465.0193, 465.0196, 465.0197, 465.022 FS. History–New________.

 

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: June 8, 2011

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: September 30, 2011