The Board proposes the rule promulgation to create a rule for a Class III Institutional Pharmacy Permit as required by Chapter 2018-95, Laws of Florida.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.750Class III Institutional Pharmacies.

PURPOSE AND EFFECT: The Board proposes the rule promulgation to create a rule for a Class III Institutional Pharmacy Permit as required by Chapter 2018-95, Laws of Florida.

SUMMARY: A rule will be promulgated for Class III Institutional Pharmacy Permits.

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: 465.019(2)(d), 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:

64B16-28.750 Class III Institutional Pharmacies.

(1)(a) Class III Institutional Pharmacies are those Institutional Pharmacies authorized by section 465.019(2)(d), F.S.  All Class III Institutional Pharmacies must be affiliated with a hospital.  An Institutional Pharmacy may hold only a Class III Institutional Pharmacy Permit, or may hold a Class III Institutional Permit in conjunction with other permits authorized by Florida statute or administrative rule.

(b) A Class III Institutional Permit may be issued to existing Class II or Modified Class II Institutional Pharmacy Permittees or as an initial permit to new pharmacy facilities meeting the statute’s requirements or Central Distribution Facilities under common control with a hospital.

(2)  Change of Association for Existing Permittees.  Institutional Pharmacies affiliated with a hospital currently holding Class II or Modified Class II Institutional Pharmacy Permits may request the facility be associated as a Class III Institutional Pharmacy Permit by completing Form DH5033-MQA, 08/2018, “Change of Permit Association – Class III Pharmacy,” Rev 06/2018, which is incorporated by reference and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-       .  Upon approval of the request, the existing Class II or Modified Class II permit will be re-associated as a Class III Institutional Pharmacy Permit, with no change of permit number.  Because pharmacy permits are non-transferrable, this option is not available if there is any change in the ownership or identity of the business entity holding the existing Class II or Modified Class II Institutional Pharmacy Permit.

(3)(a) New Class III Permits.  Applicants for a new Class III Institutional Pharmacy permit must complete an application for a permit using an original Form DH5032-MQA, 08/2018, “Class III Institutional Pharmacy Permit Application and Information,” Rev 06/18, which is incorporated by reference herein and is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-       .  Applicants for an Institutional Pharmacy Permit must designate a consultant pharmacist of record as required by Section 465.019, F.S. and Rule 64B16-28.501, F.A.C.

(b) A copy of the permittee’s policy and procedure manual as provided herein shall accompany the permit application. The original policy and procedure manual shall be kept within the Class III Institutional Pharmacy and shall be available for inspection by the Department of Health or authorized representative of the Board.

(5)(a) The policy and procedure manual of facilities which are issued or re-associated as a Class III Institutional Permit shall, at a minimum, include the following:

1. The process for designation of the consultant pharmacist responsible for pharmaceutical services, including maintenance of drug records required by law and drug handling procedures.

2. Safe practices for the preparation, dispensing, prepackaging, distribution, and transportation of medicinal drugs and prepackaged drug products.

3. Provisions for maintaining records to monitor the movement, dispensing, distribution, and transportation of medicinal drugs and prepackaged drug products.

4. Provisions for maintaining records of pharmacy staff responsible for each step in the preparation, dispensing, prepackaging, transportation, and distribution of medicinal drugs and prepackaged drug products.

5. Identification of medicinal drugs and prepackaged drug products that may not be safely distributed among Class III Institutional Pharmacies and health care establishment permittees.

6. If an Institutional Formulary system is to be adopted and used, the policies and procedures for the development and approval of the system.

7. The establishment of a Pharmacy Services Committee which shall meet at least annually.

8. Provisions for the secure ordering, storage and recordkeeping of all medicinal drugs at the facility.

9. Provisions for the utilization of a perpetual inventory system for all controlled substances.

10. Provisions to ensure prepackaged drug products are not adulterated and are free of contamination or cross-contamination.

11. Provisions to ensure medicinal drugs and prepackaged drug products are transported according to manufacturer’s recommended guidelines for storage and transportation, including exposure to light, heat, etc.

12. Provisions regarding compliance with all state and Federal laws, regulations, and rules regarding controlled substances, including ordering, inventory and anti-diversion mechanisms.

13. Provisions regarding the labeling of medicinal drugs and prepackaged drug products, including, if applicable, labels related to transfers between Class III pharmacies, transportation requirements, or safe handling/hazardous precautions.

(b) The Class III Institutional Pharmacy’s policies and procedures shall be based upon authoritative literature, studies, and materials generally accepted and commonly relied upon by the Pharmacy and pharmaceutical professions, which must be identified in the policies and procedures.

(c) In addition to the policies and procedures manual, the Class III Institutional Pharmacy shall create and maintain documentation of: the hospital with which the permittee is affiliated; all other Class III Institutional Pharmacy Permits under common control with the permittee; all health care clinic establishments under common control with the permittee; and the way/manner in which the permittee and other entities are under common control.   Such documentation shall be maintained by the permittee and shall be available for review by a Department Inspector or authorized agent of the Board.

(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.

(6)  As required by Rule 64B16-28.100(1)(c), F.A.C., prior to issuance of a Class III Institutional Pharmacy Permit, the applicant must pass an on-site inspection.  For applicants who currently hold Institutional Class II or Modified Class II permits, the on-site inspection required for issuance of the Class III permit shall be coordinated, to the extent practicable, with any other inspections required or recently conducted, and in no event, shall reset or disrupt the permittee’s existing inspection schedule.

(7) Each applicant must comply with the fingerprinting requirements of section 465.022, F.S., unless the applicant qualifies for the statutory exception for corporations having more than $100 million of business taxable assets in Florida.  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, unless the applicant is a corporation having more than $100 million of business taxable assets in Florida.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.019(2)(d), 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 12, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 20, 2018