The Board proposes the rule amendment to clarify language regarding registered pharmacy technician to pharmacist ratio.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-27.410Registered Pharmacy Technician to Pharmacist Ratio

PURPOSE AND EFFECT: The Board proposes the rule amendment to clarify language regarding registered pharmacy technician to pharmacist ratio.

SUMMARY: Language regarding registered pharmacy technician to pharmacist ratio will be clarified.

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 Committee meetings and Board meetings, 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, 465.014, 465.017, 465.022 FS.

LAW IMPLEMENTED: 465.014, 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: Allison Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C08, Tallahassee, Florida 32399-3258 or by email at [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-27.410 Registered Pharmacy Technician to Pharmacist Ratio.

(1) General Conditions. When the pharmacist delegates tasks to a registered pharmacy technician, such delegation must enhance the ability of the pharmacist to practice pharmacy to serve the patient population. A pharmacist shall not supervise more than one (1) registered pharmacy technician nor shall a pharmacy allow a supervision ratio of more than one (1) registered pharmacy technician to one (1) pharmacist (1:1), unless the pharmacy is in full compliance with the following guidelines specifically authorized to do so pursuant to the provisions of this rule.

(2) Required Documentation. Regardless of the technician ratio, Eevery pharmacy, pharmacist, Prescription Department Manager (PDM) and Consultant Pharmacist (CP) that employs or utilizes registered pharmacy technicians in a ratio greater than (1:1) must comply with the following conditions:

(a) Establish and maintain a written Policy and Procedures Manual regarding the number of registered pharmacy technician positions and their utilization that includes the specific scope of delegable tasks of the technicians, job descriptions, and task protocols. The Policy and Procedures Manual or Manuals must include policies and the procedures for implementing the policies for each category enumerated below:

1. through 3. No change.

4. General duties and responsibilities of the registered pharmacy technicians as per Florida law and Rule 64B16-27.420;

5. All functions related to prescription processing;

6. All functions related to prescription legend drug and controlled substance ordering and inventory control, including procedures for documentation and recordkeeping;

7. All functions related to retrieval of prescription files, patient files, patient profile information and other records pertaining to the practice of pharmacy;

8. All delegable tasks and non-delegable tasks as enumerated in Rule 64B16-27.420, F.A.C.;

5. 9. Confidentiality Confidentially and privacy laws and rules;

10. Prescription refill and renewal authorization;

11. Registered pharmacy technician functions related to automated pharmacy systems; and,

6. 12. No change.

(b) through (c) No change.

(3) No change.

(4) Three to One (3:1) Ratio: Any pharmacy or any pharmacist engaged in sterile compounding shall not exceed a ratio of up to three (3) registered pharmacy technicians to one (1) pharmacist (3:1). The 3:1 ratio only applies to pharmacists and technicians engaged in sterile compounding, and does not affect the technician ratios for other activities not involving sterile compounding in areas of the pharmacy physically separated from the area in which sterile compounding activities take place.

(5) Six to One (6:1) Ratio: Any pharmacy or any pharmacist may allow a supervision ratio of up to six (6) registered pharmacy technicians to one (1) pharmacist (6:1), as long as the pharmacist or registered pharmacy technicians are not engaged in sterile compounding.

(6) Eight to One (8:1) Ratio:

(a) Non-dispensing pharmacies. Any pharmacy which does not dispense medicinal drugs, and the pharmacist(s) employed by such pharmacy, may allow a supervision ratio of up to eight (8) registered pharmacy technicians to one (1) pharmacist (8:1), as long as the pharmacist or registered pharmacy technicians are not engaged in sterile compounding.

(b) Dispensing pharmacies. A pharmacy which dispenses medicinal drugs may utilize an eight to one (8:1) ratio in any physically separate area of the pharmacy from which medicinal drugs are not dispensed. A “physically separate area” is a part of the pharmacy which is separated by a permanent wall or other barrier which restricts access between the two areas.

(4)(7) The determination of the appropriate pharmacist-technician supervision ratio shall be made by the supervising pharmacist Prescription Department Manager or Consultant Pharmacist of Record. No other person, permittee, or licensee shall interfere with the exercise of the supervising pharmacist Prescription Department Manager or Consultant Pharmacist of Record’s independent professional judgment in setting the pharmacist to technician ratio(s).

Rulemaking Authority 465.005, 465.014, 465.017, 465.022 FS. Law Implemented 465.014, 465.022 FS. History–New 2-14-77, Amended 3-31-81, Formerly 21S-4.02, Amended 8-31-87, Formerly 21S-4.002, Amended 9-9-92, Formerly 21S-27.410, 61F10-27.410, Amended 1-30-96, Formerly 59X-27.410, Amended 2-23-98, 10-15-01, 1-1-10, 1-7-15, 7-6-15, 5-8-18, 1-16-19,                             .

 

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 15, 2023

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 24, 2023