For Rule 27.410, the Board proposes the rule amendment to update the rule regarding the registered pharmacy technician to pharmacist ratio and to restructure and revise existing requirements in order to make the rule easier to understand and apply. ...

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NOS.:RULE TITLES:

64B16-27.410Registered Pharmacy Technician to Pharmacist Ratio

64B16-27.420Pharmacy Technician - Delegable and Non-Delegable Tasks

PURPOSE AND EFFECT: For Rule 27.410, F.A.C. the Board proposes the rule amendment to update the rule regarding the registered pharmacy technician to pharmacist ratio and to restructure and revise existing requirements in order to make the rule easier to understand and apply. For Rule 27.420, F.A.C., the Board proposes the rule amendment to reorganize existing rule requirements in order to make the rule easier to understand.

SUMMARY: For Rule 27.410, F.A.C., the registered pharmacy technician to pharmacist ratio will be updated and the rule will be made easier to understand and apply by restructuring and revising existing requirements. For Rule 27.420, the rule will be made easier to understand by reorganizing existing rule requirements.

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: For Rule 27.410, F.A.C., the proposed amendments restructure and revise existing requirements, which will make the rule more comprehensible and easier to apply, which the Board believes shall reduce regulatory costs and burdens. In addition, the proposed amendments will allow certain additional pharmacies to utilize a 6:1 technician ratio, which will result in cost savings to small businesses, regulated entities, and government. For Rule 27.420, F.A.C., the proposed amendments reorganize existing rule provisions to increase clarity and readability. Since the proposed amendments do not impose any new or additional requirements, the amendments will not impose any costs on small business, regulated entities, or government.

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, 456.069(1), 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 #C04, Tallahassee, Florida 32399-3254.

 

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 greater than one (1) registered pharmacy technician nor shall a pharmacy allow a supervision ratio of more greater than one (1) registered pharmacy technician to one (1) pharmacist (1:1), unless specifically authorized to do so pursuant to the provisions of this rule.

(2)(1) Required Documentation. General Conditions: Regardless of the technician ratio, every pharmacy, pharmacist, Prescription Department Manager (PDM) and or Consultant Pharmacist (CP) that employs or utilizes registered pharmacy technicians 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 12. No change.

(b) Establish and maintain documentation that is signed by the registered pharmacy technician acknowledging the technician has reviewed the Policy and Procedures Manual(s). Compliance with this paragraph must be achieved by April 1, 2015, or within ninety (90) days from the date the registered pharmacy technician is hired. Each registered pharmacy technician shall have 90 days from the effective date of this rule, [January 7, 2015], to comply with this provision and all registered pharmacy technicians hired subsequent to this rule’s effective date shall have ninety (90) days from the date of hire.

(c) Establish and maintain documentation that demonstrates the registered pharmacy technician has received training is knowledgeable in the established job description, delegable tasks, task protocols, and policy and procedures in the specific pharmacy setting where the delegable tasks will be performed. Documentation shall consist of one of the following items:

1. Certification by the supervising licensee;

2. Certification by an instructor, trainer, or other similar person;

3. Training attendance logs or completion certificates, accompanied by an outline of the materials addressed; or

4. Exam or written questionnaires.

(3)(2) The Policy and Procedures Manual(s) required by paragraph (2)(a)(1) must be maintained on-site where the pharmacy technician will perform the delegable tasks and must be available during a Department inspection or at the request of the Board of Pharmacy.  However, any and all documentation required by paragraphs (2)(1)(b) and (c) must be maintained and must be provided to the Board of Pharmacy or a Department inspector within 72 hours of a request.

(4)(3) Three to One (3:1) Ratio: Any pharmacy or any pharmacist engaged in Registered pharmacy technicians assisting with delegable tasks involving sterile compounding shall not exceed a ratio of up to three (3) registered pharmacy technicians to one (1) pharmacist (3:1).

(5)(4) Four to One (4:1) Ratio: Any pharmacy pharmacist or any pharmacist pharmacy may allow a supervision ratio of up to four (4) registered pharmacy technicians to one (1) pharmacist (4:1), as long as the pharmacist or pharmacy is not engaged in delegable tasks do not involve sterile compounding.

(6)(5) Six to One (6:1) Ratio:

(a) Non-dispensing pharmacies. Any A pharmacy which does not dispense medicinal drugs, and the pharmacist(s) employed by such pharmacy, may allow a supervision ratio of up to six (6) registered pharmacy technicians to one (1) pharmacist (6:1), as long as the pharmacy or pharmacist is not involved in delegable tasks do not involve sterile compounding.

(b) Dispensing pharmacies. A pharmacy which dispenses medicinal drugs may utilize a six to one (6:1) 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.

Rulemaking Authority 465.005, 456.069(1), 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,_____.

 

64B16-27.420 Pharmacy Technician – Delegable and Non-Delegable Tasks.

A pharmacy technician may only assist a pharmacist in executing or carrying out the practice of the profession of pharmacy, but shall never themselves engage in the practice of the profession of pharmacy as defined in Chapter 465, F.S. Therefore, pharmacy technicians may only perform delegable tasks as identified and defined pursuant to this rule.

(1) Definition of Delegable Tasks. – Delegable tasks are those tasks that are performed pursuant to a pharmacist’s direction, without the exercise of the pharmacy technician’s own judgment and discretion, and which do not require the pharmacy technician to exercise the independent professional judgment that is the foundation of the practice of the profession of pharmacy. The following tasks are delegable:

(2) Delegable Tasks – The following tasks are delegable:

(a) through (l) No change.

(2)(3) Non-Delegable Tasks – The following tasks may not be delegated and the pharmacy technician shall not:

(a) through (k) No change.

Rulemaking Authority 465.005, 465.014 FS. Law Implemented 465.014 FS. History–New 8-31-87, Formerly 21S-4.0025, Amended 7-30-91, Formerly 21S-27.420, 61F10-27.420, 59X-27.420, Amended 2-23-98, 1-1-10, 8-26-12, 2-5-15,____________.

 

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 10, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: February 27, 2015