Fla. Admin. Code R. 64B16-27.410

Current through Reg. 50, No. 253; December 31, 2024

Section 64B16-27.410 - Guidelines for Pharmacist Supervision of More than One Registered Pharmacy Technician

(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 specifically authorized to do so pursuant to the provisions of this rule.

(2) Required Documentation. Every pharmacy or pharmacist 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. Supervision by a pharmacist;

2. Minimum qualifications of the registered pharmacy technician as established by statute and rule;

3. In-service education or on-going training and demonstration of competency specific to the practice site and job function;

4. General duties and responsibilities of the registered pharmacy technicians;

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.;

9. Confidentiality and privacy laws and rules;

10. Prescription refill and renewal authorization;

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

12. Continuous Quality Improvement Program.

(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 7, 2015, or within ninety (90) days from the date the registered pharmacy technician is hired.

(c) Establish and maintain documentation that demonstrates the registered pharmacy technician has received training 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) The Policy and Procedures Manual(s) required by paragraph (2)(a), must be maintained onsite 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)(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) 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.

(7) Any closed-door pharmacy may allow a supervision ratio of up to 12:1. For purposes of this section a closed-door pharmacy is a pharmacy that provides specialized services and is not open to the general public.

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

Fla. Admin. Code Ann. R. 64B16-27.410

Rulemaking Authority 465.005, 465.014, 465.017, 465.022 FS. Law Implemented 465.014, 465.022 FS.

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, Amended by Florida Register Volume 40, Number 247, December 23, 2014, effective 1/7/2015, Amended by Florida Register Volume 41, Number 121, June 23, 2015 effective 7/6/2015, Amended by Florida Register Volume 44, Number 080, April 24, 2018 effective 5/8/2018, Amended by Florida Register Volume 45, Number 001, January 2, 2019 effective 1/16/2019, Amended by Florida Register Volume 50, Number 231, November 26, 2024 effective 12/12/2024.