Fla. Admin. Code Ann. R. 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).
Notes
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, 1-7-15, 7-6-15, 5-8-18, 1-16-19.
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